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Sample records for cardiovascular outcome trial

  1. Effect of antioxidant vitamin supplementation on cardiovascular outcomes: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yizhou Ye

    Full Text Available BACKGROUND: Antioxidant vitamin (vitamin E, beta-carotene, and vitamin C are widely used for preventing major cardiovascular outcomes. However, the effect of antioxidant vitamin on cardiovascular events remains unclear. METHODOLOGY AND PRINCIPAL FINDINGS: We searched PubMed, EmBase, the Cochrane Central Register of Controlled Trials, and the proceedings of major conferences for relevant literature. Eligible studies were randomized controlled trials that reported on the effects of antioxidant vitamin on cardiovascular outcomes as compared to placebo. Outcomes analyzed were major cardiovascular events, myocardial infarction, stroke, cardiac death, total death, and any possible adverse events. We used the I(2 statistic to measure heterogeneity between trials and calculated risk estimates for cardiovascular outcomes with random-effect meta-analysis. Independent extraction was performed by two reviewers and consensus was reached. Of 293 identified studies, we included 15 trials reporting data on 188209 participants. These studies reported 12749 major cardiovascular events, 6699 myocardial infarction, 3749 strokes, 14122 total death, and 5980 cardiac deaths. Overall, antioxidant vitamin supplementation as compared to placebo had no effect on major cardiovascular events (RR, 1.00; 95%CI, 0.96-1.03, myocardial infarction (RR, 0.98; 95%CI, 0.92-1.04, stroke (RR, 0.99; 95%CI, 0.93-1.05, total death (RR, 1.03; 95%CI, 0.98-1.07, cardiac death (RR, 1.02; 95%CI, 0.97-1.07, revascularization (RR, 1.00; 95%CI, 0.95-1.05, total CHD (RR, 0.96; 95%CI, 0.87-1.05, angina (RR, 0.98; 95%CI, 0.90-1.07, and congestive heart failure (RR, 1.07; 95%CI, 0.96 to 1.19. CONCLUSION/SIGNIFICANCE: Antioxidant vitamin supplementation has no effect on the incidence of major cardiovascular events, myocardial infarction, stroke, total death, and cardiac death.

  2. Interpretation of cardiovascular outcome trials in type 2 diabetes needs a multiaxial approach.

    Science.gov (United States)

    Johansen, Odd Erik

    2015-08-10

    In cardiovascular (CV) diabetology a "one-size fits-all" approach needs caution as vasculopathy and CV manifestations in patients with type 2 diabetes (T2D) with short disease duration are different as compared to those with longer duration. This is of relevance when interpreting results of CV outcome trials as responses to any intervention aimed to reduce CV risk might be different in patients with established vasculopathy as compared to those without, where also the duration of the intervention may play a role. Additionally, the mode-of-action of the intervention and its assumed time to peak CV risk modulation need to be taken into account: an intervention with possibly immediate effects, like on blood pressure or other direct functional dynamic parameters such as endothelial function or renal hemodynamics, could likely provide a meaningful impact on CV outcomes over a shorter time span than interventions that primarily target pathways that work on atherosclerotic processes, organ-remodelling, or vessel integrity. We are now faced with CV outcome results to interpret from a plethora of outcomes trials in T2D, some of which are testing the CV risk modulation predominantly beyond glucose lowering, e.g., as is the case for several trials testing the newer therapy classes di-peptidyl peptidase-4 inhibitors, glucagon-like protein-1 receptor analogues and sodium glucose co-transporter-2 inhibitors, and this paper reviews the data that support a call for a multiaxial approach to interpret these results.

  3. Interpretation of cardiovascular outcome trials in type 2diabetes needs a multiaxial approach

    Institute of Scientific and Technical Information of China (English)

    2015-01-01

    In cardiovascular (CV) diabetology a "one-size fitsall"approach needs caution as vasculopathy and CVmanifestations in patients with type 2 diabetes (T2D)with short disease duration are different as comparedto those with longer duration. This is of relevance wheninterpreting results of CV outcome trials as responsesto any intervention aimed to reduce CV risk might bedifferent in patients with established vasculopathy ascompared to those without, where also the durationof the intervention may play a role. Additionally, themode-of-action of the intervention and its assumedtime to peak CV risk modulation need to be takeninto account an intervention with possibly immediateeffects, like on blood pressure or other direct functionaldynamic parameters such as endothelial function orrenal hemodynamics, could likely provide a meaningfulimpact on CV outcomes over a shorter time span thaninterventions that primarily target pathways that workon atherosclerotic processes, organ-remodelling, orvessel integrity. We are now faced with CV outcomeresults to interpret from a plethora of outcomes trials inT2D, some of which are testing the CV risk modulationpredominantly beyond glucose lowering, e.g. , as isthe case for several trials testing the newer therapyclasses di-peptidyl peptidase-4 inhibitors, glucagonlikeprotein-1 receptor analogues and sodium glucoseco-transporter-2 inhibitors, and this paper reviews thedata that support a call for a multiaxial approach tointerpret these results.

  4. BP, Cardiovascular Disease, and Death in the Folic Acid for Vascular Outcome Reduction in Transplantation Trial

    Science.gov (United States)

    John, Alin; Weir, Matthew R.; Smith, Stephen R.; Hunsicker, Lawrence; Kasiske, Bertram L.; Kusek, John W.; Bostom, Andrew; Ivanova, Anastasia; Levey, Andrew S.; Solomon, Scott; Pesavento, Todd; Weiner, Daniel E.

    2014-01-01

    The optimal BP level in kidney transplant recipients remains uncertain. This post hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) trial cohort assessed associations of BP with a pooled cardiovascular disease (CVD) outcome and with all-cause mortality. In 3474 prevalent kidney transplant patients, mean age was 52±9 years, 63% were men, 76% were white, 20% had a history of CVD, 40% had a history of diabetes mellitus, and the median time since transplant was 4.1 years (25th to 75th percentiles, 1.7–7.4); mean systolic BP was 136±20 mmHg and mean diastolic BP was 79±12 mmHg. There were 497 CVD events and 406 deaths. After adjustment for demographic and transplant characteristics and CVD risk factors, each 20-mmHg increase in baseline systolic BP associated with a 32% increase in subsequent CVD risk (hazard ratio [HR], 1.32; 95% confidence interval [95% CI], 1.19 to 1.46) and a 13% increase in mortality risk (HR, 1.13; 95% CI, 1.01 to 1.27). Similarly, after adjustment, at diastolic BP levels70 mmHg, there was no significant relationship between diastolic BP and outcomes. Higher systolic BP strongly and independently associated with increased risk of CVD and all-cause mortality, without evidence of a J shape, whereas only lower levels of diastolic BP associated with increased risk of CVD and death in this trial. PMID:24627349

  5. BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial.

    Science.gov (United States)

    Carpenter, Myra A; John, Alin; Weir, Matthew R; Smith, Stephen R; Hunsicker, Lawrence; Kasiske, Bertram L; Kusek, John W; Bostom, Andrew; Ivanova, Anastasia; Levey, Andrew S; Solomon, Scott; Pesavento, Todd; Weiner, Daniel E

    2014-07-01

    The optimal BP level in kidney transplant recipients remains uncertain. This post hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) trial cohort assessed associations of BP with a pooled cardiovascular disease (CVD) outcome and with all-cause mortality. In 3474 prevalent kidney transplant patients, mean age was 52±9 years, 63% were men, 76% were white, 20% had a history of CVD, 40% had a history of diabetes mellitus, and the median time since transplant was 4.1 years (25th to 75th percentiles, 1.7-7.4); mean systolic BP was 136±20 mmHg and mean diastolic BP was 79±12 mmHg. There were 497 CVD events and 406 deaths. After adjustment for demographic and transplant characteristics and CVD risk factors, each 20-mmHg increase in baseline systolic BP associated with a 32% increase in subsequent CVD risk (hazard ratio [HR], 1.32; 95% confidence interval [95% CI], 1.19 to 1.46) and a 13% increase in mortality risk (HR, 1.13; 95% CI, 1.01 to 1.27). Similarly, after adjustment, at diastolic BP levels70 mmHg, each 10-mmHg decrease in diastolic BP level associated with a 31% increase in CVD risk (HR, 1.31; 95% CI, 1.06 to 1.62) and a 31% increase in mortality risk (HR, 1.31; 95% CI, 1.03 to 1.66). However, at diastolic BP levels>70 mmHg, there was no significant relationship between diastolic BP and outcomes. Higher systolic BP strongly and independently associated with increased risk of CVD and all-cause mortality, without evidence of a J shape, whereas only lower levels of diastolic BP associated with increased risk of CVD and death in this trial.

  6. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease.

    Science.gov (United States)

    Green, Jennifer B; Bethel, M Angelyn; Paul, Sanjoy K; Ring, Arne; Kaufman, Keith D; Shapiro, Deborah R; Califf, Robert M; Holman, Rury R

    2013-12-01

    Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, lowers blood glucose when administered as monotherapy or in combination with other antihyperglycemic agents. TECOS will evaluate the effects of adding sitagliptin to usual diabetes care on cardiovascular outcomes and clinical safety. TECOS is a pragmatic, academically run, multinational, randomized, double-blind, placebo-controlled, event-driven trial recruiting approximately 14,000 patients in 38 countries who have type 2 diabetes (T2DM), are at least 50 years old, have cardiovascular disease, and have an hemoglobin A1c value between 6.5% and 8.0%. Eligible participants will be receiving stable mono- or dual therapy with metformin, sulfonylurea, or pioglitazone, or insulin alone or in combination with metformin. Randomization is 1:1 to double-blind sitagliptin or matching placebo, in addition to existing therapy in a usual care setting. Follow-up occurs at 4-month intervals in year 1 and then twice yearly until 1300 confirmed primary end points have occurred. Glycemic equipoise between randomized groups is a desired aim. The primary composite cardiovascular endpoint is time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina, with cardiovascular events adjudicated by an independent committee blinded to study therapy. TECOS is a pragmatic-design cardiovascular outcome trial assessing the cardiovascular effects of sitagliptin when added to usual T2DM management.

  7. Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial

    DEFF Research Database (Denmark)

    Kjøller, Erik; Hilden, Jørgen; Winkel, Per;

    2014-01-01

    UNLABELLED: The objective of this study is to describe the agreement between randomized trial outcome assessment by committee and outcomes entirely identified through public registers. METHODS: In the CLARICOR trial, 4,372 patients with stable coronary heart disease received a short course...... of Diseases-coded diagnoses of the public registries into the same categories. After cross-tabulation of the committee diagnoses with National Patient Register diagnoses and Register of Causes of Death, we calculate agreement and compare the estimated intervention effects of the 2 data sets. RESULTS...

  8. Impact of treatment with rosuvastatin and atorvastatin on cardiovascular outcomes: evidence from the Archimedes-simulated clinical trials

    Directory of Open Access Journals (Sweden)

    Colivicchi F

    2015-11-01

    Full Text Available Furio Colivicchi,1 Catarina Sternhufvud,2 Sanjay K Gandhi3 1Cardiology Division, Emergency Department, San Filippo Neri Hospital, ASL Roma E, Rome, Italy; 2Global Payer Evidence and Pricing, AstraZeneca R&D, Mölndal, Sweden; 3Global Health Economics and Outcomes Research, TEVA Pharmaceuticals, Frazer, PA, United States Objective: No clinical trials have been conducted to directly compare the effect of the two high-intensity statins, rosuvastatin and atorvastatin, on cardiovascular outcomes. However, three such trials have been computer-simulated using the Archimedes model, an individual-based simulation of human physiology and behaviors, treatment interventions, and health care systems. The results are reviewed here.Methods: The first simulated trial assessed clinical outcomes in patients receiving available doses of the two drugs. The second assessed the impact of initial treatment decisions, while the third assessed the effect of switching from rosuvastatin to atorvastatin.Results: In the first simulated trial, treatment with rosuvastatin was estimated to result in greater reductions than treatment with atorvastatin in major adverse cardiac event (MACE rates at 5 years and 20 years at all doses examined (relative risk [RR]: 0.897, 0.888, and 0.930 at 5 years for rosuvastatin 20 mg vs atorvastatin 40 mg, rosuvastatin 40 mg vs atorvastatin 80 mg, and rosuvastatin 20 mg vs atorvastatin 80 mg, respectively; all P<0.05. In the second simulated trial, outcomes were significantly better in patients initially prescribed rosuvastatin than in those initially prescribed atorvastatin (RR of MACE at 5 years: 0.918; P<0.001. In the third simulated trial, risk of MACE was significantly greater in patients switching from rosuvastatin to atorvastatin than in those remaining on rosuvastatin (RR at 5 years: 1.109; P<0.001.Conclusion: The results of these simulated clinical trials suggest improved outcomes among patients receiving rosuvastatin relative to

  9. Relationship of Albuminuria and Renal Artery Stent Outcomes: Results From the CORAL Randomized Clinical Trial (Cardiovascular Outcomes With Renal Artery Lesions).

    Science.gov (United States)

    Murphy, Timothy P; Cooper, Christopher J; Pencina, Karol M; D'Agostino, Ralph; Massaro, Joseph; Cutlip, Donald E; Jamerson, Kenneth; Matsumoto, Alan H; Henrich, William; Shapiro, Joseph I; Tuttle, Katherine R; Cohen, David J; Steffes, Michael; Gao, Qi; Metzger, D Christopher; Abernethy, William B; Textor, Stephen C; Briguglio, John; Hirsch, Alan T; Tobe, Sheldon; Dworkin, Lance D

    2016-11-01

    Randomized clinical trials have not shown an additional clinical benefit of renal artery stent placement over optimal medical therapy alone. However, studies of renal artery stent placement have not examined the relationship of albuminuria and treatment group outcomes. The CORAL study (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) is a prospective clinical trial of 947 participants with atherosclerotic renal artery stenosis randomized to optimal medical therapy with or without renal artery stent which showed no treatment differences (3(5.8% and 35.1% event rate at mean 43-month follow-up). In a post hoc analysis, the study population was stratified by the median baseline urine albumin/creatinine ratio (n=826) and analyzed for the 5-year incidence of the primary end point (myocardial infarction, hospitalization for congestive heart failure, stroke, renal replacement therapy, progressive renal insufficiency, or cardiovascular disease- or kidney disease-related death), for each component of the primary end point, and overall survival. When baseline urine albumin/creatinine ratio was ≤ median (22.5 mg/g, n=413), renal artery stenting was associated with significantly better event-free survival from the primary composite end point (73% versus 59% at 5 years; P=0.02), cardiovascular disease-related death (93% versus 85%; P≤ 0.01), progressive renal insufficiency (91% versus 77%; P=0.03), and overall survival (89% versus 76%; P≤0.01), but not when baseline urine albumin/creatinine ratio was greater than median (n=413). These data suggest that low albuminuria may indicate a potentially large subgroup of those with renal artery stenosis that could experience improved event-free and overall-survival after renal artery stent placement plus optimal medical therapy compared with optimal medical therapy alone. Further research is needed to confirm these preliminary observations.

  10. Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients: Primary Results from the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial

    Science.gov (United States)

    Bostom, Andrew G.; Carpenter, Myra A.; Kusek, John W.; Levey, Andrew S.; Hunsicker, Lawrence; Pfeffer, Marc A.; Selhub, Jacob; Jacques, Paul F.; Cole, Edward; Gravens-Mueller, Lisa; House, Andrew A.; Kew, Clifton; McKenney, Joyce L.; Pacheco-Silva, Alvaro; Pesavento, Todd; Pirsch, John; Smith, Stephen; Solomon, Scott; Weir, Matthew

    2015-01-01

    Background Kidney transplant recipients, like other patients with chronic kidney disease (CKD), experience excess risk of cardiovascular disease (CVD) and elevated total homocysteine (tHcy) concentrations. Observational studies of patients with CKD suggest increased homocysteine is a risk factor for CVD. The impact of lowering total homocysteine (tHcy) levels in kidney transplant recipients is unknown. Methods and Results In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing tHcy concentrations reduced the rate of the primary composite arteriosclerotic CVD outcome (myocardial infarction, stroke, CVD death, resuscitated sudden death, coronary artery or renal artery revascularization, lower extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n= 547 total events; hazards ratio [95% confidence interval] = 0.99 [0.84–1.17]), or secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86–1.26]) or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93–1.43]) compared to the low dose multivitamin. Conclusions Treatment with a high dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level. PMID:21482964

  11. Maintained intentional weight loss reduces cardiovascular outcomes

    DEFF Research Database (Denmark)

    Caterson, I D; Finer, N; Coutinho, W

    2012-01-01

    Aim: The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Methods: Overweight/obese...... change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although...... more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild...

  12. The Danish Cardiovascular Screening Trial (DANCAVAS)

    DEFF Research Database (Denmark)

    Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke

    2015-01-01

    /iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. TRIAL REGISTRATION: Current......) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. OBJECTIVE: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular...... events, and whether the possible health benefits are cost effective. OUTCOME: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). RANDOMIZATION: Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those...

  13. Excess pressure integral predicts cardiovascular events independent of other risk factors in the conduit artery functional evaluation substudy of Anglo-Scandinavian Cardiac Outcomes Trial.

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    Davies, Justin E; Lacy, Peter; Tillin, Therese; Collier, David; Cruickshank, J Kennedy; Francis, Darrel P; Malaweera, Anura; Mayet, Jamil; Stanton, Alice; Williams, Bryan; Parker, Kim H; McG Thom, Simon A; Hughes, Alun D

    2014-07-01

    Excess pressure integral (XSPI), a new index of surplus work performed by the left ventricle, can be calculated from blood pressure waveforms and may indicate circulatory dysfunction. We investigated whether XSPI predicted future cardiovascular events and target organ damage in treated hypertensive individuals. Radial blood pressure waveforms were acquired by tonometry in 2069 individuals (aged, 63±8 years) in the Conduit Artery Functional Evaluation (CAFE) substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). Measurements of left ventricular mass index (n=862) and common carotid artery intima media thickness (n=923) were also performed. XSPI and the integral of reservoir pressure were lower in people treated with amlodipine±perindopril than in those treated with atenolol±bendroflumethiazide, although brachial systolic blood pressure was similar. A total of 134 cardiovascular events accrued during a median 3.4 years of follow-up; XSPI was a significant predictor of cardiovascular events after adjustment for age and sex, and this relationship was unaffected by adjustment for conventional cardiovascular risk factors or Framingham risk score. XSPI, central systolic blood pressure, central augmentation pressure, central pulse pressure, and integral of reservoir pressure were correlated with left ventricular mass index, but only XSPI, augmentation pressure, and central pulse pressure were associated positively with carotid artery intima media thickness. Associations between left ventricular mass index, XSPI, and integral of reservoir pressure and carotid artery intima media thickness and XSPI were unaffected by multivariable adjustment for other covariates. XSPI is a novel indicator of cardiovascular dysfunction and independently predicts cardiovascular events and targets organ damage in a prospective clinical trial.

  14. LEADER 7 : Cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

    NARCIS (Netherlands)

    Rutten, Guy E H M; Tack, Cees J.; Pieber, Thomas R.; Comlekci, Abdurrahman; Ørsted, David Dynnes; Baeres, Florian M M; Marso, Steven P.; Buse, John B.

    2016-01-01

    Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. Methods: Baseline data, stratified for prior cardiovascular

  15. Predictors of cardiovascular events in a contemporary population with impaired glucose tolerance : an observational analysis of the Nateglinide and Valsartan in impaired glucose tolerance outcomes research (NAVIGATOR) trial

    NARCIS (Netherlands)

    Preiss, David; Thomas, Laine E.; Sun, Jie-Lena; Haffner, Steven M.; Holman, Rury R.; Standl, Eberhard; Leiter, Lawrence A.; Mazzone, Theodore; Rutten, Guy E.; Tognoni, Gianni; Martinez, Felipe A.; Chiang, Fu-Tien; Califf, Robert M.; McMurray, John J.

    2012-01-01

    Objectives: Risk factors for cardiovascular events are well established in general populations and those with diabetes but have been sparsely studied in impaired glucose tolerance (IGT). We sought to identify predictors of (1) a composite cardiovascular outcome (cardiovascular death, non-fatal myoca

  16. Serial Measurement of High Sensitivity Troponin I and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus in the EXAMINE Trial.

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Jarolim, Petr; Bakris, George L; Cushman, William C; Kupfer, Stuart; Gao, Qi; Mehta, Cyrus R; Zannad, Faiez; Cannon, Christopher P; Morrow, David A

    2017-02-28

    Background -We sought to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular (CV) outcomes. Methods -The Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) was a phase IIIb clinical outcomes trial designed to evaluate the CV safety of alogliptin, a non-selective dipeptidyl peptidase 4 (DPP-4) inhibitor. Patients with type 2 diabetes mellitus (T2DM), glycated hemoglobin between 6.5%-11% (or 7%-11% if they were on insulin), and a recent acute coronary syndrome (between 15-90 days prior to randomization) were eligible for the trial. hsTnI was measured using the Abbott ARCHITECT assay at baseline and 6 months in patients randomized in the EXAMINE trial. This analysis was restricted to patients randomized ≥30 days after qualifying ACS in order to mitigate the potential for persistent hsTnI elevation following ACS (n=3808). The primary endpoint of the trial was CV death, MI, or stroke. CV death or heart failure (HF) was a pre-specified, adjudicated secondary endpoint. Results -At baseline, hsTnI was detectable (≥1.9 ng/L) in 93% of patients and above the 99(th)% URL in 16%. There was a strong relationship between increasing hsTnI, both at baseline and 6 months, and the incidence of CV events through 24 months (pURL at 6 months were at increased risk of CV death, MI, or stroke when compared to patients with hsTnI URL irrespective of whether hsTnI was newly elevated (28.1% vs. 8.8%; HRadj 2.65, 95%CI 1.64-4.28, p<0.001) or persistently so (22.5% vs. 8.8%; HRadj 1.90, 95%CI 1.33-2.70, p<0.001). Alogliptin neither increased nor decreased the risk of CV events compared to placebo in patients with high baseline hsTnI (22.3% vs. 23.0%; HR 0.87, 95% CI 0.60-1.25 p=0.44). Conclusions -Serial assessment of hsTnI revealed a substantial proportion of patients with T2DM without clinically recognized events had dynamic or persistently elevated values and were at high risk of recurrent

  17. EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus.

    Science.gov (United States)

    Schernthaner, Guntram; Schernthaner-Reiter, Marie Helene; Schernthaner, Gerit-Holger

    2016-06-01

    During the last decade, the armamentarium for glucose-lowering drugs has increased enormously by the development of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, allowing individualization of antidiabetic therapy for patients with type 2 diabetes (T2DM). Some combinations can now be used without an increased risk for severe hypoglycemia and weight gain. Following a request of the US Food and Drug Administration, many large cardiovascular (CV) outcome studies have been performed in patients with longstanding disease and established CV disease. In the majority of CV outcome studies, CV risk factors were well controlled and a high number of patients were already treated with ACE inhibitors/angiotensin receptor blockers, statins and antiplatelet drugs. Most studies with insulin glargine and newer glucose-lowering drugs (saxagliptin, alogliptin, sitagliptin, lixisenatide) demonstrated safety of newer glucose-lowering agents but did not show superiority in the CV outcomes compared with placebo. By contrast, in the EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study, CV death, all-cause mortality, and hospitalization for heart failure were significantly decreased when empagliflozin was added instead of placebo to therapy for patients with high CV risk and T2DM already well treated with statins, glucose-lowering drugs, and blood pressure-lowering drugs as well as antiplatelet agents. In addition, renal endpoints including endstage renal disease were also significantly reduced when empagliflozin was added instead of placebo. Interestingly, the reduction of these clinically relevant end points was observed after a few months, making antiatherogenic effects an unlikely cause. The fact that the incidence of myocardial infarction (MI) and stroke were not reduced is in line with the hypothesis that hemodynamic factors in particular have contributed to the impressive improvement of the prognosis. To

  18. Influence of Cardiovascular and Noncardiovascular Co-morbidities on Outcomes and Treatment Effect of Heart Rate Reduction With Ivabradine in Stable Heart Failure (from the SHIFT Trial).

    Science.gov (United States)

    Böhm, Michael; Robertson, Michele; Ford, Ian; Borer, Jeffrey S; Komajda, Michel; Kindermann, Ingrid; Maack, Christoph; Lainscak, Mitja; Swedberg, Karl; Tavazzi, Luigi

    2015-12-15

    Incidence of chronic heart failure (HF) increases with age and cardiovascular (CV) morbidity. Co-morbidities increase hospitalization and mortality in HF, and non-CV co-morbidities may lead to preventable hospitalizations. We studied the impact of co-morbidities on mortality and morbidity in Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial, and investigated whether the impact of ivabradine was affected by co-morbidities. We analyzed the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trialpopulation, with moderate-to-severe HF and left ventricular dysfunction (in sinus rhythm with heart rate at rest ≥70 beats/min), according to co-morbidity: chronic obstructive pulmonary disease, diabetes mellitus, anemia, stroke, impaired renal function, myocardial infarction, hypertension, and peripheral artery disease. Co-morbidity load was classed as 0, 1, 2, 3, 4+ or 1 to 2 co-morbidities, or 3+ co-morbidities. Co-morbidities were evenly distributed between the placebo and ivabradine groups. Patients with more co-morbidities were likely to be older, women, had more advanced HF, were less likely to be on β blockers, with an even distribution on ivabradine 2.5, 5, or 7.5 mg bid and placebo at all co-morbidity loads. Number of co-morbidities was related to outcomes. Cardiovascular death or HF hospitalization events significantly increased (p 3 co-morbidities for both, ivabradine and placebo. There was no interaction between co-morbidity load and the treatment effects of ivabradine. Hospitalization rate was lower at all co-morbidity loads for ivabradine. In conclusion, cardiac and noncardiac co-morbidities significantly affect CV outcomes, particularly if there are >3 co-morbidities. The effect of heart rate reduction with ivabradine is maintained at all co-morbidity loads.

  19. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

    DEFF Research Database (Denmark)

    Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning;

    2009-01-01

    BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the comb...

  20. Acute effect of weight loss on levels of total bilirubin in obese, cardiovascular high-risk patients: an analysis from the lead-in period of the Sibutramine Cardiovascular Outcome trial

    DEFF Research Database (Denmark)

    Andersson, Charlotte; Weeke, Peter; Fosbøl, Emil Loldrup;

    2009-01-01

    Low levels of bilirubin are associated with an increased risk of cardiovascular adverse events. Weight reduction is known to reduce several cardiovascular risk factors, but effects on bilirubin levels have not been reported. We studied the response of weight loss therapy with sibutramine...... and lifestyle change on levels of total bilirubin in an overweight or obese, cardiovascular high-risk population. Data from the first 4 weeks of the lead-in period of the Sibutramine Cardiovascular Outcome study were analyzed. A total of 10 198 patients provided body weight measurements before and after 4 weeks......, respectively. At screening, bilirubin concentrations were similar between weight loss groups (around 11 micromol/L, P = .7) and increased linearly as a function of weight loss. The effect was significantly more pronounced in men compared with women (P for interaction = .003). Adjusted for multiple variables...

  1. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study

    Science.gov (United States)

    Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  2. Does pharmacotherapy improve cardiovascular outcomes in hemodialysis patients?

    Science.gov (United States)

    Mittal, Mayank; Aggarwal, Kul; Littrell, Rachel L; Agrawal, Harsh; Alpert, Martin A

    2015-10-01

    Cardiovascular disease (CVD) occurs commonly in patients with chronic kidney disease (CKD) including those treated with hemodialysis (HD), and is associated with poor outcomes in this population. Pharmacologic management of hypertension, dyslipidemia, acute and chronic coronary artery disease, and atrial fibrillation in the general population is supported by the results of high-quality, randomized, controlled clinical trials. Pharmacotherapy of these disorders in the general population is effective in improving clinical outcomes. In contrast, information concerning the effect of pharmacotherapy on mortality and cardiovascular outcomes in patients with CKD, and particularly in HD patients, is limited. Available data suggest that, in general, pharmacotherapy of hypertension and dyslipidemia, anti-platelet therapy of CVD, and anticoagulant therapy in patients with atrial fibrillation are less effective in HD patients than in the general population or even in patients with early stage of CKD.

  3. Pulse pressure is not an independent predictor of outcome in type 2 diabetes patients with chronic kidney disease and anemia--the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT).

    Science.gov (United States)

    Theilade, S; Claggett, B; Hansen, T W; Skali, H; Lewis, E F; Solomon, S D; Parving, H-H; Pfeffer, M; McMurray, J J; Rossing, P

    2016-01-01

    Pulse pressure (PP) remains an elusive cardiovascular risk factor with inconsistent findings. We clarified the prognostic value in patients with type 2 diabetes, chronic kidney disease (CKD) and anemia in the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin alfa) Therapy. In 4038 type 2 diabetes patients, darbepoetin alfa treatment did not affect the primary outcome. Risk related to PP at randomization was evaluated in a multivariable model including age, gender, kidney function, cardiovascular disease (CVD) and other conventional risk factors. End points were myocardial infarction (MI), stroke, end stage renal disease (ESRD) and the composite of cardiovascular death, MI or hospitalization for myocardial ischemia, heart failure or stroke (CVD composite). Median (interquartile range) age, gender, eGFR and PP was 68 (60-75) years, 57.3% women, 33 (27-42) ml min(-1) per 1.73 m2 and 60 (50-74) mm Hg. During 29.1 months (median) follow-up, the number of events for composite CVD, MI, stroke and ESRD was 1010, 253, 154 and 668. In unadjusted analyses, higher quartiles of PP were associated with higher rates per 100 years of follow-up of all end points (P⩽0.04), except stroke (P=0.52). Adjusted hazard ratios (95% confidence interval) per one quartile increase in PP were 1.06 (0.99-1.26) for MI, 0.96 (0.83-1.11) for stroke, 1.01 (0.94-1.09) for ESRD and 1.01 (0.96-1.07) for CVD composite. Results were similar in continuous analyses of PP (per 10 mm Hg). In patients with type 2 diabetes, CKD and anemia, PP did not independently predict cardiovascular events or ESRD. This may reflect confounding by aggressive antihypertensive treatment, or PP may be too rough a risk marker in these high-risk patients.

  4. Pulse pressure is not an independent predictor of outcome in type 2 diabetes patients with chronic kidney disease and anemia--the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT)

    DEFF Research Database (Denmark)

    Theilade, S; Claggett, B; Hansen, T W

    2016-01-01

    Pulse pressure (PP) remains an elusive cardiovascular risk factor with inconsistent findings. We clarified the prognostic value in patients with type 2 diabetes, chronic kidney disease (CKD) and anemia in the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin alfa) Therapy. In 4038......, CKD and anemia, PP did not independently predict cardiovascular events or ESRD. This may reflect confounding by aggressive antihypertensive treatment, or PP may be too rough a risk marker in these high-risk patients....

  5. Blood pressure changes associated with sibutramine and weight management - an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes trial (SCOUT)

    DEFF Research Database (Denmark)

    Sharma, A M; Caterson, I D; Coutinho, W

    2009-01-01

    of a cardiovascular event. During the 6-week lead-in period, 10,742 patients received sibutramine and weight management. Vital sign changes were assessed post hoc by initial blood pressure (mmHg) categorized as normal (high-normal (130 to hypertensive (>or=140/>or=90); weight change...... in the class of antihypertensive medication used and who did not report an increase in antihypertensive medication use were analysed. RESULTS: At entry, approximately 50% of patients were hypertensive and 26% were high-normal. In hypertensive patients, blood pressure changes (mmHg) decreased by median [5th, 95.......5 systolic [-15.0, 19.5] and 1.0 diastolic [-10.5, 13.0] (p hypertensive had a lower blood pressure category at end-point. Concomitant antihypertensive medication classes did not affect blood pressure...

  6. Niacin and statin combination therapy for atherosclerosis regression and prevention of cardiovascular disease events: reconciling the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial with previous surrogate endpoint trials.

    Science.gov (United States)

    Michos, Erin D; Sibley, Christopher T; Baer, Jefferson T; Blaha, Michael J; Blumenthal, Roger S

    2012-06-01

    Despite substantial risk reductions targeting low-density lipoprotein cholesterol with statins, there remains significant residual risk as evidenced by incident and recurrent cardiovascular disease (CVD) events among statin-treated patients. Observational studies have shown that low levels of high-density lipoprotein cholesterol (HDL-C) are associated with increased CVD risk. It remains unclear whether strategies aimed at increasing HDL-C in addition to background statin therapy will further reduce risk. The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial, which compared combined niacin/simvastatin with simvastatin alone, failed to demonstrate an incremental benefit of niacin among patients with atherosclerotic CVD and on-treatment low-density lipoprotein cholesterol values equivalents, or atherosclerosis. This viewpoint summarizes these imaging trials studying niacin and places them in the context of the failure of AIM-HIGH to support the HDL-C-increasing hypothesis.

  7. Assessing quality-of-life outcomes in cardiovascular clinical research.

    Science.gov (United States)

    Mark, Daniel B

    2016-05-01

    The field of quality-of-life (QOL) measurement grew out of attempts in the 1960s and 1970s to connect the ever-increasing levels of public expenditure on technology-based health care for chronic diseases with evidence of the benefits and harms to patients. Most of the concepts, methods, and standards for measuring QOL were derived from psychometrics, but the degree to which current tools adhere to these methods varies greatly. Despite the importance of QOL, patient-reported outcomes are not measured in most cardiovascular clinical trials. Lack of familiarity with QOL measures and their interpretation, and unrealistic expectations about the information these measures can provide, are obstacles to their use. Large clinical trials of revascularization therapy for coronary artery disease and medical treatments for heart failure show small-to-moderate QOL effects, primarily detected with disease-specific instruments. Larger treatment effects, seen in trials of device therapy for heart failure and ablation therapy for atrial fibrillation, have been detected with both generic and disease-specific instruments. A large gap remains between the parameters currently being measured in clinical research and the data needed to incorporate the 'patient's voice' into therapeutic decision-making.

  8. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

    DEFF Research Database (Denmark)

    Marso, Steven P; Daniels, Gilbert H; Brown-Frandsen, Kirstine;

    2016-01-01

    BACKGROUND: The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. METHODS: In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive ...

  9. Cardiovascular effects of dipeptidyl peptidase-4 inhibitors: from risk factors to clinical outcomes.

    Science.gov (United States)

    Scheen, André J

    2013-05-01

    Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) are oral incretin-based glucose-lowering agents with proven efficacy and safety in the management of type 2 diabetes mellitus (T2DM). In addition, preclinical data and mechanistic studies suggest a possible additional non-glycemic beneficial action on blood vessels and the heart, via both glucagon-like peptide-1-dependent and glucagon-like peptide-1-independent effects. As a matter of fact, DPP-4 inhibitors improve several cardiovascular risk factors: they improve glucose control (mainly by reducing the risk of postprandial hyperglycemia) and are weight neutral; may lower blood pressure somewhat; improve postprandial (and even fasting) lipemia; reduce inflammatory markers; diminish oxidative stress; improve endothelial function; and reduce platelet aggregation in patients with T2DM. In addition, positive effects on the myocardium have been described in patients with ischemic heart disease. Results of post hoc analyses of phase 2/3 controlled trials suggest a possible cardioprotective effect with a trend (sometimes significant) toward lower incidence of major cardiovascular events with sitagliptin, vildagliptin, saxagliptin, linagliptin, or alogliptin compared with placebo or other active glucose-lowering agents. However, the definite relationship between DPP-4 inhibition and better cardiovascular outcomes remains to be proven. Major prospective clinical trials involving various DPP-4 inhibitors with predefined cardiovascular outcomes are under way in patients with T2DM and a high-risk cardiovascular profile: the Sitagliptin Cardiovascular Outcome Study (TECOS) on sitagliptin, the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 trial on saxagliptin, the Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE) trial on alogliptin, and the Cardiovascular Outcome

  10. Water aerobics in pregnancy: cardiovascular response, labor and neonatal outcomes

    Directory of Open Access Journals (Sweden)

    Braga Angelica F

    2008-11-01

    Full Text Available Abstract Background To evaluate the association between water aerobics, maternal cardiovascular capacity during pregnancy, labor and neonatal outcomes. Methods A randomized, controlled clinical trial was carried out in which 34 pregnant women were allocated to a water aerobics group and 37 to a control group. All women were submitted to submaximal ergometric tests on a treadmill at 19, 25 and 35 weeks of pregnancy and were followed up until delivery. Oxygen consumption (VO2 max, cardiac output (CO, physical fitness, skin temperature, data on labor and delivery, and neonate outcomes were evaluated. Frequency distributions of the baseline variables of both groups were initially performed and then analysis of the outcomes was carried out. Categorical data were compared using the chi-square test, and numerical using Student's t or Mann-Whitney tests. Wilk's Lambda or Friedman's analysis of repeat measurements were applied for comparison of physical capacity, cardiovascular outcomes and maternal temperature. Results VO2 max and physical fitness were higher in both groups in the second trimester, returning to basal levels in the third trimester. In both groups, CO increased as pregnancy progressed and peak exercise temperature was higher than resting temperature, increasing further after five minutes of recovery and remaining at this level until 15 minutes after exercise completion. There was no difference between the two groups regarding duration (457.9 ± SD 249.6 vs 428.9 ± SD 203.2 minutes or type of delivery. Labor analgesia was requested by significantly fewer women in the water aerobics group (27% vs 65%; RR = 0.42 95%CI 0.23–0.77. Neonatal results were similar in both groups. Conclusion The regular practice of moderate water aerobics by sedentary and low risk pregnant women was not detrimental to the health of the mother or the child. There was no influence on maternal cardiovascular capacity, duration of labor or type of delivery; however

  11. Allopurinol and Cardiovascular Outcomes in Adults With Hypertension.

    Science.gov (United States)

    MacIsaac, Rachael L; Salatzki, Janek; Higgins, Peter; Walters, Matthew R; Padmanabhan, Sandosh; Dominiczak, Anna F; Touyz, Rhian M; Dawson, Jesse

    2016-03-01

    Allopurinol lowers blood pressure in adolescents and has other vasoprotective effects. Whether similar benefits occur in older individuals remains unclear. We hypothesized that allopurinol is associated with improved cardiovascular outcomes in older adults with hypertension. Data from the United Kingdom Clinical Research Practice Datalink were used. Multivariate Cox-proportional hazard models were applied to estimate hazard ratios for stroke and cardiac events (defined as myocardial infarction or acute coronary syndrome) associated with allopurinol use over a 10-year period in adults aged >65 years with hypertension. A propensity-matched design was used to reduce potential for confounding. Allopurinol exposure was a time-dependent variable and was defined as any exposure and then as high (≥300 mg daily) or low-dose exposure. A total of 2032 allopurinol-exposed patients and 2032 matched nonexposed patients were studied. Allopurinol use was associated with a significantly lower risk of both stroke (hazard ratio, 0.50; 95% confidence interval, 0.32-0.80) and cardiac events (hazard ratio, 0.61; 95% confidence interval, 0.43-0.87) than nonexposed control patients. In exposed patients, high-dose treatment with allopurinol (n=1052) was associated with a significantly lower risk of both stroke (hazard ratio, 0.58; 95% confidence interval, 0.36-0.94) and cardiac events (hazard ratio, 0.65; 95% confidence interval, 0.46-0.93) than low-dose treatment (n=980). Allopurinol use is associated with lower rates of stroke and cardiac events in older adults with hypertension, particularly at higher doses. Prospective clinical trials are needed to evaluate whether allopurinol improves cardiovascular outcomes in adults with hypertension.

  12. Circulating CD62E+ microparticles and cardiovascular outcomes.

    Directory of Open Access Journals (Sweden)

    Soon-Tae Lee

    Full Text Available BACKGROUND: Activated endothelial cells release plasma membrane submicron vesicles expressing CD62E (E-selectin into blood, known as endothelial microparticles (EMPs. We studied whether the levels of endothelial microparticles expressing CD62E(+, CD31(+/Annexin-V(+, or CD31(+/CD42(- predict cardiovascular outcomes in patients with stroke history. METHODS/PRINCIPAL FINDINGS: Patients with stroke history at least 3 months prior to enrolment were recruited. Peripheral blood EMP levels were measured by flow cytometry. Major cardiovascular events and death were monitored for 36 months. Three hundred patients were enrolled, of which 298 completed the study according to protocol. Major cardiovascular events occurred in 29 patients (9.7%. Nine patients died, five from cardiovascular causes. Cumulative event-free survival rates were lower in patients with high levels of CD62E(+ microparticles. Multivariate Cox regression analysis adjusted for cardiovascular risk factors, medications and stroke etiologic groups showed an association between a high CD62E(+ microparticle level and a risk of major cardiovascular events and hospitalization. Levels of other kinds of EMPs expressing CD31(+/Annexin-V(+ or CD31(+/CD42(- markers were not predictive of cardiovascular outcomes. CONCLUSION: A high level of CD62E(+ microparticles is associated with cardiovascular events in patients with stroke history, suggesting that the systemic endothelial activation increases the risk for cardiovascular morbidities.

  13. Effect of folic acid supplementation on cardiovascular outcomes: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yu-Hao Zhou

    Full Text Available BACKGROUND: Folic acid is widely used to lower homocysteine concentrations and prevent adverse cardiovascular outcomes. However, the effect of folic acid on cardiovascular events is not clear at the present time. We carried out a comprehensive systematic review and meta-analysis to assess the effects of folic acid supplementation on cardiovascular outcomes. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles, and proceedings of major meetings for relevant literature. We included randomized placebo-controlled trials that reported on the effects of folic acid on cardiovascular events compared to placebo. Of 1594 identified studies, we included 16 trials reporting data on 44841 patients. These studies reported 8238 major cardiovascular events, 2001 strokes, 2917 myocardial infarctions, and 6314 deaths. Folic acid supplementation as compared to placebo had no effect on major cardiovascular events (RR, 0.98; 95% CI, 0.93-1.04, stroke (RR, 0.89; 95% CI,0.78-1.01, myocardial infarction (RR, 1.00; 95% CI, 0.93-1.07, or deaths from any cause (RR, 1.00;95% CI, 0.96-1.05. Moreover, folic acid as compared to placebo also had no effect on the following secondary outcomes: risk of revascularization (RR, 1.05; 95%CI, 0.95-1.16, acute coronary syndrome (RR, 1.06; 95%CI, 0.97-1.15, cancer (RR, 1.08; 95%CI, 0.98-1.21, vascular death (RR, 0.94; 95%CI,0.88-1.02, or non-vascular death (RR, 1.06; 95%CI, 0.97-1.15. CONCLUSION/SIGNIFICANCE: Folic acid supplementation does not effect on the incidence of major cardiovascular events, stroke, myocardial infarction or all cause mortality.

  14. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

    Science.gov (United States)

    Holman, Rury R; Bethel, Mary Angelyn; George, Jyothis; Sourij, Harald; Doran, Zoë; Keenan, Joanne; Khurmi, Nardev S; Mentz, Robert J; Oulhaj, Abderrahim; Buse, John B; Chan, Juliana C; Iqbal, Nayyar; Kundu, Sudeep; Maggioni, Aldo P; Marso, Steven P; Öhman, Peter; Pencina, Michael J; Poulter, Neil; Porter, Lisa E; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F

    2016-04-01

    Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338.

  15. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

    Science.gov (United States)

    Cushman, William C; Grimm, Richard H; Cutler, Jeffrey A; Evans, Gregory W; Capes, Sarah; Corson, Marshall A; Sadler, Laurie S; Alderman, Michael H; Peterson, Kevin; Bertoni, Alain; Basile, Jan N

    2007-06-18

    The Action to Control Cardiovascular Disease in Diabetes (ACCORD) blood pressure trial is an unmasked, open-label, randomized trial with a sample size of 4,733 participants. This report describes the rationale, design, and methods of the blood pressure interventions in ACCORD. Participants eligible for the blood pressure trial are randomized to 1 of 2 groups with different treatment goals: systolic blood pressure <120 mm Hg for the more intensive goal and systolic blood pressure <140 mm Hg for the less intensive goal. The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease (CVD) event, specifically nonfatal myocardial infarction or stroke, or cardiovascular death during a follow-up period ranging from 4-8 years. The ACCORD blood pressure trial should provide the first definitive clinical trial data on the possible benefit of treating to a more aggressive systolic blood pressure goal in reducing CVD events in patients with diabetes mellitus.

  16. Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes.

    Science.gov (United States)

    Fisman, Enrique Z; Tenenbaum, Alexander

    2015-01-01

    The traditional oral pharmacological therapy for type 2 diabetes mellitus (T2DM) has been based on the prescription of metformin, a biguanide, as first line antihyperglycemic agent world over. It has been demonstrated that after 3 years of treatment, approximately 50% of diabetic patients could achieve acceptable glucose levels with monotherapy; but by 9 years this had declined to only 25%. Therefore, the implementation of a combined pharmacological therapy acting via different pathways becomes necessary, and its combination with a compound of the sulfonylurea group was along decades the most frequently employed prescription in routine clinical practice. Meglitinides, glitazones and alpha-glucosidase inhibitors were subsequently developed, but the five mentioned groups of oral antihyperglycemic agents are associated with variable degrees of undesirable or even severe cardiovascular events. The gliptins-also called dipeptidyl peptidase 4 (DPP4) inhibitors--are an additional group of antidiabetic compounds with increasing clinical use. We review the status of the gliptins with emphasis on their capabilities to positively or negatively affect the cardiovascular system, and their potential involvement in major adverse cardiovascular events (MACE). Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin and vildagliptin are the compounds currently in clinical use. Regardless differences in chemical structure and metabolic pathways, gliptins as a group exert favorable changes in experimental models. These changes, as an almost general rule, include improved endothelial function, reduction of inflammatory markers, oxidative stress ischemia/reperfusion injury and atherogenesis. In addition, increased adiponectin levels and modest decreases in lipidemia and blood pressure were reported. In clinical settings, several trials--notably the longer one, employing sitagliptin, with a mean follow-up period of 3 years--did not show an increased risk for ischemic

  17. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis

    DEFF Research Database (Denmark)

    Ahlehoff, O; Skov, L; Gislason, G

    2014-01-01

    intervals (CIs) of cardiovascular events associated with use of biological drugs, methotrexate, cyclosporine, retinoids and other antipsoriatic therapies, including topical treatments, phototherapy and climate therapy. RESULTS: A total of 6902 patients (9662 treatment exposures) with a maximum follow......-up of 5 years were included. Incidence rates per 1000 patients-years for cardiovascular events were 4.16, 6.28, 6.08, 18.95 and 14.63 for biological drugs, methotrexate, cyclosporine, retinoid and other therapies respectively. Relative to other therapies, methotrexate (HR 0.53; CI 0...... during long-term follow-up compared to patients treated with other antipsoriatic therapies. The treatment strategy in patients with severe psoriasis may have an impact on cardiovascular outcomes and randomized trials to evaluate the cardiovascular safety and efficacy of systemic antipsoriatic therapies...

  18. Does treatment of SDB in children improve cardiovascular outcome?

    Science.gov (United States)

    Vlahandonis, Anna; Walter, Lisa M; Horne, Rosemary S C

    2013-02-01

    Sleep disordered breathing (SDB) is a common disorder in both adults and children and is caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main treatment option is adenotonsillectomy (T&A). It is well known that obstructive sleep apnoea in adults increases the risk for hypertension, coronary artery disease and stroke, and there is now mounting evidence that SDB also has a significant impact on the cardiovascular system in children with reports of elevated blood pressure, endothelial dysfunction and altered autonomic cardiovascular control. As there is now substantial evidence that elevated blood pressure in childhood is carried on to adulthood it is important to know if treatment of SDB improves cardiovascular outcomes. Studies in adults have shown that treatment of SDB leads to improvements in cardiovascular function, including a reduction in pulmonary artery pressure, systemic blood pressure and endothelial dysfunction. However, studies exploring the outcomes of treatment of SDB in children on the cardiovascular system are limited and varied in their methodology and outcome measures. As a number of cardiovascular disturbances are sequelae of SDB, early detection and management could result in the reduction of elevated blood pressure in children, and consequently a reduction in cardiovascular morbidity in adulthood. The aim of this review is to summarise the findings of studies to date which have investigated the cardiovascular outcomes in children treated for SDB and to make recommendations for future management of this very common disease.

  19. Infertility trial outcomes: healthy moms and babies.

    Science.gov (United States)

    Silver, Robert

    2014-05-01

    Traditionally, the primary outcome of infertility trials has been a positive pregnancy test or a clinically recognized pregnancy. However, parents desire a healthy baby that grows up to be a healthy adult, rather than a positive pregnancy test. Too often results of infertility trials are lacking in crucial obstetric details. This is problematic because treatments for infertility have the capacity to increase the risk for a variety of adverse obstetric outcomes. This review will outline important obstetric variables that should be included when reporting infertility research. The rationale for including these data, precise definitions of the variables, and cost-effective strategies for obtaining these obstetric details will be highlighted.

  20. Patients’ preferences for selection of endpoints in cardiovascular clinical trials

    Directory of Open Access Journals (Sweden)

    Robert D. Chow

    2014-02-01

    Full Text Available Background: To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied. Objective: To determine the preferences of patients in the design of cardiovascular trials. Design: Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process. Participants: One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting. Key results: Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004 on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001, angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001, and stroke (4.73 vs. 2.43, p<0.001. Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%, incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers, and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect. Conclusions: Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but

  1. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)

    DEFF Research Database (Denmark)

    Poulter, Neil R; Wedel, Hans; Dahlöf, Björn;

    2005-01-01

    Results of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA) show significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-based combination drug regimen than in those allocated an atenolol-based combination drug regimen (HR...... 0.86 and 0.77, respectively). Our aim was to assess to what extent these differences were due to significant differences in blood pressures and in other variables noted after randomisation....

  2. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Schwartz, Lisa; Woloshin, Steven

    2010-01-01

    admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable...... extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component. RESULTS: Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three...... also to the most important component. CONCLUSIONS: The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well...

  3. A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes

    DEFF Research Database (Denmark)

    Simmons, Rebecca K; Borch-Johnsen, Knut; Lauritzen, Torsten

    2016-01-01

    BACKGROUND: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. OBJECTIVE: To quantify the cost-effectiveness of intensive multifactorial treatment....... INTERVENTIONS: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. MAIN OUTCOME MEASURES: The primary end point...... and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective...

  4. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial

    DEFF Research Database (Denmark)

    Sever, Peter; Dahlöf, Björn; Poulter, Neil;

    2006-01-01

    A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events.......A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events....

  5. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  6. [EMPA-REG OUTCOME: Empagliflozin reduces mortality in patients with type 2 diabetes at high cardiovascular risk].

    Science.gov (United States)

    Scheen, A J

    2015-11-01

    EMPA-REG OUTCOME is an international, prospective, placebo-controlled clinical trial investigating the cardiovascular outcomes of empagliflozin, an inhibitor of sodium-glucose cotransporters type 2 (SGLT2), in patients with type 2 diabetes mellitus and known cardiovascular disease. The trial succeeded in reaching the primary objective of non-inferiority and, in addition, showed, after a median follow up of 3.1 years, a superiority of empagliflozin (10 or 25 mg/day) versus placebo as regards the primary composite cardiovascular endpoint (hasard ratio or HR = 0.86; 95% CI 0.74-0.99; P = 0.04), hospitalisations for heart failure (-35%), cardiovascular mortality (-38%) and all-cause mortality (-32%, each p < 0.001). The reductionin mortality appeared early (< 6 months) and concerned all subgroups, without any obvious heterogeneity. This reduction in mortality does not seem to be fully explained by the concomitant slight reductions in HbA1c, body weight, waist circumference, blood pressure and serum uric acid levels in the empagliflozin groups versus the placebo group. Finally, the tolerance and safety profile of empagliflozin was good, with only a moderate increase in benign mycotic genital infections, a well-known adverse event with SGLT2 inhibitors. The remarkable effects of empagliflozin in the EMPA-REG OUTCOME trial, especially on mortality, should modify the management of patients with type 2 diabetes and a high cardiovascular risk in a near future.

  7. Statin therapy and clinical outcomes in myocardial infarction patients complicated by acute heart failure : insights from the EPHESUS trial

    NARCIS (Netherlands)

    Dobre, Daniela; Rossignol, Patrick; Murin, Jan; Parkhomenko, Alexander; Lamiral, Zohra; Krum, Henry; van Veldhuisen, Dirk J.; Pitt, Bertram; Zannad, Faiez

    2013-01-01

    Several clinical trials have shown that in patients with acute myocardial infarction (MI), statin therapy improves cardiovascular (CV) outcomes, but in these trials patients with acute heart failure (HF) were excluded or only a few were included. In patients with chronic HF, statin therapy does not

  8. Current trends in the cardiovascular clinical trial arena (I

    Directory of Open Access Journals (Sweden)

    Pater Cornel

    2004-06-01

    Full Text Available Abstract The existence of effective therapies for most cardiovascular disease states, coupled with increased requirements that potential benefits of new drugs be evaluated on clinical rather than surrogate endpoints, makes it increasingly difficult to substantiate any incremental improvements in efficacy that these new drugs might offer. Compounding the problem is the highly controversial issue of comparing new agents with placebos rather than active pharmaceuticals in drug efficacy trials. Despite the recent consensus that placebos may be used ethically in well-defined, justifiable circumstances, the problem persists, in part because of increased scrutiny by ethics committees but also because of considerable lingering disagreement regarding the propriety and scientific value of placebo-controlled trials (and trials of antihypertensive drugs in particular. The disagreement also substantially affects the most viable alternative to placebo-controlled trials: actively controlled equivalence/noninferiority trials. To a great extent, this situation was prompted by numerous previous trials of this type that were marked by fundamental methodological flaws and consequent false claims, inconsistencies, and potential harm to patients. As the development and use of generic drugs continue to escalate, along with concurrent pressure to control medical costs by substituting less-expensive therapies for established ones, any claim that a new drug, intervention, or therapy is "equivalent" to another should not be accepted without close scrutiny. Adherence to proper methods in conducting studies of equivalence will help investigators to avoid false claims and inconsistencies. These matters will be addressed in the third article of this three-part series.

  9. Optimizing outcomes in patients with cardiovascular disease and chronic kidney disease.

    Science.gov (United States)

    Marrs, Joel C

    2011-12-01

    Chronic kidney disease (CKD) is an independent risk factor for the development of cardiovascular disease (CVD). Often, CKD and CVD coexist, and patients warrant optimal pharmacotherapy to reduce the risk of future cardiovascular (CV) events. Randomized trials have evaluated the role of antihypertensive therapy and lipid-lowering therapy as means to reduce CVD in patients with CKD. Many clinical trials support the role of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in the CKD population. In addition, many clinical trials have evaluated the role of statin therapy in reducing CV events in early- and late-stage CKD. The struggle with interpreting results from these trials is that there are a number of different CV composite end points and a lack of consistency in defining CKD, especially in some post hoc subanalyses. Overall, ACEI/ARB therapy is supported by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) and the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) hypertension guidelines and statin therapy is supported by the Adult Treatment Panel (ATP) III and NKF KDOQI dyslipidemia guidelines to optimally manage patients with CKD and CV risk factors. Questions remain as to the optimal role of statin therapy in patients with CKD receiving dialysis. JNC 8 and ATP IV guidelines will be available in the next year, and it is expected that there will be specific recommendations on both hypertension and dyslipidemia management in the CKD population.

  10. Managing cardiovascular risk in people with chronic kidney disease: a review of the evidence from randomized controlled trials.

    Science.gov (United States)

    Jun, Min; Lv, Jicheng; Perkovic, Vlado; Jardine, Meg J

    2011-07-01

    Cardiovascular disease is the leading cause of death and morbidity in people with chronic kidney disease (CKD) making measures to modify cardiovascular risk a clinical priority. The relationship between risk factors and cardiovascular outcomes is often substantially different in people with CKD compared with the general population, leading to uncertainty around pathophysiological mechanisms and the validity of generalizations from the general population. Furthermore, published reports of subgroup analyses from clinical trials have suggested that a range of interventions may have different effects in people with kidney disease compared with those with normal kidney function. There is a relative scarcity of randomized controlled trials (RCTs) conducted in CKD populations, and most such trials are small and underpowered. As a result, evidence to support cardiovascular risk modification measures for people with CKD is largely derived from small trials and post hoc analyses of RCTs conducted in the general population. In this review, we examine the available RCT evidence on interventions aimed at preventing cardiovascular events in people with kidney disease to identify beneficial treatments as well as current gaps in knowledge that should be a priority for future research.

