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Efficacy and safety of risperidone long-acting injection in elderly people with schizophrenia  

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Full Text Available Dhiren Singh1,2, Daniel W O’Connor11Department of Psychological Medicine, Monash University, Melbourne, Australia; 2Peninsula Mental Health Service, Melbourne, AustraliaAbstract: Antipsychotic medication is the mainstay of treatment in elderly patients with psychosis. In recent years, second generation antipsychotics have come to be preferred. Longacting risperidone is the first such antipsychotic available for use in this vulnerable group of patients and offers an attractive alternative to traditional medications. The available literature revealed that long-acting risperidone is generally well tolerated and is effective in treating both the positive and negative symptoms of schizophrenia. Despite a lack of randomized trials and head-to-head studies, it appears to be a useful addition to the treatment armory for patients with chronic psychosis who require a depot preparation. Further research into its endocrine and metabolic side effects is needed.Keywords: risperidone, long-acting injection, old age, efficacy, safety

Dhiren Singh

2009-08-01

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Risperidone long-acting injection: a review of its long term safety and efficacy  

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Full Text Available Michael K RainerMemory-Clinic and Psychiatric Department, Donauspital, Vienna, AustriaAbstract: A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low.Keywords: risperidone, schizophrenia, psychotic disorders, patient compliance; delayed-action preparations, injections, intramuscular

Michael K Rainer

2008-08-01

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Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison.  

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Early in the course of illness, patients with schizophrenia may be particularly susceptible to adverse events (AEs). In this post-hoc, subgroup analysis of a 13-week, double-blind, double-dummy, multicenter study, patients recently diagnosed with schizophrenia (? 5 years) were administered once-monthly flexible-dose paliperidone palmitate (PP) (n=161; initiation doses, 150 mg eq day 1 and 100 mg eq day 8) [PP doses can be expressed as milligram equivalents (mg eq) of paliperidone or as milligrams (mg) of PP. 150 mg eq paliperidone=234 mg PP; 100 mg eq paliperidone=156 mg PP. In the USA, dosing tends to be expressed in mg] or oral risperidone [during initiation of risperidone long-acting injection (RLAI) days 1-28] and biweekly flexible-dose RLAI (n=173; initial injection day 8). Assessments were performed at baseline and days 4, 15, 22, 36, 64, and 92. Because of RLAI's release profile, data through day 22 correspond to oral risperidone in the RLAI arm. During this period, the AE profile and onset of efficacy of PP and oral risperidone were similar. The overall AE rates at week 13 for PP and RLAI were 54.7 and 50.3%, respectively, for any AE; 11.2 and 8.1% for extrapyramidal symptom-related AEs; and 2.5 and 2.3% for prolactin-related AEs. No significant differences in the mean weight change, most metabolic parameters, or mean efficacy measures were observed at end point. In patients with recently diagnosed schizophrenia, the tolerability and efficacy of PP and RLAI were generally similar over 13 weeks. PMID:24113628

Fu, Dong-Jing; Bossie, Cynthia A; Sliwa, Jennifer K; Ma, Yi-Wen; Alphs, Larry

2014-01-01

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Combination treatment with risperidone long-acting injection and psychoeducational approaches for preventing relapse in schizophrenia  

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A recent meta-analysis showed that long-acting injectable (LAI) antipsychotics were not superior to oral antipsychotics for preventing relapse in patients with schizophrenia. We therefore designed a treatment strategy combining risperidone LAI and COMPASS (COMprehensive Psycho-educational Approach and Scheme Set), an original psychoeducational program supporting treatment with risperidone LAI and evaluating subjective treatment satisfaction, transition of symptoms, and effectiveness in preventing symptomatic relapse. The aim of this study was to examine whether addition of COMPASS to risperidone LAI was more effective in preventing relapse in schizophrenia patients than risperidone LAI alone, with the latter group consisting of patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients were followed up for 6 months, with COMPASS continuously implemented from the transition to the observation phase. The primary efficacy measurements were relapse rate (rates of rehospitalization and discontinuation due to inefficacy). Secondary efficacy measurements were the Brief Psychiatric Rating Scale (BPRS) and Global Assessment of Functioning (GAF) scores. Of the 96 patients originally enrolled, 19 (19.8%) were discontinued from all causes. During the 6-month study period, ten of the 96 patients (10.4%) relapsed, compared with a 12.2% relapse rate in patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients showed significant improvements in BPRS total scores (P = 0.0031), BPRS positive (P = 0.0451), BRPS negative (P < 0.0001), and general subscale scores (P = 0.0031), and GAF (P < 0.0001) from baseline to 6 months. In conclusion, the lower relapse rate observed in patients treated with COMPASS plus risperidone LAI than in patients treated with risperidone LAI alone suggests that COMPASS may have benefits in the treatment of schizophrenia, indicating a need for randomized, controlled trials in larger numbers of patients. PMID:24194642

Zhao, Yueren; Kishi, Taro; Iwata, Nakao; Ikeda, Manabu

2013-01-01

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Combination treatment with risperidone long-acting injection and psychoeducational approaches for preventing relapse in schizophrenia  

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Full Text Available Yueren Zhao,1–3 Taro Kishi,1 Nakao Iwata,1 Manabu Ikeda3,4 1Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan; 2Department of Psychiatry, Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan; 3Department of Neuropsychiatry, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan; 4Department of Neuropsychiatry, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan Abstract: A recent meta-analysis showed that long-acting injectable (LAI antipsychotics were not superior to oral antipsychotics for preventing relapse in patients with schizophrenia. We therefore designed a treatment strategy combining risperidone LAI and COMPASS (COMprehensive Psycho-educational Approach and Scheme Set, an original psychoeducational program supporting treatment with risperidone LAI and evaluating subjective treatment satisfaction, transition of symptoms, and effectiveness in preventing symptomatic relapse. The aim of this study was to examine whether addition of COMPASS to risperidone LAI was more effective in preventing relapse in schizophrenia patients than risperidone LAI alone, with the latter group consisting of patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients were followed up for 6 months, with COMPASS continuously implemented from the transition to the observation phase. The primary efficacy measurements were relapse rate (rates of rehospitalization and discontinuation due to inefficacy. Secondary efficacy measurements were the Brief Psychiatric Rating Scale (BPRS and Global Assessment of Functioning (GAF scores. Of the 96 patients originally enrolled, 19 (19.8% were discontinued from all causes. During the 6-month study period, ten of the 96 patients (10.4% relapsed, compared with a 12.2% relapse rate in patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients showed significant improvements in BPRS total scores (P = 0.0031, BPRS positive (P = 0.0451, BRPS negative (P < 0.0001, and general subscale scores (P = 0.0031, and GAF (P < 0.0001 from baseline to 6 months. In conclusion, the lower relapse rate observed in patients treated with COMPASS plus risperidone LAI than in patients treated with risperidone LAI alone suggests that COMPASS may have benefits in the treatment of schizophrenia, indicating a need for randomized, controlled trials in larger numbers of patients. Keywords: adherence, risperidone long-acting injection, psychoeducation, schizophrenia

Zhao Y

2013-10-01

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Long-acting injectable risperidone for the treatment of schizophrenia: clinical perspectives.  

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Schizophrenia remains a severe disorder that is associated with a poor outcome in a large subgroup of patients. Major efforts should be made to improve treatment for all patients who have this debilitating disease. Second-generation antipsychotics were a major step forward in this respect; however, important unmet needs remain, such as a better solution for frequent noncompliance problems. Depot formulations are known to have advantages in this respect. However, for a long time, only depot formulations of conventional antipsychotics were available, with their high risk of extrapyramidal adverse effects. Therefore, there has been only very restricted use of depot antipsychotics, which mainly focused on patients with chronic disease who were difficult to treat and had a high risk of noncompliance. The situation may change with the advent of a depot formulation of an atypical antipsychotic. The first depot formulation of an atypical antipsychotic to be introduced to the market is long-acting injectable risperidone. On the basis of the pharmacokinetic properties of the depot formulation, a 2-week interval between administrations is recommended. The antipsychotic efficacy of long-acting risperidone was demonstrated in two 12-week, double-blind, randomised, phase III studies, one versus placebo and the other versus oral risperidone. These two studies, together with one open-label, long-term study over 12 months, belong to the core group of trials that were relevant for the licensing of long-acting risperidone. A relapse-prevention, control group study comparing the long-acting formulation versus oral risperidone was not performed because of the known principal methodological problems of such a comparison. Instead, as much clinical data as possible was collected from observational studies that investigated questions relevant for clinical practice, such as efficacy, safety and tolerability in different subgroups, and transition from pre-treatment with different kinds of antipsychotics to long-acting risperidone. On the basis of these data, it can be stated that the efficacy of the long-term formulation of risperidone is proven, and that the safety and tolerability are more or less comparable to those of oral risperidone. The local tolerability at the injection site is good. Because it is well known that noncompliance is a frequent feature of the treatment of schizophrenia, and considering the advantages of atypical antipsychotics, consideration of whether long-acting atypical antipsychotics should have a broader indication than is the case with the depot formulations of the classical antipsychotics is warranted. PMID:17661527

Möller, Hans-Jürgen

2007-01-01

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Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics  

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Full Text Available Larry Alphs,1 Cynthia A Bossie,1 Jennifer Kern Sliwa,2 Dong-Jing Fu,1 Yi-Wen Ma,3 Joseph Hulihan11CNS Medical Affairs, 2Medical Information, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Biostatistics, B&P, Janssen Research & Development LLC, Titusville, NJ, USABackground: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI, in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics.Methods: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914 if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS total score of 60–120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing or RLAI (25–50 mg biweekly, with oral risperidone supplementation on days 1–28, plus matched placebo injections/tablets.Results: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107, other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203, or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56. Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from ?17.5 to ?19.5, all P < 0.0001. Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P < 0.0001.Conclusion: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.Keywords: paliperidone palmitate, risperidone long-acting injection, schizophrenia

Alphs L

2013-03-01

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Evaluation of a treatment manual for risperidone long-acting injectable.  

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We evaluated the usefulness of a treatment manual to facilitate the use of long-acting injectable risperidone in community mental health centers (CMHCs) during an open-label observational study. Perceived clinical utility and clinician adherence to the manual were evaluated. Patient adherence to treatment satisfaction, Clinical Global Impression of Severity (CGI-S) and the Schizophrenia Quality-of-Life Scale (SQLS) were assessed. Mean score for overall utility of the guidebook was 4.2 +/- .6 (scale ratings ranged from 1 = not at all to 5 = extremely). Most clinicians (89-100%) found the guidebook useful, and were adherent to key aspects of appropriate treatment use including concomitant oral risperidone use and injection and dosing parameters for long-acting risperidone. Most patients were adherent to treatment (86.7%), preferred long-acting risperidone over oral risperidone (72.6%) or other oral antipsychotics (78.4%) and were satisfied with long-acting risperidone (90.1%). The open-label observational design limits interpretation of these data. However, in this study manual-supported use of long-acting risperidone was associated with successful implementation of this pharmacologic treatment in the CMHC setting. PMID:17345148

Docherty, John P; Jones, Robert; Turkoz, Ibrahim; Lasser, Robert A; Kujawa, Mary

2007-06-01

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Successful Treatment of Anorexia Nervosa in a 10-year-old Boy with Risperidone Long-acting Injection  

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Although the effectiveness of medication in the treatment of anorexia nervosa is uncertain, atypical antipsychotics such as olanzapine and risperidone have been used empirically for decades. we describe the case of a 10-year-old boy with anorexia nervosa in whom remarkable improvement was seen following the administration of risperidone or risperidone long-acting injection and deterioration when these agents were ceased. Because this is, to the best of our knowledge, the first report describing the usefulness of risperidone long-acting injection for adolescent anorexia nervosa. PMID:24851123

Iga, Junichi; Ohmori, Tetsuro

2014-01-01

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The cost associated with administering risperidone long-acting injections in the Australian community  

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Full Text Available Abstract Background Risperidone long-acting injection (LAI is mostly administered twice weekly to people with schizophrenia by nurses at community mental health centres (CMHC or through mobile outreach visits. This study estimates the cost of resource utilisation associated with the administration of risperidone LAI and the potential savings from substituting two-weekly injections with a longer interval product of therapeutic equivalence. Methods A survey of mental health staff overseeing the administration of risperidone LAI at 253 distinct Australian CMHCs was undertaken in November 2009. For the two-week period prior to the survey, respondents were asked questions on injection time (and related tasks and, for mobile outreach visits, distance and time travelled as well as reduction in visits. Results were stratified by Australian Standard Geographical Classification (ASGC region. Resource use was quantified and valued in Australian dollars. Results Results are derived from 74 CMHCs, representing approximately 26% of the national average risperidone LAI unit two-week sales. Stratified average injection time (including related tasks for risperidone LAI ranged from 18-29 minutes, with a national average of 20.12 minutes. For mobile outreach visits, average distance per patient ranged from 19.4 to 55.5 km for One Staff Visits and 15.2 to 218.1 km for More Than One Staff Visits, and average time travelled ranged from 34.1 to 54.5 minutes for One Staff Visits and 29.2 to 136.3 minutes for More Than One Staff visits. The upper range consistently reflected greater resource utilisation in rural areas compared to urban areas. If administration of risperidone LAI had not been required, 20% fewer mobile outreach visits would have occurred. Conclusions The national average saving per two-weekly risperidone long-acting injection avoided is $75.14. In 2009 in Australia, this would have saved ~$11 million for injection administration costs alone if all patients taking two-weekly risperidone LAI had instead been treated with a therapeutically equivalent long-acting injectable antipsychotic requiring one less injection per month.

Hertel Judy

2011-09-01

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Costs and efficacy ofolanzapine and risperidone in schizophrenia  

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Full Text Available Introduction: schizophrenia is a serious and long lasting psychiatric disease. The new “atypical” antipsychotic drugs, introduced in the 90s, have substantially improved the effectiveness of medical treatments, compared to previous neuroleptic drugs. Nowadays they tend to be used as first choice drugs. The ddd cost of atypicals may differ by 20% and health authorities may have an incentive to deliver the less costly drug, especially if they are generic. However the various drugs show differential effectiveness rates and a rational choice should consider both cost and effectiveness.?Objective: the purpose of this analysis is to review the existing evidence on cost-effectiveness studies of olanzapine and risperidone, the two most prescribed drugs in Italy. Six published studies were identified, but attention was focused on two articles that reported consistent and methodologically sound results.?Results: most reviewed studies are cost-minimization analyses, since effectiveness indicators show no significant statistical difference between the two drugs, and are inconclusive since the results depend on the evaluation setting. However one observational retrospective study showed a significant severity reduction over 12 months for patients treated with olanzapine (-2.46 on HoNOS scale; p<0.05, compared to a smaller non significant reduction of the risperidone group (-0.57. Despite the higher drug cost, the average total cost per reduced severity score was lower for olanzapine than for risperidone patients (€ 4,554 vs. € 10,897. The only medical and related health care costs for risperidone patients were higher than total costs for olanzapine patients. Another study comparing cohorts of patients with similar starting severity showed a significant severity reduction and global functioning increase over 12 months for olanzapine but no significant increase for risperidone patients (-0.35, p<0.01 on CGI scale; +3.66, p <0.05 on GAF scale, compared respectively to -0.27, p<0.05 and +2.00 n.s.. Again average cost per reduced severity/increased functioning score was higher for risperidone than olanzapine patients (€ 4,568 vs. € 4,170 for CGI and € 2,284 vs. € 1,139 for GAF scales respectively.?Conclusion: the use of olanzapine in the treatment of schizophrenia is the most cost-effective alternative for the SSN (Italian National health service, as it minimizes the cost per score of severity reduction or functioning increase. Even if the price of risperidone were to be reduced by 50% (becoming a generic, total 12 months treatment costs would exceed those of olanzapine in its highest ddd (30 mg.?

Vittorio Mapelli

2007-06-01

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Efficacy of olanzapine and risperidone in schizophrenia: a randomized double-blind crossover design.  

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This article compares the efficacy of olanzapine and risperidone for positive and negative symptoms using an 18-week, randomized, double-blind, crossover design. The hypotheses were that olanzapine would be more efficacious for treating negative symptoms, and that risperidone would be superior in treating positive symptoms. Positive and negative symptoms scores improved throughout treatment, regardless of medication type. Differences between the medications were found for negative and general psychopathology rating scales. Overall, olanzapine led to greater improvements in negative symptoms than did risperidone. When each scale was analyzed individually, greater improvements were found for olanzapine on Positive and Negative Symptoms Scale (PANSS) General,PANSS total, and Scale for the Assessment of Negative Symptoms (SANS)attention. A nearly significant trend favoring olanzapine was found for the Calgary Depression Scale. Several negative symptom subscales followed a nonsignificant trend toward olanzapine being more efficacious than risperidone.Thus, there was a very consistent pattern of greater efficacy for olanzapine, particularly for negative symptoms. Despite the small number of subjects, this study shows the potential of a within-subject design to elucidate differences in efficacy. PMID:17065975

Canive, Jose M; Miller, Gregory A; Irwin, Jessica G; Moses, Sandra N; Thoma, Robert J; Edgar, J Christopher; Sherwood, Andrea; Torres, Fernando; Lanoue, Marianna; Lewis, Stephen; Hanlon, Faith M; Weisend, Michael P; Mead, Valerie; Tuason, Vicente B

2006-01-01

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Long-acting injectable risperidone in partially adherent and nonadherent patients with schizophrenia  

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Full Text Available Mário Rodrigues Louzã1, Helio Elkis1, Sandra Ruschel2, Irismar Reis de Oliveira3, Rodrigo Affonseca Bressan4, Paulo Belmonte-de-Abreu5, Hamilton Grabowski6, José Carlos Appolinário71Universidade de São Paulo, São Paulo; 2Hospital Mário Kroeff, Rio de Janeiro; 3Universidade Federal da Bahia, Salvador; 4Universidade Federal de São Paulo, São Paulo; 5Universidade Federal do Rio Grande do Sul, Porto Alegre; 6Hospital Bom Retiro, Curitiba; 7Janssen-Cilag Farmaceutica Ltda, São Paulo, BrazilBackground: Long-acting injectable antipsychotics may improve medication adherence, thereby improving overall treatment effectiveness. This study aimed to evaluate the effectiveness, safety, and tolerability of risperidone long-acting injection in schizophrenic patients switched from oral antipsychotic medication.Methods: In a 12-month, multicenter, open-label, noncomparative study, symptomatically stable patients on oral antipsychotic medication with poor treatment adherence during the previous 12 months received intramuscular injections of risperidone long-acting injection (25 mg starting dose every 2 weeks. The primary endpoint was the change in Positive and Negative Syndrome Scale (PANSS total score.Results: Of the 60 patients who were screened, 53 received at least one injection (safety population, and 51 provided at least one postbaseline assessment. Mean PANSS total scores improved significantly throughout the study and at endpoint. Significant improvements were also observed in Clinical Global Impression of Severity, Personal and Social Performance, and Drug Attitude Inventory scales. Risperidone long-acting injection was safe and well-tolerated. Severity of movement disorders on the Extrapyramidal Symptom Rating Scale was reduced significantly. The most frequently reported adverse events were insomnia (22.6%, increased prolactin (17.0%, and weight gain (13.2%.Conclusion: Risperidone long-acting injection was associated with significant symptomatic improvements in stable patients with schizophrenia following a switch from previous antipsychotic medications.Keywords: patient compliance, adherence, risperidone, delayed-action preparations, schizophrenia

Louzã M

2011-06-01

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Prognostic indicators for early discontinuation of risperidone long-acting injection.  

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Although efficacy trials have been conducted on risperidone long-acting injection (RLAI), its most appropriate utilization in clinical practice remains unclear. This 6-month, follow-up study investigated prognostic indicators for early discontinuation of RLAI. Consecutive sampling was conducted for adult patients with a psychotic disorder commenced on RLAI, whose injection was dispensed by one of three South London psychiatric hospital pharmacies. Prescription data were collected prospectively and clinical data retrospectively. Eightly-one out of 88 (92.0%) eligible patients were included, of whom 29 (35.8%) had treatment refractoriness and 30 (37.0%) discontinued within 6 months. Patients with a preceding oral antipsychotic were more likely to discontinue RLAI than those with a preceding depot; treatment refractoriness weakly confounded this relationship [summary adjusted odds ratio (OR) 2.68, 95% confidence interval (CI) 0.95-7.53, P=0.061]. After adjusting for preceding antipsychotic type, patients with treatment refractoriness were no more likely to discontinue than those without (summary adjusted OR 1.55, 95% CI 0.59-4.11, P=0.376). Sociodemographic factors and other clinical factors were non-predictive of discontinuation. For this first wave of patients commenced on RLAI, many had treatment refractoriness. RLAI discontinuation is high early on but subsequently tapers off. Preceding antipsychotic type (depot versus oral) is a stronger prognostic indicator than treatment refractoriness for RLAI discontinuation. PMID:15201571

Patel, Maxine X; Young, Corina; Samele, Chiara; Taylor, David M; David, Anthony S

2004-07-01

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Emerging treatments in the management of bipolar disorder – focus on risperidone long acting injection  

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Full Text Available Wissam El-Hage1, Simon A Surguladze21Inserm U930 ERL CNRS 3106, Université François Rabelais and Clinique Psychiatrique Universitaire, CHRU de Tours, Tours, France; 2Institute of Psychiatry, King’s College London, UKAbstract: Bipolar disorder is a life-long psychiatric illness characterized by a high frequency of relapses and substantial societal costs. Almost half of the patients are prescribed second generation antipsychotics for treatment of manic states, or as the maintenance therapy. ­Risperidone long acting injection (RLAI as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder was approved by Food and Drug Administration (FDA in United States in May 2009. In this review we will consider the aspects of pharmacology, pharmacokinetics, metabolism, safety and tolerability, and clinical trials focusing on the efficacy of RLAI in bipolar disorder. The patients’ perspective and attitudes to long-acting injections will also be discussed.Keywords: second generation, antipsychotics, patient attitudes, lithium, valproate, monotherapy

Wissam El-Hage

2010-07-01

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Clinical outcomes of long-acting injectable risperidone in patients with schizophrenia: six-month follow-up from the Electronic Schizophrenia Treatment Adherence Registry in Latin America  

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Rogelio Apiquian1, Rodrigo Córdoba2, Mario Louzã31Americas University, Behavior and Development Sciences Division, Mexico City, Mexico; 2Nervous System Research Center-CISNE, Bogota, Colombia; 3Schizophrenia Research Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, BrazilBackground: Risperidone long-acting injection (RLAI) has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy. The ...

Mario Louzã; Amp Oacute Rdoba, Rodrigo C.; Rogelio Apiquian

2010-01-01

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Cost effectiveness of long-acting risperidone injection versus alternative antipsychotic agents in patients with schizophrenia in the USA.  

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The availability of long-acting risperidone injection may increase adherence and lead to improved clinical and economic outcomes for individuals with schizophrenia. The objective of this study was to assess the cost effectiveness of long-acting risperidone, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot in patients with schizophrenia over 1 year from a healthcare system perspective. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were utilized to populate a decision analytical model comparing the seven treatment alternatives. The model captured rates of patient compliance, the rates, frequency and duration of relapse, incidence of adverse events, and healthcare resource utilization and associated costs. Primary outcomes were expressed in terms of percentage of patients relapsing per year, number of relapse days per year (number and duration of relapses per patient per year), and total direct 2003 medical cost per patient per year. On the basis of model projections, the proportions of patients experiencing a relapse requiring hospitalization in 1 year were 66% for haloperidol depot, 41% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 26% for long-acting risperidone, whereas the proportions of patients with an exacerbation not requiring hospitalization were 60% for haloperidol depot, 37% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 24% for long-acting risperidone. The mean number of days of relapse requiring hospitalization per patient per year were 28 for haloperidol depot, 18 for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 11 for long-acting risperidone, whereas the mean number of days of exacerbation not requiring hospitalization were eight for haloperidol depot, five for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and three for long-acting risperidone. This would translate into direct medical cost savings with long-acting risperidone compared with oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot of US dollars 161, 1425, 508, 259, 1068, and 8224, respectively. These findings were supported by sensitivity analyses. The utilization of long-acting risperidone is predicted to result in better clinical outcomes and lower total healthcare costs than its comparators, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot. Long-acting risperidone may therefore be a cost saving therapeutic option for patients with schizophrenia. PMID:16416763

Edwards, Natalie C; Locklear, Julie C; Rupnow, Marcia F T; Diamond, Ronald J

2005-01-01

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Emerging treatments in the management of bipolar disorder – focus on risperidone long acting injection  

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Bipolar disorder is a life-long psychiatric illness characterized by a high frequency of relapses and substantial societal costs. Almost half of the patients are prescribed second generation antipsychotics for treatment of manic states, or as the maintenance therapy. Risperidone long acting injection (RLAI) as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder was approved by Food and Drug Administration (FDA) in United States in...

El-hage, Wissam; Surguladze, Simon A.

2010-01-01

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Changes in prolactin levels and sexual functioning after switching from long-acting injectable risperidone to paliperidone palmitate in young psychotic patients: a case series  

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Statement of the problem : Long-acting injectable (LAI) antipsychotics have been developed to increase compliance in schizophrenia. Risperidone-LAI was the first LAI atypical antipsychotic, as a biweekly injection. Paliperidone Palmitate (PP) is a recently developed LAI atypical antipsychotic that is administered monthly. PP is hydrolized to paliperidone (9-hydroxyrisperidone), the primary active metabolite of risperidone. Although both risperidone and paliperidone are associated with increas...

Itziar Montalvo; Laura Ortega; Pez, Xavi L. X. F.; Montse Solé; Rosa Monseny; Joan Franch; Javier Labad

2012-01-01

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An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia  

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Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (?10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was qualitatively similar to those of other studies in adult subjects with schizophrenia and in other psychiatric studies of risperidone in pediatric populations. Conclusions Risperidone maintenance treatment in adolescents over 6 to 12 months was well tolerated, consistent with related studies in this clinical population, and associated with continued efficacy. Clinical trials ClinicalTrials.gov registration number: NCT00246285 http://clinicaltrials.gov/ct2/show/NCT00246285?term=NCT00246285&rank=1

Pandina Gahan

2012-06-01

 
 
 
 
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Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)  

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Objective: The objective of this study was to report the long-term remission results from the ConstaTRE relapse prevention trial, in which clinically stable adults with schizophrenia or schizoaffective disorder treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to risperidone long-acting injectable (RLAI) or oral quetiapine, dosed according to package-insert recommendations. Methods: In the ConstaTRE trial, efficacy and tolerability were recorded for up to 24 months. This post hoc analysis presents remission data, defined, according to the Schizophrenia Working Group criteria, as achieving and maintaining eight core symptoms of schizophrenia that are mild or less over 6 months. Additional secondary outcome measures are also presented. Results: A total of 710 patients were randomized to RLAI (n = 355) or quetiapine (n = 355). Mean mode ± standard deviation (SD) drug doses were RLAI 33 ± 10 mg every 2 weeks and quetiapine 413 ± 159 mg daily. Full remission was achieved by 51.1% of patients with RLAI and 39.3% with quetiapine (p = 0.003). Mean ± SD of full remission durations were not significantly different with RLAI (540 ± 181 days) and quetiapine (508 ± 188 days). Overall tolerability was similar between treatment groups. Conclusions: Among stable patients with schizophrenia or schizoaffective disorder, remission was more likely after switching to RLAI than quetiapine. PMID:24167692

Cavallaro, Roberto; Folnegovic-Smalc, Vera; Bidzan, Leszek; Emin Ceylan, Mehmet; Schreiner, Andreas

2013-01-01

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Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome? An assessment of safety databases.  

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Long-acting injectable (LAI) formulations of antipsychotics are valuable treatment alternatives for patients with psychotic disorders, and understanding their safe use is critical. Post-injection delirium/sedation syndrome (PDSS) has been reported following treatment with one atypical antipsychotic LAI. Clinical databases of risperidone LAI and paliperidone palmitate were explored to identify if cases of PDSS had been observed. No cases of PDSS were identified in 15 completed trials of 3,164 subjects (approximately 115,000 injections) or the postmarketing safety database of risperidone LAI. Only one case of PDSS was identified among 10 completed trials (3,817 subjects, 33,906 injections) of paliperidone palmitate-that case having been reported in a patient randomized to treatment with placebo. Examination of these prospective databases finds no evidence that risperidone LAI and paliperidone palmitate are associated with PDSS and suggest that findings seen with another antipsychotic LAI are not generalizable. PMID:21047303

Alphs, Larry; Gopal, Srihari; Karcher, Keith; Kent, Justine; Sliwa, Jennifer Kern; Kushner, Stuart; Nuamah, Isaac; Singh, Jaskaran

2011-02-01

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A six month randomized controlled trial of long acting injectable risperidone 50 and 100mg in treatment resistant schizophrenia.  

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It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial. We hypothesized that RLAI, 100mg, would be more effective than RLAI, 50mg. However, both doses produced clinically significant and equivalent improvement in PANSS Total, Positive, and Negative subscale scores, as well as key cognitive, global and functional measures, with increasing response during the course of the study, confirming the value of longer clinical trial duration for patients with TRS, but not superiority of the higher dose. The overall response rate was comparable to that previously reported for clozapine and high dose olanzapine, another A-APD, in TRS. Both doses of RLAI were equally well tolerated, producing minimal extrapyramidal side effects and few drop outs. Plasma levels of the active moiety, risperidone+9-hydroxyrisperidone, during treatment with RLAI 100mg, were comparable to those for 6-8 mg/day oral risperidone, which have not been effective in TRS. Further study of RLAI, ? 50-100mg biweekly, should compare it with clozapine and oral risperidone in TRS, with duration of treatment ? six months. PMID:24630262

Meltzer, H Y; Lindenmayer, J-P; Kwentus, J; Share, D B; Johnson, R; Jayathilake, K

2014-04-01

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Clinical utility of the risperidone formulations in the management of schizophrenia  

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Full Text Available Vishal Madaan1, Durga P Bestha2, Venkata Kolli2, Saurabh Jauhari2, Roger C Burket1 1University of Virginia Health System, Charlottesville, VA, USA; 2Creighton University Medical Center, Omaha, NE, USA Abstract: Risperidone is one of the early second-generation antipsychotics that came into the limelight in the early 1990s. Both the oral and long-acting injectable formulations have been subject to numerous studies to assess their safety, efficacy, and tolerability. Risperidone is currently one of the most widely prescribed antipsychotic medications, used for both acute and long-term maintenance in schizophrenia. Risperidone has better efficacy in the treatment of psychotic symptoms than placebo and possibly many first-generation antipsychotics. Risperidone fares better than placebo and first-generation antipsychotics in the treatment of negative symptoms. Risperidone's long acting injectable preparation has been well tolerated and is often useful in patients with medication nonadherence. Risperidone has a higher risk of hyperprolactinemia comparable to first-generation antipsychotics (FGAs but fares better than many second-generation antipsychotics with regards to metabolic side effects. In this article, we briefly review the recent literature exploring the role of risperidone formulations in schizophrenia, discuss clinical usage, and highlight the controversies and challenges associated with its use. Keywords: risperidone, schizophrenia, formulation, antipsychotic, side effects

Madaan V

2011-10-01

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Clinical outcomes of long-acting injectable risperidone in patients with schizophrenia: six-month follow-up from the Electronic Schizophrenia Treatment Adherence Registry in Latin America  

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Full Text Available Rogelio Apiquian1, Rodrigo Córdoba2, Mario Louzã31Americas University, Behavior and Development Sciences Division, Mexico City, Mexico; 2Nervous System Research Center-CISNE, Bogota, Colombia; 3Schizophrenia Research Program, Institute of Psychiatry, Faculty of Medicine, University of São Paulo, BrazilBackground: Risperidone long-acting injection (RLAI has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy. The aim of this work was to determine the effect of RLAI on clinical outcome and hospitalization rate in patients with schizophrenia or schizoaffective disorder enrolled in the electronic Schizophrenia Treatment Adherence Registry in Latin America.Methods: Data were collected at baseline, retrospectively for the 12 months prior to baseline, and prospectively every three months for 24 months. Hospitalization prior to therapy was assessed by a retrospective chart review. Efficacy and functioning were evaluated using Clinical Global Impression of Illness Severity (CGI-S, Personal and Social Performance (PSP, and Global Assessment of Functioning (GAF scores. Relapse and treatment were also registered.Results: Patients were recruited in Mexico (n = 53, Brazil (n = 11, and Colombia (n = 15. Sixty-five percent (n = 52 were male, and mean age was 32.9 years. Patients were classified as having schizophrenia (n = 73 or schizoaffective disorder (n = 6. The mean dose of RLAI at six months was 34.1 mg (standard deviation = 10.2 mg. The percentage of hospitalized patients before treatment was 28.2% and 5.1% at six months after initiating RLAI (P < 0.001. Significant changes were registered on CGI-S, GAF, and PSP scores.Conclusions: RLAI was associated with an improvement in clinical symptoms and functioning, and a greater reduction in hospitalization.Keywords: long-acting, risperidone, schizophrenia, schizoaffective disorder, Latin America

Mario Louzã

2010-12-01

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Are the Long-Acting Intramuscular Formulations of Risperidone or Paliperidone Palmitate Associated with Post-Injection Delirium/Sedation Syndrome? An Assessment of Safety Databases  

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Long-acting injectable (LAI) formulations of antipsychotics are valuable treatment alternatives for patients with psychotic disorders, and understanding their safe use is critical. Post-injection delirium/sedation syndrome (PDSS) has been reported following treatment with one atypical antipsychotic LAI. Clinical databases of risperidone LAI and paliperidone palmitate were explored to identify if cases of PDSS had been observed.

Alphs, Larry; Gopal, Srihari; Karcher, Keith; Kent, Justine; Kern Sliwa, Jennifer; Kushner, Stuart; Nuamah, Isaac; Singh, Jaskaran

2011-01-01

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Preparation and in-vitro characterization of Risperidone-cyclodextrin inclusion complexes as a potential injectable product  

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Full Text Available "n  "n Background and the purpose of the study: This investigation deals with risperidone cyclodextrin (CD complexation for parenteral administration to improve its aqueous solubility which would be beneficial over immediate and sustained release formulations available in market especially for agitated and non-cooperative psychotic patients. "nMethods: The phase solubility study of the drug with ?-CD, hydroxypropyl (HP-?-CD and ?-CD was conducted and CDs with higher stability constants were selected for complexation. The complexes of Risperidone with ?-CD and HP-?-CD were prepared by precipitation and vacuum drying methods, respectively. Fourier transform-infrared, X-ray diffraction and differential scanning calorimetry techniques were used for characterization of complexes. Drug precipitation study of complex's solution in water for injection and 100 ml of 0.1 M pH 7.4 phosphate buffer saline and stability study in accelerated condition were also carried out. "nResults: The stability constants of the CD were in the following order: ?-CD (341.953±11.87 M-1 > HP-?-CD (170.817± 5.93 M-1 > ?-CD (93.716 ± 3.25 M-1. CDs with high stability constants were selected to prepare the drug CD complex. The complexation efficiencies of ?-CD and HP-?-CD were 95.23 ± 2.27% and 97.59 ±1.97%, respectively. Both types of CDs exhibited complexation at 1:2 molar stoichiometric ratio. The drug precipitation study indicated complete solubility (100% drug dissolution without a trace of precipitate within 5 mins. The complexes were found to be stable for a period of 3 months under accelerated stability conditions. Major conclusion:Stable complexes of risperidone were successfully formulated using both ?-CD and HP-?-CD by simple and highly efficient methods of complexation for parenteral administration.

D Shukla

2009-12-01

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Clinical utility of the risperidone formulations in the management of schizophrenia  

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Vishal Madaan1, Durga P Bestha2, Venkata Kolli2, Saurabh Jauhari2, Roger C Burket1 1University of Virginia Health System, Charlottesville, VA, USA; 2Creighton University Medical Center, Omaha, NE, USA Abstract: Risperidone is one of the early second-generation antipsychotics that came into the limelight in the early 1990s. Both the oral and long-acting injectable formulations have been subject to numerous studies to assess their safety, efficacy, and tolerability. Risperidone is currently one...

Madaan V; Dp, Bestha; Vb, Kolli; Jauhari S; Rc, Burket

2011-01-01

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A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia.  

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This 13-week double-blind study was designed to assess noninferiority of the recently approved (in the U.S.) injectable atypical antipsychotic paliperidone palmitate (PP) versus risperidone long-acting injectable (RIS-LAI) in adult patients with schizophrenia. Patients (N=1220) were randomized (1:1) to either a) PP: deltoid injections on day 1 (150 mg eq.), day 8 (100 mg eq.), and once-monthly flexible dosing as deltoid or gluteal injections on day 36 (50 mg eq. or 100 mg eq.) and day 64 (50 mg eq. or 100 mg eq. or 150 mg eq.) or b) RIS-LAI: gluteal injections days 8 and 22 (25mg), days 36, 50 (25 or 37.5mg) and days 64, 78 (25, 37.5 or 50mg). RIS-LAI-treated patients received oral supplementation with RIS 1-6 mg/day (days 1 to 28), and PP-treated patients received oral placebo. The safety analysis set (n=1214) included 58% men, 78% white, with mean (SD) baseline PANSS total score: PP, 84.1 (12.09); and RIS-LAI, 83.6 (11.28). Mean (SD) change from baseline to endpoint in PANSS total score decreased similarly in both groups; PP (-18.6 [15.45]) and RIS-LAI (-17.9 [14.24]). PP treatment was noninferior to RIS-LAI (point estimate [95% CI]: 0.4 [-1.62;2.38], per-protocol analysis set [primary analysis]). The tolerability and safety of PP was generally similar to RIS-LAI with no new safety or tolerability findings. PMID:21092748

Pandina, Gahan; Lane, Rosanne; Gopal, Srihari; Gassmann-Mayer, Cristiana; Hough, David; Remmerie, Bart; Simpson, George

2011-01-15

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Descriptive analyses of the aripiprazole arm in the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE).  

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A recent randomized, open-label, relapse prevention trial (ConstaTRE) compared outcomes with risperidone long-acting injectable (RLAI) versus the oral atypical antipsychotic quetiapine. This study also included a small descriptive arm in which patients could also be randomized to aripiprazole. Results of this exploratory analysis are described here. Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or an oral conventional antipsychotic were randomized to RLAI or aripiprazole. Efficacy and tolerability were monitored for up to 24 months. A total of 45 patients were treated with aripiprazole (10-30 mg/day) and 329 patients with RLAI (25-50 mg i.m. every 2 weeks). Relapse occurred in 27.3% (95% CI: 15.0-42.8%) of aripiprazole-treated and 16.5% (95% CI: 12.7-21.0%) of RLAI-treated patients. Kaplan-Meier estimates of mean (standard error) relapse-free period were 313.7 (20.4) days for aripiprazole and 607.1 (11.4) days for RLAI patients. Remission was achieved by 34.1% (95% CI: 20.5-49.9%) of aripiprazole and 51.1% (95% CI: 45.5-56.6%) of RLAI patients. Clinical global impression-change was improved ("minimally improved" to "very much improved") in 26.4% with RLAI and 15.9% with aripiprazole patients. Tolerability was generally good for both treatment groups. Weight gain (7.0% with RLAI vs. 4.4% with aripiprazole), extrapyramidal adverse events (AEs) (10.3% vs. 4.4%), and potentially prolactin-related AEs (4.6% vs. 0%) were more common with RLAI treatment, and gastrointestinal disorders were more common in aripiprazole-treated patients (22.2% vs. 6.1%). Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder was numerically longer in RLAI-treated patients than in aripiprazole-treated patients although not statistically significant. Both treatments were generally well tolerated. PMID:21809168

de Arce Cordón, Rosario; Eding, Evelin; Marques-Teixeira, Joao; Milanova, Vihra; Rancans, Elmars; Schreiner, Andreas

2012-03-01

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Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons  

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Full Text Available Haya Ascher-Svanum1, William S Montgomery2, David P McDonnell3, Kristina A Coleman4, Peter D Feldman11Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly Australia Pty Ltd, West Ryde, New South Wales, Australia; 3Eli Lilly and Company, Cork, Ireland; 4OptumInsight, Lilyfield, New South Wales, AustraliaBackground: Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.Methods: Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a “sensitivity analysis,” using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates.Results: Comparison of olanzapine long-acting injection data (931 patients with the pooled data from the nine risperidone long-acting injection studies (3950 patients provided almost identical 12-month treatment-completion rates (72.7% versus 72.4%; P = 0.87. When the two most similar studies were compared, the 12-month completion rate for olanzapine long-acting injection was significantly higher than for risperidone long-acting injection (81.3% versus 47.0%; P < 0.001. However, any conclusions drawn from this comparison may be limited by differences in the studies' geographic catchment areas.Conclusion: Using treatment-completion rates as a proxy measure of medication effectiveness, olanzapine long-acting injection did not differ significantly from risperidone long-acting injection when including all eligible studies. However, the findings of this exploratory analysis should be interpreted with caution, considering the methodological limitations of these indirect, cross-study comparisons.Keywords: antipsychotic drugs, intramuscular injection, olanzapine, risperidone, schizophrenia

Ascher-Svanum H

2012-05-01

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Efficacy and safety of long acting injectable atypical antipsychotics: a review.  

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Schizophrenia is a chronic, severe and recurrent brain disorder that requires continuous, long-term treatment with antipsychotic medication to minimize relapse and provide clinical benefit to patients. For patients with schizophrenia, non-adherence to medication is a major risk factor for relapse and re-hospitalization. Long-acting injectable formulations of second-generation antipsychotics (SGAs-LAIs) provide constant medication delivery and the potential for improved adherence. Currently, three drugs are available for the treatment of schizophrenia, risperidone longacting injectable, olanzapine pamoate and paliperidone palmitate. Several studies have also demonstrated efficacy and safety of such drugs in patients with acute schizophrenia. In the present paper the literature on LAI atypical antipsychotics will be reviewed and practical advice will be given concerning the use of these drugs in the clinical practice. PMID:23343445

De Berardis, Domenico; Marini, Stefano; Carano, Alessandro; Lang, Antonella Padovan; Cavuto, Marilde; Piersanti, Monica; Fornaro, Michele; Perna, Giampaolo; Valchera, Alessandro; Mazza, Monica; Iasevoli, Felice; Martinotti, Giovanni; Di Giannantonio, Massimo

2013-08-01

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Differences in treatment effect among clinical subgroups in a randomized clinical trial of long-acting injectable risperidone and oral antipsychotics in unstable chronic schizophrenia.  

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A long-term randomized trial of unstable patients with schizophrenia found no benefit of long-acting injectable (LAI) risperidone over oral treatment in preventing or delaying time to psychiatric hospitalizations or on clinical outcomes. The initial analyses did not examine whether benefits of LAI emerged in selected subgroups.Patients with schizophrenia or schizoaffective disorder who had been hospitalized within the past 2 years or judged to be at risk for hospitalization because of increasing psychiatric service use were randomly assigned to LAI risperidone 12.5 to 50 mg per injection biweekly or to the psychiatrist's choice of oral antipsychotics and followed for up to 2 years. The primary endpoint was psychiatric rehospitalization. Symptoms, quality of life, and global functioning were assessed through blinded videoconference interviews. Cox's regression and mixed effects models were used to assess difference in treatment effect within 12 subgroups defined by hospitalization at study entry, substance abuse, race, symptom severity, quality of life, body mass index, age, race or sex, or reported medication compliance.Mixed models and Cox's regression using up to 24 months of follow-up data showed no significant differences in treatment effect in 10 of 12 subgroups on psychiatric symptoms, quality of life, or time to hospitalization. With adjustment for multiple comparisons, treatment effect differed by race on substance use outcomes, with white participants showing more benefit from LAI than other groups.LAI risperidone showed no superiority to psychiatrist's choice of oral treatment in most clinically defined subgroups, although the white patients benefited more than the other groups on substance abuse outcomes. PMID:24375206

Leatherman, Sarah M; Liang, Matthew H; Krystal, John H; Lew, Robert A; Valley, Danielle; Thwin, Soe Soe; Rosenheck, Robert A

2014-01-01

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Comparative Effectiveness of Risperidone Long-Acting Injectable vs First-Generation Antipsychotic Long-Acting Injectables in Schizophrenia : Results From a Nationwide, Retrospective Inception Cohort Study  

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Objective: To compare in a generalizable sample/setting objective outcomes in patients receiving first-generation antipsychotic long-acting injectables (FGA-LAIs) or risperidone-LAI (RIS-LAI). Methods: Nationwide, retrospective inception cohort study of adults with International Classification of Diseases-10 schizophrenia using Danish registers from 1995 to 2009 comparing outcomes between clinician's/patient's choice treatment with FGA-LAIs or RIS-LAI. Primary outcome was time to psychiatric hospitalization using Cox-regression adjusting for relevant covariates. Secondary outcomes included time to all-cause discontinuation and psychiatric hospitalization in patients without LAI possession gap >28 days, and number of bed-days after psychiatric hospitalization. Results: Among 4532 patients followed for 2700 patient-years, 2078 received RIS-LAI and 2454 received FGA-LAIs (zuclopenthixol decanoate = 52.2%, perphenazine decanoate = 37.2%, haloperidol decanoate = 5.0%, flupenthixol decanoate = 4.4%, fluphenazine decanoate = 1.3%). RIS-LAI was similar to FGA-LAIs regarding time to hospitalization (RIS-LAI = 246.2±323.7 days vs FGA-LAIs = 276.6±383.3 days; HR = 0.95, 95% confidence interval (CI) = 0.87-1.03, P = 0.199) and time to all-cause discontinuation (RIS-LAI = 245.8±324.0 days vs FGA-LAIs = 287.0±390.9 days; HR = 0.93, 95% CI = 0.86-1.02, P = 0.116). Similarly, in patients without LAI discontinuation, RIS-LAI and FGA-LAIs did not differ regarding time to hospitalization (RIS-LAI = 175.0±268.1 days vs FGA-LAIs = 210.7±325.3 days; HR = 0.95, 95% CI = 0.86-1.04, P = 0.254). Finally, duration of hospitalization was also similar (incidence rate ratio = 0.97, 95% CI = 0.78-1.19, P = 0.744). Results were unchanged when analyzing only patients treated after introduction of RIS-LAI. Conclusions: In this nationwide cohort study, RIS-LAI was not superior to FGA-LAIs regarding time to psychiatric hospitalization, all-cause discontinuation, and duration of hospitalization. Given the cost of hospitalization and second-generation antipsychotic (SGA)-LAIs, these findings require consideration when making treatment choices, but also need to be balanced with the individual relevance of adverse effects/patient centered outcomes. In future, head-to-head trials and additional nationwide database studies including other SGA-LAIs is needed.

Nielsen, Jimmi; Jensen, Signe O W

2014-01-01

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A model-based approach to characterize the population pharmacokinetics and the relationship between the pharmacokinetic and safety profiles of RBP-7000, a new, long-acting, sustained-released formulation of risperidone.  

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RBP-7000 is a sustained-release (once-monthly injection for subcutaneous administration) formulation of risperidone using the ATRIGEL® Delivery System, developed for treatment of schizophrenia to address compliance issues associated with oral administration. The objective of this analysis was to report the results of a population pharmacokinetic analysis and to describe the relationship between risperidone and 9-hydroxyrisperidone levels with dopamine (DA) D2-receptor occupancy, prolactin levels, and adverse events using data collected in 45 clinically stable schizophrenic patients receiving RBP-7000 in single ascending doses (risperidone) of 60, 90, and 120?mg. The population PK model accounted for an initial peak, a delayed and slow delivery, the disposition of risperidone, and the conversion of risperidone to 9-hydroxyrisperidone. BMI was a covariate affecting absorption of risperidone and ultimately formation of 9-hydroxyrisperidone. A logistic analysis indicated a correlation between the increase in Active Moiety (risperidone?+?9-OH-risperidone) exposure (Cmax ) and the probability of observing GI disorders. An Emax population PK/prolactin model best described the relationship between the circulating Active Moiety and the serum prolactin levels. Gender was a significant covariate associated with Emax . These data provided a comprehensive characterization of the relationship between circulating Active Moiety and the efficacy/safety profile of RBP-7000 in clinically stable schizophrenic patients. PMID:23868656

Gomeni, R; Heidbreder, C; Fudala, P J; Nasser, A F

2013-10-01

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Cost-effectiveness of long-acting injectable risperidone versus flupentixol decanoate in the treatment of schizophrenia: a Markov model parameterized using administrative data.  

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We use longitudinal patient-level data from a German sickness fund with 7.26 million insured in a Markov-simulation model to assess the cost-effectiveness of long-acting injectable risperidone (LAI-RIS) compared with long-acting injectable flupentixol (LAI-FLX) in the long-term management of schizophrenia. We simulate treatment costs from the payer's perspective, hospitalization, the probability to be prescribed co-medication, and treatment discontinuation over a 2-year time horizon. Model inputs were derived from 935 patients hospitalized with schizophrenia between 2005 and 2008 who received either LAI-RIS or LAI-FLX for at least 1 month. After 2 years, 89.4% (95.8%) of patients who were initiated on LAI-RIS (LAI-FLX) discontinued the initial regimen. The number of days spent in hospital per month and patient was slightly lower with LAI-RIS (1.08 vs. 1.28 days, pdecision-maker's point of view, the use of health insurance data as a source of input for decision models appears to be a reasonable alternative to models driven by clinical data only. PMID:23420082

Frey, Simon; Linder, Roland; Juckel, Georg; Stargardt, Tom

2014-03-01

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Relapse prevention in schizophrenia and schizoaffective disorder with risperidone long-acting injectable vs quetiapine: results of a long-term, open-label, randomized clinical trial.  