  11. Renal outcomes in hypertensive Black patients at high cardiovascular risk.

    Science.gov (United States)

    Weir, Matthew R; Bakris, George L; Weber, Michael A; Dahlof, Bjorn; Devereux, Richard B; Kjeldsen, Sverre E; Pitt, Bertram; Wright, Jackson T; Kelly, Roxzana Y; Hua, Tsushung A; Hester, R Allen; Velazquez, Eric; Jamerson, Kenneth A

    2012-03-01

    The ACCOMPLISH trial (Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension) was a 3-year multicenter, event-driven trial involving patients with high cardiovascular risk who were randomized in a double-blinded manner to benazepril plus either hydrochlorothiazide or amlodipine and titrated in parallel to reach recommended blood pressure goals. Of the 8125 participants in the United States, 1414 were of self-described Black ethnicity. The composite kidney disease end point, defined as a doubling in serum creatinine, end-stage renal disease, or death was not different between Black and non-Black patients, although the Blacks were significantly more likely to develop a greater than 50% increase in serum creatinine to a level above 2.6 mg/dl. We found important early differences in the estimated glomerular filtration rate (eGFR) due to acute hemodynamic effects, indicating that benazepril plus amlodipine was more effective in stabilizing eGFR compared to benazepril plus hydrochlorothiazide in non-Blacks. There was no difference in the mean eGFR loss in Blacks between therapies. Thus, benazepril coupled to amlodipine was a more effective antihypertensive treatment than when coupled to hydrochlorothiazide in non-Black patients to reduced kidney disease progression. Blacks have a modestly higher increased risk for more advanced increases in serum creatinine than non-Blacks.

  12. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    providing a classification of clinical trial outcomes and a descriptive study of how outcomes were classified in 200 PubMed indexed clinical trial reports published in 2012. RESULTS: We identified 90 methodological publications with some form of a classification of outcomes. Three distinct definitions were...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  13. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND:Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS......:We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION:We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  14. Visit-to-Visit Variability in Blood Pressure and Kidney and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Nephropathy : A Post Hoc Analysis From the RENAAL Study and the Irbesartan Diabetic Nephropathy Trial

    NARCIS (Netherlands)

    McMullan, Ciaran J.; Lambers Heerspink, Hiddo J.; Parving, Hans-Henrik; Dwyer, Jamie P.; Forman, John P.; de Zeeuw, Dick

    2014-01-01

    Background: Increased systolic blood pressure variability between outpatient visits is associated with increased incidence of cardiovascular end points. However, few studies have examined the association of visit-to-visit variability in systolic blood pressure with clinically relevant kidney disease

  15. Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial.

    Science.gov (United States)

    Pun, Patrick H; Abdalla, Safa; Block, Geoffrey A; Chertow, Glenn M; Correa-Rotter, Ricardo; Dehmel, Bastian; Drüeke, Tilman B; Floege, Jürgen; Goodman, William G; Herzog, Charles A; London, Gerard M; Mahaffey, Kenneth W; Moe, Sharon M; Parfrey, Patrick S; Wheeler, David C; Middleton, John P

    2016-07-01

    Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum-dialysate calcium gradients have been associated with higher risks of in-dialysis facility or peri-dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum-dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum-dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum-dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum-dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events

  16. Endothelial dysfunction: cardiovascular risk factors, therapy, and outcome

    Directory of Open Access Journals (Sweden)

    Hadi AR Hadi

    2005-10-01

    Full Text Available Hadi AR Hadi, Cornelia S Carr, Jassim Al SuwaidiDepartment of Cardiology and Cardiovascular Surgery, Hamad General Hospital – Hamad Medical Corporation, Doha, State of QatarAbstract: Endothelial dysfunction is a well established response to cardiovascular risk factors and precedes the development of atherosclerosis. Endothelial dysfunction is involved in lesion formation by the promotion of both the early and late mechanisms of atherosclerosis including up-regulation of adhesion molecules, increased chemokine secretion and leukocyte adherence, increased cell permeability, enhanced low-density lipoprotein oxidation, platelet activation, cytokine elaboration, and vascular smooth muscle cell proliferation and migration. Endothelial dysfunction is a term that covers diminished production/availability of nitric oxide and/or an imbalance in the relative contribution of endothelium-derived relaxing and contracting factors. Also, when cardiovascular risk factors are treated the endothelial dysfunction is reversed and it is an independent predictor of cardiac events. We review the literature concerning endothelial dysfunction in regard to its pathogenesis, treatment, and outcome.Keywords: endothelial dysfunction, coronary atherosclerosis, coronary artery disease

  17. Randomized trial evaluating the framing of cardiovascular risk and its impact on blood pressure control [ISRCTN87597585

    Directory of Open Access Journals (Sweden)

    Peters Tim J

    2001-10-01

    Full Text Available Abstract Background The format or frame in which the results of randomized trials are presented has been shown to influence health professional's self-reported practice. We sought to investigate the effect of framing cardiovascular risk as two different formats in a randomized trial. Methods We recruited 457 patients aged between 60 and 79 years with high blood pressure from 20 family practices in Avon, UK. Patients were randomized to cardiovascular risk presented either as 1 an absolute risk level (AR or as 2 the number needed to treat to prevent an adverse event (NNT. The main outcome measures were: 1 percentage of patients in each group with a five-year cardiovascular risk ≥ 10%, 2 systolic and diastolic blood pressure, 3 intensity of prescribing of cardiovascular medication. Results Presenting cardiovascular risk as either an AR or NNT had no impact reducing cardiovascular risk at 12 month follow up, adjusted odds ratio 1.53 (95%CI 0.76 to 3.08. There was no difference between the two groups in systolic (adjusted difference 0.97 mmHg, 95%CI -2.34 mmHg to 4.29 mmHg or diastolic (adjusted difference 0.70 mmHg, 95%CI -1.05 mmHg to 2.45 mmHg blood pressure. Intensity of prescribing of blood pressure lowering drugs was not significantly different between the two groups at six months follow up. Conclusions Presenting cardiovascular risk in clinical practice guidelines as either an AR or NNT had a similar influence on patient outcome and prescribing intensity. There is no difference in patient outcomes when these alternative formats of risk are used in clinical practice guidelines.

  18. Role of prophylactic coronary revascularisation in improving cardiovascular outcomes during non-cardiac surgery: A narrative review.

    Science.gov (United States)

    Rahat, T; Nguyen, T; Latif, F

    2016-10-01

    Coronary revascularisation has been a topic of debate for over three decades in patients undergoing high-risk non-cardiac surgery. The paradigm shifted from routine coronary angiography toward stress test guided decision-making based on larger randomised trials. However, this paradigm is challenged by relatively newer data where routine coronary angiography and revascularisation is shown to improve perioperative cardiovascular outcomes. We review major studies performed over a long period including more contemporary data with regard to the 2014 American College of Cardiology/American Heart Association as well as 2014 European Society of Cardiology guideline on perioperative cardiovascular evaluation of patients undergoing non-cardiac surgery.

  19. What Are We Learning from the FDA-Mandated Cardiovascular Outcome Studies for New Pharmacological Antidiabetic Agents?

    Science.gov (United States)

    Lovre, Dragana; Htun, Wynn; Carrion, Carly; Fonseca, Vivian A

    2016-10-01

    Cardiovascular disease (CVD) is common in patients with diabetes. For these patients, clinicians should seek diabetes treatment that is beneficial rather than harmful in relation to CVD. Until recently, there have been many treatments for hyperglycemia, whose impact on CVD has been controversial. The aims of this review are to evaluate the effectiveness of antihyperglycemic medications on risk factors for CVD and to examine the impact of these drugs on CVD in cardiovascular (CV) outcome trials. In this article, we summarize current knowledge about the impacts of these drugs on various risk factors as well as CV outcomes. We identify the recent emergence of trials with antihyperglycemic agents showing newly discovered CV benefits as well as past trials with antihyperglycemic agents not showing much benefit on CV events. Rather than focusing on treatment strategies, we review the effects of individual drug classes on CV outcomes. We also briefly review goal-driven glycemia reduction and its impact on CVD. We conclude that antihyperglycemic agents are associated with improvement in CV risk factors in patients with diabetes and insulin resistance; in fact, a few drugs reduced CV events in randomized CV outcome trials. Therefore, the use of these drugs is appropriate for reducing glucose and decreasing CV event risk in a select subpopulation.

  20. Is blood pressure during the night more predictive of cardiovascular outcome than during the day?

    DEFF Research Database (Denmark)

    Li, Yan; Boggia, Jose; Thijs, Lutgarde;

    2008-01-01

    in relation to Cardiovascular Outcome. Using Cox models, we calculated hazard ratios (HR) adjusted for cohort and cardiovascular risk factors. Over 9.6 years (median), 983 deaths and 943 cardiovascular events occurred. Nighttime BP predicted mortality outcomes (HR, 1.18-1.24; P.... Conversely, daytime systolic (HR, 0.84; Ppredicted only noncardiovascular mortality after adjustment for nighttime BP. Both daytime BP and nighttime BP consistently predicted all cardiovascular events (HR, 1.11-1.33; P....01). Daytime BP lost its prognostic significance for cardiovascular events in patients on antihypertensive treatment. Adjusted for the 24-h BP, NDR predicted mortality (P

  1. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  2. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn;

    2008-01-01

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT...... mortality, all cause mortality, development of chronic stable angina, heart failure, and peripheral arterial disease. By the end of ASCOT-LLA, there was a 36% relative risk reduction in primary events (n = 254) in favour of atorvastatin [hazard ratio (HR) 0.64, 95% CI: 0.50-0.83, P = 0.0005]. At the end...... essentially unchanged and in the case of all cause mortality, the risk reduction of 15% now achieved borderline statistical significance (P = 0.02). Conclusion Carry-over benefits from those originally assigned atorvastatin but no longer taking the drug may account for unchanged relative risk reductions...

  3. Outcome measures in amyotrophic lateral sclerosis clinical trials

    Science.gov (United States)

    Paganoni, Sabrina; Cudkowicz, Merit; Berry, James D

    2017-01-01

    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3–5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of ‘traditional’ outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials. However, their utility in early-phase ALS trials is limited. For these early trials, outcome measures focused on target engagement or biological pathway analysis might improve trial outcomes and better support the drug development process.

  4. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    IJzelenberg Wilhelmina

    2012-09-01

    Full Text Available Abstract Background The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established. The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD compared with usual care. Methods A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71 or control group (n = 75 using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. Results The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference. In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. Conclusions Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive

  5. Do treatment quality indicators predict cardiovascular outcomes in patients with diabetes?

    Directory of Open Access Journals (Sweden)

    Grigory Sidorenkov

    Full Text Available BACKGROUND: Landmark clinical trials have led to optimal treatment recommendations for patients with diabetes. Whether optimal treatment is actually delivered in practice is even more important than the efficacy of the drugs tested in trials. To this end, treatment quality indicators have been developed and tested against intermediate outcomes. No studies have tested whether these treatment quality indicators also predict hard patient outcomes. METHODS: A cohort study was conducted using data collected from >10.000 diabetes patients in the Groningen Initiative to Analyze Type 2 Treatment (GIANTT database and Dutch Hospital Data register. Included quality indicators measured glucose-, lipid-, blood pressure- and albuminuria-lowering treatment status and treatment intensification. Hard patient outcome was the composite of cardiovascular events and all-cause death. Associations were tested using Cox regression adjusting for confounding, reporting hazard ratios (HR with 95% confidence intervals. RESULTS: Lipid and albuminuria treatment status, but not blood pressure lowering treatment status, were associated with the composite outcome (HR = 0.77, 0.67-0.88; HR = 0.75, 0.59-0.94. Glucose lowering treatment status was associated with the composite outcome only in patients with an elevated HbA1c level (HR = 0.72, 0.56-0.93. Treatment intensification with glucose-lowering but not with lipid-, blood pressure- and albuminuria-lowering drugs was associated with the outcome (HR = 0.73, 0.60-0.89. CONCLUSION: Treatment quality indicators measuring lipid- and albuminuria-lowering treatment status are valid quality measures, since they predict a lower risk of cardiovascular events and mortality in patients with diabetes. The quality indicators for glucose-lowering treatment should only be used for restricted populations with elevated HbA1c levels. Intriguingly, the tested indicators for blood pressure-lowering treatment did not predict patient

  6. Effect of Allopurinol on Cardiovascular Outcomes in Hyperuricemic Patients

    DEFF Research Database (Denmark)

    Larsen, Kasper Søltoft; Pottegård, Anton; Lindegaard, Hanne M;

    2015-01-01

    BACKGROUND: Hyperuricemia and gout have been associated with increased cardiovascular risk. Allopurinol is an effective urate-lowering drug. Whether lowering of urate by allopurinol improves the cardiovascular risk in hyperuricemic patients remains to be established. OBJECTIVE: Our objective...

  7. Sustained postoperative anaemia is associated with an impaired outcome after coronary artery bypass graft surgery : insights from the IMAGINE trial

    NARCIS (Netherlands)

    Westenbrink, B. Daan; Kleijn, Lennaert; de Boer, Rudolf A.; Tijssen, Jan G.; Warnica, Wayne J.; Baillot, Richard; Rouleau, Jean L.; van Gilst, Wiek H.

    2011-01-01

    Objective To investigate the association between sustained postoperative anaemia and outcome after coronary artery bypass graft (CABG) surgery. Design Retrospective analysis of the IMAGINE trial, which tested the effect of the ACE inhibitor quinapril on cardiovascular events after CABG. Setting Thor

  8. Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    NARCIS (Netherlands)

    Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao-Yin; Cooper, Mark E.; de Zeeuw, Dick; Eckardt, Kai-Uwe; Ivanovich, Peter; Kewalramani, Reshma; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet; McMurray, John J. V.; Parfrey, Patrick; Parving, Hans-Henrik; Remuzzi, Giuseppe; Singh, Ajay K.; Solomon, Scott D.; Toto, Robert; Uno, Hajime

    2009-01-01

    Background: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and ther

  9. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    DEFF Research Database (Denmark)

    Pfeffer, Marc A; Burdmann, Emmanuel A; Chen, Chao-Yin

    2009-01-01

    BACKGROUND: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and t...

  10. Outcomes of patients calling emergency medical services for suspected acute cardiovascular disease

    DEFF Research Database (Denmark)

    Schoos, Mikkel Malby; Sejersten, Maria Sejersten; Baber, Usman;

    2015-01-01

    , this study emphasizes the need for an efficient prehospital phase with focus on CV disease and proper triage of patients suitable for invasive evaluation if the outcomes of acute heart disease are to be improved further in the current international context of hospitals merging into highly specialized......Adequate health care is increasingly dependent on prehospital systems and cardiovascular (CV) disease remains the most common cause for hospital admission. However the prevalence of CV dispatches of emergency medical services (EMS) is not well reported and survival data described in clinical trials...... and registries are subject to selection biases. We aimed to describe the prevalence and prognosis of acute CV disease and the effect of invasive treatment, in an unselected and consecutive prehospital cohort of 3,410 patients calling the national emergency telephone number from 2005 to 2008 with follow...

  11. Physical Performance and Clinical Outcomes in Dialysis Patients: A Secondary Analysis of the Excite Trial

    Directory of Open Access Journals (Sweden)

    Claudia Torino

    2014-07-01

    Full Text Available Background/Aims: Scarce physical activity predicts shorter survival in dialysis patients. However, the relationship between physical (motor fitness and clinical outcomes has never been tested in these patients. Methods: We tested the predictive power of an established metric of motor fitness, the Six-Minute Walking Test (6MWT, for death, cardiovascular events and hospitalization in 296 dialysis patients who took part in the trial EXCITE (ClinicalTrials.gov Identifier: NCT01255969. Results: During follow up 69 patients died, 90 had fatal and non-fatal cardiovascular events, 159 were hospitalized and 182 patients had the composite outcome. In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of 20 walked metres during the 6MWT was associated to a 6% reduction of the risk for the composite end-point (P=0.001 and a similar relationship existed between the 6MWT, mortality (PConclusions: Poor physical performance predicts a high risk of mortality, cardiovascular events and hospitalizations in dialysis patients. Future studies, including phase-2 EXCITE, will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population.

  12. Adverse pregnancy outcomes and cardiovascular risk factor management.

    Science.gov (United States)

    Mehta, Puja K; Minissian, Margo; Bairey Merz, C Noel

    2015-06-01

    Cardiovascular disease (CVD) is the leading health threat to American women. In addition to establish risk factors for hypertension, hyperlipidemia, diabetes, smoking, and obesity, adverse pregnancy outcomes (APOs) including pre-eclampsia, eclampsia, and gestational diabetes are now recognized as factors that increase a woman's risk for future CVD. CVD risk factor burden is disproportionately higher in those of low socioeconomic status and in ethnic/racial minority women. Since younger women often use their obstetrician/gynecologist as their primary health provider, this is an opportune time to diagnose and treat CVD risk factors early. Embedding preventive care providers such as nurse practitioners or physician assistants within OB/GYN practices can be considered, with referral to family medicine or internist for ongoing risk assessment and management. The American Heart Association (AHA)/American Stroke Association (ASA) stroke prevention guidelines tailored to women recommend that women with a history of pre-eclampsia can be evaluated for hypertension and other CVD risk factors within 6 months to 1-year post-partum. Given the burden and impact of CVD on women in our society, the entire medical community must work to establish feasible practice and referral patterns for assessment and treatment of CVD risk factors.

  13. A Framework for Designing Cluster Randomized Trials with Binary Outcomes

    Science.gov (United States)

    Spybrook, Jessaca; Martinez, Andres

    2011-01-01

    The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

  14. Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    OpenAIRE

    Kyte, DG; Draper, H; Ives, J.; Liles, C; Gheorghe, A.; Calvert, M

    2013-01-01

    BACKGROUND: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this revie...

  15. Advances in the management of cardiovascular risk for patients with type 2 diabetes: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes

    Science.gov (United States)

    Schernthaner, Guntram; Jarvis, Sarah; Lotan, Chaim; Prázný, Martin; Wanner, Christoph; Wascher, Thomas C

    2017-01-01

    Diabetes is a global health emergency projected to affect 642 million people by 2040. Type 2 diabetes (T2D) represents 90% of diabetes cases and is associated with a range of cardiovascular (CV) risk factors that are more than double the incidence of CV disease and significantly increase mortality rates. Diabetes treatments have typically focused on improving glycemic control but their effect on CV outcomes has remained uncertain. In 2008, the US Food and Drug Administration (FDA) looked to address this knowledge gap and mandated CV outcome trials (CVOTs) for all new antidiabetic therapies. In 2015, EMPA-REG OUTCOME® became the first CVOT to present results for a sodium/glucose cotransporter 2 (SGLT2; also known as SLC5A2) inhibitor, empagliflozin. Subsequently, a regional meeting of the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D) brought together a respected faculty of international experts and 150 physicians from 14 countries to discuss the current unmet medical needs of patients with T2D, the results from the EMPA-REG OUTCOME study and the implications of these results for clinical practice. This article summarizes the current scientific evidence and the discussions that took place at the ACROSS T2D regional meeting, which was held in Vienna, Austria, on May 30, 2016. PMID:28144148

  16. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    2001-01-01

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  17. A systematic review of internet-based worksite wellness approaches for cardiovascular disease risk management: outcomes, challenges & opportunities.

    Directory of Open Access Journals (Sweden)

    Ehimen C Aneni

    Full Text Available CONTEXT: The internet is gaining popularity as a means of delivering employee-based cardiovascular (CV wellness interventions though little is known about the cardiovascular health outcomes of these programs. In this review, we examined the effectiveness of internet-based employee cardiovascular wellness and prevention programs. EVIDENCE ACQUISITION: We conducted a systematic review by searching PubMed, Web of Science and Cochrane library for all published studies on internet-based programs aimed at improving CV health among employees up to November 2012. We grouped the outcomes according to the American Heart Association (AHA indicators of cardiovascular wellbeing--weight, BP, lipids, smoking, physical activity, diet, and blood glucose. EVIDENCE SYNTHESIS: A total of 18 randomized trials and 11 follow-up studies met our inclusion/exclusion criteria. Follow-up duration ranged from 6-24 months. There were significant differences in intervention types and number of components in each intervention. Modest improvements were observed in more than half of the studies with weight related outcomes while no improvement was seen in virtually all the studies with physical activity outcome. In general, internet-based programs were more successful if the interventions also included some physical contact and environmental modification, and if they were targeted at specific disease entities such as hypertension. Only a few of the studies were conducted in persons at-risk for CVD, none in blue-collar workers or low-income earners. CONCLUSION: Internet based programs hold promise for improving the cardiovascular wellness among employees however much work is required to fully understand its utility and long term impact especially in special/at-risk populations.

  18. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes

    DEFF Research Database (Denmark)

    Marso, Steven P; Bain, Stephen C; Consoli, Agostino

    2016-01-01

    cardiovascular causes were similar in the two groups. Rates of new or worsening nephropathy were lower in the semaglutide group, but rates of retinopathy complications (vitreous hemorrhage, blindness, or conditions requiring treatment with an intravitreal agent or photocoagulation) were significantly higher...... (hazard ratio, 1.76; 95% CI, 1.11 to 2.78; P=0.02). Fewer serious adverse events occurred in the semaglutide group, although more patients discontinued treatment because of adverse events, mainly gastrointestinal. Conclusions In patients with type 2 diabetes who were at high cardiovascular risk, the rate......Background Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half...

  19. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Science.gov (United States)

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Hypertension Indication: Drug... for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive...

  20. Drug Does Not Improve Set of Cardiovascular Outcomes for Diastolic Heart Failure

    Science.gov (United States)

    ... not improve set of cardiovascular outcomes for diastolic heart failure NIH-supported study finds drug does appear to reduce hospitalizations for diastolic heart failure. A drug that blocks the action of a ...

  1. Outcome Measures in Clinical Trials for Multiple Sclerosis.

    Science.gov (United States)

    van Munster, Caspar E P; Uitdehaag, Bernard M J

    2017-02-09

    Due to the heterogeneous nature of the disease, it is a challenge to capture disease activity of multiple sclerosis (MS) in a reliable and valid way. Therefore, it can be difficult to assess the true efficacy of interventions in clinical trials. In phase III trials in MS, the traditionally used primary clinical outcome measures are the Expanded Disability Status Scale and the relapse rate. Secondary outcome measures in these trials are the number or volume of T2 hyperintense lesions and gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) of the brain. These secondary outcome measures are often primary outcome measures in phase II trials in MS. Despite several limitations, the traditional clinical measures are still the mainstay for assessing treatment efficacy. Newer and potentially valuable outcome measures increasingly used or explored in MS trials are, clinically, the MS Functional Composite and patient-reported outcome measures, and on MRI, brain atrophy and the formation of persisting black holes. Several limitations of these measures have been addressed and further improvements will probably be proposed. Major improvements are the coverage of additional functional domains such as cognitive functioning and assessment of the ability to carry out activities of daily living. The development of multidimensional measures is promising because these measures have the potential to cover the full extent of MS activity and progression. In this review, we provide an overview of the historical background and recent developments of outcome measures in MS trials. We discuss the advantages and limitations of various measures, including newer assessments such as optical coherence tomography, biomarkers in body fluids and the concept of 'no evidence of disease activity'.

  2. No association between anxiety and depression and adverse clinical outcome among patients with cardiovascular disease

    DEFF Research Database (Denmark)

    Kornerup, Henriette; Zwisler, Ann-Dorthe Olsen; Prescott, Eva

    2011-01-01

    Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far.......Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far....

  3. Evaluation of left pulmonary artery sling, associated cardiovascular anomalies, and surgical outcomes using cardiovascular computed tomography angiography

    Science.gov (United States)

    Xie, Jiajun; Juan, Yu-Hsiang; Wang, Qiushi; Chen, Jimei; Zhuang, Jian; Xie, Zhaofeng; Liang, Changhong; Zhu, Yulei; Yu, Zhuliang; Li, Jinglei; Saboo, Sachin S.; Liu, Hui

    2017-01-01

    We evaluated the prevalence, image appearance, associated cardiovascular anomalies, and surgical outcomes of left pulmonary artery sling (LPAS) using cardiovascular computed tomography angiography (CCTA). A retrospective search of patients from our database between October 2007 and December 2014 identified 52,200 patients with congenital heart diseases (CHD) referred for CCTA, echocardiography, or magnetic resonance imaging. Clinical information, CCTA findings, associated cardiovascular anomalies, and surgical outcomes were analyzed. We showed a hospital-based prevalence of 71 patients with LPAS (0.14%, 71/52,200) among CHD patients. Of these, 47 patients with CCTA examinations were assessed further. Most patients (40/47, 85%) had associated cardiovascular anomalies, of which ventricular septal defects (22/47, 47%), atrial septal defects (20/47, 43%), patent ductus arteriosus (16/47, 34%), persistent left superior vena cava (14/47, 30%), and abnormal branching of the right pulmonary artery (ABRPA) (14/47, 30%) were most commonly identified. In total, 28 patients underwent LPA reanastomosis and/or tracheoplasty in our center, and 5 died. LPAS had a hospital-based prevalence of 0.14% among CHD patients. ABRPA is not uncommon and must be recognized. CCTA is a feasible method for demonstrating LPAS and its associated cardiovascular anomalies for an optimal pre-operative assessment of LPAS. PMID:28053308

  4. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed;

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... on long-term risk of cardiovascular events. METHODS: A total of 1386 patients undergoing either elective or emergency laparotomy were randomised to 80% versus 30% oxygen during and two hours after surgery. At follow-up, the primary outcome of acute coronary syndrome was assessed. Secondary outcomes...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  5. The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study: protocol of a randomized trial

    Directory of Open Access Journals (Sweden)

    McMahon Emma J

    2012-10-01

    Full Text Available Abstract Background Despite evidence implicating dietary sodium in the pathogenesis of cardiovascular disease (CVD in chronic kidney disease (CKD, quality intervention trials in CKD patients are lacking. This study aims to investigate the effect of reducing sodium intake on blood pressure, risk factors for progression of CKD and other cardiovascular risk factors in CKD. Methods/design The LowSALT CKD study is a six week randomized-crossover trial assessing the effect of a moderate (180 mmol/day compared with a low (60 mmol/day sodium intake on cardiovascular risk factors and risk factors for kidney function decline in mild-moderate CKD (stage III-IV. The primary outcome of interest is 24-hour ambulatory blood pressure, with secondary outcomes including arterial stiffness (pulse wave velocity, proteinuria and fluid status. The randomized crossover trial (Phase 1 is supported by an ancillary trial (Phase 2 of longitudinal-observational design to assess the longer term effectiveness of sodium restriction. Phase 2 will continue measurement of outcomes as per Phase 1, with the addition of patient-centered outcomes, such as dietary adherence to sodium restriction (degree of adherence and barriers/enablers, quality of life and taste assessment. Discussion The LowSALT CKD study is an investigator-initiated study specifically designed to assess the proof-of-concept and efficacy of sodium restriction in patients with established CKD. Phase 2 will assess the longer term effectiveness of sodium restriction in the same participants, enhancing the translation of Phase 1 results into practice. This trial will provide much-needed insight into sodium restriction as a treatment option to reduce risk of CVD and CKD progression in CKD patients. Trial registration Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932

  6. Outcome Measures for Clinical Drug Trials in Autism

    OpenAIRE

    Aman, Michael G; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D.; King, Bryan H; Pearson, Deborah A.; Gernsbacher, Morton Ann; Chez, Michael

    2004-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no “perfect” choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across t...

  7. Cardiovascular Risk Behavior among Sedentary Female Smokers and Smoking Cessation Outcomes

    Directory of Open Access Journals (Sweden)

    Quiles Zandra

    2005-01-01

    Full Text Available Abstract Background We examined female sedentary smokers' additional cardiovascular disease (CVD risk behaviors and their associations to smoking cessation. Methods This study was part of a randomized controlled trial testing the effectiveness of exercise and nicotine gum in smoking cessation. Included in the analyses were 148 participants. Dietary habits and alcohol consumption were measured as additional CVD risk behaviors. High-fat diet and heavy alcohol use were considered those risk behaviors. Nicotine dependence, length of the longest quit attempt, depressive symptoms, self-efficacy, and education were examined as other baseline variables. Abstinence from tobacco was recorded through 12 months. Results Diet was related to depressive symptoms at baseline. Alcohol use was related to nicotine dependence and education level. Heavy alcohol use alone and accumulation of two added risk behaviors predicted poorer smoking cessation outcome. Although diet alone was not associated with cessation outcome the high-fat diet interacted with depressive symptoms, such that the depressed women with high-fat diet were significantly more likely to relapse in their quit attempt compared to other subgroups. Conclusion Non-moderate alcohol use alone and accumulation of multiple CVD risk behaviors seem to be associated with lower success in smoking cessation.

  8. Cardiovascular Risk Behavior among Sedentary Female Smokers and Smoking Cessation Outcomes

    Directory of Open Access Journals (Sweden)

    Terwal Donna

    2005-12-01

    Full Text Available Abstract Background We examined female sedentary smokers' additional cardiovascular disease (CVD risk behaviors and their associations to smoking cessation. Methods This study was part of a randomized controlled trial testing the effectiveness of exercise and nicotine gum in smoking cessation. Included in the analyses were 148 participants. Dietary habits and alcohol consumption were measured as additional CVD risk behaviors. High-fat diet and heavy alcohol use were considered those risk behaviors. Nicotine dependence, length of the longest quit attempt, depressive symptoms, self-efficacy, and education were examined as other baseline variables. Abstinence from tobacco was recorded through 12 months. Results Diet was related to depressive symptoms at baseline. Alcohol use was related to nicotine dependence and education level. Heavy alcohol use alone and accumulation of two added risk behaviors predicted poorer smoking cessation outcome. Although diet alone was not associated with cessation outcome the high-fat diet interacted with depressive symptoms, such that the depressed women with high-fat diet were significantly more likely to relapse in their quit attempt compared to other subgroups. Conclusion Non-moderate alcohol use alone and accumulation of multiple CVD risk behaviors seem to be associated with lower success in smoking cessation.

  9. Salt and Cardiovascular Outcomes%食盐与心血管结局

    Institute of Scientific and Technical Information of China (English)

    秦俊法

    2014-01-01

    This paper introduces the latest research results of salt and cardiovascular outcomes , salt intake and cardiovascular outcome have the J shape relationship;low salt and high salt increased the risk of cardiovascular;the common salt reduction recommended is nonsupported .%介绍了食盐与心血管结局关系的最新研究结果,食盐摄入量与心血管结局之间呈J形关系;低盐和高盐都增加心血管危险;不支持普遍减盐推荐。

  10. [Hyperglycemia and cardiovascular risk: lessons from randomized trials].

    Science.gov (United States)

    Grimaldi, André

    2010-04-20

    Diabetes is a major cardiovascular risk factor However, hyperglycemia is much more closely associated with microangiopathy than with macrovascular complications. Epidemiologic studies have shown a 15% increase of myocardial infarction for 1% increase in HbA1c level. It is accepted but not absolutely demonstrated, that reduction of HbA1c results in an equal reduction of cardiovascular events. An initial good glycemic control has long-term benefical effects on the risk of cardiovascular disease. On the contrary, benefit of an intensive glucose control is not demonstrated in diabetic patients with previous myocardial infarction. Two recent studies (ACCORD and VADT) showed an increase of cardiovascular mortality by severe hypoglycemia. In diabetic patients with previous myocardial infarction, glycemic goal must be modulated by the hypoglycaemic risk. A goal of 7.5% HbA1c seems reasonable for the diabetic patients treated by sulfonylureas or insulin, at risk of hypoglycaemia. HbA1c target < 7% remains the general goal and HbA1c target < 6.5% is appropriated to the patients treated by insulin sensitizing medications without risk of hypoglycaemia.

  11. Blood pressure variability in relation to outcome in the International Database of Ambulatory blood pressure in relation to Cardiovascular Outcome

    DEFF Research Database (Denmark)

    Stolarz-Skrzypek, Katarzyna; Thijs, Lutgarde; Richart, Tom;

    2010-01-01

    Ambulatory blood pressure (BP) monitoring provides information not only on the BP level but also on the diurnal changes in BP. In the present review, we summarized the main findings of the International Database on Ambulatory BP in relation to Cardiovascular Outcome (IDACO) with regard to risk...... variability as captured by the average of the daytime and nighttime s.d. weighted for the duration of the daytime and nighttime interval (s.d.(dn)) and the average real variability (ARV(24)) predicted the outcome, but improved the prediction of the composite of all cardiovascular events by only 0...

  12. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis

    DEFF Research Database (Denmark)

    Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning

    2007-01-01

    BACKGROUND: A recent meta-analysis raised concern regarding an increased risk of myocardial infarction and death from cardiovascular causes associated with rosiglitazone treatment of type 2 diabetes. METHODS: We conducted an unplanned interim analysis of a randomized, multicenter, open-label, non......BACKGROUND: A recent meta-analysis raised concern regarding an increased risk of myocardial infarction and death from cardiovascular causes associated with rosiglitazone treatment of type 2 diabetes. METHODS: We conducted an unplanned interim analysis of a randomized, multicenter, open...... group). The primary end point was hospitalization or death from cardiovascular causes. RESULTS: Because the mean follow-up was only 3.75 years, our interim analysis had limited statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone group and 202 patients...... group and the control group regarding myocardial infarction and death from cardiovascular causes or any cause. There were more patients with heart failure in the rosiglitazone group than in the control group (hazard ratio, 2.15; 95% CI, 1.30 to 3.57). CONCLUSIONS: Our interim findings from this ongoing...

  13. Early-onset preeclampsia : Constitutional factors and consequences for future pregnancy outcome and cardiovascular health

    NARCIS (Netherlands)

    van Rijn, B.B.

    2008-01-01

    In this thesis, maternal constitutional factors related to long-term cardiovascular health and subsequent pregnancy outcome in women with early-onset preeclampsia is addressed. Aims of the thesis: To evaluate subsequent pregnancy outcome in women with a first pregnancy complicated by early-onset pre

  14. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...

  15. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  16. Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches

    Directory of Open Access Journals (Sweden)

    Friedrich Jan O

    2009-01-01

    Full Text Available Abstract Background A recent and provocative meta-analysis, based on few outcome events, suggested that rosiglitazone increased cardiovascular mortality and myocardial infarction. However, results of meta-analyses of trials with sparse events, often performed when examining uncommon adverse effects due to common therapies, can vary substantially depending on methodologic decisions. The objective of this study was to assess the robustness of the rosiglitazone results by using alternative reasonable methodologic approaches and by analyzing additional related outcomes. Findings In duplicate and independently, we abstracted all myocardial and cerebrovascular ischemic events from all randomized controlled trials listed on the manufacturer's web site meeting inclusion criteria of the original meta-analysis (at least 24 weeks of rosiglitazone exposure in the intervention group and any control group without rosiglitazone. We performed meta-analyses of these data under different methodologic conditions. An unconfounded comparison that includes only trials (or arms of trials in which medications apart from rosiglitazone are identical suggests higher risks than previously reported, making even the risk of cardiovascular death statistically significant. Alternatively, meta-analysis that includes all trials comparing a treatment arm receiving rosiglitazone to any control arm without rosiglitazone (as in the original meta-analysis but also including trials with no events in both the rosiglitazone and control arms (not incorporated in the original meta-analysis, shows adverse but non-statistically significant effects of rosiglitazone on myocardial infarction and cardiovascular mortality. Rosiglitazone appears to have inconsistent effects on a wider range of cardiovascular outcomes. It increases the risk of a broad range of myocardial ischemic events (not just myocardial infarction. However, its effect on cerebrovascular ischemic events suggests benefit

  17. Progression of Blood Pressure and Cardiovascular Outcomes in Hypertensive Patients in a Reference Center

    Energy Technology Data Exchange (ETDEWEB)

    Guimarães Filho, Gilberto Campos, E-mail: camposguimaraes@yahoo.com.br; Sousa, Ana Luiza Lima; Jardim, Thiago de Souza Veiga; Souza, Weimar Sebba Barroso; Jardim, Paulo César Brandão Veiga [Liga de Hipertensão da Faculdade de Medicina da Universidade Federal de Goiânia, Goiás, GO (Brazil)

    2015-04-15

    Hypertension is a public health problem, considering its high prevalence, low control rate and cardiovascular complications. Evaluate the control of blood pressure (BP) and cardiovascular outcomes in patients enrolled at the Reference Center for Hypertension and Diabetes, located in a medium-sized city in the Midwest Region of Brazil. Population-based study comparing patients enrolled in the service at the time of their admission and after an average follow-up of five years. Participants were aged ≥18 years and were regularly monitored at the Center up to 6 months before data collection. We assessed demographic variables, BP, body mass index, risk factors, and cardiovascular outcomes. We studied 1,298 individuals, predominantly women (60.9%), and with mean age of 56.7±13.1 years. Over time, there was a significant increase in physical inactivity, alcohol consumption, diabetes, dyslipidemia, and excessive weight. As for cardiovascular outcomes, we observed an increase in stroke and myocardial revascularization, and a lower frequency of chronic renal failure. During follow-up, there was significant improvement in the rate of BP control (from 29.6% to 39.6%; p = 0.001) and 72 deaths, 91.7% of which were due to cardiovascular diseases. Despite considerable improvements in the rate of BP control during follow-up, risk factors worsened and cardiovascular outcomes increased.

  18. ISCHEMIA in chronic kidney disease: improving the representation of patients with chronic kidney disease in cardiovascular trials.

    Science.gov (United States)

    Wyatt, Christina M; Shineski, Matthew; Chertow, Glenn M; Bangalore, Sripal

    2016-06-01

    Despite the high cardiovascular risk associated with chronic kidney disease, a recent systematic review confirmed that patients with kidney disease remain underrepresented in cardiovascular trials. Two ongoing trials are assessing the risk:benefit of aggressive evaluation and intervention for ischemic heart disease in patients with advanced chronic kidney disease.

  19. Blood pressure variability in relation to outcome in the International Database of Ambulatory blood pressure in relation to Cardiovascular Outcome

    DEFF Research Database (Denmark)

    Stolarz-Skrzypek, Katarzyna; Thijs, Lutgarde; Richart, Tom

    2010-01-01

    Ambulatory blood pressure (BP) monitoring provides information not only on the BP level but also on the diurnal changes in BP. In the present review, we summarized the main findings of the International Database on Ambulatory BP in relation to Cardiovascular Outcome (IDACO) with regard to risk...

  20. Orthostatic Hypotension in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Blood Pressure Trial: Prevalence, Incidence, and Prognostic Significance.

    Science.gov (United States)

    Fleg, Jerome L; Evans, Gregory W; Margolis, Karen L; Barzilay, Joshua; Basile, Jan N; Bigger, J Thomas; Cutler, Jeffrey A; Grimm, Richard; Pedley, Carolyn; Peterson, Kevin; Pop-Busui, Rodica; Sperl-Hillen, JoAnn; Cushman, William C

    2016-10-01

    Orthostatic hypotension (OH) is associated with hypertension and diabetes mellitus. However, in populations with both hypertension and diabetes mellitus, its prevalence, the effect of intensive versus standard systolic blood pressure (BP) targets on incident OH, and its prognostic significance are unclear. In 4266 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) BP trial, seated BP was measured 3×, followed by readings every minute for 3 minutes after standing. Orthostatic BP change, calculated as the minimum standing minus the mean seated systolic BP and diastolic BP, was assessed at baseline, 12 months, and 48 months. The relationship between OH and clinical outcomes (total and cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure hospitalization or death and the primary composite outcome of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) was assessed using proportional hazards analysis. Consensus OH, defined by orthostatic decline in systolic BP ≥20 mm Hg or diastolic BP ≥10 mm Hg, occurred at ≥1 time point in 20% of participants. Neither age nor systolic BP treatment target (intensive, <120 mm Hg versus standard, <140 mm Hg) was related to OH incidence. Over a median follow-up of 46.9 months, OH was associated with increased risk of total death (hazard ratio, 1.61; 95% confidence interval, 1.11-2.36) and heart failure death/hospitalization (hazard ratio, 1.85, 95% confidence interval, 1.17-2.93), but not with the primary outcome or other prespecified outcomes. In patients with type 2 diabetes mellitus and hypertension, OH was common, not associated with intensive versus standard BP treatment goals, and predicted increased mortality and heart failure events.

  1. NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

    Directory of Open Access Journals (Sweden)

    Cochrane Thomas

    2012-11-01

    Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.

  2. Omega-3 fatty acids in high-risk cardiovascular patients: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Bielinski Michael

    2010-06-01

    Full Text Available Abstract Background Multiple randomized controlled trials (RCTs have examined the cardiovascular effects of omega-3 fatty acids and have provided unexplained conflicting results. A meta-analysis of these RCTs to estimate efficacy and safety and potential sources of heterogeneity may be helpful. Methods The Cochrane library, MEDLINE, and EMBASE were systematically searched to identify all interventional trials of omega-3 fatty acids compared to placebo or usual diet in high-risk cardiovascular patients. The primary outcome was all-cause mortality and secondary outcomes were coronary restenosis following percutaneous coronary intervention and safety. Meta-analyses were carried out using Bayesian random-effects models, and heterogeneity was examined using meta-regression. Results A total of 29 RCTs (n = 35,144 met our inclusion criteria, with 25 reporting mortality and 14 reporting restenosis. Omega-3 fatty acids were not associated with a statistically significant decreased mortality (relative risk [RR] = 0.88, 95% Credible Interval [CrI] = 0.64, 1.03 or with restenosis prevention (RR = 0.89, 95% CrI = 0.72, 1.06, though the probability of some benefit remains high (0.93 and 0.90, respectively. However in meta-regressions, there was a >90% probability that larger studies and those with longer follow-up were associated with smaller benefits. No serious safety issues were identified. Conclusions Although not reaching conventional statistical significance, the evidence to date suggests that omega-3 fatty acids may result in a modest reduction in mortality and restenosis. However, caution must be exercised in interpreting these benefits as results were attenuated in higher quality studies, suggesting that bias may be at least partially responsible. Additional high quality studies are required to clarify the role of omega-3 fatty acid supplementation for the secondary prevention of cardiovascular disease.

  3. [Hypertensive disorders during pregnancy: Cardiovascular long-term outcomes].

    Science.gov (United States)

    Alvarez-Alvarez, B; Martell-Claros, N; Abad-Cardiel, M; García-Donaire, J A

    2016-07-06

    Pregnancy-induced hypertension (PIH) induces maternal and fetal damage, but it can also be the beginning of future metabolic and vascular disorders. The relative risk of chronic hypertension after PIH is between 2.3 and 11, and the likelihood of subsequent development of type 2 diabetes is multiplied by 1.8. Women with prior preeclampsia/eclampsia have a twofold risk of stroke and a higher frequency of arrhythmias and hospitalization due to heart failure. Furthermore, a tenfold greater risk for long-term chronic kidney disease is observed as well. The relative risk of cardiovascular death is 2.1 times higher compared to the group without pregnancy-induced hypertension problems, although the risk is between 4 and 7 times higher in preterm birth associated with gestational hypertension or pre-existing hypertension The postpartum period is a great opportunity to intervene on lifestyle, obesity, make an early diagnosis of chronic hypertension and DM and provide the necessary treatments to prevent cardiovascular complications in women.

  4. Patient reported outcomes (PROs in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    Directory of Open Access Journals (Sweden)

    Derek G Kyte

    Full Text Available BACKGROUND: Patient reported outcomes (PROs are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. METHODS AND FINDINGS: Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97, and validity (<2% residual category coding. The majority of guidelines present were concerned with 'pre-trial' activities (72%, for example, outcome measure selection and study design issues, or 'post-trial' activities (16% such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. CONCLUSIONS: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

  5. Simulating the impact of improved cardiovascular risk interventions on clinical and economic outcomes in Russia.

    Directory of Open Access Journals (Sweden)

    Kenny Shum

    Full Text Available OBJECTIVES: Russia faces a high burden of cardiovascular disease. Prevalence of all cardiovascular risk factors, especially hypertension, is high. Elevated blood pressure is generally poorly controlled and medication usage is suboptimal. With a disease-model simulation, we forecast how various treatment programs aimed at increasing blood pressure control would affect cardiovascular outcomes. In addition, we investigated what additional benefit adding lipid control and smoking cessation to blood pressure control would generate in terms of reduced cardiovascular events. Finally, we estimated the direct health care costs saved by treating fewer cardiovascular events. METHODS: The Archimedes Model, a detailed computer model of human physiology, disease progression, and health care delivery was adapted to the Russian setting. Intervention scenarios of achieving systolic blood pressure control rates (defined as systolic blood pressure <140 mmHg of 40% and 60% were simulated by modifying adherence rates of an antihypertensive medication combination and compared with current care (23.9% blood pressure control rate. Outcomes of major adverse cardiovascular events; cerebrovascular event (stroke, myocardial infarction, and cardiovascular death over a 10-year time horizon were reported. Direct health care costs of strokes and myocardial infarctions were derived from official Russian statistics and tariff lists. RESULTS: To achieve systolic blood pressure control rates of 40% and 60%, adherence rates to the antihypertensive treatment program were 29.4% and 65.9%. Cardiovascular death relative risk reductions were 13.2%, and 29.6%, respectively. For the current estimated 43,855,000-person Russian hypertensive population, each control-rate scenario resulted in an absolute reduction of 1.0 million and 2.4 million cardiovascular deaths, and a reduction of 1.2 million and 2.7 million stroke/myocardial infarction diagnoses, respectively. Averted direct costs from

  6. Reporting outcomes of back pain trials: A modified Delphi study

    DEFF Research Database (Denmark)

    Froud, Robert; Eldridge, Sandra; Kovacs, Francisco;

    2011-01-01

    BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... commonly used in back pain trials, are reported using between-group mean differences (accompanied by minimally important difference (between-group/population-level) thresholds where these exist), the proportion of participants improving and deteriorating according to established and relevant minimally...... pain experts reached a high level of consensus on a statement recommending reporting methods for patient-reported outcomes in future low back pain trials. The statement has the potential to increase interpretability and improve patient care....

  7. Intensified multifactorial intervention and cardiovascular outcome in type 2 diabetes

    DEFF Research Database (Denmark)

    Pedersen, Oluf; Gaede, Peter

    2003-01-01

    , and autonomic neuropathy (secondary end points) was diminished by about 60% in the intensively treated group. In conclusion, an intensified and goal-oriented multipronged approach to the treatment of type 2 diabetes reduces cardiovascular events, as well as nephropathy, retinopathy, and autonomic neuropathy......-risk type 2 diabetic patients with microalbuminuria-a strong risk factor of both macrovascular and microvascular complications-aged 55.1 years, who were randomly assigned to a conventional or an intensive, multifactorial intervention for a period of 7.8 years. In the intensive group, a stepwise treatment...... plan was adopted involving both continuous lifestyle education and motivation and an ambitious goal-oriented pharmacological treatment of known modifiable risk factors. The conventional group was treated in accordance with national guidelines for type 2 diabetes with less stringent goals. The specific...

  8. Relation between renal dysfunction and cardiovascular outcomes after myocardial infarction

    DEFF Research Database (Denmark)

    Anavekar, Nagesh S; McMurray, John J V; Velazquez, Eric J;

    2004-01-01

    BACKGROUND: The presence of coexisting conditions has a substantial effect on the outcome of acute myocardial infarction. Renal failure is associated with one of the highest risks, but the influence of milder degrees of renal impairment is less well defined. METHODS: As part of the Valsartan in A...

  9. A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome.

    Science.gov (United States)

    Klupp, Nerida L; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z; Chang, Dennis H

    2016-08-11

    This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [-0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [-0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705.

  10. Are there genetic paths common to obesity, cardiovascular disease outcomes, and cardiovascular risk factors?

    Science.gov (United States)

    Rankinen, Tuomo; Sarzynski, Mark A; Ghosh, Sujoy; Bouchard, Claude

    2015-02-27

    Clustering of obesity, coronary artery disease, and cardiovascular disease risk factors is observed in epidemiological studies and clinical settings. Twin and family studies have provided some supporting evidence for the clustering hypothesis. Loci nearest a lead single nucleotide polymorphism (SNP) showing genome-wide significant associations with coronary artery disease, body mass index, C-reactive protein, blood pressure, lipids, and type 2 diabetes mellitus were selected for pathway and network analyses. Eighty-seven autosomal regions (181 SNPs), mapping to 56 genes, were found to be pleiotropic. Most pleiotropic regions contained genes associated with coronary artery disease and plasma lipids, whereas some exhibited coaggregation between obesity and cardiovascular disease risk factors. We observed enrichment for liver X receptor (LXR)/retinoid X receptor (RXR) and farnesoid X receptor/RXR nuclear receptor signaling among pleiotropic genes and for signatures of coronary artery disease and hepatic steatosis. In the search for functionally interacting networks, we found that 43 pleiotropic genes were interacting in a network with an additional 24 linker genes. ENCODE (Encyclopedia of DNA Elements) data were queried for distribution of pleiotropic SNPs among regulatory elements and coding sequence variations. Of the 181 SNPs, 136 were annotated to ≥ 1 regulatory feature. An enrichment analysis found over-representation of enhancers and DNAse hypersensitive regions when compared against all SNPs of the 1000 Genomes pilot project. In summary, there are genomic regions exerting pleiotropic effects on cardiovascular disease risk factors, although only a few included obesity. Further studies are needed to resolve the clustering in terms of DNA variants, genes, pathways, and actionable targets.

  11. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

    Directory of Open Access Journals (Sweden)

    Alejandro Macchia

    Full Text Available BACKGROUND: The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG among patients with type II diabetes mellitus and no previous cardiovascular events. METHODOLOGY/PRINCIPAL FINDINGS: Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks, assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018. On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716. The effects of treatments on measurements of TG using other agonists were consistent. CONCLUSIONS/SIGNIFICANCE: While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG. TRIAL REGISTRATION: ClinicalTrials.gov NCT00793754.

  12. Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Yushmanova Irina

    2011-03-01

    Full Text Available Abstract It is important for patients that treatments for diabetes not increase cardiovascular (CV risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk (RR of CV events with exenatide BID versus a pooled comparator (PC group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA1c (8.33-8.38%, BMI (31.3-31.5 kg/m2, and duration of diabetes (8 y were similar between groups. Trials included patients with histories of microvascular and/or macrovascular disease. Customized primary major adverse CV events (MACE included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR (0.7; 95% CI 0.38, 1.31, calculated by the Mantel-Haenszel method (stratified by study, suggested that exenatide use (vs. PC did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials (≤1 y, and a single active comparator (insulin. The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies. Keywords: GLP-1 receptor agonist, diabetes, cardiovascular safety

  13. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Derek Ong Lai Teik

    Full Text Available There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement.Using a double-blind, placebo controlled, crossover design, participants (N = 24 received two doses of Panax Ginseng (500, 1000 mg or Ginkgo Biloba (120, 240 mg (N = 24, and underwent a series of cognitive tests while systolic, diastolic, and heart rate readings were taken. Ginkgo Biloba improved aspects of executive functioning (Stroop and Berg tasks in females but not in males. Ginseng had no effect on cognition. Ginkgo biloba in females reversed the initial (i.e. placebo increase in cardiovascular reactivity (systolic and diastolic readings increased compared to baseline to cognitive tasks. This effect (reversal was most notable after those tasks (Stroop and Iowa that elicited the greatest cardiovascular reactivity during placebo. In males, although ginkgo also decreased cardiovascular readings, it did so from an initial (placebo blunted response (i.e. decrease or no change from baseline to cognitive tasks. Ginseng, on the contrary, increased cardiovascular readings compared to placebo.These results suggest that cardiovascular reactivity may be a mechanism by which ginkgo but not ginseng, in females is associated with certain forms of cognitive improvement.ClinicalTrials.gov NCT02386852.

  14. Visit-to-Visit Variability in Blood Pressure and Kidney and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Nephropathy

    DEFF Research Database (Denmark)

    McMullan, Ciaran J; Lambers Heerspink, Hiddo J; Parving, Hans-Henrik;

    2014-01-01

    disease outcomes. We analyzed the association of systolic blood pressure visit-to-visit variability with renal and cardiovascular morbidity and mortality among individuals with diabetes and nephropathy. STUDY DESIGN: Observational analysis of IDNT (Irbesartan Diabetic Nephropathy Trial) and the RENAAL...... (Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan) Study. SETTING & PARTICIPANTS: 2,739 participants with type 2 diabetes and nephropathy with at least 1 year of blood pressure measurements available. PREDICTORS: Systolic blood pressure visit......, but not with the cardiovascular outcome. LIMITATIONS: Observational study with the potential for confounding. CONCLUSIONS: In diabetic individuals with nephropathy, systolic blood pressure visit-to-visit variability is associated independently with hard kidney disease outcomes....

  15. Outcome Measures for Clinical Drug Trials in Autism

    Science.gov (United States)

    Aman, Michael G.; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D.; King, Bryan H.; Pearson, Deborah A.; Gernsbacher, Morton Ann; Chez, Michael

    2015-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no “perfect” choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across the age range. In trials where the intention is to alter core features of ASDs, adaptive behavior scales are also worthy of consideration. Several “behavior complexes” common to ASDs are identified, and instruments are recommended for assessment of these. Given the prevalence of cognitive impairment in ASDs, it is important to assess any cognitive effects, although cognitive data from ASD randomized clinical trials, thus far, are minimal. Guidance from trials in related pharmacologic areas and behavioral pharmacology may be helpful. We recommend routine elicitation of side effects, height and weight, vital signs, and (in the case of antipsychotics) extrapyramidal side-effects assessment. It is often appropriate to include laboratory tests and assessments for continence and sleep pattern. PMID:14999174

  16. Cardiovascular and affective outcomes of active gaming: using the nintendo wii as a cardiovascular training tool.

    Science.gov (United States)

    Naugle, Keith E; Naugle, Kelly M; Wikstrom, Erik A

    2014-02-01

    Active-video gaming is purported to produce similar cardiovascular responses as aerobic fitness activities. This study compared the emotional and cardiovascular effects of Wii games with those of traditional exercise in college-aged adults with different exercise backgrounds. Specifically, the percentage of heart rate reserve, rate of perceived exertion (RPE), level of enjoyment, and Positive and Negative Affect Schedule scores were compared between subjects who reported exercising frequently at high intensities (high-intensity exerciser group: age = 20.18 years [0.87]; Height = 165.23 cm [9.97]; Mass = 62.37 kg [11.61]), N = 11 and those who exercise more often at lower intensities (low-intensity exercisers group: age = 20.72 years [1.19]; Height = 164.39 cm [8.05]; Mass = 68.04 kg [10.71]), N = 11. The subjects completed six 20-minute exercises sessions: treadmill walking, stationary cycling, and Wii's Tennis, Boxing, Cycling, and Step. The low-intensity exerciser group achieved a greater percentage of heart rate reserve (a) during traditional exercise compared with that during Wii boxing, (b) playing Wii boxing compared with that for Wii tennis, and (c) playing Wii boxing compared with that when the high-intensity exercisers group played any Wii games (p games, particularly for individuals who typically exercise at lower intensities.