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Chronic management of schizophrenia and schizoaffective disorders is frequently complicated by symptomatic relapse. An open-label, randomized, active-controlled, 2-year trial evaluated 710 patients with schizophrenia or related disorders who were switched from stable treatment with oral risperidone, olanzapine, or conventional neuroleptics to risperidone long-acting injectable (RLAI) or oral quetiapine. Primary effectiveness evaluation was time-to-relapse. Safety evaluations included adverse events (AEs) reported for the duration of the study, Extrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests, and vital signs. A total of 666 patients (n=329 RLAI, n=337 quetiapine) were evaluable for effectiveness measures. Baseline demographics were similar between treatment groups. Kaplan-Meier estimate of time-to-relapse was significantly longer with RLAI (p<0.0001). Relapse occurred in 16.5% of patients with RLAI and 31.3% with quetiapine. RLAI and quetiapine were both safe and well tolerated. Weight gain affected 7% of patients with RLAI and 6% with quetiapine, with mean end point increases of 1.25±6.61 and 0±6.55?kg, respectively. There were no significant between-group differences in weight gain. ESRS total scores decreased similarly after randomization to either RLAI or quetiapine. Extrapyramidal AEs occurred in 10% of patients with RLAI and 6% with quetiapine. Treatment-emergent potentially prolactin-related AEs were reported in 15 (5%) patients with RLAI and 5 (2%) patients with quetiapine; hyperprolactinemia was reported in 43 (13.1%) patients with RLAI and 5 (1.5%) patients with quetiapine. Somnolence occurred in 2% of patients with RLAI and 11% with quetiapine. To our knowledge, this is the first report of a randomized clinical trial directly comparing relapse prevention with a second-generation long-acting injectable antipsychotic and oral therapy. Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder was significantly longer in patients randomized to RLAI compared with those randomized to oral quetiapine. Both antipsychotics were generally well tolerated. PMID:20686456

Gaebel, Wolfgang; Schreiner, Andreas; Bergmans, Paul; de Arce, Rosario; Rouillon, Frédéric; Cordes, Joachim; Eriksson, Lars; Smeraldi, Enrico

2010-11-01

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Risperidone long-acting injection in the treatment of schizophrenia: 24-month results from the electronic Schizophrenia Treatment Adherence Registry in Canada  

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Full Text Available Richard Williams,1 Ranjith Chandrasena,2 Linda Beauclair,3 Doanh Luong,4 Annette Lam4 On behalf of the e-STAR study group 1Vancouver Island Health Authority, Victoria, BC, Canada; 2Chatham-Kent Health Alliance, Chatham, ON, Canada; 3Allan Memorial Institute, Montreal, QC, Canada; 4Janssen Inc., Toronto, ON, Canada Objective: To assess outcomes over 24 months in Canadian patients with schizophrenia initiated on risperidone long-acting injection (RLAI and participating in the electronic Schizophrenia Treatment Adherence Registry (e-STAR. Materials and methods: Patients with schizophrenia or schizoaffective disorder were enrolled from 24 sites after an independent decision to initiate RLAI. Subsequent patient management was based on usual clinical practice at each site and was not protocol-driven. Relevant data were collected retrospectively by chart review for 12 months prior to RLAI and prospectively for 24 months following RLAI initiation. Results: Patients (n=188 had a mean age of 39.2 years, were 66.3% male, and 27.7% were inpatients at baseline. Twenty-four months after initiating therapy (initial dose =28.7 mg, 34.1% (95% confidence interval 27.2%–42.2% of patients had discontinued RLAI with a mean time to discontinuation of 273.4±196 days. Over the treatment period, there were significant (P<0.001 changes from baseline in Clinical Global Impression-Severity (CGI-S; 3.48 versus [vs] 4.31 at baseline, Global Assessment of Functioning (GAF; 56.1 vs 48.1, and Personal and Social Performance (PSP; 59.1 vs 46.9 scale scores. In addition, after 12 months, there were significant (P<0.001 decreases in the percentage of patients hospitalized (23.9% vs 58.5% pre-RLAI, mean length of stay (11.4 vs 30.4 days, and number of hospitalizations (0.32 vs 0.87 compared to the 12-month pre-RLAI period. Reductions in hospitalization continued into the second 12 months of therapy, when only 9% of patients were hospitalized and mean length of stay was 2.0 days. Conclusion: In a routine clinical practice setting, patients switched to RLAI showed significant improvements in clinical outcomes and in global and social functioning, and hospitalization was significantly reduced. The data confirm that RLAI provides effective long-term management of schizophrenia in Canada. Keywords: schizophrenia, Canada, risperidone long-acting injection, e-STAR

Williams R

2014-02-01

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Long-acting injectable risperidone and oral antipsychotics in patients with schizophrenia: results from a prospective, 1-year, non-interventional study (InORS).  

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Abstract Objective. To explore differences in outcomes for patients with schizophrenia treated with risperidone long-acting treatment (RLAT) or oral antipsychotics (oAP). Methods. The International Observational Registry on Schizophrenia (InORS) explored flexible doses of newly initiated RLAT and oAPs for adults with schizophrenia, exploring 6-month retrospective hospitalization data and 12-month prospective medication use, outcomes, and tolerability. Efficacy outcomes included hospitalizations, the Clinical Global Impression of Schizophrenia (CGI-SCH), and the Global Assessment of Functioning (GAF). Medication switch patterns were also analysed. Results. Data were analysed from 1083 patients (561 RLAT, 522 oAP). At baseline, RLAT patients had higher symptom severity, greater functional impairment, and poorer compliance. Percentages of patients hospitalized were similar between groups, and median duration per hospitalization decreased after RLAT initiation and with oAP. The difference in duration of hospitalization between the retrospective and prospective period was significantly better with RLAT (P = 0.002). Mean CGI-SCH change from baseline was significantly better for RLAT vs. oAP patients for overall, positive, and negative symptom scores (P < 0.05). Mean functional improvement from baseline was significantly higher with RLAT vs. oAP (P < 0.001). Conclusions. Hospitalizations and symptomatic and functional outcomes were better with RLAT vs. oAP; frequent medication switches were associated with less favourable outcomes. PMID:24779526

Schreiner, Andreas; Svensson, Anders; Wapenaar, Robert; Cherubin, Pierre; Princet, Patricia; Serazetdinova, Larisa; Zink, Mathias

2014-09-01

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Risperidone or Aripiprazole in Children and Adolescents with Autism and/or Intellectual Disability: A Bayesian Meta-Analysis of Efficacy and Secondary Effects  

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Second-generation antipsychotics (SGAs) induce frequent adverse effects in children and adolescents with each compound appearing to have a specific adverse effect profile. Aripiprazole and risperidone are FDA-approved medications for behavioral disturbances associated with autism and/or intellectual disabilities (ID) in children and adolescents.…

Cohen, David; Raffin, Marie; Canitano, Roberto; Bodeau, Nicolas; Bonnot, Olivier; Perisse, Didier; Consoli, Angele; Laurent, Claudine

2013-01-01

 
 
 
 
41

Effect of acute and chronic treatment with risperidone on the serotonin and dopamine receptors in the rat brain  

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The therapeutic efficacy of antipsychotic drugs is generally attributed to their ability to block dopamine D{sub 2} receptors. Classical D{sub 2} antagonists are not effective to treat negative symptoms and produce extrapyramidal side effects. On the other hand, atypical antipsychotic agents ameliorate negative symptoms without producing extrapyramidal side effects, and it is reported to be associated with blockade of serotonin 5-HT{sub 2} receptors. The purpose of this study was to evaluate the effect of risperidone on neuroreceptors in the rat brain by quantitative autoradiography method. In acute treatment group, risperidone was injected into peritoneal cavity of male Wistar rats with dose of 0, 0.1, 0.25, 0.5, 1.0 and 2.0mg/kg in each group (5/group), and they were decapitated after 2 hours. In chronic treatment group, risperidone was injected with dose of 0, 0.1, and 1m/kg (I.P.) for 21 ays and decapitated after 24 hours following last treatment. The effect of risperodone on the binding of [{sup 3}H) spiperone to 5-HT{sub 2} and D{sub 2} receptors were analysed in 4 discrete regions of the striatum, nucleus accumbens, and frontal cortex by quantitative autoradiography. Acute treatment with risperidone reduced cortical 5-HT{sub 2} specific [{sup 3}H]spiperone binding to 32% of vehicle-treated control. Subcortical 5-HR{sub 2} specific [{sup 3}H]spiperone binding was not affected at all dose groups whereas a significant reduction (57%) in D{sub 2} specific [{sup 3}H]spiperone binding was observed in risperidone treated group at doses of 1-2mg/kg. Chronic treatment with risperidone produced a decrease in the maximal number of cortical 5-HT{sub 2} receptors to 51% and 46% of control in 0.1mg/kg and 1mg/kg treated group respectively. In conclusion, risperidone is a cortical serotonin receptor antagonist with relatively weak antagonistic action on dopamine receptors. These effects on neuroreceptors may explain the therapeutic effect of risperidone as a atypical antipsychotic agents.

Choi, Yun Young; Moon, Dae Hyuk; Son, Hye Kyung; Kim, Chang Yoon; Lee, Chul; Lee, Hee Kyung [College of Medicine, Ulsan Univ., Seoul (Korea, Republic of)

1997-03-01

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Effect of acute and chronic treatment with risperidone on the serotonin and dopamine receptors in the rat brain  

International Nuclear Information System (INIS)

The therapeutic efficacy of antipsychotic drugs is generally attributed to their ability to block dopamine D2 receptors. Classical D2 antagonists are not effective to treat negative symptoms and produce extrapyramidal side effects. On the other hand, atypical antipsychotic agents ameliorate negative symptoms without producing extrapyramidal side effects, and it is reported to be associated with blockade of serotonin 5-HT2 receptors. The purpose of this study was to evaluate the effect of risperidone on neuroreceptors in the rat brain by quantitative autoradiography method. In acute treatment group, risperidone was injected into peritoneal cavity of male Wistar rats with dose of 0, 0.1, 0.25, 0.5, 1.0 and 2.0mg/kg in each group (5/group), and they were decapitated after 2 hours. In chronic treatment group, risperidone was injected with dose of 0, 0.1, and 1m/kg (I.P.) for 21 ays and decapitated after 24 hours following last treatment. The effect of risperodone on the binding of [3H) spiperone to 5-HT2 and D2 receptors were analysed in 4 discrete regions of the striatum, nucleus accumbens, and frontal cortex by quantitative autoradiography. Acute treatment with risperidone reduced cortical 5-HT2 specific [3H]spiperone binding to 32% of vehicle-treated control. Subcortical 5-HR2 specific [3H]spiperone binding was not affected at all dose groups whereas a significant reduction (57%) in D2 specific [3H]spiperone binding was observed in risperidone treated group at doses of 1-2mg/kg. Chronic treatment with risperidone produced a decrease in the maximal number of cortical 5-HT2 receptors to 51% and 46% of control in 0.1mg/kg and 1mg/kg treated group respectively. In conclusion, risperidone is a cortical serotonin receptor antagonist with relatively weak antagonistic action on dopamine receptors. These effects on neuroreceptors may explain the therapeutic effect of risperidone as a atypical antipsychotic agents

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Managing knee ostheoarthritis: efficacy of hyaluronic acid injections.  

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Osteoarthritis (OA) is the most common form of chronic arthritis worldwide. The etiology of pain in osteoarthritis is multifactoral, and includes mechanical and inflammatory processes. The use of intra-articular viscosupplementation in the nonoperative management of patients with osteoarthritis has become quite popular. Recent clinical data have demonstrated that the anti-inflammatory and chondroprotective actions of hyaluronic acid viscosupplementation reduce pain, from 4 to 14 weeks after injection, while improving patient function. Viscosupplements are comparable in efficacy to systemic forms of active intervention, with more local reactions but fewer systemic adverse events, and hyaluronic acid has more prolonged effects than IA corticosteroids. Although several randomized controlled trials have established the efficacy of this treatment modality, additional high quality randomized control studies with appropriate comparison are still required to clearly define the role of intra-articular hyaluronic acid injections in the treatment of osteoarthritis. We review the basic science and development of viscosupplementation and discuss the mounting evidence in support of its efficacy and safety profile. PMID:24149011

Roque, V; Agre, M; Barroso, J; Brito, I

2013-01-01

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Efficacy of adjunctive intravitreous injection with Lucentis for neovascular glaucoma  

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Full Text Available AIM: To observe the clinical efficacy of adjunctive intravitreous injection with Lucentis for the treatment of neovascular glaucoma(NVG. METHODS: The retrospective case series study included 25 eyes of 25 patients who underwentintravitreous injection with Lucentis. Patients firstly received an intravitreous injection with Lucentis(0.5mg/0.05mL, after the regression of neovascularization of the iris, patients accepted different surgical treatments according to different etiopathogenesis condition. Iris, chamber angle neovascularization condition, intraocular pressure, and visual acuity were observed postoperatively. The follow-up duration was 3mo.RESULTS: After 3-7d of intravitreous Lucentis injecting, iris and chamber angle neovascularization was totally faded in 20 cases(20 eyesand was not completely faded in 5 cases(5 eyes. Additional treatments were compound trabeculectomy(14 cases, 14 eyes, vitrectomy(4 cases, 4 eyes. The patients' mean intraocular pressure was 43.42±10.99mmHg before treatment, which decreased rapidly when they came out of the hospital(14.26±7.64mmHg, PPCONCLUSION:Intravitreous injection with Lucentis can be used as an assisted treatment of NVG. According to different etiopathogenesis condition, it is an effective treatment to combine with other treatment methods for NVG.

Rui-Dong Gu

2014-06-01

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Changes in plasma concentrations of risperidone and 9-hydroxyrisperidone and the associated clinical effects during the switch from oral risperidone to extended-release paliperidone tablets in patients with schizophrenia.  

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This study aimed to investigate changes in plasma concentrations of risperidone and 9-hydroxy-risperidone (9-OHR) and the associated clinical effects when switching from oral risperidone to extended-release (ER) paliperidone in patients with schizophrenia. This study included 25 patients with schizophrenia. Following a one-week screening period with a stable dose of risperidone, a six-week open-label switch study from risperidone to extended-release paliperidone (paliperidone ER) was conducted. Efficacy and safety assessments were performed on Day 1 and at Weeks 1, 2, 4, and 6. Plasma levels of the active fractions of oral risperidone and paliperidone ER were measured on Day 1 and at Week 1, respectively. Plasma levels of the active moiety (risperidone plus 9-OHR) while taking risperidone (mean dose: 4.0 mg) were significantly higher than plasma levels of 9-OHR while taking 6 mg of paliperidone ER. For 12 subjects taking only 3 mg of risperidone, plasma concentrations of the active moiety of risperidone were also significantly higher than those of 9-OHR while taking 6 mg of paliperidone ER. The amount of reduction in plasma levels was correlated with a temporal deterioration of clinical symptoms. These findings suggest that for patients with schizophrenia taking 3 mg or more of risperidone, an initial switching dose of 6 mg of paliperidone ER may be relatively low in terms of subsequent plasma concentrations and the associated clinical response. PMID:24346811

Yang, Dong Suk; Seong, Sook Jin; Yoon, Young-Ran; Lim, Mi-Sun; Kwak, Kyung-Hwa; Lee, Seung Jae

2014-04-01

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A Comparative Study between Olanzapine and Risperidone in the Management of Schizophrenia  

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Introduction. Since a variety of comparisons between risperidone and olanzapine have resulted in diverse outcomes, so safety and efficacy of them were compared again in a new trial. Method. Sixty female schizophrenic patients entered into one of the assigned groups for random allocation to olanzapine or risperidone (n = 30 in each group) in a double-blind, 12-week clinical trial. Scale for Assessment of Positive Symptoms (SAPS) and Scale for Assessment of Negative Symptoms (SANS) were used as the primary outcome measures. Clinical Global Impressions-Severity Scale (CGI-S), Schedule for Assessment of Insight (SAI), and finally Simpson Angus Scale (SAS) as well were employed as secondary scales. Results. While both of olanzapine and risperidone were significantly effective for improvement of positive symptoms (P olanzapine (P olanzapine and risperidone were equally effective for improvement of positive symptoms and insight, olanzapine showed superior efficacy with respect to negative symptoms, along with lesser extrapyramidal side effects, in comparison with risperidone. PMID:25247096

Shoja Shafti, Saeed; Gilanipoor, Mahsa

2014-01-01

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Effectiveness of long-acting injectable risperidone versus oral antipsychotics in the treatment of recent-onset schizophrenia: a case-control study.  

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Long-acting injectable antipsychotics may offer a relevant improvement in treatment adherence in recent-onset psychosis, leading to a decreased rate of hospital readmission, a better rate of clinical remission and improved psychosocial adjustment. The aim of the study was to compare the clinical remission rates, number of hospital readmissions and personal and social functioning after 2 years between patients with recent-onset schizophrenia (long-acting injectable (RLAI) and patients with recent-onset schizophrenia receiving oral antipsychotics. This is a case-control study comparing patients with recent-onset schizophrenia who initiated RLAI treatment between 2004 and 2008 (n=26) with a control group matched for age and sex, diagnosed with recent-onset schizophrenia and treated with oral antipsychotics (n=26). Study assessments included sociodemographic variables, the Positive and Negative Syndrome Scale, the Personal and Social Functioning Scale, the number of hospital readmissions and the Andreasen remission criteria. To assess the effect of treatment on each dependent variable, separate generalized estimating equations models were constructed. After 2 years of treatment, and adjusting for educational level, the RLAI group showed a greater reduction in the Positive and Negative Syndrome Scale total scale [mean (SD)=47.7 (12.0) vs. 66.2 (18.5); mean difference =-17.56; 95% confidence interval (CI)=-27.11 to -8.00; Pantipsychotic group. Personal and Social Functioning Scale scores were also higher in the RLAI group [mean (SD)=72.4 (14.8) vs. 59.7 (13.5); mean difference=13.41; 95% CI=5.65-21.18; Pantipsychotics in recent-onset schizophrenia might improve clinical symptoms and social functioning. The efficacy of RLAI treatment on remission and readmission rates should be researched further. PMID:23587986

Barrio, Pablo; Batalla, Albert; Castellví, Pere; Hidalgo, Diego; García, Marta; Ortiz, Ana; Grande, Iria; Pons, Alexandre; Parellada, Eduard

2013-07-01

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Formulation, in vitro and in vivo evaluation of transdermal patches containing risperidone.  

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The efficacy of oral risperidone treatment in prevention of schizophrenia is well known. However, oral side effects and patient compliance is always a problem for schizophrenics. In this study, risperidone was formulated into matrix transdermal patches to overcome these problems. The formulation factors for such patches, including eudragit RL 100 and eudragit RS 100 as matrix forming polymers, olive oil, groundnut oil and jojoba oil in different concentrations as enhancers and amount of drug loaded were investigated. The transdermal patches containing risperidone were prepared by solvent casting method and characterized for physicochemical and in vitro permeation studies through excised rat skin. Among the tested preparations, formulations with 20% risperidone, 3:2 ERL 100 and ERS 100 as polymers, mixture of olive oil and jojoba oil as enhancer, exhibited greatest cumulative amount of drug permeated (1.87 ± 0.09 mg/cm(2)) in 72 h, so batch ROJ was concluded as optimized formulation and assessed for pharmacokinetic, pharmacodynamic and skin irritation potential. The pharmacokinetic characteristics of the optimized risperidone patch were determined using rabbits, while orally administered risperidone in solution was used for comparison. The calculated relative bioavailability of risperidone transdermal patch was 115.20% with prolonged release of drug. Neuroleptic efficacy of transdermal formulation was assessed by rota-rod and grip test in comparison with control and marketed oral formulations with no skin irritation. This suggests the transdermal application of risperidone holds promise for improved bioavailability and better management of schizophrenia in long-term basis. PMID:22335586

Aggarwal, Geeta; Dhawan, Sanju; Hari Kumar, S L

2013-01-01

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Long-acting risperidone: a review of its role in the treatment of bipolar disorder.  

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Bipolar disorder is a multidimensional illness typified by fluctuating periods of depression and mania, cognitive dysfunction, abnormal circadian rhythms, and multiple comorbid psychiatric and general medical conditions. Indefinite pharmacological treatment is often required, yet the modest effects of available treatments and frequent difficulties with tolerability and adherence present complex challenges to patients. Long-acting injectable medications offer a therapeutic alternative to oral mood stabilizers and may help facilitate long-term treatment adherence. This article will provide a succinct review of the latest data on the use of long-acting injectable risperidone (LAR) during the maintenance-phase treatment of bipolar disorder. The specific role of LAR in comparison to other atypical antipsychotics, and the limitations of available studies will be discussed from the perspectives of efficacy, tolerability, and sequential positioning in treatment guidelines. PMID:19562274

Kemp, David E; Canan, Fatih; Goldstein, Benjamin I; McIntyre, Roger S

2009-06-01

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[Efficacy of praziquantel injectable solution against feline and canine tapeworms.].  

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Praziquantel, which has been used in the treatment and control of canine and feline tapeworm infections for about 35 years, has not been tested against these parasites for a long period in Turkey. This study was performed to evaluate the current efficacy of praziquantel against dog and cat tapeworms. Praziquantel injectable solution was administered to 26 dogs (14 of them were infected with Dipylidium caninum, 8 with Taenia spp and 2 with Echinococcus granulosus, 2 with both Dipylidium caninum and Taenia spp) and 2 cats (infected with Joyeuxiella pasqualei) subcutaneously at a dose of 0.1 ml/kg (5.68 mg active ingredient/kg). After treatment, animals were put in individual cages and their feces were taken daily for examination. Feces were examined macroscopically for tapeworm segments and scolexes and microscopically for tapeworm eggs by Fülleborn's flotation and Teleman's sedimentation (for fatty stools). To confirm results of analysis the examinations after treatment were repeated until two subsequent fecal analyses were negative. The parasites disappeared from the feces of all infected animals in 2 or 3 days after the treatment and the drug was found to be 100% effective against both dog and cat tapeworms. No adverse reactions were observed in both dogs and cats treated. PMID:20340081

Tüzer, Erkut; Bilgin, Zahide; Oter, Kerem; Erçin, Süleyman; Tinar, Recep

2010-01-01

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Efficacy of Endoscopic Injection Sclerotherapy for Rectal Varices  

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Full Text Available AIM: The study's aim was to evaluate the efficacy of endoscopicinjection sclerotherapy (EIS in treating rectal varices.METHODS: Data from 32 consecutive patients who underwentEIS for rectal varices were analyzed the clinical outcomes, includingcomplications related to EIS. EIS was performed weekly using 5%ethanolamine oleate with iopamidol, which was injected to rectalvarices intermittently under fluoroscopy.RESULTS: In all 32 patients, EIS was performed weekly 2 to 5times (mean, 2.7, and the total amount of sclerosant ranged from3.2 to 12.0 mL (mean, 5.3 mL. After EIS, colonoscopy revealedshrinkage of the rectal varices in all 32 patients. There were noserious complications such as portal thrombosis and peritonitis.Colonoscopy revealed oozing bleeding from ulcers after EIS,however, no additional treatments were required. The recurrence ratefor rectal varices was 6 of 25 (24.0% receiving EIS, over a 1-yearfollow-up period. The recurrence of bleeding was only one patient.CONCLUSION: EIS is useful and safety treatment for rectal variceswith regard to effectiveness and complications.

Takahiro Sato

2013-01-01

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Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly Eficácia e segurança de risperidona solução oral na agitação associada a demência em idosos  

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Full Text Available BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To evaluate efficacy and tolerability of risperidone oral solution (ROS given once daily to demented elderly outpatients with BPSD (agitation. METHOD: Patients (n=26, 76.35±8.63 years, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D and Clinical Global Impression (CGI measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.FUNDAMENTOS: Sintomas psicológicos e do comportamento nas demências (BPSD contribuem para a sobrecarga dos cuidadores e institucionalização dos idosos. Neurolépticos são prescritos para agitação. Efeitos colaterais dos típicos são prejudiciais, sendo os atípicos indicáveis. OBJETIVO: Avaliar eficácia e tolerabilidade da risperidona solução oral (RSO, dose única diária, em idosos demenciados ambulatoriais com BPSD (agitação. MÉTODO: Pacientes (n=26, 76,35±8,63 anos, critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais 4.ed. (DSM-IV para demência. RSO administrada, com dose inicial de 0,25 mg e incrementos de 0,25 mg toda semana. Foram utilizados mini-mental (MEEM para estado cognitivo, behavioral and emotional activities manifested in dementia (BEAM-D e clinical and global impression (CGI para BPSD, extrapyramidal symptom rating scale (ESRS para sintomas extrapiramidais. Efeitos colaterais cardiovasculares foram avaliados clinicamente. RESULTADOS: Houve redução de 26% na agitação, sem efeitos colaterais cardiovasculares, numa faixa de 1,0 a 1,25 mg. Efeitos colaterais foram mais prevalentes acima de 2,5 mg. CONCLUSÃO: Risperidona melhorou agitação com boa tolerabilidade entre 0,5 e 1,25 mg. Dose única diária e aumentos de 0,25 mg podem ser mais aceitáveis para pacientes e cuidadores.

Jerson Laks

2001-12-01

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Efficacy and safety of risperidone oral solution in agitation associated with dementia in the elderly / Eficácia e segurança de risperidona solução oral na agitação associada a demência em idosos  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: English Abstract in portuguese FUNDAMENTOS: Sintomas psicológicos e do comportamento nas demências (BPSD) contribuem para a sobrecarga dos cuidadores e institucionalização dos idosos. Neurolépticos são prescritos para agitação. Efeitos colaterais dos típicos são prejudiciais, sendo os atípicos indicáveis. OBJETIVO: Avaliar eficác [...] ia e tolerabilidade da risperidona solução oral (RSO), dose única diária, em idosos demenciados ambulatoriais com BPSD (agitação). MÉTODO: Pacientes (n=26), 76,35±8,63 anos, critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais 4.ed. (DSM-IV) para demência. RSO administrada, com dose inicial de 0,25 mg e incrementos de 0,25 mg toda semana. Foram utilizados mini-mental (MEEM) para estado cognitivo, behavioral and emotional activities manifested in dementia (BEAM-D) e clinical and global impression (CGI) para BPSD, extrapyramidal symptom rating scale (ESRS) para sintomas extrapiramidais. Efeitos colaterais cardiovasculares foram avaliados clinicamente. RESULTADOS: Houve redução de 26% na agitação, sem efeitos colaterais cardiovasculares, numa faixa de 1,0 a 1,25 mg. Efeitos colaterais foram mais prevalentes acima de 2,5 mg. CONCLUSÃO: Risperidona melhorou agitação com boa tolerabilidade entre 0,5 e 1,25 mg. Dose única diária e aumentos de 0,25 mg podem ser mais aceitáveis para pacientes e cuidadores. Abstract in english BACKGROUND: Behavioral and psychological symptoms in dementia (BPSD) contribute to caregiver burden and institutionalization of elderly. Neuroleptics are prescribed to control agitation. Side effects of typical neuroleptics are harmful, making atypical neuroleptics an indication. OBJECTIVES: To eval [...] uate efficacy and tolerability of risperidone oral solution (ROS) given once daily to demented elderly outpatients with BPSD (agitation). METHOD: Patients (n=26), 76.35±8.63 years, Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) criteria for dementia. RSO was given, starting dose of 0.25 mg and increments of 0.25 mg every week. Mini-Mental State Examination (MMSE) assessed cognitive status, Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) and Clinical Global Impression (CGI) measured BPSD, Extrapiramidal Symptom Rating Scale (ESRS) evaluated extrapyramidal symptoms. Cardiovascular side effects were evaluated clinically. RESULTS: There was a 26% reduction in agitation and no cardiovascular side effects in the range from 1.0 to 1.25 mg. Side effects were more prevalent above 2.5 mg. CONCLUSION: Risperidone oral solution improved agitation with good tolerability from 0.5 to 1.25 mg. A single dose with increments of 0.25 mg may be more acceptable to patients and caregivers.

Jerson, Laks; Eliasz, Engelhardt; Valeska, Marinho; Marcia, Rozenthal; Fernando de Castro e, Souza; Josué, Bacaltchuk; Alberto, Stoppe Jr.; R.C.R., Ferreira; Cassio, Bottino; Mônica, Scalco.

2001-12-01

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Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis  

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Full Text Available Abstract Background To compare the efficacy and tolerability of paliperidone extended-release (ER with risperidone immediate-release using propensity score methodology. Methods Six double-blind, randomized, placebo-controlled, short-term clinical trials for acute schizophrenia with availability of individual patient-level data were identified (3 per compound. Propensity score pairwise matching was used to balance observed covariates between the paliperidone ER and risperidone patient populations. Scores were generated using logistic regression models, with age, body mass index, race, sex, baseline Positive and Negative Syndrome Scale (PANSS total score and baseline Clinical Global Impressions–Severity (CGI-S score as factors. The dosage range of paliperidone ER (6-12 mg/day was compared with 2 risperidone dosage ranges: 2-4 and 4-6 mg/day. The primary efficacy measure was change in PANSS total score at week 6 end point. Tolerability end points included adverse event (AE reports and weight. AEs with rates ?5% and with a ?2% difference between paliperidone ER and risperidone were identified. Results Completion rates for placebo-treated subjects in paliperidone ER trials (n = 95 and risperidone trials (n = 122 groups were 36.8% and 51.6%, respectively; end point changes on PANSS total scores were similar (p = 0.768. Completion rates for subjects receiving paliperidone ER 6-12 mg/day (n = 179, risperidone 2-4 mg/day (n = 113 or risperidone 4-6 mg/day (n = 129 were 64.8%, 54.0% and 66.7%, respectively (placebo-adjusted rates: paliperidone ER vs risperidone 2-4 mg/day, p = 0.005; paliperidone ER vs risperidone 4-6 mg/day, p = 0.159. PANSS total score improvement with paliperidone ER was greater than with risperidone 2-4 mg/day (difference in mean change score, -6.7; p Conclusions This indirect database analysis suggested that paliperidone ER 6-12 mg/day may be more efficacious than risperidone 2-4 mg/day and as efficacious as risperidone 4-6 mg/day. The AE-adjusted incidence rates suggest differences between treatments that may be relevant for individual patients. Additional randomized, direct, head-to-head clinical trials are needed to confirm these findings.

Schooler Nina

2011-02-01

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Risperidone versus other atypical antipsychotics for schizophrenia  

Science.gov (United States)

Background In many countries of the industrialised world second-generation (“atypical”) antipsychotics (SGAs) have become the first line drug treatment for people with schizophrenia. The question as to whether and if so how much the effects of the various SGAs differ is a matter of debate. In this review we examined how the efficacy and tolerability of risperidone differs from that of other SGAs. Objectives To evaluate the effects of risperidone compared with other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychosis. Search methods 1. Electronic searching We searched the Cochrane Schizophrenia Group Trials Register (April 2007) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. 2. Reference searching We inspected the references of all identified studies for more trials. 3. Personal contact We contacted the first author of each included study for missing information. 4. Drug companies We contacted the manufacturers of all atypical antipsychotics included for additional data. Selection criteria We included all randomised, blinded trials comparing oral risperidone with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychosis. Data collection and analysis We extracted data independently. For dichotomous data we calculated risk ratio (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated mean differences (MD), again based on a random-effects model. Main results The review currently includes 45 blinded RCTs with 7760 participants. The number of RCTs available for each comparison varied: four studies compared risperidone with amisulpride, two with aripiprazole, 11 with clozapine, 23 with olanzapine, eleven with quetiapine, two with sertindole, three with ziprasidone and none with zotepine. Attrition from these studies was high (46.9%), leaving the interpretation of results problematic. Furthermore, 60% were industry sponsored, which can be a source of bias. There were few significant differences in overall acceptability of treatment as measured by leaving the studies early. Risperidone was slightly less acceptable than olanzapine, and slightly more acceptable than ziprasidone in this regard. Risperidone improved the general mental state (PANSS total score) slightly less than olanzapine (15 RCTs, n = 2390, MD 1.94 CI 0.58 to 3.31), but slightly more than quetiapine (9 RCTs, n = 1953, MD ?3.09 CI ?5.16 to ?1.01) and ziprasidone (3 RCTs, n = 1016, MD ?3.91 CI ?7.55 to ?0.27). The comparisons with the other SGA drugs were equivocal. Risperidone was also less efficacious than olanzapine and clozapine in terms of leaving the studies early due to inefficacy, but more efficacious than ziprasidone in the same outcome. Risperidone produced somewhat more extrapyramidal side effects than a number of other SGAs (use of antiparkinson medication versus clozapine 6 RCTs, n = 304, RR 2.57 CI 1.47 to 4.48, NNH 6 CI 33 to 3; versus olanzapine 13 RCTs, n = 2599, RR 1.28 CI 1.06 to 1.55, NNH 17 CI 9 to 100; versus quetiapine 6 RCTs, n = 1715, RR 1.98 CI 1.16 to 3.39, NNH 20 CI 10 to 100; versus ziprasidone 2 RCTs, n = 822, RR 1.42 CI 1.03 to 1.96, NNH not estimable; parkinsonism versus sertindole 1 RCT, n = 321, RR 4.11 CI 1.44 to 11.73, NNH 14 CI 100 to 8). Risperidone also increased prolactin levels clearly more than all comparators, except for amisulpride and sertindole for which no data were available. Other adverse events were less consistently reported, but risperidone may well produce more weight gain and/or associated metabolic problems than amisulpride (weight gain: 3 RCTs, n = 585, MD 0.99 CI 0.37 to 1.61), aripiprazole (cholesterol increase: 1 RCT, n = 83, MD 22.30 CI 4.91 to 39.69) and ziprasidone (cholesterol increase 2 RCTs, n = 767

Komossa, Katja; Rummel-Kluge, Christine; Schwarz, Sandra; Schmid, Franziska; Hunger, Heike; Kissling, Werner; Leucht, Stefan

2014-01-01

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POST MARKETING SURVEILLANCE STUDY ON RISPERIDONE IN PATIENTS SUFFERING FROM SCHIZOPHRENIA  

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Schizophrenia is one of the commonest psychiatric ailments. It has been estimated that approximately 1% of the population and 15% of the adults suffers from this disease. Risperidone, atypical antipsychotic, acts mainly by 5HT2 blockade action. Produce virtually no extra pyramidal side effects at low dose, has a broad efficacy. But extra pyramidal dysfunction can appear at higher doses. We conducted a post marketing surveillance study on risperidone in 40 patients suffering from schizophrenia...

Zaveri, J. R.; Vipul Chaudhari

2011-01-01

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Risperidone versus zuclopenthixol in the treatment of schizophrenia with substance abuse comorbidity: a long-term randomized, controlled, crossover study  

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Background: Substance use disorders (SUDs) are present in more than 50% of subjects diagnosed with schizophrenia. However, there are no controlled studies assessing the efficacy of antipsychotic drugs in this subgroup of patients. The aim of the present work was to compare the efficacy of risperidone and zuclopenthixol in a sample of schizophrenic subjects with dual diagnosis. Method: Thirty-three male were selected for treatment with risperidone, while another 33 were treated with zuclopenth...

Gabriel Rubio; Isabel Martínez; Ana Recio; Guillermo Ponce; Francisco López-Muñoz; Cecilio Alamo; Miguel Ángel Jiménez-Arriero; Tomás Palomo

2006-01-01

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Extrapyramidal Side Effects of Risperidone in Iranian Schizophrenic Patients  

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Full Text Available Risperidone is one of a new generation of antipsychotic drugs with relatively fewer side effects and better efficacy. Our objects were study of relationship between the incidence of Iranian produced risperidone Extrapyramidal Side Effects (EPSE and its relationship with age, sex, dosage and duration of treatment in patients with schizophrenia or schizoaffective disorders. One-hundred patients with schizophrenia or schizoaffective disorders admitted in Razi hospital of Tabriz, which underwent treatment with risperidone were selected by convenience method and the incidence of EPSE was evaluated for 6 weeks; the results were analyzed statistically. Seventy-two percent of patients showed no complications and 28% of them affected by EPSE. The incidence of complications was not related significantly with age and sex of patients but there was significant relationship between the duration of medication and dosage of drug (pv<0.05. The most EPSE were rigidity, tremor and bradykynesia, but there were not any acute dystonic reaction. Risperidone is one of the new generation antipsychotic drugs with lower side effects and its EPSE are dose-dependent. It is recommended that the treatment be initiated with minimum effective dose.

2008-01-01

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Efficacy observation of danshen injection iontophoresis treatment for vitreous hemorrhage  

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AIM: To probe into the clinical value of danshen injection iontophoresis in treatment of vitreous hemorrhage. METHODS: Eighty-eight vitreous hemorrhage patients(88 eyes)were selected from June 2012 to June 2013 in our hospital. The patients were divided into observation group and control group randomly, with 44 cases(44 eyes)in each group. The patients in control group were treated with xueshuantong clinical drug treatment. The patients in observation group were treated with danshen inject...

Jing Hao; Guang-Wei Cui

2013-01-01

60

Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.  

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There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term. PMID:24343476

Ghanizadeh, Ahmad; Haghighi, Alireza

2014-10-01

 
 
 
 
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Efficacy observation of danshen injection iontophoresis treatment for vitreous hemorrhage  

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Full Text Available AIM: To probe into the clinical value of danshen injection iontophoresis in treatment of vitreous hemorrhage. METHODS: Eighty-eight vitreous hemorrhage patients(88 eyeswere selected from June 2012 to June 2013 in our hospital. The patients were divided into observation group and control group randomly, with 44 cases(44 eyesin each group. The patients in control group were treated with xueshuantong clinical drug treatment. The patients in observation group were treated with danshen injection iontophoresis clinical drug treatment. The clinical treatment and visual recovery situations of the patients in two groups were compared and analyzed. RESULTS: The cure rate and total effective rate of observation group were 75% and 95%. The cure rate and total effective rate of control group were 59% and 77%. There were statistically significant differences(PPCONCLUSION: Danshen injection iontophoresis therapy has positive role in improving clinical outcomes and promoting visual function for patients with vitreous hemorrhage.

Jing Hao

2013-11-01

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Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR): Resultados clínicos del uso de risperidona inyectable de liberación prolongada a dos años de seguimiento / Electronic Schizophrenia Treatment Adherence Registry in Latin America (e-STAR): Clinical outcomes of long-acting injectable risperidone in a 2-year follow up  

Scientific Electronic Library Online (English)

Full Text Available SciELO Mexico | Language: Spanish Abstract in spanish La esquizofrenia genera elevados costos al sistema de salud. La falta de adherencia al tratamiento es una de las principales causas de recaídas y hospitalizaciones en la esquizofrenia. Lo anterior conduce a un pobre pronóstico y deterioro funcional de los pacientes. La risperidona inyectable de libe [...] ración prolongada (RILP) ha demostrado su eficacia en el tratamiento de la esquizofrenia, ofreciendo la posibilidad de que los pacientes tengan una mayor adherencia terapéutica. Objetivo Determinar la eficacia y efecto sobre la funcionalidad y el uso de recursos hospitalarios de la RILP en una muestra de pacientes con esquizofrenia de América Latina a dos años de seguimiento. Método El Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR) es un estudio observacional del uso de la RILP en la esquizofrenia. Se reclutaron pacientes de México, Colombia y Brasil. Se registró la información clínica del paciente un año previo al inicio del tratamiento con la RILP y de forma prospectiva cada tres meses hasta cumplir los 24 meses de seguimiento. Se registraron las hospitalizaciones y el esquema de tratamiento con la RILP. La escala de Impresión Clínica Global-Gravedad (CGI-S) se utilizó como indicador de eficacia mientras que la Escala Global de Funcionamiento (GAF) y la Escala de Desempeño Personal y Social (PSP) se utilizaron para evaluar el funcionamiento. Resultados Setenta y tres pacientes completaron los dos años de seguimiento. La proporción de pacientes hospitalizados disminuyó del 16.4 al 4.1% después de dos años de tratamiento con la RILP. El 2.7% descontinuó el tratamiento debido a falta de eficacia. Se observó una mejoría significativa en cuanto a la gravedad del padecimiento y el funcionamiento global. Discusión En la práctica clínica cotidiana, la RILP resulta ser un tratamiento a largo plazo efectivo para la esquizofrenia con el beneficio adicional de una menor utilización de recursos del sistema de salud. Abstract in english Schizophrenia is a chronic psychiatric disorder associated to high healthcare costs mainly driven by inpatient care. Lack of adherence to antipsychotic treatment is a common reason for relapse and rehospitalization leading to poor prognosis and global functional impairment of patients. Risperidone l [...] ong-acting injection (RLAI) has demonstrated its efficacy in treating symptoms of schizophrenia and offers the potential to improve adherence to treatment. Objective To determine clinical and functional efficacy of RLAI and use of health resources (eg., hospitalizations) in a 2-year follow up study among patients with schizophrenia from Latin America. Method The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is an observational study of patients who start treatment with RLAI. Data from patients recruited in Mexico, Colombia and Brazil were collected retrospectively for one year prior to baseline, at baseline and every three months for 24 months. Hospitalization rates and treatment regime were registered. Efficacy was assessed using the Clinical Global Impression of Illness-Severity Scale (CGI-S), while the Global Assessment of Functioning (GAF) and the Personal and Social Performance (PSP) were used for the evaluation of functioning. Results Seventy-three patients completed the two-year follow-up. The proportion of patients hospitalized declined from 16.4% before treatment to 4.1% after 2 years of treatment with RLAI. Only 2.7% discontinued the treatment due to lack of efficacy. Significant improvements were reported in illness severity as well as in global functioning assessed by the CGI-S, GAF and PSP scales, respectively. Discussion Our results give further support of the efficacy of RLAI for the treatment of schizophrenia. Additional to symptom severity reduction and functional recovery, improved treatment adherence and reduced hospitalization rates were observed with the use of RLAI. In a real world clinical setting, RLAI offer an

Rogelio, Apiquian; Rodrigo, Córdoba; Mario, Louzã; Ana, Fresán.

2013-02-01

63

Efficacy of injectable and oral paste formulations of ivermectin against gastrointestinal parasites in ponies.  

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A controlled test was used in ponies to compare the antiparasitic efficacy of ivermectin (22,23-dihydro-avermectin B1) in an injectable micelle solution administered IM with the efficacy of the same drug in an oral paste formulation. Parasite infections were naturally acquired in southern Louisiana. The drug was tested in both formulations at a dosage level of 0.2 mg/kg of body weight. Ivermectin in both formulations tested had an efficacy greater than 98% against Gasterophilus intestinalis and G nasalis larvae. Trichostrongylus axei, Habronema spp, Strongylus vulgaris, S. edentatus, and species of small strongyles present. Efficacy of ivermectin against Oxyuris equi larvae was 100% in the paste formulation and 93% in the injectable formulation. The ponies were less uniformly infected with S equinus, Draschia megastoma, Parascaris equorum, O equi adults, Anoplocephala perfoliata, and A magna. However, observations indicated that the drug in either formulation was also effective against these parasites, except Anoplocephala spp. PMID:6896613

Torbert, B J; Kramer, B S; Klei, T R

1982-08-01

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Risperidone versus zuclopenthixol in the treatment of schizophrenia with substance abuse comorbidity: a long-term randomized, controlled, crossover study  

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Full Text Available Background: Substance use disorders (SUDs are present in more than 50% of subjects diagnosed with schizophrenia. However, there are no controlled studies assessing the efficacy of antipsychotic drugs in this subgroup of patients. The aim of the present work was to compare the efficacy of risperidone and zuclopenthixol in a sample of schizophrenic subjects with dual diagnosis. Method: Thirty-three male were selected for treatment with risperidone, while another 33 were treated with zuclopenthixol. Substances most commonly used were alcohol, cannabis (both 82% and cocaine (32%. Patients were randomized and treated for the first six months with one antipsychotic and the second six months with the other antipsychotic. Psychopathological and clinical scales were used every two months. Participants received training on how to reduce their consumption of substances (Substance Abuse Management Module, SAMM. Results: During the first six months risperidone group patients presented fewer positive urine tests and showed better compliance with the SAMM programme. In the second period the patients treated with risperidone significantly improved their scores on the PANSS-negative subscale. Differences between the CGIs indicated that the subjects who moved from risperidone to zuclopenthixol worsened, while those who moved from zuclopenthixol to risperidone significantly improved. Conclusions: Risperidone was more effective than zuclopenthixol in improving the symptoms of schizophrenia and substance use.

Gabriel Rubio

2006-09-01

65

Risperidone versus zuclopenthixol in the treatment of schizophrenia with substance abuse comorbidity: a long-term randomized, controlled, crossover study  

Scientific Electronic Library Online (English)

Full Text Available SciELO Spain | Language: English Abstract in english Background: Substance use disorders (SUDs) are present in more than 50% of subjects diagnosed with schizophrenia. However, there are no controlled studies assessing the efficacy of antipsychotic drugs in this subgroup of patients. The aim of the present work was to compare the efficacy of risperidon [...] e and zuclopenthixol in a sample of schizophrenic subjects with dual diagnosis. Method: Thirty-three male were selected for treatment with risperidone, while another 33 were treated with zuclopenthixol. Substances most commonly used were alcohol, cannabis (both 82%) and cocaine (32%). Patients were randomized and treated for the first six months with one antipsychotic and the second six months with the other antipsychotic. Psychopathological and clinical scales were used every two months. Participants received training on how to reduce their consumption of substances (Substance Abuse Management Module, SAMM). Results: During the first six months risperidone group patients presented fewer positive urine tests and showed better compliance with the SAMM programme. In the second period the patients treated with risperidone significantly improved their scores on the PANSS-negative subscale. Differences between the CGIs indicated that the subjects who moved from risperidone to zuclopenthixol worsened, while those who moved from zuclopenthixol to risperidone significantly improved. Conclusions: Risperidone was more effective than zuclopenthixol in improving the symptoms of schizophrenia and substance use.

Gabriel, Rubio; Isabel, Martínez; Ana, Recio; Guillermo, Ponce; Francisco, López-Muñoz; Cecilio, Alamo; Miguel Ángel, Jiménez-Arriero; Tomás, Palomo.

66

Risperidone versus zuclopenthixol in the treatment of schizophrenia with substance abuse comorbidity: a long-term randomized, controlled, crossover study  

Scientific Electronic Library Online (English)

Full Text Available SciELO Spain | Language: English Abstract in english Background: Substance use disorders (SUDs) are present in more than 50% of subjects diagnosed with schizophrenia. However, there are no controlled studies assessing the efficacy of antipsychotic drugs in this subgroup of patients. The aim of the present work was to compare the efficacy of risperidon [...] e and zuclopenthixol in a sample of schizophrenic subjects with dual diagnosis. Method: Thirty-three male were selected for treatment with risperidone, while another 33 were treated with zuclopenthixol. Substances most commonly used were alcohol, cannabis (both 82%) and cocaine (32%). Patients were randomized and treated for the first six months with one antipsychotic and the second six months with the other antipsychotic. Psychopathological and clinical scales were used every two months. Participants received training on how to reduce their consumption of substances (Substance Abuse Management Module, SAMM). Results: During the first six months risperidone group patients presented fewer positive urine tests and showed better compliance with the SAMM programme. In the second period the patients treated with risperidone significantly improved their scores on the PANSS-negative subscale. Differences between the CGIs indicated that the subjects who moved from risperidone to zuclopenthixol worsened, while those who moved from zuclopenthixol to risperidone significantly improved. Conclusions: Risperidone was more effective than zuclopenthixol in improving the symptoms of schizophrenia and substance use.

Gabriel, Rubio; Isabel, Martínez; Ana, Recio; Guillermo, Ponce; Francisco, López-Muñoz; Cecilio, Alamo; Miguel Ángel, Jiménez-Arriero; Tomás, Palomo.

2006-09-01

67

A case of priapism with risperidone.  

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Priapism is a urologic emergency defined as a prolonged, possibly painful, penile erection. There are several known causes of priapism including psychotropic medications. One of the mechanisms by which antipsychotics are believed to induce priapism is through alpha-1 antagonism. This is case of a 50-year-old male with a history of schizophrenia with previous priapism related to trazodone, who presents with new onset priapism associated with risperidone. In this case, the treatment of priapism includes discontinuation of the offending agent and drainage of the corpus cavernosum twice along with intracavernosal phenylephrine injections. It is important to educate patients on priapism as a possible side effect of medications. It is also important to consider previous episodes of medication-induced priapism when prescribing psychotropic medications as this may increase the patient's future risk of priapism. PMID:25379316

Ginory, Almari; Nguyen, Mathew

2014-01-01

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Valproate-Risperidone versus Valproate-Lithium combination in acute mania  

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Full Text Available Background: We evaluated the efficacy of valproate plus risperidone versus valproate plus lithium combination in the treatment of acute mania. Methods: In 2-week, randomized, double-blind, parallel group study, 46 acute manic patients according to DSM-IV criteria were randomly assigned to receive combination of valproate 20 mg/ kg/day plus risperidone 2-4 mg/day (n=23 or lithium600-1200 mg/day (n=23. The assessment of efficacy measures were according to Young Mania Rating Scale (YMRS and Clinical Global Impressions-Severity (CGI-S and Improvement (CGI-I scale. Other effectiveness measures included YMRS response (YMRS reduction >50 % and YMRS remission (YMRS total scores <12. Results: In each group, 16 of 23 patients (70 % completed the study. YMRS response, CGI-Improvement, and reduction in the total scores of YMRS and CGI-S observed in both groups, significantly greater for valproate-risperidone than valproate-lithium combination group (P=0.006, P=0.015, P=0.004, and P=0.007, respectively.YMRS remission were shown in both groups without statistical significance (P=0.073. The total scores of YMRS at 4th, 8th, and 14th days of trial were lower in valproate-risperidone than valproate-lithium combination group (P=0.017, P=0.005, and P=0.004, respectively. The rate of adverse events and mean weight gain in both groups were not statistically different. Conclusion: In acute manic patients, both combinations of valproate with lithium or with risperidone had efficacy in acutely manic patients, but valproate-risperidone combination was more effective. Both treatments were safe and well tolerated. Considering the small sample size and limited period of observation, further studies need to be conducted to find out the best combination in the treatment of acute mania. Key words: Acute mania, Valproate, Risperidone, Lithium, Combination Therapy

M Barekatain

2005-09-01

69

Intra-articular and soft tissue injections, a systematic review of relative efficacy of various corticosteroids.  