  17. Voiding trial outcome following pelvic floor repair without incontinence procedures

    Science.gov (United States)

    Wang, Rui; Won, Sara; Haviland, Miriam J.; Bargen, Emily Von; Hacker, Michele R.; Li, Janet

    2016-01-01

    Introduction and hypothesis Our aim was to identify predictors of postoperative voiding trial failure among patients who had a pelvic floor repair without a concurrent incontinence procedure in order to identify low-risk patients in whom postoperative voiding trials may be modified. Methods We conducted a retrospective cohort study of women who underwent pelvic floor repair without concurrent incontinence procedures at two institutions from 1 November 2011 through 13 October 2013 after abstracting demographic and clinical data from medical records. The primary outcome was postoperative retrograde voiding trial failure. We used modified Poisson regression to calculate the risk ratio (RR) and 95 % confidence interval (CI). Results Of the 371 women who met eligibility criteria, 294 (79.2 %) had complete data on the variables of interest. Forty nine (16.7%) failed the trial, and those women were less likely to be white (p = 0.04), more likely to have had an anterior colporrhaphy (p = 0.001), and more likely to have had a preoperative postvoid residual (PVR) ≥150 ml (p = 0.001). After adjusting for race, women were more likely to fail their voiding trial if they had a preoperative PVR of ≥150 ml (RR: 1.9; 95 % CI: 1.1–3.2); institution also was associated with voiding trial failure (RR: 3.0; 95 % CI: 1.6–5.4). Conclusions Among our cohort, postoperative voiding trial failure was associated with a PVR of ≥150 ml and institution at which the surgery was performed. PMID:26886553

  18. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

    Science.gov (United States)

    Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emilio H; Bruscato, Neide M; Kesties; Vivian, Lilian; Schumacher, Marina; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Rodrigues, Milena P; Baldissera, Dúnnia M B; Tres, Glaucia S; Lisbôa, Hugo R K; Bem, João B J; Reolão, Jose B C; Deucher, Keyla L A L; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa; Torres, Rosileide S; Verríssimo, Adriana O L; Guterres, Aldair S; Cardos, Andrea F R; Coutinho, Dalva B S; Negrão, Mayara G; Alencar, Mônica F A; Pinho, Priscila M; Barbosa, Socorro N A A; Carvalho, Ana P P F; Taboada, Maria I S; Pereira, Sheila A; Heyde, Raul V; Nagano, Francisca E Z; Baumgartner, Rebecca; Resende, Fernanda P; Tabalipa, Ranata; Zanini, Ana C; Machado, Michael J R; Araujo, Hevila; Teixeira, Maria L V; Souza, Gabriela C; Zuchinali, Priccila; Fracasso, Bianca M; Ulliam, Karen; Schumacher, Marina; Pierotto, Moara; Hilário, Thamires; Carlos, Daniele M O; Cordeiro, Cintia G N C; Carvalho, Daniele A; Gonçalves, Marília S; Vasconcelos, Valdiana B; Bosquetti, Rosa; Pagano, Raira; Romano, Marcelo L P; Jardim, César A; de Abreu, Bernardo N A; Marcadenti, Aline; Schmitt, Alessandra R; Tavares, Angela M V; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Trescastro, Eduardo P; Pellegrini, Lívia A; Pinto, Jéssika C; Telles, Cristina T; Sousa, Antonio C S; Almeida, Andreza S; Costa, Ariane A; Carmo, José A C; Silva, Juliana T; Alves, Luciana V S; Sales, Saulo O C; Ramos, Maria E M; Lucas, Marilia C S; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana M P; Lucena, Ana C A; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma M F S; Baía, Sandra R D; Pinheiro, Josilene M F; Cassiano, Alexandra N; Melo, Andressa N L; Cavalcanti, Anny K O; Souza, Camila V S; Queiroz, Dayanna J M; Farias, Hercilla N C F; Souza, Larissa C F; Santos, Letícia S; Lima, Luana R M; Hoffmann, Meg S; Ribeiro, Átala S Silva; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José A F; Santos, Alexsandro F; Sousa, Rosângela M L; Dias, Luciana Pereira P; Lima, Maria T M A; Modanesi, Victor G; Teixeira, Adriana F; Estrada, Luciana C N C D; Modanesi, Paulo V G; Gomes, Adriana B L; Rocha, Bárbara R S; Teti, Cristina; David, Marta M; Palácio, Bruna M; Junior, Délcio G S; Faria, Érica H S; Oliveira, Michelle C F; Uehara, Rose M; Sasso, Sandramara; Moreira, Annie S B; Cadinha, Ana C A H; Pinto, Carla W M; Castilhos, Mariana P; Costa, Mariana; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele F C A; da Silva, Renata A; Monteiro, Aline S; dos Santos, Karina G; Moreira, Priscila; Amparo, Fernanda C; Paiva, Catharina C J; Poloni, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Moreira, Annie S B; Damaceno, Aline M S; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia P S; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília M S; Reis, Nailson A; Vasconcelos, Sandra M L; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica M S; Neto, Juvenal G C; Navarro, Laís N P; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kato, Juliana T; Izar, Maria C O; Asoo, Marina T; de Capitani, Mariana D; Machado, Valéria A; Fonzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia H A; Machado, Sheila D; de Oliveira, Susane R U; Bressan, Josefina; Caldas, Ana P S; Lima, Hatanne C F M; Hermsdorff, Helen H M; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Neves, Adila de Queiroz; Cheim, Loanda M G; Silva, Nilma F; Reis, Silvia R L; Penafort, Andreza M; de Queirós, Ana Paula O; Farias, Geysa M N; de los Santos, Mônica L P; Ambrozio, Cíntia L; Camejo, Cirília N; dos Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Oliveira, Rosane E C; Lima, Súsi M B; Bortolini, Vera M S

    2016-01-01

    This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease.

  19. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R;

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics an...

  20. The impact of initial statin treatment decisions on cardiovascular outcomes in clinical care settings: estimates using the Archimedes Model

    Directory of Open Access Journals (Sweden)

    van Herick A

    2012-11-01

    Full Text Available Andrew van Herick,1 C Andy Schuetz,1 Peter Alperin,1 Michael Bullano,2 Sanjeev Balu,2 Sanjay Gandhi21Archimedes, Inc, San Francisco, CA, USA; 2AstraZeneca Pharmaceuticals LP, Wilmington, DE, USAPurpose: Many patients treated for dyslipidemia do not achieve recommended cholesterol goals despite the widespread availability of effective statins. Pharmaceutical claims show a strong tendency for patients to remain on their initially assigned treatment. With computer simulations, the impact of initial statin treatment decisions on medium- and long-term cardiovascular outcomes were examined.Patients and methods: Using the Archimedes Model, three treatment scenarios were simulated. Patients initiated treatment with simvastatin (20, 40, or 80 mg, atorvastatin (10, 20, 40, or 80 mg, or rosuvastatin (10, 20, or 40 mg, and periodically intensified treatment. The simulated population consisted of 50,025 patients, aged 45–70 years, with low-density lipoprotein cholesterol exceeding goal. The proportion of patients initiating each dose was calibrated to United States pharmacy claims. Patients not reaching goal intensified the dose of their current statin or switched to an appropriate dose of rosuvastatin at rates matching pharmacy claims. Biomarkers and major adverse cardiovascular events (MACE were tracked for 10 years and several high-risk subpopulations were analyzed. Statin models used biomarker effects from the STELLAR (Statin Therapies for Elevated Lipid Levels Compared Across Doses to Rosuvastatin trial and outcomes data from various trials.Results: Initiating therapy with rosuvastatin reduced MACE more than simvastatin or atorvastatin. The 5- year relative risk of MACE was 0.906 (95% confidence interval: 0.888–0.923; P < 0.001 for initial treatment with atorvastatin rather than simvastatin, 0.831 (0.812–0.850; P < 0.001 for rosuvastatin rather than simvastatin, and 0.918 (0.898–0.938; P < 0.001 for rosuvastatin rather than atorvastatin

  1. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics...... and beta blockers. Our aim, therefore, was to compare the effect on non-fatal myocardial infarction and fatal CHD of combinations of atenolol with a thiazide versus amlodipine with perindopril....

  2. Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib.

    Science.gov (United States)

    White, William B; Faich, Gerald; Borer, Jeffrey S; Makuch, Robert W

    2003-08-15

    To determine whether the cyclooxygenase-2 (COX-2) inhibitor celecoxib affects cardiovascular thrombotic risk, we analyzed the incidence of cardiovascular events for celecoxib, placebo, and nonsteroidal anti-inflammatory drugs (NSAIDs) in the entire controlled, arthritis clinical trial database for celecoxib. The primary analysis used the Antiplatelet Trialists' Collaboration end points, which include: (1) cardiovascular, hemorrhagic, and unknown deaths, (2) nonfatal myocardial infarction, and (3) nonfatal stroke. Other secondary thrombotic events were also examined. Separate analyses were performed for all patients and for those not taking aspirin. Data from all controlled, completed arthritis trials of > or =4 weeks duration, including 13 new drug application studies and 2 large post-marketing trials (CLASS and SUCCESS) were included for analyses. Patients were randomized to celecoxib at doses from 100 to 400 mg twice daily (18,942 patients; 5,668.2 patient-years of exposure), diclofenac 50 to 75 mg twice daily, ibuprofen 800 mg thrice daily, naproxen 500 mg twice daily (combined NSAID exposure of 11,143 patients; 3,612.2 patient-years), or placebo (1,794 subjects; 199.9 subject-years). Data from a long-term uncontrolled trial with 5,209 patients (6,950 patients-years) treated with celecoxib were included in a supplemental analysis. The entire 15-trial database was searched for possible serious thrombotic events as well as to identify all deaths. For these patients, detailed clinical data were obtained and reviewed by 2 of the investigators (WBW and JSB), who were independently and blinded to exposure, to classify the event as primary, secondary, or neither. All analyses were done using the intent-to-treat population, and time-to-event analyses were performed using per-patient data. To examine heterogeneity of results among studies, tests of interaction were performed using the Cox model. Incidences of the primary and secondary events were not significantly

  3. Innovative pharmaceutical interventions in cardiovascular disease: Focusing on the contribution of non-HDL-C/LDL-C-lowering versus HDL-C-raisingA systematic review and meta-analysis of relevant preclinical studies and clinical trials

    NARCIS (Netherlands)

    Kühnast, S.; Fiocco, M.; Hoorn, J.W.A. van der; Princen, H.M.G.; Jukema, J.W.

    2015-01-01

    Non-HDL-cholesterol is well recognised as a primary causal risk factor in cardiovascular disease. However, despite consistent epidemiological evidence for an inverse association between HDL-C and coronary heart disease, clinical trials aimed at raising HDL-C (AIM-HIGH, HPS2-THRIVE, dal-OUTCOMES) fai

  4. Association of variants in NEDD4L with blood pressure response and adverse cardiovascular outcomes in hypertensive patients treated with thiazide diuretics

    Science.gov (United States)

    McDonough, Caitrin W.; Burbage, Sarah E.; Duarte, Julio D.; Gong, Yan; Langaee, Taimour Y.; Turner, Stephen T.; Gums, John G.; Chapman, Arlene B.; Bailey, Kent R.; Beitelshees, Amber L.; Boerwinkle, Eric; Pepine, Carl J.; Cooper-DeHoff, Rhonda M.; Johnson, Julie A.

    2013-01-01

    Objective Single-nucleotide polymorphisms (SNPs) in NEDD4L may influence the ability of the NEDD4L protein to reduce epithelial sodium channel expression. A variant in NEDD4L, rs4149601, was associated with antihypertensive response and cardiovascular outcomes during treatment with thiazide diuretics and β-blockers in a Swedish population. We sought to further evaluate associations between NEDD4L polymorphisms, blood pressure response and cardiovascular outcomes with thiazide diuretics and β-blockers. Methods Four SNPs, rs4149601, rs292449, rs1008899 and rs75982813, were genotyped in 767 patients from the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) clinical trial and association was assessed with blood pressure response to hydrochlorothiazide and atenolol. One SNP, rs4149601, was also genotyped in 1345 patients from the International Verapmil SR Trandolapril Study (INVEST), and association was examined with adverse cardiovascular outcomes relative to hydrochlorothiazide treatment. Results Significant associations or trends were found between rs4149601, rs292449, rs75982813 and rs1008899 and decreases in blood pressure in whites on hydrochlorothiazide, and a significant association was observed with increasing copies of the GC rs4149601-rs292449 haplotype and greater blood pressure response to hydrochlorothiazide in whites (P = 0.0006 and 0.006, SBP and DBP, respectively). Significant associations were also seen with rs4149601 and an increased risk for adverse cardiovascular outcomes in whites not treated with hydrochlorothiazide [P = 0.022, odds ratio (95% confidence interval) = 10.65 (1.18–96.25)]. Conclusion NEDD4L rs4149601, rs292449 and rs75982813 may be predictors for blood pressure response to hydrochlorothiazide in whites, and NEDD4L rs4149601 may be a predictor for adverse cardiovascular outcomes in whites not treated with hydrochlorothiazide. PMID:23353631

  5. Progression of Blood Pressure and Cardiovascular Outcomes in Hypertensive Patients in a Reference Center.

    Science.gov (United States)

    Guimarães Filho, Gilberto Campos; Sousa, Ana Luiza Lima; Jardim, Thiago de Souza Veiga; Souza, Weimar Sebba Barroso; Jardim, Paulo César Brandão Veiga

    2015-02-03

    Background: Hypertension is a public health problem, considering its high prevalence, low control rate and cardiovascular complications. Objective: Evaluate the control of blood pressure (BP) and cardiovascular outcomes in patients enrolled at the Reference Center for Hypertension and Diabetes, located in a medium-sized city in the Midwest Region of Brazil. Methods: Population-based study comparing patients enrolled in the service at the time of their admission and after an average follow-up of five years. Participants were aged ≥18 years and were regularly monitored at the Center up to 6 months before data collection. We assessed demographic variables, BP, body mass index, risk factors, and cardiovascular outcomes. Results: We studied 1,298 individuals, predominantly women (60.9%), and with mean age of 56.7±13.1 years. Over time, there was a significant increase in physical inactivity, alcohol consumption, diabetes, dyslipidemia, and excessive weight. As for cardiovascular outcomes, we observed an increase in stroke and myocardial revascularization, and a lower frequency of chronic renal failure. During follow-up, there was significant improvement in the rate of BP control (from 29.6% to 39.6%; p = 0.001) and 72 deaths, 91.7% of which were due to cardiovascular diseases. Conclusion: Despite considerable improvements in the rate of BP control during follow-up, risk factors worsened and cardiovascular outcomes increased.Fundamento: A hipertensão arterial é um problema de saúde pública devido à sua elevada prevalência, baixa taxa de controle e complicações cardiovasculares. Objetivo: Avaliar o controle da pressão arterial (PA) e desfechos cardiovasculares em pacientes atendidos no Centro de Referência em Hipertensão e Diabetes, localizado em uma cidade de médio porte da Região Centro-Oeste do Brasil. Métodos: Estudo de base populacional, que comparou pacientes matriculados no serviço no momento de sua admissão e após seguimento por período m

  6. Cardiovascular effects of cholecalciferol treatment in dialysis patients – a randomized controlled trial

    OpenAIRE

    2014-01-01

    Background Patients on chronic dialysis are at increased risk of vitamin D deficiency. In observational studies plasma 25-hydroxyvitamin D (p-25(OH) D) levels are inversely correlated with plasma BNP and adverse cardiovascular outcomes. Whether a causal relation exists has yet to be established. The aim of this study was to test the hypothesis that cholecalciferol supplementation improves cardiac function and reduces blood pressure (BP) and pulse wave velocity (PWV) in patients on chronic dia...

  7. The Anglo-Scandinavian Cardiac Outcomes Trial: blood pressure-lowering limb: effects in patients with type II diabetes

    DEFF Research Database (Denmark)

    Ostergren, Jan; Poulter, Neil R; Sever, Peter S;

    2008-01-01

    OBJECTIVE: To compare the effects of two antihypertensive treatment strategies for the prevention of coronary heart disease and other cardiovascular events in the large subpopulation (n=5137) with diabetes mellitus in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial...... by 48% (P=0.004) and noncoronary revascularization procedures by 57% (Pdeaths and nonfatal myocardial infarctions (the primary endpoint), which were reduced...... nonsignificantly by 8% (hazard ratio 0.92, confidence interval 0.74-1.15). CONCLUSION: In the large diabetic subgroup in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial, the benefits of amlodipine-based treatment, compared with atenolol-based treatment, on the incidence of total...

  8. Improving cardiovascular outcomes among Aboriginal Australians: Lessons from research for primary care

    Directory of Open Access Journals (Sweden)

    Sandra C Thompson

    2016-11-01

    Full Text Available Background: The Aboriginal people of Australia have much poorer health and social indicators and a substantial life expectancy gap compared to other Australians, with premature cardiovascular disease a major contributor to poorer health. This article draws on research undertaken to examine cardiovascular disparities and focuses on ways in which primary care practitioners can contribute to reducing cardiovascular disparities and improving Aboriginal health. Methods: The overall research utilised mixed methods and included data analysis, interviews and group processes which included Aboriginal people, service providers and policymakers. Workshop discussions to identify barriers and what works were recorded by notes and on whiteboards, then distilled and circulated to participants and other stakeholders to refine and validate information. Additional engagement occurred through circulation of draft material and further discussions. This report distils the lessons for primary care practitioners to improve outcomes through management that is attentive to the needs of Aboriginal people. Results: Aspects of primordial, primary and secondary prevention are identified, with practical strategies for intervention summarised. The premature onset and high incidence of Aboriginal cardiovascular disease make prevention imperative and require that primary care practitioners understand and work to address the social underpinnings of poor health. Doctors are well placed to reinforce the importance of healthy lifestyle at all visits to involve the family and to reduce barriers which impede early care seeking. Ensuring better information for Aboriginal patients and better integrated care for patients who frequently have complex needs and multi-morbidities will also improve care outcomes. Conclusion: Primary care practitioners have an important role in improving Aboriginal cardiovascular care outcomes. It is essential that they recognise the special needs of their

  9. Basic fibroblast growth factor predicts cardiovascular disease occurrence in participants from the Veterans Affairs Diabetes Trial

    Directory of Open Access Journals (Sweden)

    Mark B Zimering

    2013-11-01

    Full Text Available Aim: Cardiovascular disease is a leading cause of morbidity and mortality in adults with type 2 diabetes mellitus. The aim of the present study was to test whether plasma basic fibroblast growth factor (bFGF levels predict future cardiovascular disease (CVD occurrence in adults from the Veterans Affairs Diabetes Trial. Methods: Nearly four- hundred veterans, 40 years of age or older, having a mean baseline diabetes duration of 11.4 years were recruited from outpatient clinics at six geographically distributed sites in the Veterans Affairs Diabetes Trial (VADT. Within the VADT, they were randomly assigned to intensive or standard glycemic treatment, with follow-up as much as seven and one-half years. Cardiovascular disease occurrence was examined at baseline in the patient population and during randomized treatment. Plasma bFGF was determined with a sensitive, specific two-site enzyme-linked immunoassay at the baseline study visit in all 399 subjects. Results: One hundred-five first cardiovascular events occurred in these 399 subjects. The best fit model of risk factors associated with the time to first cardiovascular disease occurrence (in the study over a seven and one-half year period had as significant predictors: prior cardiovascular event, (hazard ratio [HR] 3.378; 95% confidence intervals [CI] 3.079- 3.807; P < .0001, baseline plasma bFGF (HR 1.008; 95% CI 1.002-1.014; P =.01, age, (HR 1.027; 95% CI 1.004-1.051; P =.019, baseline plasma triglycerides, (HR 1.001; 95% CI 1.000-1.002; P =.02 and diabetes duration-treatment interaction (P =.03. Intensive glucose-lowering was associated with significantly decreased hazard ratios for CVD occurrence (0.38-0.63 in patients with known diabetes duration of 0-10 years, and non-significantly increased hazard ratios for CVD occurrence (0.82-1.78 in patients with longer diabetes duration. Conclusion: High level ofplasma basic fibroblast growth factor is a predictive biomarker of future cardiovascular

  10. Exercise on Prescription: trial protocol and evaluation of outcomes

    Directory of Open Access Journals (Sweden)

    Puggaard Lis

    2007-03-01

    Full Text Available Abstract Background In many countries exercise prescriptions are used in an attempt to initiate a physically active lifestyle in sedentary populations. Previous studies have primarily evaluated low intensive exercise prescription interventions and found moderately positive effects on physical activity and aerobic fitness. In a highly intensive Danish exercise prescription scheme called 'Exercise on Prescription' (EoP the general practitioners can prescribe EoP to sedentary patients with lifestyle diseases. The aim of this randomized trial is to assess the short- and long-term effects of the EoP scheme. Thus, the aim of this paper is to describe the randomized controlled trial designed for evaluating effectiveness of EoP, and to present results from validations of outcome measures. Methods/Design EoP involves a 16-week supervised training intervention and five counselling sessions (health profiles. All patients referred to EoP were eligible for the trial and were offered participation during the baseline health profile. Comparisons between the EoP group and the control group were made at baseline, and after four and ten months. Physiological measures used were maximal oxygen uptake (VO2max, glycosylated haemoglobin (HbA1c, bodyweight, and BMI. Patient-reported measures used were physical activity, health-related quality of life, amount and intensity of exercise, compliance with national guidelines for physical activity, and physical fitness. The validation of the cycle ergometer test found a strong correlation between maximal work capacity and VO2max, and acceptable test-retest reliability at group level. Calibration of the HbA1c apparatus was stable over ten weeks with minimal use, and test-retest reliability was good. High agreement percents were found for test-retest reliability for the self-administered questionnaire. Discussion The trial is designed to provide information about the effectiveness of the EoP scheme. The trial is part of a

  11. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

    Directory of Open Access Journals (Sweden)

    Kayambu Geetha

    2011-10-01

    Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

  12. Imputation strategies for missing binary outcomes in cluster randomized trials

    Directory of Open Access Journals (Sweden)

    Akhtar-Danesh Noori

    2011-02-01

    Full Text Available Abstract Background Attrition, which leads to missing data, is a common problem in cluster randomized trials (CRTs, where groups of patients rather than individuals are randomized. Standard multiple imputation (MI strategies may not be appropriate to impute missing data from CRTs since they assume independent data. In this paper, under the assumption of missing completely at random and covariate dependent missing, we compared six MI strategies which account for the intra-cluster correlation for missing binary outcomes in CRTs with the standard imputation strategies and complete case analysis approach using a simulation study. Method We considered three within-cluster and three across-cluster MI strategies for missing binary outcomes in CRTs. The three within-cluster MI strategies are logistic regression method, propensity score method, and Markov chain Monte Carlo (MCMC method, which apply standard MI strategies within each cluster. The three across-cluster MI strategies are propensity score method, random-effects (RE logistic regression approach, and logistic regression with cluster as a fixed effect. Based on the community hypertension assessment trial (CHAT which has complete data, we designed a simulation study to investigate the performance of above MI strategies. Results The estimated treatment effect and its 95% confidence interval (CI from generalized estimating equations (GEE model based on the CHAT complete dataset are 1.14 (0.76 1.70. When 30% of binary outcome are missing completely at random, a simulation study shows that the estimated treatment effects and the corresponding 95% CIs from GEE model are 1.15 (0.76 1.75 if complete case analysis is used, 1.12 (0.72 1.73 if within-cluster MCMC method is used, 1.21 (0.80 1.81 if across-cluster RE logistic regression is used, and 1.16 (0.82 1.64 if standard logistic regression which does not account for clustering is used. Conclusion When the percentage of missing data is low or intra

  13. Cardiovascular magnetic resonance imaging assessment of outcomes in acute myocardial infarction

    Science.gov (United States)

    Khan, Jamal N; McCann, Gerry P

    2017-01-01

    Cardiovascular magnetic resonance (CMR) imaging uniquely characterizes myocardial and microvascular injury in acute myocardial infarction (AMI), providing powerful surrogate markers of outcomes. The last 10 years have seen an exponential increase in AMI studies utilizing CMR based endpoints. This article provides a contemporary, comprehensive review of the powerful role of CMR imaging in the assessment of outcomes in AMI. The theory, assessment techniques, chronology, importance in predicting left ventricular function and remodelling, and prognostic value of each CMR surrogate marker is described in detail. Major studies illustrating the importance of the markers are summarized, providing an up to date review of the literature base in CMR imaging in AMI. PMID:28289525

  14. Cardiovascular risk reduction by reversing endothelial dysfunction: ARBs, ACE inhibitors,  or both? Expectations from The ONTARGET  Trial Programme

    Directory of Open Access Journals (Sweden)

    Luis Miguel  Ruilope

    2007-03-01

    Full Text Available Luis Miguel  Ruilope1, Josep Redón2, Roland Schmieder31Servicio de Nefrologia, Unidad de Hipertension Hospital, 12 de Octubre, Madrid, Spain; 2Department of Internal Medicine, Hospital Clinico University of Valencia, Valencia, Spain; 3Department of Nephrology and Hypertension, Friedrich-Alexander-Universitat, Erlangen-Nurnberg, GermanyAbstract: Endothelial dysfunction is the initial pathophysiological step in a progression of vascular damage that leads to overt cardiovascular and chronic kidney disease. Angiotensin II, the primary agent of the renin–angiotensin system (RAS, has a central role in endothelial dysfunction. Therefore, RAS blockade with an angiotensin receptor blocker (ARB and/or angiotensin-converting enzyme (ACE inhibitor provides a rational approach to reverse endothelial dysfunction, reduce microalbuminuria, and, thus, improves cardiovascular and renal prognosis. ARBs and ACE inhibitors act at different points in the RAS pathway and recent evidence suggests that there are differences regarding their effects on endothelial dysfunction. In addition to blood pressure lowering, studies have shown that ARBs reduce target-organ damage, including improvements in endothelial dysfunction, arterial stiffness, the progression of renal dysfunction in patients with type 2 diabetes, proteinuria, and left ventricular hypertrophy. The ONgoing Telmisartan Alone in combination with Ramipril Global Endpoint Trial (ONTARGET Programme is expected to provide the ultimate evidence of whether improved endothelial func tion translates into reduced cardiovascular and renal events in high-risk patients, and to assess possible differential outcomes with telmisartan, the ACE inhibitor ramipril, or a combination of both (dual RAS blockade. Completion of ONTARGET is expected in 2008. Keywords: angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, endothelial dysfunction, ONTARGET, renin–angiotensin system, telmisartan

  15. Effect of lowering blood pressure on cardiovascular events and mortality in patients on dialysis : a systematic review and meta-analysis of randomised controlled trials

    NARCIS (Netherlands)

    Heerspink, HiddoJ Lambers; Ninomiya, Toshiharu; Zoungas, Sophia; de Zeeuw, Dick; Grobbee, Diederick E.; Jardine, Meg J.; Gallagher, Martin; Roberts, Matthew A.; Cass, Alan; Neal, Bruce; Perkovic, Vlado

    2009-01-01

    Background Patients undergoing dialysis have a substantially increased risk of cardiovascular mortality and morbidity. Although several trials have shown the cardiovascular benefits of lowering blood pressure in the general population, there is uncertainty about the efficacy and tolerability of redu

  16. Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

    Science.gov (United States)

    2014-10-01

    Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand...PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate measures in persons with chronic

  17. An international randomised placebo-controlled trial of a four-component combination pill ("polypill" in people with raised cardiovascular risk.

    Directory of Open Access Journals (Sweden)

    Anthony Rodgers

    Full Text Available BACKGROUND: There has been widespread interest in the potential of combination cardiovascular medications containing aspirin and agents to lower blood pressure and cholesterol ('polypills' to reduce cardiovascular disease. However, no reliable placebo-controlled data are available on both efficacy and tolerability. METHODS: We conducted a randomised, double-blind placebo-controlled trial of a polypill (containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg in 378 individuals without an indication for any component of the polypill, but who had an estimated 5-year cardiovascular disease risk over 7.5%. The primary outcomes were systolic blood pressure (SBP, LDL-cholesterol and tolerability (proportion discontinued randomised therapy at 12 weeks follow-up. FINDINGS: At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to 12.1 mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9 mmol/L. The discontinuation rates in the polypill group compared to placebo were 23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00, p = 0.2. There was an excess of side effects known to the component medicines (58% vs 42%, p = 0.001, which was mostly apparent within a few weeks, and usually did not warrant cessation of trial treatment. CONCLUSIONS: This polypill achieved sizeable reductions in SBP and LDL-cholesterol but caused side effects in about 1 in 6 people. The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher. Nonetheless, substantial net benefits would be expected among patients at high risk. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12607000099426.

  18. The effect of different cardiovascular risk presentation formats on intentions, understanding and emotional affect: a randomised controlled trial using a web-based risk formatter (protocol

    Directory of Open Access Journals (Sweden)

    Newcombe Robert

    2010-07-01

    Full Text Available Abstract Background The future risk of heart disease can be predicted with increasing precision. However, more research is needed into how this risk is conveyed and presented. The aim of this study is to compare the effects of presenting cardiovascular risk in different formats on individuals' intention to change behaviour to reduce risk, understanding of risk information and emotional affect. Methods/design A randomised controlled trial comprising four arms, with a between subjects design will be performed. There will be two intervention groups and two control groups. The first control comprises a pre-intervention questionnaire and presents risk in a bar graph format. The second control presents risk in a bar graph format without pre-intervention questionnaire. These two control groups are to account for the potential Hawthorne effect of thinking about cardiovascular risk before viewing actual risk. The two intervention groups comprise presenting risk in either a pictogram or metonym format (image depicting seriousness of having a myocardial infarction. 800 individuals' aged between 45 and 64 years, who have not been previously diagnosed with heart disease and have access to a computer with internet, will be given a link to a website comprising a risk calculator and electronic questionnaires. 10-year risk of having a coronary heart disease event will be assessed and presented in one of the three formats. A post-intervention questionnaire will be completed after viewing the risk format. Main outcome measures are (i intention to change behaviour, (ii understanding of risk information, (iii emotional affect and (iv worry about future heart disease. Secondary outcomes are the sub-components of the theory of planned behaviour: attitudes, perceived behavioural control and subjective norms. Discussion Having reviewed the literature, we are not aware of any other studies which have used the assessment of actual risk, in a trial to compare different

  19. Remote health monitoring: predicting outcome success based on contextual features for cardiovascular disease.

    Science.gov (United States)

    Alshurafa, Nabil; Eastwood, Jo-Ann; Pourhomayoun, Mohammad; Liu, Jason J; Sarrafzadeh, Majid

    2014-01-01

    Current studies have produced a plethora of remote health monitoring (RHM) systems designed to enhance the care of patients with chronic diseases. Many RHM systems are designed to improve patient risk factors for cardiovascular disease, including physiological parameters such as body mass index (BMI) and waist circumference, and lipid profiles such as low density lipoprotein (LDL) and high density lipoprotein (HDL). There are several patient characteristics that could be determining factors for a patient's RHM outcome success, but these characteristics have been largely unidentified. In this paper, we analyze results from an RHM system deployed in a six month Women's Heart Health study of 90 patients, and apply advanced feature selection and machine learning algorithms to identify patients' key baseline contextual features and build effective prediction models that help determine RHM outcome success. We introduce Wanda-CVD, a smartphone-based RHM system designed to help participants with cardiovascular disease risk factors by motivating participants through wireless coaching using feedback and prompts as social support. We analyze key contextual features that secure positive patient outcomes in both physiological parameters and lipid profiles. Results from the Women's Heart Health study show that health threat of heart disease, quality of life, family history, stress factors, social support, and anxiety at baseline all help predict patient RHM outcome success.

  20. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction

    DEFF Research Database (Denmark)

    O'Donoghue, Michelle L; Glaser, Ruchira; Cavender, Matthew A

    2016-01-01

    IMPORTANCE: p38 Mitogen-activated protein kinase (MAPK)-stimulated inflammation is implicated in atherogenesis, plaque destabilization, and maladaptive processes in myocardial infarction (MI). Pilot data in a phase 2 trial in non-ST elevation MI indicated that the p38 MAPK inhibitor losmapimod...... potentially eligible for enrollment if they had been hospitalized with an acute MI and had at least 1 additional predictor of cardiovascular risk. INTERVENTIONS: Patients were randomized to either twice-daily losmapimod (7.5 mg; n = 1738) or matching placebo (n = 1765) on a background of guideline...

  1. Core domain and outcome measurement sets for shoulder pain trials are needed: Systematic review of physical therapy trials

    NARCIS (Netherlands)

    M.J. Page (Matthew J.); J.E. McKenzie (Joanne E.); S.E. Green (Sally E.); D.E. Beaton (Dorcas E.); N.B. Jain (Nitin B.); M. Lenza (Mario); A.P. Verhagen (Arianne P.); S. Surace (Stephen); J. Deitch (Jessica); R. Buchbinder (Rachelle)

    2015-01-01

    textabstractObjectives To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). Study Design and Setting We included tri

  2. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    Science.gov (United States)

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  3. The effects of cinacalcet on blood pressure, mortality and cardiovascular endpoints in the EVOLVE trial.

    Science.gov (United States)

    Chang, T I; Abdalla, S; London, G M; Block, G A; Correa-Rotter, R; Drüeke, T B; Floege, J; Herzog, C A; Mahaffey, K W; Moe, S M; Parfrey, P S; Wheeler, D C; Dehmel, B; Goodman, W G; Chertow, G M

    2016-03-01

    Patients with end-stage renal disease often have derangements in calcium and phosphorus homeostasis and resultant secondary hyperparathyroidism (sHPT), which may contribute to the high prevalence of arterial stiffness and hypertension. We conducted a secondary analysis of the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial, in which patients receiving hemodialysis with sHPT were randomly assigned to receive cinacalcet or placebo. We sought to examine whether the effect of cinacalcet on death and major cardiovascular events was modified by baseline pulse pressure as a marker of arterial stiffness, and whether cinacalcet yielded any effects on blood pressure. As reported previously, an unadjusted intention-to-treat analysis failed to conclude that randomization to cinacalcet reduces the risk of the primary composite end point (all-cause mortality or non-fatal myocardial infarction, heart failure, hospitalization for unstable angina or peripheral vascular event). However, after prespecified adjustment for baseline characteristics, patients randomized to cinacalcet experienced a nominally significant 13% lower adjusted risk (95% confidence limit 4-20%) of the primary composite end point. The effect of cinacalcet was not modified by baseline pulse pressure (Pinteraction=0.44). In adjusted models, at 20 weeks cinacalcet resulted in a 2.2 mm Hg larger average decrease in systolic blood pressure (P=0.002) and a 1.3 mm Hg larger average decrease in diastolic blood pressure (P=0.002) compared with placebo. In summary, in the EVOLVE trial, the effect of cinacalcet on death and major cardiovascular events was independent of baseline pulse pressure.

  4. Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention

    Institute of Scientific and Technical Information of China (English)

    Guo-Shuang Feng; Harry HX Xia; Ji-You Li; Shiu Kum Lam; Wei-Cheng You; Jun-Ling Ma; Benjamin CY Wong; Lian Zhang; Wei-Dong Liu; Kai-Feng Pan; Lin Shen; Xiao-Dong Zhang; Jie Li

    2008-01-01

    AIM: To evaluate the long-term risk of gastroduodenal ulcer and cardiovascular events induced by celecoxib in a population-based, randomized, double-blind,placebo-controlled study.METHODS: From 2004 to 2006, a total of 1024 Chinese patients (aged 35 to 64 years) with severe chronic atrophic gastritis, intestinal metaplasia or dysplasia were randomly assigned to receive 200 mg of celecoxib twice daily or placebo in Linqu County (Shandong Province, China), a high-risk area of gastric cancer. All gastroduodenal ulcer and cardiovascular events occurred were recorded and the patients were followed up for 1.5 years after treatment. At the end of the trial, a systematic interview survey about other adverse events was conducted.RESULTS: Gastroduodenal ulcer was detected in 19 of 463 (3.72%) patients who Received: celecoxib and 17 of 473 (3.31%) patients who Received placebo,respectively (odds ratio = 1.13, 95% CI = 0.58-2.19).Cardiovascular (CV) events occurred in 4 patients who received celecoxib and in 5 patients who received placebo,respectively.Compared with those who received placebo,patients who received celecoxib had no significant increase in occurrence of Cvevents (hazard ratio = 0.84,95% CI =0.23-3.15).Among the adverse events acquired by interview survey,only the frequency of bloating was significantly higher in patients treated with celecoxib than in those treated with placebo.CONCLUSION:Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.

  5. Heart rate control with adrenergic blockade: Clinical outcomes in cardiovascular medicine

    Directory of Open Access Journals (Sweden)

    David Feldman

    2010-05-01

    Full Text Available David Feldman1, Terry S Elton2, Doron M Menachemi3, Randy K Wexler41Heart Failure/Transplant and VAD Programs, Minneapolis Heart Institute, Minneapolis, Minnesota, USA; 2Division of Pharmacology, College of Pharmacology, The Ohio State University, Columbus, Ohio, USA; 3Heart Failure Services, Edith Wolfson Medical Center, The Heart Institute, Sakler School of Medicine, Tel-Aviv University, Holon, Israel; 4Department of Clinical Family Medicine, The Ohio State University, Columbus, Ohio, USAAbstract: The sympathetic nervous system is involved in regulating various cardiovascular parameters including heart rate (HR and HR variability. Aberrant sympathetic nervous system expression may result in elevated HR or decreased HR variability, and both are independent risk factors for development of cardiovascular disease, including heart failure, myocardial infarction, and hypertension. Epidemiologic studies have established that impaired HR control is linked to increased cardiovascular morbidity and mortality. One successful way of decreasing HR and cardiovascular mortality has been by utilizing β-blockers, because their ability to alter cell signaling at the receptor level has been shown to mitigate the pathogenic effects of sympathetic nervous system hyperactivation. Numerous clinical studies have demonstrated that β-blocker-mediated HR control improvements are associated with decreased mortality in postinfarct and heart failure patients. Although improved HR control benefits have yet to be established in hypertension, both traditional and vasodilating β-blockers exert positive HR control effects in this patient population. However, differences exist between traditional and vasodilating β-blockers; the latter reduce peripheral vascular resistance and exert neutral or positive effects on important metabolic parameters. Clinical evidence suggests that attainment of HR control is an important treatment objective for patients with cardiovascular

  6. [The outcome of trial of labor after cesarean section].

    Science.gov (United States)

    Qu, Z Q; Ma, R M; Xiao, H; Tian, Y Q; Li, B L; Liang, K; Du, M Y; Chen, Z; Geng, L; Yang, M H; Tao, Y P; Zhu, B

    2016-10-25

    Objective: To explore the outcome of trial of labor after cesarean section(TOLAC). Methods: Totally 614 TOLAC were conducted in the First Affiliated Hospital of Kunming Medical University from July 2013 to June 2016. Among them, 586 cases of singleton pregnancy with one prior cesarean section(gestational age≥28 weeks)were studied retrospectively. The maternal and neonatal outcomes among the vaginal birth after cesarean(VBAC)group(481 cases), failed TOLAC group(105 cases)and the elective repeat cesarean section(ERCS)group(1 145 cases)were compared. Multiple logistic regression was used to determine the risk factors of admission to neonatal intensive care unit(NICU). Results: (1)The TOLAC rate was 29.62%(614/2 073)from July 2013 to June 2016, and the VBAC rate was 82.6%(507/614). The cesarean section rate was reduced by VBAC by 3.147%(507/16 112).(2)The comparison of adverse maternal outcomes: in the VBAC group, the postpartum hemorrhage volume was(431±299)ml, the rate of postpartum fever was 6.4%(31/481), the birth weight of the neonates was(3 085± 561)g, and the rate of large for gestational age was 2.9%(14/481). All were significantly lower than those in the failed TOLAC group and the ERCS group(P0.05). Multiple logistic regression showed no association between VBAC and admission to the NICU(OR=0.84, 95%CI: 0.58-1.21). The isolated risk factors for admission to the NICU were preterm birth(OR=16.71, 95% CI: 11.44-24.40), hypertensive disorder complicating pregnamcy(OR=3.89, 95% CI: 2.39-6.35), meconium stained amniotic fluid(OR=2.48, 95% CI: 1.62-3.80), small for gestational age(OR=2.00, 95% CI: 1.19-3.36)and diabetes mellitus(OR=1.69, 95% CI: 1.14-2.50). Conclusions: VBAC reduces cesarean section rate, with good outcomes in both mother and neonate. It is a safe and feasible way of labor in women with only one cesarean section history.

  7. Baseline plasma fatty acids profile and incident cardiovascular events in the SU.FOL.OM3 trial: the evidence revisited.

    Directory of Open Access Journals (Sweden)

    Léopold K Fezeu

    Full Text Available OBJECTIVE: We aimed to investigate the association between baseline plasma fatty acids profile and the risk of future major cardiovascular events in patients with a history of ischaemic heart disease or ischemic stroke. METHODS: Baseline plasma fatty acids as well as established cardiovascular risk factors were measured in 2,263 patients enrolled in the SUpplementation with FOLate, vitamins B-6 and B-12 and/or OMega-3 fatty acids randomized controlled trial. Incident major cardiovascular, cardiac and cerebrovascular events were ascertained during the 4.7 years of follow up. Hazard ratios were obtained from Cox proportional hazards models after adjustment for cardiovascular risk factors. RESULTS: During the follow-up, 154, 379 and 84 patients had major cardiovascular, cardiac and cerebrovascular events respectively. Upon adjustment for gender, initial event, baseline age and BMI, the risk of developing a major cardiovascular event decreased significantly in successive quartiles of arachidonic acid (P trend<0.002, total omega 3 polyunsaturated fatty acids (P trend<0.03, docosapentaenoic acid (P trend<0.019, docosahexaenoic acid (P trend<0.004, eicosapentaenoic acid + docosahexaenoic acid (P trend<0.03 and eicosapentaenoic acid + docosapentaenoic acid + docosahexaenoic acid (P trend<0.02. This inverse association was borderline significant with increased quartiles of stearidonic acid (P trend<0.06. In the full model, only stearidonic acid remained inversely associated with the risk of developing a major cardiovascular event (P trend<0.035, a cardiac event (P trend<0.016 or a cerebrovascular event (P trend<0.014, while arachidonic acid was inversely associated with the risk a cerebrovascular event (P trend<0.033. CONCLUSION: The inverse association of long chain omega 3 polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN

  8. The diabetes subgroup baseline characteristics of the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH) trial.

    Science.gov (United States)

    Bakris, George; Hester, Allen; Weber, Michael; Dahlof, Bjorn; Pitt, Bert; Velasquez, Eric; Staikos-Byrne, Linda; Shi, Victor; Jamerson, Ken

    2008-01-01

    The Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH) trial is the first cardiovascular outcome trial designed to compare initial use of 2 different fixed-dose antihypertensive regimens, benazepril plus hydrochlorothiazide vs benazepril plus amlodipine, on cardiovascular end points in hypertensive patients at high cardiovascular risk secondary to previous major events or presence of diabetes mellitus (DM). Of the 11,464 patients, 60.4% had DM. Compared with non-DM patients, DM patients were less likely to have previous myocardial infarctions (15% vs 37%) or strokes (8% vs 21%). Those with DM were more likely to be female (43% vs 34%), black (15% vs 8%), overweight (body mass index, 32 vs 29 kg/m(2)). At baseline, DM patients were more likely to have the metabolic syndrome, manifested by higher levels of fasting glucose (145 vs 101 mg/dL) and triglycerides (178 vs 150 mg/dL) and slightly lower high-density lipoprotein cholesterol values (48 vs 51 mg/dL) compared to the non-DM cohort. Although estimated glomerular filtration rate (80 vs 76 mL/min/1.73 m(2)) was similar in the DM and non-DM groups, presence of both albuminuria (8.7% vs 3.5%) and microalbuminuria (29% vs 20%) were more prevalent in the DM group. After 6 months of treatment, blood pressure control rates (<140/90 mm Hg) using blinded data (both therapeutic groups combined) for DM demonstrated that 42.8% of DM patients had blood pressure levels <130/80 mm Hg. ACCOMPLISH will provide valuable guidance on optimizing treatment strategies in hypertensive patients at high cardiovascular risk with and without DM.

  9. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  10. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  11. Clinical Trial Registries Are of Minimal Use for Identifying Selective Outcome and Analysis Reporting

    Science.gov (United States)

    Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.

    2014-01-01

    Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…

  12. Plasma branched-chain amino acids and incident cardiovascular disease in the PREDIMED trial

    Science.gov (United States)

    Ruiz-Canela, Miguel; Toledo, Estefania; Clish, Clary B.; Hruby, Adela; Liang, Liming; Salas-Salvadó, Jordi; Razquin, Cristina; Corella, Dolores; Estruch, Ramón; Ros, Emilio; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; Lapetra, José; Serra-Majem, Lluis; Martínez-González, Miguel A.; Hu, Frank B.

    2016-01-01

    Background The role of branched-chain amino acids (BCAAs) in cardiovascular disease (CVD) remains poorly understood. We hypothesized that baseline BCAA concentrations predict future risk of CVD and that a Mediterranean Diet (MedDiet) intervention may counteract this effect. Methods We developed a case-cohort study within the “PREvención con DIeta MEDiterránea” (PREDIMED), with 226 incident CVD cases and 781 non-cases. We used LC-MS/MS to measure plasma BCAAs (leucine, isoleucine and valine), both at baseline and after 1-year follow-up. The primary outcome was a composite of incident stroke, myocardial infarction, or cardiovascular death. Results After adjustment for potential confounders, baseline leucine and isoleucine concentrations were associated with higher CVD risk: the hazard ratios (HRs) for the highest vs. lowest quartile were 1.70 (95% confidence interval, 1.05–2.76) and 2.09 (1.27–3.44), respectively. Stronger associations were found for stroke. For both CVD and stroke, we found higher HRs across successive quartiles of BCAAs in the control group than in the MedDiet groups. Using stroke as the outcome, a significant interaction (P=0.009) between the baseline BCAA score and the intervention with MedDiet was observed. No significant effect of the intervention on 1-yr changes in BCAAs nor any association between 1-year changes in BCAAs and CVD were observed. Conclusions Higher concentrations of baseline BCAAs were associated with increased risk of CVD, especially stroke, in a high cardiovascular risk population. A Mediterranean-style diet had a negligible effect on 1-year changes in BCAAs, but it may counteract the harmful effects of BCAAs on stroke. PMID:26888892

  13. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  14. Cardiovascular and cerebrovascular outcomes in elderly hypertensive patients treated with either ARB or ACEI

    Institute of Scientific and Technical Information of China (English)

    Cong Ma; Jian Cao; Xue-Chun Lu; Xin-Hong Guo; Yan Gao; Xian-Feng Liu; Li Fan

    2012-01-01

    Background Although angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) are equally important in the treatment of hypertension, there is less evidence whether they have equal cardiovascular and cerebrovascular protective effects, especially in elder hypertensive patients. This study aims to clarify this unresolved issue. Methods This cross-sectional study included clinical data on 933 aged male patients with hypertension who received either an ARB or ACEI for more than two months between January 2007 and May 2011. The primary outcome was the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary endpoints were unstable angina, new atrial fibrillation, and transient ischemic attack. Results The median follow-up time was 24 months. Age, drug types, cerebral infarction history, renal dysfunction history were the independent predictors of the primary endpoint. The risk of an occurrence of a primary endpoint event was higher in the ARB group than the ACEI group [P = 0.037, hazard ratios occurrence was higher in the ARB group than the ACEI group (P = 0.04). In regard to the secondary endpoints, there were no significant were independent predictors of the secondary endpoint. Conclusion ACEI were more effective than ARB in reducing cardiovascular and cerebrovascular morbidity and mortality in aged patients with hypertension.

  15. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

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    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  16. Following the results of the EMPA-REG OUTCOME trial with empagliflozin, is it possible to speak of a class effect?

    Science.gov (United States)

    Ampudia-Blasco, Francisco Javier; Romera, Irene; Ariño, Bernat; Gomis, Ramón

    2017-01-01

    Background The recently published cardiovascular outcomes data for the first sodium–glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin, have shown cardiovascular safety and additional benefits in patients with type 2 diabetes and established cardiovascular disease. Empagliflozin showed lower rates of death from cardiovascular causes or from any causes and lower hospitalization rates from heart failure compared with placebo, both in addition to standard care. This commentary discusses the existence of a possible class effect considering the available evidence described for other SGLT2 inhibitors. Main text Empagliflozin, dapagliflozin and canagliflozin share the same mechanism of action, and it is a plausible hypothesis that some of the benefits of empagliflozin treatment could also be expected from other SGLT2 inhibitors. However, the rapid and persistent occurrence of cardiovascular benefits observed with empagliflozin and the different results shown by the three inhibitors in meta-analyses of some of their respective Phase II and III trials might suggest another possible mechanism of action, perhaps related to the different selectivity to inhibit SGLT-2 and other SGLT family members that these compounds present. Conclusion There is still lack of evidence to answer whether the cardiovascular benefits observed with empagliflozin in the EMPA-REG OUTCOME study could be seen as a “class effect”, which is also attributable to dapagliflozin and canagliflozin. PMID:28144158

  17. Can exaggerated stress reactivity and prolonged recovery predict negative health outcomes? The case of cardiovascular disease.

    Science.gov (United States)

    Lovallo, William R

    2015-04-01

    Researchers and laypersons have long argued that stress is bad for health, particularly when responses are large, prolonged, and frequent. By extension, individuals who have the largest and the most prolonged responses are assumed to have worse outcomes than do less reactive persons. Research in animals has been supportive of the connection between stress and poor health, but evidence in humans has been slow to accumulate. The current issue of Psychosomatic Medicine presents a meta-analysis of 33 studies of delayed recovery from stress and its association with poor cardiovascular disease outcomes and all-cause mortality. The analysis supports the contention that slower recovery to baseline after exercise or psychological stress may predict earlier death due to all causes. This finding raises questions for psychosomatic theories of disease and points the direction for further study of how or whether to incorporate reactivity measures into standard risk profiles.

  18. Clinical Characteristics and Outcome of Cardiovascular Implantable Electronic Device Infections in Turkey.

    Science.gov (United States)

    Aydin, Mesut; Yildiz, Abdulkadir; Kaya, Zeynettin; Kaya, Zekeriya; Basarir, Ahmet Ozgur; Cakmak, Nazmiye; Donmez, Ibrahim; Morrad, Baktash; Avci, Ahmet; Demir, Kenan; Cagliyan, Emre Caglar; Yuksel, Murat; Elbey, Mehmet Ali; Kayan, Fethullah; Ozaydogdu, Necdet; Islamoglu, Yahya; Cayli, Murat; Alan, Said; Ulgen, Mehmet Siddik; Ozhan, Hakan

    2016-07-01

    Infection is one of the most devastating outcomes of cardiovascular implantable electronic device (CIED) implantation and is related to significant morbidity and mortality. In our country, there is no evaluation about CIED infection. Therefore, our aim was to investigate clinical characteristics and outcome of patients who had infection related to CIED implantation or replacement. The study included 144 consecutive patients with CIED infection treated at 11 major hospitals in Turkey from 2005 to 2014 retrospectively. We analyzed the medical files of all patients hospitalized with the diagnosis of CIED infection. Inclusion criteria were definite infection related to CIED implantation, replacement, or revision. Generator pocket infection, with or without bacteremia, was the most common clinical presentation, followed by CIED-related endocarditis. Coagulase-negative staphylococci and Staphylococcus aureus were the leading causative agents of CIED infection. Multivariate analysis showed that infective endocarditis and ejection fraction were the strongest predictors of in-hospital mortality.

  19. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    Science.gov (United States)

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (PJournal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  20. Molecular sources of residual cardiovascular risk, clinical signals, and innovative solutions: relationship with subclinical disease, undertreatment, and poor adherence: implications of new evidence upon optimizing cardiovascular patient outcomes

    Directory of Open Access Journals (Sweden)

    Kones R

    2013-10-01

    would be cardioprotective. When LDL cholesterol is aggressively lowered to targets, low HDL cholesterol levels are still inversely related to MCVE. The efflux capacity, or ability to relocate cholesterol out of macrophages, is believed to be a major antiatherogenic mechanism responsible for reduction in MCVE mediated in part by healthy HDL. HDL cholesterol is a complex molecule with antioxidative, anti-inflammatory, antithrombotic, antiplatelet, and vasodilatory properties, among which is protection of LDL from oxidation. HDL-associated paraoxonase-1 has a major effect on endothelial function. Further, HDL promotes endothelial repair and progenitor cell health, and supports production of nitric oxide. HDL from patients with cardiovascular disease, diabetes, and autoimmune disease may fail to protect or even become proinflammatory or pro-oxidant. Mendelian randomization and other clinical studies in which raising HDL cholesterol has not been beneficial suggest that high plasma levels do not necessarily reduce cardiovascular risk. These data, coupled with extensive preclinical information about the functional heterogeneity of HDL, challenge the “HDL hypothesis”, ie, raising HDL cholesterol per se will reduce MCVE. After the equivocal AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes study and withdrawal of two major cholesteryl ester transfer protein compounds, one for off-target adverse effects and the other for lack of efficacy, development continues for two other agents, ie, anacetrapib and evacetrapib, both of which lower LDL cholesterol substantially. The negative but controversial HPS2-THRIVE (the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events trial casts further doubt on the HDL cholesterol hypothesis. The growing impression that HDL functionality, rather than abundance, is clinically important is supported by experimental evidence highlighting

  1. Allopurinol therapy in gout patients does not associate with beneficial cardiovascular outcomes: a population-based matched-cohort study.

    Directory of Open Access Journals (Sweden)

    Victor C Kok

    Full Text Available Previous studies have shown an association between gout and/or hyperuricemia and a subsequent increase in cardiovascular disease (CVD outcomes. Allopurinol reduces vascular oxidative stress, ameliorates inflammatory state, improves endothelial function, and prevents atherosclerosis progression. Accordingly, we tested the hypothesis that a positive association between allopurinol therapy in gout patients and future cardiovascular outcomes is present using a population-based matched-cohort study design.Patients aged ≥40 years with newly diagnosed gout having no pre-existing severe form of CVD were separated into allopurinol (n = 2483 and non-allopurinol (n = 2483 groups after matching for age, gender, index date, diabetes mellitus, hypertension, hyperlipidemia, and atrial fibrillation. The two groups were also balanced in terms of uric acid nephrolithiasis, acute kidney injury, hepatitis, and Charlson comorbidity index.With a median follow-up time of 5.25 years, the allopurinol group had a modest increase in cardiovascular risk [relative risk, 1.20; 95% confidence interval (CI, 1.08-1.34]. A Cox proportional hazard model adjusted for chronic kidney disease, uremia, and gastric ulcer gave a hazard ratio (HR for cardiovascular outcomes of 1.25 (95% CI, 1.10-1.41 in gout patients receiving allopurinol compared with the non-allopurinol group. In further analysis of patients receiving urate-lowering therapy, the uricosuric agent group (n = 1713 had an adjusted HR of 0.83 (0.73-0.95 for cardiovascular events compared with the allopurinol group.The current population-based matched-cohort study did not support the association between allopurinol therapy in gout patients with normal risk for cardiovascular sequels and beneficial future cardiovascular outcomes. Several important risk factors for cardiovascular disease, such as smoking, alcohol consumption, body mass index, blood pressure were not obtainable in the current retrospective cohort

  2. Effect of angiotensin receptor blockers in the prevention of type 2 diabetes and cardiovascular events: a meta-analysis of randomized trials

    Institute of Scientific and Technical Information of China (English)

    SONG Hui-fen; WANG Su; LI Hong-wei

    2012-01-01

    Background As the incidence of type 2 diabetes is rapidly increasing,prevention of the disease should be considered as a crucial objective in the near future.Several studies have shown angiotensin receptor blockers (ARBs) may contribute to the prevention of new-onset type 2 diabetes.This study was conducted to determine if ARBs as monotherapy or combination therapy may experience a decreased incidence of new-onset type 2 diabetes and prevent cardiovascular events.Methods Relevant experimental and clinical studies were identified by searching MEDLINE (1969 to May 30,2011) to extract a consensus of trial data involving the effect of ARBs on prevention of new-onset type 2 diabetes and cardiovascular events.Studies were included if they were randomized controlled trials versus placebo/routine therapy.A random-effects model was utilized.Subgroup and sensitivity analyses were conducted.Results Eleven trials were identified,including 82738 patients.ARBs prevented new-onset type 2 diabetes (odds ratio 0.8 (95% CI 0.76,0.85)).Regardless of indication for use,essential hypertension (seven trials),impaired glucose tolerance (one trial),cardiocerebrovascular disease (two trials) or heart failure (one trial),reductions in new-onset type 2 diabetes were maintained (0.75 (0.69,0.82),0.85 (0.78,0.92),0.80 (0.76,0.85) and 0.80 (0.64,0.99),respectively).No statistical heterogeneity was observed for any evaluation.However,ARBs did not significantly reduce the odds of all-cause mortality,myocardial infarction and heart failure versus control therapy among all of these studies.But ARBs did reduce the odds of cardiac death and heart failure among the heart failure study versus control therapy.Conclusion ARBs have significant ability to reduce risk of developing new-onset type 2 diabetes but does not improve cardiovascular outcomes over the study follow-up periods among all of included studies.

  3. cardiovasculares

    Directory of Open Access Journals (Sweden)

    Cristina Guerrero

    2006-01-01

    Full Text Available Uno de los aspectos que más discusión ha suscitado en los últimos tiempos entre quienes nos dedicamos al estudio de la emoción tiene que ver con la eventual asociación entre percepción, valoración y respuesta fisiológica. Esto es, siguiendo la máxima aristotélica, cabría cuestionar si las cosas son como son o son como cada quien las percibe. El objetivo de este experimento ha sido establecer la existencia de una conexión entre percepción de control y responsividad cardiovascular. La muestra estudiada ha estado conformada por estudiantes de la Universidad de Castellón; todos ellos han participado de forma voluntaria. La prueba de estrés ha consistido en un examen real de una asignatura troncal de la titulación que cursaban los participantes. Así pues, utilizando una situación de estrés real, hipotetizamos que las respuestas cardiovasculares (medidas a través de la tasa cardiaca, la presión sanguínea sistólica y la presión sanguínea diastólica dependen de la percepción de control que el individuo tiene, o cree tener, sobre la situación.

  4. A Systematic Review of Effects of Waterpipe Smoking on Cardiovascular and Respiratory Health Outcomes

    Science.gov (United States)

    Haddad, Linda; Kelly, Debra Lynch; Weglicki, Linda S.; Barnett, Tracey E.; Ferrell, Anastasiya V.; Ghadban, Roula

    2016-01-01

    BACKGROUND Waterpipe smoking (WPS) is a social custom common in many Middle Eastern, North African, and Asian countries and has become increasingly popular in the US, especially among youth; however, WPS smoking may be increasing in the US adult population as well. There is a common belief among waterpipe (WP) smokers that WPS is less harmful than smoking cigarettes. Thus, this review aims to systematically explore the literature on the effects of WP tobacco smoking with a particular focus on cardiovascular and respiratory health outcomes as well as on oxidative stress, immunity, and cell cycle interference health outcomes. METHODOLOGY We conducted a systematic review, guided by the criteria of The Preferred Reporting Items for Systematic Reviews and Meta-Analyses, using the following online databases MEDLINE, CINAHL, ScienceDirect, PMC, and Cochrane Library. Results were summarized qualitatively. RESULTS Forty studies met the inclusion criteria established for this review. Based on the existing evidence, several cardiovascular and respiratory physiologic health indicators and conditions have been shown to be negatively affected by WPS. In addition to the effects of nicotine and chemical toxicant exposures, WPS was significantly associated with an increase in heart rate, blood pressure, and lower pulmonary function test results, as well as a number of health conditions such as lung cancer, alterations in oxidative stress, immunity, and cell cycle interference. CONCLUSION The current literature provides evidence that WPS is associated with a number of negative health indicators and outcomes. There is need for more research related to WPS and its effects on health so that appropriate campaigns and prevention interventions can be implemented to control the epidemic increase of WPS in the US. PMID:27398028

  5. Baseline characteristics in the Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: a hypertensive population at high cardiovascular risk.

    Science.gov (United States)

    Weber, Michael A; Bakris, George L; Dahlöf, Björn; Pitt, Bertram; Velazquez, Eric; Gupte, Jitendra; Lefkowitz, Martin; Hester, Allen; Shi, Victor; Weir, Matthew; Kjeldsen, Sverre; Massie, Barry; Nesbitt, Shawna; Ofili, Elizabeth; Jamerson, Kenneth

    2007-01-01

    ACCOMPLISH is the first trial designed to compare the effects on major fatal and non-fatal cardiovascular endpoints of two forms of antihypertensive combination therapy: benazepril plus hydrochlorothiazide and amlodipine plus benazepril in hypertensive patients at high cardiovascular risk. Enrollment for this trial is now complete and this report describes the clinical characteristics of the study cohort. Patients with hypertension and a previous history of cardiovascular events, strokes or diabetes mellitus were randomized to double-blind treatment with either of the two combination regimens. The data in this report detail the clinical history and demographic characteristics in patients immediately prior to randomization to study drugs. A total of 11,454 patients were randomized. Mean age (+/-SD) was 68.4+/-6.9 years, 60% were men, and 1360 (12%) were African American. Mean body mass index (BMI) was 31.0+/-6.3 kg/m(2). At study entry, 46% of patients had a history of acute coronary syndromes, coronary artery bypass grafts or percutaneous coronary interventions; 13% had a history of stroke. A history of diabetes mellitus was reported in 6928 (60%) of patients. Mean blood pressure at baseline (on prior hypertension therapy) was 145.4/80.0 mmHg; only 38% of patients had a BP less than 140/90 mmHg. Overall, 97% of patients had received previous antihypertensive treatment (74% on at least two drugs); 53% were on oral diabetes therapy or insulin, 68% on anti-lipid therapy and 63% on anti-platelet agents. In summary, the ACCOMPLISH trial has recruited hypertensive patients at high risk of cardiovascular morbidity and mortality. It is noteworthy that the mean BMI of 31 in this cohort is clearly above the accepted diagnostic criterion of obesity and that 60% of patients are diabetic, possibly reflecting secular trends in clinical disease.

  6. Cardiovascular risk reduction in high-risk pediatric patients: a scientific statement from the American Heart Association Expert Panel on Population and Prevention Science; the Councils on Cardiovascular Disease in the Young, Epidemiology and Prevention, Nutrition, Physical Activity and Metabolism, High Blood Pressure Research, Cardiovascular Nursing, and the Kidney in Heart Disease; and the Interdisciplinary Working Group on Quality of Care and Outcomes Research: endorsed by the American Academy of Pediatrics.

    Science.gov (United States)

    Kavey, Rae-Ellen W; Allada, Vivek; Daniels, Stephen R; Hayman, Laura L; McCrindle, Brian W; Newburger, Jane W; Parekh, Rulan S; Steinberger, Julia

    2006-12-12

    Although for most children the process of atherosclerosis is subclinical, dramatically accelerated atherosclerosis occurs in some pediatric disease states, with clinical coronary events occurring in childhood and very early adult life. As with most scientific statements about children and the future risk for cardiovascular disease, there are no randomized trials documenting the effects of risk reduction on hard clinical outcomes. A growing body of literature, however, identifies the importance of premature cardiovascular disease in the course of certain pediatric diagnoses and addresses the response to risk factor reduction. For this scientific statement, a panel of experts reviewed what is known about very premature cardiovascular disease in 8 high-risk pediatric diagnoses and, from the science base, developed practical recommendations for management of cardiovascular risk.

  7. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial

    NARCIS (Netherlands)

    D.R. Holmes Jr (David); J.R. Granett (Jeffrey); J.J. Popma (Jeffrey); P.J. Fitzgerald (Peter); D. Fischman (David); J.J. Ferguson (James); A.M. Lincoff (Michael); S. Goldberg (Sheldon); J.A. Brinker; R. Chan; B.R. Davis (Barry); M. Poland; A.M. Zeiher (Andreas); J.T. Willerson (James); S.B. King 3rd (Spencer); L.M. Shapiro; M. Savage (Michael); J.M. Lablanche (Jean Marc); J.E. Tcheng (James); L. Grip (Lars); P.W.J.C. Serruys (Patrick)

    2002-01-01

    textabstractBACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral age

  8. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue;

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

  9. Greater clinical benefit of more intensive oral antiplatelet therapy with prasugrel in patients with diabetes mellitus in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-Thrombolysis in Myocardial Infarction 38.

    NARCIS (Netherlands)

    Wiviott, S.D.; Braunwald, E.; Angiolillo, D.J.; Meisel, S.; Dalby, A.J.; Verheugt, F.W.A.; Goodman, S.G.; Corbalan, R.; Purdy, D.A.; Murphy, S.A.; McCabe, C.H.; Antman, E.M.

    2008-01-01

    BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for recurrent cardiovascular events after acute coronary syndromes, in part because of increased platelet reactivity. The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysi

  10. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial

    Directory of Open Access Journals (Sweden)

    Wouters Patrick

    2011-05-01

    Full Text Available Abstract Background Pre- and postconditioning describe mechanisms whereby short ischemic periods protect an organ against a longer period of ischemia. Interestingly, short ischemic periods of a limb, in itself harmless, may increase the ischemia tolerance of remote organs, e.g. the heart (remote conditioning, RC. Although several studies have shown reduced biomarker release by RC, a reduction of complications and improvement of patient outcome still has to be demonstrated. Atrial fibrillation (AF is one of the most common complications after coronary artery bypass graft surgery (CABG, affecting 27-46% of patients. It is associated with increased mortality, adverse cardiovascular events, and prolonged in-hospital stay. We hypothesize that remote ischemic pre- and/or post-conditioning reduce the incidence of AF following CABG, and improve patient outcome. Methods/design This study is a randomized, controlled, patient and investigator blinded multicenter trial. Elective CABG patients are randomized to one of the following four groups: 1 control, 2 remote ischemic preconditioning, 3 remote ischemic postconditioning, or 4 remote ischemic pre- and postconditioning. Remote conditioning is applied at the arm by 3 cycles of 5 minutes of ischemia and reperfusion. Primary endpoint is the incidence AF in the first 72 hours after surgery, detected using a Holter-monitor. Secondary endpoints include length-of-stay on the intensive care unit and in-hospital, and the occurrence of major adverse cardiovascular events at 30 days, 3 months and 1 year. Based on an expected incidence in the control group of 27%, 195 patients per group are needed to detect with 80% power a reduction by 45% following either pre- or postconditioning, while allowing for a 10% dropout and at an alpha of 0.05. With the combined intervention expected to be stronger, we need 75 patients in this group to detect a reduction in incidence of AF of 60%. Discussion The RICO-trial (the effect of

  11. Molecular sources of residual cardiovascular risk, clinical signals, and innovative solutions: relationship with subclinical disease, undertreatment, and poor adherence: implications of new evidence upon optimizing cardiovascular patient outcomes.

    Science.gov (United States)

    Kones, Richard

    2013-01-01

    cholesterol levels are still inversely related to MCVE. The efflux capacity, or ability to relocate cholesterol out of macrophages, is believed to be a major antiatherogenic mechanism responsible for reduction in MCVE mediated in part by healthy HDL. HDL cholesterol is a complex molecule with antioxidative, anti-inflammatory, anti-thrombotic, antiplatelet, and vasodilatory properties, among which is protection of LDL from oxidation. HDL-associated paraoxonase-1 has a major effect on endothelial function. Further, HDL promotes endothelial repair and progenitor cell health, and supports production of nitric oxide. HDL from patients with cardiovascular disease, diabetes, and autoimmune disease may fail to protect or even become proinflammatory or pro-oxidant. Mendelian randomization and other clinical studies in which raising HDL cholesterol has not been beneficial suggest that high plasma levels do not necessarily reduce cardiovascular risk. These data, coupled with extensive preclinical information about the functional heterogeneity of HDL, challenge the "HDL hypothesis", ie, raising HDL cholesterol per se will reduce MCVE. After the equivocal AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) study and withdrawal of two major cholesteryl ester transfer protein compounds, one for off-target adverse effects and the other for lack of efficacy, development continues for two other agents, ie, anacetrapib and evacetrapib, both of which lower LDL cholesterol substantially. The negative but controversial HPS2-THRIVE (the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) trial casts further doubt on the HDL cholesterol hypothesis. The growing impression that HDL functionality, rather than abundance, is clinically important is supported by experimental evidence highlighting the conditional pleiotropic actions of HDL. Non-HDL cholesterol reflects the cholesterol in all

  12. Outcome markers for clinical trials in cerebral amyloid angiopathy

    NARCIS (Netherlands)

    S.M. Greenberg (Steven); R.A.S. Salman (Rustam Al-Shahi); G.J. Biessels (Geert Jan); M.A. van Buchem (Mark); C. Cordonnier (Charlotte); J.-M. Lee (Jin-Moo); J. Montaner (Joan); J.A. Schneider (Julie); E.E. Smith (Eric); M.W. Vernooij (Meike); D.J. Werring (David)

    2014-01-01

    textabstractEfforts are underway for early-phase trials of candidate treatments for cerebral amyloid angiopathy, an untreatable cause of haemorrhagic stroke and vascular cognitive impairment. A major barrier to these trials is the absence of consensus on measurement of treatment effectiveness. A ran

  13. The Evolution of Cardiovascular Surgery in Elderly Patient: A Review of Current Options and Outcomes

    Directory of Open Access Journals (Sweden)

    Francesco Nicolini

    2014-01-01

    Full Text Available Due to the increase in average life expectancy and the higher incidence of cardiovascular disease with advancing age, more elderly patients present for cardiac surgery nowadays. Advances in pre- and postoperative care have led to the possibility that an increasing number of elderly patients can be operated on safely and with a satisfactory outcome. Currently, coronary artery bypass surgery, aortic and mitral valve surgery, and major surgery of the aorta are performed in elderly patients. The data available show that most cardiac surgical procedures can be performed in elderly patients with a satisfactory outcome. Nevertheless, the risk for these patients is only acceptable in the absence of comorbidities. In particular, renal dysfunction, cerebrovascular disease, and poor clinical state are associated with a worse outcome in elderly patients. Careful patient selection, flawless surgery, meticulous hemostasis, perfect anesthesia, and adequate myocardial protection are basic requirements for the success of cardiac surgery in elderly patients. The care of elderly cardiac surgical patients can be improved only through the strict collaboration of geriatricians, anesthesiologists, cardiologists, and cardiac surgeons, in order to obtain a tailored treatment for each individual patient.

  14. The impact of β 2 adrenergic receptor polymorphisms on the outcomes in cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Ersilia Cipolletta

    2014-12-01

    Full Text Available Cardiovascular diseases (CVD include a heterogeneous group of multifactorial conditions and represent the major health problem in the western society. Many studies have evidenced that inter-individual variability affects the prognosis and the response to pharmacological treatment in patients with CVD. The identification of genetic markers to select patients more susceptible to develop cardiovascular complications has a therapeutic interest for undertaking individualized therapeutic approach. The sympathetic nervous system acts through adrenergic receptor subtypes and plays a key role in the development and prognosis of CVD. In particular, β-2 adrenergic receptors (β2AR, expressed in a wide variety of tissues, are critical regulators of cardiac output, peripheral vascular resistance and metabolism. Several variations with multiple single-nucleotide polymorphisms have been identified in β2AR gene. There are 3 common β2AR polymorphisms characterized in more detail for their influence on functional receptor activity. In particular, the changing an arginine for a glycine at position 16 of the receptor protein (Arg16Gly is associated with increased agonist-induced down-regulation; the substitution of glutamine with glutamic acid at position 27 (Gln27Glu leads to resistance to down-regulation; the substitution of threonine with isoleucine (Thr164Ile at position 164 causes receptor uncoupling from the G protein. Many studies have indicated the association of β2AR polymorphisms with various cardiovascular and metabolic diseases and have contributed to indicate the β2AR gene variants an appropriate target for investigating possible links between receptor polymorphisms, drug responses and susceptibility to CVD. However, the reports on the association of β2AR polymorphisms with clinical outcomes of CVD have been contradictory. In this review, we will illustrate the effects of β2ARs genetic variability on the management of CVD.

  15. Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation.

    Science.gov (United States)

    Hussain, Samia; Knight, Simon R

    2016-11-01

    Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.

  16. Patient-specific system for prognosis of surgical treatment outcomes of human cardiovascular system

    Science.gov (United States)

    Golyadkina, Anastasiya A.; Kalinin, Aleksey A.; Kirillova, Irina V.; Kossovich, Elena L.; Kossovich, Leonid Y.; Menishova, Liyana R.; Polienko, Asel V.

    2015-03-01

    Object of study: Improvement of life quality of patients with high stroke risk ia the main goal for development of system for patient-specific modeling of cardiovascular system. This work is dedicated at increase of safety outcomes for surgical treatment of brain blood supply alterations. The objects of study are common carotid artery, internal and external carotid arteries and bulb. Methods: We estimated mechanical properties of carotid arteries tissues and patching materials utilized at angioplasty. We studied angioarchitecture features of arteries. We developed and clinically adapted computer biomechanical models, which are characterized by geometrical, physical and mechanical similarity with carotid artery in norm and with pathology (atherosclerosis, pathological tortuosity, and their combination). Results: Collaboration of practicing cardiovascular surgeons and specialists in the area of Mathematics and Mechanics allowed to successfully conduct finite-element modeling of surgical treatment taking into account various features of operation techniques and patching materials for a specific patient. Numerical experiment allowed to reveal factors leading to brain blood supply decrease and atherosclerosis development. Modeling of carotid artery reconstruction surgery for a specific patient on the basis of the constructed biomechanical model demonstrated the possibility of its application in clinical practice at approximation of numerical experiment to the real conditions.

  17. Improved Cardiovascular Disease Outcomes in Older Adults [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Daniel E. Forman

    2016-01-01

    Full Text Available Longevity is increasing and the population of older adults is growing. The biology of aging is conducive to cardiovascular disease (CVD, such that prevalence of coronary artery disease, heart failure, valvular heart disease, arrhythmia and other disorders are increasing as more adults survive into old age.  Furthermore, CVD in older adults is distinctive, with management issues predictably complicated by multimorbidity, polypharmacy, frailty and other complexities of care that increase management risks (e.g., bleeding, falls, and rehospitalization and uncertainty of outcomes.  In this review, state-of-the-art advances in heart failure, acute coronary syndromes, transcatheter aortic valve replacement, atrial fibrillation, amyloidosis, and CVD prevention are discussed.  Conceptual benefits of treatments are considered in relation to the challenges and ambiguities inherent in their application to older patients.

  18. Cardiovascular and Renal Outcomes of Renin-Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses.

    Directory of Open Access Journals (Sweden)

    Ferrán Catalá-López

    2016-03-01

    Full Text Available Medications aimed at inhibiting the renin-angiotensin system (RAS have been used extensively for preventing cardiovascular and renal complications in patients with diabetes, but data that compare their clinical effectiveness are limited. We aimed to compare the effects of classes of RAS blockers on cardiovascular and renal outcomes in adults with diabetes.Eligible trials were identified by electronic searches in PubMed/MEDLINE and the Cochrane Database of Systematic Reviews (1 January 2004 to 17 July 2014. Interventions of interest were angiotensin-converting enzyme (ACE inhibitors, angiotensin receptor blockers (ARBs, and direct renin (DR inhibitors. The primary endpoints were cardiovascular mortality, myocardial infarction, and stroke-singly and as a composite endpoint, major cardiovascular outcome-and end-stage renal disease [ESRD], doubling of serum creatinine, and all-cause mortality-singly and as a composite endpoint, progression of renal disease. Secondary endpoints were angina pectoris and hospitalization for heart failure. In all, 71 trials (103,120 participants, with a total of 14 different regimens, were pooled using network meta-analyses. When compared with ACE inhibitor, no other RAS blocker used in monotherapy and/or combination was associated with a significant reduction in major cardiovascular outcomes: ARB (odds ratio [OR] 1.02; 95% credible interval [CrI] 0.90-1.18, ACE inhibitor plus ARB (0.97; 95% CrI 0.79-1.19, DR inhibitor plus ACE inhibitor (1.32; 95% CrI 0.96-1.81, and DR inhibitor plus ARB (1.00; 95% CrI 0.73-1.38. For the risk of progression of renal disease, no significant differences were detected between ACE inhibitor and each of the remaining therapies: ARB (OR 1.10; 95% CrI 0.90-1.40, ACE inhibitor plus ARB (0.97; 95% CrI 0.72-1.29, DR inhibitor plus ACE inhibitor (0.99; 95% CrI 0.65-1.57, and DR inhibitor plus ARB (1.18; 95% CrI 0.78-1.84. No significant differences were showed between ACE inhibitors and ARBs with

  19. Assurance calculations for planning clinical trials with time-to-event outcomes.

    Science.gov (United States)

    Ren, Shijie; Oakley, Jeremy E

    2014-01-15

    We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods.

  20. Progesterone therapy, endothelial function and cardiovascular risk factors: a 3-month randomized, placebo-controlled trial in healthy early postmenopausal women.

    Directory of Open Access Journals (Sweden)

    Jerilynn C Prior

    Full Text Available BACKGROUND: Progesterone is effective treatment for hot flushes/night sweats. The cardiovascular effects of progesterone therapy are unknown but evidence suggests that premenopausal normal estradiol with also normal progesterone levels may provide later cardiovascular protection. We compared the effects of progesterone to placebo on endothelial function, weight, blood pressure, metabolism, lipids, inflammation and coagulation. METHODS AND RESULTS: We conducted a randomized, double-blind, 3-month placebo-controlled trial of progesterone (300 mg daily among 133 healthy postmenopausal women in Vancouver, Canada from 2003-2009. Endothelial function by venous occlusion plethysmography was a planned primary outcome. Enrolled women were 1-11 y since last menstruation, not using hormones (for >6 months, non-smoking, without diabetes, hypertension, heart disease or their medications. Randomized (1∶1 women (55 ± 4 years, body mass index 25 ± 3 initially had normal blood pressure, fasting lipid, glucose and electrocardiogram results. Endothelial function (% forearm blood flow above saline was not changed with progesterone (487 ± 189%, n = 18 compared with placebo (408 ± 278%, n = 16 (95% CI diff [-74 to 232], P = 0.30. Progesterone (n = 65 and placebo (n = 47 groups had similar changes in systolic and diastolic blood pressure, resting heart rate, weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein cholesterol and triglyceride levels. High-density lipoprotein was lower (-0.14 mmol/L, P = 0.001 on progesterone compared with placebo. Fasting glucose, hs-C-reactive protein, albumin and D-dimer changes were all comparable to placebo. Framingham General Cardiovascular Risk Profile scores were initially low and remained low with progesterone therapy and not statistically different from placebo. CONCLUSIONS: Results indicate that progesterone has short-term cardiovascular safety. Endothelial

  1. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study.

    Directory of Open Access Journals (Sweden)

    Margareta K Eriksson

    Full Text Available BACKGROUND: Successfully transferring the findings of expensive and tightly controlled programmes of intensive lifestyle modification to the primary care setting is necessary if such knowledge is to be of clinical utility. The objective of this study was to test whether intensive lifestyle modification, shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals, can reduce cardiovascular risk factor levels in the primary care setting. METHODOLOGY / PRINCIPAL FINDINGS: The Swedish Björknäs study was a randomized controlled trial conducted from 2003 to 2006 with follow-up on cardiovascular risk factors at 3, 12, 24 and 36 months. A total of 151 middle-aged men and women at moderate- to high-risk of cardiovascular disease from northern Sweden were randomly assigned to either an intensive lifestyle intervention (n = 75 or control (n = 76 group. The intervention was based broadly on the protocol of the Diabetes Prevention Program. The three-month intervention period was administered in the primary care setting and consisted of supervised exercise sessions and diet counselling, followed by regular group meetings during three years. The control group was given general advice about diet and exercise and received standard clinical care. Outcomes were changes in anthropometrics, aerobic fitness, self-reported physical activity, blood pressure, and metabolic traits. At 36 months post-randomisation, intensive lifestyle modification reduced waist circumference (-2.2 cm: p = 0.001, waist-hip ratio (-0.02: p<0.0001, systolic blood pressure (-4.9 mmHg: p = 0.036, and diastolic blood pressure (-1.6 mmHg: p = 0.005, and improved aerobic fitness (5%; p = 0.038. Changes in lipid or glucose values did not differ statistically between groups. At 36 months, self-reported time spent exercising and total physical activity had increased more in the intervention group than in the control group (p<0

  2. Built Environment, Selected Risk Factors and Major Cardiovascular Disease Outcomes: A Systematic Review

    Science.gov (United States)

    Malambo, Pasmore; Kengne, Andre P.; De Villiers, Anniza; Lambert, Estelle V.; Puoane, Thandi

    2016-01-01

    Introduction Built environment attributes have been linked to cardiovascular disease (CVD) risk. Therefore, identifying built environment attributes that are associated with CVD risk is relevant for facilitating effective public health interventions. Objective To conduct a systematic review of literature to examine the influence of built environmental attributes on CVD risks. Data Source Multiple database searches including Science direct, CINAHL, Masterfile Premier, EBSCO and manual scan of reference lists were conducted. Inclusion Criteria Studies published in English between 2005 and April 2015 were included if they assessed one or more of the neighborhood environmental attributes in relation with any major CVD outcomes and selected risk factors among adults. Data Extraction Author(s), country/city, sex, age, sample size, study design, tool used to measure neighborhood environment, exposure and outcome assessments and associations were extracted from eligible studies. Results Eighteen studies met the inclusion criteria. Most studies used both cross-sectional design and Geographic Information System (GIS) to assess the neighborhood environmental attributes. Neighborhood environmental attributes were significantly associated with CVD risk and CVD outcomes in the expected direction. Residential density, safety from traffic, recreation facilities, street connectivity and high walkable environment were associated with physical activity. High walkable environment, fast food restaurants, supermarket/grocery stores were associated with blood pressure, body mass index, diabetes mellitus and metabolic syndrome. High density traffic, road proximity and fast food restaurants were associated with CVDs outcomes. Conclusion This study confirms the relationship between neighborhood environment attributes and CVDs and risk factors. Prevention programs should account for neighborhood environmental attributes in the communities where people live. PMID:27880835

  3. A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed. Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension’s region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation. Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic

  4. Cardiovascular and Renal Outcomes of Renin–Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses

    Science.gov (United States)

    Catalá-López, Ferrán; Macías Saint-Gerons, Diego; González-Bermejo, Diana; Rosano, Giuseppe M.; Davis, Barry R.; Ridao, Manuel; Zaragoza, Abel; Montero-Corominas, Dolores; Tobías, Aurelio; de la Fuente-Honrubia, César; Tabarés-Seisdedos, Rafael; Hutton, Brian

    2016-01-01

    Background Medications aimed at inhibiting the renin–angiotensin system (RAS) have been used extensively for preventing cardiovascular and renal complications in patients with diabetes, but data that compare their clinical effectiveness are limited. We aimed to compare the effects of classes of RAS blockers on cardiovascular and renal outcomes in adults with diabetes. Methods and Findings Eligible trials were identified by electronic searches in PubMed/MEDLINE and the Cochrane Database of Systematic Reviews (1 January 2004 to 17 July 2014). Interventions of interest were angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and direct renin (DR) inhibitors. The primary endpoints were cardiovascular mortality, myocardial infarction, and stroke—singly and as a composite endpoint, major cardiovascular outcome—and end-stage renal disease [ESRD], doubling of serum creatinine, and all-cause mortality—singly and as a composite endpoint, progression of renal disease. Secondary endpoints were angina pectoris and hospitalization for heart failure. In all, 71 trials (103,120 participants), with a total of 14 different regimens, were pooled using network meta-analyses. When compared with ACE inhibitor, no other RAS blocker used in monotherapy and/or combination was associated with a significant reduction in major cardiovascular outcomes: ARB (odds ratio [OR] 1.02; 95% credible interval [CrI] 0.90–1.18), ACE inhibitor plus ARB (0.97; 95% CrI 0.79–1.19), DR inhibitor plus ACE inhibitor (1.32; 95% CrI 0.96–1.81), and DR inhibitor plus ARB (1.00; 95% CrI 0.73–1.38). For the risk of progression of renal disease, no significant differences were detected between ACE inhibitor and each of the remaining therapies: ARB (OR 1.10; 95% CrI 0.90–1.40), ACE inhibitor plus ARB (0.97; 95% CrI 0.72–1.29), DR inhibitor plus ACE inhibitor (0.99; 95% CrI 0.65–1.57), and DR inhibitor plus ARB (1.18; 95% CrI 0.78–1.84). No significant

  5. Incidence, management and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants

    Science.gov (United States)

    Fernandez, Erika; Watterberg, Kristi L.; Faix, Roger G.; Yoder, Bradley A.; Walsh, Michele C.; Lacy, Conra Backstrom; Osborne, Karen A.; Das, Abhik; Kendrick, Douglas E.; Stoll, Barbara J.; Poindexter, Brenda B.; Laptook, Abbot R.; Kennedy, Kathleen A.; Schibler, Kurt; Bell, Edward F.; Van Meurs, Krisa P.; Frantz, Ivan D.; Goldberg, Ronald N.; Shankaran, Seetha; Carlo, Waldemar A.; Ehrenkranz, Richard A.; Sánchez, Pablo J.; Higgins, Rosemary D.

    2014-01-01

    Objective To characterize the incidence, management and short term outcomes of cardiovascular insufficiency (CVI) in mechanically ventilated newborns, evaluating 4 separate pre-specified definitions. Study Design Multicenter, prospective cohort study of infants ≥34 weeks gestational age (GA) and on mechanical ventilation during the first 72 hours. CVI was prospectively defined as either (1) mean arterial pressure (MAP) outcomes included death, days on ventilation, oxygen, and to full feedings and discharge. Results Of 647 who met inclusion criteria, 419 (65%) met ≥1 definition of CVI. Of these, 98% received fluid boluses, 36% inotropes and 17% corticosteroids. Of treated infants, 46% did not have CVI as defined by a MAP < GA ± signs of inadequate perfusion. Inotrope therapy was associated with increased mortality (11.1% vs. 1.3%; P < 0.05). Conclusion More than half of the infants met at least one definition of CVI. However, almost half of the treated infants met none of the definitions. Inotropic therapy was associated with increased mortality. These findings can help guide the design of future studies of CVI in newborns. PMID:24515617

  6. Individualized prediction of the effect of angiotensin receptor inhibition on renal and cardiovascular outcomes in patients with diabetic nephropathy

    NARCIS (Netherlands)

    van der Sande, Nicolette G C; Dorresteijn, Jannick A N; Visseren, Frank L J; Dwyer, Jamie P; Blankestijn, Peter J; van der Graaf, Yolanda; Heerspink, Hiddo L

    2016-01-01

    Aims Angiotensin receptor blockers (ARBs) reduce cardiovascular and renal complications in patients with diabetic nephropathy but treatment effects may vary across patients. Predicting individualized treatment effect of ARBs on both outcomes may help clinicians and patients to assess the benefit of

  7. Ankle-Brachial Index Is a Powerful Predictor of Renal Outcome and Cardiovascular Events in Patients with Chronic Kidney Disease

    Directory of Open Access Journals (Sweden)

    Fu-An Chen

    2012-01-01

    Full Text Available Ankle-brachial index (ABI is an accurate tool to diagnose peripheral arterial disease. The aim of this study was to evaluate whether ABI is also a good predictor of renal outcome and cardiovascular events in patients with chronic kidney disease (CKD. We enrolled 436 patients with stage 3–5 CKD who had not been undergoing dialysis. Patients were stratified into two groups according to the ABI value with a cut point of 0.9. The composite renal outcome, including doubling of serum creatinine level and commencement of dialysis, and the incidence of cardiovascular events were compared between the two groups. After a median follow-up period of 13 months, the lower ABI group had a poorer composite renal outcome (OR=2.719, P=0.015 and a higher incidence of cardiovascular events (OR=3.260, P=0.001. Our findings illustrated that ABI is a powerful predictor of cardiovascular events and renal outcome in patients with CKD.

  8. Dealing with missing outcome data in randomized trials and observational studies.

    NARCIS (Netherlands)

    Groenwold, R.H.; Donders, A.R.T.; Roes, K.C.; Harrell Jr, F.E.; Moons, K.G.

    2012-01-01

    Although missing outcome data are an important problem in randomized trials and observational studies, methods to address this issue can be difficult to apply. Using simulated data, the authors compared 3 methods to handle missing outcome data: 1) complete case analysis; 2) single imputation; and 3)

  9. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  10. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...

  11. Cardiovascular benefits from ancient grain bread consumption: findings from a double-blinded randomized crossover intervention trial.

    Science.gov (United States)

    Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco

    2017-02-01

    Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.

  12. Cardiovascular exercise and burden of arrhythmia in patients with atrial fibrillation - A randomized controlled trial

    DEFF Research Database (Denmark)

    Skielboe, Ane Katrine; Bandholm, Thomas Quaade; Hakmann, Stine

    2017-01-01

    BACKGROUND: Physical activity at moderate-high intensity is recommended to prevent lifestyle diseases. Patients with atrial fibrillation are at risk of a sedentary lifestyle due to fear of exercise-induced episodes of atrial fibrillation. The burden of arrhythmia can be reduced by physical exercise....... The effect of exercise intensity on burden of atrial fibrillation needs to be studied further. METHODS AND RESULTS: In a 12-week randomized controlled trial, 76 patients with paroxysmal/persistent atrial fibrillation were allocated to perform exercise at either low intensity or high intensity (50% and 80......% of maximal perceived exertion, respectively). Primary outcome was burden of AF measured by daily electrocardiography-reporting during 12 weeks. Secondarily, change in maximal oxygen uptake (peak VO2) and 1-year hospitalization was compared between low and high intensity exercise. Sixty-three patients...

  13. Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: the clinical evaluation of the dose of erythropoietins (C.E. DOSE trial protocol

    Directory of Open Access Journals (Sweden)

    Strippoli Giovanni FM

    2010-06-01

    Full Text Available Abstract Background Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD. Erythropoietin Stimulating Agents (ESA are commonly used to increase hemoglobin levels in this population. In observational studies, higher hemoglobin levels (around 11-13 g/dL are associated with improved survival and quality of life compared to hemoglobin levels around 9-10 g/dL. A systematic review of randomized trials found that targeting higher hemoglobin levels with ESA causes an increased risk of adverse vascular outcomes. It is possible, but has never been formally tested in a randomized trial, that ESA dose rather than targeted hemoglobin concentration itself mediates the increased risk of adverse vascular outcomes. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE trial will assess the benefits and harms of a high versus a low fixed ESA dose for the management of anemia in patients with end stage kidney disease. Methods/Design This is a randomized, prospective open label blinded end-point (PROBE trial due to enrol 2204 hemodialysis patients in Italy. Patients will be randomized 1:1 to 4000 IU/week versus 18000 IU/week of intravenous epoietin alfa or beta, or any other ESA in equivalent doses. The dose will be adjusted only if hemoglobin levels fall outside the 9.5-12.5 g/dL range. The primary outcome will be a composite of all-cause mortality, non fatal stroke, non fatal myocardial infarction and hospitalization for cardiovascular causes. Quality of life and costs will also be assessed. Discussion The C.E.DOSE study will help inform the optimal therapeutic strategy for the management of anemia of hemodialysis patients, improving clinical outcomes, quality of life and costs, by ascertaining the potential benefits and harms of different fixed ESA doses. Trial registration Clinicaltrials.gov NCT00827021

  14. Depression screening and patient outcomes in cardiovascular care : a systematic review

    NARCIS (Netherlands)

    Thombs, Brett D.; de Jonge, Peter; Coyne, James C.; Whooley, Mary A.; Frasure-Smith, Nancy; Mitchell, Alex J.; Zuidersma, Marij; Eze-Nliam, Chete; Lima, Bruno B.; Smith, Cheri G.; Soderlund, Karl; Ziegelstein, Roy C.

    2008-01-01

    Context Several practice guidelines recommend that depression be evaluated and treated in patients with cardiovascular disease, but the potential benefits of this are unclear. Objective To evaluate the potential benefits of depression screening in patients with cardiovascular disease by assessing (

  15. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

    OpenAIRE

    Justin B. Miller; Banks, Sarah J.; Léger, Gabriel C; Cummings, Jeffrey L.

    2014-01-01

    Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturb...

  16. Cardiovascular exercise and burden of arrhythmia in patients with atrial fibrillation - A randomized controlled trial

    Science.gov (United States)

    Bandholm, Thomas Quaade; Hakmann, Stine; Mourier, Malene; Kallemose, Thomas; Dixen, Ulrik

    2017-01-01

    Background Physical activity at moderate-high intensity is recommended to prevent lifestyle diseases. Patients with atrial fibrillation are at risk of a sedentary lifestyle due to fear of exercise-induced episodes of atrial fibrillation. The burden of arrhythmia can be reduced by physical exercise. The effect of exercise intensity on burden of atrial fibrillation needs to be studied further. Methods and results In a 12-week randomized controlled trial, 76 patients with paroxysmal/persistent atrial fibrillation were allocated to perform exercise at either low intensity or high intensity (50% and 80% of maximal perceived exertion, respectively). Primary outcome was burden of AF measured by daily electrocardiography-reporting during 12 weeks. Secondarily, change in maximal oxygen uptake (peak VO2) and 1-year hospitalization was compared between low and high intensity exercise. Sixty-three patients completed the follow-up. In the intention-to-treat analysis, we found no statistical difference in burden of atrial fibrillation between low and high intensity exercise (incidence rate ratio 0.742, 95% CI 0.29–1.91, P = 0.538). No serious adverse events were reported and there was no difference in hospitalization between the two exercise groups. Both exercise groups improved significantly in peak VO2 (low intensity: 3.62 mL O2/kg/min, SD 3.77; high intensity: 2.87 mL O2/kg/min, SD 4.98), with no statistical difference between-groups (mean difference: 0.76 mL O2/kg/min, 95% CI -3.22–1.7). Conclusions High intensity physical exercise was not superior to low intensity physical exercise in reducing burden of atrial fibrillation. HI exercise was well tolerated; no evidence of an increased risk was found for HI compared to LI exercise. Larger studies are required to further prove our findings. Trial registration ClinicalTrials.gov NCT01817998 PMID:28231325

  17. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta......-analyses in knee osteoarthritis (OA). Methods A systematic literature search was conducted in high impact factor journals. Eligible were randomized controlled trials, using two or more PROs measuring pain or disability. A prioritized list was developed based on the capacity to discriminate between intervention...

  18. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Christensen Helen

    2011-01-01

    Full Text Available Abstract Background Depression, cardiovascular disease (CVD risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. Methods/Design This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Discussion Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on

  19. Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial

    Science.gov (United States)

    Dixon, Padraig; Ara, Roberta; Edwards, Louisa; Foster, Alexis

    2016-01-01

    Objectives To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. Design A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. Intervention A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. Results The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. Conclusions The intervention was likely to be cost-effective under a lifetime perspective. Trial registration number ISRCTN27508731; Results. PMID:27670521

  20. The CHANGE trial: no superiority of lifestyle coaching plus care coordination plus treatment as usual compared to treatment as usual alone in reducing risk of cardiovascular disease in adults with schizophrenia spectrum disorders and abdominal obesity.

    Science.gov (United States)

    Speyer, Helene; Christian Brix Nørgaard, Hans; Birk, Merete; Karlsen, Mette; Storch Jakobsen, Ane; Pedersen, Kamilla; Hjorthøj, Carsten; Pisinger, Charlotta; Gluud, Christian; Mors, Ole; Krogh, Jesper; Nordentoft, Merete

    2016-06-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and standardized to age 60. At follow-up, the mean 10-year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.

  1. Internet-delivered cognitive behavioural therapy for adults with mild to moderate depression and high cardiovascular disease risks: a randomised attention-controlled trial.

    Directory of Open Access Journals (Sweden)

    Nicholas Glozier

    Full Text Available BACKGROUND AND AIM: Mild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD risks. METHODS: Randomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (E-couch with an internet-delivered attention control health information package (HealthWatch, n = 282. The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9 (trial registration: ACTRN12610000085077. RESULTS: 487/562 (88% participants completed the endpoint assessment. 383/562 (70% were currently treated for cardiovascular disease and 314/562 (56% had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23-1.89 points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012. There were also larger improvements in adherence (2.16 points; 95% CI: 0.33-3.99, reductions in anxiety (0.96 points; 95% CI: 0.19-1.73, and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01-3.61 in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events. CONCLUSIONS: In people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (http://www.ecouch.anu.edu.au produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000085077.

  2. Resveratrol Supplementation in Schizophrenia Patients: A Randomized Clinical Trial Evaluating Serum Glucose and Cardiovascular Risk Factors

    Directory of Open Access Journals (Sweden)

    Karine Zortea

    2016-01-01

    Full Text Available Background: Patients with schizophrenia (SZ are generally overweight or obese and have several metabolic disorders. Additionally, such patients have a lower life expectancy and the main cause of their increased mortality is cardiovascular disease (CVD. The objective of this study was to determine the efficacy of resveratrol supplementation on serum glucose and CVD risk factors in individuals with SZ. Methods and Results: This is a four-week randomized, double-blind controlled trial (registration No.: NCT 02062190 in which 19 men with a diagnosis of SZ, aged 18 to 65, were assigned to either a resveratrol supplement group (200 mg/day or a placebo group (200 mg/day. In short, we did not observe significant changes after resveratrol supplementation. In the placebo group, we found a significant increase in total cholesterol levels (p = 0.024 and in LDL-cholesterol (p = 0.002, as well as a decrease in body fat percentage (p = 0.038. The placebo group also showed an increase in triglycerides (9.19% and a reduction in HDL-cholesterol (4.88%. In the resveratrol group, triglycerides decreased (7.64%. Conclusion: In summary, oral resveratrol in reasonably low dosages (200 mg daily brought no differences to body weight, waist circumference, glucose, and total cholesterol. It was possible to note that the lipid profile in the placebo group worsened and, although no significant differences were found, we can assume that resveratrol might prevent lipid profile damage and that the intervention affected the lipoprotein metabolism at various levels.

  3. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  4. Multifactorial intervention with nurse practitioners does not change cardiovascular outcomes in patients with chronic kidney disease.

    Science.gov (United States)

    van Zuilen, Arjan D; Bots, Michiel L; Dulger, Arzu; van der Tweel, Ingeborg; van Buren, Marjolijn; Ten Dam, Marc A G J; Kaasjager, Karin A H; Ligtenberg, Gerry; Sijpkens, Yvo W J; Sluiter, Henk E; van de Ven, Peter J G; Vervoort, Gerald; Vleming, Louis-Jean; Blankestijn, Peter J; Wetzels, Jack F M

    2012-09-01

    Strict implementation of guidelines directed at multiple targets reduces vascular risk in diabetic patients. Whether this also applies to patients with chronic kidney disease (CKD) is uncertain. To evaluate this, the MASTERPLAN Study randomized 788 patients with CKD (estimated GFR 20-70 ml/min) to receive additional intensive nurse practitioner support (the intervention group) or nephrologist care (the control group). The primary end point was a composite of myocardial infarction, stroke, or cardiovascular death. During a mean follow-up of 4.62 years, modest but significant decreases were found for blood pressure, LDL cholesterol, anemia, proteinuria along with the increased use of active vitamin D or analogs, aspirin and statins in the intervention group compared to the controls. No differences were found in the rate of smoking cessation, weight reduction, sodium excretion, physical activity, or glycemic control. Intensive control did not reduce the rate of the composite end point (21.3/1000 person-years in the intervention group compared to 23.8/1000 person-years in the controls (hazard ratio 0.90)). No differences were found in the secondary outcomes of vascular interventions, all-cause mortality or end-stage renal disease. Thus, the addition of intensive support by nurse practitioner care in patients with CKD improved some risk factor levels, but did not significantly reduce the rate of the primary or secondary end points.

  5. A Novel Socioeconomic Measure Using Individual Housing Data in Cardiovascular Outcome Research

    Directory of Open Access Journals (Sweden)

    Duk Won Bang

    2014-11-01

    Full Text Available Background: To assess whether the individual housing-based socioeconomic status (SES measure termed HOUSES was associated with post-myocardial infarction (MI mortality. Methods: The study was designed as a population-based cohort study, which compared post-MI mortality among Olmsted County, Minnesota, USA, residents with different SES as measured by HOUSES using Cox proportional hazards models. Subjects’ addresses at index date of MI were geocoded to real property data to formulate HOUSES (a z-score for housing value, square footage, and numbers of bedrooms and bathrooms. Educational levels were used as a comparison for the HOUSES index. Results: 637 of the 696 eligible patients with MI (92% were successfully geocoded to real property data. Post-MI survival rates were 60% (50–72, 78% (71–85, 72% (60–87, and 87% (81–93 at 2 years for patients in the first (the lowest SES, second, third, and fourth quartiles of HOUSES, respectively (p < 0.001. HOUSES was associated with post-MI all-cause mortality, controlling for all variables except age and comorbidity (p = 0.036 but was not significant after adjusting for age and comorbidity (p = 0.24. Conclusions: Although HOUSES is associated with post-MI mortality, the differential mortality rates by HOUSES were primarily accounted for by age and comorbid conditions. HOUSES may be useful for health disparities research concerning cardiovascular outcomes, especially in overcoming the paucity of conventional SES measures in commonly used datasets.

  6. Correlates of Medical Nutrition Therapy and Cardiovascular Outcomes in Youth with Type 1 Diabetes

    Science.gov (United States)

    The, Natalie S.; Crandell, Jamie L.; Thomas, Joan; Couch, Sarah C.; Shah, Amy S.; Maahs, David M; Dabelea, Dana; Marcovina, Santica M.; D'Agostino, Ralph B.; Mayer-Davis, Elizabeth J.

    2013-01-01

    Objective To examine whether the types of medical nutrition therapies (MNTs) taught to and used by youth with type 1 diabetes (T1D) varies by socio-demographic characteristics and cardiovascular (CVD) risk factors Design Cross-sectional study Setting The SEARCH for Diabetes in Youth study is a population-based cohort of individuals with clinical diagnosed diabetes Participants 1,191 individuals with T1D Main Outcome Measures Types of MNTs and frequency of use Analysis Bivariate analysis and multivariate linear regression (P<0.05) Results More race/ethnic minorities (vs. whites), individuals with parents

  7. Transthyretin Predicts Cardiovascular Outcome In Hemodialysis Patients With Diabetes Mellitus Type 2

    Directory of Open Access Journals (Sweden)

    Andrea Henze

    2012-06-01

    A low TTR concentration was associated with an increased risk for CVE for the total study cohort (HR 1.65; 95% CI 1.27-2.14, patients with BMI ≥23kg/m² (HR 1.70; 95% CI 1.22–2.37, albumin ≥3.8g/dL (HR 1.68; 95% CI 1.17–2.42 and the combination of both (HR 1.69; 95% CI 1.13-2.53. Additionally, a low TTR concentration predicted all-cause mortality for the total study cohort (HR 1.79; 95% CI 1.43–2.24 and patients with BMI ≥23kg/m² (HR 1.46; 95% CI 1.09–1.95. In conclusion, the present study demonstrated that TTR is a useful predictor for cardiovascular outcome and mortality in hemodialysis patients. TTR was particularly useful in patients who were not identified to be at risk by BMI or albumin status.

  8. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2003-06-01

    Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

  9. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  10. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe

    2010-01-01

    In the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, combined ezetimibe (10 mg) and simvastatin (40 mg) decreased low-density lipoprotein cholesterol levels by 50% and ischemic cardiovascular event (ICE) risk by 22% compared to placebo. A larger decrease in ICE risk might have been...... expected for the degree of lipid-lowering observed. This analysis investigated relations between changes in lipoprotein components (LCs), and ICE risk decrease in the SEAS trial in all patients, by severity of aortic stenosis (AS), and compared to results of other clinical trials. A total of 1,570 patients...... with baseline aortic jet velocity (JV) data, baseline and 1-year low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B, and no ICEs during the first year were included in the analysis. Relations between on-treatment measurements of 1-year LCs and time-to-ICE occurrence...

  11. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  12. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H;

    2012-01-01

    recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes......, and measurement of biomarkers, show promise as adjuncts to the current disability measures, but are insufficiently validated to serve as substitutes. A collaborative approach that involves academic experts, regulators, industry representitives, and funding agencies is needed to most effectively develop disability...

  13. Electrocardiographic J Wave and Cardiovascular Outcomes in the General Population (from the Atherosclerosis Risk In Communities Study).

    Science.gov (United States)

    O'Neal, Wesley T; Wang, Yi Grace; Wu, Hau-Tieng; Zhang, Zhu-Ming; Li, Yabing; Tereshchenko, Larisa G; Estes, E Harvey; Daubechies, Ingrid; Soliman, Elsayed Z

    2016-09-15

    The association between the J wave, a key component of the early repolarization pattern, and adverse cardiovascular outcomes remains unclear. Inconsistencies have stemmed from the different methods used to measure the J wave. We examined the association between the J wave, detected by an automated method, and adverse cardiovascular outcomes in 14,592 (mean age = 54 ± 5.8 years; 56% women; 26% black) participants from the Atherosclerosis Risk In Communities (ARIC) study. The J wave was detected at baseline (1987 to 1989) and during follow-up study visits (1990 to 1992, 1993 to 1995, and 1996 to 1998) using a fully automated method. Sudden cardiac death, coronary heart disease death, and cardiovascular mortality were ascertained from hospital discharge records, death certificates, and autopsy data through December 31, 2010. A total of 278 participants (1.9%) had evidence of a J wave. Over a median follow-up of 22 years, 4,376 of the participants (30%) died. In a multivariable Cox regression analysis adjusted for demographics, cardiovascular risk factors, and potential confounders, the J wave was not associated with an increased risk of sudden cardiac death (hazard ratio [HR] 0.74, 95% CI 0.36 to 1.50), coronary heart disease death (HR 0.72, 95% CI 0.40 to 1.32), or cardiovascular mortality (HR 1.16, 95% CI 0.87 to 1.56). An interaction was detected for cardiovascular mortality by gender with men (HR 1.54, 95% CI 1.09 to 2.19) having a stronger association than women (HR 0.74, 95% CI 0.43 to 1.25; P-interaction = 0.030). In conclusion, our findings suggest that the J wave is a benign entity that is not associated with an increased risk for sudden cardiac arrest in middle-aged adults in the United States.

  14. Evaluation of the Effectiveness of Tai Chi versus Brisk Walking in Reducing Cardiovascular Risk Factors: Protocol for a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Aileen W. K. Chan

    2016-07-01

    Full Text Available Physical inactivity is one of the major modifiable lifestyle risk factors for cardiovascular disease (CVD. This protocol aims to evaluate the effectiveness of Tai Chi versus brisk walking in reducing CVD risk factors. This is a randomized controlled trial with three arms, namely, Tai Chi group, walking group, and control group. The Tai Chi group will receive Tai Chi training, which consists of two 60-min sessions each week for three months, and self-practice for 30 min every day. The walking group will perform brisk walking for 30 min every day. The control group will receive their usual care. 246 subjects with CVD risk factors will be recruited from two outpatient clinics. The primary outcome is blood pressure. Secondary outcomes include fasting blood for lipid profile, sugar and glycated haemoglobin (HbA1c; body mass index, waist circumference, body fat percentage; perceived stress level and quality of life. Data collections will be conducted at baseline, 3-month, 6-month and 9-month. Generalized estimating equations model will be used to compare the changes in outcomes across time between groups. It is expected that both the Tai Chi and walking groups could maintain better health and have improved quality of life, and that Tai Chi will be more effective than brisk walking in reducing CVD risk factors.

  15. Evaluation of the Effectiveness of Tai Chi versus Brisk Walking in Reducing Cardiovascular Risk Factors: Protocol for a Ranomized Controlled Trial.

    Science.gov (United States)

    Chan, Aileen W K; Sit, Janet W H; Chair, Sek Ying; Leung, Doris Y P; Lee, Diana T F; Wong, Eliza M L; Fung, Lawrence C W

    2016-07-05

    Physical inactivity is one of the major modifiable lifestyle risk factors for cardiovascular disease (CVD). This protocol aims to evaluate the effectiveness of Tai Chi versus brisk walking in reducing CVD risk factors. This is a randomized controlled trial with three arms, namely, Tai Chi group, walking group, and control group. The Tai Chi group will receive Tai Chi training, which consists of two 60-min sessions each week for three months, and self-practice for 30 min every day. The walking group will perform brisk walking for 30 min every day. The control group will receive their usual care. 246 subjects with CVD risk factors will be recruited from two outpatient clinics. The primary outcome is blood pressure. Secondary outcomes include fasting blood for lipid profile, sugar and glycated haemoglobin (HbA1c); body mass index, waist circumference, body fat percentage; perceived stress level and quality of life. Data collections will be conducted at baseline, 3-month, 6-month and 9-month. Generalized estimating equations model will be used to compare the changes in outcomes across time between groups. It is expected that both the Tai Chi and walking groups could maintain better health and have improved quality of life, and that Tai Chi will be more effective than brisk walking in reducing CVD risk factors.

  16. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    OpenAIRE

    Koo John; Thompson Christine; Stone Stephen P; Bresnahan Brian W; Shikiar Richard; Revicki Dennis A

    2003-01-01

    Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome m...

  17. 02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

    OpenAIRE

    Rioux, Jennifer; Saper, Robert; Vinjamury, Sivarama; Elder, Charles

    2013-01-01

    Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific...

  18. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.

  19. An exercise programme for patients with intermittent claudication: randomised trial of health outcomes and cost analysis

    OpenAIRE

    Guidon, Marie

    2011-01-01

    As peripheral arterial disease (PAD) is a chronic, progressive disease with a significant cardiovascular and cerebrovascular risk burden, it has a considerable impact on functional capacity and quality of life (QoL). Exercise programmes result in significant improvements in walking distances but these correlate poorly with patient-reported functioning and QoL and the long-term outcomes are unknown. The aim of this study was to assess the long-term (one year) effects of participation in a 1...

  20. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.;

    2008-01-01

    . Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. PERSPECTIVE: Systematically collecting and reporting the recommended information needed to evaluate the clinical importance......A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group...... of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  1. Patient-reported outcomes (PRO) in ovarian cancer clinical trials-lost opportunities and lessons learned.

    Science.gov (United States)

    Friedlander, M; Mercieca-Bebber, R L; King, M T

    2016-04-01

    Despite increased recognition of the value of including patient-reported outcomes (PROs) as important end points in phase III clinical trials, there has been a lack of pre-specified PRO hypotheses and shortcomings with the analyses and interpretation of PROs in many ovarian cancer trials. This paper discusses and provides examples of the so-called lost opportunities in ovarian cancer trials. These include: (i) no clear pre-specified PRO hypotheses; (ii) PRO end points not included; (iii) insensitive PRO end point selection; (iv) collection of poor-quality PRO data not suitable for analysis; (v) differences in PROs between treatment arms ignored; and (vi) poor reporting quality. We can learn from the past and with relatively little additional effort, improve the collection and interpretation of PRO data in future ovarian cancer trials. The importance of doing so is underpinned by recent initiatives to improve the standard and usefulness of PRO data in clinical trials. These include the Food and Drug Administration (FDA) Guidance for PROs to support labelling claims, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO MCBS), the International Society for Quality-of-Life Research PRO reporting guidance and the Consolidated Standards of Reporting Clinical Trials (CONSORT)-PRO-extension statement which includes a checklist of recommended items to include in PRO sections of trial protocols. Promoting the importance of hypothesis-driven PROs in ovarian cancer clinical trials will lead to improvements in the design of these trials and the interpretation of their results.

  2. Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review

    Directory of Open Access Journals (Sweden)

    Hart Anna

    2005-03-01

    Full Text Available Abstract Good quality clinical trials are essential to inform the best cystic fibrosis (CF management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4; home versus hospital administration of antibiotics (1; steroids (1; mucolytic therapies (6; exercise (3 and pancreatic enzymes (1. Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.

  3. Utilization of preventive care services and their effect on cardiovascular outcomes in the United States

    Directory of Open Access Journals (Sweden)

    Varun Vaidya

    2011-01-01

    Full Text Available Varun Vaidya, Gautam Partha, Jennifer HowePharmacy Health Care Administration, Department of Pharmacy Practice, University of Toledo College of Pharmacy, Toledo, OH, USAObjective: To describe and analyze utilization of preventive care services and their effect on cardiovascular outcomes in the United States.Methods: Data from the 2007 Medical Expenditure Panel Survey (MEPS were used to analyze utilization of preventive care services and their effect on cardiovascular outcomes. Recommendations by the Seventh Report of the Joint Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure and the National Cholesterol Education Program were used to determine appropriate levels of preventive care utilization. Utilization of blood pressure screening and cholesterol checkup services were used as the dependent variable, while age, gender, race, ethnicity, insurance status, and perceived health status were used as independent variables. Since guidelines differ for people with elevated blood pressure, respondents with elevated blood pressure were identified in the MEPS database by self-reported diagnosis. Descriptive statistics were used to describe the population, while a multivariate logistic regression model was built to predict odds of utilizing appropriate levels of preventive services.Results: Total number of adult respondents for which data were available for blood pressure checkup and cholesterol checkup was 20,523 and 15,784, respectively. Overall, MEPS respondents were found to adhere to guideline recommendations for preventive care utilization. Multivariate logistic regression showed that odds of utilization of preventive care services were higher for elderly patients (age >65 years for blood pressure (odds ratio [OR] = 2.39, 95% confidence interval [CI]: 1.92–2.97 and cholesterol (OR = 3.05, 95% CI: 2.18–4.27 preventive services compared with younger population (age 18–54 years. Males had much lower odds of

  4. Measured outcomes with hypnosis as an experimental tool in a cardiovascular physiology laboratory.

    Science.gov (United States)

    Casiglia, Edoardo; Tikhonoff, Valérie; Giordano, Nunzia; Andreatta, Elisa; Regaldo, Giuseppe; Tosello, Maria T; Rossi, Augusto M; Bordin, Daniele; Giacomello, Margherita; Facco, Enrico

    2012-01-01

    The authors detail their multidisciplinary collaboration of cardiologists, physiologists, neurologists, psychologists, engineers, and statisticians in researching the effects of hypnosis on the cardiovascular system and their additions to that incomplete literature. The article details their results and provides guidelines for researchers interested in replicating their research on hypnosis' effect on the cardiovascular system.