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The comparative efficacy of various Corticosteroid (CS) injections commonly used to treat musculoskeletal conditions has not been systematically studied. Our objective is to synthesize data about comparative efficacy of various CS used for intra-articular and periarticular soft tissue injections. Online databases were searched including MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effectiveness, and bibliographies of studies till November 2013. We included all randomized controlled trials comparing two CS for intra-articular and periarticular injections, selected according to Preferred Reporting Items for Systematic reviews and Meta-Analyses methodology. Seven good quality trials were selected for qualitative data synthesis. Two trials comparing triamcinolone hexacetonide (TH) and methylprednisolone (MP) for knee arthritis suggested faster pain relief with TH for rheumatoid arthritis (RA) at day 7 (p?efficacy. One trial suggested faster pain relief with MP compared to triamcinolone acetonide (TA) for rotator cuff tendonitis at 2 weeks (percentage of patients improving 92 % vs. 50 %; p?=?0.02) but similar long-term efficacy, while another trial suggested no difference between TA and MP for knee OA. Two trials for knee arthritis suggested a substantially better efficacy for TH than TA (response rate at 24 months 77 % vs 39 %; p?=?0.001) and betamethasone (BM) at day 42 (p?efficacy of various CS injections. Limited number of studies favored TH over other CS (TA, MP, BM). PMID:24651914

Garg, Neha; Perry, Lisa; Deodhar, Atul

2014-12-01

70

Ethanol injection of ornamental trees facilitates testing insecticide efficacy against ambrosia beetles (Coleoptera: Curculionidae: Scolytinae).  

Science.gov (United States)

Exotic ambrosia beetles are damaging pests in ornamental tree nurseries in North America. The species Xylosandrus crassiusculus (Motshulsky) and Xylosandrus germanus (Blandford) are especially problematic. Management of these pests relies on preventive treatments of insecticides. However, field tests of recommended materials on nursery trees have been limited because of unreliable attacks by ambrosia beetles on experimental trees. Ethanol-injection of trees was used to induce colonization by ambrosia beetles to evaluate insecticides and botanical formulations for preventing attacks by ambrosia beetles. Experiments were conducted in Ohio, Tennessee, and Virginia. Experimental trees injected with ethanol had more attacks by ambrosia beetles than uninjected control trees in all but one experiment. Xylosandrus crassiusculus and X. germanus colonized trees injected with ethanol. In most experiments, attack rates declined 8 d after ethanol-injection. Ethanol-injection induced sufficient pressure from ambrosia beetles to evaluate the efficacy of insecticides for preventing attacks. Trunk sprays of permethrin suppressed cumulative total attacks by ambrosia beetles in most tests. Trunk sprays of the botanical formulations Armorex and Veggie Pharm suppressed cumulative total attacks in Ohio. Armorex, Armorex + Permethrin, and Veggie Pharm + Permethrin suppressed attacks in Tennessee. The bifenthrin product Onyx suppressed establishment of X. germanus in one Ohio experiment, and cumulative total ambrosia beetle attacks in Virginia. Substrate drenches and trunk sprays of neonicotinoids, or trunk sprays of anthranilic diamides or tolfenpyrad were not effective. Ethanol-injection is effective for inducing attacks and ensuring pressure by ambrosia beetles for testing insecticide efficacy on ornamental trees. PMID:23448043

Reding, Michael E; Oliver, Jason B; Schultz, Peter B; Ranger, Christopher M; Youssef, Nadeer N

2013-02-01

71

Therapeutic Efficacy of Doramectin Injectable Against Gastrointestinal Nematodes in Donkeys (Equus asinus in Khartoum, Sudan  

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Full Text Available A study was conducted to evaluate the therapeutic efficacy of doramectin administered intramuscularly and subcutaneously at a dose rate of 0.2 mg/kg to donkeys naturally infected with gastrointestinal nematodes in Khartoum State, Sudan. The study involved 34 donkeys, animals were randomly allocated to a non-medicated control group or doramectin treated groups (DT1 and DT2. On day 0, donkeys in DT1 received an intramuscular injection of doramectin (0.2 mg/kg, whereas those in group DT2 received a single subcutaneous injection of doramectin (0.2 mg/kg. Individual faecal egg counts were performed daily for the first week and then on days 14, 21, and 28. Between days 14 and 20, two animals from each group were slaughtered, and worm burdens were determined. Treatment efficacy was based on the mean faecal egg count reduction (FECR 14 days post treatment. Faecal egg reduction of 100% was found after treatment with doramectin intramuscularly, but only 99.24% reduction was found after subcutaneous injection. At necropsy, only adult nematodes and mainly Strongylus vulgaris (L4 were recovered. Doramectin injected intramuscularly was highly efficacious against gastrointestinal nematodes of the donkey. Despite the fact that the drug has not being registered for use in donkeys, no abnormal clinical signs nor adverse reactions were observed in any of the donkeys treated with doramectin.

A. A. Ismail

2004-01-01

72

THE EFFICACY OF ORAL GLUCOSE FOR RELIEVING PAIN FOLLOWING INTRAMUSCULAR INJECTION IN TERM NEONATES  

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Full Text Available Pain in neonates can be associated with various risks and it seems essential to find a simple and acceptable method for relieving pain. Pharmacologic agents are not recommended in neonates for pain relief in minor procedures but orally administered glucose solution is found to be effective. The objective of this study was to assess the efficacy of oral 30% glucose during intramuscular injection in term neonates. Sixty-four healthy term neonates were recruited for this study during 1 month. The inclusion criteria were gestational age 37-42 weeks, birth weight 2500-4000 gr, and Apgar score > 7. The intervention consists of administration of either 2 ml of oral 30% glucose or 2ml of sterile water 2 minutes before injection. The primary out come measure was the cumulative Neonatal Infant Pain Scale (NIPS score at 3 minutes after injection. Thirty-two neonates received 30% glucose and 32 neonates received sterile water. The cumulative NIPS score at 3 minutes after injection for neonates given 30% glucose was significantly (P = 0.000 lower than for neonates given sterile water. The heart rate immediately after injection for neonates given 30% glucose was significantly (P = 0.002 lower than for neonates given sterile water. Oral 30% glucose given 2 minutes before injection was effective in reducing neonatal pain following injection. It is a simple, safe and fast acting analgesic and should be considered for minor invasive procedures in term neonates.

F. Sajedi

2006-09-01

73

Efficacy of acupuncture versus local methylprednisolone acetate injection in De Quervain's tenosynovitis: a randomized controlled trial.  

Science.gov (United States)

There is no consensus on the management of De Quervain's tenosynovitis, but local corticosteroid injection is considered the mainstay of treatment. However, some patients are reluctant to take steroid injections. This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of this disease. Thirty patients were consequently treated in two groups. The acupuncture group received five acupuncture sessions of 30 minutes duration on classic points of LI-5, LU-7, and LU-9 and on ahshi points. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. We demonstrated short-term improvement of pain and function in both groups. Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain's tenosynovitis. PMID:24929455

Hadianfard, Mohammadjavad; Ashraf, Alireza; Fakheri, Maryamsadat; Nasiri, Aref

2014-06-01

74

Review of risperidone for the treatment of pediatric and adolescent bipolar disorder and schizophrenia  

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Full Text Available Jeffrey R Bishop1,2, Mani N Pavuluri21Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA; 2Department of Psychiatry, Pediatric Mood Disorders Program and Center for Cognitive Medicine, University of Illinois at Chicago College of Medicine, Chicago, IL, USAAbstract: Risperidone is a commonly used medication for the treatment of bipolar disorder and schizophrenia in children and adolescents. It has been studied as a monotherapy treatment in early onset schizophrenia and as both monotherapy and combination therapy for pediatric bipolar disorder. Studies to date indicate that risperidone is an effective treatment for positive and negative symptoms of schizophrenia and mania symptoms of bipolar disorder. In young patient populations, side effects such as weight gain, extrapyramidal side effects, and prolactin elevation require consideration when evaluating the risk benefit ratio for individual patients. Here we review published studies of risperidone for the treatment of bipolar disorder and schizophrenia in children and adolescents to provide practitioners with an overview of published data on the efficacy and safety of risperidone in these patient populations.Keywords: risperidone, bipolar disorder, schizophrenia, children, adolescents

Jeffrey R Bishop

2008-03-01

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POST MARKETING SURVEILLANCE STUDY ON RISPERIDONE IN PATIENTS SUFFERING FROM SCHIZOPHRENIA  

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Full Text Available Schizophrenia is one of the commonest psychiatric ailments. It has been estimated that approximately 1% of the population and 15% of the adults suffers from this disease. Risperidone, atypical antipsychotic, acts mainly by 5HT2 blockade action. Produce virtually no extra pyramidal side effects at low dose, has a broad efficacy. But extra pyramidal dysfunction can appear at higher doses. We conducted a post marketing surveillance study on risperidone in 40 patients suffering from schizophrenia at Psychiatric department of Civil Hospital, Ahmedabad. In this study we specially studied its efficacy and safety. The results of this study are consistent with phase III clinical studies on risperidone carried out in Indian patients except its effects on food intake. As far as the efficacy of risperidone in patient with schizophrenia is concerned, it provided good symptomatic relief In term of safety, 7 patients out of 40, experience adverse effects like decrease appetite, constipation, insomnia, EPS and NMS. Patient with NMS was admitted in hospital and was died later on. [National J of Med Res 2011; 1(2.000: 34-36

J R Zaveri

2011-04-01

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Sucrose acetate isobutyrate as an in situ forming system for sustained risperidone release.  

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The objective of this study was to develop sustained-release sucrose acetate isobutyrate (SAIB) in situ formulations of risperidone for parenteral delivery. The formulations contained SAIB, solvent (anhydrous ethanol, ethyl lactate, or N-methyl-2-pyrrolidone), and additives such as polylactic acid (PLA). In vitro release profiles of risperidone from the SAIB formulations, which followed the Higuchii square root law, were obtained. An increase in SAIB content from 75% to 85% resulted in a reduction in the initial burst and the rate of risperidone release. The initial drug release could be increased by reducing the pH of the release medium and the release rate could be increased by an increase in drug loading. The burst release fell significantly from 20.0% to 3.5% following the inclusion of 10% (w/w) PLA in the formulations. In the case of this high viscosity depot system containing SAIB, anhydrous ethanol, PLA, and 25 mg/g risperidone, the in vivo biocompatible test results obtained support the use of SAIB as an injectable risperidone sustained-release formulation. PMID:17721936

Lu, Yaxin; Yu, Yeling; Tang, Xing

2007-12-01

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Development of Risperidone PLGA Microspheres.  

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The aim of this study was to design and evaluate biodegradable PLGA microspheres for sustained delivery of Risperidone, with an eventual goal of avoiding combination therapy for the treatment of schizophrenia. Two PLGA copolymers (50?:?50 and 75?:?25) were used to prepare four microsphere formulations of Risperidone. The microspheres were characterized by several in vitro techniques. In vivo studies in male Sprague-Dawley rats at 20 and 40?mg/kg doses revealed that all formulations exhibited an initial burst followed by sustained release of the active moiety. Additionally, formulations prepared with 50?:?50 PLGA had a shorter duration of action and lower cumulative AUC levels than the 75?:?25 PLGA microspheres. A simulation of multiple dosing at weekly or 15-day regimen revealed pulsatile behavior for all formulations with steady state being achieved by the second dose. Overall, the clinical use of Formulations A, B, C, or D will eliminate the need for combination oral therapy and reduce time to achieve steady state, with a smaller washout period upon cessation of therapy. Results of this study prove the suitability of using PLGA copolymers of varying composition and molecular weight to develop sustained release formulations that can tailor in vivo behavior and enhance pharmacological effectiveness of the drug. PMID:24616812

D'Souza, Susan; Faraj, Jabar A; Giovagnoli, Stefano; Deluca, Patrick P

2014-01-01

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Effectiveness of risperidone in psychogenic stiff neck.  

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A 48-year-old woman suffering from treatment-resistant psychogenic stiff neck and severe depression had been treated with a varied regimen of medications, including antidepressants, neuroleptics, and antiepileptics. These treatments did not result in improvement. Therefore, she was treated with a combination of sertraline and risperidone. Depressive symptoms decreased within a few weeks of treatment initiation. The psychogenic stiff neck, which had begun to improve within the first 2 weeks, had disappeared completely after 6 months of treatment with risperidone alone. This case report suggests that risperidone may be effective in some neurological motor disorders comorbid with mood disorders. PMID:15908897

Marazziti, Donatella; Dell'Osso, Bernardo

2005-06-01

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Risperidone: effects of formulations on oral bioavailability.  

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The bioavailability of risperidone was evaluated in an open-label, randomized, two-way, crossover study comparing a 1-mg tablet with a 1-mg/ml oral solution. Both formulations were administered as a single 1-mg dose with a 10-day washout period between treatments. Of 26 healthy men who entered the study, 23 completed both treatment periods. Plasma concentrations of risperidone and the active moiety (risperidone plus its active metabolite, 9-hydroxyrisperidone) were determined by radioimmunoassays. For key pharmacokinetic values (Cmax, AUC), the 90% CIs on the relative bioequivalence of risperidone, 9-hydroxyrisperidone, and the active moiety were contained within the equivalence range of 80-120% (80-125% for log-transformed data). The results demonstrate that the 1-mg/ml oral solution and the 1-mg tablet are bioequivalent. PMID:9165565

Gutierrez, R; Lee, P I; Huang, M L; Woestenborghs, R

1997-01-01

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Efficacy of intravitreal ranibizumab injection combined with macular grid photocoagulation for diabetic macular edema  

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Full Text Available AIM:To evaluate the clinical efficacy of intravitreal injection of ranibizumab combined with macular grid photocoagulation for diabetic macular edema(DME.METHODS:Totally 60 eyes(60 patientswith DME were randomly divided into 2 groups: 30 eyes of simple injection group underwent intravitreal injection of ranibizumab, and 30 eyes of combined treatment group underwent intravitreal injection of ranibizumab and macular grid photocoagulation 1wk later. The best corrected visual acuity(BCVA, central macular thickness(CMTmeasured by optical coherence tomography(OCTand postoperative complications were observed.RESULTS:In simple injection group, the BCVA after operation were separately 0.390±0.075(4wk, 0.367±0.088(8wkand 0.319±0.064(12wk,the CMT after operation were separately 221.63±112.34?m(4wk, 337.73±99.56?m(8wkand 432.92±100.46?m(12wk, which were much better than pre-operation. But during follow-up, the BCVA presented down trend and the CMT was on the rise slowly. In combined treatment group, the BCVA after operation were separately 0.385±0.036(4wk, 0.382±0.079(8wkand 0.377±0.097(12wk,the CMT after operation were separately 249.77±106.55?m(4wk, 270.40±92.88?m(8wkand 275.84±97.34?m(12wk, which were satisfactory and steady during follow-up, better than simple injection group(PCONCLUSION:Intravitreal injection of ranibizumab can effectively improve visual acuity and decrease central foveal thickness for patients with DME, combining with macular grid photocoagulation can ensure therapeutic effects steady and permanent.

Hu-Lin Jiang

2014-07-01

 
 
 
 
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Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study.  

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Depressive symptoms are associated with poor outcomes, increased risk of relapse, and high suicide rates in patients with schizophrenia and schizoaffective disorder. This randomized, open-label, parallel-group, flexible-dose study (NCT00640562) assessed the efficacy of quetiapine extended release (XR) versus risperidone on depressive symptoms in this patient population. Noninferiority of quetiapine XR versus risperidone from baseline to week 12 was assessed by least squares mean (LSM) reduction in the Calgary Depression Scale for Schizophrenia (CDSS). Noninferiority was indicated if the difference in CDSS reductions between quetiapine XR and risperidone had a 95% confidence interval (CI) lower limit of more than -2.7. Overall, 216 patients received quetiapine XR (n = 109; 400-800 mg/day) or risperidone (n = 107; 4-6 mg/day). In the per-protocol population, LSM CDSS reductions for quetiapine XR and risperidone were 8.4 and 6.2 points, respectively (95% CI 0.8-3.7). As the lower limit of the 95% CI was more than -2.7 and the LSM reduction for quetiapine XR was 2.2 points higher than that for risperidone, noninferiority of quetiapine XR versus risperidone was demonstrated. Adverse events for quetiapine XR and risperidone were comparable. In this study, quetiapine XR was noninferior to risperidone at reducing depressive symptoms in patients with schizophrenia or schizoaffective disorder. PMID:24681810

Di Fiorino, Mario; Montagnani, Gino; Trespi, Graziella; Kasper, Siegfried

2014-05-01

82

Trials with rafoxanide. 8. Efficacy of an injectable solution against trematodes and nematodes in cattle.  

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Four experiments are described in which the efficacy of an experimental 5% injectable solution of rafoxanide was evaluated against various adult and immature helminths in cattle. Subcutaneous injection at a dosage of 3 mg/kg live mass resulted in the following reductions in mean worm burdens: adult Fasciola hepatica, 82,6%; adult Fasciola gigantica, 99,8% immature Paramphistomum microbothrium, 10,1% adult Haemonchus placei, 99,6%, third stage H. placei, 73,7%; adult Bunostomum phlebotomum, 99,8%; adult Oesophagostomum radiatum, 99,9%; and fourth stage O. radiatum, 76,9%. At 5 mg/kg live mass, rafoxanide solution was 97,5% and 99,2% effective against 8-week old F. gigantica and third stage H. placei respectively and at 7,5 mg/kg, 92,4% against 6-week old F. gigantica. PMID:144191

Schröder, J; Honer, M R; Louw, J P

1977-06-01

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A pharmacogenetic study of risperidone on chemokine (C-C motif) ligand 2 (CCL2) in Chinese Han schizophrenia patients.  

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Previous observations of the pathophysiological distribution and pharmacological profile of the chemokine (C-C motif) ligand 2 (CCL2) have indicated its potential role in antipsychotic drug actions. More information on the pharmacogenetics of CCL2 may therefore be useful in developing individualized therapy. However, to our knowledge, rare studies have been reported in this area. This investigation was attempted to clarify whether CCL2 polymorphism could affect risperidone efficacy. We genotyped four SNPs (rs4795893, rs1024611, rs4586 and rs2857657) distributed throughout the CCL2 gene and examined them for association using the Positive and Negative Syndrome Scale (PANSS) score in two independent cohorts of Chinese schizophrenic patients (n = 208) from two different geographic areas, following an 8-week period of risperidone monotherapy. We found that all genotyped SNPs were significantly associated with risperidone treatment (rs4795893: p = 1.66E-04, rs4586: p = 0.001, rs2857657: p = 0.004, at week 4, in ANOVA). Our results indicate that there may be some effect of variations in the CCL2 gene on therapeutic efficacy of risperidone, and the associated polymorphisms may be a potential genetic marker for predicting the therapeutic effect of risperidone. PMID:24495780

Xiong, Yuyu; Wei, Zhiyun; Huo, Ran; Wu, Xi; Shen, Lu; Li, Yang; Gong, Xueli; Wu, Zhenqiang; Feng, Guoyin; Li, Wenqiang; He, Lin; Xing, Qinghe; Qin, Shengying

2014-06-01

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Efficacy of ivermectin and moxidectin injection against larvae of Wohlfahrtia magnifica (Diptera: Sarcophagidae) in sheep.  

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The therapeutic efficacies of ivermectin (Ivomec injection, Merck Sharp & Dohme B.V.) and moxidectin (Cydectin 1% injection, American Cyanamid Company) were evaluated in sheep naturally infested with larvae of Wohlfahrtia magnifica. Sheep were randomly allocated to one of the 2 groups, each consisting of 19 animals. Sheep in one group received ivermectin and those in the other, moxidectin by subcutaneous injection at a dose of 0.2 mg/kg body weight. Evaluation was performed at 19, 24, 28, 39, 43, 48, 52, 63, 67, 72, 87, 96, 120, 144 and 168 h after treatment. At 144 and 168 h post-treatment, late third-instar larvae were collected from wounds of four sheep in both groups and from untreated, infested sheep. These larvae were reared in the laboratory to assess adult emergence. Neither ivermectin nor moxidectin was effective as a rapid acting treatment or as a long-term, or even short-term, prophylactic. Despite the treatment, 30-40% of sheep had live larvae at every evaluation. Although larvae disappeared from the wounds of some sheep in both groups after the treatment, the wounds in these animals failed to recover and were reinfested by larvae of W. magnifica. On day 7 post-treatment the trial had to be finished because the majority of treated sheep were severely infested by Wohlfahrtia maggots. The average number of infested sheep in the two groups and the number of adults that were produced from larvae collected from treated sheep indicate that ivermectin and moxidectin did not differ significantly in efficacy. PMID:8825451

Farkas, R; Hall, M J; Dániel, M; Börzsönyi, L

1996-01-01

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Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia  

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Full Text Available Hongyan Zhang1, Huafang Li2, Liang Shu1, Niufan Gu2, Gang Wang3, Yongzhen Weng3, Shiping Xie4, Xinbao Zhang4, Ting Li5, Cui Ma5, Wei Yu6, Bruce Parsons7, Manjula Schou81Institute of Mental Health, Peking University, Beijing, China; 2Shanghai Mental Health Center, Shanghai, China; 3Capital Medical University, Beijing An Ding Hospital, Beijing, China; 4Nanjing Brain Hospital, Nanjing, China; 5Guangzhou Brain Hospital, Guangzhou, China; 6Pfizer China, Beijing, China; 7Pfizer Inc, New York, NY, USA; 8Pfizer Australia, Sydney, AustraliaBackground: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.Methods: In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS total score ?60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40–80 mg twice daily or risperidone 1–3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.Results: The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction from baseline to week 6 in PANSS total score was (-35.6 [95% CI: -38.6, -32.6] for ziprasidone and (-37.1 [95% CI: -39.9, -34.4] for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: -2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (-3.5 ng/mL, but significantly increased for risperidone (61.1 ng/mL; P < 0.001. More risperidone-treated subjects (14.9% than ziprasidone-treated subjects (4.2% reported weight gain ?7%. Akathisia and somnolence in the ziprasidone group and akathisia and insomnia in the risperidone group were the most common side effects. Treatment-related/treatment-emergent adverse events were reported by 79.7% and 71.1% of ziprasidone-treated and risperidone-treated subjects, respectively.Conclusion: In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.Keywords: ziprasidone, risperidone, schizophrenia

Hongyan Zhang

2011-03-01

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Effectiveness, safety, and tolerability of risperidone in adolescents with schizophrenia: an open-label study.  

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Data on risperidone's efficacy and tolerability in adolescents with schizophrenia are scarce. We found only one prospective, open-label study in this population. The aim of this open-label, prospective study was to estimate the effectiveness, safety, and tolerability of risperidone treatment in adolescents with first-episode schizophrenia. Subjects were adolescent inpatients diagnosed with Diagnostic and Statistical Manual of Mental Disorders (fourth edition) first-episode schizophrenia by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present Episode version. Most of the patients (10/11) were drug naïve. Improvement was assessed during the first 6 weeks of treatment using the Positive and Negative Syndrome Scale (PANSS), the Brief Psychiatric Rating Scale (BPRS), and the Clinical Global Impression (CGI) scale. Side effects were monitored using the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Udvalg for Kliniske Undersogelser Side Effect Rating Scale. Eleven adolescents between 15.5 and 20 years of age (mean = 17.27, SD = 1.27 years) were included in this study. Risperidone in an average dose of 3.14 mg/day (SD = 1.60 mg/day) produced a significant improvement on the total PANSS score (28%, p PANSS. The major side effects were extrapyramidal side effects, somnolence, depression, and weight gain. In conclusion risperidone appears to be a safe, acceptably tolerated, and effective antipsychotic medication for the treatment of adolescent-onset schizophrenia. PMID:14642020

Zalsman, Gil; Carmon, Einat; Martin, Andrés; Bensason, Daniela; Weizman, Abraham; Tyano, Samuel

2003-01-01

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The Efficacy of Intradiscal Steroid Injections in Degenerative Lumbar Disc Disease  

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Full Text Available Objective: We aimed to investigate the efficacy of intradiscal steroid injection in patients with chronic low back pain due to degenerative disc disease.Materials and Methods: A total of 18 patients (9 female, 9 male with chronic low back pain of discogenic origin were enrolled in the study. The intervertebral disc level which met the diagnostic criteria for provocative discography was defined as discogenic pain level. After identification of positive disc level, 1 cc betamethasone was injected into the disc. The outcome measures (visual analog pain scale and Quebec Back Pain Disability Scale scores, finger-tip-to-floor distance and duration of sitting without pain were assessed before the treatment and at second week and third month post injection. Results: The reduction in low back pain intensity between the baseline and second week, and between the baseline and third month was statistically significant (p=0.001 and p=0.002. Besides, statistically significant improvement was observed in Quebec Disability Scores between the baseline and second week, and between the baseline and third month (p=0.001 and p=0.002. The finger-tip-to-floor distance between the baseline and second week, and between the baseline and third month showed a statistically significant improvement (p=0.002 and p=0.02. The duration of sitting without pain between the baseline and second week, and between the baseline and third month showed a statistically significant increase (p=0.001 and p=0.009. Conclusion: As a result, we suggest that intradiscal steroid injection may be effective in short-term and mid-term for reducing the intensity of spinal pain and the proportion of disability due to chronic discogenic low back pain in patients who do not respond to conservative treatment. Turk J Phys Med Re­hab 2012;58:88-92.

Ferdi Yavuz

2012-06-01

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A 12-week intramuscular toxicity study of risperidone-loaded microspheres in Beagle dogs.  

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Long-acting formulations of antipsychotics are important treatment options to increase the compliance of schizophrenic patients. Risperidone, a 5-HT2 and dopaminergic D2 receptor antagonist, was developed as long-acting sustained-release microspheres with poly(lactide-co-glycolide) (PLGA) as a drug carrier for the treatment of schizophrenia. In the present study, the main objective is to determine the nonclinical safety profile of risperidone-loaded microspheres (RM) in Beagle dogs after intramuscular administration for 3 months, once in 2 weeks, followed by 8-week recovery phase. No animal death was found and no special toxicological findings were observed. The findings, such as hypoactivity, ptosis, increased heart rate, and elevated serum and pituitary prolactin levels, were observed and related to the pharmacological effects of risperidone. The changes in the reproductive system (uterus, ovary, vagina, cervix, and mammary gland) were considered secondary to the prolactin elevation, and the congestion of spleen was related to risperidone. The foreign body granulomas at injection sites might be caused by PLGA. At the end of recovery phase, the above changes mostly recovered to normal, and on administering 3 mg/kg dose level once in 2 weeks on Beagle dogs showed no observed adverse effect. Taken together, RM had exhibited the acceptable safety. PMID:23925946

Tian, J; Wang, W; Ye, L; Cen, X; Guan, X; Zhang, J; Yu, P; Du, G; Liu, W; Li, Y

2014-05-01

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Combined use of ozone and collagenase injection for the treatment of lumbar disc herniation:comparison of therapeutic efficacy with simple ozone injection  

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Objective: To observe the therapeutic effects of combined use of ozone and collagenase injection in treating lumbar disc herniation and to make a comparison of therapeutic efficacy with simple ozone injection. Methods: Under DSA guidance,percutaneous puncturing of diseased lumbar disk with a gauge 9 needle was performed in 76 patient with lumbar disc herniation. After the needle position was confirmed in the right site simple ozone injection (control group, n=38) or combined use of ozone and collagenase injection (study group, n=38) was carried outs. The clinical results were evaluated and compared between two groups. Results: After the treatment, all 76 patients were followed up regularly at 1, 3 and 6 months. At 1, 3 and 6 months after the therapy, the effective rate of study group was 89.5%, 92.1% and 94.7% respectively, while the effective rate of control group was 86.8%, 84.2% and 81.6% respectively. Conclusion: For the treatment of lumbar disc herniation, the therapeutic effect of combined use of ozone and collagenase injection is much better than that by using simple ozone injection, moreover, it carries a quite stable long-term efficacy. (authors)

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Efficacy and Tolerability of Fixed-Dose Combination of Dexketoprofen and Dicyclomine Injection in Acute Renal Colic  

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Objective. To evaluate the efficacy and tolerability of a fixed-dose combination of dexketoprofen and dicyclomine (DXD) injection in patients with acute renal colic. Patients and Methods. Two hundred and seventeen patients were randomized to receive either DXD (n = 109) or fixed-dose combination of diclofenac and dicyclomine injection (DLD; n = 108), intramuscularly. Pain intensity (PI) was self-evaluated by patients on visual analogue scale (VAS) at baseline and at 1, 2, 4, 6, and 8 hours. E...

Kshirsagar, S. N.; Basu, I.; Naik, R. C.; Dhorepatil, S.; Walvekar, R. S.; Bhatnagar, S. K.; Badadare, A.; Enadle, R. P.; Kamat, V.; Balamurugan, S.; Sheth, D. N.; Erram, S. S.; Oswal, D. S.; Mahajan, A. D.; Porwal, A.

2012-01-01

91

Risperidone in the treatment of conduct disorder in preschool children without intellectual disability  

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Full Text Available Abstract Background The DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th edition Textrevision highlights the especially poor outcomes of early-onset conduct disorder (CD. The strong link between the patient's age at treatment and its efficacy points the importance of early intervention. Risperidone is one of the most commonly studied medications used to treat CD in children and adolescents. The aim of this study is to obtain preliminary data about the efficacy and tolerability of risperidone treatment in otherwise typically developing preschool children with conduct disorder and severe behavioral problems. Method We recruited 12 otherwise normally developing preschoolers (ten boys and two girls with CD for this study. We could not follow up with 4 children at control visits properly; thus, 8 children (six girls, two boys; mean age: 42.4 months completed the study. We treated the patients with risperidone in an open-label fashion for 8 weeks, starting with a daily dosage of 0.125 mg/day or 0.25 mg/day depending on the patient's weight (20 kg children: 0.25 mg/day. Dosage titration and increments were performed at 2-week interval clinical assessments. The Turgay DSM-IV Based Disruptive Behavior Disorders Child and Adolescent Rating & Screening Scale (T-DSM-IV-S as well as the Clinical Global Impression Scale (CGI assessed treatment efficacy; the Extrapyramidal Symptom Rating Scale (ESRS and laboratory evaluations assessed treatment safety. Results The mean daily dosage of risperidone at the end of 8 weeks was 0.78 mg/day (SD: 0.39 with a maximum dosage of 1.50 mg/day. Based on the CGI global improvement item, we classified all patients as "responders" (very much or much improved. Risperidone was associated with a 78% reduction in the CGI Severity score. We also detected significant improvements on all of the subscales of the T-DSM-IV-S. Tolerability was good, and serious adverse effects were not observed. We detected statistically significant prolactin level increments (p Conclusion The results of this study suggest that risperidone may be an effective and well-tolerated atypical antipsychotic for the treatment of CD in otherwise normally developing preschool children. The findings of the study should be interpreted as preliminary data considering its small sample size and open-label methodology.

Durak Sibel

2011-04-01

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Treatment of Schizophrenia With Long-Acting Fluphenazine, Haloperidol, or Risperidone  

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Objective: This study compares 3 cohorts of patients with schizophrenia before, during, and after initiating treatment with fluphenazine decanoate (FD), haloperidol decanoate (HD), or long-acting injectable risperidone (LAR). Methods: Administrative data are analyzed from California Medicaid (Medi-Cal) beneficiaries with schizophrenia who initiated FD, HD, or LAR treatment. Patients were required to have been continuously enrolled in Medi-Cal for 180 days before and 180 days after the start o...

Olfson, Mark; Marcus, Steven C.; Ascher-svanum, Haya

2007-01-01

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Cognitive-Behavioral Therapy vs Risperidone for Augmenting Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder  

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IMPORTANCE Obsessive-compulsive disorder (OCD) is one of the world’s most disabling illnesses according to the World Health Organization. Serotonin reuptake inhibitors (SRIs) are the only medications approved by the Food and Drug Administration to treat OCD, but few patients achieve minimal symptoms from an SRI alone. In such cases, practice guidelines recommend adding antipsychotics or cognitive-behavioral therapy consisting of exposure and ritual prevention (EX/RP). OBJECTIVE To compare the effects of these 2 SRI augmentation strategies vs pill placebo for the first time, to our knowledge, in adults with OCD. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial (conducted January 2007–August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18–70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry. Of 163 who were eligible, 100 were randomized (risperidone, n = 40; EX/RP, n = 40; and placebo, n = 20), and 86 completed the trial. INTERVENTIONS While continuing their SRI at the same dose, patients were randomized to the addition of 8 weeks of risperidone (up to 4 mg/d), EX/RP (17 sessions delivered twice weekly), or pill placebo. Independent assessments were conducted every 4 weeks. MAIN OUTCOME AND MEASURE The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure OCD severity. RESULTS Patients randomized to EX/RP had significantly greater reduction in week 8 Y-BOCS scores based on mixed-effects models (vs risperidone: mean [SE], ?9.72 [1.38]; PY-BOCS score decrease ?25%: 80% for EX/RP, 23% for risperidone, and 15% for placebo; P Y-BOCS score ?12: 43% for EX/RP, 13% for risperidone, and 5% for placebo; P = .001). Adding EX/RP was also superior to risperidone and placebo in improving insight, functioning, and quality of life. CONCLUSIONS AND RELEVANCE Adding EX/RP to SRIs was superior to both risperidone and pill placebo. Patients with OCD receiving SRIs who continue to have clinically significant symptoms should be offered EX/RP before antipsychotics given its superior efficacy and less negative adverse effect profile. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389493. PMID:24026523

Simpson, Helen Blair; Foa, Edna B.; Liebowitz, Michael R.; Huppert, Jonathan D.; Cahill, Shawn; Maher, Michael J.; McLean, Carmen P.; Bender, James; Marcus, Sue M.; Williams, Monnica T.; Weaver, Jamie; Vermes, Donna; Van Meter, Page E.; Rodriguez, Carolyn I.; Powers, Mark; Pinto, Anthony; Imms, Patricia; Hahn, Chang-Gyu; Campeas, Raphael

2014-01-01

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Efficacy of Optical Internal Urethrotomy and Intralesional Injection of Vatsala-Santosh PGI Tri-Inject (Triamcinolone, Mitomycin C, and Hyaluronidase) in the Treatment of Anterior Urethral Stricture  

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Purpose. To study the efficacy of optical internal urethrotomy with intralesional injection of Vatsala-Santosh PGI tri-inject (triamcinolone, mitomycin C, and hyaluronidase) in the treatment of anterior urethral stricture. Material and Methods. A total of 103 patients with symptomatic anterior urethral stricture were evaluated on the basis of clinical history, physical examination, uroflowmetry, and retrograde urethrogram preoperatively. All patients were treated with optical internal urethrotomy followed by injection of tri-inject at the urethrotomy site. Tri-inject was prepared by diluting the combination of triamcinolone 40?mg, mitomycin C 2?mg, and hyaluronidase 3000 in 5–10?mL of saline according to length of stricture. An indwelling 18?Fr silicone catheter was left in place for a period of 7–21 days. All patients were followed up for 6–18 months postoperatively on the basis of history, uroflowmetry, and, if required, retrograde urethrogram and micturating urethrogram every 3 months. Results. The overall recurrence rate after first OIU is 19.4% (20 out of 103 patients), that is, a success rate of 80.6%. Overall recurrence rate after second procedure was 5.8% (6 out of 103 patients), that is, a success rate of 94.2%. Conclusion. Optical internal urethrotomy with intralesional injection of Vatsala-Santosh PGI tri-inject (triamcinolone, mitomycin C, and hyaluronidase) is a safe and effective minimally invasive therapeutic modality for short segment anterior urethral strictures. PMID:25349604

Singh, Shrawan Kumar; Mandal, Arup Kumar

2014-01-01

95

Efficacy of injections of phosphatidylcholine into fat deposits-a non-surgical alternative to liposuction in body-contouring  

Directory of Open Access Journals (Sweden)

Full Text Available Injecting phosphatidylcholine has been used in South America as a non-surgical treatment in body contouring. The objective of this study was to demonstrate the efficacy of injecting phosphatidylcholine in the reduction of localised fat deposits. 86 patients were included in the study. Patients received 1-3 treatments in localised fat deposits in various areas of the body using phosphatidylcholine. After treatment with phosphatidylcholine (250 mg / 5 ml, fat deposits show an average circumferential reduction per application of 2.70 cm. No patient showed irregularities, dimples or any serious side effect after treatment. Results remained stable during the time of follow up. All patients showed remarkable reductions of the fat deposits treated with phosphatidylcholine. Using the correct technique, injecting phosphatidylcholine may be a safe and efficacious alternative to liposuction in patients objecting to surgery.

Karl-G Heinrich

2005-01-01

96

Assessment And Comparing The Efficacy Of Propofol Pretreatment With Dexamethasone In Prevalence And Severity Of Its Pain On Injection.  

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Full Text Available Background: One of the disturbing complications of propofol is pain on venous injection. Some investigators had reported that corticosteroids effectively induce and prolong the duration of local anesthetics. The aim of this study was to assess and comparing the efficacy of propofol pretreatment with dexamethasone in prevalence and severity of its pain on injection. Materials and Methods: In a randomized, double-blinded, placebo-controlled prospective study, 90ASA I and II, 20 to 60 years-old patients scheduled for elective surgery under general anesthesia were enrolled. In all patients, one of the veins of both hands was catheterized with a 20 G catheter. Then randomly, and simultaneously 2 ml dexamethasone (8 mg was injected to one of them and 2 ml of normal saline was injected to other. After 30 seconds, 2 ml propofol (20 mg was injected to both hands, at the same time in 30 seconds. Pain intensity was measured using VAS system. Results: The age mean was 32.87±5.61. Twenty nine patients were male (32.2%. The mean of pain during propofol injection was significantly lower in dexamethasone group than normal saline group (1.61 vs.4.21 respectively, p 0.05. Conclusion: Intravenous administration of 8 mg dexamethasone before propofol IV injection significantly decreases the pain on injection of propofol.

Shoeibi G

2005-05-01

97

Treatment Efficacy of Electromyography versus Fiberscopy-Guided Botulinum Toxin Injection in Adductor Spasmodic Dysphonia Patients: A Prospective Comparative Study  

Science.gov (United States)

Introduction. This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance (EMG group) and percutaneous botulinum toxin injection under flexible fiberscopic guidance (fiberscopy group). Methods. Thirty patients with adductor spasmodic dysphonia (ADSD), who had never received treatment, were randomly allocated into EMG- or fiberscopy-guided botulinum toxin injections between March 2008 and February 2010. We assessed acoustic and aerodynamic voice parameters, and the voice handicap index (VHI) before injection and at 1, 3, and 6 months after injection. Results. The mean total dosage of botulinum toxin was similar for both groups: 1.7 ± 0.5?U for the EMG group and 1.8 ± 0.4?U for the fiberscopy group (P > 0.05). There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration. Conclusion. Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable. PMID:25383369

Kim, Jae Wook; Park, Jae Hong; Park, Ki Nam; Lee, Seung Won

2014-01-01

98

Efficacy and safety of atypical antipsychotic drugs (quetiapine, risperidone, aripiprazole and paliperidone) compared with placebo or typical antipsychotic drugs for treating refractory schizophrenia: overview of systematic reviews / Eficácia e segurança dos antipsicóticos atípicos (quetiapina, risperidona, aripiprazol, paliperidona) em comparação com um placebo ou medicamentos antipsicóticos típicos no tratamento da esquizofrenia refratária: overview de revisão sistemática  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: English Abstract in portuguese CONTEXTO E OBJETIVO: De acordo com alguns estudos de coorte, a prevalência da esquizofrenia refratária (ER) está entre 20-40%. Nosso objetivo foi avaliar a efetividade e segurança de aripiprazol, paliperidona, quetiapina e risperidona no tratamento da esquizofrenia refratária. MÉTODOS: Avaliação crí [...] tica das revisões Cochrane publicadas na Biblioteca Cochrane e complementação com referências de ensaios clínicos randomizados (ECRs) mais atualizados sobre ER. As seguintes bases de dados foram pesquisadas: Medline (Medical Literature Analysis and Retrieval System Online) (1966-2009), Ensaios Controlados da Colaboração Cochrane (2009, edição 2), Embase (Excerpta Database) (1980-2009), Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) (1982-2009). Não houve restrição a idiomas. Ensaios clínicos randomizados, revisões sistemáticas e metanálises que avaliaram antipsicóticos atípicos no tratamento da esquizofrenia refratária foram incluídos. RESULTADOS: Sete revisões sistemáticas Cochrane e 10 ECRs complementares foram incluídos nessa revisão. No geral os dados demonstram pequenas diferenças entre os antipsicóticos atípicos avaliados e os típicos na melhora dos sintomas da doença, apesar da melhor adesão ao tratamento com os atípicos. A risperidona foi avaliada especificamente em pacientes com esquizofrenia refratária em uma das revisões sistemáticas incluídas, a qual demonstrou desfechos favoráveis, porém não definitivos quando comparada a drogas também com eficácia comprovada como amisulprida, clozapina e olanzapina. CONCLUSÕES: Os dados reforçam a dificuldade de tratar esses pacientes, com elevadas taxas de desistência do tratamento e padrões de melhora modestos nas avaliações de eficácia. Os antipsicóticos atípicos têm vantagens sobre os típicos principalmente pelo melhor perfil de segurança, o que leva a melhor adesão ao tratamento. A associação de antipsicóticos também pode ser uma opção em alguns pacientes refratários ao tratamento. Abstract in english CONTEXT AND OBJECTIVE: According to some cohort studies, the prevalence of refractory schizophrenia (RS) is 20-40%. Our aim was to evaluate the effectiveness and safety of aripiprazole, paliperidone, quetiapine and risperidone for treating RS. METHODS: This was a critical appraisal of Cochrane revie [...] ws published in the Cochrane Library, supplemented with reference to more recent randomized controlled trials (RCTs) on RS. The following databases were searched: Medical Literature Analysis and Retrieval System Online (Medline) (1966-2009), Controlled Trials of the Cochrane Collaboration (2009, Issue 2), Embase (Excerpta Medica) (1980-2009), Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs) (1982-2009). There was no language restriction. Randomized controlled trials, systematic reviews and meta-analyses evaluating atypical antipsychotics for treating RS were included. RESULTS: Seven Cochrane systematic reviews and 10 additional RCTs were included in this review. The data generally showed minor differences between the atypical antipsychotics evaluated and typical antipsychotics, regarding improvement in disease symptoms, despite better adherence to treatment with atypical antipsychotics. Risperidone was specifically evaluated in patients with RS in one of the systematic reviews included, with favorable outcomes, but without definitive superiority compared with other drugs of proven efficacy, like amisulpride, clozapine and olanzapine. CONCLUSIONS: The findings underscore the difficulty in treating these patients, with high dropout rates and treatment patterns of modest improvement in assessments of effectiveness. Atypical antipsychotics have advantages over typical antipsychotics mainly through their better safety profile, which leads to better adherence to treatment. A combination of antipsychotics may also be an option for some refractory patients.

Tamara, Melnik; Bernardo Garcia, Soares; Maria Eduarda dos Santos, Puga; Álvaro Nagib, Atallah.

2010-05-01

99

Efficacy and safety of atypical antipsychotic drugs (quetiapine, risperidone, aripiprazole and paliperidone) compared with placebo or typical antipsychotic drugs for treating refractory schizophrenia: overview of systematic reviews / Eficácia e segurança dos antipsicóticos atípicos (quetiapina, risperidona, aripiprazol, paliperidona) em comparação com um placebo ou medicamentos antipsicóticos típicos no tratamento da esquizofrenia refratária: overview de revisão sistemática  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: English Abstract in portuguese CONTEXTO E OBJETIVO: De acordo com alguns estudos de coorte, a prevalência da esquizofrenia refratária (ER) está entre 20-40%. Nosso objetivo foi avaliar a efetividade e segurança de aripiprazol, paliperidona, quetiapina e risperidona no tratamento da esquizofrenia refratária. MÉTODOS: Avaliação crí [...] tica das revisões Cochrane publicadas na Biblioteca Cochrane e complementação com referências de ensaios clínicos randomizados (ECRs) mais atualizados sobre ER. As seguintes bases de dados foram pesquisadas: Medline (Medical Literature Analysis and Retrieval System Online) (1966-2009), Ensaios Controlados da Colaboração Cochrane (2009, edição 2), Embase (Excerpta Database) (1980-2009), Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) (1982-2009). Não houve restrição a idiomas. Ensaios clínicos randomizados, revisões sistemáticas e metanálises que avaliaram antipsicóticos atípicos no tratamento da esquizofrenia refratária foram incluídos. RESULTADOS: Sete revisões sistemáticas Cochrane e 10 ECRs complementares foram incluídos nessa revisão. No geral os dados demonstram pequenas diferenças entre os antipsicóticos atípicos avaliados e os típicos na melhora dos sintomas da doença, apesar da melhor adesão ao tratamento com os atípicos. A risperidona foi avaliada especificamente em pacientes com esquizofrenia refratária em uma das revisões sistemáticas incluídas, a qual demonstrou desfechos favoráveis, porém não definitivos quando comparada a drogas também com eficácia comprovada como amisulprida, clozapina e olanzapina. CONCLUSÕES: Os dados reforçam a dificuldade de tratar esses pacientes, com elevadas taxas de desistência do tratamento e padrões de melhora modestos nas avaliações de eficácia. Os antipsicóticos atípicos têm vantagens sobre os típicos principalmente pelo melhor perfil de segurança, o que leva a melhor adesão ao tratamento. A associação de antipsicóticos também pode ser uma opção em alguns pacientes refratários ao tratamento. Abstract in english CONTEXT AND OBJECTIVE: According to some cohort studies, the prevalence of refractory schizophrenia (RS) is 20-40%. Our aim was to evaluate the effectiveness and safety of aripiprazole, paliperidone, quetiapine and risperidone for treating RS. METHODS: This was a critical appraisal of Cochrane revie [...] ws published in the Cochrane Library, supplemented with reference to more recent randomized controlled trials (RCTs) on RS. The following databases were searched: Medical Literature Analysis and Retrieval System Online (Medline) (1966-2009), Controlled Trials of the Cochrane Collaboration (2009, Issue 2), Embase (Excerpta Medica) (1980-2009), Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs) (1982-2009). There was no language restriction. Randomized controlled trials, systematic reviews and meta-analyses evaluating atypical antipsychotics for treating RS were included. RESULTS: Seven Cochrane systematic reviews and 10 additional RCTs were included in this review. The data generally showed minor differences between the atypical antipsychotics evaluated and typical antipsychotics, regarding improvement in disease symptoms, despite better adherence to treatment with atypical antipsychotics. Risperidone was specifically evaluated in patients with RS in one of the systematic reviews included, with favorable outcomes, but without definitive superiority compared with other drugs of proven efficacy, like amisulpride, clozapine and olanzapine. CONCLUSIONS: The findings underscore the difficulty in treating these patients, with high dropout rates and treatment patterns of modest improvement in assessments of effectiveness. Atypical antipsychotics have advantages over typical antipsychotics mainly through their better safety profile, which leads to better adherence to treatment. A combination of antipsychotics may also be an option for some refractory patients.

Tamara, Melnik; Bernardo Garcia, Soares; Maria Eduarda dos Santos, Puga; Álvaro Nagib, Atallah.

100

The Efficacy of Local Injection of Methylprednisolone and Lidocaine with and Without Splint, in Treating Patients with De Quervain's Tenosynovitis  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Introduction: Suffering from de Quervain's tenosynovitis due to repetitive and routine activities leads to considerable referrals to orthopedic clinics and increasing health care costs and wasting of patients' time. The present study aimed to compare the efficacy of local injection of methylprednisolone with and without splint for treatment of patients suffering from de Quervain's tenosynovitis. Methods: In a clinical trial study, 72 patients with de Quervain's tenosynovitis were selected in ...

Saleh; Dehghan; Sherafat

2012-01-01

 
 
 
 
101

Pharmacokinetic and efficacy study of cisplatin and paclitaxel formulated in a new injectable poly(sebacic-co-ricinoleic acid) polymer.  

Science.gov (United States)

Injectable biodegradable polymer poly(sebacic-co-ricinoleic acid), P(SA-RA) is currently under development for intratumoral (IT) delivery of drugs for treating solid tumors. This study presents formulation development, pharmacokinetic and efficacy studies of two anticancer drugs (cisplatin and paclitaxel) formulated with P(SA-RA) polymer. In pharmacokinetic study, systemic exposure and pharmacokinetic parameters of cisplatin/paclitaxel following single intravenous (IV) or subcutaneous (SC) doses of cisplatin/paclitaxel was compared with intramuscular (IM) or SC doses of cisplatin/paclitaxel formulated with P(SA-RA) polymer in male CD rat. Simultaneously, the tumor reduction effect and toxicity for these formulations were evaluated in human FaDu head and neck tumor xenograft subcutaneous nude mouse model. Pharmacokinetic data reflect the lower maximal concentrations and sustained release of polymer-cisplatin/paclitaxel formulations compared to standard cisplatin/paclitaxel administration. Regarding efficacy study, a single IT or near the tumor injection (NT) of polymer-paclitaxel or polymer-cisplatin formulation significantly reduced the tumor size, compared to the standard paclitaxel or cisplatin treatments. No death or toxicity and no effect on body weight as well as macroscopic and/or microscopic changes in or near the injected area were observed, proving biocompatibility and acceptability of polymer-formulations. In conclusion, the developed formulation demonstrated controlled release and significant efficacy in delivering these agents and exhibit potential for further clinical development. PMID:22732267

Levy-Nissenbaum, Etgar; Khan, Wahid; Pawar, Rajendra P; Tabakman, Rinat; Naftali, Esmira; Winkler, Ilan; Kaufman, Olga; Klapper, Leah; Domb, Abraham J

2012-09-01

102

Adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptoms  

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Full Text Available Abstract Background The objective of this exploratory analysis was to characterize efficacy and onset of action of a 3-month treatment period with risperidone long-acting injection (RLAI, adjunctive to an individual's treatment regimen, in subjects with symptomatic bipolar disorder who relapsed frequently and had significant symptoms of mania and/or depression. Methods Subjects with bipolar disorder with ?4 mood episodes in the past 12 months entered the open-label stabilization phase preceding a placebo-controlled, double-blind study. Subjects with significant depressive or manic/mixed symptoms at baseline were analyzed. Significant depressive symptoms were defined as Montgomery-Åsberg Depression Rating Scale (MADRS ?16 and Young Mania Rating Scale (YMRS t tests; categorical differences were assessed using Fisher exact test. No adjustment was made for multiplicity. Results 162 subjects who relapsed frequently met criteria for significant mood symptoms at open-label baseline; 59/162 (36.4% had depressive symptoms, 103/162 (63.6% had manic/mixed symptoms. Most subjects (89.5% were receiving ?1 medication for bipolar disorder before enrollment. Significant improvements were observed for the total population on the CGI-BP-S, MADRS, and YMRS scales (p Conclusions Exploratory analysis of changes in overall clinical status and depression/mania symptoms in subjects with symptomatic bipolar disorder who relapse frequently showed improvements in each of these areas after treatment with RLAI, adjunctive to a subject's individualized treatment. Prospective controlled studies are needed to confirm these findings.

Haskins John T

2011-10-01

103

Efficacy and tolerability of fixed-dose combination of dexketoprofen and dicyclomine injection in acute renal colic.  

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Objective. To evaluate the efficacy and tolerability of a fixed-dose combination of dexketoprofen and dicyclomine (DXD) injection in patients with acute renal colic. Patients and Methods. Two hundred and seventeen patients were randomized to receive either DXD (n = 109) or fixed-dose combination of diclofenac and dicyclomine injection (DLD; n = 108), intramuscularly. Pain intensity (PI) was self-evaluated by patients on visual analogue scale (VAS) at baseline and at 1, 2, 4, 6, and 8 hours. Efficacy parameters were proportion of responders, difference in PI (PID) at 8 hours, and sum of analogue of pain intensity differences (SAPID). Tolerability was assessed by patients and physicians. Results. DXD showed superior efficacy in terms of proportion of responders (98.17% versus 81.48; P < 0.0001), PID at 8 hours (P = 0.002), and SAPID(0-8?hours) (P = 0.004). The clinical global impression for change in pain was significantly better for DXD than DLD. The incidence of adverse events was comparable in both groups. However, global assessment of tolerability was rated significantly better for DXD. Conclusion. DXD showed superior efficacy and tolerability than DLD in patients clinically diagnosed to be suffering from acute renal colic. PMID:22577544

Porwal, A; Mahajan, A D; Oswal, D S; Erram, S S; Sheth, D N; Balamurugan, S; Kamat, V; Enadle, R P; Badadare, A; Bhatnagar, S K; Walvekar, R S; Dhorepatil, S; Naik, R C; Basu, I; Kshirsagar, S N; Keny, J V; Sengupta, S

2012-01-01

104

Association between a COMT polymorphism and clinical response to risperidone treatment: a pharmacogenetic study.  

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A total of 130 Chinese schizophrenic patients (45 male, 85 female) were enrolled in the study. Clinical efficacy was determined using Brief Psychiatric Rating Scale (BPRS) scores. We genotyped 10 single-nucleotide polymorphisms (SNPs) of the catechol-O-methyl transferase gene (COMT) in our patients and re-examined them for association with changes in BPRS scores after 8 weeks of risperidone monotherapy. COMT is one of the genes that confer susceptibility to schizophrenia, both because of its role in neurotransmitter metabolism and because of its location in the high-risk schizophrenia-related region 22q11. Recent studies also found that COMT functional polymorphisms influenced individual response to antipsychotic medication. Our aim in this study was to explore the influence of COMT polymorphisms on pharmacological response to risperidone in the Chinese population. Statistical analysis revealed a significant association between an upstream COMT SNP, rs9606186, and scores reduction of BPRS in all patients and in the male subgroup but not in the female subgroup (allele analysis: P=0.055 for all, P=0.012 for male patients; genotype analysis: P=0.046 for all, P=0.020 for male patients, uncorrected, odds ratio=3.95). The COMT gene polymorphism, SNP rs9606186, is associated with risperidone therapy efficiency in the Chinese population. This association exhibited a sexually dimorphic difference, which may shed light on the genetics of COMT and its enzymatic sex-dependent mechanism. PMID:22935916

Zhao, Qing-Zhu; Liu, Bao-Cheng; Zhang, Jing; Wang, Lei; Li, Xing-Wang; Wang, Yang; Ji, Jue; Yang, Feng-Ping; Wan, Chun-Ling; Xu, Yi-Feng; Feng, Guo-Yin; He, Lin; He, Guang

2012-12-01

105

Efficacy of a single ultrasound-guided injection for the treatment of hip osteoarthritis.  

LENUS (Irish Health Repository)

Intra-articular injection is effective for osteoarthritis, but the best single injection strategy is not known, nor are there established predictors of response. The objectives of this study were to assess and predict response to a single ultrasound-guided injection in moderate to severe hip osteoarthritis.

Atchia, Ismaël

2011-01-01

106

Haloperidol and risperidone in the treatment of delirium and its subtypes  

Scientific Electronic Library Online (English)

Full Text Available SciELO Spain | Language: English Abstract in english Background and Objectives: To compare the safety and efficacy of haloperidol and risperidone in the treatment of delirium and its subtypes Methods: We collected sociodemographic data and medical variables in addition to systematically rating all patients with delirium with the Memorial Delirium Asse [...] ssment Scale (MDAS), Karnofsky Performance Status Scale (KPS) and abbreviated Udvalg for Kliniske Undersogelser (UKU) at baseline (T1), 2-3 days (T2) and 4-7 days (T3) and created an IRB-approved delirium database. For this secondary analysis we extracted all data containing haloperidol (HAL) and risperidone (RIS). Results: We were able to retrieve 32 patients treated with haloperidol (HAL) and risperidone (RIS) each. Both samples did not significantly differ in respect to age, cancer diagnoses or etiologies. The MDAS scores at baseline were higher in HAL treated subjects (20.2) compared to RIS treated subjects (17.7). The treatment results between HAL and RIS were not significantly different: Over the course of treatment MDAS scores improved from 20.2 to 8.3 (HAL) and 17.7 to 7.5 in (RIS), delirium resolution rates were 68.8% (HAL) and 84.4% (RIS). In hypoactive delirium the MDAS scores improved from 18.5 to 9.3 (HAL) and from 15.3 to 6.6 (RIS), delirium resolution rates were 64.3% (HAL) and 91.3% (RIS). In hyperactive delirium the MDAS scores improved from 22.5 to 6.6 (HAL) and 20.1 to 8.4 (RIS), delirium resolution rates were 72.2% (HAL) and 75% (RIS). There were no significant differences in KPS scores at all observation times. Treatment with HAL caused more EPS. Conclusions: Both haloperidol and risperidone may be equally effective in the treatment of delirium and its subtypes. Treatment with haloperidol resulted in more side effects.

Soenke, Boettger; William, Breitbart; Steven, Passik.

107

A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study  

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Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

2011-01-01

108

Preparation and Biological Evaluation of Radioiodinated Risperidone and Lamotrigine as Models for Brain Imaging  

International Nuclear Information System (INIS)

Brain imaging technology is becoming an important tool in both research and clinical care. Due to the sensitivity of brain imaging technology, neuroscientists are able to visualize brain structure and function from the level of individual molecules to the whole brain, recognize and diagnose neurological disorders, develop new strategies for treatment and determine how therapies work. The study aimed to take advantages from drugs that are able to cross the brain barrier for the development of potential radiopharmaceuticals for non-invasive brain imaging. Risperidone and lamotrigine were successfully labeled with 125I via direct electrophilic substitution reaction at 80 degree C. The reaction parameters affecting the preparation process were studied. 125I-risperidone and 125I-lamotrigine gave maximum labeling yield of 89 % ± 3.75 and 97.5 % ± 1.0 %, respectively and their stability were up to 6 and 24 h, respectively. Biodistribution studies showed that maximum uptake of 125I-risperidone and 125I-lamotrigine in the brain of mice were 4.27 % ± 0.38 and 2.45 % ± 0.18 of the injected activity/g tissue organ, at 10

109

Efficacy of ultrasound-guided intra-articular injections of platelet-rich plasma versus hyaluronic acid for hip osteoarthritis.  

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Intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA) represent efficacious medical treatments for osteoarthritis (OA), although no comparative study on long-term efficacy in hip OA exists. The goals of the current study were to compare the clinical efficacy of PRP vs HA at 12 months of follow-up in patients with hip OA and evaluate the influence of the type of infiltration and patient age, sex, body mass index, and degree of OA on temporal clinical evolution. One hundred patients with chronic unilateral symptomatic hip OA were consecutively enrolled and randomly assigned to 1 of 2 groups: group A received PRP and group B received HA administered via intra-articular ultrasound-guided injections. Patients were evaluated at baseline and after 1, 3, 6, and 12 months using the Harris Hip Score (HHS) and visual analog scale (VAS). An overall improvement was detected in both groups between 1- and 3-month follow-up. Despite a slightly progressive worsening between 6- and 12-month follow-up, the final clinical scores remained higher compared with baseline (P<.0005), with no significant differences between PRP and HA. Regarding clinical temporal evolution, multivariate analysis showed that HHS was not influenced by the type of infiltration, patient age, sex, body mass index, or degree of OA, whereas a significant association was detected between OA grade IV and VAS evolution (P<.0005). Intra-articular injections of PRP are efficacious in terms of functional improvement and pain reduction but are not superior to HA in patients with symptomatic hip OA at 12-month follow-up. PMID:24579221

Battaglia, Milva; Guaraldi, Federica; Vannini, Francesca; Rossi, Giuseppe; Timoncini, Antonio; Buda, Roberto; Giannini, Sandro

2013-12-01

110

Experimental study on effects of Shengmai Injection: enhancing 5-FU anti-tumor efficacy and reducing its toxicity  

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Full Text Available Objevtive: To observe the effects of Shengmai Injection on enhancing efficacy and reducing toxicity of 5-fluorouracil (5-FU. Methods: Fifty hepatoma 22 bearing mice were randomly divided into five groups: control group, 5-Fu group, Shengmai Injection (low, medium and high dose combined with 5-FU groups. There were 10 mice in each group. Mice in the five groups were injected introperitoneally the same amount of normal saline, 5-FU (20 mg·kg?1·d?1 and Shengmai Injection (3.5 ml·kg?1·d?1, 7 ml·kg?1·d?1 and 14 ml·kg?1·d?1 combined with 5-FU respectively, once a day for 14 days. After that, all mice were killed and the tumor inhibiting rates, index of immunological function, liver and kidney function and the blood cells in the peripheral blood were observed. Results: The tumor inhibiting rates were higher in each Shengmai Injection combined with 5-FU group than that in the 5-FU group (P?0.05. The levels of CD3, CD4, CD4/CD8, IgG, IgM in 5-FU group were lower (P?0.05, while those in the three Shengmai Injection combined with 5-FU groups were higher than those in the control group (P?0.05. The level of serum alanine aminotransferase (ALT was higher and the WBC and PLT counts in the peripheral blood were lower in 5-FU group than those in the control group (P?0.05. But the levels of serum ALT in the three Shengmai Injection combined with 5-FU groups were consistent with that in the control group and the amounts of WBC decreased slightly. Conclusion: Shengmai Injection can enhance the anti-tumor effect of 5-FU. It can also improve the immunological function and reduce the adverse reactions of chemotherapy.

CHEN Zhen

2005-11-01

111

Efficacy of Methylprednisolone Acetate Injection for the Treatment of Plantar Heel Pain  

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Full Text Available Background: To assess the short term results of local methyl prednisolone acetate injection for the treatment of heel pain syndrome. Materials and Methods: This prospective study was carried out on 109 patients with plantar heel pain who were treated by local methyl prednisolone acetate injection. Reduction of pain and tenderness were the primary measurement outcome. Results: Rest pain, walking pain and tenderness at 3 weeks was relived in 70 and 67 and 74 patients, and after 3 months in 72, 68 and 81 patients respectively. Mean patient's pain score was 8.2±2.2 before injection, 4.1±1.5 at 3 weeks, and 3.9±1.4 at 3 months after injection. Conclusion: Local injection of methyl prednisolone acetate was associated with a fairly high satisfactory short term results in the treatment of heel pain.

S. Abdolhossein Mehdi-Nasab

2014-01-01

112

The Efficacy of Local Injection of Methylprednisolone and Lidocaine with and Without Splint, in Treating Patients with De Quervain's Tenosynovitis  

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Full Text Available Introduction: Suffering from de Quervain's tenosynovitis due to repetitive and routine activities leads to considerable referrals to orthopedic clinics and increasing health care costs and wasting of patients' time. The present study aimed to compare the efficacy of local injection of methylprednisolone with and without splint for treatment of patients suffering from de Quervain's tenosynovitis. Methods: In a clinical trial study, 72 patients with de Quervain's tenosynovitis were selected in 2010 and were randomly divided into two groups. Therapeutic intervention in the first group was injection of 40 mg methylprednisone and 1 ml lidocaine with splint, and in the second group it was injection 40 mg methylprednisone and 1ml lidocaine without splint. Both groups followed this treatment for three periods(21 day. The related data were collected by visual analogue scale. Then data was analyzed by SPSS (ver. 16 using Fisher exact test and t test. Results: The findings of this study revealed that after the 3-week period of treatment the mean reduced pain intensity and improvement in the first group was significantly lower than the second group(p<0/05. Conclusion: Therefore, local injection of methylprednisone and lidocaine with splint is an effective method in the treatment of de Quervain's tenosynovitis.

Saleh

2012-02-01

113

Intra-articular steroid injection for temporomandibular joint arthritis in juvenile idiopathic arthritis : A systematic review on efficacy and safety  

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OBJECTIVE: To determine the current level of evidence for the use of intra-articular corticosteroid injections (IACI) against temporomandibular joint (TMJ) arthritis in patients with juvenile idiopathic arthritis (JIA) with a particular focus on clinical and radiological improvements and safety profile. METHODS: A comprehensive electronic search strategy was performed in all major medical databases in February 2012. Studies were selected independently by two reviewers in accordance with a pre-specified protocol and a risk of bias assessment for all included studies. RESULTS: Ninety-four unique citations were identified of which seven remained after the inclusion criteria were applied and all of these were assessed to have a high risk of bias. The current limited level of evidence suggests potential beneficial properties of IACI in patients with TMJ arthritis-related symptoms and/or MRI-verified signs of TMJ inflammation. Currently, no scientific evidence substantiates the effect of IACI in terms of (I) improving maximal mouth opening capacity significantly, (II) reducing radiological disease progression, (III) normalising/improving mandibular growth, and (IV) increasing efficacy upon repeated injections. CONCLUSION: The current level of evidence allows only very limited conclusions on the effect of IACI therapy in patients with TMJ arthritis. Knowledge on the long-term impact of IACI on mandibular growth is not available. Future studies designed in accordance with evidence-based standards are needed to allow a more general conclusion on efficacy and safety of this treatment modality in patients with TMJ arthritis.

Stoustrup, Peter; Kristensen, Kasper D

2013-01-01

114

Efficacy of Intra-Articular Injection of Celecoxib in a Rabbit Model of Osteoarthritis  

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Full Text Available Introduction: Osteoarthritis is the most common form of arthritis. It is a slowly progressive joint disease typically seen in middle-age to elderly people. Intra-articular injection of hyaluronic acid is a well-documented treatment for knee osteoarthritis. Celebrex® (celecoxib is a novel nonsteroidal anti-inflammatory drug, which could help to reduce inflammation and to reduce pain. The aim of this study was to evaluate the effects of intra-articular injection of celecoxib in a rabbit osteoarthritis model. Methods: Thirty New Zealand white rabbits underwent unilateral knee joint surgery using the Hulth technique. Six weeks post-surgery, the animals were randomly divided into three groups, and each group was respectively given weekly intra-articular injections with Celebrex®, hyaluronic acid and saline. On the sixth week, the results were assessed in rabbit models by gross observation, histological evaluation, and expression of IL-1?, TNF-?, MMP-3. Results: In the group given Celebrex® and hyaluronic acid, the pathological changes in the rabbit articular cartilage improved significantly, much more than in the saline group. The statistically significant suppression of IL-1?, TNF-?, MMP-3 was shown in the Celebrex group. No significant differences were detected between two treatment groups. Conclusions: Intra-articular injection of celecoxib is beneficial for knee osteoarthritis. It might repair and protect early osteoarthritis cartilage by delaying cartilage degeneration and impairing the function of inflammatory mediators, therefore, intra-articular injection of celecoxib can be used as an alternative to the current treatment of osteoarthritis.

Huilin Yang

2010-10-01

115

Comparison of risperidone oral solution and intramuscular haloperidol with the latter shifting to oral therapy for the treatment of acute agitation in patients with schizophrenia.  

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This randomized, parallel-group, open study investigated the efficacy and safety of risperidone oral solution (RIS-OS) in combination with clonazepam and intramuscular haloperidol for the treatment of acute agitation in patients with schizophrenia, and the study explored the possibility of decreasing the efficacy of an acute 6-week treatment by switching intramuscular haloperidol injection to RIS-OS. Two hundred and five agitation-exhibiting schizophrenic inpatients at six hospitals were originally included in the study. The 47-day trial consisted of 5 days (session I) of receiving either oral treatment (RIS-OS plus clonazepam) or intramuscular treatment (intramuscular haloperidol) and a 42-day (session II) period of either withdrawing from clonazepam or shifting from intramuscular haloperidol to a RIS-OS period. The primary efficacy outcome was measured as the change in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) in session I and the change in the PANSS in session II. Safety was assessed by the frequency of the adverse events. Mean PANSS-EC improvement was significant after 5 days of treatment in both groups (P>0.05) and was similar between the two treatment groups (P0.05). However, combination treatment exhibited greater efficacy, and adverse events, especially extrapyramidal symptoms, were lower with the oral treatment than with the intramuscular treatment in session I. These results show that RIS-OS in combination with clonazepam is an effective treatment, comparable with intramuscular haloperidol, and is well-tolerated for acute agitation in patients with schizophrenia. PMID:22233697

Fang, Maosheng; Chen, Honghui; Li, Le-Hua; Wu, Renrong; Li, Yi; Liu, Lianzhong; Ye, Meng; Huang, Jizhong; Zhu, Suoyu; Wang, Gang; Zhang, Qinge; Zheng, Hongbo; Zhang, Lulu; Wang, Bo; Zhou, Jianchu; Zhao, Jing-Ping

2012-03-01

116

Development of Analytical Method for Risperidone by UV Spectrophotometry  

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A simple, sensitive, specific, spectrophotometric method developed for the detection of Risperidone in bulk drug and Pharmaceutical formulation. The optimum conditions for the analysis of the drug wereestablished. The ? max of the Risperidone was found to be 280 nm. The method shows high sensitivity with linearity 2 to 6? g/ml. The lower limit of detection and the limit of quantification was found to be 1.012 and 3.036 respectively. All the calibration curves shows a linear relationship bet...

M.Sravan Kumar,; Anton Smith, A.; G.Alagumani Vasagam,; Kottai Muthu, A.; Manavalan, R.

2010-01-01

117

Percutaneous Ethanol Injection of Unresectable Medium-to-Large-Sized Hepatomas Using a Multipronged Needle: Efficacy and Safety  

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Fine needles with an end hole or multiple side holes have traditionally been used for percutaneous ethanol injection (PEI) of hepatomas. This study retrospectively evaluates the safety and efficacy of PEI of unresectable medium-to-large (3.5-9 cm) hepatomas using a multipronged needle and with conscious sedation. Twelve patients, eight men and four women (age 51-77 years; mean: 69) received PEI for hepatomas, mostly subcapsular or exophytic in location with average tumor size of 5.6 cm (range: 3.5-9.0 cm). Patients were consciously sedated and an 18G retractable multipronged needle (Quadrafuse needle; Rex Medical, Philadelphia, PA) was used for injection under real-time ultrasound guidance. By varying the length of the prongs and rotating the needle, the alcohol was widely distributed within the tumor. The progress of ablation was monitored by contrast-enhanced ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) after each weekly injection and within a month after the final (third) injection and 3 months thereafter. An average total of 63 mL (range: 20-154 ml) of alcohol was injected per patient in an average of 2.3 sessions. Contrast-enhanced CT, ultrasound, or MRI was used to determine the degree of necrosis. Complete necrosis was noted in eight patients (67%), near-complete necrosis (90-99%) in two (16.7%), and partial success (50-89%) in two (16.7%). Follow-up in the first 9 months showed local recurrence in two patients and new lesions in anonce in two patients and new lesions in another. There was no mortality. One patient developed renal failure, liver failure, and localized perforation of the stomach. He responded to medical treatment and surgery was not required for the perforation. One patient had severe postprocedural abdominal pain and fever, and another had transient hyperbilirubinemia; both recovered with conservative treatment. PEI with a multipronged needle is a new, safe, and efficacious method in treating medium-to-large-sized hepatocellular carcinoma under conscious sedation. Its survival benefits require further investigations

118

Injection-associated pain in femoral arteriography: A European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide  

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Purpose. To evaluate injection-associated pain, safety, and efficacy with the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) compared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography. Methods. A multicenter, double-blind, randomized, parallel-group clinical investigation was carried out in 54 hospitals in Europe. Of the patients evaluated, 1225 received iodixanol and 1227 iopromide in conventional and/or digital subtraction angiography. Results. The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p<0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19.8% in the iopromide group (p<0.001). In the iodixanol group, 1.8% of the patients experienced contrast-related adverse events vs 2.4% in the iopromide group (p=NS). Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide group (p=NS). Conclusions. Iodixanol 270 mg I/ml causes significantly less injection-associated pain during femoral arteriography and is as safe and efficatious as iopromide 300 mg I/ml

119

A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study  

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Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS, the Hamilton Anxiety Scale (Ham-A, the Hamilton Depression Rating Scale (Ham-D, the Sheehan Panic Anxiety Scale-Patient (SPAS-P, and the Clinical Global Impression scale (CGI. Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

Galynker Igor I

2009-05-01

120

Factors associated with uptake, adherence, and efficacy of hepatitis C treatment in people who inject drugs: a literature review  

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Full Text Available Viktor Mrav?ík,1,2 Lisa Strada,3 Josef Štolfa,4,5 Vladimir Bencko,6 Teodora Groshkova,7 Jens Reimer,3 Bernd Schulte3 1National Monitoring Centre for Drugs and Drug Addiction, 2Department of Addictology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic; 3Centre for Interdisciplinary Addiction Research, University of Hamburg, Hamburg, Germany; 4Department of General Practice, Institute for Postgraduate Medical Education in Prague, 5Department of General Practice, Second Faculty of Medicine, 6Institute of Hygiene and Epidemiology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic; 7European Monitoring Centre for Drugs and Drug Addiction, Lisbon, Portugal Introduction and methods: Hepatitis C virus (HCV infections are highly prevalent amongst people who inject drugs (PWID. Despite well documented evidence of its effectiveness, suggested cost-effectiveness, and potential to reduce HCV prevalence rates, the uptake of antiviral HCV treatment by PWID is low. This nonsystematic literature review describes factors associated with the uptake, adherence, and efficacy of HCV treatment among PWID and discusses strategies to increase their uptake of treatment. Results: Low HCV treatment uptake among PWID is associated with a number of patient-related and provider-related barriers. Beliefs and fears about low efficacy and adverse effects on the patient’s part are common. A substantial number of factors are associated with the chaotic lifestyle and altered social functioning of PWID, which are often associated with decompensation or relapsing into drug addiction. This may lead to perceived low adherence with treatment and low efficacy on the provider’s part too, where lack of support, inadequate management of addiction, and other drug-related problems and poor treatment of side effects have been described. Practical issues such as the accessibility of treatment and finances also play a role. Strategies to improve the HCV treatment rate among PWID involve pretreatment management and assessment, a multidisciplinary approach, management of side effects, and enhanced education and counseling. Conclusion: Specific factors are associated with poorer treatment outcomes in PWID on the side of both the patient and the treatment system. However, given that PWID can achieve treatment adherence and sustained virologic response rates comparable with those in nondrug users, drug use per se should not be considered a criterion for exclusion from treatment. Further development of measures leading to higher uptake of treatment and adherence in PWID and appropriate adaptation of HCV treatment guidelines represent important tools in this regard. Keywords: hepatitis C virus, people who inject drugs, treatment uptake, adherence, efficacy

Mrav?ík V

2013-10-01

 
 
 
 
121

Efficacy of hyaluronic acid injections in patients with osteoarthritis of the temporomandibular joint. A comparative study.  

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The aim of the present study was to report the 1-year therapeutic outcome of intra-articular injections of high-molecular-weight hyaluronic acid (HA) without arthrocentesis in a group of 25 patients with osteoarthritis (OA) of the temporomandibular joint (TMJ). The results were compared with those of a group of 10 patients with OA of the TMJ, treated with nonsteroidal anti-inflammatory drugs.Twenty-five patients (group A) underwent a cycle of 5 injections of HA into the TMJ. Ten patients (group B) underwent a therapy with nonsteroidal anti-inflammatory drugs for 1 month. The follow-up assessments after the end of treatment were at 1, 3, 6, and 12 months.Regarding the first follow-up (1 month), statistical analysis for all clinical parameters showed no significant differences (ie, beneficial effect for 2 groups) between groups A and B (P > 0.001). Significant statistical differences (ie, encouraging effect for group A) for all clinical parameters were recorded 1 year after the end of treatment between groups A and B (P intra-articular injections of HA without arthrocentesis for patients with OA of the TMJ is considered successful at 1-year follow-up period. PMID:24220392

Triantaffilidou, Katherine; Venetis, Gregory; Bika, Olga

2013-11-01

122

Efficacy of lumbar epidural corticosteroid injections on clinical status of the patients with radiculopathy  

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Full Text Available Objective: To investigate the effect of lumbar epidural steroid injection in patients with radiculopathy Materials-Methods: 37 patients with radiculopathy were recruited retrospectively in the study. Radicular, low back pain and paresthesia intensity were evaluated using visual analog scale (VAS; the evidence of nerve stretch was evaluated by straight leg rising (SRL, disability levels were evaluated using the Oswestry Disability Index (ODI and the quality of life was evaluated by SF-36. Results: A significant improvement was observed in VAS-radicular and lomber pain levels at the 24th hours post-injection (p0.01, at the 1st week (p0.01, at 1st month(p 0.01 and 3rd month (p0.05. Recovery rate of straight leg raising test was found to be 88% (p0.05. A statistically significant improvement was found in the ODI levels and the quality of life as assessed by the SF-36 at the1st week (p0.01 and after 3 months of the treatment (p0.05. Conclusion: During the first 3 months of treatment, lumbar epidural corticosteroid injections were effective in patients with radiculopathy

Jülide Öncü

2014-01-01

123

Once-monthly paliperidone injection for the treatment of schizophrenia  

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Full Text Available Delia BisharaPharmacy Department, South London and Maudsley NHS Foundation Trust, London, United KingdomAbstract: Paliperidone palmitate is a new long-acting antipsychotic injection for the treatment of acute and maintenance therapy in schizophrenia. Paliperidone (9-hydroxyrisperidone is the major active metabolite of risperidone and acts at dopamine D2 and serotonin 5HT2A receptors. As with other atypical antipsychotics, it exhibits a high 5HT2A:D2 affinity ratio. It also has binding activity as an antagonist at ?1- and ?2 adrenergic receptors and H1 histaminergic receptors, but has virtually no affinity for cholinergic receptors. Paliperidone palmitate has been shown to be effective in reducing Positive and Negative Syndrome Scale total scores in four short-term trials in acute schizophrenia. It was also effective as maintenance therapy in a long-term trial in which time to recurrence of symptoms was significantly longer in paliperidone-treated patients compared with placebo. In addition, paliperidone was shown to be noninferior to risperidone long-acting injection in one study, but this noninferiority was not established in another longer study comparing the two drugs. Treatment should be initiated with 234 mg on day 1 and 156 mg on day 8, followed by a recommended monthly maintenance dose of 39–234 mg based on efficacy and tolerability. Paliperidone palmitate is generally well tolerated, although it can cause weight gain and a rise in prolactin levels, which is generally greater in women than in men. Overall, paliperidone palmitate may have advantages over other currently available long-acting injections, and therefore may be a useful alternative for the treatment of schizophrenia, although further long-term trials comparing it with active treatments are warranted.Keywords: paliperidone palmitate, injection, schizophrenia, long-acting

Delia Bishara

2010-09-01

124

Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial  

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Full Text Available Abstract Background Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs. The Bergen Psychosis Project (BPP is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis. Methods Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D and the Calgary Depression Scale for Schizophrenia (CDSS. Results A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ?6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p Conclusions There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis. Trial Registration ClinicalTrials.gov ID; URL: http://www.clinicaltrials.gov/: NCT00932529

Løberg Else-Marie

2011-08-01

125

Factors associated with uptake, adherence, and efficacy of hepatitis C treatment in people who inject drugs: a literature review  

Science.gov (United States)

Introduction and methods Hepatitis C virus (HCV) infections are highly prevalent amongst people who inject drugs (PWID). Despite well documented evidence of its effectiveness, suggested cost-effectiveness, and potential to reduce HCV prevalence rates, the uptake of antiviral HCV treatment by PWID is low. This nonsystematic literature review describes factors associated with the uptake, adherence, and efficacy of HCV treatment among PWID and discusses strategies to increase their uptake of treatment. Results Low HCV treatment uptake among PWID is associated with a number of patient-related and provider-related barriers. Beliefs and fears about low efficacy and adverse effects on the patient’s part are common. A substantial number of factors are associated with the chaotic lifestyle and altered social functioning of PWID, which are often associated with decompensation or relapsing into drug addiction. This may lead to perceived low adherence with treatment and low efficacy on the provider’s part too, where lack of support, inadequate management of addiction, and other drug-related problems and poor treatment of side effects have been described. Practical issues such as the accessibility of treatment and finances also play a role. Strategies to improve the HCV treatment rate among PWID involve pretreatment management and assessment, a multidisciplinary approach, management of side effects, and enhanced education and counseling. Conclusion Specific factors are associated with poorer treatment outcomes in PWID on the side of both the patient and the treatment system. However, given that PWID can achieve treatment adherence and sustained virologic response rates comparable with those in nondrug users, drug use per se should not be considered a criterion for exclusion from treatment. Further development of measures leading to higher uptake of treatment and adherence in PWID and appropriate adaptation of HCV treatment guidelines represent important tools in this regard. PMID:24204126

Mravcik, Viktor; Strada, Lisa; Stolfa, Josef; Bencko, Vladimir; Groshkova, Teodora; Reimer, Jens; Schulte, Bernd

2013-01-01

126

Comparison of Acceptance, Preference, and Efficacy Between Jet Injection INJEX and Local Infiltration Anesthesia in 6 to 11 Year Old Dental Patients  

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Needleless devices have been developed to provide anesthesia without injections. Little controlled research has examined the acceptability of needleless devices in pediatric patients. The aims of the study were to compare children’s acceptance and preference for one type of needleless jet injection with classical local infiltration as well as to evaluate the efficacy of the needleless anesthesia. Eighty-seven nonfearful children with no previous experience of dental anesthesia were studied ...

Arapostathis, Konstantinos Nikolaos; Dabarakis, Nikolaos Nestoras; Coolidge, Trilby; Tsirlis, Anastasios; Kotsanos, Nikolaos

2010-01-01

127

Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database  

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Full Text Available Abstract Background This observational study was designed to collect treatment outcomes data in patients using the electronic Schizophrenia Treatment Adherence Registry (e-STAR. Methods Patients with schizophrenia or schizoaffective disorder in Australia who were prescribed risperidone long-acting injection (RLAI between 2003 and 2007 were assessed 12-months retrospectively, at baseline and 24-months prospectively at 3-monthly intervals. The intent-to-treat population, defined as all patients who received at least one dose of RLAI at baseline, was used for the efficacy and safety analyses. Results At total of 784 patients (74% with schizophrenia, 69.8% male with a mean age of 37.1 ± 12.5 years and 10.6 ± 9.5 years since diagnosis were included in this Australian cohort. A significant improvement in mean Clinical Global Impression - severity score was observed at 24-months (4.52 ± 1.04 at baseline, 3.56 ± 1.10 at 24-months. Most of this improvement was seen by 3-months and was also reflected in mean Global Assessment of Functioning score, which improved significantly at 24-months (42.9 ± 14.5 at baseline, 59 ± 15.4 at 24-months. For patients still receiving RLAI at 24-months there was an increase from a mean baseline RLAI dose of 26.4 ± 5 mg to 43.4 ± 15.7 mg. Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded. Conclusion Over the 24-month period, initiation of RLAI was associated with improved patient functioning and illness severity in patients with schizophrenia or schizoaffective disorder. Improved outcomes were observed early and sustained throughout the study. Trial Registration Clinical Trials Registration Number, NCT00283517.

Lambert Tim

2012-03-01

128

The evaluation of efficacy of subtenon triamcinolone injection combined with focal laser photocoagulation in diabetic macular edema  

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Full Text Available Objectives: The aim of this study was to investigate efficacyand safety of subtenon triamcinolone (ST in combinationwith focal laser photocoagulation in diabetic macularedema (DME.Materials and methods: Medical records of patients withDME, treated with 40 mg subtenon injection of triamcinoloneacetonid prior to focal laser photocoagulation wereretrospectively analyzed. Seventeen eyes of 17 patientswith DME were enrolled in the study. All patients underwenta comprehensive ophthalmological examinationbefore the treatment. Efficacy of the treatment after STinjection was evaluated by visual acuity and flouresceinangiography (FA. Follow-up visits were performed at 1st,3rd, 6th and 12th months. Repeated measures ANOVA wasused for statistical analysis.Results: The mean age was 61.5 ± 8.7 years and themean visual acuity in the study eyes was 0.22 ± 0.13 beforethe treatment, 0.39 ± 0.15 at 1st month, 0.36 ± 0.18at 3rd month, 0.33 ± 0.15 at 6th month and 0.34 ± 0.16 at12th month. The differences in the visual acuity before thetreatment and follow-up visits were significant (p ?0.05.Visual acuity was increased in 13 (%76,4 patients, decreasedin 1 (%5,8 and unchanged in 3 (%17,6.Conclusion: Injection of 40 mg of triamsinolon via subtenonroute combined with focal laser photocoagulation isa safe and beneficial treatment in cases of DME

Hüseyin Öksüz

2012-06-01

129

Efficacy of musculoskeletal injections given by primary care providers in the office  

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Full Text Available Tasnim Eghbal Eftekhaari,1 Mirzaali Nazarnezhad,1 Iman Ghasemzadeh2 1Clinical Research Development Unit, Hormozgan University of Medical Sciences Bandar Abbas, Iran; 2Infectious Disease Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, IranPatients commonly present to primary care physicians with musculoskeletal symptoms. Clinicians qualified in internal medicine must be knowledgeable about the diagnosis and management of musculoskeletal diseases, yet they often receive inadequate postgraduate training on this topic. The musculoskeletal problems most frequently encountered in our busy injection practice involve, in decreasing order, the knees, trochanteric bursae, and glenohumeral joints.1 However, patients usually present to a primary care physician and embark on treatment there, despite having the option of referral to a subspecialist fully trained in this procedure.View original paper by Bhagra and colleagues.

Eghbal Eftekhaari T

2013-09-01

130

Influence of age and gender on risperidone plasma concentrations.  

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There is limited information on gender- and age-specific effects on plasma concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone. The present study investigated dose- and weight-adjusted plasma concentrations of risperidone and its metabolite in three age groups (45 years, 45-60 years, over 60 years). Gender-specific differences were examined in the whole sample and for the premenopausal subgroup. One hundred and twenty-nine patients (18-93 years) were included in the study, 52 (40%) male and 77 (60%) female. Concentrations of risperidone and 9-hydroxyrisperidone were measured at steady-state by high-performance liquid chromatography with electrochemical detection (HPLC-ED). When total plasma concentrations (risperidone plus 9-hydroxyrisperidone) were adjusted for daily maintenance dose (ng/mL/mg C/D ratio), significant differences between all age groups were found. We found a mean increase of the C/D ratio by 34.8% per decade in patients older than 42 years. No significant sex-related differences in the average plasma concentrations were observed for the whole sample and for the premenopausal subgroup. This study shows clear evidence of higher risperidone total plasma concentrations for patients over 40 years of age. This linear increase (over 30% per decade) may then lead to an increased incidence of adverse effects in elderly patients. PMID:15982995

Aichhorn, Wolfgang; Weiss, Ulrike; Marksteiner, Josef; Kemmler, Georg; Walch, Thomas; Zernig, Gerald; Stelzig-Schoeler, Renate; Stuppaeck, Christoph; Geretsegger, Christian

2005-07-01

131

A Case of Diabetic Ketoacidosis Associated with Risperidone Treatment  

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Full Text Available The association between schizophrenia and diabetes has been previously documented. Case reports have also demonstrated that initiation of atypical antipsychotic agents may induce or exacerbate diabetes mellitus. A 26-year-old man without a family history of diabetes mellitus presented with deep coma after 5 months of treatment with risperidone. He was diagnosed with diabetic ketoacidosis, was given insulin and saline infusion, and his antipsychotic agent was changed from risperidone to ziprasidone.Insulin therapy and oral agent was discontinued within two months of follow-up. The rapid onset of diabetes, and the disappearance of hyperglycemia after discontinuation of the drug suggested that risperidone had been a factor in his diabetic ketoacidosis. During three years of subsequent follow-up, testing revealed no evidence of elevated serum glucose levels or impaired glucose tolerance. In our opinion psychiatrists should routinely ask patients treated with antipsychotic agents such as risperidone for diabetic symptoms, weight loss, lethargy, polydipsia and/or polyuria, and monitor serum glucose levels. Although there is no consensus on the best way to switch from one antipsychotic drug to another, for those patients who develop diabetes during therapy with risperidone a change to ziprasidone treatment may maintain normal glucose levels.

Zeynel Beyhan

2008-12-01

132

Risperidone reduces aggression in boys with a disruptive behaviour disorder and below average intelligence quotient: analysis of two placebo-controlled randomized trials.  

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The present study aimed to analyse the effect of risperidone on a priori defined core aggression items. Data were pooled from 163 boys (aged 5-12 years, with or without comorbid attention-deficit/hyperactivity disorder) with a DSM-IV diagnosis of either conduct disorder or oppositional defiant disorder who had participated in either of two identical, 6-week, randomized, double-blind, placebo-controlled trials. All received treatment with either placebo or oral risperidone solution (0.01-0.06 mg/kg/day). Subjects had below average intelligence [intelligence quotient (IQ) 36-84] and a score of > or =24 on the Conduct Problem subscale of the Nisonger Child Behaviour Rating Form (N-CBRF). An expert advisory panel selected six core aggression items from the N-CBRF, from which a total Aggression Score (AS, range 0-18) was constructed. Compared to those treated with placebo, risperidone-treated subjects experienced significantly greater mean decreases from baseline in the AS at each of weeks 1-6 (Prisperidone-treated subjects had declined by 56.4% (mean baseline AS 10.1; mean endpoint AS 4.4), which was more than twice that of placebo-treated subjects (mean baseline AS 10.6; mean endpoint AS 8.3; 21.7% reduction). Risperidone was efficacious in reducing symptoms of aggression in boys of below average IQ with disruptive behaviour disorders. PMID:16096518

LeBlanc, John C; Binder, Carin E; Armenteros, Jorge L; Aman, Michael G; Wang, Jenny S; Hew, Huong; Kusumakar, Vivek

2005-09-01

133

Risperidone oral solution versus standard tablets for the acute treatment of patients with schizophrenia.  

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The time required to attain the maximum plasma level of risperidone (RIS) is shorter for RIS oral solution (OS) than for RIS standard tablets (ST), although both forms have equal bioavailability. The objective of this study was to clarify whether RIS-OS shows a faster onset of efficacy and lower adverse events than RIS-ST. The two forms of risperidone were compared with respect to effectiveness including a speed of response, efficacy and tolerability. An open-label, 24-week, multicentre, randomized, flexible-dose study comparing the RIS-OS (mean dose, 3.7 mg; N=44) to the RIS-ST (mean dose, 3.7 mg; N=37) in acutely ill patients with schizophrenia showed no differences. Outcome measures included psychopathology, tolerability (extrapyramidal symptoms and serum prolactin), and Drug Attitude Inventory. This study was conducted between October 2006 and October 2008. Both RIS-OS- and RIS-ST-treated patients showed statistically significant reductions from the baseline in the mean scores of the Positive and Negative Syndrome Scale (PANSS)-total and PANSS-excite component, with no statistically significant differences between the treatment groups. The accumulated treatment response ratio was similar between the two groups. There was no significant difference in the Drug-Induced Extrapyramidal Symptom Scale score or serum prolactin increase between the treatment groups, but RIS-OS appeared to induce less serum prolactin increase than RIS-ST in drug-naïve female patients. Because there is no theoretical reason why this should be so, these results will require confirmation from a double-blind study in a larger sample. No significant difference was observed in the subjective drug attitude between the two groups. The original hypothesis that RIS-OS shows an earlier onset of efficacy or less adverse events than RIS-ST was not supported in this study. Subsequent studies should carefully establish the differences among various forms of antipsychotic drugs. PMID:21168464

Kusumi, Ichiro; Honda, Minoru; Ito, Koichi; Uemura, Keiichi; Kumazawa, Yukie; Ishikane, Tomohito; Niide, Yasushi; Koyama, Tsukasa

2011-03-30

134

Olanzapine vs. Risperidone in Patients with First-Episode Schizophrenia and a Lifetime History of Cannabis Use Disorders: 16-Week Clinical and Substance Use outcomes  

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The purpose of this study is to compare the efficacy of olanzapine and risperidone for the acute treatment of first-episode schizophrenia patients with cannabis use disorders. This secondary analysis of a previously published study included forty-nine first-episode patients with a diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a co-occurring lifetime diagnosis of cannabis use disorders randomly assigned to treatment with either olanzapine (n=28) or risp...

Sevy, Serge; Robinson, Delbert G.; Sunday, Suzanne; Napolitano, Barbara; Miller, Rachel; Mccormack, Joanne; Kane, John M.

2011-01-01

135

Risperidone and Corrected QT-interval Prolongation in Surface Electrocardiogram  

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Full Text Available Risperidone is an antipsychotic medication suspected of causing QT prolongation and several cases are reported in this regard. However, available information with respect to its effect on QT interval is limited especially from different settings. The aim of this study was to assess the effect of risperidone in lengthening QT interval among psychotic patients referred to a psychiatric ward in North West of Iran. A controlled cohort study was conducted on psychotic patients referred to Razi Hospital from April 2010-2011. The treatment cohort groups were 120 patients receiving risperidone for the first time during their treatment. The comparison cohort included 60 control patients who were not receiving risperidone. An electrocardiogram was obtained from all the study participants at admission time, one week afterwards and at discharge. Corrected QT interval (QTc was determined using Bazett’s formula. QTc dispersion was calculated as MaxQTc-MinQTc. Data were analyzed using SPSS statistical software package. The mean change in QTc measures over time was not statistically significant in control group. However, QTc increment was statistically significant over time in V1 and V3 leads in risperidone group. Multivariate longitudinal data analysis, using between-effects model, to manage multiple measurements over time found the overall QTc trend to be different between the groups (p<0.01. Risperidone may have significant effects on QT interval and QT dispersion. Physicians and psychiatrists should be aware that prolonged QTc interval is a potential indicator of cardiovascular risk and should be cautious in prescribing potentially QT-prolonging medications, at least to certain patients.

N.M. Ahmadi

2012-01-01

136

One-Shot Percutaneous Ethanol Injection of Liver Tumors Under General Anesthesia: Preliminary Data on Efficacy and Complications  

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Purpose: To verify the efficacy of ultrasound (US)-guided injection of large amounts of ethanol into large or multiple liver lesions, in a single session under general anesthesia (one-shot PEI) for percutaneous ablation of hepatic tumors. Methods: Twenty-nine patients (27 with 51 hepatocellular carcinoma (HCC) nodules on cirrhosis, diameter range 1.0-9.0 cm; two patients with a single metastasis from the gastroenteric tract, 5.0 and 9.0 cm, respectively, in diameter) were treated with one-shot PEI. Results: The total volume of alcohol delivered per patient ranged from 16 to 210 ml. Mean ethanol volume in all patients was 49 ml. Dynamic computed tomography (CT) examination showed complete necrosis in 41 of 50 lesions. Two patients died of hypovolemic shock due to massive upper gastrointestinal bleeding, 3 and 7 days, respectively, after the interventional procedure. All the remaining patients are alive (follow-up 5-14 months) except one who died of liver failure 5 months after. New HCC nodules occurred in six patients within 6 months and one intralesional relapse was recorded. Conclusion: In this preliminary experience, one-shot PEI is as effective in inducing liver tumor necrosis as traditional PEI; its advantages are shorter treatment time and the capability of treating larger and multiple liver lesions

137

Paliperidone palmitate injection for the acute and maintenance treatment of schizophrenia in adults  

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Full Text Available Shiyun Kim,1 Hugo Solari,2 Peter J Weiden,2 Jeffrey R Bishop11Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, 2Department of Psychiatry, University of Illinois at Chicago College of Medicine, Chicago, IL, USAPurpose: To review the use of paliperidone palmitate in treatment of patients with schizophrenia.Methods: Published clinical trial data for the development and utilization of paliperidone palmitate for the treatment of schizophrenia were assessed in this review. Four short-term, randomized, double-blind, placebo-controlled trials investigated the efficacy of paliperidone palmitate in acute exacerbation of schizophrenia. Paliperidone palmitate was also studied as a maintenance treatment to prevent or delay relapse in stable schizophrenia. In addition, paliperidone palmitate was compared to risperidone long-acting injection for noninferiority in three studies.Results: Paliperidone palmitate has been shown to be effective in reducing symptoms as measured by the Positive and Negative Syndrome Scale total scores in the four acute treatment studies. In the maintenance treatment studies, paliperidone palmitate was found to be more effective than placebo in preventing or delaying the time to first relapse in stable schizophrenia patients. In addition, paliperidone palmitate was shown to be noninferior to risperidone long-acting injection in two studies. It was shown to be reasonably well tolerated in all clinical trials. Acute treatment phase should be initiated with a dose of 234 mg on day one and 156 mg on day eight, followed by a recommended monthly maintenance dose of 39–234 mg based on efficacy and tolerability results from the clinical studies.Conclusion: Providing an optimal long-term treatment can be challenging. Paliperidone palmitate can be used as an acute treatment even in outpatient setting, and it has shown to be well tolerated by patients. Also, it does not require overlapping oral antipsychotic supplementation while being initiated, and is dosed once per month.Keywords: schizophrenia, antipsychotic, long-acting injection, paliperidone

Kim S

2012-07-01

138

Relationship between Addiction Relapse and Self-Efficacy Rates in Injection Drug Users Referred to Maintenance Therapy Center of Sari, 1391  

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Full Text Available Background and Purpose: Self-efficacy is the belief that one has the ability to implement the behaviors needed to produce a desired effect. There has been growing interest in the role of self-efficacy as a predictor and/or mediator of treatment outcome in number of domains. In numerous studies of substance abuse treatment, self-efficacy has emerged as an important predictor of outcome, or as a mediator of treatment effects. In the event of a slip, highly self-efficacious persons are inclined to regard the slip as a temporary setback and to reinstate control, whereas those who have low self-efficacy are more likely to proceed to a full-blown relapse. This study was carried out to determine relationship between relapse and self-efficacy and other factors in injected drug users. Materials and Methods: We conducted this study in 200 addicts in the center of counseling behavioral disease in health center of sari city (methadone maintenance therapy center or MMTC. A cross-sectional study was carried out on all of these addicts. Results: The average age in addictions was38 and its range was 20-60.72%of them were married and the first drug used was opium. All of them had relapse at least one time .we found a relationship between relapse and self-efficacy as well as the relationship between self-efficacy with the age of the first of drug use, dose, and procrastination for treatment, marriage, employment and job was significant. Conclusion: This study found that there was a significant difference between relapse and self-efficacy as well as other related factors. It is important to include drug users and common society organizations representing them in every stage of the governmental policy and program development process to make them responsive to the needs of the community.

Zahra Abdollahi

2014-01-01

139

Long-acting injectable antipsychotics: focus on olanzapine pamoate  

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Full Text Available JP LindenmayerDepartment of Psychiatry, New York University School of Medicine, New York NY, USAAbstract: Medication non-adherence in patients with schizophrenia continues to be a significant problem and threatens successful treatment outcomes. Medication non-adherence is often associated with negative consequences, including symptom exacerbation, more frequent emergency room visits, re-hospitalizations and relapse. Long-acting injectable (LAI forms of antipsychotics allow for rapid identification of non-adherence, obviate the need for the patient to take the medication on a daily basis and increase adherence to some significant degree. Eli Lilly has developed a long-acting depot formulation of olanzapine, olanzapine pamoate, which has recently been approved by the FDA for the US market, and which will be reviewed here. Olanzapine LAI appears to be an effective antipsychotic at dosages of 210 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks in patients with acute schizophrenia, and at 150 mg every 2 weeks, 300 mg every 2 weeks and at 405 mg every 4 weeks for the maintenance treatment of stable patients. Oral supplementation appears not to be needed, particularly not at the onset of treatment with the LAI as is necessary with risperidone LAI. Its efficacy is in general comparable to the efficacy seen with oral olanzapine at a corresponding dose. The side effect profile is also comparable to the side effects observed with oral olanzapine, including lower rates of extrapyramidal symptoms, prolactin elevation and cardiovascular side effects, but significant metabolic effects. The latter include significant weight gain, lipid abnormalities and glucose dysregulation. While the injection site adverse events are overall mild, the most significant serious adverse event is the post-injection delirium sedation syndrome (PDSS. While rare, this syndrome results from inadvertent intravascular injection of olanzapine LAI and can cause a range of olanzapine overdose-type of symptoms. Olanzapine LAI needs therefore to be administered by trained personnel in settings where a post-injection observation period for at least 3 hours by medical personnel is available. The overall use of olanzapine LAI will probably be limited by the possibility of a PDSS event. Patients who have a history of good response to oral olanzapine and are in need of assured medication administration may present a good indication for its use, provided that the appropriate mental health delivery setting is available.Keywords: olanzapine, risperidone, schizophrenia

JP Lindenmayer

2010-05-01

140

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: Retrospective study of thirty-one cases].  