  5. Cardiovascular outcomes of a positive nuclear stress test but negative coronary angiography in a multiethnic male predominant cohort

    Directory of Open Access Journals (Sweden)

    Daniel Addison

    2014-01-01

    Full Text Available Background: Patients presenting with chest pain and evidence of functional ischemia by myocardial perfusion imaging (MPI, but lacking commensurate angiographic disease pose a diagnostic and therapeutic dilemma. They are often dismissed as having ′false-positive MPI′. Moreover, a majority of the available long-term outcome data for it has been derived from homogenous female populations. In this study, we sought to evaluate the long-term outcomes of this presentation in a multiethnic male-predominant cohort. Materials and Methods: We retrospectively identified 47 patients who presented to our institution between 2002 and 2005 with chest pain and evidence of ischemia on MPI, but with no significant angiographic disease on subsequent cardiac catheterization (cases. The occurrence of adverse cardiovascular outcomes (chest pain, congestive heart failure, acute myocardial infarction and stroke post-index coronary angiogram was tracked. Similar data was collected for 37 patients who also presented with chest pain, but normal MPI over the same period (controls. Overall average follow-up was over 22 months. Results: Fifty-three percent (26/47 of the cases had one or more of the adverse outcomes as compared with 22% (8/37 of controls (P < 0.01. Of these, 13 (50.0% and 3 (37.5% were males, respectively. Conclusions: Ischemia on MPI is predictive of long-term adverse cardiovascular outcomes despite normal (′false-negative′ coronary angiography. This appears to be gender-neutral.

  6. A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes

    Institute of Scientific and Technical Information of China (English)

    Heather Ann Hausenblas; Kacey Heekin; Heather Lee Mutchie; Stephen Anton

    2015-01-01

    BACKGROUND: Throughout the past three decades, increased scientiifc attention has been given to examining saffron’s (Crocus sativusL.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. OBJECTIVE: The purpose of this systematic review is to examine and categorize the current state of scientiifc evidence from randomized controled trials (RCTs) regarding the efifcacy of saffron on psychological/behavioral outcomes. SEARCH STRATEGY: Electronic and non-electronic systematic searches were conducted to identify al relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).” Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. INCLUSION CRITERIA:Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. DATA EXTRACTION AND ANALYSIS:The methodological quality of al included studies was independently evaluated by two reviewers using the Jadad score. Mean scores andP-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). RESULTS:Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efifcacy of saffron as compared to placebo in improving the folowing conditions:depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition

  7. Adaptive Programming Improves Outcomes in Drug Court: An Experimental Trial.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Croft, Jason R

    2012-04-01

    Prior studies in Drug Courts reported improved outcomes when participants were matched to schedules of judicial status hearings based on their criminological risk level. The current experiment determined whether incremental efficacy could be gained by periodically adjusting the schedule of status hearings and clinical case-management sessions in response to participants' ensuing performance in the program. The adjustments were made pursuant to a priori criteria specified in an adaptive algorithm. Results confirmed that participants in the full adaptive condition (n = 62) were more than twice as likely as those assigned to baseline-matching only (n = 63) to be drug-abstinent during the first 18 weeks of the program; however, graduation rates and the average time to case resolution were not significantly different. The positive effects of the adaptive program appear to have stemmed from holding noncompliant participants more accountable for meeting their attendance obligations in the program. Directions for future research and practice implications are discussed.

  8. Factors associated with patient-reported cosmetic outcome in the Young Boost Breast Trial

    NARCIS (Netherlands)

    Brouwers, Patricia J. A. M.; van Werkhoven, Erik; Bartelink, Harry; Fourquet, Alain; Lemanski, Claire; van Loon, Judith; Maduro, John H.; Russell, Nicola S.; Scheijmans, Luc J. E. E.; Schinagl, Dominic A. X.; Westenberg, Antonia H.; Poortmans, Philip; Boersma, Liesbeth J.

    2016-01-01

    Purpose: To investigate which factors are related to patient reported cosmetic outcome (PRCO) after breast conserving therapy. Methods: From 2004 to 2011, 2421 cT1-2N0-2a breast cancer patients were randomised in the Young Boost Trial between a 16 and a 26 Gy boost to the tumour bed. Cosmesis was sc

  9. The impact of renal dysfunction on outcomes in the ExTRACT-TIMI 25 trial.

    NARCIS (Netherlands)

    Fox, K.A.; Antman, E.M.; Montalescot, G.; Agewall, S.; SomaRaju, B.; Verheugt, F.W.A.; Lopez-Sendon, J.; Hod, H.; Murphy, S.A.; Braunwald, E.

    2007-01-01

    OBJECTIVES: The ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) trial provided the opportunity to evaluate the impact of renal dysfunction on outcomes in patients with ST-segment elevation myocardial infarct

  10. Prognosis of white-coat and masked hypertension: International Database of HOme blood pressure in relation to Cardiovascular Outcome.

    Science.gov (United States)

    Stergiou, George S; Asayama, Kei; Thijs, Lutgarde; Kollias, Anastasios; Niiranen, Teemu J; Hozawa, Atsushi; Boggia, José; Johansson, Jouni K; Ohkubo, Takayoshi; Tsuji, Ichiro; Jula, Antti M; Imai, Yutaka; Staessen, Jan A

    2014-04-01

    Home blood pressure monitoring is useful in detecting white-coat and masked hypertension and is recommended for patients with suspected or treated hypertension. The prognostic significance of white-coat and masked hypertension detected by home measurement was investigated in 6458 participants from 5 populations enrolled in the International Database of HOme blood pressure in relation to Cardiovascular Outcomes. During a median follow-up of 8.3 years, 714 fatal plus nonfatal cardiovascular events occurred. Among untreated subjects (n=5007), cardiovascular risk was higher in those with white-coat hypertension (adjusted hazard ratio 1.42; 95% CI [1.06-1.91]; P=0.02), masked hypertension (1.55; 95% CI [1.12-2.14]; Phypertension (2.13; 95% CI [1.66-2.73]; Phigh office and low home blood pressure (white-coat) and treated controlled subjects (low office and home blood pressure; 1.16; 95% CI [0.79-1.72]; P=0.45). However, treated subjects with masked hypertension (low office and high home blood pressure; 1.76; 95% CI [1.23-2.53]; P=0.002) and uncontrolled hypertension (high office and home blood pressure; 1.40; 95% CI [1.02-1.94]; P=0.04) had higher cardiovascular risk than treated controlled patients. In conclusion, white-coat hypertension assessed by home measurements is a cardiovascular risk factor in untreated but not in treated subjects probably because the latter receive effective treatment on the basis of their elevated office blood pressure. In contrast, masked uncontrolled hypertension is associated with increased cardiovascular risk in both untreated and treated patients, who are probably undertreated because of their low office blood pressure.

  11. The verdict on jury trials for juveniles: the effects of defendant's age on trial outcomes.

    Science.gov (United States)

    Warling, Diane; Peterson-Badali, Michele

    2003-01-01

    With the progression to more adult-like policies and procedures for youth in the justice system, the right to a jury trial has been extended to young offenders. These youth would not be tried by a jury of their peers, however, but by a jury of adults. The concern is that adult jurors may hold negative attitudes about youth that might influence their decision making in a case involving a young defendant. Two studies examined whether and under what conditions defendant's age affects jurors' decisions about the guilt and sentencing of an accused. In study 1, data were gathered from two samples of jury eligible adults: one university sample and one public sample. Mock jurors read written transcripts of a trial involving a defendant who was presented as either 13, 17, or 25 years of age. Results indicated that the defendant's age had no effect on mock jurors' verdict or their ratings of defendant guilt. However, younger defendants were granted shorter sentences than the adult defendants. In study 2, mock jurors read the same trial presented in study 1 but were asked to deliberate about the case and render group verdicts. These group verdicts did not differ significantly by defendant's age. Age-related themes that emerged from group deliberations were identified, and results indicated that age tended to be used as a mitigating factor in favor of youth rather than against them. These findings are discussed in terms of their implications for youth justice policy and practice.

  12. Assessment of long-term outcomes for the STRokE DOC telemedicine trial.

    Science.gov (United States)

    Meyer, Brett C; Raman, Rema; Ernstrom, Karin; Tafreshi, Gilda M; Huisa, Branko; Stemer, Andrew B; Hemmen, Thomas M

    2012-05-01

    Telemedicine can provide stroke evaluations in locations with limited available expertise. The reliability of telestroke has been established. Decision making efficacy has been shown in the National Institutes of Health's STRokE DOC trial. No prospective trial has assessed long-term telestroke outcomes, however. In an institutional review board-approved trial (NCT00936455), we contacted patients originally enrolled in the STRokE DOC trial. A telephone script was used to verify consent. Patients were asked standardized questions regarding disposition, modified Rankin Scale (mRS) score, mortality, and recurrent stroke for 2 retrospective time points (6 and 12 months postevent) and one current time point. Blind was maintained. Primary outcome measures of mortality and percent mRS score of 0-1 [%mRS(0-1)] at 6 months are reported. Wilcoxon's rank-sum test was used for continuous variables, and Fisher's exact was used for categorical variables. Of the original 222 participants, 75 patients or surrogates could be contacted. Mean time from enrollment was 3.96 ± 1.0 years (range, 2.33-5.45 years). Mean National Institutes of Health Stroke Scale (NIHSS) score was 8 ± 7 (5 ± 8 for telephone; 12 ± 8 for telemedicine; P = .002). The rate of intravenous recombinant tissue plasminogen activator (rt-PA) use was 31%. Six-month %mRS(0-1) outcome was not different, at 42%. Mortality after imputation to the entire study sample also was not different, at 18%. There was no difference in the rate of recurrent stroke (P = .61). Some 85% of patients were home at 6 months. This study reports a good 6-month outcome for stroke patients evaluated by telemedicine or telephone. This design is limited by the time since original enrollment and resultant inability to contact participants. Although these findings can add to the limited data on telemedicine outcomes, a prospective trial is needed.

  13. Safety Events in Kidney Transplant Recipients: Results from the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) Trial

    Science.gov (United States)

    Weir, Matthew R.; Gravens-Muller, Lisa; Costa, Nadiesda; Ivanova, Anastasia; Manitpisitkul, Wana; Bostom, Andrew G.; Diamantidis, Clarissa J.

    2015-01-01

    Background Kidney transplant recipients are at increased risk for adverse safety events related to their reduced renal function and many medications. Methods We determined the incidence of adverse safety events based on previously defined Agency for Healthcare and Research Quality (AHRQ) ICD-9 code-derived patient safety indicators (PSI) in the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) trial participants who had a hospitalization stratified by tertiles of estimated glomerular filtration rate. We also examined the frequency of Micromedex defined two precautionary drug-drug interactions, and two medications whose use may be contraindicated due to reduced GFR from the FAVORIT trial Medication Thesaurus at baseline, and annually among 4110 participants. Logistic regression was used to examine the relationship between patient safety events and baseline demographic and clinical variables at a participant level. Event rates were estimated at participant and visit levels. Results Of the 2514 patients with a hospitalization, 978 (38.9%) experienced an AHRQ PSI. Factors which were associated with more common AHRQ PSI included: US location, history of cardiovascular disease or diabetes, and lower tertile of estimated GFR. At a participant level, 2524 of the 4110 participants (61.4%) were taking a CNI and a statin, 378 (9.2%) were taking azathioprine and an ACE inhibitor, 171 (12.9%) were taking a sulfonylurea ), 45 (3.4%) were taking metformin despite a baseline GFR below 40 ml/min/1.73m2. Conclusions We conclude that patient safety events are not uncommon in kidney transplant recipients. Careful monitoring is necessary to prevent adverse outcomes. PMID:25393158

  14. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation

    DEFF Research Database (Denmark)

    Nordell, Anna D; McKenna, Matthew; Borges, Álvaro H

    2014-01-01

    BACKGROUND: In the general population, raised levels of inflammatory markers are stronger predictors of fatal than nonfatal cardiovascular disease (CVD) events. People with HIV have elevated levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), and D-dimer; HIV-induced acti...... with a greater risk of fatal CVD and a greater risk of death after a nonfatal CVD event. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrial.gov Unique identifier: SMART: NCT00027352, ESPRIT: NCT00004978, SILCAAT: NCT00013611....

  15. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

    DEFF Research Database (Denmark)

    Bosch, Jackie; Gerstein, Hertzel C; Dagenais, Gilles R

    2012-01-01

    The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown.......The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown....

  16. CARDIOVASCULAR OUTCOMES IN FRAMINGHAM PARTICIPANTS WITH DIABETES: THE IMPORTANCE OF BLOOD PRESSURE

    OpenAIRE

    Chen, Guanmin; McAlister, Finlay A; Walker, Robin L; Hemmelgarn, Brenda R; Campbell, Norm RC

    2011-01-01

    We designed this study to explore to what extent the excess risk of cardiovascular events in diabetic individuals is attributable to hypertension. We retrospectively analyzed prospectively collected data from the Framingham Original and Offspring cohorts. Of the 1145 Framingham subjects newly diagnosed with diabetes who did not have a prior history of cardiovascular events, 663 (58%) had hypertension at the time diabetes was diagnosed. During 4154 person-years of follow-up, 125 died and 204 s...

  17. Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants

    OpenAIRE

    Giannì, Maria Lorella; Roggero, Paola; Amato, Orsola; Picciolini, Odoardo; Piemontese, Pasqua; Liotto, Nadia; Taroni, Francesca; Mosca, Fabio

    2014-01-01

    Background Preterm infants are at risk for adverse neurodevelopment. Furthermore, nutrition may play a key role in supporting neurodevelopment. The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months (term-corrected age). Methods We conducted an observer-blinded, single-center, randomized controlled trial in infants admitted to the Fondazione IRCCS Cà Granda Ospedale Maggiore Po...

  18. A randomized controlled trial of patient-reported outcomes with tai chi exercise in Parkinson's disease.

    Science.gov (United States)

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2014-04-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared between tai chi and resistance training and between tai chi and stretching exercise. Patient-reported outcome measures were perceptions of health-related benefits resulting from participation, assessed by the Parkinson's Disease Questionnaire (PDQ-8) and Vitality Plus Scale (VPS). Clinical outcome measures included motor symptoms, assessed by a modified Unified Parkinson's Disease Rating Scale-Motor Examination (UPDRS-ME) and a 50-foot speed walk. Information on continuing exercise after the structured interventions were terminated was obtained at a 3-month postintervention follow-up. Tai chi participants reported significantly better improvement in the PDQ-8 (-5.77 points, P = 0.014) than did resistance training participants and in PDQ-8 (-9.56 points, P tai chi, patient-reported improvement in the PDQ-8 and VPS was significantly correlated with their clinical outcomes of UPDRS-ME and a 50-foot walk, but these correlations were not statistically different from those shown for resistance training or stretching. However, patient-reported outcomes from tai chi training were associated with greater probability of continued exercise behavior than were either clinical outcomes or patient-reported outcomes from resistance training or stretching. Tai chi improved patient-reported perceptions of health-related benefits, which were found to be associated with a greater probability of exercise adherence. The findings indicate the potential of patient perceptions to drive exercise

  19. Reducing cardiovascular risk in spouses of cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Yates, Bernice C; Rowland, Sheri; Mancuso, Kerry; Kupzyk, Kevin A; Norman, Joseph F; Shurmur, Scott; Tesina, Karen

    2015-01-01

    Few studies have examined risk-reducing interventions in spouses of coronary artery bypass patients. This study examined the effects of the Partners Together in Health (PaTH) intervention versus usual care on cardiovascular risk factors. Spouses in the experimental group (n = 17/group) attended cardiac rehabilitation with patients and made the same physical activity and healthy eating changes as patients. Spouses in the usual care group attended educational classes with patients. Spouses' 30-year cardiovascular risk was calculated using the Lifetime Risk Scale before and after cardiac rehabilitation (3 months), and at 6 months. Spouses in both groups significantly reduced 30-year risk scores at 3 and 6 months. Exercise was the key ingredient in lowering risk. There was a trend toward reduction in systolic blood pressure and an increase in high-density lipoprotein cholesterol in both groups. Although there were no group differences, having spouses participate in cardiac rehabilitation with the patient was effective for reducing spouses' cardiovascular risk.

  20. Cardiovascular Prevention of Cognitive Decline

    Directory of Open Access Journals (Sweden)

    Jean-Jacques Monsuez

    2011-01-01

    Full Text Available Midlife cardiovascular risk factors, including diabetes, hypertension, dyslipemia, and an unhealthy lifestyle, have been linked to subsequent incidence, delay of onset, and progression rate of Alzheimer disease and vascular dementia. Conversely, optimal treatment of cardiovascular risk factors prevents and slows down age-related cognitive disorders. The impact of antihypertensive therapy on cognitive outcome in patients with hypertension was assessed in large trials which demonstrated a reduction in progression of MRI white matter hyperintensities, in cognitive decline and in incidence of dementia. Large-scale database correlated statin use and reduction in the incidence of dementia, mainly in patients with documented atherosclerosis, but clinical trials failed to reach similar conclusions. Whether a multitargeted intervention would substantially improve protection, quality of life, and reduce medical cost expenditures in patients with lower risk profile has not been ascertained. This would require appropriately designed trials targeting large populations and focusing on cognitive decline as a primary outcome endpoint.

  1. Cardiovascular effects of growth hormone in adult hemodialysis patients: results from a randomized controlled trial

    DEFF Research Database (Denmark)

    Køber, Lars; Rustom, Rana; Wiedmann, Jonas;

    2010-01-01

    The high morbidity and mortality rates in hemodialysis (HD) patients are due, at least in part, to their increased risk for cardiovascular diseases (CVD). This prospective study evaluated the effect of growth hormone (GH) on a number of CVD risk markers in adult patients on HD.......The high morbidity and mortality rates in hemodialysis (HD) patients are due, at least in part, to their increased risk for cardiovascular diseases (CVD). This prospective study evaluated the effect of growth hormone (GH) on a number of CVD risk markers in adult patients on HD....

  2. Gender differences in clinical outcomes for cocaine dependence: Randomized clinical trials of behavioral therapy and disulfiram✩

    Science.gov (United States)

    DeVito, Elise E.; Babuscio, Theresa A.; Nich, Charla; Ball, Samuel A.; Carroll, Kathleen M.

    2014-01-01

    Background Despite extensive research on gender differences in addiction, there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials. Methods An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence (N = 434) was evaluated for gender differences in clinical outcomes. Secondary analyses compared gender differences in outcome by medication condition (disulfiram versus no medication) and across multiple behavioral treatment conditions. Results Women, compared with men, had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up. These results appear to be primarily accounted for by disulfiram being less effective in women compared with men. There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated. Conclusions These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction. Conversely, some addiction pharmacotherapies, such as disulfiram, may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation. PMID:25457739

  3. The JUPITER and AURORA clinical trials for rosuvastatin in special primary prevention populations: perspectives, outcomes, and consequences

    Directory of Open Access Journals (Sweden)

    Venkata Narla

    2009-11-01

    Full Text Available Venkata Narla, Michael J Blaha, Roger S Blumenthal, Erin D MichosThe Ciccarone Preventive Cardiology Center, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USAAbstract: Statins have emerged at the forefront of preventive cardiology and have significantly reduced cardiovascular events and mortality. Nonetheless, cardiovascular disease remains the leading cause of death in the United States and in other developed countries, as well as the etiology of significant morbidity and health-care expenditure. In an attempt to reduce potentially missed opportunities for instituting preventive therapy, the JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin and the AURORA study (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events examined the effect of statins in two specific patient populations who currently do not meet the guidelines for statin treatment, but nonetheless, are at high cardiovascular risk. This review outlines the JUPITER and AURORA trials, interprets the data and significance of the results, analyses the drawbacks and impact of both trials and delineates the potential for further clinical trials.Keywords: JUPITER, AURORA, rosuvastatin, cardiovascular disease

  4. Cardiovascular outcomes in framingham participants with diabetes: the importance of blood pressure.

    Science.gov (United States)

    Chen, Guanmin; McAlister, Finlay A; Walker, Robin L; Hemmelgarn, Brenda R; Campbell, Norm R C

    2011-05-01

    We designed this study to explore to what extent the excess risk of cardiovascular events in diabetic individuals is attributable to hypertension. We retrospectively analyzed prospectively collected data from the Framingham original and offspring cohorts. Of the 1145 Framingham subjects newly diagnosed with diabetes mellitus who did not have a previous history of cardiovascular events, 663 (58%) had hypertension at the time that diabetes mellitus was diagnosed. During 4154 person-years of follow-up, 125 died, and 204 experienced a cardiovascular event. Framingham participants with hypertension at the time of diabetes mellitus diagnosis exhibited higher rates of all-cause mortality (32 versus 20 per 1000 person-years; Pdiabetes mellitus. After adjustment for demographic and clinical covariates, hypertension was associated with a 72% increase in the risk of all-cause death and a 57% increase in the risk of any cardiovascular event in individuals with diabetes mellitus. The population-attributable risk from hypertension in individuals with diabetes mellitus was 30% for all-cause death and 25% for any cardiovascular event (increasing to 44% and 41%, respectively, if the 110 normotensive subjects who developed hypertension during follow-up were excluded from the analysis). In comparison, after adjustment for concurrent hypertension, the population-attributable risk from diabetes mellitus in Framingham subjects was 7% for all-cause mortality and 9% for any cardiovascular disease event. Although diabetes mellitus is associated with increased risks of death and cardiovascular events in Framingham subjects, much of this excess risk is attributable to coexistent hypertension.

  5. Management of Patient-Reported Outcome (PRO Alerts in Clinical Trials: A Cross Sectional Survey.

    Directory of Open Access Journals (Sweden)

    Derek Kyte

    Full Text Available Assessment of patient-reported outcomes (PROs provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint.We conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39-50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient.Research personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO

  6. Cardiovascular effects of gliptins.

    Science.gov (United States)

    Scheen, André J

    2013-02-01

    Dipeptidyl peptidase 4 (DPP-4) inhibitors (commonly referred to as gliptins) are a novel class of oral antihyperglycaemic agents with demonstrated efficacy in the treatment of type 2 diabetes mellitus (T2DM). Preclinical data and mechanistic studies have indicated a possible beneficial action on blood vessels and the heart, via both glucagon-like peptide 1 (GLP-1)-dependent and GLP-1-independent effects. DPP-4 inhibition increases the concentration of many peptides with potential vasoactive and cardioprotective effects. Clinically, DPP-4 inhibitors improve several risk factors in patients with T2DM. They improve blood glucose control (mainly by reducing postprandial glycaemia), are weight neutral (or even induce modest weight loss), lower blood pressure, improve postprandial lipaemia, reduce inflammatory markers, diminish oxidative stress, and improve endothelial function. Some positive effects on the heart have also been described in patients with ischaemic heart disease or congestive heart failure, although their clinical relevance requires further investigation. Post-hoc analyses of phase II-III, controlled trials suggest a possible cardioprotective effect with a trend for a lower incidence of major cardiovascular events with gliptins than with placebo or active agents. However, the actual relationship between DPP-4 inhibition and cardiovascular outcomes remains to be proven. Major prospective clinical trials with predefined cardiovascular outcomes and involving various DPP-4 inhibitors are now underway in patients with T2DM and a high-risk cardiovascular profile.

  7. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    Energy Technology Data Exchange (ETDEWEB)

    Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  8. Non-linear Equation using Plasma Brain Natriuretic Peptide Levels to Predict Cardiovascular Outcomes in Patients with Heart Failure

    Science.gov (United States)

    Fukuda, Hiroki; Suwa, Hideaki; Nakano, Atsushi; Sakamoto, Mari; Imazu, Miki; Hasegawa, Takuya; Takahama, Hiroyuki; Amaki, Makoto; Kanzaki, Hideaki; Anzai, Toshihisa; Mochizuki, Naoki; Ishii, Akira; Asanuma, Hiroshi; Asakura, Masanori; Washio, Takashi; Kitakaze, Masafumi

    2016-11-01

    Brain natriuretic peptide (BNP) is the most effective predictor of outcomes in chronic heart failure (CHF). This study sought to determine the qualitative relationship between the BNP levels at discharge and on the day of cardiovascular events in CHF patients. We devised a mathematical probabilistic model between the BNP levels at discharge (y) and on the day (t) of cardiovascular events after discharge for 113 CHF patients (Protocol I). We then prospectively evaluated this model on another set of 60 CHF patients who were readmitted (Protocol II). P(t|y) was the probability of cardiovascular events occurring after >t, the probability on t was given as p(t|y) = -dP(t|y)/dt, and p(t|y) = pP(t|y) = αyβP(t|y), along with p = αyβ (α and β were constant); the solution was p(t|y) = αyβ exp(-αyβt). We fitted this equation to the data set of Protocol I using the maximum likelihood principle, and we obtained the model p(t|y) = 0.000485y0.24788 exp(-0.000485y0.24788t). The cardiovascular event-free rate was computed as P(t) = 1/60Σi=1,…,60 exp(-0.000485yi0.24788t), based on this model and the BNP levels yi in a data set of Protocol II. We confirmed no difference between this model-based result and the actual event-free rate. In conclusion, the BNP levels showed a non-linear relationship with the day of occurrence of cardiovascular events in CHF patients.

  9. Reappraisal of effects of serum chemerin and adiponectin levels and nutritional status on cardiovascular outcomes in prevalent hemodialysis patients

    Science.gov (United States)

    Chen, Hung-Yuan; Chiu, Yen-Lin; Hsu, Shih-Ping; Pai, Mei-Fen; Yang, Ju-Yeh; Wu, Hon-Yen; Peng, Yu-Sen

    2016-01-01

    Although chemerin, an adipokine, increases the cardiovascular (CV) risk in obese people, it is associated with a survival advantage in incident hemodialysis (HD) patients. We explored the potential effects of chemerin on CV outcomes in prevalent HD patients. This prospective study included 343 prevalent HD patients. The composite outcome was the occurrence of CV events and death during follow-up. We used multivariate Cox regression analysis to test the predictive power of different chemerin and adiponectin levels and geriatric nutritional risk index (GNRI) for the outcomes. HD patients with higher chemerin levels (≥211.4 ng/mL) had a lower risk of CV events (adjusted hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.41–0.98) and composite CV outcome (adjusted HR, 0.67; 95% CI, 0.45–0.99) than those with lower chemerin levels (<211.4 ng/mL). When evaluating CV outcomes, we identified an interaction between chemerin levels and GNRI, but not between chemerin and adiponectin levels. The findings remained robust in the sensitivity analysis. Thus, in prevalent HD patients with negligible residual renal function, higher chemerin levels predict more favourable CV outcomes. PMID:27667092

  10. WHAT CAN WE EXPECT USING ACE INHIBITOR RAMIPRIL IN PERSONS WITH HIGH CARDIOVASCULAR RISK AND EARLY DISORDERS OF CARBOHYDRATE METABOLISM? LESSONS OF DREAM TRIAL

    OpenAIRE

    M. N. Mamedov; M. B. Stroeva

    2008-01-01

    Primary prevention of diabetes in persons with high cardiovascular risk is an actual problem. Results of DREAM trial are discussed. Influence of ACE inhibitor, ramipril, on risk of diabetes onset in patients with pre-diabetes and low cardiovascular risk is focused. Metabolic effects of other groups of antihypertensive drugs and their ability to prevent diabetes onset are compared. Ramipril three years therapy resulted in normalization in glucose level but did not have effect on frequency of d...

  11. Cardiovascular disease after treatment for Hodgkin's lymphoma : an analysis of nine collaborative EORTC-LYSA trials

    NARCIS (Netherlands)

    Maraldo, Maja V.; Giusti, Francesco; Vogelius, Ivan R.; Lundemann, Michael; van der Kaaij, Marleen A. E.; Ramadan, Safaa; Meulemans, Bart; Henry-Amar, Michel; Aleman, Berthe M. P.; Raemaekers, John; Meijnders, Paul; Moser, Elisabeth C.; Kluin-Nelemans, Hanneke C.; Feugier, Pierre; Casasnovas, Olivier; Fortpied, Catherine; Specht, Lena

    2015-01-01

    Background Cardiovascular disease after treatment is an important concern in cancer survivors. However, knowledge of cardiotoxicity is limited by the retrospective nature of data, which often does not contain details of treatment exposure. To facilitate individual risk counselling of patients, we ai

  12. Cardiovascular disease after treatment for Hodgkin's lymphoma: an analysis of nine collaborative EORTC-LYSA trials

    NARCIS (Netherlands)

    Maraldo, M.V.; Giusti, F.; Vogelius, I.R.; Lundemann, M.; Kaaij, M.A. van der; Ramadan, S.; Meulemans, B.; Henry-Amar, M.; Aleman, B.M.; Raemaekers, J.M.M.; Meijnders, P.; Moser, E.C.; Kluin-Nelemans, H.C.; Feugier, P.; Casasnovas, O.; Fortpied, C.; Specht, L.

    2015-01-01

    BACKGROUND: Cardiovascular disease after treatment is an important concern in cancer survivors. However, knowledge of cardiotoxicity is limited by the retrospective nature of data, which often does not contain details of treatment exposure. To facilitate individual risk counselling of patients, we a

  13. Cardiovascular disease after treatment for Hodgkin's lymphoma: an analysis of nine collaborative EORTC-LYSA trials

    DEFF Research Database (Denmark)

    Maraldo, Maja V.; Giusti, Francesco; Vogelius, Ivan R.

    2015-01-01

    BACKGROUND: Cardiovascular disease after treatment is an important concern in cancer survivors. However, knowledge of cardiotoxicity is limited by the retrospective nature of data, which often does not contain details of treatment exposure. To facilitate individual risk counselling of patients, we...

  14. A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

    Science.gov (United States)

    Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

    2010-01-01

    Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

  15. Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial

    Directory of Open Access Journals (Sweden)

    Bhattacharyya Onil

    2010-04-01

    Full Text Available Abstract Background The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (CDA created an implementation strategy to improve the implementation of its 2008 guidelines. This study will evaluate the impact of the strategy to improve cardiovascular disease (CVD screening, prevention and treatment for people with diabetes. Design A pragmatic cluster-randomized trial will be conducted to evaluate the CDA's CVD Toolkit. All family physicians in Ontario, Canada were randomly allocated to receive the Toolkit, which includes several printed educational materials targeting CVD screening, prevention and treatment, either in spring 2009 (intervention arm or in spring 2010 (control arm. Randomization occurred at the level of the practice. Forty family physicians from each arm will be recruited to participate, and the medical records for 20 of their diabetic patients at high risk for CVD will be retrospectively reviewed. Outcome measures will be assessed for each patient between July 2009 and March 2010. The primary outcome will be that the patient is receiving a statin. Secondary outcomes will include 1 the receipt of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 2 various intermediate measures (A1c, blood pressure, LDL-cholesterol, total-/HDL-cholesterol ratio, body mass index and waist circumference, and 3 clinical inertia (the failure to change therapy in response to an abnormal A1c, blood pressure or cholesterol reading. The analysis will be carried out using multilevel hierarchical logistic regression models to account for the clustered nature of the data. The group assignment will be a physician-level variable. In addition, a process evaluation study with six focus groups of family physicians will assess the acceptability of the CDA's Toolkit and will explore factors

  16. Betaine and Trimethylamine-N-Oxide as Predictors of Cardiovascular Outcomes Show Different Patterns in Diabetes Mellitus: An Observational Study.

    Directory of Open Access Journals (Sweden)

    Michael Lever

    Full Text Available Betaine is a major osmolyte, also important in methyl group metabolism. Concentrations of betaine, its metabolite dimethylglycine and analog trimethylamine-N-oxide (TMAO in blood are cardiovascular risk markers. Diabetes disturbs betaine: does diabetes alter associations between betaine-related measures and cardiovascular risk?Plasma samples were collected from 475 subjects four months after discharge following an acute coronary admission. Death (n = 81, secondary acute MI (n = 87, admission for heart failure (n = 85, unstable angina (n = 72 and all cardiovascular events (n = 283 were recorded (median follow-up: 1804 days.High and low metabolite concentrations were defined as top or bottom quintile of the total cohort. In subjects with diabetes (n = 79, high plasma betaine was associated with increased frequencies of events; significantly for heart failure, hazard ratio 3.1 (1.2-8.2 and all cardiovascular events, HR 2.8 (1.4-5.5. In subjects without diabetes (n = 396, low plasma betaine was associated with events; significantly for secondary myocardial infarction, HR 2.1 (1.2-3.6, unstable angina, HR 2.3 (1.3-4.0, and all cardiovascular events, HR 1.4 (1.0-1.9. In diabetes, high TMAO was a marker of all outcomes, HR 2.7 (1.1-7.1 for death, 4.0 (1.6-9.8 for myocardial infarction, 4.6 (2.0-10.7 for heart failure, 9.1 (2.8-29.7 for unstable angina and 2.0 (1.1-3.6 for all cardiovascular events. In subjects without diabetes TMAO was only significant for death, HR 2.7 (1.6-4.8 and heart failure, HR 1.9 (1.1-3.4. Adding the estimated glomerular filtration rate to Cox regression models tended to increase the apparent risks associated with low betaine.Elevated plasma betaine concentration is a marker of cardiovascular risk in diabetes; conversely low plasma betaine concentrations indicate increased risk in the absence of diabetes. We speculate that the difference reflects control of osmolyte retention in tissues. Elevated

  17. Study protocol for a randomised controlled trial of brief, habit-based, lifestyle advice for cancer survivors: exploring behavioural outcomes for the Advancing Survivorship Cancer Outcomes Trial (ASCOT)

    Science.gov (United States)

    Beeken, Rebecca J; Croker, Helen; Heinrich, Maggie; Smith, Lee; Williams, Kate; Hackshaw, Allan; Hines, John; Machesney, Michael; Krishnaswamy, Madhavan; Cavanagh, Sharon; Roylance, Rebecca; Hill, Alison; Pritchard-Jones, Kathy; Wardle, Jane; Fisher, Abigail

    2016-01-01

    Introduction Positive health behaviours such as regular physical activity and a healthy diet have significant effects on cancer outcomes. There is a need for simple but effective behaviour change interventions with the potential to be implemented within the cancer care pathway. Habit-based advice encourages repetition of a behaviour in a consistent context so that the behaviour becomes increasingly automatic in response to a specific contextual cue. This approach therefore encourages long-term behaviour change and can be delivered through printed materials. ‘Healthy Habits for Life’ is a brief intervention based on habit theory, and incorporating printed materials plus a personally tailored discussion, that has been designed specifically for patients with a diagnosis of cancer. The aim of this trial was to test the effect of ‘Healthy Habits for Life’ on a composite health behaviour risk index (CHBRI) over 3 months in patients with a diagnosis of breast, colorectal or prostate cancer. Method and analysis A 2-arm, individually randomised controlled trial in patients with breast, colorectal and prostate cancer. Patients will be recruited over 18 months from 7 National Health Service Trusts in London and Essex. Following baseline assessments and allocation to intervention or usual care, patients are followed up at 3 and 6 months. The primary outcome will be change in CHBRI at 3 months. Maintenance of any changes over 6 months, and changes in individual health behaviours (including dietary intake, physical activity, alcohol consumption and smoking status) will also be explored. Ethics and dissemination Ethical approval was obtained through the National Research Ethics Service Committee South Central—Oxford B via the Integrated Research Application System (reference number 14/SC/1369). Results of this study will be disseminated through peer-reviewed publications and scientific presentations. Trial registration number 17421871. PMID:27881518

  18. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials.

    Science.gov (United States)

    Kaul, Sanjay; Diamond, George A

    2007-01-01

    Active control noninferiority trials are being used with increasing frequency in new drug or device development when standard placebo-controlled trials are considered unethical. Nevertheless, the design and analysis of these trials are founded on a number of assumptions and arbitrary criteria that are generally not well understood or justifiable. Trials designed to show noninferiority require an appropriate reference population, a proven active control and dose, an appropriate margin of noninferiority that is clinically relevant and statistically justifiable, a high level of adherence to treatment, and adequate statistical power to reliably conclude that a treatment is truly noninferior and therefore effective. Accordingly, if noninferiority trials are to be applied to clinical and regulatory decisions regarding the marketing and use of new treatments, the assumptions must be made explicit and their influence on the resultant conclusions must be assessed rigorously. When conservative criteria were applied to each of the key assumptions underlying 2 representative noninferiority trials, they materially undermined the conclusions regarding noninferiority failing to confirm reported conclusions regarding noninferiority despite enthusiastic dissemination and acceptance of the results. Because the clinical, regulatory, and economic impact of active control noninferiority trials is substantial, robust criteria should be used routinely in their design, analysis, and interpretation to reach their intended objectives and to keep them from becoming wasted efforts.

  19. SCANDCLEFT RANDOMIZED TRIALS: SPEECH OUTCOMES IN 5-YEAR-OLDS WITH UCLP - velopharyngeal competency and hypernasality

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth;

    2016-01-01

    Objective: Adequate velopharyngeal function and speech is a main objective in treatment of cleft palate. The aim was to investigate if there were differences in velopharyngeal competency and hypernasality at 5 years of age in children with UCLP randomized to different surgical methods for primary...... palatal repair were tested against a common procedure. Main Outcome Measures: VPC-Sum, a composite score of velopharyngeal competency, and hypernasality from blinded assessments. Results: Occurrence of more than mild hypernasality and VPC-Sum scores of incompetence varied between 18 and 40......% with no statistical significant difference between the arms in any of the three trials. Conclusions: The methods within each trial revealed similar results regarding velopharyngeal competency at age 5 years. Similar speech outcome was reached with different methods for primary palatal repair but the burden of care...

  20. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...... data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making....

  1. Cardiovascular mortality: quality diagnostics analysis and causal statistics of lethal outcomes

    Directory of Open Access Journals (Sweden)

    Nikulina N.N.

    2011-03-01

    Full Text Available The high cardiovascular mortality (CVM proves the necessity of verification analysis of cardiovascular death causes. The research goal is to determine the quality, facilities and peculiarities of cardiovascular diseases (CVD of postmortem diagnostics and statistical recording as a cause of death. 1972 successive cases of CVM in Voronezh, Ryazan and Khanty-Mansiysk have been analyzed. The majority of deaths caused by CVD were classified as fatalities occurring outside hospital and in the absence of medical care (88.0%. Incidence of cardiovascular deaths was confirmed by autopsy in 28.3% cases. With increasing age, the incidence of detecting CVD as a cause of death increased, while the frequency of referral to autopsy consistently decreased. Chronic Ischemic Heart Disease (IHD forms comprising 48.3% of all CVM were confirmed by autopsy results only in 29.5% of cases. Acute IHD forms (including myocardial infarction accounted for only 11.6% of CVM; however this diagnosis was based on autopsy results in 72.4% of cases. The high death rate outside hospital and in the absence of medical care with the rare referral to autopsy, especially for elderly having chronic CVD, does not provide reliable statistical information on CVM

  2. Glycemia and Its Relationship to Outcomes in the Metformin in Gestational Diabetes Trial

    OpenAIRE

    2009-01-01

    OBJECTIVE To determine how glucose control in women with GDM treated with metformin and/or insulin influenced pregnancy outcomes. RESEARCH DESIGN AND METHODS Women randomly assigned to metformin or insulin treatment in the Metformin in Gestational Diabetes (MiG) trial had baseline glucose tolerance test (OGTT) results and A1C documented, together with all capillary glucose measurements during treatment. In the 724 women who had glucose data for analysis, tertiles of baseline glucose values an...

  3. Analysis on Outcome of 3537 Patients with Coronary Artery Disease: Integrative Medicine for Cardiovascular Events

    Directory of Open Access Journals (Sweden)

    Zhu-ye Gao

    2013-01-01

    Full Text Available Aims. To investigate the treatment of hospitalized patients with coronary artery disease (CAD and the prognostic factors in Beijing, China. Materials and Methods. A multicenter prospective study was conducted through an integrative platform of clinical and research at 12 hospitals in Beijing, China. The clinical information of 3537 hospitalized patients with CAD was collected from September 2009 to May 2011, and the efficacy of secondary prevention during one-year followup was evaluated. In addition, a logistic regression analysis was performed to identify some factors which will have independent impact on the prognosis. Results. The average age of all patients was 64.88 ± 11.97. Of them, 65.42% are males. The medicines for patients were as follows: antiplatelet drugs accounting for 91.97%, statins accounting for 83.66%, β-receptor blockers accounting for 72.55%, ACEI/ARB accounting for 58.92%, and revascularization (including PCI and CABG accounting for 40.29%. The overall incidence of cardiovascular events was 13.26% (469/3537. The logistic stepwise regression analysis showed that heart failure (OR, 3.707, 95% CI = 2.756–4.986, age ≥ 65 years old (OR, 2.007, 95% CI = 1.587–2.53, and myocardial infarction (OR, 1.649, 95% CI = 1.322–2.057 were the independent risk factors of others factors for cardiovascular events that occurred during followup of one-year period. Integrative medicine (IM therapy showed the beneficial tendency for decreasing incidence of cardiovascular events, although no statistical significance was found (OR, 0.797, 95% CI = 0.613~1.036. Conclusions. Heart failure, age ≥ 65 years old, and myocardial infarction were associated with an increase in incidence of cardiovascular events, and treatment with IM showed a tendency for decreasing incidence of cardiovascular events.

  4. Choice of design and outcomes in trials among children with moderate acute malnutrition.

    Science.gov (United States)

    Friis, Henrik; Michaelsen, Kim F; Wells, Jonathan C

    2015-03-01

    There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials are needed, special designs, such as cluster-randomized, stepped-wedged or factorial designs may offer advantages. Anthropometry is widely used as the primary outcome in such trials, but anthropometric traits do not refer directly to specific organs, tissues, or functions. Thus, it is difficult to understand what components of health might be impacted by public health programs, or the underlying mechanisms whereby improved nutritional status might benefit short- and long-term health. Measurement of body composition, specific growth markers and functional outcomes may provide greater insight into the nature and implications of growth failure and recovery. There are now several methodologies suitable for application in infants and young children, e.g., measuring body composition with deuterium dilution, physical activity with accelerometers and linear growth with knemometers. To evaluate the generalizability of the findings from nutrition trials, it is important to collect data on baseline nutritional status.

  5. Exploitation of resources and cardiovascular outcomes in low-risk patients with chest pain hospitalized in coronary care units

    Directory of Open Access Journals (Sweden)

    Saadat H

    2011-10-01

    Full Text Available Habibollah Saadat¹, Hossein Shiri², Zahra Salarpour², Tahereh Ashktorab² , Hamid Alavi Majd², Zahra Saadat¹, Hosein Vakili¹ 1Cardiovascular Research Center, Modarres Hospital, Shaheed Beheshti University of Medical Sciences, Tehran; 2Nursing School, Shaheed Beheshti University of Medical Sciences, Tehran, Iran Background: Most patients who present to medical centers due to chest pain do not suffer from acute coronary syndromes and do not need to be hospitalized in coronary care units (CCUs. This study was done to determine exploitation of resources and cardiovascular outcomes in low-risk patients with chest pain hospitalized in CCUs of educational hospitals affiliated with a major medical university. Methods: Over a 4-month period, 550 patients with chest pain who were hospitalized in the CCUs belonging to six hospitals affiliated to the authors' medical university were recruited by census method. Using Thrombolysis in Myocardial Infarction risk score, 95 patients (17.27% were categorized as low-risk patients. This group was evaluated with respect to demographics, bed occupancy rate, mean hospitalization period, expenses during admission, and cardiovascular outcomes in the 30-day period postdischarge. Results: Mean (± standard deviation hospitalization duration was 3.04 (±0.71 days. No significant difference was seen between the six surveyed hospitals regarding hospitalization duration (P = 0.602. The highest bed occupancy rate was seen in Taleghani and Shohada Tajrish hospitals and the lowest was in Modarres Hospital. The mean paid treatment expenses by low-risk patients was IRR 2,050,000 (US$205. Mean total hospitalization expenses was US$205. No significant difference was seen between the six surveyed hospitals (P = 0.699. Of the patients studied, 89.5% did not show any cardiovascular complications in 1 month and no deaths occurred. Conclusion: Given the high bed-occupancy rate by low-risk patients, associated high hospitalization

  6. Influenza vaccines for preventing cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Christine Clar

    Full Text Available ABSTRACTBACKGROUND: This is an update of the original review published in 2008. The risk of adverse cardiovascular outcomes is increased with influenza-like infection, and vaccination against influenza may improve cardiovascular outcomes.OBJECTIVES: To assess the potential benefits of influenza vaccination for primary and secondary prevention of cardiovascular disease.METHODS:Search methods:We searched the following electronic databases on 18 October 2013: The Cochrane Library (including Cochrane Central Register of Controlled Trials (CENTRAL, Database of Abstracts of Reviews of Effects (DARE, Economic Evaluation Database (EED and Health Technology Assessment database (HTA, MEDLINE, EMBASE, Science Citation Index Expanded, Conference Proceedings Citation Index - Science and ongoing trials registers (www.controlled-trials.com/ and www.clinicaltrials.gov. We examined reference lists of relevant primary studies and systematic reviews. We performed a limited PubMed search on 20 February 2015, just before publication.Selection criteria:Randomised controlled trials (RCTs of influenza vaccination compared with placebo or no treatment in participants with or without cardiovascular disease, assessing cardiovascular death or non-fatal cardiovascular events.Data collection and analysis:We used standard methodological procedures as expected by The Cochrane Collaboration. We carried out meta-analyses only for cardiovascular death, as other outcomes were reported too infrequently. We expressed effect sizes as risk ratios (RRs, and we used random-effects models.MAIN RESULTS: We included eight trials of influenza vaccination compared with placebo or no vaccination, with 12,029 participants receiving at least one vaccination or control treatment. We included six new studies (n = 11,251, in addition to the two included in the previous version of the review. Four of these trials (n = 10,347 focused on prevention of influenza in the general or elderly population

  7. Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors

    Directory of Open Access Journals (Sweden)

    Morgan Timothy

    2005-03-01

    Full Text Available Abstract Background Surrogate measures for cardiovascular disease events have the potential to increase greatly the efficiency of clinical trials. A leading candidate for such a surrogate is the progression of intima-media thickness (IMT of the carotid artery; much experience has been gained with this endpoint in trials of HMG-CoA reductase inhibitors (statins. Methods and Results We examine two separate systems of criteria that have been proposed to define surrogate endpoints, based on clinical and statistical arguments. We use published results and a formal meta-analysis to evaluate whether progression of carotid IMT meets these criteria for HMG-CoA reductase inhibitors (statins. IMT meets clinical-based criteria to serve as a surrogate endpoint for cardiovascular events in statin trials, based on relative efficiency, linkage to endpoints, and congruency of effects. Results from a meta-analysis and post-trial follow-up from a single published study suggest that IMT meets established statistical criteria by accounting for intervention effects in regression models. Conclusion Carotid IMT progression meets accepted definitions of a surrogate for cardiovascular disease endpoints in statin trials. This does not, however, establish that it may serve universally as a surrogate marker in trials of other agents.

  8. A simple method for analyzing data from a randomized trial with a missing binary outcome

    Directory of Open Access Journals (Sweden)

    Freedman Laurence S

    2003-05-01

    Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.

  9. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  10. Nutrition-Related Cardiovascular Disease Risk Factors In Chronic Kidney Disease: Relationship With Clinical Outcome

    Directory of Open Access Journals (Sweden)

    Emma McMahon

    2012-06-01

    Traditional CV-risk factors in this CKD population were not associated with clinical outcome. Despite being within clinical reference range, serum phosphate and albumin were independently associated with clinical outcome. This may highlight a potential therapeutic target for risk management to delay or prevent renal end-points in CKD.

  11. Use of angiotensin-converting enzyme inhibitors and cardiovascular outcomes following primary vascular surgery

    DEFF Research Database (Denmark)

    Høgh, Annette Langager; Lindholt, Jes S; Nielsen, Henrik;

    2012-01-01

    To examine the association between angiotensin-converting enzyme (ACE) inhibitor use and clinical outcome after primary vascular reconstruction in a population-based follow-up study.......To examine the association between angiotensin-converting enzyme (ACE) inhibitor use and clinical outcome after primary vascular reconstruction in a population-based follow-up study....

  12. Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

    Science.gov (United States)

    Thorlacius, Linnea; Garg, Amit; Villumsen, Bente; Esmann, Solveig; Kirby, Joslyn S; Gottlieb, Alice B; Merola, Joseph F; Dellavalle, Robert; Jemec, Gregor B E

    2017-01-01

    Introduction Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS. Method and analysis An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation. Ethics and dissemination The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well

  13. Justification of exclusion criteria was underreported in a review of cardiovascular trials

    NARCIS (Netherlands)

    Schmidt, Amand F.; Groenwold, Rolf H H; Van Delden, Johannes J M; Van Der Does, Yuri; Klungel, Olaf H.; Roes, Kit C B; Hoes, Arno W.; Van Der Graaf, Rieke

    2014-01-01

    Objectives Ethical guidelines for human subject research require that the burdens and benefits of participation be equally distributed. This study aimed to provide empirical data on exclusion of trial participants and reasons for this exclusion. As a secondary objective, we assessed to what extent e

  14. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

    2015-01-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the statistica

  15. 75 FR 47819 - Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

    Science.gov (United States)

    2010-08-09

    ... support from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the... developing devices for the pediatric cardiology market. The information gathered in this and future workshops will help to develop future guidance on optimal designs for pediatric cardiology device trials....

  16. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared to clopidogrel: Data from the PLATO trials

    DEFF Research Database (Denmark)

    Patel, Manesh R.; Becker, Richard C.; Wojdyla, Daniel M.;

    Abstract 14299: Cardiovascular Events in Acute Coronary Syndrome Patients With Peripheral Arterial Disease Treated With Ticagrelor Compared to Clopidogrel: Data From the PLATO Trial Manesh R Patel1; Richard C Becker1; Daniel M Wojdyla2; Håkan Emanuelsson3; William Hiatt4; Jay Horrow5; Steen Husted6...

  17. Alterations in left ventricular, left atrial, and right ventricular structure and function to cardiovascular risk factors in adolescents with type 2 diabetes participating in the TODAY clinical trial

    Science.gov (United States)

    Data on cardiovascular disease (CVD) risk in adolescents with type 2 diabetes (T2D) are limited. Echocardiography was performed in the last year of the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial (median 4.5 yr from diagnosis of T2D, average age 18 yr), incl...

  18. Randomized clinical trial of small-incision and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis: primary and clinical outcomes.

    NARCIS (Netherlands)

    Keus, F.; Werner, J.E.; Gooszen, H.G.; Oostvogel, H.J.M.; Laarhoven, C.J.H.M. van

    2008-01-01

    OBJECTIVE: To evaluate the primary and clinical outcomes in laparoscopic and small-incision cholecystectomy. DESIGN: Blinded randomized single-center trial emphasizing methodologic quality and generalizability. SETTING: General teaching hospital in the Netherlands. PATIENTS: A total of 257 patients

  19. Innovative pharmaceutical interventions in cardiovascular disease: Focusing on the contribution of non-HDL-C/LDL-C-lowering versus HDL-C-raising: A systematic review and meta-analysis of relevant preclinical studies and clinical trials.

    Science.gov (United States)

    Kühnast, Susan; Fiocco, Marta; van der Hoorn, José W A; Princen, Hans M G; Jukema, J Wouter

    2015-09-15

    Non-HDL-cholesterol is well recognised as a primary causal risk factor in cardiovascular disease. However, despite consistent epidemiological evidence for an inverse association between HDL-C and coronary heart disease, clinical trials aimed at raising HDL-C (AIM-HIGH, HPS2-THRIVE, dal-OUTCOMES) failed to meet their primary goals. This systematic review and meta-analysis investigated the effects of established and novel treatment strategies, specifically targeting HDL, on inhibition of atherosclerosis in cholesteryl ester transfer protein-expressing animals, and the prevention of clinical events in randomised controlled trials. Linear regression analyses using data from preclinical studies revealed associations for TC and non-HDL-C and lesion area (R(2)=0.258, P=0.045; R(2)=0.760, PHDL-C (R(2)=0.030, P=0.556). In clinical trials, non-fatal myocardial infarction risk was significantly less in the treatment group with pooled odd ratios of 0.87 [0.81; 0.94] for all trials and 0.85 [0.78; 0.93] after excluding some trials due to off-target adverse events, whereas all-cause mortality was not affected (OR 1.05 [0.99-1.10]). Meta-regression analyses revealed a trend towards an association between between-group differences in absolute change from baseline in LDL-C and non-fatal myocardial infarction (P=0.066), whereas no correlation was found for HDL-C (P=0.955). We conclude that the protective role of lowering LDL-C and non-HDL-C is well-established. The contribution of raising HDL-C on inhibition of atherosclerosis and the prevention of cardiovascular disease remains undefined and may be dependent on the mode of action of HDL-C-modification. Nonetheless, treatment strategies aimed at improving HDL function and raising apolipoprotein A-I may be worth exploring.

  20. Systematic Review of the Association between Dairy Product Consumption and Risk of Cardiovascular-Related Clinical Outcomes.

    Science.gov (United States)

    Drouin-Chartier, Jean-Philippe; Brassard, Didier; Tessier-Grenier, Maude; Côté, Julie Anne; Labonté, Marie-Ève; Desroches, Sophie; Couture, Patrick; Lamarche, Benoît

    2016-11-01

    The objective of this systematic review was to determine if dairy product consumption is detrimental, neutral, or beneficial to cardiovascular health and if the recommendation to consume reduced-fat as opposed to regular-fat dairy is evidence-based. A systematic review of meta-analyses of prospective population studies associating dairy consumption with cardiovascular disease (CVD), coronary artery disease (CAD), stroke, hypertension, metabolic syndrome (MetS), and type 2 diabetes (T2D) was conducted on the basis of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Quality of evidence was rated by using the Grading of Recommendations Assessment, Development, and Evaluation scale. High-quality evidence supports favorable associations between total dairy intake and hypertension risk and between low-fat dairy and yogurt intake and the risk of T2D. Moderate-quality evidence suggests favorable associations between intakes of total dairy, low-fat dairy, cheese, and fermented dairy and the risk of stroke; intakes of low-fat dairy and milk and the risk of hypertension; total dairy and milk consumption and the risk of MetS; and total dairy and cheese and the risk of T2D. High- to moderate-quality evidence supports neutral associations between the consumption of total dairy, cheese, and yogurt and CVD risk; the consumption of any form of dairy, except for fermented, and CAD risk; the consumption of regular- and high-fat dairy, milk, and yogurt and stroke risk; the consumption of regular- and high-fat dairy, cheese, yogurt, and fermented dairy and hypertension risk; and the consumption of regular- and high-fat dairy, milk, and fermented dairy and T2D risk. Data from this systematic review indicate that the consumption of various forms of dairy products shows either favorable or neutral associations with cardiovascular-related clinical outcomes. The review also emphasizes that further research is urgently needed to compare the impact of

  1. Depression beliefs, treatment preference, and outcomes in a randomized trial for major depressive disorder.

    Science.gov (United States)

    Dunlop, Boadie W; Kelley, Mary E; Mletzko, Tanja C; Velasquez, Cristina M; Craighead, W Edward; Mayberg, Helen S

    2012-03-01

    Previous studies suggest that individual preferences for medication- or psychotherapy-based treatments for depression may affect outcomes in clinical trials that compare these two forms of treatment. We assessed patients' beliefs about the causes of their depression, their preferred treatment, and strength of that preference in 80 patients participating in a 12-week clinical trial evaluating neuroimaging predictors of response to cognitive behavior therapy (CBT) or escitalopram. Forty-five patients expressed a preference for one of the 2 treatments, but being matched to preference did not influence remission or completion rates. Medication-preferring patients were more likely to terminate the trial early, regardless of treatment received. CBT-preferring patients rarely endorsed unknown causes for their depression, and medication-preferring patients were highly unlikely to identify pessimistic attitudes as a source of their depression. Among patients willing to be randomized to treatment, preference does not appear to strongly influence outcome. Specific preferences for CBT or medication may reflect differing conceptualizations about depressive illness, knowledge of which may enhance treatment retention and efficacy.