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Triamcinolone acetonide (Kenacort(®)) is a corticosteroid that can be administrated by subconjunctival injection, with an extended release for up to three months. Our retrospective study aims to analyze safety and efficacy of subconjunctival triamcinolone injections in the treatment of uveitic macular edema. We included 31 eyes of 30 patients, who had one or several injections. We studied the progression of visual acuity, central macular thickness by optical coherence tomography (OCT), intraocular pressure, and presence or absence of cataract, on the day of injection (T0), and at 1, 3, 6 and 12 months after injection. Twenty-one patients had only one injection; 10 patients had 2. The 12-month follow-up showed an improvement in visual acuity with an initial mean of 0.36±0.27logMAR to 0.23±0.33 logMAR at 3 months of follow-up (Pcentral macular thickness was measured by OCT, from a mean of 444±112?m (0.24±0.11logSD-OCT) at T0 to 355±103?m (0.14 $±0.10 logSD-OCT) at 3 months (P=0.0002). We did not find a significant increase in intraocular pressure, and we diagnosed one cataract during follow-up but this occurred in the uninjected eye as well. Subconjunctival injection of triamcinolone acetonide is a safe and effective treatment of macular edema related to uveitis. Initial clinical monitoring is necessary to detect iatrogenic events. PMID:25199486

Bleriot, A; Couret, C; Le Meur, G; Lebranchu, P; Weber, M

2014-10-01

 
 
 
 
141

Clinical result of intra-arterial lymphocyte injection therapy for treatment of lymphedema and the evaluation of the efficacy of the therapy. Quantitative analysis by an injection of {sup 111}In-labeled lymphocytes and by MR imaging  

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We have employed the intra-arterial lymphocytes injection therapy for treatment of lymphedema of the limbs with various causes. In the present study, we observed the clinical outcome of our therapy in 38 patients with lymphedema of the limbs. Results showed that the therapy was effective in 26 of 38 patients (68% of the total). Moreover, a marked efficacy was obtained in 13 of 38 patients (34% of the total). In the latest 5 patients, to evaluate the efficacy of our therapy, we examined the distribution of the {sup 111}In-oxine labeled lymphocytes injected into the proximal artery of the affected limb. The radioactivities of the affected limbs were apparently higher than that of the healthy limbs in effective cases. Moreover, MR imaging showed that the reduction of STIR ratio and T{sub 2} ratio well correlate with the results of clinical course. Thus, the efficacy of the lymphocyte injection therapy is able to be evaluated by radiolabeled lymphocytes and MR imaging. (author).

Yoshizumi, Masanori; Kitagawa, Tetsuya; Hori, Takaki; Katoh, Itsuo; Harada, Masashi; Matsumoto, Takahiro; Nishitani, Hiromu [Tokushima Univ. (Japan). School of Medicine

1995-11-01

142

Clinical result of intra-arterial lymphocyte injection therapy for treatment of lymphedema and the evaluation of the efficacy of the therapy. Quantitative analysis by an injection of 111In-labeled lymphocytes and by MR imaging  

International Nuclear Information System (INIS)

We have employed the intra-arterial lymphocytes injection therapy for treatment of lymphedema of the limbs with various causes. In the present study, we observed the clinical outcome of our therapy in 38 patients with lymphedema of the limbs. Results showed that the therapy was effective in 26 of 38 patients (68% of the total). Moreover, a marked efficacy was obtained in 13 of 38 patients (34% of the total). In the latest 5 patients, to evaluate the efficacy of our therapy, we examined the distribution of the 111In-oxine labeled lymphocytes injected into the proximal artery of the affected limb. The radioactivities of the affected limbs were apparently higher than that of the healthy limbs in effective cases. Moreover, MR imaging showed that the reduction of STIR ratio and T2 ratio well correlate with the results of clinical course. Thus, the efficacy of the lymphocyte injection therapy is able to be evaluated by radiolabeled lymphocytes and MR imaging. (author)

143

Comparison of the Efficacy of Oral and Injectable Forms of Prophylactic Antibiotics in Grade Ii Traumatic Ulcers in Emergency Wards of University Hospitals of Yazd  

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Introduction: Traumatic ulcers are one of the most common causes of referral to emergency wards and interfere with wound healing. Even in a complete sterile condition, all of the ulcers may be contaminated with bacteria, but a few of them progress and cause clinical manifestations. There is a controversy on the use prophylactic antibiotics in traumatic ulcers. In this study we compare the efficacy of oral and injectable forms of antibiotics in prophylaxis of infection. Methods: In this clinic...

MR Hajiesmaieli; Shiryazdi, M.; Kargar, S.; Modir, A.; Mh, Mirshamsi; Zare, M.

2007-01-01

144

Comparison of the efficacy of weekly vs. twice a week intralesional injections of meglumine antimoniate in the treatment of anthroponotic cutaneous leishmaniasis: a randomized clinical trial  

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Full Text Available "nBackground and Aim: Treatment of cutaneous leishmaniasis, especially when caused by L. tropica, is challenging. Meglumine antimoniate (Glucantime® is used as the standard treatment, but multiple injectiond are necessary. The objective of this study was to compare the efficacy of weekly intralesional injections with twice weekly injections of Glucantime for the treatment of anthroponotic cutaneous leishmaniasis (ACL."n"nMethods: This randomized open clinical trial was conducted, in Bam, Kerman province, Iran. 96 eligible patients according to inclusion and exclusion criteria who were willing to participate were included. The included patients were randomly assigned into two groups, one group treated with weekly intralesional injections of Glucantime® and the other group treated with intralesional Glucantime® twice a week. Type and size of each lesion (induration, ulcer and scar were recorded weekly. Complete healing was defined as complete re-epithelialization and absence of induration in all lesions and was considered as the primary outcome measure."n"nResults: A total of 48 patients completed the study; complete cure was seen in 24 of 27 (89% patients who received weekly intralesional MA with a mean duration of healing equals to 70±10 days. Complete cure was seen in 24 of 31 (77% patients who received intralesional MA twice a week, the mean duration of healing in the latter group was 58±5 days. There was no significant difference between the two groups (P=0.23."n"nConclusion: It seems that the efficacy of intralesional injections of Glucantime® once a week is similar to efficacy of twice a week Glucantime® injections.

Ali Khamesipour

2010-12-01

145

FORMULATION DEVELOPMENT AND EVALUATION OF EXTENDED RELEASE MINI TABLETS OF RISPERIDONE  

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The present study was carried out to formulate Risperidone mini tablets filled into hard gelatin capsule, as it is administered for the treatment of psychosis. The preformulation studies of Risperidone were carried out and drug –polymer compatibility studies were performed by FT-IR spectra analysis. The precompression parameters revealed that all the 6 formulations had good flow Carr’s index, Hausner’s ratio and angle of repose within the limit. Risperidone is formulated with different ...

Vishnu Vardhan Reddy, B.; Dinesh Babu, G.; Premswaroop, A.; Chandra Sekhar, M.; Ramya.Y

2012-01-01

146

Risperidone, quetiapine, and olanzapine adjunctive treatments in major depression with psychotic features: a comparative study  

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Full Text Available A Gabriel Departments of Psychiatry and Community Health Sciences, University of Calgary, Calgary, AB, Canada Objectives: The purpose of this study was to compare the effectiveness of novel antipsychotics in the treatment of psychotic depression. Method: Consecutive patients who were admitted (n = 51 with a confirmed diagnosis of major depression with psychotic features (delusions or hallucinations or both participated in this open-label, naturalistic study. All patients were treated with selective serotonin reuptake inhibitors (SSRIs and serotonin–norepinephrine reuptake inhibitors (SNRIs (citalopram or venlafaxine extended release [XR], and atypical antipsychotic agents were added, as tolerated, during the first week of initiating the citalopram or venlafaxine. There were patients (n = 16 who received risperidone, who received quetiapine (n = 20, and who received olanzapine (n = 15, as an adjunctive treatment to either citalopram or venlafaxine for at least 8 weeks. Outcome measures included the Clinical Global Impression-Severity subscale (CGI-S, as the primary outcome measure, as well as the Hamilton Rating Scale for Depression-21 item (HAM-D21 and the Brief Psychiatric Rating Scale (BPRS. Tolerance to treatments and weight changes were monitored over the period of the trial. Results: All patients completed the trial with no drop outs. At 8 weeks, there was a statistically significant (P 0.01 in the olanzapine group. Conclusion: Quetiapine, risperidone, and olanzapine, given as adjunctive treatment with SSRIS or SNRIs can significantly and equally improve depressive and psychotic symptoms, in the short-term treatment of major depression with psychotic features. The author recommends that large controlled trials be conducted to examine the differences in long-term efficacy and tolerance between the atypical antipsychotic agents, in the treatment of major depression with or without psychotic features. Keywords: depression, novels, antipsychotics, treatment, augmentation

Gabriel A

2013-04-01

147

Multi-drug overdose risperidone, ziprasidone, valproate, trihexyphenidyl, and clonazepam  

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Risperidone and ziprasidone are commonly used as first line drugs for the treatment of psychotic disorders and overdose with these agents is increasingly being reported. Relatively few of these reports have involved co-ingestion of multiple psychotropic agents. We report a case of overdose with risperidone, ziprasidone, valproate, trihexyphenidyl and clonazepam in a 25 years female, who recovered uneventfully with supportive management. Notwithstanding the benign outcome in this instance, age, co-ingested drugs, active metabolites and medical co-morbidity are critical issues in overdose with atypical antipsychotics. As prescription of these drugs continues to increase in developing countries, systematic studies evaluating their clinical toxicity and management are necessary. The issues associated with overdose of multiple psychotropic agents and appropriate management policies are highlighted.

Rajamani, Anto Praveen Rajkumar; Jebaraj, P

2007-01-01

148

Efficacy of the computed tomographic scanning (CT) with contrast media injection from foot vein for abdominal mass of the child  

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CT with contrast media injection from forearm vein revealed poor information about the inferior vena cava (IVC), in two cases of neuroblastoma from the right adrenal gland. While, CT with contrast media injection from foot vein well demonstrated the tumor extension around the IVC in one case of neuroblastoma, and the tumor, thrombus in the IVC in two cases of Wilms' tumor. Bolus injection from foot vein is helpful to evaluate the extension of malignant tumor around the IVC. (author)

149

Efficacy of the computed tomographic scanning (CT) with contrast media injection from foot vein for abdominal mass of the child  

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CT with contrast media injection from forearm vein revealed poor information about the inferior vena cava (IVC), in two cases of neuroblastoma from the right adrenal gland. While, CT with contrast media injection from foot vein well demonstrated the tumor extension around the IVC in one case of neuroblastoma, and the tumor, thrombus in the IVC in two cases of Wilms' tumor. Bolus injection from foot vein is helpful to evaluate the extension of malignant tumor around the IVC.

Aoki, Katsuhiko; Ohba, Satoshi; Kohno, Sumio; Arai, Takeo; Uemura, Sadatoshi; Ohya, Toshiki; Itoh, Shinichi

1988-04-01

150

Peripheral Edema Occurring during Treatment with Risperidone Combined with Citalopram  

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An 80-year-old female presented with symptoms of depression, worthlessness, hopelessness, loss of energy, insomnia, impatience, and forgetfulness associated with persecutory delusion that had begun about one year before her visit. She was diagnosed with major depression with psychotic signs and began treatment with risperidone (2?mg/night) and citalopram (20?mg/day). After 20 days, she returned and reported partial improvement in her symptoms, although she had developed severe swelling of...

Amirhossein Ahmadi; Seyed Hamzeh Hosseini

2012-01-01

151

Comparison of Hemostatic Efficacy of Argon Plasma Coagulation with and without Distilled Water Injection in Treating High-Risk Bleeding Ulcers  

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Background. Argon plasma coagulation (APC) is useful to treat upper gastrointestinal bleeding, but its hemostatic efficacy has received little attention. Aims. This investigation attempted to determine whether additional endoscopic injection before APC could improve hemostatic efficacy in treating high-risk bleeding ulcers. Methods. From January 2007 to April 2011, adult patients with high-risk bleeding ulcers were included. This investigation compared APC plus distilled water injection (combined group) to APC alone for treating high-risk bleeding ulcers. Outcomes were assessed based on initial hemostasis, surgery, blood transfusion, hospital stay, rebleeding, and mortality at 30 days posttreatment. Results. Totally 120 selected patients were analyzed. Initial hemostasis was accomplished in 59 patients treated with combined therapy and 57 patients treated with APC alone. No significant differences were noted between these groups in recurred bleeding, emergency surgery, 30-day mortality, hospital stay, or transfusion requirements. Comparing the combined end point of mortality plus the failure of initial hemostasis, rebleeding, and the need for surgery revealed an advantage for the combined group (P = 0.040). Conclusions. Endoscopic therapy with APC plus distilled water injection was no more effective than APC alone in treating high-risk bleeding ulcers, whereas combined therapy was potentially superior for patients with poor overall outcomes. PMID:25243138

Hsu, Ping-I; Chan, Hoi-Hung; Wang, Kai-Ming; Tsai, Wei-Lun; Yu, Hsien-Chung; Tsay, Feng-Woei

2014-01-01

152

Long term safety, efficacy, and patient acceptability of hyaluronic acid injection in patients with painful osteoarthritis of the knee  

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Full Text Available Benjamin A McArthur, Christopher J Dy, Peter D Fabricant, Alejandro Gonzalez Della ValleDepartment of Orthopedic Surgery, Hospital for Special Surgery, New York, NY, USAAbstract: The increasing prevalence of painful knee osteoarthritis has created an additional demand for pharmacologic management to prevent or delay surgical management. Viscosupplementation, via intraarticular injection of hyaluronic acid (HA, aims to restore the favorable milieu present in the nonarthritic joint. The safety profile of intraarticular HA injections for painful knee osteoarthritis is well established, with the most common adverse effect being a self-limited reaction at the injection site. Although acceptance of the early literature has been limited by publication bias and poor study quality, more recent and rigorous meta-analysis suggests that intraarticular HA injection is superior to placebo injection for pain relief and matches, if not surpasses, the effect size of other nonoperative treatments, such as nonsteroidal anti-inflammatory medication. Intraarticular HA injection is effective in providing temporary pain relief in patients with painful knee osteoarthritis. Future investigations should focus on optimizing the composition and administration of HA agents to provide prolonged relief of painful osteoarthritis in the knee and other joints.Keywords: intraarticular injection, hyaluronate, viscosupplementation, osteoarthritis, knee

McArthur BA

2012-12-01

153

Human 5-HT7 Receptor-Induced Inactivation of Forskolin-Stimulated Adenylate Cyclase by Risperidone, 9-OH-Risperidone and Other “Inactivating Antagonists”  

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We have previously reported on the unusual human 5-hydroxytryptamine7 (h5-HT7) receptor-inactivating properties of risperidone, 9-OH-risperidone, bromocriptine, methiothepin, metergoline, and lisuride. Inactivation was defined as the inability of 10 ?M 5-HT to stimulate cAMP accumulation after brief exposure and thorough removal of the drugs from HEK293 cells expressing h5-HT7 receptors. Herein we report that brief exposure of the h5-HT7 receptor-expressing cells ...

Toohey, Nicole; Klein, Michael T.; Knight, Jessica; Smith, Carol; Teitler, Milt

2009-01-01

154

Ablation of lumbar sympathetic ganglia by absolute ethanol injection and paravertebral catheter placement under CT guidance: evaluation of the efficacy  

International Nuclear Information System (INIS)

Objective: To evaluate the ablation of lumbar sympathetic ganglia by using single injection of absolute ethanol and retaining a paravertebral catheter under CT guidance for the treatment of lower extremity ischemia. Methods: Single absolute ethanol injection of L2 sympathetic ganglia was done in 25 cases (group B), single absolute ethanol injection of L2 sympathetic ganglia together with placement of a paravertebral catheter at L3 was carried out in 23 cases (group BT). All the procedures were performed under CT guidance. Three days after the procedure, the pain severity of the lower limbs was evaluated based on VAS method. If the patient in group BT still had a VAS score ?4 on the third day, 3 ml of 1% lidocaine was infected via the retained catheter in the prone position. If VAS score became ?3 at 5 min after the injection, additional 5 ml of ethanol was given through the catheter. The pain severity was evaluated again one week later. VAS score, analgesic dose and temperature of lower limbs were recorded. Results: One week after the procedure the excellent rate and effective rate for group B were 32% and 80% respectively, while for group BT were 60.9% and 95.7% respectively, with a significant difference between two groups (P<0.01). Conclusion: For the ablation of lumbar sympathetic ganglia the combination of single absolute ethanol injection with paravertebral catheter placement under CT guidance is superior to the single absolute ethanol injection. This technibsolute ethanol injection. This technique is more individual with better results and is more likely to be accepted by the patients. (authors)

155

Efficacy and safety of second-generation long-acting injections in schizophrenia: a meta-analysis of randomized-controlled trials.  

Science.gov (United States)

The aim of the present article is to test at a meta-analytical level the efficacy and safety of second-generation long-acting antipsychotic injections (SGLAI) in schizophrenia. Thirteen randomized-controlled trials comparing SGLAI with either placebo or oral antipsychotics were included in a quantitative meta-analysis (6313 patients). Efficacy and safety measures as well as demographic and clinical variables were extracted from each publication or obtained directly from authors. Publication bias was assessed with funnel plots and Egger's intercept. Heterogeneity was addressed with the Q statistic and the I² index. SGLAI were more effective than placebo injections [Hedges's g=0.336, 95% confidence interval (CI) 0.246-0.426, Z=7.325, P<0.001] in reducing the Positive and Negative Syndrome Scale (PANSS) scores, but no differences were observed compared with oral antipsychotics (Hedges's g=0.072, 95% CI -0.072 to 0.217, Z=0.983, P=0.326). There were more responders under SGLAI than placebo (47 vs. 24%, NNT 4, 95% CI 3-6), but no differences in comparison with oral antipsychotics [relative risk (RR)=0.962, P=0.094]. SGLAI and controls groups shared a common safety profile with respect to the number of deaths, overall number of treatment-adverse events, insomnia, QT prolongation, or pain in the injection site. There was a greater risk of developing extrapyramidal side effects with SGLAI than with placebo (RR=2.037, P<0.001) or with oral antipsychotics (RR=1.451, P=0.048). There was no evidence of publication bias (Egger's P=0.476), and sensitivity analysis confirmed the robustness of results. The present meta-analysis shows superior efficacy for the SGLAI over placebo on psychotic symptoms, although with a relatively small effect size; no evidence of superiority in efficacy over oral antipsychotics; and modest evidence of greater symptoms of extrapyramidal side effects. These data suggest that SGLAI lack an advantage in reducing psychotic symptoms over oral medications. Their potential effects on relapse prevention should be better addressed by future randomized-controlled trials. PMID:23165366

Fusar-Poli, Paolo; Kempton, Matthew J; Rosenheck, Robert A

2013-03-01

156

8-week, single blind, randomized controlled trial comparing risperidone versus olanzapine augmentation of serotonin reuptake inhibitors in the treatment-resistant obsessive-compulsive disorder  

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The aim of the present pilot study was to investigate in a single-blind manner, over a period of 8 weeks, the comparative efficacy and tolerability of risperidone versus olanzapine addition in the treatment of OCD patients who did not show a >or=35% decrease in the YBOCS score after 16-week SRI treatment (defined as resistant). The study consisted of two different phases: a 16-week open-label prospective phase to ascertain resistance to SRI treatment and an 8-week single-blind addition phase ...

Bogetto, Filippo; Maina, Giuseppe; Pessina, Enrico; Albert, Umberto

2008-01-01

157

Risperidone induced weight gain leading to benign intracranial hypertension.  

Science.gov (United States)

Benign intracranial hypertension (BIH) is a condition which is strongly associated with weight gain. A well-known potential adverse effect of anti-psychotic treatment, especially the atypical group, is weight gain. Our case describes the use of risperidone in a young obese lady who gained significant weight after commencing the antipsychotic and later developed headache and blurred vision. Withdrawing the offending drug (causing reduction in her weight) in addition to acetazolamide drastically improved her symptoms within a month. Our case highlights that, obese patients started on antipsychotic medication, who develop headache, should be considered for investigation of BIH. PMID:22689727

Ahmed, Hira; Ali, Hala

2011-01-01

158

Development of Analytical Method for Risperidone by UV Spectrophotometry  

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Full Text Available A simple, sensitive, specific, spectrophotometric method developed for the detection of Risperidone in bulk drug and Pharmaceutical formulation. The optimum conditions for the analysis of the drug wereestablished. The ? max of the Risperidone was found to be 280 nm. The method shows high sensitivity with linearity 2 to 6? g/ml. The lower limit of detection and the limit of quantification was found to be 1.012 and 3.036 respectively. All the calibration curves shows a linear relationship between the absorbance and concentration and coefficient correlation was higher than 0.99. The regression of the curve was Y = 0.039x - 0.002. Precision of the method was found to be 2.0325 ± 0.044 against the label claim of 2mg. The percentage recovery was found to be 102 ? 0.188. The sample solution was stable up to 2 hours. The proposed method will be suitable for the analysis of RIS in bulk and pharmaceutical formulation.

M.Sravan Kumar,

2010-03-01

159

Applying a mathematical model to estimate the fractional accessibility to quenching of serum albumin by risperidone  

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In this work we report the results from application of a mathematical model to estimate the fractional accessibility to fluorescence quenching by risperidone in human and bovine sera albumins. Risperidone is an atypical antipsychotic drug used to treat many kinds of psychiatric disorders. Results showed that but the fractional accessibility for trypyophan 134, sub domain 1B, is about 3 times higher than that to tryptophan 212, showing that the primary binding site for risperidone is close to tryptophan 134, in domain IB of BSA.

Carqueja, Marilena; Cortez, Celia Martins

2014-10-01

160

Risperidone Versus Yokukansan in the Treatment of Severe Alzheimer’s Disease  

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Full Text Available PURPOSE: Patients with AD commonly exhibit behavioral and psychological symptoms of dementia (BPSD. This study is aimed to compare the efficacy of yokukansan (YKS and risperidone (RIS on BPSD in patients with severe Alzheimer’s disease (AD. METHODS: Thirty eight inpatients with AD were investigated. Patients were randomly as-signed to the YKS group (N = 18 or the RIS group (N = 20 and treated for 4 weeks. The primary outcomes were changes in the scores on the Neuropsychiatric Inventory (NPI, the Mini-Mental State Examination (MMSE, the Bar-thel Index, and the Cohen-Mansfield Agitation Inventory (CMAI. The frequency of extrapyramidal symptoms (EPS and other adverse events were recorded at every visit. RESULTS: All participants in both groups completed the trial. The Barthel Index did not significantly change either in the RIS group or the YKS group. The MMSE scores did not change either in the RIS group or the YKS group. Significant improvements in mean total NPI and CMAI scores showed in both groups. Between the YKS and the RIS groups, there were no significant differences in the NPI or the CMAI scores. EPS and other serious adverse effects were not observed in either group. CONCLUSIONS: In this 4-week trial, YKS treatment significantly improved BPSD in the patients with severe AD. The present study suggests that YKS is as effective as RIS on BPSD with severe AD.

Yuko Furuhashi

2011-05-01

 
 
 
 
161

Microsphere delivery of Risperidone as an alternative to combination therapy.  

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The purpose of this study was to develop a parenteral delivery system of Risperidone that would provide initial and extended drug release and thereby avoid the need for co-administration of oral tablets. Key formulation parameters utilized to achieve desired therapeutic levels in vivo were particle size and drug loading. Three poly (D,L-lactide-co-glycolide) (PLGA) microsphere formulations (Formulations A, B, and C) that encapsulated Risperidone were prepared by varying particle size (19-49 ?m) and drug loading parameters (31-37%) but with a uniform bulk density (0.66-0.69)g/cc and internal porosity, utilizing the solvent extraction/evaporation method. The microspheres were characterized for drug content by HPLC, particle size by laser diffractometry, surface morphology by scanning electron microscopy (SEM), and in vivo drug release. In vivo studies were performed in male Sprague-Dawley rats, and levels of the active moiety (Risperidone and its metabolite, 9-hydroxyrisperidone) were assessed. In vivo release profiles from the three microsphere formulations were dependent on particle size and drug loading. The smaller sized microspheres (Formulation A) exhibited a large initial burst and a shorter duration of action, while the larger particles exhibited a smaller initial burst (Formulations B and C) but released drug for a much longer period in vivo. Extended duration of drug release was ascribed to higher drug content in the microspheres. A biweekly simulation of multiple dosing revealed that Formulation C, the selected formulation, with a high load and large particle size would provide adequate initial and maintenance levels of the active moiety (Risperidone and its metabolite, 9-hydroxyrisperidone). A comparison of biweekly dosing in vivo of Formulation C with the marketed product showed that at steady state, though average concentrations for both preparations were similar, the time taken to achieve steady state was much faster for Formulation C. The delay in attaining steady state with Risperdal Consta® was attributed to the 3 week latency in drug release from the microspheres and was in accordance with previous studies indicating a good corroboration with clinical findings. Calculated cumulative AUC (area under the curve) levels for Formulation C were similar to the Risperdal Consta®, though there were marked differences in AUC levels at the early time points. Comparison of Risperidal Consta® and Formulation C by multiple dosing in vivo experiments revealed that the marketed preparation demonstrated a substantial delay in providing an initial loading dose, continuous circulating levels, and attainment of steady state; all of which were observed rapidly with Formulation C. Findings from the current study strongly suggest that a microsphere dosage form of Risperidone can be formulated with an optimum particle size and drug loading to provide an initial bolus followed by maintenance levels, thereby eliminating combination therapy and improving patient compliance. PMID:23892159

D'Souza, Susan; Faraj, Jabar; DeLuca, Patrick

2013-11-01

162

Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data  

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Full Text Available Abstract Background To treat acute schizophrenia, a long-acting injectable antipsychotic needs a rapid onset of action and therapeutic profile similar to that of oral agents. The present post-hoc analyses compared results from a randomized, double-blind, placebo-controlled trial of olanzapine long-acting injection (LAI for acute schizophrenia with those observed in similarly designed trials of oral olanzapine. Methods Six-week results from the olanzapine LAI study (N?=?404 were compared with those of 3 oral studies (study 1: olanzapine vs. haloperidol vs. placebo [N?=?335]; study 2: olanzapine vs. haloperidol vs. low-dose olanzapine [N?=?431]; study 3: olanzapine vs. placebo vs. low-dose olanzapine [N?=?152]. All patients had baseline Brief Psychiatric Rating Scale (BPRS scores ?24 (0–6 scale. Six-week effect sizes were calculated. Efficacy onset, pharmacokinetics, discontinuations, weight gain, and extrapyramidal symptoms were also assessed. Results At 6?weeks, mean BPRS scores decreased by 14 to 15 points for olanzapine LAI (405?mg/4?weeks, 210 or 300?mg/2?weeks, by 8 to 16 for oral olanzapine (10?±?2.5 or 15?±?2.5?mg/day, and by 12 to 13 for haloperidol (15?±?5?mg/day. For those same dose groups, effect sizes vs. placebo for the BPRS were 0.7 to 0.8 for olanzapine LAI, 0.5 to 0.7 for oral olanzapine, and 0.6 for haloperidol. The first statistically significant separation from placebo on the BPRS occurred at 3?days for the olanzapine LAI groups and at 1?week for oral olanzapine and haloperidol (15?±?5?mg/day in oral study 1 although as late as week 6 for the 10-mg/day olanzapine dose in oral study 3. Olanzapine concentrations were similar across studies. Weight gain ?7% of baseline occurred in up to 35% of olanzapine LAI and oral patients versus up to 12% of haloperidol and placebo patients. Extrapyramidal symptoms were lowest in the olanzapine LAI groups and significantly greater in the haloperidol groups. No post-injection delirium/sedation syndrome events occurred in the olanzapine LAI study. Conclusions Patients treated acutely with olanzapine LAI showed a similar pattern of improvement to that seen historically with oral olanzapine. With the exception of injection-related adverse events, the efficacy and tolerability profile of olanzapine LAI is similar to oral olanzapine. Trial registration ClinicalTrials.gov ID; URL: http://http//www.clinicaltrials.gov/: NCT00088478; ClinicalStudyResults.org ID; URL: http://www.clinicalstudyresults.org/: 917, 978, 982, and 5984.

Detke Holland C

2012-05-01

163

Induction of Drug Transporters Alters Disposition of Risperidone - A Study in Mice  

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Full Text Available Pharmacokinetic interactions, e.g. modulation of drug transporters like P-glycoprotein at the blood-brain barrier, can be a reason for treatment non-response. This study focuses on the influence of induction of drug transporters on the disposition of the antipsychotic drugs risperidone and 9-hydroxyrisperidone. Brain and serum concentrations of risperidone and its active metabolite 9-hydroxyrisperidone, which are known P-glycoprotein substrates, were measured after drug transporter induction with rifampicin, dexamethasone or 5-pregnene-3beta-ol-20-on-16alpha-carbonitrile using high performance liquid chromatography. Disposition of risperidone and 9-hydroxyrisperidone was dramatically decreased in mouse brain and serum after drug transporter induction. The metabolism of risperidone was also affected.

David Holthoewer

2010-06-01

164

Effect of In-Plume Aerosol Processing on the Efficacy of Marine Cloud Albedo Enhancement from Controlled Sea-Spray Injections  

Science.gov (United States)

The intentional enhancement of cloud albedo via controlled sea-spray injection from ships has been proposed as a possible method to control anthropogenic global warming (1); however, there remains significant uncertainty in the efficacy of this method due to uncertainties in aerosol and cloud microphysics. A major assumption used in multiple recent studies (2,3) is that all sea-spray was emitted uniformly into some oceanic grid boxes, and thus did not account for sub-grid aerosol microphysics within the sea-spray plumes. However, as a consequence of the fast sea-spray injection rates which are proposed, in the order of 10^17 1/s (1), particle concentrations in these plumes may be quite high and particle coagulation may significantly reduce the number of emitted particles and increase their average size. Therefore, it is possible that the emissions necessary to reach a desired cooling may be even larger than currently assumed. We explore the evolution of these sea-salt plumes using a multi-shelled Gaussian plume model with size-resolved aerosol coagulation. We determine how the final number and size of particles depends on the emission rate and size distribution of the emitted sea-spray plume and local atmospheric conditions, including wind speed and boundary-layer stability. Under the injection rates reported in (1) and typical marine conditions, we find that the number of aerosol particles is reduced by about 40%. This fraction decreases for decreasing emission rates or increasing wind speeds due to lower particle concentrations in the plume. Finally, we make suggestions for effective size-resolved emissions for use in climate models. (1) Salter, S. et al., Phil. Trans. R. Soc. A., 2008. (2) Korhonen, H. et al., Atmos. Chem. Phys., 10, 4133-4143, 2010. (3) Partanen, A.-I. et al., J. Geophys. Res., 117, D02203, 2012.

Stuart, G. S.; Stevens, R. G.; Spracklen, D. V.; Korhonen, H.; Pierce, J. R.

2012-12-01

165

Comparison of the Efficacy of Oral and Injectable Forms of Prophylactic Antibiotics in Grade Ii Traumatic Ulcers in Emergency Wards of University Hospitals of Yazd  

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Full Text Available Introduction: Traumatic ulcers are one of the most common causes of referral to emergency wards and interfere with wound healing. Even in a complete sterile condition, all of the ulcers may be contaminated with bacteria, but a few of them progress and cause clinical manifestations. There is a controversy on the use prophylactic antibiotics in traumatic ulcers. In this study we compare the efficacy of oral and injectable forms of antibiotics in prophylaxis of infection. Methods: In this clinical trial study, 237 cases suffering from grade II traumatic ulcers were selected by simple random method and divided into 2 groups; first group was administered 1 gram cephazoline prior to suturing and received no other antibiotics , while the second group received 500 mg cephalexin capsule before suturing and continued the treatment for 24 hours. (500 mg QID .Patients were followed up on day 7, 10 and 30 after discharge from hospital for infection of the wounds. The collected data was analyzed by SPSS 11 software using Chi-squire and Fisher exact tests. Results: According to the findings, confounding variables such as sex, age, width of the wound, traumatic cause and site and also the time course until referral to the emergency ward were similar in both groups. Prevalence of infection in the group receiving oral and injection forms of antibiotic was 2.5% and 1.7%, respectively, difference of which was not significant.(P=0.683 Conclusion: As the prevalence of wound infection is similar in both groups, oral forms of antibiotics can be used instead of injectable forms for wound infection prophylaxis.

MR Hajiesmaieli

2007-12-01

166

Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth  

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Full Text Available Alex C Vidaeff, Michael A BelfortDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USAAbstract: Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol.Keywords: preterm delivery, prevention, 17 alpha-hydroxyprogesterone caproate, efficacy, safety, acceptability

Vidaeff AC

2013-07-01

167

The effects of ketamine and risperidone on eye movement control in healthy volunteers.  

Science.gov (United States)

The non-competitive N-methyl-D-aspartate receptor antagonist ketamine leads to transient psychosis-like symptoms and impairments in oculomotor performance in healthy volunteers. This study examined whether the adverse effects of ketamine on oculomotor performance can be reversed by the atypical antipsychotic risperidone. In this randomized double-blind, placebo-controlled study, 72 healthy participants performed smooth pursuit eye movements (SPEM), prosaccades (PS) and antisaccades (AS) while being randomly assigned to one of four drug groups (intravenous 100?ng?ml(-1) ketamine, 2?mg oral risperidone, 100 ?ng?ml(-1) ketamine plus 2?mg oral risperidone, placebo). Drug administration did not lead to harmful adverse events. Ketamine increased saccadic frequency and decreased velocity gain of SPEM (all P or = 0.07). An effect of risperidone was observed for amplitude gain and peak velocity of PS and AS, indicating hypometric gain and slower velocities compared with placebo (both P or = 0.26). The results confirm that the administration of ketamine produces oculomotor performance deficits similar in part to those seen in schizophrenia. The atypical antipsychotic risperidone did not reverse ketamine-induced deteriorations. These findings do not support the cognitive enhancing potential of risperidone on oculomotor biomarkers in this model system of schizophrenia and point towards the importance of developing alternative performance-enhancing compounds to optimise pharmacological treatment of schizophrenia. PMID:24326395

Schmechtig, A; Lees, J; Perkins, A; Altavilla, A; Craig, K J; Dawson, G R; William Deakin, J F; Dourish, C T; Evans, L H; Koychev, I; Weaver, K; Smallman, R; Walters, J; Wilkinson, L S; Morris, R; Williams, S C R; Ettinger, U

2013-01-01

168

Treatment with the Antipsychotic Agent, Risperidone, Reduces Disease Severity in Experimental Autoimmune Encephalomyelitis  

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Recent studies have demonstrated that atypical antipsychotic agents, which are known to antagonize dopamine D2 and serotonin 5-HT2a receptors, have immunomodulatory properties. Given the potential of these drugs to modulate the immune system both peripherally and within the central nervous system, we investigated the ability of the atypical anti-psychotic agent, risperidone, to modify disease in the animal model of multiple sclerosis (MS)4, experimental autoimune encephalomyelitis (EAE). We found that chronic oral administration of risperidone dose-dependently reduced the severity of disease and decreased both the size and number of spinal cord lesions. Furthermore, risperidone treatment substantially reduced antigen-specific interleukin (IL)-17a, IL-2, and IL-4 but not interferon (IFN)-? production by splenocytes at peak disease and using an in vitro model, we show that treatment of macrophages with risperidone alters their ability to bias naïve T cells. Another atypical antipsychotic agent, clozapine, showed a similar ability to modify macrophages in vitro and to reduce disease in the EAE model but this effect was not due to antagonism of the type 1 or type 2 dopamine receptors alone. Finally, we found that while risperidone treatment had little effect on the in vivo activation of splenic macrophages during EAE, it significantly reduced the activation of microglia and macrophages in the central nervous system. Together these studies indicate that atypical antipsychotic agents like risperidone are effective immunomodulatory agents with the potential to treat immune-mediated diseases such as MS. PMID:25116424

Stone, Sarrabeth; Zareie, Pirooz; Kharkrang, Marie; Fong, Dahna; Connor, Bronwen; La Flamme, Anne Camille

2014-01-01

169

Early onset of treatment effects with oral risperidone  

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Full Text Available Abstract Background The dogma of a delayed onset of antipsychotic treatment effects has been maintained over the past decades. However, recent studies have challenged this concept. We therefore performed an analysis of the onset of antipsychotic treatment effects in a sample of acutely decompensated patients with schizophrenia. Methods In this observational study, 48 inpatients with acutely decompensated schizophrenia were offered antipsychotic treatment with oral risperidone. PANSS-ratings were obtained on day 0, day 1, day 3, day 7 and day 14. Results Significant effects of treatment were already present on day 1 and continued throughout the study. The PANSS positive subscore and the PANSS total score improved significantly more than the PANSS negative subscore. Conclusion Our results are consistent with the growing number of studies suggesting an early onset of antipsychotic treatment effects. However, non-pharmacological effects of treatment also need to be taken into consideration.

Naber Dieter

2007-01-01

170

Patient and Health Care Provider Perspectives on Long Acting Injectable Antipsychotics in Schizophrenia and the Introduction of Olanzapine Long-Acting Injection  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Olanzapine long acting injection has joined risperidone and paliperidone as the second generation long acting antipsychotic injection options for treatment of patients with schizophrenia. Long acting injections are important alternatives to oral medications for patients who have difficulty adhering to daily or multiple daily medication administrations, yet may be underutilized or not well understood. Patient perceptions, adherence, and preferences are important issues for health care provider...

Wehring, Heidi J.; Sheryl Thedford; Maju Koola; Kelly, Deanna L.

2011-01-01

171

Efficacy of postoperative bladder irrigation with water for injection in reducing recurrence rates of non muscle invasive bladder cancer.  

Science.gov (United States)

The aim of the study was to investigate the results of bladder irrigation with Water for Injection (WFI) after transurethral resection of bladder tumours for comparison with those for adjuvant use of BCG. A total of 239 patients (158 with single tumours, group A, and 81 with multiple tumours, group B) received continuous intravesical postoperative irrigation with WFI. Some 128 patients received intravesical irrigation with WFI, followed by weekly instillations of BCG (group C). Recurrence-free rate (RFR) and recurrence-free intervals (RFI) were recorded. RFR for those patients who received only intravesical irrigation with WFI (groups A and B) was 75.8%, 66.2% and 63.2% at the 1st, 2nd and 3rd year of follow up, respectively. Corresponding rates for group C were 61.7%, 55.4% and 49%. Median RFI in group B were 18, 11, 15, 15 and 12 months for Ta, T1, grade 1, grade 2 and grade 3 tumours, respectively. In group C corresponding intervals were 20, 33, 8, 20 and 42 months. BCG improved RFR only in T1 (p=0.014) and grade 3 tumours (p=0.007). In conclusion, postoperative bladder irrigation with WFI could increase RFR during the first and second year of follow up. PMID:24716967

Grivas, Nikolaos; Hastazeris, Konstantinos; Kafarakis, Vasileios; Tsimaris, Ioannis; Aspiotis, Spiridon; Stratis, Antonios; Stavropoulos, Nikolaos Efthimios

2014-01-01

172

A study on the energy and emission efficacy of multi-pulse fuel injection on low-temperature combustion  

Energy Technology Data Exchange (ETDEWEB)

A numerical and experimental study was conducted to investigate the characteristics of low-temperature combustion mode in modern diesel engines. The purpose was to better understand the spatial and temporal evolution of nitrogen oxide (NOx) and soot in diesel engines. The low-temperature diesel combustion tests were conducted in a modern common-rail diesel engine with heavy exhaust gas recirculation (EGR) and 3 injection cycles which were timed before top-dead centre (TDC). The low-temperature combustion reduced NOx and soot and achieved emission norms. However, the low-temperature combustion experiment results showed new trends such as the NOx-HC tradeoff. The conventional single shot diesel combustion trend such as NOx-PM trade-off is no longer valid for this combustion mode. It was determined that the engine operation requires a sophisticated control strategy which is currently under development. The preliminary experimental results revealed that low temperature combustion can decrease the NOx and the soot simultaneously, to the point where they are below the emission standards of 2007/2010. 12 refs., 1 tab., 8 figs.

Kumar, R.; Zheng, M.; Reader, G.T.; Mulenga, C.M.; Bombardier, W.; Ko, S.J.; Wang, M. [Windsor Univ., ON (Canada). Dept. of Mechanical, Automotive and Materials Engineering

2006-07-01

173

Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth.  

Science.gov (United States)

Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol. PMID:23874089

Vidaeff, Alex C; Belfort, Michael A

2013-01-01

174

Influence of aripiprazole, risperidone, and amisulpride on sensory and sensorimotor gating in healthy 'low and high gating' humans and relation to psychometry.  

Science.gov (United States)

Despite advances in the treatment of schizophrenia spectrum disorders with atypical antipsychotics (AAPs), there is still need for compounds with improved efficacy/side-effect ratios. Evidence from challenge studies suggests that the assessment of gating functions in humans and rodents with naturally low-gating levels might be a useful model to screen for novel compounds with antipsychotic properties. To further evaluate and extend this translational approach, three AAPs were examined. Compounds without antipsychotic properties served as negative control treatments. In a placebo-controlled, within-subject design, healthy males received either single doses of aripiprazole and risperidone (n=28), amisulpride and lorazepam (n=30), or modafinil and valproate (n=30), and placebo. Prepulse inhibiton (PPI) and P50 suppression were assessed. Clinically associated symptoms were evaluated using the SCL-90-R. Aripiprazole, risperidone, and amisulpride increased P50 suppression in low P50 gaters. Lorazepam, modafinil, and valproate did not influence P50 suppression in low gaters. Furthermore, low P50 gaters scored significantly higher on the SCL-90-R than high P50 gaters. Aripiprazole increased PPI in low PPI gaters, whereas modafinil and lorazepam attenuated PPI in both groups. Risperidone, amisulpride, and valproate did not influence PPI. P50 suppression in low gaters appears to be an antipsychotic-sensitive neurophysiologic marker. This conclusion is supported by the association of low P50 suppression and higher clinically associated scores. Furthermore, PPI might be sensitive for atypical mechanisms of antipsychotic medication. The translational model investigating differential effects of AAPs on gating in healthy subjects with naturally low gating can be beneficial for phase II/III development plans by providing additional information for critical decision making. PMID:24801767

Csomor, Philipp A; Preller, Katrin H; Geyer, Mark A; Studerus, Erich; Huber, Theodor; Vollenweider, Franz X

2014-09-01

175

Effect of In-Plume Aerosol Processing on the Efficacy of Marine Cloud Albedo Enhancement from Controlled Sea-Spray Injections  

Science.gov (United States)

The intentional enhancement of cloud albedo via controlled sea-spray injection from ships has been suggested as a possible means to control anthropogenic global warming (1); however, there remains significant uncertainty in the efficacy of this method due to uncertainties in aerosol and cloud microphysics. Recent analysis showed that more sea-spray may be necessary than previously assumed to reach a desired cooling due to nonlinearities in the aerosol/cloud microphysics (2). A major assumption used in (2) is that all sea-spray was emitted uniformly into some oceanic grid boxes, and thus did not account for sub-grid aerosol microphysics within the sea-spray plumes. However, as a consequnce of the fast sea-spray injection rates which are proposed, in the order of 1x10^17 1/s (1), particle concentrations in these plumes may be quite high and particle coagulation may significantly reduce the number of emitted particles and increase their average size. Therefore, it is possible that the emissions necessary to reach a desired cooling may be even larger than currently assumed. We explore the processing of the freshly emitted sea-spray plumes in the Large-Eddy Simulation (LES)/Cloud Resolving Model (CRM) the System for Atmospheric Modelling (SAM, 3) with the online aerosol microphysics module TOMAS (4). We determine how the final number and size of particles (once well mixed with background air) depends on the emission rate and size distribution of the sea-spray plume and on the pre-existing aerosol concentrations and local atmospheric conditions. Finally, we make suggestions for effective size-resolved emissions for use in climate models. (1) Salter, S. et al., Phil. Trans. R. Soc. A., 2008. (2) Korhonen, H. et al., Atmos. Chem. Phys., 10, 4133-4143, 2010. (3) Khairoutdinov, M., and Randall, D.,. J. Atmos. Sci., 60, 607-625, 2003. (4) Pierce, J. and Adams, P., Atmos. Chem. Phys., 9, 1339-1356, 2009.

Stevens, R. G.; Spracklen, D.; Korhonen, H.; Pierce, J. R.

2010-12-01

176

Potential bias in testing for hyperprolactinemia and pituitary tumors in risperidone-treated patients: a claims-based study  

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Full Text Available Abstract Background A reporting association of risperidone with pituitary tumors has been observed. Because such tumors are highly prevalent, there may be other reasons why they were revealed in association with risperidone treatment. We assessed two potential explanations: disproportionately more prolactin assessment and head/brain imaging in risperidone-treated patients vs patients treated with other antipsychotics. Methods Treatment episodes with risperidone, clozapine, olanzapine, quetiapine, ziprasidone, aripiprazole, haloperidol, perphenazine and 'other typical' antipsychotics were identified in two databases (large commercial, Medicaid. Comparisons used proportional hazards regression to determine whether prolactin testing was disproportionate with risperidone, regardless of prior potentially prolactin-related adverse events (PPAEs. Logistic regression determined whether magnetic resonance imaging (MRI/computed tomography (CT were disproportionate in risperidone-treated patients vs other patients, regardless of hyperprolactinemia or PPAEs. In each regression, the 'other typical' antipsychotic category served as the comparator. Regression models controlled for age, gender, and other factors. Results Altogether, 197,926 treatment episodes were analyzed (63,878 risperidone. Among patients with or without preceding PPAEs, risperidone treatment was associated with a significantly greater likelihood of prolactin assessment (hazard ratio (HR 1.34, 95% confidence interval (CI = 1.09 to 1.66, p = 0.007. Among patients with hyperprolactinemia or PPAEs, those treated with risperidone (odds ratio (OR 1.66, 95% CI 1.23 to 2.23, p = 0.001 or ziprasidone (OR 1.66, 95% CI 1.06 to 2.62, p = 0.028 had a higher likelihood of MRI/CT. Conclusion Risperidone-treated patients are more likely to undergo prolactin assessment regardless of prior PPAEs, and more likely to undergo MRI/CT in association with hyperprolactinemia or PPAEs. Thus, a predisposition for more evaluations in risperidone-treated patients may contribute to disproportionate identification and reporting of prevalent pituitary adenoma.

Wu Jasmanda

2009-02-01

177

Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis : impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP  

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OBJECTIVE: To investigate the short-term and long-term efficacy of intra-articular betamethasone injections, and the impact of joint area, repeated injections, MRI pathology, anticyclic citrullinated peptide (CCP) and immunoglobulin M rheumatoid factor (IgM-RF) status in patients with early rheumatoid arthritis (RA).METHODS: During 2 years of follow-up in the CIMESTRA trial, 160 patients received intra-articular betamethasone in up to four swollen joints/visit in combination with disease-modifying antirheumatic drugs. Short-term efficacy was assessed by EULAR good response. Long-term efficacy by Kaplan-Meier plots of the joint injection survival (ie, the time between injection and renewed flare). Potential predictors of joint injection survival were tested.RESULTS: 1373 Unique joints (ankles, elbows, knees, metacarpophalangeal (MCP), metatarsophalangeal, proximal interphalangeal (PIP), shoulders, wrists) were injected during 2 years. 531 Joints received a second injection, and 262 a third. At baseline, the median numbers of injections (dose of betamethasone) was 4 (28 mg), declining to 0 (0 mg) at subsequent visits. At weeks 2, 4 and 6, 50.0%, 58.1% and 61.7% had achieved a EULAR good response. After 1 and 2 years, respectively, 62.3% (95% CI 58.1% to 66.9%) and 55.5% (51.1% to 60.3%) of the joints injected at baseline had not relapsed. All joint areas had good 2-year joint injection survival, longest for the PIP joints: 73.7% (79.4% to 95.3%). 2-Year joint injection survival was higher for first injections: 56.6% (53.7% to 59.8%) than for the second: 43.4% (38.4% to 49.0%) and the third: 31.3% (25.0% to 39.3%). Adverse events were mild and transient. A high MRI synovitis score of MCP joints and anti-CCP-negativity were associated with poorer joint injection survival, whereas IgM-RF and C-reactive protein were not.CONCLUSION: In early RA, intra-articular injections of betamethasone in small and large peripheral joints resulted in rapid, effective and longlasting inflammatory control. The cumulative dose of betamethasone was low, and the injections were well tolerated.

Hetland, Merete Lund; Østergaard, Mikkel

2012-01-01

178

A Comparative Study between Olanzapine and Risperidone Regarding Drug-Induced Electrocardiographic Changes  

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Introduction. Among atypical antipsychotics, none has been linked to torsade de pointes. In the present study, the electrocardiographic changes induced by olanzapine have been compared with risperidone. Method and Materials. 268 patients were entered into an open study for random assignment to olanzapine or risperidone. ECG was taken at baseline and at the end of the treatment. The parameters that had been assessed included Q-T interval (corrected = Q-Tc) and other related parameters. Correction of the observed Q-T interval was done according to Frederica's formula (QTcF). Results. While 14.86% and 25% of the cases in the olanzapine group showed prolongation and shortening of QTcF, respectively, comparable changes in the risperidone group were restricted to its prolongation (32.5%). Comparison of means between baseline QTcF of risperidone group versus its posttreatment measurement showed a significant increment (P = 0.02). Also, the quantity of cases with shortening of QTcF in the olanzapine group was significantly more than its opposite (P = 0.02). Conclusion. Comparable propensity of olanzapine and risperidone for induction of electrocardiographic changes demands adequate cautiousness by clinicians, particularly with respect to shortening of Q-T interval, which was mainly noticeable in the olanzapine group. PMID:25276418

Shoja Shafti, Saeed; Fallah Jahromi, Parisa

2014-01-01

179

Desipramine enhances the ability of risperidone to decrease alcohol intake in the Syrian golden hamster.  

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The atypical antipsychotic clozapine reduces alcohol drinking in patients with schizophrenia. We have proposed that clozapine?s ability to decrease alcohol drinking relates to its weak blockade of the dopamine D2 receptor and potent blockade of the norepinephrine ?-2 receptor, as well as its ability to elevate plasma and brain norepinephrine. Another atypical antipsychotic, risperidone, which is a potent blocker of both the dopamine D2 receptor and norepinephrine ?-2 receptor, does not decrease alcohol drinking. In this study, we used the Syrian golden hamster to test whether the ability of risperidone to reduce alcohol drinking would be enhanced if it was used in combination with the norepinephrine reuptake inhibitor desipramine. Hamsters were given free access to water and alcohol (15% v/v) until they reached a steady drinking baseline. They were then treated daily with each drug or drug combination for 20 days. Risperidone (0.2mg/kg) only transiently decreased alcohol drinking. However, 5.0mg/kg, and possibly 1.0mg/kg, desipramine added to 0.2mg/kg risperidone appeared to produce a more substantial and relatively sustained effect than risperidone alone. Data from this study provide leads toward the development of new treatments for patients with schizophrenia and alcoholism, and also for those with alcoholism alone. PMID:24836200

Gulick, Danielle; Chau, David T; Khokhar, Jibran Y; Dawson, Ree; Green, Alan I

2014-08-30

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Brief Report: Two-Year Control of Behavioral Symptoms with Risperidone in Two Profoundly Retarded Adults with Autism.  

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Presents information on 24 and 34 months of successful treatment with Risperidone of a young woman and young man with autism and profound mental retardation. Treatment with Risperidone resulted in positive changes for aggressive, self-injurious, and anti-social behavior. After treatment, subjects were able to participate in social activities. (CR)

Dartnall, Nancy A.; Holmes, Janice P.; Morgan, Susan Naylor; McDougle, Christopher J.

1999-01-01

 
 
 
 
181

Study on the luminescence behavior of sulfobutylether-?-cyclodextrin with risperidone and its analytical application  

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The interaction of sulfobutylether-?-cyclodextrin (SBE-?-CD) with risperidone (RISP) was first described with luminol-SBE-?-CD chemiluminescence (CL) system by flow injection analysis (FIA). In luminol-SBE-?-CD CL system, the 1:1 SBE-?-CD⋯luminol? complexation could enhance CL intensity of luminol and produce the effect of complexation enhancement of CL (CEC). It was found that RISP could quench the CL intensity of SBE-?-CD⋯luminol? and caused the effect of complexation enhancement of quenching (CEQ), the formation constant KR-CD 3.4 × 104 L mol-1 and the stoichiometric ratio 1:1 of RISP⋯SBE-?-CD complex were obtained by the proposed CL model. Association degree ? 0.036 of RISP⋯SBE-?-CD complex was also given by CL method. Based on the linear relationship to the decrement of luminol-SBE-?-CD-RISP CL intensity and the logarithm of RISP concentration, RISP also can be quantified in the linear range of 3.0-500.0 nmol L-1 with a detection limit of 1.0 nmol L-1 (3?). The proposed method was successfully applied to monitoring excreted RISP in human urine. It was found that RISP reached its maximum after oral administration for 1.5 h with the total excretion of 14.26% within 8.5 h; the elimination rate constant k and half-life time t1/2 were 0.474 and 1.5 h, respectively.

Wu, Min; Chen, Donghua; Song, Zhenghua

2012-10-01

182

Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection  

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Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot) antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine). In this respect, the emergence of long-acting aripiprazole injection (ALAI), approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10–20 mg/day) or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP)2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (Paripiprazole 10–30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk–benefit profile.

Wang, Sheng-Min; Han, Changsu; Lee, Soo-Jung; Patkar, Ashwin A; Masand, Prakash S; Pae, Chi-Un

2014-01-01

183

Correlates of weight gain during long-term risperidone treatment in children and adolescents  

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Full Text Available Abstract Background Most clinical trials of antipsychotics in children are brief, failing to address their long-term safety, particularly when taken concurrently with other psychotropics. This hypothesis-generating analysis evaluates potential correlates of weight gain in children receiving extended risperidone treatment. Methods Medically healthy 7–17?year-old patients treated with risperidone for six months or more were enrolled. Anthropometric measurements were conducted. Developmental and medication history was obtained from the medical record. Information related to birth weight, dietary intake, physical activity, and parental weight was collected. Mixed regression analyses explored the contribution of various demographic and clinical factors to age- and sex-adjusted weight and body mass index (BMI z scores over the treatment period. Results The sample consisted of 110 patients (89% males with a mean age of 11.8?years (sd?=?2.9 upon enrollment. The majority had an externalizing disorder and received 0.03?mg/kg/day (sd?=?0.02 of risperidone, for 2.5?years (sd?=?1.7, to primarily target irritability and aggression (81%. Polypharmacy was common with 71% receiving psychostimulants, 50% selective serotonin reuptake inhibitors (SSRIs, and 32% ?2-agonists. Weight and BMI z score were positively correlated with baseline weight at the start of risperidone, treatment duration, and the weight-adjusted dose of risperidone but inversely associated with the weight-adjusted dose of psychostimulants and the concurrent use of SSRIs and ?2-agonists. The effect of risperidone dose appeared to attenuate as treatment extended while that of psychostimulants became more significant. The rate of change in weight (or BMI z score prior to and within the first 12?weeks of risperidone treatment did not independently predict future changes neither did birth weight, postnatal growth, dietary intake, physical activity, or parental weight. Conclusions This comprehensive analysis exploring correlates of long-term weight (or BMI change in risperidone-treated youths revealed that pharmacotherapy exerts significant but complex effects. Trial Registration Not applicable.

Calarge Chadi

2012-05-01

184

Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis  

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Introduction: The prevalence of symptomatic knee osteoarthritis (OA) among Asians ?65 years is estimated to double by 2040. This study was designed to evaluate the safety and efficacy of a single, 6-mL intra-articular injection of hylan G-F 20 in Indian patients with knee OA at 26 weeks through to 52 weeks. Methods: This study was an open-label, multicentre, phase 4 clinical trial. Enrolled patients (N=394) were ?30 years old with Kellgren-Lawrence grade 1–3 OA; all patients received hylan G-F 20. WOMAC, SF-12, PTGA, and COGA scores, and OA medication use were evaluated at weeks 1, 4, 12, 26, 39, and 52 (initial treatment phase). At 26, 39, or 52 weeks, eligible patients could participate in a repeat treatment phase. McNemar-Bowkers, paired t-tests and ANOVA analyses were performed (alpha=0.05). Results: At 26 weeks, statistically significant changes from baseline were observed in all efficacy parameters, including the primary efficacy endpoint of WOMAC A1 (plocal target knee AEs. Conclusion: Among Indian patients within this study, a 6-mL hylan G-F 20 injection was well tolerated and effective in treating symptomatic knee OA with significant long-term (1 year) improvement of outcomes. When needed, repeat treatment was safe and efficacious for 4 weeks. Trial Registration: Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php. PMID:25328555

Pal, Sarvajeet; Thuppal, Sreedhar; Reddy, K.J; Avasthi, Sachin; Aggarwal, Anish; Bansal, Himanshu; Mohanasundaram, Senthilnathan; Bailleul, Francois

2014-01-01

185

A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss  

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Full Text Available Abstract Background As schizophrenia patients are typically suspicious of, or are hostile to changes they may be reluctant to accept generic substitution, possibly affecting compliance. This may counteract drug costs savings due to less symptom control and increased hospitalization risk. Although compliance losses following generic substitution have not been quantified so far, one can estimate the possible health-economic consequences. The current study aims to do so by considering the case of risperidone in Germany. Methods An existing DES model was adapted to compare staying on branded risperidone with generic substitution. Differences include the probability of non-compliance and medication costs. Incremental probability of non-compliance after generic substitution was varied between 2.5% and 10%, while generic medication costs were assumed to be 40% lower. Effect of medication price was assessed as well as the effect of applying compliance losses to all treatment settings. The probability of staying on branded risperidone being cost-effective was calculated for various outcomes of a hypothetical study that would investigate non-compliance following generic substitution of risperidone. Results If the incremental probability of non-compliance after generic substitution is 2.5%, 5.0%, 7.5% and 10% respectively, incremental effects of staying on branded risperidone are 0.004, 0.007, 0.011 and 0.015 Quality Adjusted Life Years (QALYs. Incremental costs are €757, €343, -€123 and -€554 respectively. Benefits of staying on branded risperidone include improved symptom control and fewer hospitalizations. If generic substitution results in a 5.2% higher probability of non-compliance, the model predicts staying on branded risperidone to be cost-effective (NICE threshold of ?30,000 per QALY gained. Compliance losses of more than 6.9% makes branded risperidone the dominant alternative. Results are sensitive to the locations at which compliance loss is applied and the price of generic risperidone. The probability that staying on branded risperidone is cost-effective would increase with larger compliance differences and more patients included in the hypothetical study. Conclusion The model predicts that it is cost-effective to keep a patient with schizophrenia in Germany on branded risperidone instead of switching him/her to generic risperidone (assuming a 40% reduction in medication costs, if the incremental probability of becoming non-compliant after generic substitution exceeds 5.2%.

Möller Hans-Jürgen

2009-02-01

186

Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications  

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Background Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders. The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Methods Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). Results There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Conclusion Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no ‘spillover’ effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation. PMID:24927744

2014-01-01

187

Low-Dose Risperidone-Induced Oculogyric Crises in an Adolescent Male with Autism, Tourette's and Developmental Delay.  

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This article will review the case of a young patient with mental retardation, autistic disorder, and Tourette Syndrome who exhibited a favourable treatment response preferentially to risperidone. His presentation, however, was complicated by an exquisite sensitivity to risperidone displayed in the form of recurrent oculogyric crises. In this article, we will outline a review of the case, a survey of the incidence and risk factors of oculogyric crises, as well as a review of the literature on risperidone sensitivity, followed by a review of alternate options for the prevention of oculogyric crises. PMID:21804851

Masliyah, Tamara; Ad-Dab'bagh, Yasser

2011-08-01

188

Dietary Status and Impact of Risperidone on Nutritional Balance in Children with Autism: A Pilot Study  

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Background: Risperidone may be effective in improving tantrums, aggression, or self-injurious behaviour in children with autism, but often leads to weight gain. Method: Using a quantitative Food Frequency Questionnaire (FFQ), we prospectively examined the nutritional intake of 20 children with autism participating in a randomised…

Lindsay, Ronald L.; Arnold, L. Eugene; Aman, Michael G.; Vitiello, Benedetto; Posey, David J.; McDougle, Christopher J.; Scahill, Lawrence; Pachler, Maryellen; McCracken, James T.; Tierney, Elaine; Bozzolo, Dawn

2006-01-01

189

Sexual Dysfunction in Male Subjects Receiving Trifluoperazine, Risperidone, or Olanzapine: Rates Vary With Assessment Questionnaire  

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Objective: To assess the rate and typology of sexual dysfunction in male subjects receiving trifluoperazine, risperidone, or olanzapine using the Arizona Sexual Experience Scale (ASEX), the Psychotropic Related Sexual Dysfunction Questionnaire (PRSexDQ), and the sexual function section of the modified Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU).

Nebhinani, Naresh; Grover, Sandeep; Avasthi, Ajit

2012-01-01

190

Relationship between plasma concentration levels of risperidone and clinical effects in the treatment of delirium.  

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The present study aimed to examine the relationship between plasma concentration levels of risperidone and clinical effects in the treatment of delirium. We conducted a prospective, open-label, flexible-dose study of risperidone oral solution. Ten patients with delirium were assessed using Delirium Rating Scales. Plasma concentration levels of risperidone were measured 30 min after the first administration of a 0.5 mg dose. Two patients with high plasma levels had adverse effects and one patient with the lowest plasma level did not achieve remission; the remaining seven patients achieved remission without any adverse effects. A highly significant negative correlation was observed in these responders without adverse effects between the plasma levels and durations of treatment until remission (r=-0.861, P=0.0095). The plasma concentration level of risperidone at 30 min after the first 0.5 mg dose may be a favourable response predictor in the treatment of delirium. Further studies in larger samples are needed to verify this preliminary finding. PMID:16192843

Toda, Hiroyuki; Kusumi, Ichiro; Sasaki, Yukiya; Ito, Koichi; Koyama, Tsukasa

2005-11-01

191

Risperidone treatment for ADHD in children and adolescents with bipolar disorder  

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Full Text Available Joseph Biederman, Paul Hammerness, Robert Doyle, Gagan Joshi, Megan Aleardi, Eric MickPediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, MA, USAObjective: Children and adolescents with bipolar disorder are also at high risk of having comorbid attention-deficit hyperactivity disorder (ADHD. The objective of this study was to estimate improvement in ADHD symptoms in children with bipolar disorder.Methods: This was an open-label, study of risperidone monotherapy for the treatment of pediatric bipolar disorder. Thirty-one children and adolescents 4–15 years of age (7.2 ± 2.8 years of both sexes (71%, N = 22 male with pediatric bipolar disorder (YMRS score = 32.9 ± 8.8 and ADHD (ADHD-RS score = 37.9 ± 8.9 were included in these analyses.Results: Improvement in ADHD symptoms was contingent on improvement in manic symptoms. Although both hyperactive/impulsive (?7.5 ± 5.5.6, p < 0.05 and inattentive (?6.8 ± 5.0, p < 0.05 ADHD symptoms were significantly improved with risperidone, improvement was modest, and only 29% of subjects (N = 6 showed a 30% reduction in ADHD rating scale scores and had a CGI-I ? 2.Conclusions: These results suggest that that treatment with risperidone is associated with tangible but generally modest improvement of symptoms of ADHD in children with bipolar disorder.Keywords: ADHD, bipolar disorder, children, risperidone

Joseph Biederman

2008-03-01

192

Polypyrrole Film as a Drug Delivery System for the Controlled Release of Risperidone  

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Conducting polymers are finding applications in medicine including drug delivery systems, biosensors and templates for the regeneration of nervous pathways. We aim to develop a novel system where the drug release rate can be controlled by electrical stimulation. Polypyrrole (PPY) is being used as a drug delivery system due to its inherent electrical conductivity, ease of preparation and apparent biocompatibility. Risperidone is an atypical antipsychotic drug used in the treatment of psychosis and related disorders, including schizophrenia. PPY was synthesised using p-toluene sulfonic acid as a primary dopant, in the presence of risperidone. A validated high performance liquid chromatography (HPLC) analytical method was used to quantify risperidone release. It has been demonstrated that the release rate of risperidone can be altered through the application, or absence, of electrical stimulation. Technology such as this would find use in drug-delivering implants where the dose could be adjusted through application of external stimulus, optimising benefit to side effect ratio, while simultaneously ensuring patient adherence (which is a particular challenge in mental health conditions).

Svirskis, Darren; Travas-Sejdic, Jadranka; Rodgers, Anthony; Garg, Sanjay

2009-07-01

193

Effect of risperidone metabolism and P-glycoprotein gene polymorphism on QT interval in patients with schizophrenia.  

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Risperidone (RIS) is a frequently used efficacious psychotropic drug. However, it prolongs the QTc interval and may cause fatal arrhythmia. Little is known on the determinants of this RIS side effect. RIS is metabolized by CYP2D6, and is subject to drug efflux by P-glycoprotein (P-gp) encoded by the ATP-binding cassette subfamily B member 1 (ABCB1) gene. P-gp removes both RIS and its metabolite 9-OH-RIS from cardiac tissue. To investigate the effect of RIS metabolism and ABCB1 gene polymorphisms on QTc, steady-state plasma RIS and 9-OH-RIS levels, and QTc were measured. CYP2D6, ABCB1 C3435T and G2677T/A genotypes were determined in 66 schizophrenia patients on RIS. QTc was significantly longer in patients with ABCB1 3435CT+3435 TT than in those with 3435CC (P=0.006). ABCB1 G2677T/A genotype did not affect QTc. Multiple regression analysis showed that C/T or T/T genotypes at the ABCB1 C3435T locus, lower weight, and older age prolonged QTc. In summary, the T allele of the ABCB1 C3435T genotype should be considered in future diagnostic development efforts for RIS-associated QT. PMID:24589909

Suzuki, Y; Tsuneyama, N; Fukui, N; Sugai, T; Watanabe, J; Ono, S; Saito, M; Inoue, Y; Someya, T

2014-10-01

194

A comparison of the effects of olanzapine and risperidone versus placebo on ghrelin plasma levels.  

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To thoroughly investigate the phenomenon of atypical antipsychotic-associated weight gain, a feeding laboratory paradigm was developed that included obtaining plasma levels of the orexigenic peptide ghrelin that is associated with appetite and eating. This study is a randomized, double-blind, parallel group trial comparing the effects of a 2-week exposure to olanzapine, risperidone, or placebo on plasma ghrelin area under the plasma-time curve (AUC) in 28 healthy human subjects. Subjects were randomized to receive olanzapine, risperidone, or placebo and titrated over 4 days to 10 mg/d or 4 mg/d, respectively. The mean dose at end point was 8.6 + 1.8 mg/d for the olanzapine group and 2.8 + 0.8 mg/d for the risperidone group. Weight changes were significantly different between groups at end point (F2,44 = 10.193; P = 0.0001). The olanzapine group demonstrated a significant increase in weight at end point (2.25 + 1.84 kg) compared with placebo (0.13 + 1.05 kg; P = 0.007). Because of the small subject number, the comparisons between olanzapine and risperidone and risperidone and placebo did not reach statistical significance, although olanzapine's mean weight gain was numerically greater than that of risperidone (2.25 + 1.84 kg vs 1.10 + 0.99 kg) and risperidone's mean weight gain was numerically larger than placebo (1.10 + 0.99 kg vs 0.13 + 1.05 kg). The baseline adjusted Bonferroni corrected contrast of end point ghrelin AUC demonstrated a significant difference between groups (F2,24 = 4.40; P = 0.024), and the post hoc analysis revealed a significant decrease in ghrelin AUC for the olanzapine group in comparison with the risperidone group (P = 0.021) but not between risperidone and placebo or olanzapine and placebo. Ghrelin AUC values did not change significantly from baseline to end point in either of the other 2 groups. The difference between groups approached but did not reach significance (F2,23 = 3.299; P = 0.055) when body mass index change was included as a covariate, suggesting that the difference in ghrelin AUC change followed the change in body weight. Sedation associated with both active drugs (P = 0.006) and "stuffy nose" associated with risperidone (P = 0.020) were the only statistically different adverse reactions when compared with placebo. Thus, a human feeding laboratory paradigm using a brief exposure to atypical antipsychotics functions as a method to investigate pharmacologically induced weight gain and its association with changes in the orexigenic peptide ghrelin. This rejects the hypothesis that ghrelin levels are elevated by the antipsychotic and that this is a potential cause of the weight gain phenomenon. PMID:18204336

Roerig, James L; Steffen, Kristine J; Mitchell, James E; Crosby, Ross D; Gosnell, Blake A

2008-02-01

195

78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...  

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...guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process...be used to make product-specific bioequivalence (BE) recommendations available to the public on...

2013-08-26

196

Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial  

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Full Text Available Abstract Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577 assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP, a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively] or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid, followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal. Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS, CGI-S, Personal and Social Performance (PSP, and adverse events (AEs. Analysis of covariance (ANCOVA and last-observation-carried-forward (LOCF methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92 versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg versus placebo at day 4 (P = 0.012 and day 8 (P = 0.007. After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P P P P Conclusions In this markedly to severely ill population, acute treatment with 234 mg PP improved psychotic symptoms compared with placebo by day 4. After subsequent injections, observed improvements are suggestive of a dose-dependent effect. No unexpected tolerability findings were noted.

Ma Yi-Wen

2011-04-01

197

In vivo evaluation of risperidone-SAIB in situ system as a sustained release delivery system in rats.  

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The objective of this study was to evaluate a sustained release sucrose acetate isobutyrate (SAIB) in situ system formulation of risperidone (RSP) in vivo. The formulation contained SAIB, ethanol, and polylactic acid (PLA) as a release regulator. In vivo pharmacokinetics (PK) studies have shown that PLA is effective in reducing the burst effect. After a 12.5mg/kg IM injection of a 25mg/g RSP-SAIB in situ system, the C(max) was markedly reduced from 944.1+/-80.2 to 330.4+/-33.6ng/ml by increasing PLA from 1% to 10% (w/w), the T(max) were prolonged from 2 to 4.3+/-2.0h, and the area under the curve from day 0 to 2 (AUC(0-2day)) was reduced significantly from 16294.8+/-3946.4 to 7025.3+/-1979.2ngh/ml. For the RSP-SAIB in situ system including 10% PLA, the high release rates over a short period allowed therapeutic plasma concentrations to be achieved in the initial stages after activation, and sustained release of the drug led to a stable plasma concentration (by day 25, the plasma concentration was 8% of the C(max)). These initial in vivo studies suggest that RSP-SAIB in situ system is effective as a sustained delivery system. PMID:17614267

Lu, Yaxin; Tang, Xing; Cui, Yue; Zhang, Yu; Qin, Feng; Lu, Xiumei

2008-02-01

198

Serotonin Receptor 2A blocker (Risperidone) has no effect on Human Polyomavirus JC Infection of Primary Human Fetal Glial cells  

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A recent report demonstrated that JCV employs serotonin receptor 2A (5HT2AR) to infect the glial cells. To assess the ability of a potent 5HT2AR blocker, risperidone, to inhibit JCV infection, we treated primary human fetal glial (PHFG) cells in-vitro with risperidone for 24 hr and inoculated with JCV(Mad1). There was no significant difference in JCV genome copies or mRNA transcripts and protein expression in treatment-naive and risperidone-treated PHFG cells. This data indicate that risperidone does not inhibit JCV(Mad1) attachment, internalization and replication in PHFG cells, and 5HT2AR blockers may not be effective in treating progressive multifocal leukoencephalopathy (PML). PMID:18989819

Chapagain, Moti L.; Sumibcay, Laarni; Gurjav, Ulziijargal; Kaufusi, Pakieli H.; Kast, Richard E.; Nerurkar, Vivek R.

2009-01-01

199

Risperidone inhibits contractions induced by serotonin and histamine and reduces K+ currents in smooth muscle of human umbilical artery.  

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Risperidone is an antipsychotic commonly used during pregnancy. Because it can cross the placental barrier, our objective was to evaluate its actions on the smooth muscle of the human umbilical artery (HUA). Risperidone preincubation (1-300 nmol/L for 20 minutes) produced a significant decrease in maximum force development induced by serotonin or histamine in HUA rings. When applied on top of stable contractions induced by these agonists risperidone produced quick relaxations (IC(50) = 1 nmol/L for serotonin and 72 nmol/L for histamine). Risperidone induced the contraction of vascular rings depolarized by 40 mmol/L extracellular K(+) but not in the case of 80 mmol/L K(+), suggesting inhibition of K(+) channels. The patch-clamp technique showed that risperidone (3 nmol/L) inhibited whole-cell K(+) currents in freshly isolated HUA smooth muscle cells. Our results are the first showing risperidone effects in human vascular smooth muscle and highlight that its use during pregnancy should be adequately monitored. PMID:20601536

Iveli, María Florencia; Rebolledo, Alejandro; Martín, Pedro; Enrique, Nicolás; Roldán Palomo, Ana Rocío; Rimorini, Laura; Salemme, Silvia; Milesi, Verónica

2010-09-01

200

Evaluating the Effect of 8-Week Treatment With Risperidone On Fasting Blood Glucose of Patients with Schizophrenia  

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Full Text Available  Objective: This study was designed to evaluate the effects of risperidone on fasting blood glucose (FBG in patients with Schizophrenia .  Method: Seventy five non-diabetic patients with Schizophrenia (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria entered this cross-sectional study. Patients did not receive any medications (Including risperidone affecting serum FBG levels for at least 2 weeks prior to the initiation of the study. Patients received the mean dose of 4.5mg (range 2-12mg risperidone for 8 weeks. Pregnant women, patients with diabetes mellitus and a history of any major heart disease were excluded from this study.Additionally, none of the patients should have received electroconvulsive therapy within 6 months prior to the initiation of the antiphsychotics.FBG levels were measured at the initiation and 8 weeks after starting risperidone.  Results: Fifty one patients completed the study. The mean FBG level was increased from 88.9mg/dL (baseline to 94.4 mg/dL at week 8 (P =0.003. This 8-week study showed that FBG levels may increase in schizophrenic patients receiving risperidone.  Conclusion: Measuring and monitoring FBG before the initiation and during the treatment with risperidone is suggested.

Firouzeh Raisi

2007-08-01

 
 
 
 
201

ECG parameters in children and adolescents treated with aripiprazole and risperidone.  

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Atypical antipsychotics (AP) are increasingly being used in children and adolescents for the treatment of psychiatric disorders. Atypical AP may cause QT prolongation on the electrocardiogram (ECG), which predisposes patients to an increased risk of developing threatening ventricular arrhythmias. Although this phenomenon has been exhaustively reported in adults, few studies investigated the safety of these drugs in pediatric patients. We performed an open-label, prospective study to assess the arrhythmic risk of aripiprazole and risperidone in a pediatric population. A total of 60 patients (55 M/5F, mean age 10.2+2.6 years, range 4-15 years), receiving a new prescription of aripiprazole or risperidone in monotherapy underwent a standard ECG before and after two months from the beginning of antipsychotic treatment. Basal and post-treatment ECG parameters, including mean QT (QTc) and QT dispersion (QTd), were compared within treatment groups. Twenty-nine patients were treated with aripiprazole (mean dosage 7.4+3.1mg/day) and 31 with risperidone (mean dosage 1.5+1mg/day). In our series, no patient exhibited pathological values of QTc or QTd before and after treatment for both drugs. However, treatment with risperidone was associated with a slight increase of both mean QTc and QTd values (407.4+11.9 ms vs 411.2+13.0 ms, p<0.05; and 40.0+4.4 ms vs 44.7+5.5 ms, p<0.001, respectively). Treatment with aripiprazole was associated with no changes of mean QTc, even if a small increase of QTd, (40.6+6.5 ms vs 46.3+7.2 ms, p<0.01) was observed. Although our data suggest a slight effect of aripiprazole and risperidone on ventricular repolarization, it is unlikely that such a change results in clinically relevant effects. The treatment with risperidone and aripiprazole in children with psychiatric disorders is not associated with clinically relevant modifications of QT interval. Caution in prescribing these drugs, however, is necessary in patients with family history of a genetic predisposition to arrhythmias in order to warrant a reliable assessment of drug-induced QT prolongation. PMID:24211841

Germanò, Eva; Italiano, Domenico; Lamberti, Marco; Guerriero, Laura; Privitera, Carmen; D'Amico, Gessica; Siracusano, Rosamaria; Ingrassia, Massimo; Spina, Edoardo; Calabrò, Maria Pia; Gagliano, Antonella

2014-06-01

202

Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study.  

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The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18-76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2-4 weeks. The mean duration of exposure was ?3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (Polanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome). PMID:24850228

McDonnell, David P; Landry, John; Detke, Holland C

2014-11-01

203

Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study  

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The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18–76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2–4 weeks. The mean duration of exposure was ?3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome). PMID:24850228

Landry, John; Detke, Holland C.

2014-01-01

204

A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article  

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Full Text Available This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks post-vaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %, by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05 in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

S.P.R. Bisschop

2012-05-01

205

Comparison between risperidone, an atypical antipsychotic agent and haloperidol, a conventional agent used to treat schizophrenia  

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An observational and comparative study was conducted to compare the functional outcome between the patients treated with conventional antipsychotic agent haloperidol and typical antipsychotic agent, Risperidone (Risperidal). A total of 32 patients were included in the study with established schizophrenia according to (DSM iv). The data was processed on SSPE 10th version. The primary outcome measure was the improvement of negative symptoms of schizophrenia and secondary outcome measure was to observe the superiority of the atypical drug Risperid one over conventional agent haloperidol regarding side effects. Patients were assessed at baseline, 2nd and 8th week, using four tools of assessment. For treatment group receiving haloperidol mean was 47.2+-11.50 at 8th week and for Risperidone treatment group mean was 43+-14.68. The P values for all the parameters in the Clozapine group were significant as compared to haloperidol. (author)

206

Development of novel risperidone implants using blends of polycaprolactones and in vitro in vivo correlation studies  

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The objective of this study was to develop a novel implant containing risperidone intended for long-term treatment in Schizophrenia utilizing in vitro in vivo correlation (IVIVC) studies. Different implants (F1-F8) containing an antipsychotic drug, risperidone, were prepared using a hot melt extrusion technique by taking polycaprolactones of different molecular weights (Mwt. 15000, 45000, 80000) either alone or as their blends, and PLGA (75:25). The implants contained 40% of the drug. After fabrication, the implants were characterized for various in vitro properties such as drug release and physical strength. Prior to conducting drug release studies, optimum drug release method was developed based on IVIVC studies. An optimized formulation based on drug release and physical strength at the end of fabrication was selected from the various implants fabricated. The bioactivity, reversibility, and IVIVC of optimized formulation were determined using pharmacokinetic studies in rats. Short-term stability studies were conducted with optimized formulation. Drug release depended on polymer molecular weight. Implant fabricated using 50:50 polycaprolactone 45,000 and polycaprolactone 80,000 was considered optimized implant. Optimized formulation selected released the drug for 3-months in vitro and was physically rigid. The optimized implant was able to release the drug in vivo for a period of 3 months, the implants are reversible throughout the delivery interval and, a 100% IVIVC was achieved with optimized implant, suggesting the development of 3-month drug-releasing implant for risperidone. The optimized implant was stable for 6 months at room temperature (25°C) and 45°C. A novel implant for risperidone was successfully prepared and evaluated. PMID:24959417

Navitha, Aerrolla; Jogala, Satheesh; Krishnamohan, Chinnala; Aukunuru, Jithan

2014-01-01

207

Development of novel risperidone implants using blends of polycaprolactones and in vitro in vivo correlation studies.  

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The objective of this study was to develop a novel implant containing risperidone intended for long-term treatment in Schizophrenia utilizing in vitro in vivo correlation (IVIVC) studies. Different implants (F1-F8) containing an antipsychotic drug, risperidone, were prepared using a hot melt extrusion technique by taking polycaprolactones of different molecular weights (Mwt. 15000, 45000, 80000) either alone or as their blends, and PLGA (75:25). The implants contained 40% of the drug. After fabrication, the implants were characterized for various in vitro properties such as drug release and physical strength. Prior to conducting drug release studies, optimum drug release method was developed based on IVIVC studies. An optimized formulation based on drug release and physical strength at the end of fabrication was selected from the various implants fabricated. The bioactivity, reversibility, and IVIVC of optimized formulation were determined using pharmacokinetic studies in rats. Short-term stability studies were conducted with optimized formulation. Drug release depended on polymer molecular weight. Implant fabricated using 50:50 polycaprolactone 45,000 and polycaprolactone 80,000 was considered optimized implant. Optimized formulation selected released the drug for 3-months in vitro and was physically rigid. The optimized implant was able to release the drug in vivo for a period of 3 months, the implants are reversible throughout the delivery interval and, a 100% IVIVC was achieved with optimized implant, suggesting the development of 3-month drug-releasing implant for risperidone. The optimized implant was stable for 6 months at room temperature (25°C) and 45°C. A novel implant for risperidone was successfully prepared and evaluated. PMID:24959417

Navitha, Aerrolla; Jogala, Satheesh; Krishnamohan, Chinnala; Aukunuru, Jithan

2014-04-01

208

Developing In Vitro–In Vivo Correlation of Risperidone Immediate Release Tablet  

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The present study was aimed to predict the absorption profile of a risperidone immediate release tablet (IR) and to develop the level A in vitro–in vivo correlation (IVIVC) of the drug using the gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus™. Plasma concentration data, physicochemical, and pharmacokinetic properties of the drug were used in building its absorption profile in the gastrointestinal tract. Since the frac...

Saibi, Yardi; Sato, Hitoshi; Tachiki, Hidehisa

2012-01-01

209

An open-label trial of risperidone and fluoxetine in children with autistic disorder  

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Objective: Various studies have shown the effectiveness of risperidone and fluoxetine in the management of behavioral problems in autism. Aim: The purpose of this study was to compare these two drugs in the management of behavioral problems in autism. Materials and Methods: Forty children with autism were divided into 2 groups in a 16-week open trial that compared these two drugs. Parents rated the children using the Aberrant Behavior Checklist (ABC) and the Connersȃ...

2010-01-01

210

Effect of blonanserin on cognitive and social function in acute phase Japanese schizophrenia compared with risperidone  

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Hikaru Hori, Kenji Yamada, Dan Kamada, Yuka Shibata, Asuka Katsuki, Reiji Yoshimura, Jun NakamuraDepartment of Psychiatry, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, JapanBackground: This study aims to determine the effectiveness of blonanserin (BNS) on the cognitive and social functions of patients with schizophrenia compared with risperidone (RIS) during acute-phase (8-week) treatment.Methods: A total of 39 schizophrenia inpatients were included in this study....

Hori H; Yamada K; Kamada D; Shibata Y; Katsuki A; Yoshimura R; Nakamura J

2014-01-01

211

Appraisal of efficacy and safety of intralesional injection of high concentration of bleomycin a5 for treatment of huge macrocystic lymphatic malformations in cervical region.  

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The objective of this study was to investigate the therapeutic effects and safety of intralesional injection of high concentration of bleomycin A5 for huge (more than 5 cm in diameter) macrocystic lymphatic malformations (LMs) in the cervical region. Thirty-two patients with huge macrocystic LMs were treated with percutaneous injection of bleomycin A5 in our department between 2006 and 2011. Among them, 13 patients had unilateral submandibular lesions, and 19 patients had lesions in anterior cervical regions. The age of patients ranged from 10 months to 29 years (mean age, 11.4 y). The concentration of the drug was as high as 2.7 mg/mL (8 mg/3 mL) with an addition of dexamethasone. The mean sessions of injection were 1.6 (1-3 sessions). Repeated injection interval was 4 to 6 weeks. The follow-up period was 6 months to 4 years after the last treatment, and the mean follow-up time was 18 months. The results were evaluated based on clinical examination and Doppler ultrasonography scan. The clinical follow-up showed excellent response in 28 of the 32 patients, whereas 4 of the 32 patients also had a satisfactory response. No serious complications were encountered. Intralesional injection of high concentration of bleomycin A5 was an effective and safe treatment of huge macrocystic LMs in the cervical region and can obtain satisfactory results esthetically and functionally without surgery. PMID:25119414

Xu, Da-Peng; Zhai, Qin-Kai; Cheng, Chen; Gong, He; Wang, Hong-Wei; Wang, Xu-Kai

2014-09-01

212

Long-acting injectable formulations of antipsychotic drugs for the treatment of schizophrenia.  

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Antipsychotic drugs have been used to treat patients with schizophrenia and other psychotic disorders. Long-acting injectable antipsychotic drugs are useful for improving medication compliance with a better therapeutic option to treat patients who lack insight or adhere poorly to oral medication. Several long-acting injectable antipsychotic drugs are clinically available. Haloperidol decanoate and fluphenazine decanoate are first-generation depot drugs, but the use of these medicines has declined since the advent of second-generation depot agents, such as long-acting risperidone, paliperidone palmitate, and olanzapine pamoate. The second-generation depot drugs are better tolerated and have fewer adverse neurological side effects. Long-acting injectable risperidone, the first depot formulation of an atypical antipsychotic drug, was prepared by encapsulating risperidone into biodegradable microspheres. Paliperidone palmitate is an aqueous suspension of nanocrystal molecules, and olanzapine pamoate is a microcrystalline salt of olanzapine and pamoic acid suspended in aqueous solution. This review summarizes the characteristics and recent research of formulations of each long-acting injectable antipsychotic drug. PMID:23543652

Park, Eun Ji; Amatya, Sarmila; Kim, Myung Sun; Park, Jong Hoon; Seol, Eunyoung; Lee, Heeyong; Shin, Young-Hee; Na, Dong Hee

2013-06-01

213

Developing in vitro-in vivo correlation of risperidone immediate release tablet.  

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The present study was aimed to predict the absorption profile of a risperidone immediate release tablet (IR) and to develop the level A in vitro-in vivo correlation (IVIVC) of the drug using the gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus™. Plasma concentration data, physicochemical, and pharmacokinetic properties of the drug were used in building its absorption profile in the gastrointestinal tract. Since the fraction absorbed of risperidone in simulation was more than 90% with low water solubility, the drug met the criteria of class II of the Biopharmaceutics Classification System. The IVIVC was developed based on the model built using the plasma data and the in vitro dissolution data in several dissolution media based on the Japanese Guideline for Bioequivalence Studies of Generic Products. The gastrointestinal absorption profile of risperidone was successfully predicted. A level A IVIVC was also successfully developed in all dissolution media with percent prediction error for Cmax and the area under the curve less than 10% for both reference and test drug. PMID:22696224

Saibi, Yardi; Sato, Hitoshi; Tachiki, Hidehisa

2012-09-01

214

FORMULATION DEVELOPMENT AND EVALUATION OF EXTENDED RELEASE MINI TABLETS OF RISPERIDONE  

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Full Text Available The present study was carried out to formulate Risperidone mini tablets filled into hard gelatin capsule, as it is administered for the treatment of psychosis. The preformulation studies of Risperidone were carried out and drug –polymer compatibility studies were performed by FT-IR spectra analysis. The precompression parameters revealed that all the 6 formulations had good flow Carr’s index, Hausner’s ratio and angle of repose within the limit. Risperidone is formulated with different concentration of polymers like HPMCK100M, HPMCK15M, filler like lactose and with other excipients. A total number of 6 formulations (F1,F2,F3,F4,F5 and F6were carried and evaluated. In all the formulations thickness varies between 3.90-3.94mm and the hardness of the optimized batch was found to be 3.18kg/cm2.No variation in the hardness was found in the optimized formulation that showed powder blending was uniform. Among 6 formulations, F1, F2, F3 and F6 trials were done using K100M polymer and F4, F5 with K15M polymer using optimized quantity of lactose, best batch among those is F1 because it had 90% drug release and it could sustain its action until 20thhr, and is very economical.

B.Vishnu Vardhan Reddy

2012-02-01

215

Tolerability and safety profile of risperidone in a sample of children and adolescents.  

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The aim of this prospective observational study was to verify the tolerability and safety profile of risperidone in a sample of antipsychotic-naive children/adolescent patients having a different psychiatric diagnosis. Twenty-two (mean age of 12±3.2) antipsychotic-naive patients who started therapy with risperidone were recruited. The assessment involved anthropometric data (weight, height, BMI, BMI z-score and BMI percentile), cardiovascular parameters (blood pressure and QTc interval) and blood tests (levels of glucose, triglycerides, total cholesterol, glutamic oxaloacetic and pyruvic transaminases, ?-glutamyl transferase, prolactin, free triiodothyronine, free thyroxine, thyroid-stimulating hormone, thyroglobulin, antithyroid peroxidase and antithyroglobulin). After an average follow-up of 6 months of risperidone therapy, a statistically significant increase in weight and body composition was observed. Furthermore, an increase in serum levels of prolactin was observed in 50% of patients. No other significant changes in metabolic and cardiovascular parameters were found. Although an increase in these parameters was detected, it remained in the normal range. This study suggests the use of specific protocols for monitoring children/adolescents treated with second-generation antipsychotics to manage the metabolic long-term complications and progression to more severe disease states. PMID:23689836

Margari, Lucia; Matera, Emilia; Craig, Francesco; Petruzzelli, Maria G; Palmieri, Vincenzo O; Pastore, Adriana; Margari, Francesco

2013-07-01

216

A randomised, double-masked phase III/IV study of the efficacy and safety of Avastin® (Bevacizumab intravitreal injections compared to standard therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration: clinical trial design  

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Full Text Available Abstract Background The management of neovascular age-related macular degeneration (nAMD has been transformed by the introduction of agents delivered by intravitreal injection which block the action of vascular endothelial growth factor-A (anti-VEGF agents. One such agent in widespread use is bevacizumab which was initially developed for use in oncology. Most of the evidence supporting the use of bevacizumab for nAMD has come from interventional case series and this clinical trial was initiated because of the increasing and widespread use of this agent in the treatment of nAMD (an off-label indication despite a lack of definitive unbiased safety and efficacy data. Methods and design The Avastin® (bevacizumab for choroidal neovascularisation (ABC trial is a double-masked randomised controlled trial comparing intravitreal bevacizumab injections to standard therapy in the treatment of nAMD. Patients are randomised to intravitreal bevacizumab or standard therapy available at the time of trial initiation (verteporfin photodynamic therapy, intravitreal pegaptanib or sham treatment. Ranibizumab treatment was not included in the control arm as it had not been licensed for use at the start of recruitment for this trial. The primary outcome is the proportion of patients gaining ? 15 letters of visual acuity at 1 year and secondary outcomes include the proportion of patients with stable vision and mean visual acuity change. Discussion The ABC Trial is the first double-masked randomised control trial to investigate the efficacy and safety of intravitreal bevacizumab in the treatment of nAMD. This trial fully recruited in November 2007 and results should be available in early 2009. Important design issues for this clinical trial include (a defining the control group (b use of gain in vision as primary efficacy end-point and (c use of pro re nata treatment using intravitreal bevacizumab rather than continuous therapy. Trial registration Current controlled trials ISRCTN83325075

Bunce Catey

2008-10-01

217

Dopamine transporter density assessed with [123]IPT SPECT before and after risperidone treatment in children with tourette's disorder  

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Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the dopamine transporter (DAT) densities between drug-naive children with TD and normal children, and investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using iodine-123 labelled N-(3-iodopropen-2-yl)-2?-carbomethoxy-3beta-(4-chlorophenyl)tropane ([123I]IPT) single photon emission computed tomography (SPECT). [123I]IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in nine drug-naive children with TD. Eleven normal children also underwent SPECT imaging 2 hours after an intravenous administration of [123I]IPT. Drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with risperidone in children with TD was found, although tic symptoms were significantly improved with risperidone. Thgnificantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system

218

Efficacy and safety of an intra-operative intra-articular magnesium/ropivacaine injection for pain control following total knee arthroplasty.  

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Eighty patients with osteoarthritis who underwent unilateral total knee arthroplasty were randomly assigned to two groups: the trial group received an intra-operative intra-articular injection of magnesium sulphate and ropivacaine, and the control group received an injection of normal saline. All patients received patient-controlled analgesia with morphine for 48 h post-operatively. It was found that an intra-articular injection of magnesium sulphate and ropivacaine significantly reduced morphine consumption during the 0-24 h post-operative period and total 48-h post-operative morphine consumption. Pain scores at rest and during motion in the trial group were significantly lower than in the controls during the first 24 h post-operatively. The time to be able to perform a straight leg raise and to reach a 90° knee flexion was significantly shorter in the trial group compared with the controls. This study demonstrated that an intra-operative intra-articular magnesium sulphate and ropivacaine injection reduced the use of post-operative morphine. PMID:23206490

Chen, Y; Zhang, Y; Zhu, Y-L; Fu, P-L

2012-01-01

219

Effectiveness of second-generation antipsychotics: a naturalistic, randomized comparison of olanzapine, quetiapine, risperidone, and ziprasidone  

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Full Text Available Abstract Background No clear recommendations exist regarding which antipsychotic drug should be prescribed first for a patient suffering from psychosis. The primary aims of this naturalistic study were to assess the head-to-head effectiveness of first-line second-generation antipsychotics with regards to time until drug discontinuation, duration of index admission, time until readmission, change of psychopathology scores and tolerability outcomes. Methods Patients ? 18 years of age admitted to the emergency ward for symptoms of psychosis were consecutively randomized to risperidone (n = 53, olanzapine (n = 52, quetiapine (n = 50, or ziprasidone (n = 58, and followed for up to 2 years. Results A total of 213 patients were included, of which 68% were males. The sample represented a diverse population suffering from psychosis. At admittance the mean Positive and Negative Syndrome Scale (PANSS total score was 74 points and 44% were antipsychotic drug naïve. The primary intention-to-treat analyses revealed no substantial differences between the drugs regarding the times until discontinuation of initial drug, until discharge from index admission, or until readmission. Quetiapine was superior to risperidone and olanzapine in reducing the PANSS total score and the positive subscore. Quetiapine was superior to the other drugs in decreasing the PANSS general psychopathology subscore; in decreasing the Clinical Global Impression - Severity of Illness scale score (CGI-S; and in increasing the Global Assessment of Functioning - Split version, Functions scale score (GAF-F. Ziprasidone was superior to risperidone in decreasing the PANSS positive symptoms subscore and the CGI-S score, and in increasing the GAF-F score. The drugs performed equally with regards to most tolerability outcomes except a higher increase of hip-circumference per day for olanzapine compared to risperidone, and more galactorrhoea for risperidone compared to the other groups. Conclusions Quetiapine appears to be a good starting drug candidate in this sample of patients admitted to hospital for symptoms of psychosis. Trial Registration ClinicalTrials.gov ID; URL: http://www.clinicaltrials.gov/: NCT00932529

Wentzel-Larsen Tore

2010-03-01

220

Subjective response to antipsychotic treatment and compliance in schizophrenia. A naturalistic study comparing olanzapine, risperidone and haloperidol (EFESO Study  

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Full Text Available Abstract Background In order to compare the effectiveness of different antipsychotic drugs in the treatment of schizophrenia it is very important to evaluate subjective response and compliance in patient cohorts treated according to routine clinical practice. Method Outpatients with schizophrenia entered this prospective, naturalistic study when they received a new prescription for an antipsychotic drug. Treatment assignment was based on purely clinical criteria, as the study did not include any experimental intervention. Patients treated with olanzapine, risperidone or haloperidol were included in the analysis. Subjective response was measured using the 10-item version of the Drug Attitude Inventory (DAI-10, and treatment compliance was measured using a physician-rated 4 point categorical scale. Results A total of 2128 patients initiated treatment (as monotherapy with olanzapine, 417 with risperidone, and 112 with haloperidol. Olanzapine-treated patients had significantly higher DAI-10 scores and significantly better treatment compliance compared to both risperidone- and haloperidol-treated patients. Risperidone-treated patients had a significantly higher DAI-10 score compared to haloperidol-treated patients. Conclusion Subjective response and compliance were superior in olanzapine-treated patients, compared to patients treated with risperidone and haloperidol, in routine clinical practice. Differences in subjective response were explained largely, but not completely, by differences in incidence of EPS.

Sacristán Jose A

2001-12-01

 
 
 
 
221

Eficácia da aplicação da pomada EMLA® no alivio da dor desencadeada pela injeção de toxina botulínica tipo A no tratamento do blefaroespasmo essencial benigno / Efficacy of EMLA® cream application for pain relief of periocular botulinum toxin injections  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese OBJETIVO: Demonstrar a eficácia da aplicação da pomada EMLA® (EMLA) no alívio da dor desencadeada pela injeção de toxina botulínica tipo A (BTX) no tratamento do blefaroespasmo essencial benigno (BEB). MÉTODOS: Estudo prospectivo, com a participação de 13 pacientes submetidos à aplicação de toxina b [...] otulínica na região periocular bilateral no tratamento de BEB. Aplicou-se a pomada EMLA na região periocular direita e placebo na esquerda antes das aplicações. Após a aplicação solicitou-se ao paciente uma nota de 0 a 10 referente à intensidade da dor. RESULTADOS: No lado em que foi aplicada a pomada EMLA, a média da intensidade da dor referida pelo paciente foi de 5,77±3,00 enquanto que no lado em que foi aplicado placebo, foi de 5,62±2,63 (p=0,92). CONCLUSÃO: Não se obteve uma redução estatisticamente significante da dor referida durante a aplicação de BTX em pacientes portadores de BEB após a aplicação da pomada EMLA. Abstract in english PURPOSE: To investigate the efficacy of EMLA® (EMLA) cream for pain relief before periocular botulinum toxin injection (BTX) on the treatment of essential benign blepharospasm (BEB). METHODS: In this prospective study, 13 patients given bilateral periocular botulinum injections for blepharospasm tre [...] atment were included. Prior to the injections, EMLA cream was applied to the right periocular side and placebo to the left side. Relative pain score from 0 to 10 was recorded after the procedure. RESULTS: The average pain score on the side where EMLA was applied was 5,77±3,00, whereas it was 5,62±2,63 on the placebo side (p=0,92). CONCLUSION: No statistically significant decrease in the pain score associated with BTX injection for BEB was noted after EMLA skin application.

Nadia Ajub, Moysés; Nilson Lopes da, Fonseca Júnior; José Ricardo Carvalho Lima, Rehder.

222

Safety and efficacy findings from a non-interventional study of a new hyaluronic acid/sorbitol formulation (GO-ON® matrix) for intra-articular injection to relieve pain and disability in osteoarthritis patients.  

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This non-interventional study was intended to examine the efficacy and tolerability of intra-articular injections with the GO-ON® matrix, a new viscosupplement product made of non-animal sodium hyaluronate combined with the oxygen free radical scavenger sorbitol, when used in routine clinical practice. A total of 1 147 patients (43.5% male, 53,5% female, 3% missing) aged on average 63.3 years with osteoarthritis were enrolled in 398 centers and treated with the product. The most commonly treated joint was the knee (92.9%) with a Kellgren-Lawrence classification of Grade I (6.7%), Grade II (31.4%), Grade III (48.0%), and Grade IV (13.9%).Most patients (58-66%, imputing for missing data) received 1 injection, 29-40% received 3 injections. Using a Likert scale to asses pain, the mean change in pain due to osteoarthritis was a reduction of 56.5% from baseline (2.61±0.80) to 6 months (1.07±0.86). At baseline, 56.2% of patients reported severe/very severe pain versus 5.9% after 6 months. Accordingly, 6.8% of patients reported no pain/mild pain at baseline vs. 67.1% after 6 months. At baseline, 28.9% reported no pain/mild pain vs. to 66.4% after 6 months. At baseline, 29.1% of patients reported severe/very severe functional impairment vs. 3.9% 6 months after the first injection. The 3 and 6 month results were comparable.Adverse reactions were rare and confined to musculoskeletal and connective tissue disorders. No infections were reported in any treated joints. The results confirm that the GO-ON matrix® treatment is effective and well tolerated in the treatment of symptoms due to osteoarthritis. PMID:23599036

Heisel, J; Kipshoven, C

2013-09-01

223

Eficácia da aplicação da pomada EMLA® no alivio da dor desencadeada pela injeção de toxina botulínica tipo A no tratamento do blefaroespasmo essencial benigno / Efficacy of EMLA® cream application for pain relief of periocular botulinum toxin injections  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese OBJETIVO: Demonstrar a eficácia da aplicação da pomada EMLA® (EMLA) no alívio da dor desencadeada pela injeção de toxina botulínica tipo A (BTX) no tratamento do blefaroespasmo essencial benigno (BEB). MÉTODOS: Estudo prospectivo, com a participação de 13 pacientes submetidos à aplicação de toxina b [...] otulínica na região periocular bilateral no tratamento de BEB. Aplicou-se a pomada EMLA na região periocular direita e placebo na esquerda antes das aplicações. Após a aplicação solicitou-se ao paciente uma nota de 0 a 10 referente à intensidade da dor. RESULTADOS: No lado em que foi aplicada a pomada EMLA, a média da intensidade da dor referida pelo paciente foi de 5,77±3,00 enquanto que no lado em que foi aplicado placebo, foi de 5,62±2,63 (p=0,92). CONCLUSÃO: Não se obteve uma redução estatisticamente significante da dor referida durante a aplicação de BTX em pacientes portadores de BEB após a aplicação da pomada EMLA. Abstract in english PURPOSE: To investigate the efficacy of EMLA® (EMLA) cream for pain relief before periocular botulinum toxin injection (BTX) on the treatment of essential benign blepharospasm (BEB). METHODS: In this prospective study, 13 patients given bilateral periocular botulinum injections for blepharospasm tre [...] atment were included. Prior to the injections, EMLA cream was applied to the right periocular side and placebo to the left side. Relative pain score from 0 to 10 was recorded after the procedure. RESULTS: The average pain score on the side where EMLA was applied was 5,77±3,00, whereas it was 5,62±2,63 on the placebo side (p=0,92). CONCLUSION: No statistically significant decrease in the pain score associated with BTX injection for BEB was noted after EMLA skin application.