  2. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

    Directory of Open Access Journals (Sweden)

    Fjeldsoe Brianna S

    2011-03-01

    unexpected and detrimental. Physical activity screening (alone or in combination with diet resulted in improved intervention effects for physical activity, while fruit and vegetable screening had no impact on intervention effects for these outcomes. All three types of screening impacted detrimentally on intervention effects for behaviours not being targeted by screening. Conclusions Behavioural screening may have desirable and undesirable consequences in the context of multiple behaviour intervention trials, and thus its potential merits and pitfalls should be carefully considered.

  3. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Stafford Randall S

    2006-09-01

    Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or

  4. Clinical outcome endpoints in heart failure trials : a European Society of Cardiology Heart Failure Association consensus document

    NARCIS (Netherlands)

    Zannad, Faiez; Garcia, Angeles Alonso; Anker, Stefan D.; Armstrong, Paul W.; Calvo, Gonzalo; Cleland, John G. F.; Cohn, Jay N.; Dickstein, Kenneth; Domanski, Michael J.; Ekman, Inger; Filippatos, Gerasimos S.; Gheorghiade, Mihai; Hernandez, Adrian F.; Jaarsma, Tiny; Koglin, Joerg; Konstam, Marvin; Kupfer, Stuart; Maggioni, Aldo P.; Mebazaa, Alexandre; Metra, Marco; Nowack, Christina; Pieske, Burkert; Pina, Ileana L.; Pocock, Stuart J.; Ponikowski, Piotr; Rosano, Giuseppe; Ruilope, Luis M.; Ruschitzka, Frank; Severin, Thomas; Solomon, Scott; Stein, Kenneth; Stockbridge, Norman L.; Stough, Wendy Gattis; Swedberg, Karl; Tavazzi, Luigi; Voors, Adriaan A.; Wasserman, ScottM.; Woehrle, Holger; Zalewski, Andrew; McMurray, John J. V.

    2013-01-01

    Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials in

  5. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Laura Amy Massee

    2015-05-01

    Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

  6. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Tepel, Martin; van der Giet, Markus; Statz, Mario;

    2003-01-01

    Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown.......Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown....

  7. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery.

    Science.gov (United States)

    Oomens, M A E M; Lazzari, S; Heymans, M W; Forouzanfar, T

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and maxillofacial surgery (OMFS) published from January 2000 to May 2013 listed in PubMed. The methods used were scored using the risk of bias items given in a Delphi List. Sources of funding were recorded and categorised five ways: not funded, funded by industry, not funded by industry, supported by industry, and source of funds not clear. A total of 390 RCT met the inclusion criteria, and there was a correlation between funding and favourable main outcomes, although this was not significant. There was no correlation between the risk of bias and favourable results of the main outcome of a trial, or between the risk of bias and the reported source of funding in post-hoc analysis. We were unable to show a significant correlation between funding and a higher likelihood of a favourable result for the primary outcome in RCT in OMFS. We also failed to show a significant correlation between the risk of bias of a trial and its main outcome. In contrast, the source of funding proved to affect the risk of bias of a trial significantly, although not in post-hoc analysis. Funded trials were better organised, and so had a lower risk of bias.

  8. Prediction of responders for outcome measures of Locomotor Experience Applied Post Stroke trial

    Directory of Open Access Journals (Sweden)

    Bruce H. K. Dobkin, MD

    2014-03-01

    Full Text Available The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking and 0.8 m/s (community walking. Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.

  9. 02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

    Science.gov (United States)

    Saper, Robert; Vinjamury, Sivarama; Elder, Charles

    2013-01-01

    Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific chronic low back pain in low-income minority populations; (3) an investigation of the therapeutic usefulness of Shirodhara (Ayurvedic oil dripping therapy) as a treatment for insomnia; and (4) a discussion of the evidence base supporting implementation of meditation interventions in schools and workplace settings. Discussants will present information on study designs, research methodology, and outcome measure selection to highlight special considerations in conducting research on whole medical systems that use multi-target therapies and focus on patient-centered outcomes. Ayurvedic medicine and yoga are characterized by low-cost, noninvasive interventions that can be usefully offered as part of an integrative medicine therapeutic approach.

  10. Vitamin D and the cardiovascular system.

    Science.gov (United States)

    Beveridge, L A; Witham, M D

    2013-08-01

    Vitamin D, a secosteroid hormone, affects multiple biological pathways via both genomic and nongenomic signalling. Several pathways have potential benefit to cardiovascular health, including effects on parathyroid hormone, the renin-angiotensin-aldosterone system, vascular endothelial growth factor and cytokine production, as well as direct effects on endothelial cell function and myocyte calcium influx. Observational data supports a link between low vitamin D metabolite levels and cardiovascular health. Cross-sectional data shows associations between low 25-hydroxyvitamin D levels and stroke, myocardial infarction, diabetes mellitus, hypertension, and heart failure. Longitudinal data also suggests a relationship with incident hypertension and new cardiovascular events. However, these associations are potentially confounded by reverse causality and by the effects that other cardiovascular risk factors have on vitamin D metabolite levels. Intervention studies to date suggest a modest antihypertensive effect of vitamin D, no effect on serum lipids, a small positive effect on insulin resistance and fasting glucose, and equivocal actions on arterial stiffness and endothelial function. Analysis of cardiovascular event data collected from osteoporosis trials does not currently show a clear signal for reduced cardiovascular events with vitamin D supplementation, but results may be confounded by the coadministration of calcium, and by the secondary nature of the analyses. Despite mechanistic and observational data that suggest a protective role for vitamin D in cardiovascular disease, intervention studies to date are less promising. Large trials using cardiovascular events as a primary outcome are needed before vitamin D can be recommended as a therapy for cardiovascular disease.

  11. Differences in outcomes between GOLD groups in patients with COPD in the TIOSPIR® trial

    Directory of Open Access Journals (Sweden)

    Dusser D

    2016-01-01

    Full Text Available Daniel Dusser,1 Robert A Wise,2 Ronald Dahl,3 Antonio Anzueto,4,5 Kerstine Carter,6 Andy Fowler,7 Peter M Calverley8 1Service de Pneumologie, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 2Asthma and Allergy Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 3Allergy Centre, Odense University Hospital, Odense C, Denmark; 4Pulmonary/Critical Care, University of Texas, 5South Texas Veterans Health Care System, San Antonio, TX, USA; 6Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA; 7Boehringer Ingelheim Pharma Ltd, Bracknell, UK; 8Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK  Background: The aim of this study was to evaluate whether Global Initiative for Chronic Obstructive Lung Disease (GOLD classification could predict mortality risk factors and whether baseline treatment intensity would relate to mortality within each group, using data from TIOSPIR®, the largest randomized clinical trial in COPD performed to date.Methods: A total of 17,135 patients from TIOSPIR® were pooled and grouped by GOLD grading (A–D according to baseline Medical Research Council breathlessness score, exacerbation history, and spirometry. All-cause mortality and adjudicated cardiovascular (CV and respiratory mortality were assessed.Results: Of the 16,326 patients classified, 1,248 died on treatment. Group B patients received proportionally more CV treatment at baseline. CV mortality risk, but not all-cause mortality risk, was significantly higher in Group B than Group C patients (CV mortality – hazard ratio [HR] =1.74, P=0.004; all-cause mortality – HR =1.18, P=0.11. Group D patients had a higher incidence of all-cause mortality than Group B patients (10.9% vs 6.6%. Similar trends were observed regardless of respiratory or CV medication at baseline. In contrast, respiratory deaths increased consistently from Groups A–D (0.3%, 0.8%, 1.6%, and 4.2% of

  12. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Parag R Gajendragadkar

    Full Text Available AIMS: The mechanisms by which a 'Mediterranean diet' reduces cardiovascular disease (CVD burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV. METHODS AND RESULTS: We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV, sodium nitroprusside (endothelium-independent vasodilatation; EIDV, and NG-monomethyl-L-arginine (basal nitric oxide (NO synthase activity were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: -45% to -10%, P = 0.008, despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: -1.6 to -0.9 mmol/L, P<0.001. Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: -30% to +30%, P = 0.85, also suggesting lycopene improved endothelial function. CONCLUSIONS: Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01100385.

  13. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G;

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...... (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality....

  14. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with Fosinopril and Pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT])

    NARCIS (Netherlands)

    Diercks, GFH; Janssen, WMT; van Boven, AJ; Bak, AAA; de Jong, PE; Crijns, HJGM; van Gilst, WH

    2000-01-01

    This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/day will prevent cardiovascular and renal disease in nonhypertensive (RR 10 mg/L once in an early morning spot urine and 15 to 300 mg/

  15. Diagnosis and management of atherosclerotic cardiovascular disease in chronic kidney disease: a review.

    Science.gov (United States)

    Mathew, Roy O; Bangalore, Sripal; Lavelle, Michael P; Pellikka, Patricia A; Sidhu, Mandeep S; Boden, William E; Asif, Arif

    2016-12-28

    Patients with chronic kidney disease (CKD) have a high prevalence of atherosclerotic cardiovascular disease, likely reflecting the presence of traditional risk factors. A greater distinguishing feature of atherosclerotic cardiovascular disease in CKD is the severity of the disease, which is reflective of an increase in inflammatory mediators and vascular calcification secondary to hyperparathyroidism of renal origin that are unique to patients with CKD. Additional components of atherosclerotic cardiovascular disease that are prominent in patients with CKD include microvascular disease and myocardial fibrosis. Therapeutic interventions that minimize cardiovascular events related to atherosclerotic cardiovascular disease in patients with CKD, as determined by well-designed clinical trials, are limited to statins. Data are lacking regarding other available therapeutic measures primarily due to exclusion of patients with CKD from major trials studying cardiovascular disease. Data from well-designed randomized controlled trials are needed to guide clinicians who care for this high-risk population in the management of atherosclerotic cardiovascular disease to improve clinical outcomes.

  16. Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

    Science.gov (United States)

    MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol

    2016-07-01

    Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.

  17. Choice of design and outcomes in trials among children with moderate acute malnutrition

    DEFF Research Database (Denmark)

    Friis, Henrik; Michaelsen, Kim F.; Wells, Jonathan C

    2015-01-01

    There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials...... what components of health might be impacted by public health programs, or the underlying mechanisms whereby improved nutritional status might benefit short- and long-term health. Measurement of body composition, specific growth markers and functional outcomes may provide greater insight into the nature...... and implications of growth failure and recovery. There are now several methodologies suitable for application in infants and young children, e.g., measuring body composition with deuterium dilution, physical activity with accelerometers and linear growth with knemometers. To evaluate the generalizability...

  18. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

    2010-10-15

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  19. Diabetes Care Protocol : effects on patient-important outcomes. A cluster randomized, non-inferiority trial in primary care

    NARCIS (Netherlands)

    Cleveringa, F. G. W.; Minkman, M. H.; Gorter, K. J.; van den Donk, M.; Rutten, G. E. H. M.

    2010-01-01

    P>Aims The Diabetes Care Protocol (DCP) combines task delegation, intensification of diabetes treatment and feedback. It reduces cardiovascular risk in Type 2 diabetes (T2DM) patients. This study determines the effects of DCP on patient-important outcomes. Methods A cluster randomized, non-inferiori

  20. Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams

    Directory of Open Access Journals (Sweden)

    Nazareth Irwin

    2010-03-01

    Full Text Available Abstract Background People with severe mental illnesses (SMI are at increased risk of cardiovascular disease (CVD. Clinical guidelines recommend regular screening for CVD risk factors. We evaluated a nurse led intervention to improve screening rates across the primary-secondary care interface. Methods Six community mental health teams (CMHTs were randomised to receive either the nurse led intervention plus education pack (n = 3 or education pack only (n = 3. Intervention (6 months: The nurse promoted CVD screening in primary care and then in CMHTs. Patients who remained unscreened were offered screening by the nurse. After the intervention participants with SMI were recruited from each CMHT to collect outcome data. Main outcome: Numbers screened during the six months, confirmed in General Practice notes. Results All six CMHTs approached agreed to randomisation. 121 people with SMI participated in outcome interviews during two waves of recruitment (intervention arm n = 59, control arm n = 62. Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year, with less than 20% having been screened for each risk factor. After the trial, CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure (96% vs 68%; adjusted Odds Ratio (OR 13.6; 95% CI: 3.5-38.4, cholesterol (66.7% vs 26.9%, OR 6.1; 3.2-11.5, glucose (66.7% vs 36.5% OR 4.4; 2.7-7.1, BMI (92.5% vs 65.2% OR 6.5; 2.1-19.6, and smoking status (88.2% vs 57.8% OR 5.5; 3.2-9.5 and have a 10 year CVD risk score calculated (38.2% vs 10.9% OR 5.2 1.8-15.3. Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse. Conclusions The nurse-led intervention was superior, resulting in an absolute increase of approximately 30% more people with SMI receiving screening for each

  1. Newly diagnosed and previously known diabetes mellitus and 1-year outcomes of acute myocardial infarction: the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial

    DEFF Research Database (Denmark)

    Aguilar, David; Solomon, Scott D; Køber, Lars

    2004-01-01

    BACKGROUND: A prior diagnosis of diabetes mellitus is associated with adverse outcomes after acute myocardial infarction (MI), but the risk associated with a new diagnosis of diabetes in this setting has not been well defined. METHODS AND RESULTS: We assessed the risk of death and major...... cardiovascular events associated with previously known and newly diagnosed diabetes by studying 14,703 patients with acute MI enrolled in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial. Patients were grouped by diabetic status: previously known diabetes (insulin use or diagnosis of diabetes before...... MI, n=3400, 23%); newly diagnosed diabetes (use of diabetic therapy or diabetes diagnosed at randomization [median 4.9 d after infarction], but no known diabetes at presentation, n=580, 4%); or no diabetes (n=10,719). Patients with newly diagnosed diabetes were younger and had fewer comorbid...

  2. Association of hypoglycemic treatment regimens with cardiovascular outcomes in overweight and obese subjects with type 2 diabetes

    DEFF Research Database (Denmark)

    Ghotbi, Adam Ali; Køber, Lars; Finer, Nick;

    2013-01-01

    To assess the association of hypoglycemic treatment regimens with cardiovascular adverse events and mortality in a large population of type 2 diabetic patients at increased cardiovascular risk.......To assess the association of hypoglycemic treatment regimens with cardiovascular adverse events and mortality in a large population of type 2 diabetic patients at increased cardiovascular risk....

  3. Relationship of left ventricular hypertrophy and diastolic function with cardiovascular and renal outcomes in African Americans with hypertensive chronic kidney disease.

    Science.gov (United States)

    Peterson, Gail E; de Backer, Tine; Contreras, Gabriel; Wang, Xuelei; Kendrick, Cynthia; Greene, Tom; Appel, Lawrence J; Randall, Otelio S; Lea, Janice; Smogorzewski, Miroslaw; Vagaonescu, Tudor; Phillips, Robert A

    2013-09-01

    African Americans with hypertension are at high risk for adverse outcomes from cardiovascular and renal disease. Patients with stage 3 or greater chronic kidney disease have a high prevalence of left ventricular (LV) hypertrophy and diastolic dysfunction. Our goal was to study prospectively the relationships of LV mass and diastolic function with subsequent cardiovascular and renal outcomes in the African American Study of Kidney Disease and Hypertension cohort study. Of 691 patients enrolled in the cohort, 578 had interpretable echocardiograms and complete relevant clinical data. Exposures were LV hypertrophy and diastolic parameters. Outcomes were cardiovascular events requiring hospitalization or causing death; a renal composite outcome of doubling of serum creatinine or end-stage renal disease (censoring death); and heart failure. We found strong independent relationships between LV hypertrophy and subsequent cardiovascular (hazard ratio, 1.16; 95% confidence interval, 1.05-1.27) events, but not renal outcomes. After adjustment for LV mass and clinical variables, lower systolic tissue Doppler velocities and diastolic parameters reflecting a less compliant LV (shorter deceleration time and abnormal E/A ratio) were significantly (Pchronic kidney disease. These echocardiographic risk factors may help identify high-risk patients with chronic kidney disease for aggressive therapeutic intervention.

  4. A review of the handling of missing longitudinal outcome data in clinical trials.

    Science.gov (United States)

    Powney, Matthew; Williamson, Paula; Kirkham, Jamie; Kolamunnage-Dona, Ruwanthi

    2014-06-19

    The aim of this review was to establish the frequency with which trials take into account missingness, and to discover what methods trialists use for adjustment in randomised controlled trials with longitudinal measurements. Failing to address the problems that can arise from missing outcome data can result in misleading conclusions. Missing data should be addressed as a means of a sensitivity analysis of the complete case analysis results. One hundred publications of randomised controlled trials with longitudinal measurements were selected randomly from trial publications from the years 2005 to 2012. Information was extracted from these trials, including whether reasons for dropout were reported, what methods were used for handing the missing data, whether there was any explanation of the methods for missing data handling, and whether a statistician was involved in the analysis. The main focus of the review was on missing data post dropout rather than missing interim data. Of all the papers in the study, 9 (9%) had no missing data. More than half of the papers included in the study failed to make any attempt to explain the reasons for their choice of missing data handling method. Of the papers with clear missing data handling methods, 44 papers (50%) used adequate methods of missing data handling, whereas 30 (34%) of the papers used missing data methods which may not have been appropriate. In the remaining 17 papers (19%), it was difficult to assess the validity of the methods used. An imputation method was used in 18 papers (20%). Multiple imputation methods were introduced in 1987 and are an efficient way of accounting for missing data in general, and yet only 4 papers used these methods. Out of the 18 papers which used imputation, only 7 displayed the results as a sensitivity analysis of the complete case analysis results. 61% of the papers that used an imputation explained the reasons for their chosen method. Just under a third of the papers made no reference

  5. Effect of preoperative abstinence on poor postoperative outcome in alcohol misusers: randomised controlled trial

    DEFF Research Database (Denmark)

    Tonnesen, H; Rosenberg, J; Nielsen, Hans Jørgen;

    1999-01-01

    often in the intervention group. Surgical stress responses were lower in the intervention group (P LT / =0.05). CONCLUSIONS: One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers. The mechanism is probably reduced preclinical organ dysfunction and reduction......OBJECTIVE: To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day. DESIGN: Randomised controlled trial. Setting: Copenhagen, Denmark. SUBJECTS: 42 alcoholic patients without...... liver disease admitted for elective colorectal surgery. INTERVENTIONS: Withdrawal from alcohol consumption for 1 month before operation (disulfiram controlled) compared with continuous drinking. MAIN OUTCOME MEASURES: Postoperative complications requiring treatment within the first month after surgery...

  6. Leisure time physical activity and long-term cardiovascular and cancer outcomes: the Busselton Health Study.

    Science.gov (United States)

    Gunnell, Anthony S; Knuiman, Matthew W; Divitini, Mark L; Cormie, Prue

    2014-11-01

    The study aimed to investigate whether meeting leisure time physical activity recommendations was associated with reduced incident and fatal cancer or cardiovascular disease (CVD) in a community-based cohort of middle- to late-aged adults with long-term follow-up. At baseline, 2,320 individuals were assessed on a large number of lifestyle and clinical parameters including their level of physical activity per week, other risk factors (e.g. smoking and alcohol use) various anthropometric measures, blood tests and medical history. Individuals were linked to hospital and mortality registry data to identify future cancer and cardiovascular events (fatal and non-fatal) out to 15 years of follow-up. Cox regression analyses adjusted for relevant confounders identified a priori were used to estimate risk for all-cause, cancer-specific and CVD-specific mortality. In the full cohort an estimated 21 % decreased risk for all-cause mortality (HR 0.79; 95 % CI 0.66-0.96) and 22 % decreased risk for fatal/non-fatal CVD events (HR 0.78; 95 % CI 0.66-0.92) was associated with baseline self-reported physical activity levels of 150 min or more. After exclusion of those with chronic co-morbidities (CVD, cancer, diabetes, chronic obstructive pulmonary disease, hypertension treatment) at baseline, lower risk for fatal/non-fatal CVD events remained significantly associated with 150 min or more of physical activity (HR 0.77; 95 % CI 0.62-0.96). Results from this well established prospective community-based cohort study support the role of leisure time physical activity in reducing all-cause mortality and CVD events (fatal/nonfatal) in the broader population studied. The data also suggest that physical activity associated reductions in risk for CVD events (fatal/nonfatal) were not overly impacted by prevalent key non-communicable diseases.

  7. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: dschwartz3@nshs.edu [Department of Radiation Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY (United States); Feinstein Institute for Medical Research, Manhasset, NY (United States); Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Garden, Adam S.; Thomas, Jimmy [Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Chen Yipei; Zhang Yongbin [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Lewin, Jan; Chambers, Mark S. [Department of Head and Neck Surgery, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Dong, Lei [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  8. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  9. Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group.

    Science.gov (United States)

    Walter, S D; Cook, D J; Guyatt, G H; King, D; Troyan, S

    1997-02-01

    Considerable effort is often expended to adjudicate outcomes in clinical trials, but little has been written on the administration of the adjudication process and its possible impact on study results. As a case study, we describe the function and performance of an adjudication committee in a large randomized trial of two diagnostic approaches to potentially operable lung cancer. Up to five independent adjudicators independently determined two primary outcomes: tumor status at death or at final follow-up and the cause of death. Patients for whom there was any disagreement were discussed in committee until a consensus was achieved. We describe the pattern of agreement among the adjudicators and with the final consensus result. Additionally, we model the adjudication process and predict the results if a smaller committee had been used. We found that reducing the number of adjudicators from five to two or three would probably have changed the consensus outcome in less than 10% of cases. Correspondingly, the effect on the final study results (comparing primary outcomes in both randomized arms) would have been altered very little. Even using a single adjudicator would not have affected the results substantially. About 90 minutes of person-time per patient was required for activities directly related to the adjudication process, or approximately 6 months of full time work for the entire study. This level of effort could be substantially reduced by using fewer adjudicators with little impact on the results. Thus, we suggest that when high observer agreement is demonstrated or anticipated, adjudication committees should consist of no more than three members. Further work is needed to evaluate if smaller committees are adequate to detect small but important treatment effects or if they compromise validity when the level of adjudicator agreement is lower.

  10. WHAT CAN WE EXPECT USING ACE INHIBITOR RAMIPRIL IN PERSONS WITH HIGH CARDIOVASCULAR RISK AND EARLY DISORDERS OF CARBOHYDRATE METABOLISM? LESSONS OF DREAM TRIAL

    Directory of Open Access Journals (Sweden)

    M. N. Mamedov

    2008-01-01

    Full Text Available Primary prevention of diabetes in persons with high cardiovascular risk is an actual problem. Results of DREAM trial are discussed. Influence of ACE inhibitor, ramipril, on risk of diabetes onset in patients with pre-diabetes and low cardiovascular risk is focused. Metabolic effects of other groups of antihypertensive drugs and their ability to prevent diabetes onset are compared. Ramipril three years therapy resulted in normalization in glucose level but did not have effect on frequency of diabetes onset. Change in life-style and regular usage of ACE inhibitor, ramipril, can contribute in normalization of glycemia level in patients with combination of pre-diabetes and arterial hypertension.

  11. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors.

    Directory of Open Access Journals (Sweden)

    Hilde K Brekke

    Full Text Available OBJECTIVE: To examine the effects of Diet (D and Exercise (E interventions on cardiovascular fitness, waist circumference, blood lipids, glucose metabolism, inflammation markers, insulin-like growth factor 1 (IGF-1 and blood pressure in overweight and obese lactating women. METHODS: At 10-14 wk postpartum, 68 Swedish women with a self-reported pre-pregnancy BMI of 25-35 kg/m(2 were randomized to a 12-wk behavior modification treatment with D, E, both or control using a 2×2 factorial design. The goal of D treatment was to reduce body weight by 0.5 kg/wk, accomplished by decreasing energy intake by 500 kcal/d and monitoring weight loss through self-weighing. The goal of E treatment was to perform 4 45-min walks per wk at 60-70% of max heart-rate using a heart-rate monitor. Effects were measured 12 wk and 1 y after randomization. General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable. RESULTS: There was a significant main effect of the D treatment, decreasing waist circumference (P = 0.001, total cholesterol (P = 0.007, LDL-cholesterol (P = 0.003 and fasting insulin (P = 0.042, at the end of the 12-wk treatment. The decreased waist circumference (P<0.001 and insulin (P = 0.024 was sustained and HDL-cholesterol increased (P = 0.005 at the 1-y follow-up. No effects from the E treatment or any interaction effects were observed. CONCLUSIONS: Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type 2 diabetes. This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01343238.

  12. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    John ME

    2015-01-01

    Full Text Available Michelle E John,1 John R Cockcroft,2 Tricia M McKeever,3 William R Coward,1 Dennis J Shale,2 Simon R Johnson,1 Jim G Thornton,4 Timothy W Harrison,1 Alan J Knox,1 Charlotte E Bolton1 1Nottingham Respiratory Research Unit, School of Medicine, University of Nottingham, Nottingham, UK; 2Wales Heart Research Institute, Cardiff University, Cardiff, UK; 3Division of Epidemiology and Public Health, 4Clinical Trials Unit and Department of Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham, UK Background: There is excess cardiovascular mortality in patients with chronic obstructive pulmonary disease. Aortic stiffness, an independent predictor of cardiovascular risk, and systemic and airway inflammation are increased in patients with the disease. Statins modulate aortic stiffness and have anti-inflammatory properties. A proof-of-principle, double-blind, randomized trial determined if 6 weeks of simvastatin 20 mg once daily reduced aortic stiffness and systemic and airway inflammation in patients with chronic obstructive pulmonary disease.Methods: Stable patients (n=70 were randomized to simvastatin (active or placebo. Pre-treatment and post-treatment aortic stiffness, blood pressure, spirometry, and circulating and airway inflammatory mediators and lipids were measured. A predefined subgroup analysis was performed where baseline aortic pulse wave velocity (PWV was >10 m/sec.Results: Total cholesterol dropped in the active group. There was no significant change in aortic PWV between the active group and the placebo group (-0.7 m/sec, P=0.24. In those with aortic stiffness >10 m/sec (n=22, aortic PWV improved in the active group compared with the placebo group (-2.8 m/sec, P=0.03. Neither systemic nor airway inflammatory markers changed. Conclusion: There was a nonsignificant improvement in aortic PWV in those taking simvastatin 20 mg compared with placebo, but in those with higher baseline aortic stiffness (a higher risk

  13. The Impact Exerted on Clinical Outcomes of Patients With Chronic Heart Failure by Aldosterone Receptor Antagonists: A Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    De Vecchis, Renato; Cantatrione, Claudio; Mazzei, Damiana; Barone, Augusto; Maurea, Nicola

    2017-01-01

    Background Aldosterone receptor antagonists (ARAs) have been associated with improved clinical outcomes in patients with heart failure with reduced left ventricular ejection fraction (HFREF), but not in those with heart failure with preserved left ventricular ejection fraction (HFpEF). With the aim to study this topic more deeply, we carried out a meta-analysis of selective and non-selective ARAs in HFREF and HFpEF. Methods We searched PubMed and Scopus databases. We decided to incorporate in the meta-analysis only randomized controlled trials (RCTs) of ARAs in patients with chronic heart failure (CHF) if they met the following criteria: experimental groups included patients with CHF treated with ARAs in addition to the conventional therapy; control groups included patients with CHF receiving conventional therapy without ARAs. Outcomes of interest were all-cause death, hospitalizations from cardiovascular cause, hyperkalemia, or gynecomastia. Results We detected 15 studies representing 15,671 patients. ARAs were associated with a reduced odds of all-cause death (odds ratio (OR): 0.79; 95% confidence interval (CI): 0.73 - 0.87) and hospitalizations from cardiovascular cause (OR: 0.73; 95% CI: 0.61 - 0.89). However, subgroup analysis showed that these advantages were limited to HFREF (all-cause death: OR: 0.77, 95% CI: 0.69 - 0.84; hospitalizations from cardiovascular cause: OR: 0.66, 95% CI: 0.51 - 0.85), but they did not affect the HFpEF group (all-cause death: OR: 0.91, 95% CI: 0.76 - 1.1; hospitalizations from cardiovascular cause: OR: 0.85, 95% CI: 0.7 - 1.09). ARAs increased the risk of hyperkalemia (OR: 2.17; 95% CI: 1.88 - 2.5). Non-selective ARAs, but not selective ARAs, increased the risk of gynecomastia (OR: 8.22, 95% CI: 4.9 - 13.81 vs. OR: 0.74, 95% CI: 0.43 - 1.27). Conclusions ARAs reduced the risk of adverse cardiac events in HFREF but not HFpEF. In particular, ARA use in HFpEF patients is questionable, since in this CHF type, no significant

  14. Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Polycystic Ovary Syndrome: A Pilot Study.

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    Ida Almenning

    Full Text Available Polycystic ovary syndrome is a common endocrinopathy in reproductive-age women, and associates with insulin resistance. Exercise is advocated in this disorder, but little knowledge exists on the optimal exercise regimes. We assessed the effects of high intensity interval training and strength training on metabolic, cardiovascular, and hormonal outcomes in women with polycystic ovary syndrome.Three-arm parallel randomized controlled trial. Thirty-one women with polycystic ovary syndrome (age 27.2 ± 5.5 years; body mass index 26.7 ± 6.0 kg/m2 were randomly assigned to high intensity interval training, strength training, or a control group. The exercise groups exercised three times weekly for 10 weeks.The main outcome measure was change in homeostatic assessment of insulin resistance (HOMA-IR. HOMA-IR improved significantly only after high intensity interval training, by -0.83 (95% confidence interval [CI], -1.45, -0.20, equal to 17%, with between-group difference (p = 0.014. After high intensity interval training, high-density lipoprotein cholesterol increased by 0.2 (95% CI, 0.02, 0.5 mmol/L, with between group difference (p = 0.04. Endothelial function, measured as flow-mediated dilatation of the brachial artery, increased significantly after high intensity interval training, by 2.0 (95% CI, 0.1, 4.0 %, between-group difference (p = 0.08. Fat percentage decreased significantly after both exercise regimes, without changes in body weight. After strength training, anti-Müllarian hormone was significantly reduced, by -14.8 (95% CI, -21.2, -8.4 pmol/L, between-group difference (p = 0.04. There were no significant changes in high-sensitivity C-reactive protein, adiponectin or leptin in any group.High intensity interval training for ten weeks improved insulin resistance, without weight loss, in women with polycystic ovary syndrome. Body composition improved significantly after both strength training and high intensity interval training. This pilot

  15. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  16. Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

    Science.gov (United States)

    Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

    2016-01-01

    Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

  17. Forecasting trial outcomes: lawyers assign higher probability to possibilities that are described in greater detail.

    Science.gov (United States)

    Fox, Craig R; Birke, Richard

    2002-04-01

    The study of judgment under uncertainty has revealed that people judge the probability of an event to be higher when the event is described as a disjunction of constituent events or when they judge constituent events separately. These observations have motivated the development of support theory (Y. Rottenstreich & A. Tversky, 1997; A. Tversky & D. J. Koehler, 1994), a descriptive model of judgment under uncertainty. The major predictions of support theory are that (1) the judged probabilities of complementary events sum to 1; (2) the judged probabilities of n > 2 exclusive and exhaustive events generally sum to more than 1; and (3) the judged probability of an event generally increases when it is described as a disjunction of specific possibilities. We test these predictions in 6 studies of experienced attorneys who judged the likelihood of particular trial outcomes or were asked to offer advice on whether or not to accept a settlement offer. The results demonstrate that attorneys are indeed susceptible to bias in forecasting trial outcomes, consistent with support theory.

  18. Predictors of Adverse Cosmetic Outcome in the RAPID Trial: An Exploratory Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, David; Truong, Pauline T. [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Parpia, Sameer [Ontario Clinical Oncology Group, McMaster University, Hamilton, Ontario (Canada); Olivotto, Ivo A. [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Berrang, Tanya [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Kim, Do-Hoon; Kong, Iwa [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); Germain, Isabelle [Centre Hospitalier Universitaire de Québec, Pavillon Hôtel-Dieu de Quebec, Quebec City, Québec (Canada); Nichol, Alan [Vancouver Centre, British Columbia Cancer Agency, Vancouver, British Columbia (Canada); Akra, Mohamed [CancerCare Manitoba, Winnipeg, Manitoba (Canada); Roy, Isabelle [Centre intégré de cancérologie de Laval, Laval, Québec (Canada); Reed, Melanie [Center for the Southern Interior, British Columbia Cancer Agency, Kelowna, British Columbia (Canada); Fyles, Anthony [University Health Network, Princess Margaret Hospital, Toronto, Ontario (Canada); Trotter, Theresa [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Perera, Francisco [London Regional Cancer Centre, London, Ontario (Canada); Balkwill, Susan [Fraser Valley Centre, British Columbia Cancer Agency, Surrey, British Columbia (Canada); Lavertu, Sophie [Centre Hospitalier de l' Université de Montréal, Hôpital Notre-Dame, Montreal, Québec (Canada); Elliott, Elizabeth [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); and others

    2015-04-01

    Purpose: To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID (Randomized Trial of Accelerated Partial Breast Irradiation) trial. Methods and Materials: Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3 years. Adverse cosmesis was defined as a score of fair or poor. Cosmetic deterioration was defined as any adverse change in score from baseline to 3 years. The analysis is based on data from the previously reported interim analysis. Logistic regression models were used to assess the association of risk factors for these outcomes among all patients and those treated with APBI only. Results: Clinicopathologic characteristics were similar between subjects randomized to APBI (n=569) or whole-breast irradiation (n=539). For all subjects, factors associated with adverse cosmesis at 3 years were older age, central/inner tumor location, breast infection, smoking, seroma volume, breast volume, and use of APBI; factors associated with cosmetic deterioration were smoking, seroma volume, and use of APBI (P<.05). For APBI subjects, tumor location, smoking, age, and seroma volume were associated with adverse cosmesis (P<.05), and smoking was associated with cosmetic deterioration (P=.02). An independent association between the V95/whole-breast volume ratio and adverse cosmesis (P=.28) or cosmetic deterioration (P=.07) was not detected. On further exploration a V95/whole-breast volume ratio <0.15 was associated with a lower risk of cosmetic deterioration (p=.04), but this accounted for only 11% of patients. Conclusion: In the RAPID trial, a number of patient tumor and treatment-related factors, including the use of APBI, were associated with adverse cosmesis and cosmetic deterioration. For patients treated with APBI alone, the high-dose treatment

  19. Plant compared with marine n-3 fatty acid effects on cardiovascular risk factors and outcomes: what is the verdict?

    Science.gov (United States)

    Sanders, Thomas A B

    2014-07-01

    Plants provide α-linolenic acid [ALA; 18:3n-3 (18:3ω-3)], which can be converted via eicosapentaenoic acid (EPA; 20:5n-3) to docosahexaenoic acid (DHA; 22:6n-3), which is required for normal visual and cognitive function. Dietary ALA is provided mainly by vegetable oils, especially soybean and rapeseed oils, but is destroyed by partial hydrogenation; it is also present in high amounts in walnuts and flaxseed. Dietary EPA and DHA are provided mainly by fish and so are absent from vegan diets and only present in trace amounts in vegetarian diets. Vegetarians and vegans have lower proportions of DHA in blood and tissue lipids compared with omnivores. High intakes of EPA and DHA (typically in the range of 3-5 g/d) but not ALA have favorable effects on several cardiovascular disease (CVD) risk factors and have been postulated to delay arterial aging and cardiovascular mortality, but these intakes are beyond the range of normal dietary intake. Arterial stiffness, which is a measure of arterial aging, appears to be lower in vegans than in omnivores; and risk of CVD in vegetarians and vegans is approximately one-third that in omnivores. Prospective cohort studies showed higher intakes of EPA+DHA, and less consistently ALA, to be associated with a lower risk of CVD, especially fatal coronary heart disease, but meta-analyses of randomized controlled trials of supplementation of EPA+DHA or ALA in secondary prevention of CVD showed no clear benefit. Current evidence is insufficient to warrant advising vegans and vegetarians to supplement their diets with EPA or DHA for CVD prevention.

  20. Incidence of the Bertillon and Gompertz effects on the outcome of clinical trials

    Science.gov (United States)

    Roehner, Bertrand M.

    2014-11-01

    The accounts of medical trials provide very detailed information about the patients’ health conditions. On the contrary, almost no vital data such as marital status or age distribution are usually given. Yet, some of these factors can have a notable impact on the overall death rate, thereby changing the outcome and conclusions of the trial. This paper focuses on two of these variables. The first is marital status; its effect on life expectancy (which will be referred to as the Bertillon effect) may double death rates in all age intervals. The second variable is the age distribution of the oldest patients. Because of the exponential nature of Gompertz’s law changes in the distribution of ages in the oldest age group can have dramatic consequences on the overall number of deaths. One should recall that the death rate at the age of 82 is 40 times higher than at the age of 37. It will be seen that randomization alone can hardly take care of these problems. Appropriate remedies are easy to formulate however. First, the marital status of patients as well as the age distribution of those over 65 should be documented for both study groups. Then, thanks to these data and based on the Bertillon and Gompertz laws, it will become possible to perform appropriate corrections. Such corrections will notably improve the reliability and accuracy of the conclusions, especially in trials which include a large proportion of elderly subjects.

  1. Baseline Cardiovascular Characteristics of Adult Patients with Chronic Kidney Disease from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD).

    Science.gov (United States)

    Kim, Hyoungnae; Yoo, Tae Hyun; Choi, Kyu Hun; Oh, Kook Hwan; Lee, Joongyub; Kim, Soo Wan; Kim, Tae Hee; Sung, Suah; Han, Seung Hyeok

    2017-02-01

    Cardiovascular disease (CVD) is the most common cause of death in patients with chronic kidney disease (CKD). We report the baseline cardiovascular characteristics of 2,238 participants by using the data of the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) study. The cohort comprises 5 subcohorts according to the cause of CKD: glomerulonephritis (GN), diabetic nephropathy (DN), hypertensive nephropathy (HTN), polycystic kidney disease (PKD), and unclassified. The average estimated glomerular filtration rate (eGFR) was 50.5 ± 30.3 mL/min⁻¹/1.73 m⁻² and lowest in the DN subcohort. The overall prevalence of previous CVD was 14.4% in all patients, and was highest in the DN followed by that in the HTN subcohort. The DN subcohort had more adverse cardiovascular risk profiles (higher systolic blood pressure [SBP], and higher levels of cardiac troponin T, left ventricular mass index [LVMI], coronary calcium score, and brachial-ankle pulse wave velocity [baPWV]) than the other subcohorts. The HTN subcohort exhibited less severe cardiovascular risk profiles than the DN subcohort, but had more severe cardiovascular risk features than the GN and PKD subcohorts. All these cardiovascular risk profiles were inversely correlated with eGFR. In conclusion, this study shows that the KNOW-CKD cohort exhibits high cardiovascular burden, as other CKD cohorts in previous studies. Among the subcohorts, the DN subcohort had the highest risk for CVD. The ongoing long-term follow-up study up to 10 years will further delineate cardiovascular characteristics and outcomes of each subcohort exposed to different risk profiles.

  2. Do Recommendations for the Management of Hypertension Improve Cardiovascular Outcome? The Canadian Experience

    Directory of Open Access Journals (Sweden)

    Peter Bolli

    2011-01-01

    Full Text Available The Canadian Hypertension Education Program (CHEP was established in 1999 as a response to the result of a national survey that showed that a high percentage of Canadians were unaware of having hypertension with only 13% of those treated for hypertension having their blood pressure controlled. The CHEP formulates yearly recommendations based on published evidence. A repeat survey in 2006 showed that the percentage of treated hypertensive patients with the blood pressure controlled had risen to 65.7%. Over the first decade of the existence of the CHEP, the number of prescriptions for antihypertensive medications had increased by 84.4% associated with a significant greater decline in the yearly mortality from stroke, heart failure and myocardial infarction and a significant decrease in the hospitalization for stroke and heart failure. Therefore, the introduction of the CHEP and the yearly issue of updated recommendations resulted in a significant increase in the awareness, diagnosis and treatment of hypertension and in a significant reduction in stroke and cardiovascular morbidity and mortality. The CHEP model could serve as a template for its adoption to other regions or countries.

  3. A win ratio approach to comparing continuous non-normal outcomes in clinical trials.

    Science.gov (United States)

    Wang, Duolao; Pocock, Stuart

    2016-05-01

    Clinical trials are often designed to compare continuous non-normal outcomes. The conventional statistical method for such a comparison is a non-parametric Mann-Whitney test, which provides a P-value for testing the hypothesis that the distributions of both treatment groups are identical, but does not provide a simple and straightforward estimate of treatment effect. For that, Hodges and Lehmann proposed estimating the shift parameter between two populations and its confidence interval (CI). However, such a shift parameter does not have a straightforward interpretation, and its CI contains zero in some cases when Mann-Whitney test produces a significant result. To overcome the aforementioned problems, we introduce the use of the win ratio for analysing such data. Patients in the new and control treatment are formed into all possible pairs. For each pair, the new treatment patient is labelled a 'winner' or a 'loser' if it is known who had the more favourable outcome. The win ratio is the total number of winners divided by the total numbers of losers. A 95% CI for the win ratio can be obtained using the bootstrap method. Statistical properties of the win ratio statistic are investigated using two real trial data sets and six simulation studies. Results show that the win ratio method has about the same power as the Mann-Whitney method. We recommend the use of the win ratio method for estimating the treatment effect (and CI) and the Mann-Whitney method for calculating the P-value for comparing continuous non-Normal outcomes when the amount of tied pairs is small. Copyright © 2016 John Wiley & Sons, Ltd.

  4. Relationship between Medication Use and Cardiovascular Disease Health Outcomes in the Jackson Heart Study

    Directory of Open Access Journals (Sweden)

    Monique S. White

    2011-06-01

    Full Text Available Even though some medications have the potential to slow the progress of atherosclerosis and development of CVD, there are many at-risk individuals who continue to resist the benefits that are available by not following the advice of medical professionals. Non-adherence to prescribed drug regimens is a pervasive medical problem that negatively affects treatment outcomes. Information from standardized interviews of 5301 African Americans participating in the Jackson Heart Study was examined to determine the association between demographic parameters, behavior including adherence to prescribed medical regimens, and health outcomes. Data were also collected at Annual Follow-Up and Surveillance visits. During the two weeks prior to the examination visit, almost 52% of the participants reported taking blood pressure medication, 14% took cholesterol medication, 16% took medication for diabetes, and 19% took blood thinning medication. Of those who did not take the prescribed medications, the reasons given were the following: 47% were in a hurry, too busy, or forgot to take medications; 23% were trying to do without medications; 18% had no money to purchase medications; 19% indicated that the medications made them feel bad; 17% felt that they could not carry out daily functions when taking medications. The African American population can benefit from heightened awareness of the risk factors that are associated with CVD and the benefits of following a prescribed treatment regimen. Unacceptable secondary effects of prescribed medication comprised an important cause of non-compliance. Encouragement of this population to communicate with their healthcare providers to ensure that medication regimens are better tolerated could increase compliance and improve health outcomes.

  5. Relationship between medication use and cardiovascular disease health outcomes in the Jackson Heart Study.

    Science.gov (United States)

    Addison, Clifton C; Jenkins, Brenda W; Sarpong, Daniel; Wilson, Gregory; Champion, Cora; Sims, Jeraline; White, Monique S

    2011-06-01

    Even though some medications have the potential to slow the progress of atherosclerosis and development of CVD, there are many at-risk individuals who continue to resist the benefits that are available by not following the advice of medical professionals. Non-adherence to prescribed drug regimens is a pervasive medical problem that negatively affects treatment outcomes. Information from standardized interviews of 5301 African Americans participating in the Jackson Heart Study was examined to determine the association between demographic parameters, behavior including adherence to prescribed medical regimens, and health outcomes. Data were also collected at Annual Follow-Up and Surveillance visits. During the two weeks prior to the examination visit, almost 52% of the participants reported taking blood pressure medication, 14% took cholesterol medication, 16% took medication for diabetes, and 19% took blood thinning medication. Of those who did not take the prescribed medications, the reasons given were the following: 47% were in a hurry, too busy, or forgot to take medications; 23% were trying to do without medications; 18% had no money to purchase medications; 19% indicated that the medications made them feel bad; 17% felt that they could not carry out daily functions when taking medications. The African American population can benefit from heightened awareness of the risk factors that are associated with CVD and the benefits of following a prescribed treatment regimen. Unacceptable secondary effects of prescribed medication comprised an important cause of non-compliance. Encouragement of this population to communicate with their healthcare providers to ensure that medication regimens are better tolerated could increase compliance and improve health outcomes.

  6. The Avoiding Cardiovascular events through COMbination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: a comparison of first-line combination therapies.

    Science.gov (United States)

    Weder, Alan B

    2005-02-01

    Although multidrug therapy is required in order to achieve good blood pressure control in many hypertensives, there are no studies directly comparing fixed-dose combinations as initial therapy. The Avoiding Cardiovascular events through COMbination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial compares regimens of benazepril plus amlodipine versus benazepril plus hydrochlorothiazide, force-titrated to 40/10 and 40/25mg, respectively. A total of 12,600 high-risk hypertensives have been randomised and will be followed for 3 - 5years, during which cardiovascular events will be monitored. The investigators hypothesise that the benazepril plus amlodipine regimen will decrease cardiovascular events by 15% compared with benazepril plus hydrochlorothiazide. Recruitment began in 2003, and the trial is expected to end in 2008. The ACCOMPLISH trial shares important limitations with many other recent trials that will make it difficult to apply the results in clinical practice. These include the focus on high-risk hypertensive patients, in whom significant reductions in relative risk will translate into meaningful reductions in absolute risk: in lower-risk hypertensives with a low absolute risk, similar relative risk reductions may not be of great impact on the population disease burden. In ACCOMPLISH, as in most industry-sponsored clinical trials, the main goal appears to be market-driven: doses of drugs tested are not those available for clinical practice. The question asked, whether the combination of benazepril with either diuretic or dihydropyridine calcium channel blocker is more efficacious, is not a clinically compelling one. Finally, the univariate subgroup analyses proposed are unlikely to lead to an understanding of whether either combination has specific advantages for patients encountered clinically, most of whom have multiple risk factors. Thus, it appears that ACCOMPLISH, as with many recent pharmacological trials, will not greatly

  7. Glucose intolerance as a risk factor for cardiovascular outcomes: Tehran Lipid and Glucose Study (TLGS

    Directory of Open Access Journals (Sweden)

    Khalili D

    2010-02-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Diabetes and dysglycemia have a high prevalence in Iranian population but the information about their impact on the cardiovascular disease (CVD risk is scarce in this population. This study aimed to determine the risk of CVD according to glucose tolerance status."n"nMethods: We ascertained cases with incident CVD in a population of 1752 men and 2273 women, 40 years old and over and free of CVD at the beginning of study, during a follow up with a median of 7.6 years. To calculate hazard ratio (HR for CVD, we controlled traditional risk factors, including age, body mass index, waist, total cholesterol, HDL-cholesterol, triglycerides, systolic blood pressure, diastolic blood pressure, education, smoking, hypertension medication, lipid lowering medication and family history of premature CVD and diabetes."n"nResults: Cardiovascular events occurred in 197 men and 143 women. Its incidence density was 11.8 per 1000 person-years (95% confidence interval: 10.6 to 13.1 totally. Multiple adjusted HR in women with known diabetes was 3.88 (95%CI: 2.40 to 6.27 and with newly diagnosed was 2.34 (95%CI: 1.39 to 3.95 and the corresponding values for men were 1.72 (95%CI: 1.00- 2.95 and 1.52 (95%CI: 1.01- 2.31 respectively

  8. Clinical Pathways Based on Integrative Medicine in Chinese Hospitals Improve Treatment Outcomes for Patients with Acute Myocardial Infarction: A Multicentre, Nonrandomized Historically Controlled Trial

    Directory of Open Access Journals (Sweden)

    Lei Wang

    2012-01-01

    Full Text Available Objective. To determine the impact of an integrative medicine clinical pathways (CPs on the length of in-hospital stay and on outcomes for patients with acute myocardial infarction (AMI. Methods. A multicenter nonrandomized controlled trial enrolling 197 consecutive patients with AMI at eight urban TCM hospitals was conducted between 1 January 2010 and 31 October 2010. These patients were enrolled in the interventional group after the CPs had been implemented. The control group included 405 patients with AMI from eight hospitals; these patients were treated between 1 January 2008 and 31 December 2009, before the CPs were implemented. Outcome measures were the length of hospital stay costs of medical care, and major cardiovascular events (MACEs during hospitalization. Results. Compared with the control group, the patients in intervention group had a shorter length of hospital stay (9.2±4.2 days versus 12.7±8.6 days, P<0.05, and reduced healthcare costs in hospital (46365.7±18266.9 versus 52866.0±35404.4, P<0.05. There were statistically significant differences in MACE between the two groups during the hospitalization period (2.5% versus 6.9%, P=0.03. Conclusion. These data suggest that the development and implementation of the clinical pathways based in Integrative Medicine could further improve quality of care and outcome for patients with AMI.

  9. Examining longitudinal stimulant use and treatment attendance as parallel outcomes in two contingency management randomized clinical trials

    Science.gov (United States)

    McPherson, Sterling; Brooks, Olivia; Barbosa-Leiker, Celestina; Lederhos, Crystal; Lamp, Amanda; Murphy, Sean; Layton, Matthew; Roll, John

    2015-01-01

    The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one ‘parallel outcomes’ model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. We used parallel multilevel modeling to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial (β = 0.060, p < 0.05). In the second trial, CM predicted negative urinalysis (−UA) over the 12-week treatment period (β = 0.069, p < 0.05). In both trials, there was a significant, positive relationship between attendance and −UA submission, but in the first trial a −UA at both baseline and over time was related to attendance over time (r = 0.117; r = 0.013, respectively) and in the second trial, a −UA submission at baseline was associated with increased attendance over time (r = 0.055). These findings indicate that stimulant use and treatment attendance over time are related but distinct outcomes that, when analyzed simultaneously, portray a more informative picture of their predictors and the separate trajectories of each. This ‘indirect reinforcement’ between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials. PMID:26456717

  10. Does an Obesity Paradox Really Exist After Cardiovascular Intervention?: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Observational Studies.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Li, Nuo; Chen, Meng-Hua

    2015-11-01

    Several studies have shown the existence of an obesity paradox after Percutaneous Coronary Intervention (PCI). However, other studies have shown its absence. This study sought to perform a systematic review and meta-analysis of studies comparing the mortality risk between high body mass index patients and normal weight patients after PCI.We have searched PubMed, Embase, and Chinese medical journal for randomized controlled trials (RCTs) and observational studies published between the year 2000 and 2015 by typing the keywords "percutaneous coronary intervention" and "obesity paradox." The main outcome was "all-cause mortality". RevMan 5.3 software was used to calculate the risk ratio (RR) with 95% confidence interval (CI) to express the pooled effect on discontinuous variables.Twenty-two studies have been included in this meta-analysis consisting of a total of 242,377 patients with 73,143 normal weight patients, 103,608 overweight, and 65,626 obese patients. Younger age, higher cardiovascular risk factors and the intensive use of medications have mainly been observed among obese patients followed by overweight and normal weight patients respectively. In-hospital, 12 months and ≥ 1 year (long-term) mortality risks were significantly lower in the overweight and obese groups with (RR: 0.67; 95% CI: 0.63-0.72, P obesity paradox" does exist after PCI. The mortality in overweight and obese patients is really significantly lower compared to the normal weight patients. However, the exact reasons for this phenomenon need further exploration and research in the future.

  11. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.;

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...... Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated...... by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between...

  12. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial

    DEFF Research Database (Denmark)

    Phillips, Andrew N; Carr, Andrew; Neuhaus, Jacquie;

    2008-01-01

    BACKGROUND: The SMART trial found a raised risk of cardiovascular disease (CVD) events in patients undergoing CD4+ T cell-count guided intermittent antiretroviral therapy (ART) compared with patients on continuous ART. Exploratory analyses were performed to better understand the reasons for this ......BACKGROUND: The SMART trial found a raised risk of cardiovascular disease (CVD) events in patients undergoing CD4+ T cell-count guided intermittent antiretroviral therapy (ART) compared with patients on continuous ART. Exploratory analyses were performed to better understand the reasons...... for this observation. METHODS: A total of 5,472 patients with CD4+ T-cell counts >350 cells/mm3 were recruited and randomized to either continuous ART (the viral suppression arm; VS) or CD4+ T-cell count-guided use of ART (the drug conservation arm; DC). RESULTS: Major CVD events developed in 79 patients. The hazard...

  13. The impact of brief parental anxiety management on child anxiety treatment outcomes: a controlled trial.

    Science.gov (United States)

    Hudson, Jennifer L; Newall, Carol; Rapee, Ronald M; Lyneham, Heidi J; Schniering, Carolyn C; Wuthrich, Viviana M; Schneider, Sophie; Seeley-Wait, Elizabeth; Edwards, Susan; Gar, Natalie S

    2014-01-01

    Parental anxiety is a risk to optimal treatment outcomes for childhood anxiety disorders. The current trial examined whether the addition of a brief parental anxiety management (BPAM) program to family cognitive behavioral therapy (CBT) was more efficacious than family CBT-only in treating childhood anxiety disorders. Two hundred nine children (aged 6-13 years, 104 female, 90% Caucasian) with a principal anxiety disorder were randomly allocated to family CBT with a five-session program of BPAM (n = 109) or family CBT-only (n = 100). Family CBT comprised the Cool Kids program, a structured 12-week program that included both mothers and fathers. Overall, results revealed that the addition of BPAM did not significantly improve outcomes for the child or the parent compared to the CBT-only group at posttreatment or 6-month follow-up. Overall, however, children with nonanxious parents were more likely to be diagnosis free for any anxiety disorder compared to children with anxious parents at posttreatment and 6-month follow-up. BPAM did not produce greater reductions in parental anxiety. The results support previous findings that parent anxiety confers poorer treatment outcomes for childhood anxiety disorders. Nevertheless the addition of BPAM anxiety management for parents in its current format did not lead to additional improvements when used as an adjunct to family CBT in the treatment of the child's anxiety disorder. Future benefits may come from more powerful methods of reducing parents' anxiety.

  14. Atorvastatin reduces the risk of cardiovascular events in patients with carotid atherosclerosis: a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Sillesen, H.; Amarenco, P.; Hennerici, M.G.

    2008-01-01

    BACKGROUND AND PURPOSE: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found that treatment with atorvastatin 80 mg per day reduced the risk of stroke and cardiovascular events in patients with a recent transient ischemic attack (TIA) or stroke. We hypothesized...... this benefit would be greatest in the subgroup of patients with carotid stenosis. METHODS: The SPARCL trial randomized patients with TIA or stroke within 1 to 6 months without known coronary heart disease (CHD) and low-density lipoprotein cholesterol 100 to 190 mg/dL to treatment with atorvastatin 80 mg per...

  15. Hormonal regulation of energy-protein homeostasis in hemodialysis patients: an anorexigenic profile that may predispose to adverse cardiovascular outcomes.

    Science.gov (United States)

    Suneja, Manish; Murry, Daryl J; Stokes, John B; Lim, Victoria S

    2011-01-01

    energy homeostasis to adverse cardiovascular outcome in the HD patients.