Nadia Ajub, Moysés; Nilson Lopes da, Fonseca Júnior; José Ricardo Carvalho Lima, Rehder.

2011-04-01

224

Hard to heal pressure ulcers (stage III-IV): efficacy of injected activated macrophage suspension (AMS) as compared with standard of care (SOC) treatment controlled trial.  

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The objective of this study was to compare local injections of AMS with SOC treatments for stage III and IV pressure ulcers in elderly patients. It was designed as historically prospective 2-arms non-parallel open controlled trial, and conducted in a department of geriatric medicine and rehabilitation of a university affiliated tertiary hospital. We studied 100 consecutive elderly patients with a total of 216 stage III or IV pressure ulcers, 66 patients were assigned to the AMS group and had their wounds injected, while 38 patients were assigned to the SOC group. Primary outcome was rate of complete wound closure. Time to complete wound closure and 1-year mortality served as secondary outcomes. Statistical analyses were performed at both patient and wound levels. Percentage of completely closed wounds (wound level and patient level) were significantly better (p<0.001/p<0.001, respectively) in all patients in favor of AMS, as well as in the subset of diabetic patients (p<0.001/p<0.001). Similarly, AMS proved significantly better for the subset of those with leg ulcers and with baseline wounds ?15 cm(2), compared with SOC. There were no statistically significant differences with regard to time to complete closure or 1-year mortality rates in the two groups. It is concluded that there is a significant difference in favor of stage III and IV wound closure rates by AMS, as compared with SOC treatments. PMID:20034682

Zuloff-Shani, Adi; Adunsky, Abraham; Even-Zahav, Aviva; Semo, Haim; Orenstein, Arie; Tamir, Jeremy; Regev, Eli; Shinar, Eilat; Danon, David

2010-01-01

225

Safety and efficacy of paliperidone extended-release in acute and maintenance treatment of schizophrenia.  

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Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) tablet formulation that minimizes peak-trough fluctuations in plasma concentrations, allowing once-daily administration and constant drug delivery. Paliperidone ER has demonstrated efficacy in the reduction of acute schizophrenia symptoms in 6-week, placebo-controlled, double-blind trials and clinical benefits were maintained in the longer-term according to extension studies of up to 52 weeks in duration. Compared with quetiapine, paliperidone ER was associated with a more rapid symptom improvement. In addition, it was more effective than placebo in the prevention of symptom recurrence. Paliperidone ER is generally well tolerated with a predictable adverse event profile. Like risperidone, it is associated with a dose-dependent risk of extrapyramidal symptoms and prolactin elevation. Short- and longer-term studies have indicated a low liability for paliperidone ER to cause metabolic (ie, weight gain, hyperglycaemia and lipid dysregulation) or cardiovascular adverse effects. Available safety data from elderly patients appear to be promising. Due to negligible hepatic biotransformation, paliperidone ER is unlikely to be involved in clinically significant metabolic drug-drug interactions. Additional active comparator trials evaluating efficacy, tolerability and cost-effectiveness are required to better define the role of paliperidone ER in the treatment of schizophrenia in relation to other currently available second-generation antipsychotics, particularly risperidone. PMID:23861636

Spina, Edoardo; Crupi, Rosalia

2011-01-01

226

Efficacy and tolerability of pharmacotherapy options for the treatment of irritability in autistic children.  

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Children with autism have a high rate of irritability and aggressive symptoms. Irritability or self-injurious behavior can result in significant harm to those affected, as well as to marked distress for their families. This paper provides a literature review regarding the efficacy and tolerability of pharmacotherapy for the treatment of irritability in autistic children. Although antipsychotics have not yet been approved for the treatment of autistic children by many countries, they are often used to reduce symptoms of behavioral problems, including irritability, aggression, hyperactivity, and panic. However, among antipsychotics, the Food and Drug Administration has approved only risperidone and aripiprazole to treat irritability in autism. Among atypical antipsychotics, olanzapine and quetiapine are limited in their use for autism spectrum disorders in children because of high incidences of weight gain and sedation. In comparison, aripiprazole and ziprasidone cause less weight gain and sedation. However, potential QTc interval prolongation with ziprasidone has been reported. Contrary to ziprasidone, no changes were evident in the QT interval in any of the trials for aripiprazole. However, head-to-head comparison studies are needed to support that aripiprazole may be a promising drug that can be used to treat irritability in autistic children. On the other hand, risperidone has the greatest amount of evidence supporting it, including randomized controlled trials; thus, its efficacy and tolerability has been established in comparison with other agents. Further studies with risperidone as a control drug are needed. PMID:24932108

Kirino, Eiji

2014-01-01

227

Weight Gain and New Onset Diabetes Associated with Olanzapine and Risperidone  

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OBJECTIVE To assess whether newer antipsychotic medications are associated with weight gain and development of diabetes. DESIGN Retrospective cohort study. SETTING Data from a comprehensive electronic medical record serving an urban public hospital and a citywide network of mental health clinics. PATIENTS/PARTICIPANTS Three thousand one hundred fifteen patients at least 18 years old who were prescribed a single antipsychotic drug for at least 1 year. METHODS We identified independent predictors of significant weight gain (?7%) and new onset of diabetes mellitus in the first year of antipsychotic drug treatment, using logistic regression adjusted for demographic characteristics, obesity, preexisting psychiatric diagnoses, alcohol and drug abuse, number of primary care, psychiatric clinic, and emergency department visits, and pretreatment weight. MEASUREMENTS AND MAIN RESULTS Twenty-five percent of patients taking older phenothiazines developed significant weight gain in the first year of treatment compared to 40% of the patients taking olanzapine (adjusted odds ratio [OR], 2.8; 95% confidence interval [CI], 1.7 to 4.6; P < .0001) and 37% of patients taking risperidone (adjusted OR, 2.3; 95% CI, 1.5 to 3.4; P < .0001). New diabetes developed in 3% of patients taking older phenothiazines was new onset diabetes compared to 8.0% of patients taking olanzapine (adjusted OR, 1.9; 95% CI, 1.1 to 3.3; P= .03) and 3.5% of patients taking risperidone (adjusted OR, 0.7; 95% CI, 0.4 to 1.4; P= .3). No association was found between significant weight gain and developing diabetes (adjusted OR, 0.7; 95% CI, 0.4 to 1.4; P= .4). CONCLUSIONS Olanzapine and risperidone use was associated with gaining weight in the first year, but only olanzapine was associated with developing diabetes mellitus. PMID:15610330

Farwell, Wildon R; Stump, Timothy E; Wang, Jane; Tafesse, Eskinder; L'Italien, Gilbert; Tierney, William M

2004-01-01

228

Gabapentin adjunctive to risperidone or olanzapine in partially responsive schizophrenia: an open-label pilot study  

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Full Text Available Adel GabrielDepartments of Psychiatry and Community Health Sciences, University of Calgary, Alberta, CanadaBackground: There is a great need in the treatment of schizophrenia for a drug, or drug ­combinations, to improve clinical response with fewer serious side effects. The objective of this study was to explore the therapeutic effects and tolerability of the anticonvulsant gabapentin as an adjunctive in the treatment of patients with partially responsive schizophrenia.Methods: Ten consenting patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision diagnosis of schizophrenia were identified. All patients failed at least one 12-week treatment trial with risperidone or olanzapine. Gabapentin was added to ongoing antipsychotic treatment with olanzapine or risperidone for eight weeks. The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS. Other scales included the Calgary Depression Scale (CDSS and the Abnormal Involuntary Movement Scale (AIMS. Repeated-measures multivariate analysis of variance was utilized to examine changes in outcome measures over time with adjunctive treatment with gabapentin.Results: There was a significant drop in the PANSS and CDSS scores at endpoint (week 8. There were no significant differences between the two treatment groups with regard to changes in all outcome measures or in AIMS score. The adjunctive treatments were well tolerated and side effects were transient.Conclusion: Gabapentin could be used successfully as an adjunct to novel antipsychotics in partially responsive schizophrenia. However, large controlled studies are needed to examine the effectiveness of gabapentin in psychotic disorders.Keywords: schizophrenia, refractory, adjunctive treatment, gabapentin, risperidone, olanzapine

Adel Gabriel

2010-10-01

229

Efficacy of 3,4,3-LI(1,2-HOPO) for decorporation of Pu,Am and U from rats injected intramuscularly with high-fired particles of MOX  

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This study aimed to assess the efficacy of 3,4,3-LI(1,2-HOPO) for reducing uranium, plutonium and americium in rats after intramuscular injection of (U-Pu)O{sub 2} particles (MOX). Sixteen rats were contaminated by intramuscular injection of a 1 mg MOX suspension and then treated daily for 7 d with LIHOPO (30 or 200 {mu}mol kg{sup -1}) or DTPA (30 {mu}mol kg{sup -1}). LIHOPO was inefficient for removing Pu, Am and U from the wound site. However, it reduced Pu retention in carcass and liver by factors of 2 and 6 respectively, and Am retention in carcass and liver by factors of 10 and 30. In contrast, the effect of LIHOPO on U was to decrease the retention in kidneys by a factor of 75. These results confirm that LIHOPO is a good candidate for use after contamination with MOX, in combination with localised wound lavage or surgical treatment aimed at removing most of the contaminant at the wound site. (author)

Paquet, F.; Chazel, V.; Houpert, P.; Guilmette, R.; Muggenburg, B

2003-07-01

230

Is High Dose Risperidone an Option for Treatment-Resistant Tourette Syndrome?  

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Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder that begins in childhood, in which multiple motor tics and one or more vocal tics are seen concomitantly. In this text, the treatment course of a severe TS case, with complete daily functioning loss, is described. Significant reductions in tics were observed with 8 mg/day risperidone treatment in this case who failed to respond to many neuroleptics. The Yale Global Tic Severity Scale (Y-GTSS) score, which was 85 before...

S? Bas?gu?l, Senem; Arpaci, Baki; C?o?pu?r, Mazlum

2009-01-01

231

Low dose intradetrusor injections of onabotulinumtoxina in women with overactive bladder symptoms or the painful bladder syndrome: unfavourable balance between clinical efficacy and the need for catheterisation  

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Full Text Available Background: We evaluated our results with low dose intradetrusor injections of onabotulinumtoxinA in women with overactive bladder symptoms and the painful bladder syndrome in terms of clinically successful outcomes and the need for clean intermittent self-catheterisation (CISC and in relation to urodynamic aspects. Materials and Methods: The files of patients treated with 100 U of onabotulinumtoxinA injected at 20 sites with sparing of the trigone were retrospectively analysed. Nearly all patients completed voiding-incontinence diaries and the King’s Health Questionnaire (KHQ pre- and post-operatively. Cystometric and pressure-flow studies were done in the majority of patients. Success was defined as the patient’s and clinician’s joint choice for re-treatment with the same dose of onabotulinumtoxinA after a period of at least six months of clinical satisfaction. Results: Twenty-six women were treated. On average, the improvement in most voiding diary parameters and in most KHQ categories lasted less than six and three months, respectively. Eight patients (31% were scheduled for re-treatment with 100 U again after at least six months. No prognostic cystometric parameters were found. Six patients (23% needed CISC. None of the bladder contraction strength parameters derived from the the pressure-flow studies appeared predictive of the need of CISC. Conclusions: We obtained a success rate of 31% after six months with 100 U of onabotulinumtoxinA, while 23% of the patients applied CISC. We consider this success rate low and find the balance between the success rate and the rate of patients needing CISC inadequate.

Jan Groen

2012-01-01

232

Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection.  

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Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot) antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine). In this respect, the emergence of long-acting aripiprazole injection (ALAI), approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10-20 mg/day) or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP)2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (P<0.0001, log-rank test). An open-label, mirror study demonstrated that total psychiatric hospitalization rates were significantly lower after switching from oral antipsychotics to ALAI. Another randomized controlled trial presented in poster form suggested that ALAI 400 mg was comparable with oral aripiprazole 10-30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk-benefit profile. PMID:25210454

Wang, Sheng-Min; Han, Changsu; Lee, Soo-Jung; Patkar, Ashwin A; Masand, Prakash S; Pae, Chi-Un

2014-01-01

233

New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia.  

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Long-acting injectable (depot) antipsychotics are one approach in the management of individuals with schizophrenia. Since the introduction of risperidone long-acting injection in 2003, three additional second-generation antipsychotics have become available in a long-acting injectable formulation: paliperidone, olanzapine and aripiprazole. Although these different depot options can help with adherence and thus encourage better treatment outcomes, they differ in terms of specific indications, approved injection sites, needle gauge, injection volume, injection interval, requirements for oral supplementation, availability of prefilled syringes, storage needs and postinjection observation period, as well as potential drug-drug interactions and commonly encountered adverse reactions. After a review of the evidence base, guidance is offered on the appropriate selection among the long-acting injectable formulations of both first and second-generation antipsychotics. PMID:23898849

Citrome, Leslie

2013-07-01

234

The efficacy of Achilles millefolium topical gel along with intralesional injection of glucantime in the treatment of acute cutaneous leishmaniasis major  

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Background: Leishmaniasis is still one of the endemic parasitic infections in many countries comprising Iran. During the past decades, several medical and surgical approaches have been applied and studied to achieve the best option to treat the cutaneous leishmaniasis in Iran and the world. This study was carried out to evaluate the effect of topical Achilles millefolium in conjunction with intralesional glucantime on acute cutaneous leishmanial lesions. Materials and Methods: sixty patients with confirmed acute cutaneous leishmaniasis were recruited in the study. Patients were randomly allocated into two groups to receive twice daily topical gel of Achilles millefolium 5% (containing 5% poly phenol) (group A) or placebo (group B) for four weeks along with weekly injection of intralesional Glucantime. Results: There was no significant difference between the two groups according to age, gender, and duration of the disease. Also, there was no significant difference in complete and relative cure rates between the two groups (P = 0.35) using Visual Analog Scale (VAS). Application site reactions were occurred in 12 patients including redness in 8 cases in group-A and 2 cases in group-B, severe itching in one case in group-A and increasing wound secretion in another case in group-A (P = 0.014). Conclusions: Given the result of the present study, there is no significant difference in cure rates of lesions between yarrow and placebo topical gels as an adjuvant drugs with intralesional glucantime in treatment of acute cutaneous leishmanial lesions. PMID:24804185

Jaffary, Fariba; Nilforoushzadeh, Mohammad Ali; Tavakoli, Naser; Zolfaghari, Behzad; Shahbazi, Foroud

2014-01-01

235

PHARMACOKINETIC STUDY OF RISPERIDONE: APPLICATION OF A HPLC METHOD WITH SOLID PHASE EXTRACTION  

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Full Text Available A new, simplified solid phase extraction procedure for the determination of risperidone and 9-hydroxyrisperidone in human plasma has been developed. This method involves the use of an optimized extraction protocol developed in Waters OASIS® HLB 30mg 1cc extraction columns using 1 mL of human serum. Separation was performed by HPLC using a Waters XTerra RP-18 (5 µm, 150x4,6 mm column with a mobile phase consisting in acetonitrile - potassium dihydrogen phosphate 50 mM pH 3.4 (27/73. UV detection at 278 nm was used to quantify analytes, encountering good linearity (r² > 0.999 in the 2-100 ng/mL concentration range. The mean recovery was 92.4 % and 92.8 % for risperidone and 9-hydroxyrisperidone respectively, with an intraday - interday precision below 7%, and accuracy below 115 %. The method has been successfully applied in pharmacokinetic studies that require a large sample number.

PABLO TORRES V

2011-01-01

236

Is High Dose Risperidone an Option for Treatment-Resistant Tourette Syndrome?  

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Full Text Available Gilles de la Tourette syndrome (TS is a chronic neuropsychiatric disorder that begins in childhood, in which multiple motor tics and one or more vocal tics are seen concomitantly. In this text, the treatment course of a severe TS case, with complete daily functioning loss, is described. Significant reductions in tics were observed with 8 mg/day risperidone treatment in this case who failed to respond to many neuroleptics. The Yale Global Tic Severity Scale (Y-GTSS score, which was 85 before treatment, declined to 48. In our case, who used this dosing regimen for six months, the reduced tic status continued after the dose was switched to 6 mg/day, the reduction status was observed to go on after six months. No significant side effect was observed. This case was thought to be important in showing that high dose risperidone might be effective in treatment-resistant TS cases. (Archives of Neuropsychiatry 2009; 46: 206-8

?. Senem BA?GÜL

2009-12-01

237

PHARMACOKINETIC STUDY OF RISPERIDONE: APPLICATION OF A HPLC METHOD WITH SOLID PHASE EXTRACTION  

Scientific Electronic Library Online (English)

Full Text Available SciELO Chile | Language: English Abstract in english A new, simplified solid phase extraction procedure for the determination of risperidone and 9-hydroxyrisperidone in human plasma has been developed. This method involves the use of an optimized extraction protocol developed in Waters OASIS® HLB 30mg 1cc extraction columns using 1 mL of human serum. [...] Separation was performed by HPLC using a Waters XTerra RP-18 (5 µm, 150x4,6 mm) column with a mobile phase consisting in acetonitrile - potassium dihydrogen phosphate 50 mM pH 3.4 (27/73). UV detection at 278 nm was used to quantify analytes, encountering good linearity (r² > 0.999) in the 2-100 ng/mL concentration range. The mean recovery was 92.4 % and 92.8 % for risperidone and 9-hydroxyrisperidone respectively, with an intraday - interday precision below 7%, and accuracy below 115 %. The method has been successfully applied in pharmacokinetic studies that require a large sample number.

PABLO, TORRES V; M. JACQUELINE, SEPÚLVEDA C; CARLOS, VON PLESSING R.

238

An open-label trial of risperidone and fluoxetine in children with autistic disorder  

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Full Text Available Objective: Various studies have shown the effectiveness of risperidone and fluoxetine in the management of behavioral problems in autism. Aim: The purpose of this study was to compare these two drugs in the management of behavioral problems in autism. Materials and Methods: Forty children with autism were divided into 2 groups in a 16-week open trial that compared these two drugs. Parents rated the children using the Aberrant Behavior Checklist (ABC and the Conners? Parent Rating Scale - Revised (CPRS-R. The author rated the children using the Children?s Psychiatric Rating Scale and Clinical Global Impression (CGI Scale. Results: The risperidone group showed significant improvement in areas like irritability and hyperactivity, while the fluoxetine group showed significant improvement in speech deviance, social withdrawal and stereotypy. When the two drugs were compared, fluoxetine showed greater improvement in stereotypy, while both drugs showed improvement on the general autism scale; and on anger, hyperactivity and irritability scales. Conclusions : In this open trial, both drugs were well tolerated and appeared to be beneficial in the treatment of common behavioral problems in children with autism. Further controlled and double-blind studies in larger samples are warranted.

Desousa Avinash

2010-01-01

239

Eficácia do resfriamento da pele no alívio da dor desencadeada pela injeção de toxina botulínica tipo A nas distonias faciais / Skin cooling efficacy on pain relief in periocular injections with botulinum toxin A in facial dystonias  

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Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese OBJETIVO: Avaliar a eficácia do resfriamento da pele com gelo no alívio da dor desencadeada pela injeção de toxina botulínica tipo A na região periocular em pacientes portadores de distonia facial. MÉTODOS: Neste estudo prospectivo, 13 pacientes receberam injeção de toxina botulínica tipo A em regiã [...] o glabelar (m. prócero) e periocular (m. orbicular) para tratamento de distonia facial. Antes das aplicações, um lado da região glabelar foi resfriado com gelo durante 5 minutos, enquanto no outro lado foi aplicada pomada Epitezan®, funcionando como placebo. A aplicação foi feita primeiramente no lado resfriado. Após a aplicação em cada um dos lados os pacientes foram instruídos a dar uma nota para a dor desencadeada pela injeção, em uma escala de 0 a 10 onde 0 era ausência de dor e 10 a dor mais intensa. RESULTADOS: A média das notas dadas pelos pacientes à dor desencadeada pela injeção no lado onde foi aplicado placebo foi 3,92 ± 3,28. No local onde foi aplicado gelo a média das notas foi de 2,92 ± 2,18 (p Abstract in english PURPOSE: To evaluate the efficacy of skin cooling with ice on pain relief in periocular injection with botulinum toxin type A in patients with facial dystonias. METHODS: In this prospective study, 13 patients received botulinum toxin type A injection in glabela (procerus m.) and periocular region (o [...] rbicular m.) for facial dystonias treatment. Before the injections, one side of the glabela was submitted to a 5-minute cooling period, while the opposite side had Epitezan® cream applied, as a placebo. The application was done at the cooled side first. After the application on each side the patients were instructed to rate the pain associated with the injection on a scale from 0 to 10, with 0 indicating no pain and 10 the worst pain. RESULTS: The average pain score on the side where cold was applied was 3,92 ± 3,28, while on the control side the average pain score was 2,92 ± 2,18 (p

Paula Barros Bandeira de Mello, Monteiro; Nilson Lopes da, Fonseca Júnior; José Ricardo Carvalho Lima, Rehder.

2012-12-01

240

Lack of effect of risperidone or olanzapine dose reduction on subjective experiences in stable patients with schizophrenia.  

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Sixty-one patients with schizophrenia stably treated with risperidone or olanzapine were randomly assigned to dose-reduction-by-half group or dose maintenance group. Subjective experiences were assessed at baseline and 28 weeks using three different self-rating scales. No significant differences in changes of subjective experiences were observed between the two groups. PMID:24768247

Takeuchi, Hiroyoshi; Suzuki, Takefumi; Remington, Gary; Watanabe, Koichiro; Mimura, Masaru; Uchida, Hiroyuki

2014-08-15

 
 
 
 
241

Near infrared spectroscopic (NIRS) analysis of drug-loading rate and particle size of risperidone microspheres by improved chemometric model.  

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Microspheres have been developed as drug carriers in controlled drug delivery systems for years. In our present study, near infrared spectroscopy (NIRS) is applied to analyze the particle size and drug loading rate in risperidone poly(d,l-lactide-co-glycolide) (PLGA) microspheres. Various batches of risperidone PLGA microspheres were designed and prepared successfully. The particle size and drug-loading rate of all the samples were determined by a laser diffraction particle size analyzer and high performance liquid chromatography (HPLC) system. Monte Carlo algorithm combined with partial least squares (MCPLS) method was applied to identify the outliers and choose the numbers of calibration set. Furthermore, a series of preprocessing methods were performed to remove signal noise in NIR spectra. Moving window PLS and radical basis function neural network (RBFNN) methods were employed to establish calibration model. Our data demonstrated that PLS-developed model was only suitable for drug loading analysis in risperidone PLGA microspheres. Comparatively, RBFNN-based predictive models possess better fitting quality, predictive effect, and stability for both drug loading rate and particle size analysis. The correlation coefficients of calibration set (Rc(2)) were 0.935 and 0.880, respectively. The performance of optimum RBFNN models was confirmed by independent verification test with 15 samples. Collectively, our method is successfully performed to monitor drug-loading rate and particle size during risperidone PLGA microspheres preparation. PMID:24954726

Song, Jia; Xie, Jing; Li, Chenliang; Lu, Jia-Hui; Meng, Qing-Fan; Yang, Zhaogang; Lee, Robert J; Wang, Di; Teng, Le-Sheng

2014-09-10

242

Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction  

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Full Text Available Abstract Background Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A, which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. Methods/Design The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5–21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont. Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. Discussion BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and deformity correction. Trial Registration NCT00412035

Finley Allen

2007-09-01

243

A Comparative Study of the Effects of Clozapine and Risperidone Monotherapy on Lipid Profile in Nigerian Patients with Schizophrenia  

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Full Text Available Although antipsychotic drugs are known to have an array of adverse effects, they also exhibit significant differences in causing these effects. The atherogenic effects of clozapine and risperidone have not been fully investigated among schizophrenics in Nigeria hence this research work. This study therefore investigated the extent to which monotherapy with clozapine and risperidone (atypical antipsychotic drugs influence lipid profile in patients with schizophrenia. The study population comprised 29 Schizophrenic patients from Psychiatric Hospital, Uselu, Benin city, Nigeria. They were placed on typical antipsychotics for six weeks: 10 patients were on risperidone (1-4 mg day-1 in divided doses and 19 patients were on clozapine (25-300 mg day-1 in divided doses. The control group comprised 30 apparently healthy volunteers. Blood samples were collected from all subjects on the first day before the commencement of treatment with antipsychotic drug and 24 h after the last administration of antipsychotics at the end of week 6 for analyses of total cholesterol (TC, triglycerides (TG, high density lipoprotein cholesterol (HDL, low density lipoprotein cholesterol (LDL and very low density Lipoprotein cholesterol (VLDL using standard methods. Comparing with the control, the basal serum TC, TG, LDL and VLDL of the clozapine treated group were not significantly different except for HDL which was significantly reduced and the atherogenic indices (TC/HDL and LDL/HDL which were significantly increased. However the risperidone treatment group showed significantly higher TC, TG, LDL and VLDL levels while HDL was significantly reduced. At the end of week 6, there was significant increase in serum TC, TG, HDL and VLDL and a significant decrease in HDL in both treatment groups compared to the control except VLDL that was not significantly different in the clozapine group. Comparing the two treatment groups, risperidone caused a more significant increase on lipid profile and atherogenic indeces than clozapine. This effect was about two times or greater with risperidone than clozapine. Conclusively, additional prospective clinical trials are required to support a specific therapeutic approach for managing dyslipidaemia that are present in clozapine and risperidone treated schizophrenic patients in an attempt to avoid its consequent adverse effects.

O.I. Iribhogbe

2012-01-01

244

Effects of risperidone and olanzapine on remnant-like lipoprotein particle cholesterol (RLP-C in schizophrenic patients  

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Full Text Available Takahiko NagamineDivision of Psychiatric Internal Medicine, Seiwakai-Kitsunan Hospital, Suzenji, JapanAbstract: Second generation antipsychotics are associated with the risk of metabolic disorders such as diabetes mellitus and hyperlipidemia. Remnant-like lipoprotein particles cholesterol (RLP-C are a known risk factor for cardiovascular events. The present study was performed to determine possible differences in fasting blood RLP-C levels between schizophrenic patients treated with risperidone as compared to olanzapine. Patients on olanzapine had significantly higher RLP-C levels than those on risperidone (p < 0.01. In olanzapine-treated patients there was no abnormality in fasting blood glucose levels, but fasting insulin levels and homeostasis model assessment of insulin resistance (HOMA-IR were elevated. RLP-C levels were significantly correlated with plasma triglyceride concentrations in both the olanzapine- (p < 0.01 and risperidone-treated patients (p < 0.01. The regression line slope was greater for the olanzapine group, suggesting a greater influence of olanzapine on RLP-C. There was a significant correlation between RLP-C and HOMA-IR in the risperidone group (p < 0.01 but not in the olanzapine group (p = 0.80. These results suggest that blood glucose monitoring may not be sufficient to detect metabolic disorder and that measurement of RLP-C might be helpful for the screening for metabolic disorders associated with olanzapine therapy.Keywords: remnant-like lipoprotein particles cholesterol (RLP-C, schizophrenia, insulin resistance, risperidone, olanzapine

Takahiko Nagamine

2008-04-01

245

No change of dopamine transporter density in basal ganglia after risperidone treatment in drug-naive children with Tourette's disorder  

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Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the DAT densities between drug-naive children with TD and normal children investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using lodine-123 labelled N-(3-iodopropen-2-yl)-2beta-carbomethoxy-3beta-(4-chlorophenyl) tropane(I-123 IPT) single photon emission computed tomography (SPECT). I-123 IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in eight drug-naive children with TD. Eight normal children also underwent SPECT imaging 2 hours after an intravenous administration of I-123 IPT and carried out both quantitative and qualitative analyses using the obtained SPECT data, which were reconstructed for the assessment of the specific/non-specific DAT binding ratio in the basal ganglia. The drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal gangliific DAT binding ratio of the basal ganglia before and after treatment with riperidone in children with TD was not found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system

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Eficacia y seguridad de la inyección intravítrea de bevacizumab en el tratamiento del glaucoma neovascular: revisión sistemática Efficacy and safety of intravitreal injection of bevacizumab in the treatment of neovascular glaucoma: systematic review  

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Full Text Available Propósito: Revisión sistemática sobre la eficacia y seguridad de la inyección intravítrea de bevacizumab (IVB en el tratamiento del glaucoma neovascular (GNV. Se incluyen todos los trabajos originales publicados en Medline hasta agosto de 2008. Métodos: Búsqueda y selección de la información en Internet y Medline, validadas mediante el Índice Kappa (K. Estudio estadístico y clínico de los resultados en los trabajos seleccionados, uno a uno. Resultados: Se encuentran 26 artículos originales que analizan la eficacia y seguridad del procedimiento en casos únicos y en series cortas de casos. 24 de ellos se analizan conjuntamente, con un total de 127 ojos intervenidos. La eficacia calculada para casos difíciles es del 68,7%. Las recidivas en un seguimiento de 4,2 meses son del 18,6%. Todos los trabajos son posteriores a 2006 y ninguno cumple criterios de ensayo clínico aleatorizado. Las complicaciones de la IVB son inferiores al 0,78% y no se observan complicaciones sistémicas. Conclusiones: El bevacizumab demuestra que las inyecciones intravítreas pueden ser muy eficaces y seguras para la manipulación terapéutica de los factores de crecimiento en el segmento anterior. La IVB se perfila como un tratamiento de primera línea en casos de GNV dificiles. Se necesitan ensayos clínicos controlados que confirmen estos resultados y autorizen el uso.Purpose: Systematic review on efficacy and safety of intravitreal bevacizumab (IVB in the treatment of neovascular glaucoma (NVG. All original papers published in Medline (prior to August 2008 were included. Methods: Search and selection of information on the internet and in Medline, validated by Kappa Index (K. Statistical and clinical study of the results in the selected articles on a one by one basis. Results: 26 original papers analyzed the efficacy and safety of the procedure in case reports and short series of cases (127 eyes. The efficacy calculated in the sample was 68.7% and the recurrence rate was 18.6% in 4.2 months of follow-up. All studies were after 2006 and none of them was a clinical randomized controlled assay. Ophthalmic complications were under 0.78% and no systemic complications were found. Conclusions: The use of bevacizumab demonstrates that intravitreal injections may be effective and useful to manipulate growth factors in the anterior chamber. IVB could serve as a first line treatment for NVG. Clinical trials are needed to confirm these results before its use is authorized.

P.A. Martínez-Carpio

2008-10-01

247

Eficacia y seguridad de la inyección intravítrea de bevacizumab en el tratamiento del glaucoma neovascular: revisión sistemática / Efficacy and safety of intravitreal injection of bevacizumab in the treatment of neovascular glaucoma: systematic review  

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Full Text Available SciELO Spain | Language: Spanish Abstract in spanish Propósito: Revisión sistemática sobre la eficacia y seguridad de la inyección intravítrea de bevacizumab (IVB) en el tratamiento del glaucoma neovascular (GNV). Se incluyen todos los trabajos originales publicados en Medline hasta agosto de 2008. Métodos: Búsqueda y selección de la información en In [...] ternet y Medline, validadas mediante el Índice Kappa (K). Estudio estadístico y clínico de los resultados en los trabajos seleccionados, uno a uno. Resultados: Se encuentran 26 artículos originales que analizan la eficacia y seguridad del procedimiento en casos únicos y en series cortas de casos. 24 de ellos se analizan conjuntamente, con un total de 127 ojos intervenidos. La eficacia calculada para casos difíciles es del 68,7%. Las recidivas en un seguimiento de 4,2 meses son del 18,6%. Todos los trabajos son posteriores a 2006 y ninguno cumple criterios de ensayo clínico aleatorizado. Las complicaciones de la IVB son inferiores al 0,78% y no se observan complicaciones sistémicas. Conclusiones: El bevacizumab demuestra que las inyecciones intravítreas pueden ser muy eficaces y seguras para la manipulación terapéutica de los factores de crecimiento en el segmento anterior. La IVB se perfila como un tratamiento de primera línea en casos de GNV dificiles. Se necesitan ensayos clínicos controlados que confirmen estos resultados y autorizen el uso. Abstract in english Purpose: Systematic review on efficacy and safety of intravitreal bevacizumab (IVB) in the treatment of neovascular glaucoma (NVG). All original papers published in Medline (prior to August 2008) were included. Methods: Search and selection of information on the internet and in Medline, validated by [...] Kappa Index (K). Statistical and clinical study of the results in the selected articles on a one by one basis. Results: 26 original papers analyzed the efficacy and safety of the procedure in case reports and short series of cases (127 eyes). The efficacy calculated in the sample was 68.7% and the recurrence rate was 18.6% in 4.2 months of follow-up. All studies were after 2006 and none of them was a clinical randomized controlled assay. Ophthalmic complications were under 0.78% and no systemic complications were found. Conclusions: The use of bevacizumab demonstrates that intravitreal injections may be effective and useful to manipulate growth factors in the anterior chamber. IVB could serve as a first line treatment for NVG. Clinical trials are needed to confirm these results before its use is authorized.

P.A., Martínez-Carpio; E., Bonafonte-Márquez; C.D., Heredia-García; S., Bonafonte-Royo.

2008-10-01

248

Atypical antipsychotics such as risperidone, but not paliperidone, worsen vascular endothelial function via upregulation of adhesion molecules VCAM-1, ICAM-1, and E-selectin in diabetic rats.  

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Schizophrenia doubles the odds of diabetes, and atypical antipsychotics (AAPs) also increase risk of diabetes. Indeed, little is known about the effects of AAPs on vascular dysfunctions associated with diabetes. This study aimed to determine the effects of risperidone (RISP) and paliperidone (PALI) on the vascular function of diabetic rats. Diabetes was induced by feeding with a high-fat diet followed by the administration of streptozotocin (35 mg·(kg body mass)(-1), by intraperitoneal injection). Rats received RISP or PALI (1.25 mg·kg(-1)·d(-1), per os) for 3 weeks. Endothelium-dependent relaxation, systolic blood pressure, lipid profile, insulin resistance, and adhesion molecules, vascular cell-adhesion-molecule-1 (VCAM-1), intracellular-adhesion-molecule-1 (ICAM-1), and E-selectin were investigated. RISP significantly worsened the impaired endothelium-dependent relaxation of diabetic aortic rings with upregulation of the adhesion molecules VCAM-1, ICAM-1, and E-selectin, and proinflammatory cytokines MPC-1 and TNF-?. RISP augmented the metabolic dysfunctions and reduced insulin sensitivity in the insulin tolerance test as well as HOMA-IR. PALI produced insignificant effects on vascular and metabolic aberrations. Our results suggest that RISP, but not PALI, aggravates the metabolic abnormalities and vascular dysfunction associated with diabetes, which may be mediated by upregulation of VCAM-1, ICAM-1, and E-selectin. Nevertheless, future investigation for the possible mechanisms underlying the difference noticed between the 2 AAPs is warranted. PMID:24289084

Aboul-Fotouh, Sawsan; Elgayar, Nesreen

2013-12-01

249

Medroxyprogesterone Injection  

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Medroxyprogesterone intramuscular (into a muscle) injection and medroxyprogesterone subcutaneous (under the skin) injection are used to prevent pregnancy. Medroxyprogesterone subcutaneous injection is also used to treat endometriosis (a condition in which ...

250

Golimumab Injection  

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... at golimumab injection before injecting it. Check the expiration date printed on the auto-injection device or carton and do not use the medication if the expiration date has passed. Do not use a prefilled syringe ...

251

Overweight induced by chronic risperidone exposure is correlated with overexpression of the SREBP-1c and FAS genes in mouse liver.  

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Weight gain and metabolic disturbances, such as dyslipidemia and hyperglycaemia, are common side effects of most antipsychotic drugs, including risperidone. The aim of this study was to investigate the effects of chronic treatment with risperidone on body weight, fat accumulation, liver weight, and hepatic expression of key genes involved in lipid metabolism in female mice. We also addressed the mechanism of risperidone induction of metabolic side effects by exploring its effect on lipid and cholesterol metabolism in primary cultures of rat hepatocytes. Eleven weeks of treatment with long-acting risperidone (12.5 mpk/week) resulted in a significant weight gain associated with an increase of liver and adipose tissue weight. These effects were positively correlated with hepatic mRNA induction of two key genes involved in lipogenesis: sterol regulatory element binding protein-1c (SREBP-1c) and fatty acid synthase (FAS). Furthermore, in line with these in vivo results, risperidone elicited significant inductions of SREBP-1 maturation and FAS mRNA expression in primary cultures of rat hepatocytes associated with an increase of free fatty acid, triacylglycerol, and phospholipid synthesis as assessed by acetate incorporation. The current investigations underscore the usefulness of a mouse model to study the weight gain observed with risperidone treatment in humans. This study shows that risperidone induces similar effects in the liver (in vivo) and in hepatocyte cell cultures (in vitro) on the expression of key genes and/or proteins that control lipid metabolism. This suggests that risperidone could alter lipid metabolism in the liver and induce weight gain in a way that is partly independent of its action on the central nervous system. PMID:21336545

Lauressergues, Emilie; Martin, Françoise; Helleboid, Audrey; Bouchaert, Emmanuel; Cussac, Didier; Bordet, Régis; Hum, Dean; Luc, Gérald; Majd, Zouher; Staels, Bart; Duriez, Patrick

2011-04-01

252

Eficacia limitada del uso de agente inyectable permanente en el tratamiento de la incontinencia urinaria de esfuerzo tras prostatectomía radical / Limited efficacy of permanent injectable agents in the treatment of stress urinary incontinence after radical prostatectomy  

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Full Text Available SciELO Spain | Language: Spanish Abstract in spanish OBJETIVO: No existen datos suficientes en relación a la eficacia del tratamiento de la incontinencia urinaria de esfuerzo (IUE) después de prostatectomía radical (PR). El propósito de este estudio es describir nuestra experiencia mediante inyección de micro esferas de carbón pirolítico (Durasphere®) [...] en el tratamiento de IUE tras PR. MÉTODOS: Entre Enero y Octubre de 2003 fueron tratados con Durasphere 8 pacientes con el diagnóstico de IUE después de PR. Se analizaron las variables edad, tiempo transcurrido desde la PR hasta el tratamiento, número diario de compresas, informe quirúrgico, respuesta subjetiva y objetiva al tratamiento, y evolución clínico quirúrgica. RESULTADOS: La edad media de los pacientes fue de 63,2 años (50-71). El tiempo mediano desde la prostatectomía radical hasta la inyección fue de 25 meses (14-134). Ningún paciente sufría incontinencia urinaria anterior a la prostatectomía radical. El número mediano de compresas usadas antes del tratamiento con Durasphere® era de 2 diarias (1-6). El volumen mediano de Durasphere® inyectado fue de 23.8 ml (15-30 ml). Ningún paciente resultó curado subjetiva u objetivamente después del tratamiento. Tras un seguimiento mediano de 5 meses (9.9-12.5), 5 pacientes (62.5%) optaron por un segundo tratamiento mas invasivo para resolver su incontinencia. CONCLUSIONES: La utilización de Durasphere® como agente inyectable permanente no supuso, entre nuestros pacientes un tratamiento efectivo de la IUE leve a moderada tras PR. Abstract in english OBJECTIVES: There is not enough evidence about efficacy in the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP). The objective of this paper is to describe our experience with the injection of pyrolytic carbon microspheres (Durasphere ®) in the treatment of SUI after R [...] P. METHODS: Between January and October 2003 8 patients with the diagnosis of SUI after RP underwent treatment. Analyzed variables included age, time from RP to treatment, number of incontinence pads per day, operative report, subjective and objective response to treatment, and clinical-surgical outcomes. RESULTS: Mean age was 63.2 years (50-71). Median time from radical prostatectomy to injection was 25 months (14-134). No patient suffered urinary incontinence before radical prostatectomy. Median number of incontinence pads required before treatment with Durasphere ® injection was 2 per day (1-6). Mean Durasphere ® volume injected was 23.8 ml (15-30 ml). No patient achieved subjective or objective cure after treatment. After a median follow-up of 5 months (9.9-12.5) 5 patients (62.5%) chose to undergo a second more invasive treatment to solve their incontinence. CONCLUSIONS: The use of Durasphere ® as a permanent injectable agent did not result effective in the treatment of mild to moderate SUI after RP in our patients.

Fernando P., Secin; Juan Ignacio, Martínez-Salamanca; Karyn S., Eilber.

253

Formulation and characterization of nanoemulsion-based drug delivery system of risperidone.  

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Risperidone nanoemulsion (NE) and mucoadhesive NE formulations were successfully prepared by the spontaneous emulsification method (titration method) using Capmul MCM as the oily phase on the basis of solubility studies. The NE formulation containing 8% oil, 44% S(mix), 48% (wt/wt) aqueous phase that displayed an optical transparency of 99.82%, globule size of 15.5 +/- 2.12 nm, and polydispersity of 0.172 +/- 0.02 was selected for the incorporation of mucoadhesive components. The mucoadhesive formulation that contained 0.5% by weight of chitosan displayed highest diffusion coefficient that followed Higuchi model was free from nasal ciliotoxicity and stable for 3 months. PMID:19016058

Kumar, Mukesh; Pathak, Kamla; Misra, Ambikanandan

2009-04-01

254

Sexual dysfunction in patients with schizophrenia treated with conventional antipsychotics or risperidone  

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Full Text Available Hong Liu-Seifert1, Bruce J Kinon1, Christopher J Tennant2, Jennifer Sniadecki1, Jan Volavka31Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; 2CJT Biomedical Consulting, South Lake Tahoe, CA, USA; 3New York University, New York, NY, USAObjective: To better understand sexual dysfunction in patients with schizophrenia and its associations with prolactin and reproductive hormones.Methods: This was a secondary analysis of an open-label, one-day study (N = 402. The primary objective of the study was to assess the prevalence of hyperprolactinemia in patients with schizophrenia who had been treated with conventional antipsychotics or risperidone. Other atypical antipsychotics available at the time of the study were not included due to a more favorable prolactin profile.Results: The majority of patients (59% of females and 60% of males reported impairment of sexual function. In postmenopausal females, risk of impaired sexual interest was increased by 31% for every 10 ng/ml increase in prolactin (p = 0.035. In males, lower testosterone was associated with higher prolactin (p < 0.001 and with orgasmic (p = 0.004 and ejaculatory dysfunction (p = 0.028.Conclusion: These findings suggest that hyperprolactinemia may be associated with sexual dysfunction. They also provide more information on the relationships between prolactin, reproductive hormones, and sexual dysfunction. Sexual dysfunction is an understudied yet important consideration in the treatment of schizophrenia. More attention is warranted in this area as it may provide opportunities for improved quality of life and adherence to treatment for patients.Keywords: sexual dysfunction, schizophrenia, hyperprolactinemia, antipsychotics, risperidone

Hong Liu-Seifert

2009-01-01

255

Injection molding  

International Nuclear Information System (INIS)

This book deals with injection molding and plastic industry with trend of plastic industry and injection molding like production and consume of plastic in the world, plastic molding such as forming and property process, various molding with shape forming, theories on main molding and the position of injection molding, prospect of injection molding. It also describes property of material on injection molding; introduction, molecule structure, density, crystalizability, transition point, heat condition quality and compressible volume.

256

Risperidone: stuttering.  

Science.gov (United States)

This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a publication available from Wolters Kluwer Health. Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a patient care scenario. References direct the reader to the full literature for more comprehensive information before patient care decisions are made. Direct questions or comments regarding Off-Label Drug Uses to jgeneral@ku.edu. PMID:24715742

Generali, Joyce A; Cada, Dennis J

2014-03-01

257

Validation of an analytical method applicable to study of 1 mg/mL oral Risperidone solution stability  

International Nuclear Information System (INIS)

A validated analytical method by high-performance liquid chromatography (HPLC) was applicable to study of 1 mg/mL Risperidone oral solution stability. The above method was linear, accurate, specific and exact. A stability study of the 1 mg/mL Risperidone oral solution was developed determining its expiry date. The shelf life study was conducted for 24 months at room temperature; whereas the accelerated stability study was conducted with product under influence of humidity and temperature; analysis was made during 3 months. Formula fulfilled the quality specifications described in Pharmacopeia. The results of stability according to shelf life after 24 months showed that the product maintains the parameters determining its quality during this time and in accelerated studies there was not significant degradation (p> 0.05) in the product. Under mentioned conditions expiry date was of 2 years

258

Relationship between dose, drug levels, and D2 receptor occupancy for the atypical antipsychotics risperidone and paliperidone.  

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Blockade of D2 family dopamine receptors (D2Rs) is a fundamental property of antipsychotics, and the degree of striatal D2R occupancy has been related to antipsychotic and motor effects of these drugs. Recent studies suggest the D2R occupancy of antipsychotics may differ in extrastriatal regions compared with the dorsal striatum. We studied this issue in macaque monkeys by using a within-subjects design. [(18)F]fallypride positron emission tomography scans were obtained on four different doses of risperidone and paliperidone (the 9-OH metabolite of risperidone) and compared with multiple off-drug scans in each animal. The half-life of the two drugs in these monkeys was determined to be between 3 and 4 h, and drug was administered by a constant infusion through an intragastric catheter. The D2R occupancy of antipsychotic was determined in the caudate, putamen, ventral striatum, and four prefrontal and temporal cortical regions and was related to serum and cerebrospinal fluid drug levels. Repeated 2-week treatment with risperidone or paliperidone did not produce lasting changes in D2R binding potential in any region examined. As expected, D2R binding potential was highest in the caudate and putamen and was approximately one-third that level in the ventral striatum and 2% of that level in the cortical regions. We found dose-dependent D2R occupancy for both risperidone and paliperidone in both basal ganglia and cortical regions of interest. We could not find evidence of regional variation in D2R occupancy of either drug. Comparison of D2R occupancy and serum drug levels supports a target of 40 to 80 ng/ml active drug for these two atypical antipsychotics. PMID:22214649

Muly, E C; Votaw, J R; Ritchie, J; Howell, L L

2012-04-01

259

Eficacia y seguridad de la risperidona en el tratamiento agudo de las conductas disruptivas en pacientes pediátricos epilépticos / Risperidone in the treatment of acute disruptive behavior in pediatrics patients with epilepsy  

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Full Text Available SciELO Mexico | Language: Spanish Abstract in spanish Introducción. Las conductas disruptivas son frecuentes en más de la mitad de los pacientes pediátricos con epilepsia, impactan sobre su funcionamiento psicosocial global y provocan el rechazo de la sociedad. El presente estudio plantea la posibilidad de coadyuvar en el tratamiento integral de los ni [...] ños con epilepsia mediante el empleo de risperidona. Material y métodos. Se seleccionaron pacientes pediátricos epilépticos (con epilepsia parcial o generalizada) que presentaban conductas disruptivas asociadas, hombres y mujeres con edades comprendidas entre los 5 y 14 años, captados en la consulta externa de Neurología del Hospital Infantil de México Federico Gómez. Se realizó un estudio clínico abierto, prospectivo, con seguimiento durante 4 semanas. Se les administró risperidona, cuya eficacia se evaluó mediante las escalas de mejoría clínica global, la de Peers y la de ADHD-RS. Se midieron el número de crisis y los efectos secundarios con la escala de Yale. Resultados. Se estudiaron 23 pacientes, 7 femeninos y 16 masculinos con una relación M:F de 1.5:1 ,todos con diagnóstico de epilepsia (parcial 19 y generalizada 4). La dosis promedio de risperidona fue de 0.75 mg/día, se hizo un seguimiento de 4 semanas, con respuesta favorable al final del mes en 91% de los pacientes. Los efectos indeseables observados fueron: incremento ponderal en 12 niños, además de síntomas extrapiramidales (discinesias de cabeza y cuello), sialorrea, sed y somnolencia. Conclusión. En el manejo agudo de conductas disruptivas en pacientes pediátricos con epilepsia, la risperidona mostró ser efectiva y segura. Abstract in english Introduction. Disruptive behavior (DB) is frequent in pediatric patients with epilepsy.This conducts impacts on the functioning of the children, and often leads to their social rejection. The objectives of this study were to observe the efficacy and safety of risperidone in the treatment of acute di [...] sruptive behavior in pediatric patients with epilepsy. Material and methods. A clinical open label, prospective study with a month follow up was carried out. Pediatric patients with epilepsy (partial or generalized) and disruptive behavior, both gender, between 5 and 14 years of age seen in the neurology department, Hospital Infantil de Mexico, were enrolled.The efficacy was evaluated with CGI, Peers scale and ADHD RS. Number of seizures and secondary effects was evaluated with the same methods. Results. A total of 23 patients, 7 females and 16 males enter the study with a relation M:F of 1.5:1. All the patients had epilepsy, either partial or generalized.The average doses of risperidone was 0.75 mg/kg/d, with and efficacy of 91 % at the final of the 4 weeks follow up.The more frequent side effects were increase in weight in 12 patients, extrapiramidal symptoms (head and neck discinesias) sialorrhea, thirst and somnolence. Conclusions. With these results, we support in this clinic open label study, the efficacy and safety of the use of risperidone in the management of acute disruptive behaviors in pediatric patients with epilepsy.

Eduardo, Barragán-Pérez; Arturo, Garza-Peña; Oscar, Benavides-Guerrero; Juan, Hernández-Aguilar.

2005-12-01

260

Ceftaroline Injection  

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Teflaro® ... Ceftaroline injection is used to treat some types of skin infections and pneumonia (lung infection) caused by certain ... Ceftaroline injection comes as a powder to be added to fluid and given through a needle or catheter ...