  16. The impact of traditional cardiovascular risk factors on cardiovascular outcomes in patients with rheumatoid arthritis: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Leena R Baghdadi

    Full Text Available Rheumatoid arthritis (RA is known to increase the risk of cardiovascular (CV disease. However, the individual impact of traditional CV risk factors in RA is unknown.To assess the strength of the association between individual CV risk factors and rate of either myocardial infarction (MI, combined CV morbidity (MI, angina pectoris, heart failure, stroke, and peripheral arterial disease (PAD or CV mortality in RA patients.RA studies reporting traditional CV risk factors [hypertension, type 2 diabetes (T2D, smoking, hypercholesterolaemia, obesity, and physical inactivity] as exposures and MI, CV morbidity (MI, angina, heart failure, stroke, and PAD combined or CV mortality alone as outcomes were searched until March 2013 using MEDLINE, Scopus and Cochrane. Meta-analyses combined relative risk (RR estimates from each study where either the RR and 95% confidence intervals or where raw counts were available.Ten studies reporting sufficient data for inclusion into meta-analyses were identified. Relevant data was available for each risk factor and MI and CV morbidity but no studies reported on CV mortality. Risk of MI increased in RA patients with hypertension (RR 1.84, 95% CI 1.38, 2.46 and T2D (RR 1.89, 95% CI 1.36, 2.63. CV morbidity increased with hypertension (RR 2.24, 95% CI 1.42, 3.06, T2D (RR 1.94, 95% CI 1.58, 2.30, smoking (RR 1.50, 95% CI 1.15, 1.84, hypercholesterolaemia (RR 1.73, 95% CI 1.03, 2.44 and obesity (RR 1.16, 95% CI 1.03, 1.29 but not with physical inactivity (RR 1.00, 95% CI 0.71, 1.29.Hypertension, T2D, smoking, hypercholesterolaemia and obesity increased CV risk in patients with RA. These results highlight the importance of managing CV risk factors in RA, similarly to non-RA patients.

  17. Effectiveness of personalized face-to-face and telephone nursing counseling interventions for cardiovascular risk factors: a controlled clinical trial 1

    Science.gov (United States)

    Vílchez Barboza, Vivian; Klijn, Tatiana Paravic; Salazar Molina, Alide; Sáez Carrillo, Katia Lorena

    2016-01-01

    Abstract Objective: to evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve health-related quality of life and strengthen self-efficacy and social support in persons using the municipal health centers' cardiovascular health program. Method: a randomized controlled clinical trial involving participants randomized into the intervention group who received traditional consultation plus personalized and telephone nursing counseling for 7 months (n = 53) and the control group (n = 56). The study followed the Consolidated Standards of Reporting Trials Statement. Results: women in the intervention group presented a significant increase in the physical and mental health components compared to the control group, with decreases in weight, abdominal circumference, total cholesterol, low-density lipoprotein cholesterol, and the atherogenic index. The effects attributable to the intervention in the men in the intervention group were increased physical and emotional roles and decreased systolic and diastolic pressure, waist circumference, total cholesterol, low-density lipoprotein cholesterol, atherogenic index, cardiovascular risk factor, and 10-year coronary risk. Conclusion: this intervention is an effective strategy for the control of three cardiovascular risk factors and the improvement of health-related quality of life. PMID:27508917

  18. Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial

    OpenAIRE

    Storm, Vera; Dörenkämper, Julia; Reinwand, Dominique A; Wienert, Julian; de Vries, Hein; Lippke, Sonia

    2016-01-01

    Background Web-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date. Objective The study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascula...

  19. Glucose-lowering therapy in type 2 diabetes. New hope after the EMPA-REG outcome trial.

    Science.gov (United States)

    Schernthaner, G; Schernthaner, G-H

    2016-05-01

    Prevention of cardiovascular morbidity and mortality remains the key factor in the treatment of type 2 diabetes (T2DM). In the early phase of T2DM, multifactorial intervention is mandatory and glucose levels should be near normal, in particular in younger patients presenting with the highest cardiovascular risk. Anti-diabetic drugs without any risk for hypoglycaemia should be preferred in order to reduce clinical inertia and increase the long-term adherence to the treatment. In patients already presenting with cardiovascular disease, the best outcome may be expected with the triple oral therapy of metformin, pioglitazone, and empagliflozin, although a controlled prospective study versus insulin therapy is needed to confirm the expectation.

  20. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available BACKGROUND: In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. METHODS AND FINDINGS: We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition. CONCLUSIONS: Very few studies address the

  1. The cardiovascular effects of peroxisome proliferator-activated receptor agonists.

    Science.gov (United States)

    Friedland, Sayuri N; Leong, Aaron; Filion, Kristian B; Genest, Jacques; Lega, Iliana C; Mottillo, Salvatore; Poirier, Paul; Reoch, Jennifer; Eisenberg, Mark J

    2012-02-01

    Although peroxisome proliferator-activated receptor agonists are prescribed to improve cardiovascular risk factors, their cardiovascular safety is controversial. We therefore reviewed the literature to identify landmark randomized controlled trials evaluating the effect of peroxisome proliferator-activated receptor gamma agonists (pioglitazone and rosiglitazone), alpha agonists (fenofibrate and gemfibrozil), and pan agonists (bezafibrate, muraglitazar, ragaglitazar, tesaglitazar, and aleglitazar) on cardiovascular outcomes. Pioglitazone may modestly reduce cardiovascular events but also may increase the risk of bladder cancer. Rosiglitazone increases the risk of myocardial infarction and has been withdrawn in European and restricted in the United States. Fibrates improve cardiovascular outcomes only in select subgroups: fenofibrate in diabetic patients with metabolic syndrome, gemfibrozil in patients with dyslipidemia, and bezafibrate in patients with diabetes or metabolic syndrome. The cardiovascular safety of the new pan agonist aleglitazar, currently in phase II trials, remains to be determined. The heterogenous effects of peroxisome proliferator-activated receptor agonists to date highlight the importance of postmarketing surveillance. The critical question of why peroxisome proliferator-activated receptor agonists seem to improve cardiovascular risk factors without significantly improving cardiovascular outcomes requires further investigation.

  2. From volume to value? Can a value-based approach help deliver the ambitious aims of the NHS cardiovascular disease outcomes strategy?

    Science.gov (United States)

    Dunbar-Rees, Rupert; Panch, Trishan; Dancy, Mark

    2014-06-01

    The last year has seen the publication of two papers which will radically shape the future organisation of healthcare in general, and cardiovascular disease in particular: Cardiovascular Outcomes Strategy (Department of Health) and The Strategy That Will Fix Healthcare (Harvard Business Review). Both publications set out a health delivery mechanism based around improvement of outcomes for groups of patients with similar needs. Instead of organising care around disease categories, it is proposed that the cardiovascular diseases are treated as a single family of diseases. We are reaching the limits of what an activity-based system organised around existing provider structures can sustainably deliver. Unless we find delivery systems which reduce costs while at the same time improving outcomes that are meaningful to patients, then we will be faced with a future of healthcare rationing. The increasing burden of chronic disease and ongoing quality concerns in delivery systems has created a 'burning platform', which must be addressed if we are to maintain a system which offers high-quality care free at the point of delivery. This paper explores what an outcomes and value-based system could look like when applied to cardiovascular disease. It explores what it means for providers and patients if we start to think about outcomes by patients with similar needs, rather than by intervention, or by clinical specialty. As a specific example, the paper explores the features of an Integrated Circulation Service, what the challenges and implications might be, and whether there is any evidence that this would deliver improved outcomes, at a lower cost to the system.

  3. Examining Longitudinal Stimulant Use and Treatment Attendance as Parallel Outcomes in Two Contingency Management Randomized Clinical Trials.

    Science.gov (United States)

    McPherson, Sterling; Brooks, Olivia; Barbosa-Leiker, Celestina; Lederhos, Crystal; Lamp, Amanda; Murphy, Sean; Layton, Matthew; Roll, John

    2016-02-01

    The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one 'parallel outcomes' model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. We used parallel multilevel modeling to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial (β=0.060, preinforcement' between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials.

  4. Sildenafil does not improve steady state cardiovascular hemodynamics, peak power, or 15-km time trial cycling performance at simulated moderate or high altitudes in men and women.

    Science.gov (United States)

    Kressler, Jochen; Stoutenberg, Mark; Roos, Bernard A; Friedlander, Anne L; Perry, Arlette C; Signorile, Joseph F; Jacobs, Kevin A

    2011-12-01

    Sildenafil improves oxygen delivery and maximal exercise capacity at very high altitudes (≥ 4,350 m), but it is unknown whether sildenafil improves these variables and longer-duration exercise performance at moderate and high altitudes where competitions are more common. The purpose of this study was to determine the effects of sildenafil on cardiovascular hemodynamics, arterial oxygen saturation (SaO(2)), peak exercise capacity (W (peak)), and 15-km time trial performance in endurance-trained subjects at simulated moderate (MA; ~2,100 m, 16.2% F(I)O(2)) and high (HA; ~3,900 m, 12.8% F(I)O(2)) altitudes. Eleven men and ten women completed two HA W (peak) trials after ingesting placebo or 50 mg sildenafil. Subjects then completed four exercise trials (30 min at 55% of altitude-specific W (peak) + 15-km time trial) at MA and HA after ingesting placebo or 50 mg sildenafil. All trials were performed in randomized, counterbalanced, and double-blind fashion. Sildenafil had little influence on cardiovascular hemodynamics at MA or HA, but did result in higher SaO(2) values (+3%, p < 0.05) compared to placebo during steady state and time trial exercise at HA. W (peak) at HA was 19% lower than SL (p < 0.001) and was not significantly affected by sildenafil. Similarly, the significantly slower time trial performance at MA (28.1 ± 0.5 min, p = 0.016) and HA (30.3 ± 0.6 min, p < 0.001) compared to SL (27.5 ± 0.6 min) was unaffected by sildenafil. We conclude that sildenafil is unlikely to exert beneficial effects at altitudes <4,000 m for a majority of the population.

  5. Incidence of the Bertillon and Gompertz effects on the outcome of clinical trials

    CERN Document Server

    Roehner, Bertrand M

    2013-01-01

    The accounts of medical trials provide very detailed information about the patients' health conditions. In contrast, only minimal data are usually given about demographic factors. Yet, some of these factors can have a notable impact on the overall death rate, thereby changing the outcome and conclusions of the trial. This paper focuses on two of these variables. The first is marital status; this effect, which will be referred to as the Bertillon effect, may change death rates by over 100%. The second is the age of the oldest patients; because of the exponential nature of Gompertz's law, changes in the distribution of ages in the oldest age group can have dramatic consequences on the overall number of deaths. It will be seen that randomization alone can hardly take care of these problems. Appropriate remedies are easy to formulate however. First, the marital status of patients as well as the age distribution of those over 65 should be documented for both study groups. Then, thanks to these data and based on th...

  6. Mathematical modeling of herpes simplex virus-2 suppression with pritelivir predicts trial outcomes

    Science.gov (United States)

    Schiffer, Joshua T.; Swan, David A.; Magaret, Amalia; Corey, Lawrence; Wald, Anna; Ossig, Joachim; Ruebsamen-Schaeff, Helga; Stoelben, Susanne; Timmler, Burkhard; Zimmermann, Holger; Melhem, Murad R.; Van Wart, Scott A.; Rubino, Christopher M.; Birkmann, Alexander

    2016-01-01

    Pharmacokinetic and pharmacodynamic models estimate the potency of antiviral agents but do not capture viral and immunologic factors that drive the natural dynamics of infection. We designed a mathematical model that synthesizes pharmacokinetics, pharmacodynamics and viral pathogenesis concepts to simulate the activity of pritelivir, a DNA helicase-primase inhibitor that targets herpes simplex virus. Our simulations recapitulate detailed viral kinetic shedding features in five dosage arms of a phase 2 clinical trial. We identify that in vitro estimates of EC50 are lower than in vivo values for the drug. Nevertheless, pritelivir potently decreases shedding at appropriate doses based on its mode of action and long half-life. While pritelivir directly inhibits replication in epithelial cells, our model indicates that pritelivir also indirectly limits downstream viral spread from neurons to genital keratinocytes, within genital ulcers, and from ulcer to new mucosal sites of infection. We validate our model based on its ability to predict outcomes in a subsequent trial with a higher dose. The model can therefore be employed to optimize dose selection in clinical practice. PMID:26843190

  7. Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia.

    LENUS (Irish Health Repository)

    Niemeyer, Charlotte M

    2015-01-01

    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.

  8. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial.

    Directory of Open Access Journals (Sweden)

    Sanne M van der Made

    Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

  9. Vitamin D and Cardiovascular Disease

    Directory of Open Access Journals (Sweden)

    Martin R. Grübler

    2013-07-01

    Full Text Available Vitamin D deficiency, as well as cardiovascular diseases (CVD and related risk factors are highly prevalent worldwide and frequently co-occur. Vitamin D has long been known to be an essential part of bone metabolism, although recent evidence suggests that vitamin D plays a key role in the pathophysiology of other diseases, including CVD, as well. In this review, we aim to summarize the most recent data on the involvement of vitamin D deficiency in the development of major cardiovascular risk factors: hypertension, obesity and dyslipidemia, type 2 diabetes, chronic kidney disease and endothelial dysfunction. In addition, we outline the most recent observational, as well as interventional data on the influence of vitamin D on CVD. Since it is still an unresolved issue whether vitamin D deficiency is causally involved in the pathogenesis of CVD, data from randomized controlled trials (RCTs designed to assess the impact of vitamin D supplementation on cardiovascular outcomes are awaited with anticipation. At present, we can only conclude that vitamin D deficiency is an independent cardiovascular risk factor, but whether vitamin D supplementation can significantly improve cardiovascular outcomes is still largely unknown.

  10. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool, a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  11. Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice

    Directory of Open Access Journals (Sweden)

    Shaw Lindsey

    2006-11-01

    Full Text Available Abstract Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261 had significant pathology, compared with 19% (49/253 in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15. In the combined educational outreach arms 15% (38/258 had significant pathology compared with 19% (48/256 in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24. Pro forma practices documented better assessment of patients at referral. Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of

  12. Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy

    Science.gov (United States)

    2012-08-01

    intent and practice of manualized PE. 1 Schnurr PP. The rocks and hard places in psychotherapy outcome research. J Trauma Stress. 2007; 20(5):779-92...foresight and planning Social cognition Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™): Managing Emotions Paper-and-pencil multiple-choice...Award Number: W81XWH-10-2-0072 TITLE: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone

  13. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

    Directory of Open Access Journals (Sweden)

    Dunkley David

    2008-09-01

    Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

  14. Effect of anti-obesity drug on cardiovascular risk factors: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yu-Hao Zhou

    Full Text Available BACKGROUND: Anti-obesity drugs are widely used to prevent the complications of obesity, however, the effects of anti-obesity drugs on cardiovascular risk factors are unclear at the present time. We carried out a comprehensively systematic review and meta-analysis to assess the effects of anti-obesity drugs on cardiovascular risk factors. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles and proceedings of major meetings for relevant literatures. We included randomized placebo-controlled trials that reported the effects of anti-obesity drugs on cardiovascular risk factors compared to placebo. Overall, orlistat produced a reduction of 2.39 kg (95%CI-3.34 to -1.45 for weight, a reduction of 0.27 mmol/L (95%CI: -0.36 to -0.17 for total cholesterol, a reduction of 0.21 mmol/L (95%CI: -0.30 to -0.12 for LDL, a reduction of 0.12 mmol/L (95%CI: -0.20 to -0.04 for fasting glucose, 1.85 mmHg reduction (95%CI: -3.30 to -0.40 for SBP, and a reduction of 1.49 mmHg (95%CI: -2.39 to -0.58 for DBP. Sibutramine only showed effects on weight loss and triglycerides reduction with statistical significances. Rimonabant was associated with statistically significant effects on weight loss, SBP reduction and DBP reduction. No other significantly different effects were identified between anti-obesity therapy and placebo. CONCLUSION/SIGNIFICANCE: We identified that anti-obesity therapy was associated with a decrease of weight regardless of the type of the drug. Orlistat and rimonabant could lead to an improvement on cardiovascular risk factors. However, Sibutramine may have a direct effect on cardiovascular risk factors.

  15. Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

    Science.gov (United States)

    Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

    2015-01-01

    Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications

  16. Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial

    Directory of Open Access Journals (Sweden)

    Decramer Marc

    2011-01-01

    Full Text Available Abstract Background Debate continues as to whether acute bronchodilator responsiveness (BDR predicts long-term outcomes in COPD. Furthermore, there is no consensus on a threshold for BDR. Methods At baseline and during the 4-year Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT® trial, patients had spirometry performed before and after administration of ipratropium bromide 80 mcg and albuterol 400 mcg. Patients were split according to three BDR thresholds: ≥12% + ≥200 mL above baseline (criterion A, ≥15% above baseline (criterion B; and ≥10% absolute increase in percent predicted FEV1 values (criterion C. Several outcomes (pre-dose spirometry, exacerbations, St. George's Respiratory Questionnaire [SGRQ] total score were assessed according to presence or absence of BDR in the treatment groups. Results 5783 of 5993 randomized patients had evaluable pre- and post-bronchodilator spirometry at baseline. Mean age (SD was 64 (8 years, with 75% men, mean post-bronchodilator FEV1 1.33 ± 0.44 L (47.6 ± 12.7% predicted and 30% current smokers. At baseline, 52%, 66%, and 39% of patients had acute BDR using criterion A, B, and C, respectively. The presence of BDR was variable at follow-up visits. Statistically significant improvements in spirometry and health outcomes occurred with tiotropium regardless of the baseline BDR or criterion used. Conclusions A large proportion of COPD patients demonstrate significant acute BDR. BDR in these patients is variable over time and differs according to the criterion used. BDR status at baseline does not predict long-term response to tiotropium. Assessment of acute BDR should not be used as a decision-making tool when prescribing tiotropium to patients with COPD.

  17. Outcome of Percutaneous Release of Tennis Elbow: A Non-Randomized Controlled Trial Study

    Science.gov (United States)

    Khatri, Kishor; Kharel, Krishna; Byanjankar, Subin; Shrestha, Rahul; Sharma, Jay R; Vaishya, Raju; Agarwal, Amit kumar; Vijay, Vipul

    2017-01-01

    Background Tennis elbow is a common disorder of the upper extremity. It can be treated conservatively in the majority of patients, but some resistant cases eventually can be treated by percutaneous release with good functional outcome. Materials and methods This non-randomized control trial was conducted at the Department of Orthopaedics Surgery in a tertiary care hospital from July 2015 to June 2016 on 50 patients who underwent percutaneous release of the common extensor origin using an 18 gauge hypodermic needle. These patients did not respond to conservative treatment including rest, nonsteroidal anti-inflammatory drugs (NSAIDS) and local steroid injections. The outcome was graded as Excellent, Good, Fair, and Poor. Results Fifty patients (50 elbows) were included in the study. Thirty-two patients were female (64%), and 18 were male (36%). The right side was affected in 37 patients (74%) and left side in 13 (26%). The time taken to achieve a completely pain-free elbow ranged from one day to two months (average of 26.2 days). Those who did not achieve a pain-free elbow had a residual pain of 1.5 to six on the visual analogue scale (VAS) (average 2.32). Excellent outcome was noticed in 24 patients (48%); Good result in eight patients (36% ); Fair in four patients (eight percent) and Poor in four patients (eight percent). Conclusion Tennis elbow probably results from the degenerative tear of the common extensor origin, and a percutaneous tenotomy using an 18 gauge hypodermic needle is a simple, safe, patient-friendly, efficient, and easily reproducible method of treating tennis elbow in those who are resistant to conservative treatment, and it can be done as an outpatient procedure. PMID:28168130

  18. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  19. Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis

    DEFF Research Database (Denmark)

    Wu, Jashin J; Strober, Bruce E; Hansen, Peter R;

    2016-01-01

    BACKGROUND: Psoriasis is a systemic inflammatory condition that is associated with a higher risk of cardiovascular (CV) disease. Tofacitinib is being investigated as a treatment for psoriasis. OBJECTIVE: We sought to evaluate the effects of tofacitinib on CV risk factors and major adverse CV even...

  20. Cocoa, blood pressure, and cardiovascular health.

    Science.gov (United States)

    Ferri, Claudio; Desideri, Giovambattista; Ferri, Livia; Proietti, Ilenia; Di Agostino, Stefania; Martella, Letizia; Mai, Francesca; Di Giosia, Paolo; Grassi, Davide

    2015-11-18

    High blood pressure is an important risk factor for cardiovascular disease and cardiovascular events worldwide. Clinical and epidemiological studies suggest that cocoa-rich products reduce the risk of cardiovascular disease. According to this, cocoa has a high content in polyphenols, especially flavanols. Flavanols have been described to exert favorable effects on endothelium-derived vasodilation via the stimulation of nitric oxide-synthase, the increased availability of l-arginine, and the decreased degradation of NO. Cocoa may also have a beneficial effect by protecting against oxidative stress alterations and via decreased platelet aggregation, decreased lipid oxidation, and insulin resistance. These effects are associated with a decrease of blood pressure and a favorable trend toward a reduction in cardiovascular events and strokes. Previous meta-analyses have shown that cocoa-rich foods may reduce blood pressure. Long-term trials investigating the effect of cocoa products are needed to determine whether or not blood pressure is reduced on a chronic basis by daily ingestion of cocoa. Furthermore, long-term trials investigating the effect of cocoa on clinical outcomes are also needed to assess whether cocoa has an effect on cardiovascular events. A 3 mmHg systolic blood pressure reduction has been estimated to decrease the risk of cardiovascular and all-cause mortality. This paper summarizes new findings concerning cocoa effects on blood pressure and cardiovascular health, focusing on putative mechanisms of action and "nutraceutical " viewpoints.

  1. Sex steroids and cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Bu Beng Yeap

    2014-04-01

    Full Text Available As men grow older, testosterone (T levels decline and the significance of this change is debated. The evidence supporting a causal role for lower circulating T, or its metabolites dihydrotestosterone (DHT and estradiol, in the genesis of atherosclerosis and cardiovascular disease (CVD in men is limited. Observational studies associate low baseline T levels with carotid atherosclerosis, aortic and peripheral vascular disease, and with the incidence of cardiovascular events and mortality. Studies using mass spectrometry suggest that when total T is assayed optimally, calculation of free T might not necessarily improve risk stratification. There is limited evidence to support an association of estradiol with CVD. Interventional studies of T therapy in men with coronary artery disease have shown beneficial effects on exercise-induced myocardial ischemia. However, placebo-controlled, randomized clinical trials (RCTs of T therapy in men with the prespecified outcomes of cardiovascular events or deaths are lacking. Meta-analyses of randomized controlled trials of T published up to 2010 found no increase in cardiovascular events, mortality, or prostate cancer with therapy. Recently, in a trial of older men with mobility limitations, men randomized to receive a substantial dose of T reported cardiovascular adverse effects. This phenomenon was not reported from a comparable trial where men received a more conservative dose of T, suggesting a prudent approach should be adopted when considering therapy in frail older men with existing CVD. Adequately powered RCTs of T in middle-aged and older men are needed to clarify whether or not hormonal intervention would reduce the incidence of CVD.

  2. Polyvascular Disease and Long-term Cardiovascular Outcomes in Older Patients with Non–ST-segment Elevation Myocardial Infarction

    Science.gov (United States)

    Subherwal, Sumeet; Bhatt, Deepak L.; Li, Shuang; Tracy Y., Wang; Thomas, Laine; Alexander, Karen P.; Patel, Manesh R.; Ohman, E. Magnus; Gibler, W. Brian; Peterson, Eric D.; Roe, Matthew T.

    2013-01-01

    Background The impact of polyvascular disease (peripheral arterial disease [PAD] and/or cerebrovascular disease [CVD]) on long-term cardiovascular outcomes among older patients with acute myocardial infarction (MI) has not been well studied. Methods Non–ST-elevation MI (NSTEMI) patients aged ≥65 years from the CRUSADE registry who survived to hospital discharge were linked to longitudinal data from the Centers for Medicare and Medicaid Services (n=34,205). All patients were presumed to have coronary artery disease (CAD) and were classified into 4 groups: 10.7% had prior CVD (CAD+CVD group); 11.5% had prior PAD (CAD+PAD); 3.1% had prior PAD and CVD (CAD+PAD+CVD); and 74.7% had no polyvascular disease (CAD alone). Cox proportional hazard modeling was used to examine the hazard of long-term mortality and the composite of death, readmission for MI, or readmission for stroke (median follow-up 35 months, IQR 17–49) among the 4 groups. Results Compared with the CAD-alone group, patients with polyvascular disease had a greater comorbidity burden, were less likely to undergo revascularization, and less often received recommended discharge interventions. Three-year mortality rates increased with a greater number of arterial beds involved: 33% for CAD alone, 49% for CAD+PAD, 52% for CAD+CVD, and 59% for CAD+PAD+CVD. Relative to the CAD-alone group, patients with all 3 arterial beds involved had the highest risk of long-term mortality (adjusted HR [95% CI]: 1.49 [1.38–1.61], with a lower risk for those with CAD+CVD, 1.38 [1.31–1.44], and those with CAD+PAD, 1.29 [1.23–1.35]). Similarly, the adjusted risk of long-term composite ischemic events was highest among the CAD+PAD+CVD group. Conclusions Older NSTEMI patients with polyvascular disease have substantially higher long-term risk, such that the 3-year mortality rate is >50%. Future studies targeting greater adherance to secondary prevention strategies and novel therapies are needed to help reduce long

  3. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    OpenAIRE

    Amelia Scott; Julia J Rucklidge; Roger T Mulder

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which...

  4. Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment

    Directory of Open Access Journals (Sweden)

    Crotty Maria

    2010-09-01

    Full Text Available Abstract Background Shoulder pain is a common complication of a stroke which can impede participation in rehabilitation programs and has been associated with poorer outcomes. The evidence base for current medical and therapeutic management options of hemiplegic shoulder pain is limited. This study will evaluate the use of suprascapular nerve block injection as part of an interdisciplinary approach to the treatment of shoulder pain following stroke. The technique has previously been proven safe and effective in the treatment of shoulder pain associated with rheumatoid arthritis and degenerative shoulder conditions but its usefulness in a stroke population is unclear. Methods/Design A double blind randomised placebo controlled trial will assess the effect of a suprascapular nerve block compared with placebo in a population of 66 stroke patients. The trial will measure effect of injection on the primary outcome of pain, and secondary outcomes of function and quality of life. Measurements will take place at baseline, and 1, 4 and 12 weeks post intervention. Both groups will continue to receive routine physiotherapy and standard ward care. Discussion The results of this study could reduce pain symptoms in persons with mechanical shoulder pain post stroke and provide improvement in upper limb function. Trial Registration This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR - ACTRN12609000621213.

  5. The Modification Effect of Influenza Vaccine on Prognostic Indicators for Cardiovascular Events after Acute Coronary Syndrome: Observations from an Influenza Vaccination Trial

    Directory of Open Access Journals (Sweden)

    Apirak Sribhutorn

    2016-01-01

    Full Text Available Introduction. The prognosis of acute coronary syndrome (ACS patients has been improved with several treatments such as antithrombotics, beta-blockers, and angiotensin-converting enzyme inhibitors (ACEI as well as coronary revascularization. Influenza vaccination has been shown to reduce adverse outcomes in ACS, but no information exists regarding the interaction of other treatments. Methods. This study included 439 ACS patients from Phrommintikul et al. A single dose of inactivated influenza vaccine was given by intramuscular injection in the vaccination group. The cardiovascular outcomes were described as major cardiovascular events (MACEs which included mortality, hospitalization due to ACS, and hospitalization due to heart failure (HF. The stratified and multivariable Cox’s regression analysis was performed. Results. The stratified Cox’s analysis by influenza vaccination for each cardiovascular outcome and discrimination of hazard ratios showed that beta-blockers had an interaction with influenza vaccination. Moreover, the multivariable hazard ratios disclosed that influenza vaccine is associated with a significant reduction of hospitalization due to HF in patients who received beta-blockers (HR = 0.05, 95% CI = 0.004–0.71, P=0.027, after being adjusted for prognostic indicators (sex, dyslipidemia, serum creatinine, and left ventricular ejection fraction. Conclusions. The influenza vaccine was shown to significantly modify the effect of beta-blockers in ACS patients and to reduce the hospitalization due to HF. However, further study of a larger population and benefits to HF patients should be investigated.

  6. Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]).

    Science.gov (United States)

    Matheny, Michael E; Morrow, David A; Ohno-Machado, Lucila; Cannon, Christopher P; Resnic, Frederic S

    2007-10-11

    We sought to validate an automated outcomes surveillance system (DELTA) using OPUS (TIMI-16), a multi-center randomized, controlled trial that was stopped early due to elevated mortality in one of the two intervention arms. Methodologies that were incorporated into the application (Statistical Process Control [SPC] and Bayesian Updating Statistics [BUS]) were compared with standard Data Safety Monitoring Board (DSMB) protocols.

  7. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  8. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials : PedIMMPACT recommendations

    NARCIS (Netherlands)

    McGrath, Patrick J.; Walco, Gary A.; Turk, Dennis C.; Dworkin, Robert H.; Brown, Mark T.; Davidson, Karina; Eccleston, Christopher; Finley, G. Allen; Goldschneider, Kenneth; Haverkos, Lynne; Hertz, Sharon H.; Ljungman, Gustaf; Palermo, Tonya; Rappaport, Bob A.; Rhodes, Thomas; Schechter, Neil; Scott, Jane; Sethna, Navil; Svensson, Ola K.; Stinson, Jennifer; von Baeyer, Carl L.; Walker, Lynn; Weisman, Steven; White, Richard E.; Zajicek, Anne; Zeltzer, Lonnie

    2008-01-01

    Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains an

  9. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    Science.gov (United States)

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  10. Acute heart failure in elderly patients : worse outcomes and differential utility of standard prognostic variables. Insights from the PROTECT trial

    NARCIS (Netherlands)

    Metra, Marco; Mentz, Robert J.; Chiswell, Karen; Bloomfield, Daniel M.; Cleland, John G. F.; Cotter, Gad; Davison, Beth A.; Dittrich, Howard C.; Fiuzat, Mona; Givertz, Michael M.; Lazzarini, Valentina; Mansoor, George A.; Massie, Barry M.; Ponikowski, Piotr; Teerlink, John R.; Voors, Adriaan A.; O'Connor, Christopher M.

    2015-01-01

    AimsPrevious heart failure (HF) trials suggested that age influences patient characteristics and outcome; however, under-representation of elderly patients has limited characterization of this cohort. Whether standard prognostic variables have differential utility in various age groups is unclear. M

  11. The influence of physical activity performed at 20-40 years of age on cardiovascular outcomes in medical patients aged 65-75

    Directory of Open Access Journals (Sweden)

    Francesco Cipollini

    2013-03-01

    Full Text Available Introduction: Several studies show that physical activity can reduce the risk of cardiovascular disease, but the vast majority of these focus on the short- to intermediate-term benefits or refer to very specific populations. This observational study was conducted to determine whether physical activity performed during the third or fourth decade of life influences the occurrence of cardiovascular events in patients aged 65-75 years. Materials and methods: We studied a cohort of 2191 unselected patients admitted to Internal Medicine Departments. Data were collected on the patients’ medical history and their physical activity level when they were 20 to 40 years old. For the latter purpose, we used a specific questionnaire to assess the levels of physical activity related to the patients’ job, daily life, leisure time, and sports. Results: Almost half (44.2% of the patients we evaluated reported moderate-intense physical activity when they were 20-40 years old. Around one third (35.8% of the patients had experienced at least one major cardiovascular event, and there was a slight trend towards fewer cardiovascular events in patients with histories of physical activity (mean risk reduction: 4%, multivariate analysis. More evident benefits were observed in the subgroup of patients with diabetes, where cardiovascular outcomes were much better in patients who had been physically active than in those with sedentary life-styles (mean risk reduction: 24%. Conclusions: Given its design, our study may have underestimated the cardiovascular benefits of physical activity. Nonetheless, our results suggest that moderate-intense exercise during young adulthood may have limited beneficial effects on cardiovascular disease in old age, except in specific high-risk populations (diabetic patients. More evident benefits are probably associated with regular physical activity throughout life.

  12. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.;

    2009-01-01

    strokes in subjects with recent stroke or transient ischemic attack (n=4731). We analyzed SPARCL trial data to determine whether treatment favorably shifts the distribution of severities of ischemic cerebrovascular outcomes. METHODS: Severity was assessed with the National Institutes of Health Stroke...... or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (P... outcome events (ischemic and hemorrhagic, Pischemic stroke (ie, excluding those having a transient ischemic attack...

  13. Improving 1-year outcome in first-episode psychosis: OPUS trial

    DEFF Research Database (Denmark)

    Petersen, Lone; Nordentoft, Merete; Jeppesen, Pia;

    2005-01-01

    Because early illness course and outcome may affect the long-term outcome of schizophrenia-spectrum disorders, it is especially important to address poor outcome in this early critical period.......Because early illness course and outcome may affect the long-term outcome of schizophrenia-spectrum disorders, it is especially important to address poor outcome in this early critical period....

  14. Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit

    Directory of Open Access Journals (Sweden)

    Choodari-Oskooei Babak

    2011-03-01

    Full Text Available Abstract background The pace of novel medical treatments and approaches to therapy has accelerated in recent years. Unfortunately, many potential therapeutic advances do not fulfil their promise when subjected to randomized controlled trials. It is therefore highly desirable to speed up the process of evaluating new treatment options, particularly in phase II and phase III trials. To help realize such an aim, in 2003, Royston and colleagues proposed a class of multi-arm, two-stage trial designs intended to eliminate poorly performing contenders at a first stage (point in time. Only treatments showing a predefined degree of advantage against a control treatment were allowed through to a second stage. Arms that survived the first-stage comparison on an intermediate outcome measure entered a second stage of patient accrual, culminating in comparisons against control on the definitive outcome measure. The intermediate outcome is typically on the causal pathway to the definitive outcome (i.e. the features that cause an intermediate event also tend to cause a definitive event, an example in cancer being progression-free and overall survival. Although the 2003 paper alluded to multi-arm trials, most of the essential design features concerned only two-arm trials. Here, we extend the two-arm designs to allow an arbitrary number of stages, thereby increasing flexibility by building in several 'looks' at the accumulating data. Such trials can terminate at any of the intermediate stages or the final stage. Methods We describe the trial design and the mathematics required to obtain the timing of the 'looks' and the overall significance level and power of the design. We support our results by extensive simulation studies. As an example, we discuss the design of the STAMPEDE trial in prostate cancer. Results The mathematical results on significance level and power are confirmed by the computer simulations. Our approach compares favourably with methodology

  15. Improving Treatment Trial Outcomes for Rett Syndrome: The Development of Rett-specific Anchors for the Clinical Global Impression Scale.

    Science.gov (United States)

    Neul, Jeffrey L; Glaze, Daniel G; Percy, Alan K; Feyma, Tim; Beisang, Arthur; Dinh, Thuy; Suter, Bernhard; Anagnostou, Evdokia; Snape, Mike; Horrigan, Joseph; Jones, Nancy E

    2015-11-01

    Rett syndrome is a genetically based neurodevelopmental disorder. Although the clinical consequences of Rett syndrome are profound and lifelong, currently no approved drug treatments are available specifically targeted to Rett symptoms. High quality outcome measures, specific to the core symptoms of a disorder are a critical component of well-designed clinical trials for individuals with neurodevelopmental disorders. The Clinical Global Impression Scale is a measure of global clinical change with strong face validity that has been widely used as an outcome measure in clinical trials of central nervous system disorders. Despite its favorable assay sensitivity in clinical trials, as a global measure, the Clinical Global Impression Scale is not specific to the signs and symptoms of the disorder under study. Development of key anchors for the scale, specific to the disorder being assessed, holds promise for enhancing the validity and reliability of the measure for disorders such as Rett syndrome.

  16. Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study [v2; ref status: indexed, http://f1000r.es/5bj

    Directory of Open Access Journals (Sweden)

    Sreeram V Ramagopalan

    2015-04-01

    Full Text Available Background: We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. Methods: A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Findings: 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3% had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome. Conclusions: Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  17. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  18. Dietary components and risk of total, cancer and cardiovascular disease mortality in the Linxian Nutrition Intervention Trials cohort in China.

    Science.gov (United States)

    Wang, Jian-Bing; Fan, Jin-Hu; Dawsey, Sanford M; Sinha, Rashmi; Freedman, Neal D; Taylor, Philip R; Qiao, You-Lin; Abnet, Christian C

    2016-03-04

    Although previous studies have shown that dietary consumption of certain food groups is associated with a lower risk of cancer, heart disease and stroke mortality in western populations, limited prospective data are available from China. We prospectively examined the association between dietary intake of different food groups at baseline and risk of total, cancer, heart disease and stroke mortality outcomes in the Linxian Nutrition Intervention Trials(NIT) cohort. In 1984-1991, 2445 subjects aged 40-69 years from the Linxian NIT cohort completed a food frequency questionnaire. Deaths from esophageal and gastric cancer, heart disease and stroke were identified through up to 26 years of follow-up. We used Cox proportional hazard models to calculate hazard ratios and 95% confidence intervals for associations between intake of groups of food items and these mortality endpoints. We concluded that higher intake of certain food groups was associated with lower risk of gastric cancer, heart disease and stroke mortality in a prospective cohort in rural China. Our findings provide additional evidence that increasing intake of grains, vegetables, beans, fruits and nuts may help reduce mortality from these diseases.

  19. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  20. The Effect of Probiotic Yogurt on Blood Glucose and cardiovascular Biomarkers in Patients with Type II Diabetes: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mahin Rezaei

    2017-01-01

    Full Text Available Background: Given the high prevalence of type II diabetes and its complications, the evidence regarding the beneficial effects of probiotic yogurt on some cardiovascular biomarkers in diabetic patients is worthy of investigation. Aim: To investigate the effect of probiotic yogurt on blood glucose level and cardiovascular biomarkers in patients with type II diabetes. Method:This randomized, clinical trial was conducted on 90 patients with type II diabetes who visited the 5 Azar diabetes clinic in Gorgan, Iran, in 2014. The intervention group consumed three 100 g packages of probiotic yogurt per day for four weeks, while the control group used an equal amount of plain yogurt. Dietary intake, as well as anthropometric and biochemical parameters were measured before and after the trial. To analyze the data, independent t-test, paired t-test, and analysis of covariance were performed, using SPSS version 18. Results: The mean ages of the intervention and control groups were 50.49±10.92 and 50.13±9.20 years, respectively. In the intervention group, paired t-test showed significant differences between mean levels of blood glucose, cholesterol, low-density lipoprotein (LDL, triglycerides, diastolic blood pressure, and glycated hemoglobin before and after four weeks of daily intake of probiotic yogurt (P0.05. At the end of trial, the independent t-test showed a significant difference between the two groups in terms of mean levels of blood glucose, LDL, triglycerides, blood pressure, and glycated hemoglobin (P

  1. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

    Directory of Open Access Journals (Sweden)

    José Rodríguez Cristóbal Juan

    2012-03-01

    Full Text Available Abstract Background We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. Results This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA in l'Hospitalet de Llobregat (Barcelona and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl, cholesterol The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. Trial Registration ClinicalTrials.gov: NCT01089530

  2. Effect of a randomized controlled exercise trial on bone outcomes: influence of adjuvant endocrine therapy.

    Science.gov (United States)

    Knobf, M Tish; Jeon, Sangchoon; Smith, Barbara; Harris, Lyndsay; Kerstetter, Jane; Thompson, A Siobhan; Insogna, Karl

    2016-02-01

    Bone loss is a significant clinical problem for female cancer survivors (FCS) and increases fracture risk. The aim of the Yale Fitness Intervention Trial (Yale FIT) was to determine the effects of a 12-month aerobic-resistance exercise intervention compared to a home-based physical activity group on bone outcomes [bone mineral density (BMD)] and biomarkers bone turnover). Early postmenopausal FCS (N = 154) were randomized to the exercise intervention (3 times/week) or to a home-based physical activity group. Calcium (1200 mg) and Vitamin D (400 IU) supplements were provided to both groups. BMD was measured at baseline and 12 months. No significant difference in BMD was observed for the exercise vs home-based group. However, subjects on Tamoxifen or no endocrine therapy did not significantly lose BMD, with the exception of the femoral neck (FN). In contrast subjects on aromatase inhibitors (AIs) had significant BMD loss at all sites. The majority of subjects had sufficient serum levels of Vitamin D (>20 ng/mL) but there was significantly less bone loss in subjects in the 20-29 ng/mL range at the LS (p = 0.01), hip (p = 0.03), and GT (p = 0.008) compared to lower or higher levels. Exercise stimulates bone remodeling but the intervention was not superior for BMD outcomes at one year. The dose of the osteogenic stimulus in the intervention has been effective in preserving BMD in healthy postmenopausal women but it may be inadequate for survivors with chemotherapy-induced menopause and for those on adjuvant AI therapy.

  3. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients.

    Science.gov (United States)

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena M; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-07-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study.

  4. Improved outcome in acute myeloid leukemia patients enrolled in clinical trials

    DEFF Research Database (Denmark)

    Østgård, Lene Sofie Granfeldt; Nørgaard, Mette; Sengeløv, Henrik;

    2016-01-01

    Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial.We conducted a population-based cohort...... study of newly diagnosed Danish AML patients treated with intensive chemotherapy between 2000-2013. We estimated accrual rates and compared characteristics, complete remission (CR) rates, and relative risks (RRs) of death at 90-day, 1-year, and 3-years in clinical trial patients to patients treated off......-trial.Of 867 patients, 58.3% (n = 504) were included in a clinical trial. Accrual rates were similar across age groups (p = 0.55). Patients with poor performance status, comorbidity, therapy-related and secondary AML were less likely to be enrolled in trials. CR rates were 80.2% in trial-patients versus 68...

  5. Testosterone Replacement Therapy and the Cardiovascular System.

    Science.gov (United States)

    Naderi, Sahar

    2016-04-01

    As testosterone replacement therapy (TRT) has emerged as a commonly prescribed therapy for symptomatic low testosterone, conflicting data have been reported in terms of both its efficacy and potential adverse outcomes. One of the most controversial associations has been that of TRT and cardiovascular morbidity and mortality. This review briefly provides background on the history of TRT, the indications for TRT, and the data behind TRT for symptomatic low testosterone. It then specifically delves into the rather limited data for cardiovascular outcomes of those with low endogenous testosterone and those who receive TRT. The available body of literature strongly suggests that more work, by way of clinical trials, needs to be done to better understand the impact of testosterone and TRT on the cardiovascular system.

  6. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  7. Outcomes of anatomical vs. functional testing for coronary artery disease : Lessons from the PROMISE trial.

    Science.gov (United States)

    Shah, R; Foldyna, B; Hoffmann, U

    2016-08-01

    The development of coronary artery disease (CAD) is a major, final common pathway in heart disease worldwide. With a rise in stress testing and increased scrutiny on cost-effectiveness and radiation exposure in medical imaging, a focus on the relative merits of anatomic versus functional characterization of CAD has emerged. In this context, coronary computed tomography angiography (CCTA) is a noninvasive alternative to functional testing as a first-line test for CAD detection but is complimentary in its nature. Here, we discuss the design, results, and implications of the PROMISE trial, a randomized comparative effectiveness study of 10,003 patients across 193 sites in the United States and Canada comparing the prognostic and diagnostic power of CCTA and standard stress testing. Specifically, we discuss the safety (e. g., contrast, radiation exposure) of CCTA versus functional testing in CAD, the need for improved selection for noninvasive testing, the frequency of downstream testing after anatomic or functional imaging, the use of imaging results in clinical management, and novel modalities of CAD risk determination using CCTA. PROMISE demonstrated that in a real-world, low-to-intermediate risk patient population referred to noninvasive testing for CAD, both CCTA and functional testing approaches have similar clinical, economic, and safety-based outcomes. We conclude with open questions in CAD imaging, specifically as they pertain to the utilization of CCTA.

  8. Working alliance and its relationship to outcomes in a randomized controlled trial (RCT of antipsychotic medication

    Directory of Open Access Journals (Sweden)

    Wykes Til

    2013-01-01

    Full Text Available Abstract Background Long acting injections (LAI have been associated with perceptions of coercion in cross sectional studies but there have been no longitudinal studies of the effects on clinical relationships with newer depot medications. Method Randomized controlled trial with (50 participants with a diagnosis of schizophrenia randomized to risperidone LAI or oral atypical antipsychotic medication. The main outcome was the Working Alliance Inventory (WAI with background variables (symptoms, side effect, social functioning, quality of life measured before randomization and at two years. Results At follow-up (14 risperidone LAI and 16 oral medication analyses including predictors of missing data and baseline score showed a trend for those on risperidone LAI to reduce WAI score and those on oral medication showing no change. Sensitivity analyses showed (i a significant detrimental effect of LAI on WAI and (ii the pattern of results was not affected by change in symptoms over the study. Conclusion This is the first study to show that the prescription of depot atypical depot medication is associated with detrimental effects on clinical relationships after 2 years of continual treatment.

  9. Vitamin D and cardiovascular disease and cancer: not too much and not too little? The need for clinical trials

    OpenAIRE

    Melamed, Michal L.; Manson, JoAnn E

    2011-01-01

    Low vitamin D levels are more common in women than in men. Low vitamin D levels have been implicated in numerous disease processes including fracture risk, falls, cardiovascular disease, hypertension, diabetes mellitus and cancers. In this article we review recent evidence regarding associations between low vitamin D levels and cancers and cardiovascular disease. We also review evidence regarding associations between high vitamin D levels and vascular calcifications and pancreatic cancer. It ...

  10. Current Role of Platelet Glycoprotein Ⅱ b/Ⅲ a Receptor Inhibitors in Clinic-al Trials of Cardiovascular Diseases

    Institute of Scientific and Technical Information of China (English)

    SHEN Di

    2001-01-01

    @@Thrombosis formation on disrupted atherosclerotic plaque is the most common acuse of cardiovascular dis eases, in the pathophysiology, increased platelet reactiv ity is a descriptor of the risk of cardiovascular events in healthy persons and in patients with overt coronary artery disease. Regardless of the stimulus for activation platelet-platelet interation and thrombus formation is ul timately regulated through the GP Ⅱ b/Ⅲ a receptor complex

  11. Data on IL-6 c.-174 G>C genotype and allele frequencies in patients with coronary heart disease in dependence of cardiovascular outcome

    Directory of Open Access Journals (Sweden)

    Stefan Reichert

    2016-09-01

    Full Text Available In this data article we present data on the distribution of alleles and genotypes of the interleukin (IL-6 c.-174 G>C polymorphism (rs 1800795 in patients with coronary heart disease (CHD in dependence of the incidence of new cardiovascular events (combined endpoint: myocardial infarction, stroke/TIA, cardiac death, death according to stroke within three years follow-up. Moreover, we investigated putative associations between individual expression of IL-6 genotypes and IL-6 serum level. This investigation is a subanalysis of the article entitled “The Interleukin 6 c.-174 CC genotype is a predictor for new cardiovascular events in patients with coronary heart disease within three years follow-up“ (ClinicalTrials.gov identifier: NCT01045070 (Reichert et al., 2016 [1].

  12. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.;

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...... by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between...

  13. Treatment-resistant hypertension and the incidence of cardiovascular disease and end-stage renal disease: results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

    Science.gov (United States)

    Muntner, Paul; Davis, Barry R; Cushman, William C; Bangalore, Sripal; Calhoun, David A; Pressel, Sara L; Black, Henry R; Kostis, John B; Probstfield, Jeffrey L; Whelton, Paul K; Rahman, Mahboob

    2014-11-01

    Apparent treatment-resistant hypertension (aTRH) is defined as uncontrolled hypertension despite the use of ≥3 antihypertensive medication classes or controlled hypertension while treated with ≥4 antihypertensive medication classes. Although a high prevalence of aTRH has been reported, few data are available on its association with cardiovascular and renal outcomes. We analyzed data on 14 684 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants to determine the association between aTRH (n=1870) with coronary heart disease, stroke, all-cause mortality, heart failure, peripheral artery disease, and end-stage renal disease. We defined aTRH as blood pressure not at goal (systolic/diastolic blood pressure ≥140/90 mm Hg) while taking ≥3 classes of antihypertensive medication or taking ≥4 classes of antihypertensive medication with blood pressure at goal during the year 2 ALLHAT study visit (1996-2000). Use of a diuretic was not required to meet the definition of aTRH. Follow-up occurred through 2002. The multivariable adjusted hazard ratios (95% confidence intervals) comparing participants with versus without aTRH were as follows: coronary heart disease (1.44 [1.18-1.76]), stroke (1.57 [1.18-2.08]), all-cause mortality (1.30 [1.11-1.52]), heart failure (1.88 [1.52-2.34]), peripheral artery disease (1.23 [0.85-1.79]), and end-stage renal disease (1.95 [1.11-3.41]). aTRH was also associated with the pooled outcomes of combined coronary heart disease (hazard ratio, 1.47; 95% confidence interval, 1.26-1.71) and combined cardiovascular disease (hazard ratio, 1.46; 95% confidence interval, 1.29-1.64). These results demonstrate that aTRH increases the risk for cardiovascular disease and end-stage renal disease. Studies are needed to identify approaches to prevent aTRH and reduce risk for adverse outcomes among individuals with aTRH.

  14. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment

    NARCIS (Netherlands)

    D.A.W.M. van der Windt (Daniëlle); B.W. Koes (Bart); M. van Aarst; M.A. Heemskerk; L.M. Bouter (Lex)

    2000-01-01

    textabstractBACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties invol

  15. Protocol for: Sheffield Obesity Trial (SHOT: A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

    Directory of Open Access Journals (Sweden)

    Wright Neil P

    2005-10-01

    Full Text Available Abstract Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention. Method/design SHOT is a randomised controlled trial where obese young people are randomised to receive; (1 exercise therapy, (2 attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity, or (3 usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1 clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard (2 no medical condition that would restrict ability to be active three times per week for eight weeks and (3 not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint and eight weeks (end of intervention from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.

  16. Therapeutic trials in lupus nephritis. Problems related to renal histology, monitoring of therapy and measures of outcome.

    Science.gov (United States)

    Balow, J E

    1981-01-01

    Approaches to treatment of lupus nephritis have been complicated by controversies in the definitions of the types of renal histology, the relevance of immunological and renal monitoring techniques as therapeutic guidelines, and lack of definitive clinical trials. It is suggested that demonstration of the efficacy of various therapeutic agents in clinical trials may be identified earlier by renal histological changes and/or assessment of drug toxicity compared to the time required for differences based on renal functional changes to emerge as ultimate measures of outcome.

  17. Baseline comparison of three health utility measures and the feeling thermometer among participants in the action to control cardiovascular risk in diabetes trial

    Directory of Open Access Journals (Sweden)

    Raisch Dennis W

    2012-07-01

    Full Text Available Abstract Background Health utility (HU measures are used as overall measures of quality of life and to determine quality adjusted life years (QALYs in economic analyses. We compared baseline values of three HUs including Short Form 6 Dimensions (SF-6D, and Health Utilities Index, Mark II and Mark III (HUI2 and HUI3 and the feeling thermometer (FT among type 2 diabetes participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD trial. We assessed relationships between HU and FT values and patient demographics and clinical variables. Methods ACCORD was a randomized clinical trial to test if intensive controls of glucose, blood pressure and lipids can reduce the risk of major cardiovascular disease (CVD events in type 2 diabetes patients with high risk of CVD. The health-related quality of life (HRQOL sub-study includes 2,053 randomly selected participants. Interclass correlations (ICCs and agreement between measures by quartile were used to evaluate relationships between HU’s and the FT. Multivariable regression models specified relationships between patient variables and each HU and the FT. Results The ICCs were 0.245 for FT/SF-6D, 0.313 for HUI3/SF-6D, 0.437 for HUI2/SF-6D, 0.338 for FT/HUI2, 0.337 for FT/HUI3 and 0.751 for HUI2/HUI3 (P P P  Conclusions The agreements between the different HUs were poor except for the two HUI measures; therefore HU values derived different measures may not be comparable. The FT had low agreement with HUs. The relationships between HUs and demographic and clinical measures demonstrate how severity of diabetes and other clinical and demographic factors are associated with HUs and FT measures. Trial registration ClinicalTrials.gov Identifier: NCT00000620

  18. Arterial stiffness and endothelial dysfunction independently and synergistically predict cardiovascular and renal outcome in patients with type 1 diabetes

    DEFF Research Database (Denmark)

    Theilade, S; Lajer, Maria Stenkil; Jorsal, Anders;

    2012-01-01

    To evaluate whether pulse pressure alone or with placental growth factor as estimates of arterial stiffness and endothelial dysfunction, predicts mortality, cardiovascular disease and progression to end-stage renal disease in patients with Type 1 diabetes.......To evaluate whether pulse pressure alone or with placental growth factor as estimates of arterial stiffness and endothelial dysfunction, predicts mortality, cardiovascular disease and progression to end-stage renal disease in patients with Type 1 diabetes....

  19. Fifteen-Year Radiotherapy Outcomes of the Randomized PORTEC-1 Trial for Endometrial Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Creutzberg, Carien L., E-mail: c.l.creutzberg@lumc.nl [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Nout, Remi A. [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Lybeert, Marnix L.M. [Department of Radiotherapy, Catharina Hospital Eindhoven (Netherlands); Warlam-Rodenhuis, Carla C. [Department of Radiation Oncology, University Medical Center Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Mens, Jan-Willem M. [Department of Radiation Oncology, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Lutgens, Ludy C.H.W. [MAASTRO clinic, Maastricht (Netherlands); Pras, Elisabeth [Department of Radiotherapy, University Medical Center Groningen (Netherlands); Poll-Franse, Lonneke V. van de [Comprehensive Cancer Centre South, Eindhoven and Center of Research on Psychology in Somatic Diseases, Tilburg University (Netherlands); Putten, Wim L.J. van [Department of Biostatistics, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands)

    2011-11-15

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.

  20. Coronary stenting does not improve the long-term cardiovascular outcome of patients with mild to moderate renal insufficiency

    Institute of Scientific and Technical Information of China (English)

    XIE Di; HOU Yu-qing; HOU Fan-fan; ZHANG Wei-ru; LI Yong; GUO Zhi-gang; GUO Zhi-jian; ZHANG Xun

    2009-01-01

    Background Several studies have shown that coronary stenting reduces the frequency of clinical and angiographic restenosis in patients with mild to moderate renal insufficiency. However, less is known about the long-term benefits of stent use in this population. This study was aimed to determine the impact of coronary stenting on extended (5 years) long-term outcomes of patients with chronic renal insufficiency. Methods The study included 602 consecutive patients who underwent successful percutaneous coronary intervention with stenting. Renal insufficiency was defined as an estimated glomerular filtration rate <60 ml·min-1·1.73 m-2. The major adverse cardiac events were compared for patients with (n=160) and without (n=442) renal insufficiency. Results After the third year of follow-up, nonfatal myocardial infarction and revascularization rates were significantly increased in patients with renal insufficiency compared with those without renal dysfunction (16.9% vs 7.7%, P=0.001; 29.4% vs 15.8%, P <0.001). In patients who had recurrent cardiovascular events, a significantly higher rate of de novo stenosis revascularization was found in patients with renal insufficiency than without renal insufficiency (57.7% vs 22.7%, P <0.001), while there was no significant difference in target lesion revascularization between the groups (51.9% vs 43.6%, P=0.323). Multivariate analysis demonstrated an independent impact of the presence of renal insufficiency on the major adverse cardiac events (hazard ratio: 1.488, 95% confidence interval: 1.051-2.106, P=0.025) and de novo stenosis (hazard ratio: 5.505, 95% confidence interval: 2.151-14.090, P <0.001 ). Conclusions The late major adverse cardiac events, after successful coronary stenting, is increased in patients with an estimated glomerular filtration rate <60 ml·min-1·1.73 m2. This might be associated with increased risk of de novo stenosis in this population.

  1. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

    Science.gov (United States)

    Maggioni, Aldo P.; Greene, Stephen J.; Fonarow, Gregg C.; Böhm, Michael; Zannad, Faiez; Solomon, Scott D.; Lewis, Eldrin F.; Baschiera, Fabio; Hua, Tsushung A.; Gimpelewicz, Claudio R.; Lesogor, Anastasia; Gheorghiade, Mihai; Ramos, Silvina; Luna, Alejandra; Miriuka, Santiago; Diez, Mirta; Perna, Eduardo; Luquez, Hugo; Pinna, Jorge Garcia; Castagnino, Jorge; Alvarenga, Pablo; Ibañez, Julio; Blumberg, Eduardo Salmon; Dizeo, Claudio; Guerrero, Rodolfo Ahuad; Schygiel, Pablo; Milesi, Rodolfo; Sosa, Carlos; Hominal, Miguel; Marquez, Lilia Lobo; Poy, Carlos; Hasbani, Eduardo; Vico, Marisa; Fernandez, Alberto; Vita, Nestor; Vanhaecke, Johan; De Keulenaer, Gilles; Striekwold, Harry; Vervoort, Geert; Vrolix, Mathias; Henry, Philippe; Dendale, Paul; Smolders, Walter; Marechal, Patrick; Vandekerckhove, Hans; Oliveira, Mucio; Neuenschwande, Fernando; Reis, Gilmar; Saraiva, Jose; Bodanese, Luiz; Canesin, Manoel; Greco, Oswaldo; Bassan, Roberto; Marino, Roberto Luis; Giannetti, Nadia; Moe, Gordon; Sussex, Bruce; Sheppard, Richard; Huynh, Thao; Stewart, Robert; Haddad, Haissam; Echeverria, Luis; Quintero, Adalberto; Torres, Adriana; Jaramillo, Mónica; Lopez, Mónica; Mendoza, Fernan; Florez, Noel; Cotes, Carlos; Garcia, Magali; Belohlavek, Jan; Hradec, Jaromir; Peterka, Martin; Gregor, Pavel; Monhart, Zdenek; Jansky, Petr; Kettner, Jiri; Reichert, Petr; Spinar, Jindrich; Brabec, Tomas; Hutyra, Martin; Solar, Miroslav; Pietilä, Mikko; Nyman, Kai; Pajari, Risto; Cohen, Ariel; Galinier, Michel; Gosse, Philippe; Livarek, Bernard; Neuder, Yannick; Jourdain, Patrick; Picard, François; Isnard, Richard; Hoppe, Uta; Kaeaeb, Stefan; Rosocha, Stefan; Prondzinsky, Roland; Felix, Stephan; Duengen, Hans-Dirk; Figulla, Hans-Reiner; Fischer, Sven; Behrens, Steffen; Stawowy, Philipp; Kruells-Muench, Juergen; Knebel, Fabian; Nienaber, Christoph; Werner, Dierk; Aron, Wilma; Remppis, Bjoern; Hambrecht, Rainer; Kisters, Klaus; Werner, Nikos; Hoffmann, Stefan; Rossol, Siegbert; Geiss, Ernst; Graf, Kristof; Hamann, Frank; von Scheidt, Wolfgang; Schwinger, Robert; Tebbe, Ulrich; Costard-Jaeckle, Angelika; Lueders, Stephan; Heitzer, Thomas; Leutermann-Oei, Marie-Louise; Braun-Dullaeus, Ruediger; Roehnisch, Jens-Uwe; Muth, Gerhard; Goette, Andreas; Rotter, Achim; Ebelt, Henning; Olbrich, Hans-Georg; Mitrovic, Veselin; Hengstenberg, Christian; Schellong, Sebastian; Zamolyi, Karoly; Vertes, Andras; Matoltsy, Andras; Palinkas, Attila; Herczeg, Bela; Apro, Dezso; Lupkovics, Geza; Tomcsanyi, Janos; Toth, Kalman; Mathur, Atul; Banker, Darshan; Bharani, Anil; Arneja, Jaspal; Khan, Aziz; Gadkari, Milind; Hiremath, Jagdish; Patki, Nitin; Kumbla, Makund; Santosh, M.J.; Ravikishore, A.G.; Abhaichand, Rajpal; Maniyal, Vijayakukmar; Nanjappa, Manjunath; Reddy, P. Naveen; Chockalingam, Kulasekaran; Premchand, Rajendra; Mahajan, Vijay; Lewis, Basil; Wexler, Dov; Shochat, Michael; Keren, Andre; Omary, Muhamad; Katz, Amos; Marmor, Alon; Lembo, Giuseppe; Di Somma, Salvatore; Boccanelli, Alessandro; Barbiero, Mario; Pajes, Giuseppe; De Servi, Stefano; Greco, Dott Cosimo; De Santis, Fernando; Floresta, Agata; Visconti, Luigi Oltrona; Piovaccari, Giancarlo; Cavallini, Claudio; Di Biase, Matteo; Masini, Dott Franco; Vassanelli, Corrado; Viecca, Maurizio; Cangemi, Dott Francesco; Pirelli, Salvatore; Borghi, Claudio; Volpe, Massimo; Branzi, Angelo; Percoco, Dott Giovanni; Severi, Silvia; Santini, Alberto; De Lorenzi, Ettore; Metra, Marco; Zacà, Valerio; Mortara, Andrea; Tranquilino, Francisco P.; Babilonia, Noe A.; Ferrolino, Arthur M.; Manlutac, Benjamin; Dluzniewski, Miroslaw; Dzielinska, Zofia; Nowalany-Kozie, Ewa; Mazurek, Walentyna; Wierzchowiecki, Jerzy; Wysokinski, Andrzej; Szachniewicz, Joanna; Romanowski, Witold; Krauze-Wielicka, Magdalena; Jankowski, Piotr; Berkowski, Piotr; Szelemej, Roman; Kleinrok, Andrzej; Kornacewicz-Jac, Zdzislawa; Vintila, Marius; Vladoianu, Mircea; Militaru, Constantin; Dan, Gheorghe; Dorobantu, Maria; Dragulescu, Stefan; Kostenko, Victor; Vishnevsky, Alexandr; Goloschekin, Boris; Tyrenko, Vadim; Gordienko, Alexander; Kislyak, Oxana; Martsevich, Sergey; Kuchmin, Alexey; Karpov, Yurii; Fomin, Igor; Shvarts, Yury; Orlikova, Olga; Ershova, Olga; Berkovich, Olga; Sitnikova, Maria; Pakhomova, Inna; Boldueva, Svetlana; Tyurina, Tatiana; Simanenkov, Vladimir; Boyarkin, Mikhail; Novikova, Nina; Tereschenko, Sergey; Zadionchenko, Vladimir; Shogenov, Zaur; Gordeev, Ivan; Moiseev, Valentin; Wong, Raymond; Ong, Hean Yee; Le Tan, Ju; Goncalvesova, Eva; Kovar, Frantisek; Skalina, Ivan; Kasperova, Viera; Hojerova, Silvia; Szentivanyi, Miroslav; Stancak, Branislav; Babcak, Marian; Kycina, Peter; Poliacik, Pavol; Toth, Peter; Sirotiakova, Jana; de Sa, Esteban Lopez; Bueno, Manuel Gomez; Selles, Manuel Martinez; Cabrera, Jose Angel; Freire, Ramon Bover; Gonzalez Juanatey, Jose Ramon; Comin, Josep; Soriano, FranciscoRidocci; Lopez, Alejandro; Vicho, Raul; Lama, Manuel Geraldia; Schaufelberger, Maria; Brunotte, Richard; Ullman, Bengt; Hagerman, Inger; Cizinsky, Stella; Cherng, Wen-Jin; Yu, Wen-Chung; Kuo, Chi-Tai; Chang, Kuan-Cheng; Lai, Wen-Ter; Kuo, Jen-Yuan; Ural, Dilek; Badak, Ozer; Akin, Mustafa; Yigit, Zerrin; Yokusoglu, Mehmet; Yilmaz, Mehmet; Abaci, Adnan; Ebinc, Haksun; Perlman, Richard; Parish, David; Bergin, James; Burnham, Kenneth; Brown, Christopher; Lundbye, Justin; Williams, Celeste; Eisen, Howard; Juneman, Elizabeth; Joseph, Susan; Peberdy, Mary Ann; Peura, Jennifer; Gupta, Vishal; Habet, Kalim; French, William; Mody, Freny; Graham, Susan; Hazelrigg, Monica; Chung, Eugene; Dunlap, Stephanie; Nikolaidis, Lazaros; Najjar, Samer; Katz, Richard; Murali, Srinivas; Izzo, Joseph L.; Callister, Tracy; Phillips, Roland; Lippolis, Nicholas; Winterton, John; Meymandi, Sheba; Heilman, Karl; Oren, Ron; Zolty, Ronald; Brottman, Michael; Gunawardena, D.R.; Adams, Kirkwood; Barnard, Denise; Klapholz, Marc; Fulmer, James

    2013-01-01

    Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64–0.99; DM: HR: 1.16, 95% CI: 0.91–1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50–0.94; DM: HR: 1.64, 95% CI: 1.15–2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71–1.93; DM: HR: 2.39, 95% CI: 1.30

  2. Capillaroscopy as an Outcome Measure for Clinical Trials on the Peripheral Vasculopathy in SSc—Is It Useful?

    Directory of Open Access Journals (Sweden)

    Maurizio Cutolo

    2010-01-01

    Full Text Available Peripheral microvascular impairment in systemic sclerosis (SSc may be easily detected and scored in a safe noninvasive way by nailfold videocapillaroscopy (NVC. The paper highlights clinical conditions related to SSc in which NVC may represent an outcome measure of therapeutical interventions, by elaborating on their already assessed relationship with the NVC patterns and eventually scores. The 3 important biological/clinical conditions are: the positivity for SSc-specific serum autoantibodies, the presence of SSc skin digital ulcers (DUs and of pulmonary arterial hypertension (PAH SSc associated. In conclusion, to the question if capillaroscopy (NVC may represent in SSc an outcome measure for clinical trials on the peripheral vasculopathy, based on the growing evidence and our detailed studies, the answer is positive. Recent therapeutic trials in SSc are confirming this role, and the experience is growing rapidly.

  3. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial.

    Science.gov (United States)

    Shaw, Triston; Williams, Marie T; Chipchase, Lucy S

    2005-01-01

    A prospective, blinded, randomised controlled trial investigated the effectiveness of quadriceps exercises following anterior cruciate ligament reconstruction. A treatment group (Quadriceps exercise group) performed straight leg raises and isometric quadriceps contractions throughout the first two postoperative weeks, and a second group (No quadriceps exercise group) did not. A battery of outcome measures assessed subjects postoperatively at day one, two weeks, and one, three and six months. A total of 103 patients (Quadriceps exercise n = 48, No quadriceps exercise n = 55) commenced the study with 91 subjects available at final follow up (Quadriceps exercise n = 47, No quadriceps exercise n = 44). Performance of quadriceps exercises significantly improved a number of knee flexion and extension range of motion measurements (p = 0.01 to 0.04). No significant differences were found between the two groups at any postoperative period for quadriceps lag (p = 0.36), functional hop testing (p = 0.49 to 0.51), isokinetic quadriceps strength (p = 0.70 to 0.72), the majority of numerical analogue scores (p = 0.1 to 0.94) and Cincinnati scores (p = 0.10 to 0.84). Subjects performing quadriceps exercises reported significantly higher pain scores with exercise on the first postoperative day (p = 0.02). At six months postoperatively, the Quadriceps exercise subjects reported significantly more favourable Cincinnati scores for symptoms (p = 0.005) and problems with sport (p = 0.05). While average knee laxity was not significantly different between treatment groups over time (p = 0.27 to 0.94), quadriceps exercise performance was associated with a significantly lower incidence of abnormal knee laxity. Isometric quadriceps exercises and straight leg raises can be safely prescribed during the first two postoperative weeks and confer advantages for faster recovery of knee range of motion and stability. It remains to be proven whether the magnitude of differences between groups is

  4. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Science.gov (United States)

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane

    2016-03-01

    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.

  5. A review of Perindopril in the reduction of cardiovascular events

    Directory of Open Access Journals (Sweden)

    Duncan J Campbell

    2006-06-01

    Full Text Available Duncan J CampbellSt. Vincent’s Institute of Medical Research and the Department of Medicine, University of Melbourne, St. Vincent’s Hospital, Fitzroy, Victoria, AustraliaBackground: Angiotensin-converting enzyme inhibitors (ACEI have a well-established role in the prevention of cardiovascular events in hypertension, left ventricular dysfunction, and heart failure. More recently, ACEI have been shown to prevent cardiovascular events in individuals with increased cardiovascular risk, where hypertension, left ventricular dysfunction, or heart failure was not the primary indication for ACEI therapy.Objective: To review studies of the effects of the ACEI perindopril on cardiovascular events.Method: The EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease Study, PROGRESS (Perindopril Protection Against Recurrent Stroke Study, and ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial – Blood Pressure Lowering Arm trials are reviewed.Results: Perindopril alone reduced cardiovascular events in subjects with stable coronary heart disease. Perindopril in combination with indapamide reduced cardiovascular events in subjects with cerebrovascular disease. Perindopril in combination with amlodipine reduced cardiovascular events in subjects with hypertension.Conclusion: Perindopril reduced cardiovascular events. The reduction of cardiovascular events by perindopril was in large part associated with reduction of blood pressure, and greater reduction in cardiovascular events was associated with greater reduction of blood pressure. Perindopril may need to be combined with other antihypertensive agents to maximize reduction of cardiovascular events.Keywords: Angiotensin-converting enzyme inhibitor, hypertension, coronary heart disease, stroke, myocardial infarction, heart failure

  6. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

    Directory of Open Access Journals (Sweden)

    Orton Jane

    2009-12-01

    Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651

  7. The Outcome of Selenium and Vitamin E Cancer Prevention Trial (SELECT) reveals the need for better understanding of selenium biology.

    Science.gov (United States)

    Hatfield, Dolph L; Gladyshev, Vadim N

    2009-02-01

    The recently completed Selenium and Vitamin E Cancer Prevention Trial (SELECT) was one of the largest human cancer prevention trials ever undertaken. Its purpose was to assess the role of selenium and vitamin E in prostate cancer prevention, but SELECT found no decline in prostate cancer. Comparison of this study to other clinical trials involving selenium and to the results of animal studies suggests that the source of the selenium supplement, L-selenomethionine, and the relatively high initial levels of selenium in the enrolled men may have contributed to this outcome. Further analysis of the clinical and animal data highlights the need for mechanistic studies to better understand selenium biology in order to target dietary selenium to appropriate subsets of the human population: those individuals most likely to benefit from this micronutrient.

  8. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders.

    Science.gov (United States)

    Wergeland, Gro Janne H; Fjermestad, Krister W; Marin, Carla E; Bjelland, Ingvar; Haugland, Bente Storm Mowatt; Silverman, Wendy K; Öst, Lars-Göran; Bjaastad, Jon Fauskanger; Oeding, Kristin; Havik, Odd E; Heiervang, Einar R

    2016-01-01

    A substantial number of children with anxiety disorders do not improve following cognitive behavioral therapy (CBT). Recent effectiveness studies have found poorer outcome for CBT programs than what is typically found in efficacy studies. The present study examined predictors of treatment outcome among 181 children (aged 8-15 years), with separation anxiety, social phobia, or generalized anxiety disorder, who participated in a randomized, controlled effectiveness trial of a 10-session CBT program in community clinics. Potential predictors included baseline demographic, child, and parent factors. Outcomes were as follows: a) remission from all inclusion anxiety disorders; b) remission from the primary anxiety disorder; and c) child- and parent-rated reduction of anxiety symptoms at post-treatment and at 1-year follow-up. The most consistent findings across outcome measures and informants were that child-rated anxiety symptoms, functional impairment, a primary diagnosis of social phobia or separation anxiety disorder, and parent internalizing symptoms predicted poorer outcome at post-treatment. Child-rated anxiety symptoms, lower family social class, lower pretreatment child motivation, and parent internalizing symptoms predicted poorer outcome at 1-year follow-up. These results suggest that anxious children with more severe problems, and children of parents with elevated internalizing symptom levels, may be in need of modified, additional, or alternative interventions to achieve a positive treatment outcome.

  9. The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures.

    Science.gov (United States)

    Scragg, Robert; Waayer, Debbie; Stewart, Alistair W; Lawes, Carlene M M; Toop, Les; Murphy, Judy; Khaw, Kay-Tee; Camargo, Carlos A

    2016-11-01

    Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.

  10. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials.

    Science.gov (United States)

    Suresh, S; Schaldenbrand, K; Wallis, B; De Oliveira, G S

    2014-09-01

    Summary The development of analgesic interventions in paediatric surgical patients is often limited by the inherent difficulties of conducting large randomized clinical trials to test interventions in those patients. Regional anaesthesia is a valid strategy to improve postoperative pain in the adult surgical population, but the effects of regional anaesthesia on postoperative pain outcomes in paediatric patients are currently not well defined. The main objective of the current review was to systematically evaluate the use of regional anaesthesia techniques to minimize postoperative pain in paediatric patients. A systematic search was performed to identify randomized controlled trials that evaluated the effects of the regional anaesthesia techniques on postoperative pain outcomes in paediatric surgical patients' procedures. Seventy-three studies on 5125 paediatric patients were evaluated. Only few surgical procedures had more than one small randomized controlled trial favouring the use of regional anaesthesia to minimize postoperative pain (ophthalmological surgery, cleft lip repair, inguinal hernia, and urological procedures). Additional evidence is required to support the use of specific regional anaesthesia techniques to improve postoperative pain for several surgical procedures (craniectomy, adenotonsillectomy, appendectomy, cardiac surgery, umbilical hernia repair, upper and lower extremity) in paediatric patients. Currently, only a very limited number of regional anaesthesia techniques have demonstrated significant improvement on postoperative pain outcomes for a restricted number of surgical procedures. More studies are needed in order to establish regional anaesthesia as a valid strategy to improve analgesia in the paediatric surgical population.

  11. Cardiovascular Outcomes of Sitagliptin in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Population-Based Cohort Study in Taiwan.

    Directory of Open Access Journals (Sweden)

    Szu-Heng Wang

    Full Text Available The cardiovascular safety and efficacy of sitagliptin, a dipeptidyl peptidase 4 (DPP-4 inhibitor, in type 2 diabetic patients after acute myocardial infarction (AMI has so far remained uncertain.We analyzed data from the National Health Insurance Research Database (NHIRD, a government-operated, population-based database, from March 1st, 2009 to December 31st, 2011. Type 2 diabetic patients hospitalized for AMI were included in our study. We compared subjects using sitagliptin with comparison group to evaluate its cardiovascular safety and efficacy. The primary endpoint was a composite of cardiovascular death, myocardial infarction, and ischemic stroke.We identified a total of 3,282 type 2 diabetic patients hospitalized for AMI (mean follow-up 1.15 years. Of these patients, 547 (16.7% who were exposed to sitagliptin were defined as the sitagliptin group and 2,735 (83.3 % who did not use sitagliptin were the comparison group. The incidence of primary composite cardiovascular outcomes was 9.50 per 100 person-years in the sitagliptin group and was 9.70 per 100 person-years in the comparison group (hazard ratio (HR, 0.97; 95% CI, 0.73-1.29, P=0.849. Compared to the non-sitagliptin group, the sitagliptin group had similar risks of all-cause mortality, hospitalization for heart failure (HF or percutaneous coronary intervention (PCI with a HR of 0.82 (95% CI, 0.61-1.11, P=0.195, 0.93 (95% CI, 0.67-1.29, P=0.660, and 0.93 (95% CI, 0.75-1.14, P=0.473, respectively.The use of sitagliptin in type 2 diabetic patients with recent AMI was not associated with increased risk of adverse cardiovascular events.

  12. Comparison of Bayesian and classical methods in the analysis of cluster randomized controlled trials with a binary outcome: The Community Hypertension Assessment Trial (CHAT

    Directory of Open Access Journals (Sweden)

    Dolovich Lisa

    2009-06-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs are increasingly used to assess the effectiveness of interventions to improve health outcomes or prevent diseases. However, the efficiency and consistency of using different analytical methods in the analysis of binary outcome have received little attention. We described and compared various statistical approaches in the analysis of CRTs using the Community Hypertension Assessment Trial (CHAT as an example. The CHAT study was a cluster randomized controlled trial aimed at investigating the effectiveness of pharmacy-based blood pressure clinics led by peer health educators, with feedback to family physicians (CHAT intervention against Usual Practice model (Control, on the monitoring and management of BP among older adults. Methods We compared three cluster-level and six individual-level statistical analysis methods in the analysis of binary outcomes from the CHAT study. The three cluster-level analysis methods were: i un-weighted linear regression, ii weighted linear regression, and iii random-effects meta-regression. The six individual level analysis methods were: i standard logistic regression, ii robust standard errors approach, iii generalized estimating equations, iv random-effects meta-analytic approach, v random-effects logistic regression, and vi Bayesian random-effects regression. We also investigated the robustness of the estimates after the adjustment for the cluster and individual level covariates. Results Among all the statistical methods assessed, the Bayesian random-effects logistic regression method yielded the widest 95% interval estimate for the odds ratio and consequently led to the most conservative conclusion. However, the results remained robust under all methods – showing sufficient evidence in support of the hypothesis of no effect for the CHAT intervention against Usual Practice control model for management of blood pressure among seniors in primary care. The

  13. Association of race/ethnicity with visual outcomes following acute optic neuritis: an analysis of the Optic Neuritis Treatment Trial.

    Science.gov (United States)

    Moss, Heather E; Gao, Weihua; Balcer, Laura J; Joslin, Charlotte E

    2014-04-01

    IMPORTANCE Retrospective studies have demonstrated disparate outcomes following acute optic neuritis in individuals of African descent compared with individuals of white race/ethnicity. However, published analyses of the prospectively collected Optic Neuritis Treatment Trial (ONTT) data identified no association between worse visual outcomes and black race/ethnicity. OBJECTIVES To investigate the associations of age, sex, and race/ethnicity with visual outcomes following acute optic neuritis through application of longitudinal data analysis techniques to the ONTT data set. DESIGN Secondary analysis of the ONTT (a prospective randomized controlled trial) data set. Our models included effects of treatment (placebo, oral prednisone, or intravenous methylprednisolone), time, and treatment × time interaction, as well as demographic covariates of age, sex, and race/ethnicity. SETTING AND PARTICIPANTS The ONTT data were collected at multiple centers in the United States. Patients of black (n = 58) and white (n = 388) race/ethnicity with acute optic neuritis who enrolled in the ONTT within 8 days of symptom onset were included in analyses. MAIN OUTCOMES AND MEASURES The contrast sensitivity and visual acuity (logMAR) in the affected eye were modeled using 2-stage mixed-effects regression techniques. All available follow-up data from baseline to 15 to 18 years were included. RESULTS The data identified no relationship of age, sex, or treatment with contrast sensitivity or visual acuity outcomes. Race/ethnicity was significantly related to contrast sensitivity (P optic neuritis, with black race/ethnicity being associated with worse scores for both. CONCLUSIONS AND RELEVANCE Race/ethnicity seems to be associated with contrast sensitivity and visual acuity outcomes in affected eyes following acute optic neuritis. To our knowledge, this is the largest cohort of black race/ethnicity with acute optic neuritis to be studied and represents the first evidence from a

  14. Cardiovascular pharmacogenetics.

    Science.gov (United States)

    Myburgh, Renier; Hochfeld, Warren E; Dodgen, Tyren M; Ker, James; Pepper, Michael S

    2012-03-01

    Human genetic variation in the form of single nucleotide polymorphisms as well as more complex structural variations such as insertions, deletions and copy number variants, is partially responsible for the clinical variation seen in response to pharmacotherapeutic drugs. This affects the likelihood of experiencing adverse drug reactions and also of achieving therapeutic success. In this paper, we review key studies in cardiovascular pharmacogenetics that reveal genetic variations underlying the outcomes of drug treatment in cardiovascular disease. Examples of genetic associations with drug efficacy and toxicity are described, including the roles of genetic variability in pharmacokinetics (e.g. drug metabolizing enzymes) and pharmacodynamics (e.g. drug targets). These findings have functional implications that could lead to the development of genetic tests aimed at minimizing drug toxicity and optimizing drug efficacy in cardiovascular medicine.

  15. Randomized controlled trial on cardiovascular risk management by practice nurses supported by self-monitoring in primary care

    NARCIS (Netherlands)

    Tiessen, Ans H.; Smit, Andries J.; Broer, Jan; Groenier, Klaas H.; van der Meer, Klaas

    2012-01-01

    Background: Treatment goals for cardiovascular risk management are generally not achieved. Specialized practice nurses are increasingly facilitating the work of general practitioners and self-monitoring devices have been developed as counseling aid. The aim of this study was to compare standard trea

  16. A Path Analysis of a Randomized "Promotora de Salud" Cardiovascular Disease-Prevention Trial among At-Risk Hispanic Adults

    Science.gov (United States)

    de Heer, Hendrik Dirk; Balcazar, Hector G.; Castro, Felipe; Schulz, Leslie

    2012-01-01

    This study assessed effectiveness of an educational community intervention taught by "promotoras de salud" in reducing cardiovascular disease (CVD) risk among Hispanics using a structural equation modeling (SEM) approach. Model development was guided by a social ecological framework proposing CVD risk reduction through improvement of protective…

  17. A Path Analysis of a Randomized "Promotora de Salud" Cardiovascular Disease-Prevention Trial among At-Risk Hispanic Adults

    Science.gov (United States)

    de Heer, Hendrik Dirk; Balcazar, Hector G.; Castro, Felipe; Schulz, Leslie

    2012-01-01

    This study assessed effectiveness of an educational community intervention taught by "promotoras de salud" in reducing cardiovascular disease (CVD) risk among Hispanics using a structural equation modeling (SEM) approach. Model development was guided by a social ecological framework proposing CVD risk reduction through improvement of…

  18. Kettlebell training for musculoskeletal and cardiovascular health

    DEFF Research Database (Denmark)

    Jay, Kenneth; Frisch, Dennis; Hansen, Klaus

    2011-01-01

    OBJECTIVE: The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health. METHODS: This single-blind randomized controlled trial involved 40 adults from occupations with a high prevalence......--consisting of ballistic full-body kettlebell exercise 3 times per week for 8 weeks--or a control group. The main outcome measures were pain intensity of the neck/shoulders and low back, isometric muscle strength, and aerobic fitness. RESULTS: Compared with the control group, pain intensity of the neck/shoulders decreased...

  19. Choice of design and outcomes in trials among children with moderate acute malnutrition

    DEFF Research Database (Denmark)

    Friis, Henrik; Michaelsen, Kim F.; Wells, Jonathan C

    2015-01-01

    There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials...

  20. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Steeds Richard P

    2011-02-01

    Full Text Available Abstract Background Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes arterial stiffening through structural vascular alterations such as medial calcification, which are already apparent in the early stages of chronic kidney disease. Aim To determine the effects of phosphate binding with sevelamer carbonate on left ventricular mass and function together with arterial stiffness in patients with stage 3 chronic kidney disease. Methods/Design A single-centre, prospective, randomised, double-blind, placebo-controlled trial of 120 subjects with stage 3 chronic kidney disease recruited from University Hospitals Birmingham NHS Foundation Trust. Baseline investigations include transthoracic echocardiography and cardiac magnetic resonance imaging to assess ventricular mass, volumes and function, applanation tonometry to determine pulse wave velocity and pulse wave analysis as surrogate measures of arterial stiffness and dual energy x-ray absorptiometry scanning to determine bone density. During an open-label run in phase, subjects will receive 1600 mg sevelamer carbonate with meals for four weeks. They will then be randomised to either continue sevelamer carbonate or receive an identical placebo (60 subjects per arm for the remaining 36 weeks. Four-weekly monitoring of serum electrolytes and bone biochemistry will be performed. All baseline investigations will be repeated at the end of the treatment period. The primary endpoint of the study is a reduction in left ventricular mass after 40 weeks of treatment. Secondary endpoints are: i change in aortic compliance; ii change in arterial stiffness; iii change in arterial elastance; iv change in left ventricular systolic and diastolic elastance; v change in left ventricular function; and vi change in bone density. Trial Registration This trial is

  1. Impact of treating dental caries on schoolchildren’s anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Alkarimi Heba A

    2012-08-01

    Full Text Available Abstract Background There are no randomized controlled trials to assess the impact of treating dental caries on various aspects of children’s health. This study was conducted to assess the impact of dental treatment of severe dental caries on children’s weight, height and subjective health related outcomes, namely dental pain, satisfaction with teeth and smile, dental sepsis and child’s appetite. Methods The study was a community-based, randomized, controlled trial in schoolchildren aged 6-7 years with untreated dental caries. Participants were randomly assigned to early (test or regular (control dental treatment. The primary outcome was Weight-for-age Z-score. Secondary outcomes were Height-for-age and BMI-for-age Z-scores, dental pain, dental sepsis, satisfaction with teeth and child’s appetite. Results 86 children were randomly assigned to test (42 children and control (44 groups. Mean duration of follow-up was 34.8 (±1.1 weeks. There were insignificant improvements in anthropometric outcomes between the groups after treatment of caries. However, treated children had significantly less pain experience (P = 0.006 (OR 0.09, [0.01-0.51] and higher satisfaction with teeth (P = 0.001 (OR 9.91, [2.68-36.51] compared to controls. Controls had significantly poorer appetites (P = 0.01 (OR 2.9, [1.24-6.82] compared to treated children. All treated children were free of clinical dental sepsis whereas 20% (9 of 44 of controls who were free of sepsis at baseline had sepsis at follow-up. Conclusions Although dental treatment did not significantly improve the anthropometric outcomes, it significantly improved the dental outcomes and children’s satisfaction with teeth, smile and appetite. This is the first study to provide evidence that treatment of severe dental caries can improve children’s appetite. Trial registration Effect of Dental Treatment on Children's Growth. Clinical Trial Gov ID# NCT01243866

  2. Clinical outcomes of biodegradable polymer drug-eluting stents for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Kwong, Joey S W; Yu, Cheuk-Man

    2014-07-01

    Biodegradable polymer drug-eluting stents (DES) are innovative concepts in the era of percutaneous coronary intervention. We systematically reviewed the latest randomized evidence on the efficacy and safety of biodegradable polymer DES as compared to durable polymer DES. MEDLINE, Embase, and the Cochrane database were searched in August 2013 for eligible randomized controlled trials (RCTs) comparing biodegradable polymer DES with durable polymer DES. Clinical outcomes of interest were mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis. A total of 20 RCTs randomizing 20 021 participants were included, of whom 11 045 were allocated to biodegradable polymer DES and 8976 to durable polymer DES. Treatment of biodegradable polymer DES was not associated with a significant reduction of any of the clinical outcomes (all-cause mortality, odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.80 to 1.10, P = 0.42; cardiovascular mortality, OR: 0.97, 95% CI: 0.79 to 1.19, P = 0.74; MI, OR: 1.07, 95% CI: 0.91 to 1.26, P = 0.41; TLR, OR: 0.87, 95% CI: 0.69 to 1.08, P = 0.20; TVR, OR: 1.05, 95% CI: 0.85 to 1.28, P = 0.67; definite/probable stent thrombosis, OR: 0.80, 95% CI: 0.59 to 1.07, P = 0.14). Current randomized data indicate that clinical efficacy and safety profiles of biodegradable polymer DES are comparable to those of durable polymer DES. Findings from large-scale studies with rigorous methodology and long follow-up duration are needed.

  3. Cardiovascular and gastrointestinal outcomes in clopidogrel users on proton pump inhibitors: results of a large Dutch cohort study.

    NARCIS (Netherlands)

    Boxel, O.S. van; Oijen, M.G.H. van; Hagenaars, M.P.; Smout, A.J.P.M.; Siersema, P.D.

    2010-01-01

    OBJECTIVES: Recent studies have raised concerns on the clinical effectiveness of clopidogrel when taken in combination with proton pump inhibitors (PPIs), demonstrating an increase in the occurrence of cardiovascular events. In this study, the association between the co-administration of a PPI and c

  4. Individualized prediction of the effect of angiotensin receptor inhibition on renal and cardiovascular outcomes in patients with diabetic nephropathy

    NARCIS (Netherlands)

    van der Sande, N. G. C.; Dorresteijn, J. A. N.; Visseren, F. L. J.; Dwyer, J. P.; Blankestijn, P. J.; van der Graaf, Y.; Heerspink, H. L. J.

    2016-01-01

    Aims: To predict individualized treatment effects of angiotensin receptor blockers (ARBs) on cardiovascular and renal complications in order to help clinicians and patients assess the benefit of treatment (or adherence) and estimate remaining disease risk. Materials and methods: In patients with dia

  5. The impact of a disease management program (COACH on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Selvaraj Francis Jude

    2012-10-01

    Full Text Available Abstract Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm and primary care physicians assisted by nurse educators (PCP-NE arm. Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE and 148 to care provided by primary care physicians (PCP alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio, Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288, with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had

  6. The Mediterranean diet, its components, and cardiovascular disease.

    Science.gov (United States)

    Widmer, R Jay; Flammer, Andreas J; Lerman, Lilach O; Lerman, Amir

    2015-03-01

    One of the best-studied diets for cardiovascular health is the Mediterranean diet. This consists of fish, monounsaturated fats from olive oil, fruits, vegetables, whole grains, legumes/nuts, and moderate alcohol consumption. The Mediterranean diet has been shown to reduce the burden, or even prevent the development, of cardiovascular disease, breast cancer, depression, colorectal cancer, diabetes, obesity, asthma, erectile dysfunction, and cognitive decline. This diet is also known to improve surrogates of cardiovascular disease, such as waist-to-hip ratio, lipids, and markers of inflammation, as well as primary cardiovascular disease outcomes such as death and events in both observational and randomized controlled trial data. These enhancements easily rival those seen with more established tools used to fight cardiovascular disease such as aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, and exercise. However, it is unclear if the Mediterranean diet offers cardiovascular disease benefit from its individual constituents or in aggregate. Furthermore, the potential benefit of the Mediterranean diet or its components is not yet validated by concrete cardiovascular disease endpoints in randomized trials or observational studies. This review will focus on the effects of the whole and parts of the Mediterranean diet with regard to both population-based and experimental data highlighting cardiovascular disease morbidity or mortality and cardiovascular disease surrogates when hard outcomes are not available. Our synthesis will highlight the potential for the Mediterranean diet to act as a key player in cardiovascular disease prevention, and attempt to identify certain aspects of the diet that are particularly beneficial for cardioprotection.

  7. Statin Therapy and Outcome After Ischemic Stroke: Systematic Review and Meta-Analysis of Observational Studies and Randomized Trials.

    LENUS (Irish Health Repository)

    2013-01-03

    Background-Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke. METHODS: The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤72 hours after stroke), and (2) thrombolysis-treated patients. RESULTS: The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients). CONCLUSIONS: In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

  8. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available BACKGROUND: Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly. METHODS AND FINDINGS: 2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used

  9. Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the international classification of functioning, disability and health as a reference

    OpenAIRE

    2004-01-01

    Objectives: To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischemic heart disease, diabetes mellitus, obesity and obstructive pulmonary disease, including asthma using the International Classification of Functioning, Disability and Health (ICF) as a reference. Methods: Randomized controlled trials between 1993 and 2003 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and...

  10. Astaxanthin in cardiovascular health and disease.

    Science.gov (United States)

    Fassett, Robert G; Coombes, Jeff S

    2012-02-20

    Oxidative stress and inflammation are established processes contributing to cardiovascular disease caused by atherosclerosis. However, antioxidant therapies tested in cardiovascular disease such as vitamin E, C and β-carotene have proved unsuccessful at reducing cardiovascular events and mortality. Although these outcomes may reflect limitations in trial design, new, more potent antioxidant therapies are being pursued. Astaxanthin, a carotenoid found in microalgae, fungi, complex plants, seafood, flamingos and quail is one such agent. It has antioxidant and anti-inflammatory effects. Limited, short duration and small sample size studies have assessed the effects of astaxanthin on oxidative stress and inflammation biomarkers and have investigated bioavailability and safety. So far no significant adverse events have been observed and biomarkers of oxidative stress and inflammation are attenuated with astaxanthin supplementation. Experimental investigations in a range of species using a cardiac ischaemia-reperfusion model demonstrated cardiac muscle preservation when astaxanthin is administered either orally or intravenously prior to the induction of ischaemia. Human clinical cardiovascular studies using astaxanthin therapy have not yet been reported. On the basis of the promising results of experimental cardiovascular studies and the physicochemical and antioxidant properties and safety profile of astaxanthin, clinical trials should be undertaken.

  11. Trial to assess the utility of genetic sequencing to improve patient outcomes

    Science.gov (United States)

    A pilot trial to assess whether assigning treatment based on specific gene mutations can provide benefit to patients with metastatic solid tumors is being launched this month by the NCI. The Molecular Profiling based Assignment of Cancer Therapeutics, or

  12. Do diet, folic acid, and vitamins matter? What did we learn from the Women's Health Initiative, the Women's Health Study, the Women's Antioxidant and Folic Acid Cardiovascular Study, and other clinical trials?

    Science.gov (United States)

    Wenger, Nanette K

    2007-01-01

    Data from recent randomized clinical trials have contributed substantially to our understanding of appropriate interventions for coronary heart disease in women. Addressed in this monograph are issues of diet, folic acid, and antioxidant vitamins. Importantly, these randomized clinical trials have helped to clarify conflicting information from observational data, and to aid clinicians and their women patients in making appropriate choices of coronary and cardiovascular preventive therapy.

  13. Interim analysis for binary outcome trials with a long fixed follow-up time and repeated outcome assessments at pre-specified times.

    Science.gov (United States)

    Parpia, Sameer; Julian, Jim A; Gu, Chushu; Thabane, Lehana; Levine, Mark N

    2014-01-01

    In trials with binary outcomes, assessed repeatedly at pre-specified times and where the subject is considered to have experienced a failure at the first occurrence of the outcome, interim analyses are performed, generally, after half or more of the subjects have completed follow-up. Depending on the duration of accrual relative to the length of follow-up, this may be inefficient, since there is a possibility that the trial will have completed accrual prior to the interim analysis. An alternative is to plan the interim analysis after subjects have completed follow-up to a time that is less than the fixed full follow-up duration. Using simulations, we evaluated three methods to estimate the event proportion for the interim analysis in terms of type I and II errors and the probability of early stopping. We considered: 1) estimation of the event proportion based on subjects who have been followed for a pre-specified time (less than the full follow-up duration) or who experienced the outcome; 2) estimation of the event proportion based on data from all subjects that have been randomized by the time of the interim analysis; and 3) the Kaplan-Meier approach to estimate the event proportion at the time of the interim analysis. Our results show that all methods preserve and have comparable type I and II errors in certain scenarios. In these cases, we recommend using the Kaplan-Meier method because it incorporates all the available data and has greater probability of early stopping when the treatment effect exists.

  14. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    OpenAIRE

    Crichton Georgina E; C Howe Peter R; Buckley Jonathan D; Coates Alison M; Murphy Karen J

    2012-01-01

    Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were...

  15. Reduced or modified dietary fat for preventing cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Lee Hooper

    Full Text Available ABSTRACT: BACKGROUND: Reduction and modification of dietary fats have differing effects on cardiovascular risk factors (such as serum cholesterol, but their effects on important health outcomes are less clear. OBJECTIVE: To assess the effect of reduction and/or modification of dietary fats on mortality, cardiovascular mortality, cardiovascular morbidity and individual outcomes including myocardial infarction, stroke and cancer diagnoses in randomised clinical trials of at least 6 months duration. METHODS: Search methods: For this review update, the Cochrane Central Register of Controlled Trials (CENTRAL, Medline and Embase, were searched through to June 2010. References of Included studies and reviews were also checked. Selection criteria: Trials fulfilled the following criteria: 1 randomized with appropriate control group, 2 intention to reduce or modify fat or cholesterol intake (excluding exclusively omega-3 fat interventions, 3 not multi factorial, 4 adult humans with or without cardiovascular disease, 5 intervention at least six months, 6 mortality or cardiovascular morbidity data available. Data collection and analysis: Participant numbers experiencing health outcomes in each arm were extracted independently in duplicate and random effects meta-analyses, meta-regression, sub-grouping, sensitivity analyses and funnel plots were performed. MAIN RESULTS: This updated review suggested that reducing saturated fat by reducing and/or modifying dietary fat reduced the risk of cardiovascular events by 14% (RR 0.86, 95% CI 0.77 to 0.96, 24 comparisons, 65,508 participants of whom 7% had a cardiovascular event, I2 50%. Subgrouping suggested that this reduction in cardiovascular events was seen in studies of fat modification (not reduction - which related directly to the degree of effect on serum total and LDL cholesterol and triglycerides, of at least two years duration and in studies of men (not of women. There were no clear effects of dietary fat

  16. Tomato Sauce Enriched with Olive Oil Exerts Greater Effects on Cardiovascular Disease Risk Factors than Raw Tomato and Tomato Sauce: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Palmira Valderas-Martinez

    2016-03-01

    Full Text Available Epidemiological studies have observed a negative association between tomato intake and the incidence of cardiovascular disease. As tomato sauces are usually cooked with the addition of oil, some studies have pointed out that both processes may increase the bioavailability of the bioactive compounds. However, the effect of consumption of raw tomatoes and tomato sauces on inflammation biomarkers and adhesion molecules related to atherosclerosis remains unknown. The aim of this study was to test the postprandial effects of a single dose of raw tomatoes (RT, tomato sauce (TS and tomato sauce with refined olive oil (TSOO on cardiovascular disease risk factors. We performed an open, prospective, randomized, cross-over, controlled feeding trial in 40 healthy subjects who randomly received: 7.0 g of RT/kg of body weight (BW, 3.5 g of TS/kg BW, 3.5 g of TSOO/Kg BW and 0.25 g of sugar solved in water/kg BW on a single occasion on four different days. Biochemical parameters and cellular and circulating inflammatory biomarkers were assessed at baseline and 6 h after each intervention. The results indicate that, compared to control intervention, a single tomato intake in any form decreased plasma total cholesterol, triglycerides and several cellular and plasma inflammatory biomarkers, and increased plasma high density lipoproteins (HDL cholesterol and interleukine (IL 10 concentrations. However, the changes of plasma IL-6 and vascular cell adhesion molecule-1 (VCAM-1, and lymphocyte function-associated antigen-1 (LFA-1 from T-lymphocytes and CD36 from monocytes were significantly greater after TSOO than after RT and TS interventions. We concluded that tomato intake has beneficial effects on cardiovascular risk factors, especially cooked and enriched with oil.

  17. GOUT OUTCOMES. LITERATURE REVIEW. PART II. COMORBID DISEASES, RISK OF DEVELOPING CARDIOVASCULAR CATASTROPHES AND DEATH IN GOUT PATIENTS

    Directory of Open Access Journals (Sweden)

    Igor Sergeevich Denisov

    2013-01-01

    Full Text Available The data showing an association between gout and hyperuricemia with renal failure, arterial hypertension, metabolic syndrome, type 2 diabetes mellitus, and ischemic heart disease are reported. The data on the role of gout and comorbid conditions as independent risk factors of developing atherosclerosis and cardiovascular catastrophes are presented. Furthermore, the effect of drug therapy for gout on the risk of developing comorbid conditions and cardiovascularcatastrophes is discussed.

  18. Experimental Benefits of Sex Hormones on Vascular Function and the Outcome of Hormone Therapy in Cardiovascular Disease

    OpenAIRE

    Ross, Reagan L.; Serock, Michelle R; Khalil, Raouf A.

    2008-01-01

    Cardiovascular disease (CVD) is more common in men and postmenopausal women than premenopausal women, suggesting vascular benefits of female sex hormones. Experimental data have shown beneficial vascular effects of estrogen including stimulation of endothelium-dependent nitric oxide, prostacyclin and hyperpolarizing factor-mediated vascular relaxation. However, the experimental evidence did not translate into vascular benefits of hormone replacement therapy (HRT) in postmenopausal women, and ...

  19. The Effect of Curcumin on some of Traditional and Non-traditional Cardiovascular Risk Factors: A Pilot Randomized, Double-blind, Placebo-controlled Trial.

    Science.gov (United States)

    Mirzabeigi, Parastoo; Mohammadpour, Amir Hooshang; Salarifar, Mojtaba; Gholami, Kheirollah; Mojtahedzadeh, Mojtaba; Javadi, Mohammad Reza

    2015-01-01

    Numerous interventional studies in clinical and preclinical setting stated that intake of curcumin may provide protection against cardiovascular disease. The aim of this trial was investigation of curcumin efficiency on some cardiovascular risk factors in patients with coronary artery disease (CAD). A total of 33 patients with CAD who fulfilled inclusion and exclusion criteria were entered the study. Patients were randomly assigned to receive curcumin or placebo, 500 mg capsules, four times daily for 8 weeks. Lipid profile, blood glucose and high sensitive C-reactive protein (hs-CRP) levels were analyzed at baseline and two months after treatment. Serum levels of triglycerides (P=0.01), LDL-cholesterol (P=0.03) and VLDL-cholesterol (P=0.04) significantly decreased in the curcumin group compared to baseline, without significant changes in total cholesterol, HDL-cholesterol, blood glucose and hs-CRP levels. In all mentioned laboratory parameters, significant difference was not detected between curcumin and placebo. Although curcumin improved some of lipid profile components, it did not show appreciable effect on inflammatory markers in patients with CAD. Therefore, more detailed assessment of metabolic effects or anti-inflammatory activities of curcumin need to perform by extensive human study.

  20. Effects of low-carbohydrate diets v. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Mansoor, Nadia; Vinknes, Kathrine J; Veierød, Marit B; Retterstøl, Kjetil

    2016-02-14

    The effects of low-carbohydrate (LC) diets on body weight and cardiovascular risk are unclear, and previous studies have found varying results. Our aim was to conduct a meta-analysis of randomised controlled trials (RCT), assessing the effects of LC diets v. low-fat (LF) diets on weight loss and risk factors of CVD. Studies were identified by searching MEDLINE, Embase and Cochrane Trials. Studies had to fulfil the following criteria: a RCT; the LC diet was defined in accordance with the Atkins diet, or carbohydrate intake of healthy; and the dietary intervention had a duration of 6 months or longer. Results from individual studies were pooled as weighted mean difference (WMD) using a random effect model. In all, eleven RCT with 1369 participants met all the set eligibility criteria. Compared with participants on LF diets, participants on LC diets experienced a greater reduction in body weight (WMD -2·17 kg; 95% CI -3·36, -0·99) and TAG (WMD -0·26 mmol/l; 95% CI -0·37, -0·15), but a greater increase in HDL-cholesterol (WMD 0·14 mmol/l; 95% CI 0·09, 0·19) and LDL-cholesterol (WMD 0·16 mmol/l; 95% CI 0·003, 0·33). This meta-analysis demonstrates opposite change in two important cardiovascular risk factors on LC diets--greater weight loss and increased LDL-cholesterol. Our findings suggest that the beneficial changes of LC diets must be weighed against the possible detrimental effects of increased LDL-cholesterol.

  1. Prognostic value of aortic stiffness and calcification for cardiovascular events and mortality in dialysis patients: outcome of the calcification outcome in renal disease (CORD) study

    DEFF Research Database (Denmark)

    Verbeke, Francis; Van Biesen, Wim; Honkanen, Eero;

    2011-01-01

    BACKGROUND AND OBJECTIVES: Radiographic calcification and arterial stiffness each individually are predictive of outcome in dialysis patients. However, it is unknown whether combined assessment of these intermediate endpoints also provides additional predictive value. DESIGN, SETTING, PARTICIPANT...

  2. Assessment and implication of prognostic imbalance in randomized controlled trials with a binary outcome--a simulation study.

    Directory of Open Access Journals (Sweden)

    Rong Chu

    Full Text Available BACKGROUND: Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1 evaluate the probability of imbalance in a binary prognostic factor (PF between two treatment arms, (2 investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3 examine the effect of sample size (n in relation to the first two objectives. METHODS: We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. RESULTS: For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5 leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2, adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. CONCLUSIONS: The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed.

  3. Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sung Valerie

    2012-08-01

    Full Text Available Abstract Background Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( Methods/Design Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i number of episodes of infant crying/fussing per 24 hours and ii infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months; iii maternal mental health scores, iv family functioning scores, v parent quality adjusted life years scores, and vi intervention cost-effectiveness (at one and six months; and vii infant faecal microbiota diversity, viii infant faecal calprotectin levels and ix Eschericia coli load (at one month only. Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. Discussion An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If

  4. Modern obesity pharmacotherapy: weighing cardiovascular risk and benefit.

    Science.gov (United States)

    Cunningham, Jonathan W; Wiviott, Stephen D

    2014-11-01

    Obesity is a major correlate of cardiovascular disease. Weight loss improves cardiovascular risk factors and has the potential to improve outcomes. Two drugs, phentermine plus topiramate and lorcaserin, have recently been approved by the US Food and Drug Administration for the indication of obesity; a third, bupropion plus naltrexone, is under consideration for approval. In clinical trials, these drugs cause weight loss and improve glucose tolerance, lipid profile, and, with the exception of bupropion plus naltrexone, blood pressure. However, their effect on cardiovascular outcomes is unknown. In defining appropriate roles for these drugs in preventive cardiology, it is important to remember the checkered history of drugs for obesity. New weight-loss drugs share the serotonergic and sympathomimetic mechanisms that proved harmful in the cases of Fen-Phen and sibutramine, respectively, albeit with significant differences. Given these risks, randomized cardiovascular outcomes trials are needed to establish the safety, and potential benefit, of these drugs. This review will discuss the history of pharmacotherapy for obesity, existing efficacy and safety data for the novel weight-loss drugs, and issues in the design of postapproval clinical trials.

  5. Is a reduction in albuminuria associated with renal and cardiovascular protection? : A post-hoc analysis of the ALTITUDE trial

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J; Ninomiya, Toshiharu; Persson, Frederik; Brenner, Barry M; Brunel, Patrick; Chaturvedi, Nish; Desai, Akshay S; Haffner, S M; Mcmurray, John J V; Solomon, Scott D; Pfeffer, Marc A; Parving, Hans-Henrik; de Zeeuw, Dick

    2015-01-01

    AIMS: In the ALTITUDE trial, direct renin inhibition with aliskiren on top of ACEi_or_ARB therapy decreased albuminuria by 14% while this did not lead to cardiorenal protection. Prior studies have demonstrated that the renoprotective effect of single RAAS blockade is associated with approximately 30

  6. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-03-01

    Full Text Available Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day or a low dairy control diet (LD, ≤1 serve/day for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347 on 24th October, 2008.

  7. The role of surgery for treatment of low back pain: insights from the randomized controlled Spine Patient Outcomes Research Trials

    Directory of Open Access Journals (Sweden)

    Peter Abraham

    2016-01-01

    Full Text Available Low back pain (LBP is a common medical problem with high morbidity and healthcare costs. The optimal management strategy, including the role of surgical intervention, remains controversial. The Spine Patient Outcomes Research Trials were randomized controlled studies conducted to assess the effectiveness of surgery for three of the most common conditions implicated in LBP: Intervertebral disc herniation, degenerative spondylolisthesis, and spinal stenosis. Despite challenges in data interpretation related to patient cross over, these studies support the efficacy of surgery as treatment for these three common conditions.

  8. Why clinical trials of vitamin E and cardiovascular diseases may be fatally flawed. Commentary on "The Relationship Between Dose of Vitamin E and Suppression of Oxidative Stress in Humans"

    Science.gov (United States)

    Many investigators have pondered the apparent paradox in the conflicting evidence about the cardiovascular benefits of vitamin E suggested by experimental and observational studies versus that reported from randomized clinical trials. In the light of recent evidence, particularly a new clinical tria...

  9. The effects of multimodal intervention for the primary prevention of cardiovascular diseases on depression, anxiety, and Type-D pattern. Initial results of the randomized controlled PreFord trial

    NARCIS (Netherlands)

    Albus, C.; Bjarnson-Wehrens, B.; Gysan, D. B.; Herold, G.; Schneider, C. A.; Eulenburg, C. Zu; Predel, H. G.

    2012-01-01

    Depression, anxiety, and Type-D pattern are associated with the earlier development and faster progression of cardiovascular disease (CVD). The aim of the randomized controlled PreFord trial was to improve multiple biological and psychosocial risk factors in the primary prevention of CVD. A total of

  10. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects...... were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks. RESULTS: For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children...... tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified....

  11. The effects of the mediterranean diet on biomarkers of vascular wall inflammation and plaque vulnerability in subjects with high risk for cardiovascular disease. A randomized trial.

    Directory of Open Access Journals (Sweden)

    Rosa Casas

    Full Text Available BACKGROUND: Adherence to the Mediterranean diet (MD is associated with reduced morbidity and mortality due to cardiovascular disease. However, how the MD exerts its effects is not fully known. AIM: To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED (Prevención con Dieta Mediterránea study. METHODS: A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups: MD supplemented with 50mL/d of extra virgin olive oil (MD+EVOO or 30 g/d of nuts (MD+Nuts and a low-fat diet. Changes in classical cardiovascular risk factors, inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention. RESULTS: Compared to participants in the low-fat diet group, those receiving MD+EVOO and MD+Nuts showed a higher decrease in systolic (6mmHg and diastolic (3mmHg blood pressure (P = 0.02; both, as well as a reduction of 10% and 8% in LDL-cholesterol (P = 0.04, respectively. Patients in the MD+Nuts group showed a significant reduction of 34% in CD40 expression on monocyte surface compared to low-fat diet patients (P = 0.03. In addition, inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45% and 35% and 95% and 90% in the MD+EVOO and MD+Nuts groups, respectively (P<0.05; all compared to the low-fat diet group. Likewise, sICAM and P-selectin were also reduced by 50% and 27%, respectively in the MD+EVOO group (P = 0.04 and P-selectin by 19% in MD+Nuts group (P = 0.04 compared to the low-fat diet group. CONCLUSIONS: Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain, at least in part, the protective role of MD against ischemic heart disease. TRIAL REGISTRATION: www.controlled-trials.com ISRCTN

  12. 10-Year cardiovascular event risks for women who experienced hypertensive disorders in late pregnancy: the HyRAS study

    Directory of Open Access Journals (Sweden)

    Ponjee Gabrielle

    2010-06-01

    Full Text Available Abstract Background Cardiovascular disease is the cause of death in 32% of women in the Netherlands. Prediction of an individual's risk for cardiovascular disease is difficult, in particular in younger women due to low sensitive and specific tests for these women. 10% to 15% of all pregnancies are complicated by hypertensive disorders, the vast majority of which develop only after 36 weeks of gestation. Preeclampsia and cardiovascular disease in later life show both features of "the metabolic syndrome" and atherosclerosis. Hypertensive disorders in pregnancy and cardiovascular disease may develop by common pathophysiologic pathways initiated by similar vascular risk factors. Vascular damage occurring during preeclampsia or gestational hypertension may contribute to the development of future cardiovascular disease, or is already present before pregnancy. At present clinicians do not systematically aim at the possible cardiovascular consequences in later life after a hypertensive pregnancy disorder at term. However, screening for risk factors after preeclampsia or gestational hypertension at term may give insight into an individual's cardiovascular risk profile. Methods/Design Women with a history of preeclampsia or gestational hypertension will be invited to participate in a cohort study 2 1/2 years after delivery. Participants will be screened for established modifiable cardiovascular risk indicators. The primary outcome is the 10-year cardiovascular event risk. Secondary outcomes include differences in cardiovascular parameters, SNP's in glucose metabolism, and neonatal outcome. Discussion This study will provide evidence on the potential health gains of a modifiable cardiovascular risk factor screening program for women whose pregnancy was complicated by hypertension or preeclampsia. The calculation of individual 10-year cardiovascular event risks will allow identification of those women who will benefit from primary prevention by tailored

  13. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  14. Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions.

    Science.gov (United States)

    Yehia, Baligh R; Long, Judith A; Stearns, Cordelia R; French, Benjamin; Tebas, Pablo; Frank, Ian

    2012-01-01

    Participation in antiretroviral therapy clinical trials (ART-RCTs) offers many advantages including access to new drugs, close monitoring, and cost savings. These same benefits may pose a risk to patients ending ART-RCTs and returning to routine care; as they may experience changes to their drug regimen, decreased monitoring, and new out-of-pocket costs. We aimed to evaluate this transition and determine its effects on viral outcomes and patient perceptions. A retrospective cohort was assembled from participants of naïve ART-RCTs at the University of Pennsylvania between 1 January 2000 and 31 December 2009. Data were collected in the 12 months prior to and after trial completion. M