 
 
 
 
261

Levofloxacin Injection  

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Levofloxacin injection is used to treat infections such as pneumonia; chronic bronchitis; and sinus, urinary tract, kidney, prostate (a male reproductive gland), and skin infections. Levofloxacin injection is also used to prevent anthrax (a ...

262

Midazolam Injection  

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Midazolam injection is used before medical procedures and surgery to cause drowsiness, relieve anxiety, and prevent any ... during surgery to produce a loss of consciousness. Midazolam injection is also used to cause a state ...

263

Fondaparinux Injection  

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Fondaparinux injection is used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg), ... warfarin (Coumadin, Jantoven) to treat DVT or PE. Fondaparinux injection is in a class of medications called ...

264

Metoclopramide Injection  

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Metoclopramide injection is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. ... feeling of fullness that lasts long after meals. Metoclopramide injection is also used to prevent nausea and ...

265

Levoleucovorin Injection  

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Levoleucovorin injection is used to prevent harmful effects of methotrexate (Rheumatrex, Trexall) when methotrexate is used to to treat certain types of cancer. Levoleucovorin injection is also used to treat people who have ...

266

Cefotetan Injection  

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... lungs, skin, bones, joints, stomach area, blood, female reproductive organs, and urinary tract. Cefotetan injection is also used before surgery to prevent infections. Cefotetan injection is in a class of medications ...

267

Mipomersen Injection  

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Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in ... procedure that removes LDL from the blood), but mipomersen injection should not be used along with this ...

268

Tositumomab Injection  

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Tositumomab injection is used to treat non-Hodgkin's lymphoma (cancer that begins in the cells of the ... after treatment with other medications, but later returned. Tositumomab injection is in a class of medications called ...

269

Tacrolimus Injection  

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Tacrolimus injection is used along with other medications to prevent rejection (attack of the transplanted organ by ... who have received kidney, liver, or heart transplants. Tacrolimus injection should only be used by people who ...

270

Differential effects of single versus multiple administrations of haloperidol and risperidone on functional outcome after experimental brain trauma  

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Objectives Antipsychotics are routinely administered to traumatic brain injured (TBI) patients even though the benefits vs. risks of this approach on behavioral recovery are unclear. To clarify the issue, the present study evaluated the effect of single and multiple administrations of haloperidol and risperidone on functional outcome after TBI. Design Prospective and randomized study in rodents. Setting Experimental research laboratory at the University of Pittsburgh. Subjects Sixty adult male Sprague-Dawley rats weighing 300–325 g. Interventions Anesthetized rats received either a cortical impact or sham injury and then were randomly assigned to five TBI groups (risperidone 0.045 mg/kg, 0.45 mg/kg, 4.5 mg/kg, haloperidol 0.5 mg/kg, or vehicle 1 mL/kg) or three sham groups (risperidone 4.5 mg/kg, haloperidol 0.5 mg/kg, or vehicle 1 mL/kg). The experiment consisted of three phases. In the first phase, a single treatment was provided (i.p.) 24 hr after surgery and motor and cognitive function was assessed on post-operative days 1–5 and 14–18, respectively. During the second phase, after completion of the initial behavioral tasks, the same rats were treated once daily for 5 days and behavior was reevaluated. During the third phase, treatments were discontinued and 3 days later the rats were assessed one final time. Measurements and Main Results Time (sec) to maintain beam balance, traverse an elevated beam, and to locate a submerged platform in a Morris water maze. Neither motor nor cognitive performance was affected after a single treatment, regardless of group assignment (p > 0.05). In contrast, both behavioral deficits reoccurred after daily treatments of risperidone (4.5 mg/kg) and haloperidol (p < 0.05). The cognitive deficits persisted even after a 3-day washout period during the third phase. Conclusions These data suggest that while single or multiple low doses of risperidone and haloperidol may be innocuous to subsequent recovery after TBI, chronic high-dose treatments are detrimental. PMID:17255872

Kline, Anthony E.; Massucci, Jaime L.; Zafonte, Ross D.; Dixon, C. Edward; DeFeo, Judith R.; Rogers, Emily H.

2011-01-01

271

Antipsychotic monotherapy among outpatients with schizophrenia treated with olanzapine or risperidone in Japan: a health care database analysis  

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Full Text Available Wenyu Ye,1 Haya Ascher-Svanum,2 Yuka Tanji,3 Jennifer A Flynn,3 Michihiro Takahashi,3,4 Robert R Conley21Lilly Suzhou Pharmaceutical Co, Ltd, Shanghai, People’s Republic of China; 2Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Research Laboratories Japan, Eli Lilly Japan KK, Kobe, Japan; 4Terauchi-Takahashi Psychiatric Clinic, Ashiya, JapanPurpose: Antipsychotic monotherapy is often recommended over antipsychotic polypharmacy because of fewer adverse events, reduced treatment complexity, and lower medication cost. This study compared the rate and the duration of antipsychotic monotherapy following initiation of olanzapine or risperidone in the treatment of outpatients with schizophrenia in Japan.Methods: Outpatients diagnosed with schizophrenia in the Japan Medical Data Center database were identified using International Statistical Classification of Diseases and Related Health Problems, 10th Revision, diagnosis codes. Patients were between 20 and 65 years old, initiated on olanzapine or risperidone therapy between August 2003 and July 2008, and continuously enrolled during the 6 months prior to and the 12 months following the initiation date. Antipsychotic polypharmacy was defined as concurrent use of two or more antipsychotics. The probability of monotherapy during the 12-month follow-up period was assessed using a propensity score-adjusted generalized estimating equation model. Duration of monotherapy was contrasted using a propensity score-adjusted bootstrapping model.Results: After applying all inclusion and exclusion criteria, the final analytic sample consisted of 332 olanzapine- and 496 risperidone-treated outpatients. At treatment initiation, 61.5% of the olanzapine-treated patients and 45.6% of the risperidone-treated patients received antipsychotic monotherapy (P < 0.001. After correcting for background differences, monotherapy was more common among olanzapine-treated patients (P = 0.001. In addition, olanzapine was used as monotherapy for a longer duration (P = 0.006.Conclusion: Consistent with prior global research, this retrospective naturalistic study of schizophrenia outpatients in Japan found that olanzapine is more likely to be used as monotherapy and to be used as monotherapy for a longer duration than risperidone.Keywords: epidemiologic studies, polypharmacy, monotherapy duration, outpatient care, Japan

Takahashi M

2012-06-01

272

Assessment of strategies for switching patients from olanzapine to risperidone: A randomized, open-label, rater-blinded study  

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Full Text Available Abstract Background In clinical practice, physicians often need to change the antipsychotic medications they give to patients because of an inadequate response or the presence of unacceptable or unsafe side effects. However, there is a lack of consensus in the field as to the optimal switching strategy for antipsychotics, especially with regards to the speed at which the dose of the previous antipsychotic should be reduced. This paper assesses the short-term results of strategies for the discontinuation of olanzapine when initiating risperidone. Methods In a 6-week, randomized, open-label, rater-blinded study, patients with schizophrenia or schizoaffective disorder, on a stable drug dose for more than 30 days at entry, who were intolerant of or exhibiting a suboptimal symptom response to more than 30 days of olanzapine treatment, were randomly assigned to the following switch strategies (common risperidone initiation scheme; varying olanzapine discontinuation: (i abrupt strategy, where olanzapine was discontinued at risperidone initiation; (ii gradual 1 strategy, where olanzapine was given at 50% entry dose for 1 week after risperidone initiation and then discontinued; or (iii gradual 2 strategy, where olanzapine was given at 100% entry dose for 1 week, then at 50% in the second week, and then discontinued. Results The study enrolled 123 patients on stable doses of olanzapine. Their mean age was 40.3 years and mean (± standard deviation (SD baseline Positive and Negative Syndrome Scale (PANSS total score of 75.6 ± 11.5. All-cause treatment discontinuation was lowest (12% in the group with the slowest olanzapine dose reduction (gradual 2 and occurred at half the discontinuation rate in the other two groups (25% in abrupt and 28% in gradual 1. The relative risk of early discontinuation was 0.77 (confidence interval 0.61–0.99 for the slowest dose reduction compared with the other two strategies. After the medication was changed, improvements at endpoint were seen in PANSS total score (-7.3; p p p = 0.171 and anxiety/depression (-1.4; p = 0.0005 subscale scores. Severity of movement disorders and weight changes were minimal. Conclusion When switching patients from olanzapine to risperidone, a gradual reduction in the dose of olanzapine over 2 weeks was associated with higher rates of retention compared with abrupt or less gradual discontinuation. Switching via any strategy was associated with significant improvements in positive and anxiety symptoms and was generally well tolerated. Trial registration ClinicalTrials.gov NCT00378183

Berry Sally A

2008-06-01

273

Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized double-blind placebo-controlled study.  

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Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [t(38) = 6.046, mean difference (±95% CI) = 3.2(1.8-3.7), P granisetron groups did not differ in their reduction of positive and general psychopathology symptoms scores. HDRS scores and its changes did not differ between the two groups. The ESRS score at week 4 was significantly lower in the granisetron than the placebo group while the two groups showed similar ESRS score at week 8. Frequency of other side effects was similar between the two groups. In summary, granisetron add-on can safely and effectively reduce the primary negative symptoms of patients with schizophrenia. PMID:23375406

Khodaie-Ardakani, Mohammad-Reza; Seddighi, Sahar; Modabbernia, Amirhossein; Rezaei, Farzin; Salehi, Bahman; Ashrafi, Mandana; Shams-Alizadeh, Narges; Mohammad-Karimi, Maryam; Esfandiari, Gholam-Reza; Hajiaghaee, Reza; Akhondzadeh, Shahin

2013-04-01

274

Comparison of plasma levels between oral solution and fine granule dosage forms of risperidone.  

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Objective. In Japan, there are several clinical reports that risperidone (RIS) oral solution (OS) requires shorter time for tranquilization and induces fewer extrapyramidal symptoms (EPS) than other dosage forms; i.e. fine granules (FG). Our aim is to compare plasma levels of RIS, its active metabolite (9-OH-RIS), and their sum (active moiety; AM) between RIS-OS and RIS-FG in a multiple-dose regimen. Method. A 12-week cross-over study was conducted in nine patients with schizophrenia treated with 3 mg of RIS twice daily. The study period was divided into four terms, each term being 3 weeks. RIS-FG and RIS-OS were given in two alternate terms each. Blood samples were collected on the last day of each term just before and at 1 h after RIS treatment to measure plasma levels of RIS, 9-OH-RIS, and prolactin. Result. Plasma levels of RIS, 9-OH-RIS, AM, and prolactin before treatment were significantly lower for RIS-OS than for RIS-FG, while no significant difference was observed between the two forms at 1 h after administration. Conclusion. In a multiple-dose regimen, RIS-OS treatment caused a larger diurnal fluctuation in plasma level of AM than RIS-FG. These variations may explain the differences in severity of EPS between the 2 forms. PMID:24916821

Yoda, Hiroo; Yamashita, Hakuei

2009-01-01

275

Interleukin-6-induced S100B secretion is inhibited by haloperidol and risperidone.  

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Although inflammation may be a physiological defense process, imbalanced neuroinflammation has been associated with the pathophysiology of brain disorders, including major depression and schizophrenia. Activated glia releases a variety of pro-inflammatory cytokines that contribute to neuronal dysfunction. Elevated levels of S100B, a glia derived protein, have been observed in the serum and CSF of schizophrenic patients suggesting a glial role in the disease. We evaluated whether S100B secretion (in C6 glioma cells and hippocampal slices in Wistar rats) could be directly modulated by the main inflammatory cytokines (IL-1?, TNF-?, IL-6 and IL-8) altered in schizophrenia, as well as the possible involvement of mitogen-activated protein kinase (MAPK) pathways in these responses. We also investigated the effects of typical and atypical antipsychotic drugs on glial cytokine-induced S100B release. Our results suggest that S100B secretion is increased by pro-inflammatory cytokines via MAPK and that oxidative stress may be a component of this modulation. These results reinforce the idea that the S100B protein is involved in the inflammatory response observed in many brain diseases, including schizophrenia. Moreover the antipsychotics, haloperidol and risperidone, were able to inhibit the secretion of S100B following IL-6 stimulation in C6 glioma cells. PMID:23246638

de Souza, Daniela Fraga; Wartchow, Krista; Hansen, Fernanda; Lunardi, Paula; Guerra, Maria Cristina; Nardin, Patrícia; Gonçalves, Carlos-Alberto

2013-06-01

276

Excessive weight gain after remission of depression in a schizophrenic patient treated with risperidone: case report  

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Full Text Available Abstract Background The use of atypical antipsychotics in schizophrenic patients has been associated with a risk of weight gain. Similarly, recovery from depression is often followed by improved appetite, greater food intake and potential increase in weight. Case presentation A Caucasian 33-year-old schizophrenic female patient was being treated with 6 mg/day of risperidone and 15 mg/day of clorazepate. She developed depressive symptomatology and 40 mg/day of fluoxetine was gradually added to her treatment regimen for about 9 months. After the remission of depression, and the discontinuation of fluoxetine, she experienced an increase in appetite and subsequently excessive weight gain of 52 kg. Re-administration of fluoxetine did not reverse the situation. The patient developed diabetes mellitus, which was successfully controlled with metformin 1700 mg/day. The addition at first of orlistat 360 mg/day and later of topiramate 200 mg/day has helped her to lose a significant part of the weight gained (30 kg. Conclusion The case suggests a probable association between the remission of depressive symptomatology and weight gain in a schizophrenic patient.

Psarros Constantin

2006-09-01

277

Simple and extraction-free spectrophotometric methods for risperidone in pure form and in dosage forms  

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Full Text Available Two simple, sensitive and extraction-free spectrophotometric methods are described for the estimation of risperidone (RSP in both pure and in pharmaceutical preparations. The proposed methods are based on the formation of ion-pair complex between RSP and the dyes, bromophenol blue (BPB in method A and Phenol red (PR in method B at room temperature to form yellow colored products which show maximum absorbance at 410 and at 400 nm in methods A and B, respectively. Beer's law was obeyed in the concentration range of 0.5-10 and 0.5-25 ?g mL-1 in methods A and B with apparent molar absorptivities of 3.43 × 104 and 0.85 × 104 L moL-1 cm-1, respectively. The limit of detection for method A is found to be 0.0056 and for method B is 0.132 ?g mL-1. The composition of the ion-pairs was established by Job’s method and it was found to be 1:1 for both the methods A and B. The proposed methods have been applied successfully to the determination of RSP in pharmaceutical preparations. The results were statistically compared with those of a reference method by applying the Student’s t-test and F-test. The methods developed were validated for accuracy and precision by performing recovery experiments via standard addition technique.

Deepakumari Hemavathi N.

2013-01-01

278

Dopamine transporter density assessed with [{sup 123}]IPT SPECT before and after risperidone treatment in children with tourette's disorder  

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Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the dopamine transporter (DAT) densities between drug-naive children with TD and normal children, and investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using iodine-123 labelled N-(3-iodopropen-2-yl)-2{beta}-carbomethoxy-3beta-(4-chlorophenyl)tropane ([{sup 123}I]IPT) single photon emission computed tomography (SPECT). [{sup 123I}]IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in nine drug-naive children with TD. Eleven normal children also underwent SPECT imaging 2 hours after an intravenous administration of [{sup 123}I]IPT. Drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with risperidone in children with TD was found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system.

Ryu, Young Hoon; Kim, Tae Hoon; Ryu, Won Gee [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)] [and others

2004-02-01

279

Risperidone and the 5-HT2A Receptor Antagonist M100907 Improve Probabilistic Reversal Learning in BTBR T?+?tf/J Mice.  

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Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impaired social interactions with restricted interests and repetitive behaviors (RRBs). RRBs can severely limit daily living and be particularly stressful to family members. To date, there are limited options for treating this feature in ASD. Risperidone, an atypical antipsychotic, is approved to treat irritability in ASD, but less is known about whether it is effective in treating "higher order" RRBs, for example cognitive inflexibility. Risperidone also has multiple receptor targets in which only a subset may be procognitive and others induce cognitive impairment. 5HT2A receptor blockade represents one promising and more targeted approach, as various preclinical studies have shown that 5HT2A receptor antagonists improve cognition. The present study investigated whether risperidone and/or M100907, a 5HT2A receptor antagonist, improved probabilistic reversal learning performance in the BTBR T?+?tf/J (BTBR) mouse model of autism. The effects of these treatments were also investigated in C57BL/6J (B6) mice as a comparison strain. Using a spatial reversal learning test with 80/20 probabilistic feedback, similar to one in which ASD individuals exhibit impairments, both risperidone (0.125?mg) and M100907 (0.01 and 0.1?mg) improved reversal learning in BTBR mice. Risperidone (0.125?mg) impaired reversal learning in B6 mice. Improvement in probabilistic reversal learning performance resulted from treatments enhancing the maintenance of the newly correct choice pattern. Because risperidone can lead to unwanted side effects, treatment with a specific 5HT2A receptor antagonist may improve cognitive flexibility in individuals with ASD while also minimizing unwanted side effects. Autism Res 2014, 7: 555-567. © 2014 International Society for Autism Research, Wiley Periodicals, Inc. PMID:24894823

Amodeo, Dionisio A; Jones, Joshua H; Sweeney, John A; Ragozzino, Michael E

2014-10-01

280

Sensitive Method for the Quantitative Determination of Risperidone in Tablet Dosage Form by High-Performance Liquid Chromatography Using Chlordiazepoxide as Internal Standard  

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A selective, sensitive and simple reversed-phase HPLC method for the determination of risperidone in bulk powder and pharmaceutical formulations was developed and validated. Risperidone can be separated on a Supelcosil LC8 DB column (250 mm × 4.6 mm i.d., 5 ?m particle size) at 40°C with a mobile phase of methanol and 0.1 M ammonium acetate pH 5.50 (60:40, v/v), pumped at flow rate 1.0 mL min-1 and detected at 274 nm. Chlordiazepoxide hydrochloride was used as internal standard. The retent...

Ashour, Safwan; Kattan, Nuha

2013-01-01

 
 
 
 
281

Ipilimumab Injection  

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Ipilimumab injection is used to treat melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. Ipilimumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow ...

282

Fluorouracil Injection  

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Fluorouracil injection comes as a solution (liquid) to be given intravenously (into a vein) by a doctor or nurse in a medical facility. The ... or temozolomide (Temodar); medications that suppress the immune system such as ... fluorouracil injection.tell your doctor if you have previously received ...

283

Olanzapine Injection  

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... happens, you may experience a serious problem called Post-injection Delirium Sedation Syndrome (PDSS). If you develop PDSS, ... is usually given once every 2 to 4 weeks.Olanzapine extended-release injection may help control your symptoms but will not ...

284

A case of psychosis due to Fahr's syndrome and response to behavioral disturbances with risperidone and oxcarbazepine.  

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Calcification of basal ganglia or Fahr's syndrome is a rare disease characterized by bilateral and symmetrical intracranial deposition of calcium mainly in cerebral basal ganglia. Motor and neuropsychiatric symptoms are prominent features. We report a case presented with a few motor symptoms, features of delirium and prominent psychiatric symptoms (disorganized behavior) predominantly evident after the improvement in delirium. Radiological findings were suggestive of bilateral basal ganglia calcification. Parathyroid hormone levels were low with no significant findings in other investigations and negative family history. Patient showed significant improvement in behavioral disturbances with risperidone, low dose of lorazepam, oxcarbazepine, and memantine. PMID:24891710

Faye, Abhijeet Dhawalram; Gawande, Sushil; Tadke, Rahul; Kirpekar, Vivek C; Bhave, Sudhir H

2014-04-01

285

Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection  

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Full Text Available Sheng-Min Wang,1 Changsu Han,2 Soo-Jung Lee,5 Ashwin A Patkar,3 Prakash S Masand,4 Chi-Un Pae3,5 1International Health Care Center, Seoul St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea; 2Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea; 3Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, 4Global Medical Education, New York, NY, USA; 5Department of Psychiatry, Bucheon St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea Abstract: Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine. In this respect, the emergence of long-acting aripiprazole injection (ALAI, approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10–20 mg/day or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (P<0.0001, log-rank test. An open-label, mirror study demonstrated that total psychiatric hospitalization rates were significantly lower after switching from oral antipsychotics to ALAI. Another randomized controlled trial presented in poster form suggested that ALAI 400 mg was comparable with oral aripiprazole 10–30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk–benefit profile. Keywords: aripiprazole, schizophrenia, depot, long-acting injectable, relapse, treatment

Wang SM

2014-08-01

286

Obinutuzumab Injection  

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... Leukeran) to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Obinutuzumab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.

287

Pertuzumab Injection  

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... Herceptin) and docetaxel (Taxotere) to treat a certain type of breast cancer that has spread to other parts of the body. Pertuzumab injection is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer ...

288

Testosterone Injection  

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Testosterone cypionate (Depo-Testosterone), testosterone enanthate (Delatestryl), testosterone undecanoate (Aveed), and testosterone pellet (Testopel) are forms of testosterone injection used to treat symptoms of low testosterone in men who do not produce ...

289

Naltrexone Injection  

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... have stopped drinking large amounts of alcohol to avoid drinking again. Naltrexone injection is also used along ... stopped abusing opiate medications or street drugs to avoid abusing the medications or street drugs again. Naltrexone ...

290

Leucovorin Injection  

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Before receiving leucovorin injection,tell your doctor and pharmacist if you are allergic to leucovorin, levoleucovorin, folic acid (Folicet, in multi-vitamins), or any other medications.tell your doctor and pharmacist what prescription and nonprescription ...

291

Omalizumab Injection  

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Omalizumab injection is used to decrease the number of asthma attacks (sudden episodes of wheezing, shortness of ... whose symptoms are not controlled with inhaled steroids. Omalizumab is in a class of medications called monoclonal ...

292

Drug induced parkinsonism caused by the concurrent use of donepezil and risperidone in a patient with traumatic brain injuries.  

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A 69-year-old male patient with previous history of traumatic brain injury 5 months ago was admitted to the Department of Neuropsychiatry because of aggressive behavior and delusional features. After starting on 2 mg of risperidone per day, his delusion, anxiety, and aggressive behavior gradually improved. Two weeks later, he was given 10 mg of donepezil per day for his mild cognitive impairment. After 6 weeks of admission in the Department of Neuropsychiatry, he showed parkinsonian features including difficulty in walking, decreased arm swing during walking, narrowed step width, scooped posture, bradykinesia, tremor, and sleep disorder. To rule out the primary Parkinsonism, dopamine transporter imaging technique [18F]fluoropropyl-carbomethoxy-iodopropyl-nor-?-tropane positron emission tomography-computed tomography (18F]FP(IT PET-CT)) was performed, and dopamine transporter activity was not decreased. We considered that his parkinsonian features were associated with the combination of risperidone and donepezil. Both drugs were stopped and symptoms rapidly disappeared in several days. PMID:23526695

Kang, Si Hyun; Kim, Don-Kyu

2013-02-01

293

Platelet cytochrome c-oxidase activity in patients with acute schizophrenia in the course of their treatment with risperidone  

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Full Text Available Objectives: Testing a hypothesis, that platelet cytochrome c-oxidase (COX activities in patients with paranoid schizophrenia, acute episode, may be linked to dynamics of their clinical patterns and quality of cognitive functioning under antipsychotic treatment. Methods: Psychopatho-logical (PANSS, NSA-16 and cognitive assess-ments; platelet COX enzymatic activity determination, post-hoc nonparametric statistical analysis. Results: Psychopathological and cognitive assessments were done and blood was sampled in patients before (at baseline and after treatment with risperidone. Following regu- larities were found after the treatment of patients: Significant elevation of COX, wherein the higher was COX at baseline, the more prominent was decrease in PANSSneg and NSA rates; significant negative correlation between COX and executive time in cognitive tests. When the patient group was divided by median of COX at baseline into two subgroups (greater or equal median, and 20% was assigned to the first subgroup; significantly larger amount of patients with PANSSneg by <20% was assigned to the second group. Conclusions: Therapy with risperidone seems to be more effective for patients with higher COX activity at baseline, but this fact requires further study.

Gulnur Sh. Burbaeva

2011-01-01

294

Long-term risperidone treatment induces visceral adiposity associated with hepatic steatosis in mice: a magnetic resonance approach.  

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Although atypical antipsychotic drugs (APDs) have led to significant advances in the treatment of psychotic disorders, they still induce metabolic disturbances. We aimed at characterizing the metabolic consequences of a risperidone treatment and at establishing a link with noninvasive MR markers, in order to develop a tool for predicting symptoms of the metabolic syndrome. Fat deposition and liver morphometry were assessed by T1-weighted imaging. Fatty acid composition and fat accumulations in tissues were determined using MR spectroscopy with and without water suppression, respectively. Risperidone treatment induced a weight gain accompanied with metabolic disturbances such as hyperglycemic status, an increase in visceral adipose tissue (VAT), and liver fat depositions. Correlations using Methylene-Water Ratio (MWR) and Polyunsaturated Index (PUI) demonstrated a concomitant increase in the weight gain, VAT and liver fat depositions, and a decrease in the quantity of polyunsaturated fatty acids. These results were consistent with a hepatic steatosis state. We evaluated the ability of MR techniques to detect subtle metabolic disorders induced by APDs. Thus, our model and methodology offer the possibility to investigate APDs side effects in order to improve the health conditions of schizophrenic patients. PMID:24876962

Auger, Florent; Duriez, Patrick; Martin-Nizard, Françoise; Durieux, Nicolas; Bordet, Régis; Pétrault, Olivier

2014-01-01

295

Long-Term Risperidone Treatment Induces Visceral Adiposity Associated with Hepatic Steatosis in Mice: A Magnetic Resonance Approach  

Science.gov (United States)

Although atypical antipsychotic drugs (APDs) have led to significant advances in the treatment of psychotic disorders, they still induce metabolic disturbances. We aimed at characterizing the metabolic consequences of a risperidone treatment and at establishing a link with noninvasive MR markers, in order to develop a tool for predicting symptoms of the metabolic syndrome. Fat deposition and liver morphometry were assessed by T1-weighted imaging. Fatty acid composition and fat accumulations in tissues were determined using MR spectroscopy with and without water suppression, respectively. Risperidone treatment induced a weight gain accompanied with metabolic disturbances such as hyperglycemic status, an increase in visceral adipose tissue (VAT), and liver fat depositions. Correlations using Methylene-Water Ratio (MWR) and Polyunsaturated Index (PUI) demonstrated a concomitant increase in the weight gain, VAT and liver fat depositions, and a decrease in the quantity of polyunsaturated fatty acids. These results were consistent with a hepatic steatosis state. We evaluated the ability of MR techniques to detect subtle metabolic disorders induced by APDs. Thus, our model and methodology offer the possibility to investigate APDs side effects in order to improve the health conditions of schizophrenic patients. PMID:24876962

Auger, Florent; Duriez, Patrick; Martin-Nizard, Francoise; Durieux, Nicolas; Bordet, Regis; Petrault, Olivier

2014-01-01

296

Conspicuous by Their Absence: Studies Comparing and Combining Risperidone and Applied Behavior Analysis to Reduce Challenging Behavior in Children with Autism  

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Both risperidone, an atypical antipsychotic drug, and function-based behavior-analytic interventions are popular and empirically validated treatments for reducing challenging behavior in children with autism. The kind of research that supports their effectiveness differs, however, and no published study has directly compared their effects or…

Weeden, Marc; Ehrhardt, Kristal; Poling, Alan

2009-01-01

297

Differential effects of olanzapine and risperidone on plasma adiponectin levels over time: results from a 3-month prospective open-label study.  

Science.gov (United States)

Second-generation antipsychotics (SGA), especially clozapine and olanzapine, are associated with an increased metabolic risk. Recent research showed that plasma adiponectin levels, an adipocyte-derived hormone that increases insulin sensitivity, vary in the same way in schizophrenic patients as in the general population according to gender, adiposity and metabolic syndrome (MetS). The aim of the present study was to investigate whether different SGAs differentially affect plasma adiponectin levels independent of body mass index (BMI) and MetS status. 113 patients with schizophrenia (65.5% males, 32.3years old) who were free of antipsychotic medication were enrolled in this open-label prospective single-center study and received either risperidone (n=54) or olanzapine (n=59). They were followed prospectively for 12weeks. Average daily dose was 4.4mg/day for risperidone and 17.4mg/day for olanzapine. Plasma adiponectin levels as well as fasting metabolic parameters were measured at baseline, 6weeks and 12weeks. The two groups had similar baseline demographic and metabolic characteristics. A significant increase in body weight was observed over time. This increase was significantly larger in the olanzapine group than in the risperidone group (+7.0kg versus +3.1kg, p<0.0002). Changes in fasting glucose and insulin levels and in HOMA-IR, an index of insulin resistance, were not significantly different in both treatment groups. MetS prevalence increased significantly more in the olanzapine group as compared to the risperidone groups where the prevalence did not change over time. We observed a significant (p=0.0015) treatment by time interaction showing an adiponectin increase in the risperidone-treated patients (from 10,154 to 11,124ng/ml) whereas adiponectin levels decreased in olanzapine treated patients (from 11,280 to 8988ng/ml). This effect was independent of BMI and the presence/absence of MetS. The differential effect of antipsychotic treatment (risperidone versus olanzapine) on plasma adiponectin levels over time, independent of changes in waist circumference and antipsychotic dosing, suggests a specific effect on adipose tissues, similar to what has been observed in animal models. The observed olanzapine-associated reduction in plasma adiponectin levels may at least partially contribute to the increased metabolic risk of olanzapine compared to risperidone. PMID:21511441

Wampers, Martien; Hanssens, Linda; van Winkel, Ruud; Heald, Adrian; Collette, Julien; Peuskens, Joseph; Reginster, Jean Yves; Scheen, Andre; De Hert, Marc

2012-01-01

298

Long-acting injectable antipsychotics in the elderly: guidelines for effective use.  

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The elderly are at increased risk for psychosis because of age-related deterioration of cortical areas and neurochemical changes, comorbid physical illnesses, social isolation, sensory deficits and polypharmacy. The prevalence of psychiatric and neuropsychiatric disorders requiring treatment with an antipsychotic agent is expected to increase dramatically among people aged >64 years. Antipsychotic agents are effective in the treatment of schizophrenia, schizoaffective disorder, behavioural symptoms in patients with dementia, and mood disorders with psychosis. However, failure to adhere to a prescribed medication regimen by patients with psychosis is one of the most frustrating problems faced by mental healthcare providers, because of the high risk of relapse associated with partial compliance. For patients with psychosis who will not or cannot take oral medications on a regular daily basis or have other characteristics, such as memory, vision or auditory impairment, which contribute to partial compliance, long-acting injectable antipsychotic medication offers a solution. Older patients are especially at risk of adverse effects associated with traditional antipsychotic agents, such as motor effects, postural hypotension, excessive sedation, and anticholinergic effects because of age-related pharmacokinetic and pharmacodynamic factors, coexisting medical illnesses and concomitant medications. Therefore, drug dosage recommendations in the elderly are much more conservative than in younger patients. The appropriate starting dose of an antipsychotic in older individuals is 25% of the usual adult dose; total daily maintenance doses ranges from 25-50% of the adult dose. There are few studies regarding the use of depot antipsychotics in elderly patients. Studies that are available indicate that traditional antipsychotic agents given as depot injections are associated with positive outcomes in the elderly. Because the risks for extrapyramidal symptoms and tardive dyskinesia are reduced dramatically with atypical antipsychotics compared with traditional agents, the development of long-acting atypical antipsychotic formulations has been pursued. Of the atypical antipsychotics, risperidone is the first agent to be approved in a long-acting injectable formulation. Unpublished clinical data have revealed that patients treated with long-acting injectable risperidone (25mg, 50mg or 75mg) are more likely to show significant clinical improvement than placebo. In addition, hospitalisation rates decreased continuously and significantly during 1 year of treatment for patients who received long-acting injectable risperidone.Long-acting injectable antipsychotic medication should be considered for older patients for whom long-term treatment is indicated. The choice of which drug to use should be based on patients' history of response and personal preference, clinician's previous experience and pharmacokinetic properties. PMID:14651433

Masand, Prakash S; Gupta, Sanjay

2003-01-01

299

Effects of two atypical neuroleptics, olanzapine and risperidone, on the function of the urinary bladder and the external urethral sphincter in anesthetized rats  

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Full Text Available Abstract Background A previous report showed that the atypical neuroleptic clozapine resulted in marked changes in urodynamic parameters and greatly inhibited the activity of the external urethral sphincter in anesthetized rats. Such findings may help explain the high incidence of urinary disturbances reported during clozapine therapy. In an effort to extend our observations to other atypical neuroleptic agents, the present study investigated the effects of two newer atypical antipsychotics, olanzapine and risperidone, on the bladder and external urethral sphincter during cystometry in anesthetized rats. Results At a dose of 0.1 mg/kg (i.v., olanzapine decreased the micturition volume and increased the residual volume. In addition, olanzapine decreased the expulsion time and the amplitude of the high frequency oscillations observed during the expulsion phase. Larger doses (1 mg/kg had a greater effect. Olanzapine also reduced the activity recorded from the external urethral sphincter, and the bursting observed during the expulsion phase was abolished by 1.0 mg/kg. Risperidone had similar effects although the maximal effects were smaller than those observed with olanzapine. The amplitude of bladder contractions elicited by electrical stimulation of the pelvic nerve was reduced by olanzapine but not risperidone suggesting a possible anti-muscarinic peripheral effect of olanzapine. Conclusions Olanzapine and risperidone significantly altered several voiding parameters and decreased the activity of the external urethral sphincter in the anesthetized rat. We propose that these effects are due to the central action of these drugs and not to peripheral effects. These findings may explain some of the clinical reports of urinary incontinence with risperidone and may predict similar occurrences with olanzapine therapy.

Vera Pedro L

2001-08-01

300

The Comparison of the Effectiveness of Thiothixene and Risperidone as a Combination with Lithium for the Treatment of Patients with Bipolar Disorder  

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Full Text Available Background: The effectiveness of various atypical antipsychotics in the treatment of acute mania is reported repeatedly, but those for typical antipsychotics are restricted to haloperidol and chlorpromazine. As there is a comparative importance of side effects for typical and atypical antipsychotics, we decided to compare the therapeutic effect of thiothixene and risperidone as a combination with lithium for the treatment of patients with bipolar disorder. Materials and Methods: In 8 week double-blind clinical trial, 84 patients with a diagnosis of bipolar disorder were randomized for treatment with lithium plus thiothixene (N=42 or lithium plus risperidone (N=42. Manic, positive-negative symptoms, anxiety and depression were measured bi-weekly with Young Mania Rating, positive and negative symptom scale (PANSS and Hamilton rating scale score. Fasting blood sugar, weight, general side effects and extrapyramidal symptoms were also evaluated. The measures analyzed using SPSS-17 software. To compare demographic characteristics t-test, ?2 test and fixed effects method were used. A fixed effects method was applied to omit missing data effects. Results: There was no significant difference between the thiothixene and risperidone groups in Young mania rating scale and other outcome measures during the 8 week trial. There was no significant difference in weight, blood sugar and clinical global impression (CGI between groups. Conclusion: Thiothixene is as effective as risperidone in the improvement of manic and psychotic symptoms. There was no significant difference with risperidone in developing extrapyramidal symptoms, so it can be used as an appropriate combination with lithium for the treatment of bipolar patients in psychotic manic episode.

Nooshin Parvaresh

2014-08-01

 
 
 
 
301

No change of dopamine transporter density in basal ganglia after risperidone treatment in drug-naive children with Tourette's disorder  

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Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the DAT densities between drug-naive children with TD and normal children investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using lodine-123 labelled N-(3-iodopropen-2-yl)-2beta-carbomethoxy-3beta-(4-chlorophenyl) tropane(I-123 IPT) single photon emission computed tomography (SPECT). I-123 IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in eight drug-naive children with TD. Eight normal children also underwent SPECT imaging 2 hours after an intravenous administration of I-123 IPT and carried out both quantitative and qualitative analyses using the obtained SPECT data, which were reconstructed for the assessment of the specific/non-specific DAT binding ratio in the basal ganglia. The drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with riperidone in children with TD was not found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system.

Ryu, W. K.; Ryu, Y. H.; Yoon, M. J.; Chun, K. A.; Lee, J. D. [College of Medicine, Univ. of Yonsei, Seoul (Korea, Republic of); Zee, D. Y. [Univ. of Inhwa, Incheon (Korea, Republic of); Choi, T. H. [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

2003-07-01

302

Gadodiamide injection and gadopentetate dimeglumine  

International Nuclear Information System (INIS)

A double-blind, randomized parallel phase III study in MR imaging of the central nervous system was conducted to compare the safety and diagnostic utility of gadodiamide injection and gadopentetate dimeglumine at a dose of 0.1 mmol/kg by b.w. in 60 adult patients. Seven patients in the gadodiomide injection group experienced 10 adverse events, 5 of the events possibly related to the contrast agent. In the gadopentate dimeglumine group 5 patients reported 3 contrast agent-related adverse events out of 8 events. All events were transient and required no treatment. Seven incidents of patient discomfort, and some minor changes in vital signs and laboratory parameters were of no clinical concern. Contrast enhancement was observed in 60% and 44% of the patients with structural abnormalities in the gadodiamide injection group and gadopentetate dimeglumine group, respectively. No difference in overall efficacy was observed. Gadodiamide injection was found to be a safe and effective contrast agent. (orig.)

303

Ibritumomab Injection  

Science.gov (United States)

... up to a week after you receive the dose. To prevent the radioactivity from spreading to people who are in close contact with you, you should be sure to wash your hands throughly ... second dose of ibritumomab injection.you should know that ibritumomab ...

304

Adverse effects associated with second-generation antipsychotic long-acting injection treatment: a comprehensive systematic review.  

Science.gov (United States)

As second-generation antipsychotic long-acting injections (SGA-LAIs) are rapidly replacing depot first-generation antipsychotics as first-line agents in treating schizophrenia spectrum disorders, a systematic assessment of their adverse effects is timely. English-language, peer-reviewed articles reporting original data on the safety and tolerability of SGA-LAIs were identified electronically by searching the MEDLINE, EMBASE, PsycINFO, and DARE databases and the Cochrane Library (January 2001-April 2013). In addition to second-generation (atypical) antipsychotics and long-acting injection (depot) antipsychotics, a separate search was performed for each available drug: aripiprazole LAI, olanzapine pamoate, paliperidone palmitate, and risperidone LAI. Articles were excluded if they were review articles, post hoc analyses, analyses of subsets of patients enrolled in previous trials, single case reports, case series studies, small naturalistic studies (involving less than 50 patients), studies providing no safety data, and studies lasting less than 8 weeks. Of 181 articles identified from the search, 140 were excluded; thus, 41 articles met the inclusion criteria. Predictably, the reviewed information revealed that SGA-LAIs have safety profiles consistent with their oral parent formulations. However, they seem to also show unforeseen and worrisome safety signals. Indeed, the routine use of olanzapine-LAI in clinical practice could be limited not only by the well-known risk of postinjection syndrome, whose clinical management remains a matter of concern, but also by the risk of worsening of psychosis. The reviewed information seems to suggest that worsening of psychotic symptoms and depression could also be associated with both risperidone-LAI and paliperidone palmitate. The leading cause of death among patients enrolled in risperidone-LAI studies was suicide. Given the exponential growth in the clinical use of SGA-LAIs, further studies must be urgently performed in order to confirm or exclude the potential safety signals associated with such drugs. PMID:23776129

Gentile, Salvatore

2013-10-01

305

Effects of typical (haloperidol) and atypical (risperidone) antipsychotic agents on protein expression in rat neural stem cells.  

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Neural stem cells (NSCs) play a crucial role in the development and maturation of the central nervous system. Recently studies suggest that antipsychotic drugs regulate the activities of NSCs. However, the molecular mechanisms underlying antipsychotic-induced changes of the activity of NSCs, particularly protein expression, are still unknown. We studied the growth and protein expression in haloperidol (HD) and risperidone (RS) treated rat NSCs. The treatment with RS (3microM) or HD (3microM) had no effect on morphology of NSCs after 24h, but significantly promotes or inhibits the differentiation of NSCs after a 96h of treatment. 2-DE based proteomics was performed at 24h, a stage before phenotypic expression of NSCs. Gel image analysis revealed that 30 protein spots in HD- and 60 spots in RS-treated groups were differentially regulated in their expression compared to control group (pschizophenia. PMID:19463880

Kashem, Mohammed A; Ummehany, Rahnuma; Ukai, Wataru; Hashimoto, Eri; Saito, Toshikazu; Mcgregor, Iain S; Matsumoto, Izuru

2009-12-01

306

Relapse in patients with schizophrenia: a comparison between risperidone and haloperidol Recaída em pacientes com esquizofrenia: uma comparação entre risperidona e haloperidol  

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Full Text Available OBJECTIVES: To compare rates of rehospitalization and time to relapse in risperidone vs. haloperidol-treated schizophrenic patients discharged from the hospital. METHODS: Randomized controlled trial comparing risperidone and haloperidol regarding relapse in patients with schizophrenia treated with flexible doses during one year. RESULTS: Twenty patients were assigned to risperidone and 13 to haloperidol. One patient from each group withdrew consent and one patient in the risperidone group was lost for follow-up. Six (30.0% patients in the risperidone group and 3 (23.1% in the haloperidol group relapsed (p=1.00. However, time to relapse was shorter in the later (logrank =4.2; p=.04. When rehospitalized, patients in the risperidone group stayed 34.5 days (median at hospital as compared to the haloperidol group (median of 61 days (p=.61. CONCLUSION: The proportion of schizophrenic patients who relapsed was similar in both groups; However, time to relapse was shorter in the haloperidol-treated patients.OBJETIVOS: Comparar taxas de re-hospitalização e o tempo para a recaída entre pacientes esquizofrênicos tratados com risperidona ou haloperidol após alta hospitalar. MÉTODOS: Ensaio controlado, randomizado, comparando risperidona e haloperidol em relação à recaída em pacientes com esquizofrenia tratados com doses flexíveis, com duração de um ano. RESULTADOS: Vinte pacientes foram alocados para a risperidona e 13 para o haloperidol. Um paciente em cada grupo retirou o consentimento e um tomando risperidona foi perdido para o seguimento. Seis (30,0% do grupo da risperidona e três (23,1% do grupo do haloperidol recaíram (p=1.00. Contudo, o tempo até a re-hospitalização foi mais curto com o haloperidol (logrank =4,2; p=0,04. Quando re-hospitalizados, os pacientes no grupo da risperidona permaneceram 34,5 dias no hospital (mediana quando comparados com o grupo do haloperidol (mediana =61 dias (p=0,61. CONCLUSÃO: A proporção de pacientes esquizofrênicos que recaíram foi similar em ambos os grupos. Contudo, o tempo para a recaída foi mais curto nos pacientes tratados com haloperidol.

Eduardo Pondé de Sena

2003-10-01

307

Relapse in patients with schizophrenia: a comparison between risperidone and haloperidol / Recaída em pacientes com esquizofrenia: uma comparação entre risperidona e haloperidol  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: English Abstract in portuguese OBJETIVOS: Comparar taxas de re-hospitalização e o tempo para a recaída entre pacientes esquizofrênicos tratados com risperidona ou haloperidol após alta hospitalar. MÉTODOS: Ensaio controlado, randomizado, comparando risperidona e haloperidol em relação à recaída em pacientes com esquizofrenia trat [...] ados com doses flexíveis, com duração de um ano. RESULTADOS: Vinte pacientes foram alocados para a risperidona e 13 para o haloperidol. Um paciente em cada grupo retirou o consentimento e um tomando risperidona foi perdido para o seguimento. Seis (30,0%) do grupo da risperidona e três (23,1%) do grupo do haloperidol recaíram (p=1.00). Contudo, o tempo até a re-hospitalização foi mais curto com o haloperidol (logrank =4,2; p=0,04). Quando re-hospitalizados, os pacientes no grupo da risperidona permaneceram 34,5 dias no hospital (mediana) quando comparados com o grupo do haloperidol (mediana =61 dias) (p=0,61). CONCLUSÃO: A proporção de pacientes esquizofrênicos que recaíram foi similar em ambos os grupos. Contudo, o tempo para a recaída foi mais curto nos pacientes tratados com haloperidol. Abstract in english OBJECTIVES: To compare rates of rehospitalization and time to relapse in risperidone vs. haloperidol-treated schizophrenic patients discharged from the hospital. METHODS: Randomized controlled trial comparing risperidone and haloperidol regarding relapse in patients with schizophrenia treated with f [...] lexible doses during one year. RESULTS: Twenty patients were assigned to risperidone and 13 to haloperidol. One patient from each group withdrew consent and one patient in the risperidone group was lost for follow-up. Six (30.0%) patients in the risperidone group and 3 (23.1%) in the haloperidol group relapsed (p=1.00). However, time to relapse was shorter in the later (logrank =4.2; p=.04). When rehospitalized, patients in the risperidone group stayed 34.5 days (median) at hospital as compared to the haloperidol group (median of 61 days) (p=.61). CONCLUSION: The proportion of schizophrenic patients who relapsed was similar in both groups; However, time to relapse was shorter in the haloperidol-treated patients.

Eduardo Pondé de, Sena; Rogério, Santos-Jesus; Ângela, Miranda-Scippa; Lucas de Castro, Quarantini; Irismar Reis de, Oliveira.

2003-10-01

308

Entropy Injection  

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Testing is the predominant software quality assurance method today, but it has a major flaw --- it cannot reliably catch race conditions, intermittent errors caused by factors that cannot be controlled during testing, such as unpredictable timing behaviour in concurrent software. We present entropy injection, a extension of traditional test methods, which enable developers to create tests for arbitrary types of race conditions in any software application, reusing the applic...

Albertsson, Lars

2007-01-01

309

Estudio de estabilidad de tabletas de risperidona 3 mg Study of stability of Risperidone (3 mg tablets  

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Full Text Available Se desarrolló el estudio de estabilidad de las tabletas de risperidona 3 mg y se determinó su fecha de vencimiento. Este estudio se realizó por los métodos de vida de estante y de estabilidad acelerada mediante cromatografía líquida de alta eficiencia, validados en el Centro de Investigación y Desarrollo de Medicamentos. El estudio de vida de estante se desarrolló por un periodo de 24 meses a temperatura ambiente; mientras que el estudio de estabilidad acelerada se efectuó sometiendo el producto a la influencia de la luz, la humedad y la temperatura; se realizó el análisis durante 3 meses, para los 2 primeros y durante 6 meses para el estudio de la temperatura. La formulación de risperidona tabletas 3 mg cumplió con las especificaciones de calidad descritas en la Farmacopea. Los resultados del estudio de estabilidad por vida de estante después de transcurridos los 24 meses indican que el producto mantiene los parámetros que determinan su calidad durante ese tiempo, y en los estudios acelerados no se observó degradación del producto. Se estableció 2 años como fecha de vencimiento en las condiciones señaladas.Stability study was conducted of 3 mg Risperidone tablets determining its caducity date and using the shelf life methods and of accelerated stability by high-performance liquid chromatography validated in Drug Development and Research Center. The shelf life study was developed during 24 months at room temperature; whereas the accelerated stability study was performed subjecting the product to light, humidity and temperature influence. The 3 mg Risperidone tablets formula fulfilled the quality specifications described in Pharmacopeia. Results from shelf life study after 24 months show that the product maintains the parameters determining its quality during that time and in accelerated studies product degradation was noted. Under conditions signaled 2 years was established as the expiry date.

Caridad Margarita García Peña

2010-06-01

310

Estudio de estabilidad de tabletas de risperidona 3 mg / Study of stability of Risperidone (3 mg) tablets  

Scientific Electronic Library Online (English)

Full Text Available SciELO Cuba | Language: Spanish Abstract in spanish Se desarrolló el estudio de estabilidad de las tabletas de risperidona 3 mg y se determinó su fecha de vencimiento. Este estudio se realizó por los métodos de vida de estante y de estabilidad acelerada mediante cromatografía líquida de alta eficiencia, validados en el Centro de Investigación y Desar [...] rollo de Medicamentos. El estudio de vida de estante se desarrolló por un periodo de 24 meses a temperatura ambiente; mientras que el estudio de estabilidad acelerada se efectuó sometiendo el producto a la influencia de la luz, la humedad y la temperatura; se realizó el análisis durante 3 meses, para los 2 primeros y durante 6 meses para el estudio de la temperatura. La formulación de risperidona tabletas 3 mg cumplió con las especificaciones de calidad descritas en la Farmacopea. Los resultados del estudio de estabilidad por vida de estante después de transcurridos los 24 meses indican que el producto mantiene los parámetros que determinan su calidad durante ese tiempo, y en los estudios acelerados no se observó degradación del producto. Se estableció 2 años como fecha de vencimiento en las condiciones señaladas. Abstract in english Stability study was conducted of 3 mg Risperidone tablets determining its caducity date and using the shelf life methods and of accelerated stability by high-performance liquid chromatography validated in Drug Development and Research Center. The shelf life study was developed during 24 months at ro [...] om temperature; whereas the accelerated stability study was performed subjecting the product to light, humidity and temperature influence. The 3 mg Risperidone tablets formula fulfilled the quality specifications described in Pharmacopeia. Results from shelf life study after 24 months show that the product maintains the parameters determining its quality during that time and in accelerated studies product degradation was noted. Under conditions signaled 2 years was established as the expiry date.

Caridad Margarita, García Peña; Antonio, Iraizoz Barrios; Vivian, Martínez Espinosa.

2010-06-01

311

Avaliação em camundongo da eficácia do antiveneno administrado no local da inoculação intramuscular do veneno de Crotalus durissus terrificus Evaluation in mice, of the antivenom efficacy injected at the same place of the intramuscular inoculation of the Crotalus durissus terrificus venom  

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Full Text Available A eficácia do antiveneno crotálico por via intramuscular (im no local da inoculação, também im, do veneno de Crotalus durissus terrificus foi avaliada em camundongos. Em três experimentos inocularam-se duas DLSO do veneno por via im e administrou-se o antiveneno de três formas: metade da DE50 por via intraperitoneal (ip e metade por via im, no mesmo local, imediatamente após (1º e 30' após (2º a inoculação do veneno; quatro quintos de DE50 por via ip e um quinto por via im, no mesmo local e 30' após a inoculação do veneno (3º. O antiveneno ofereceu, por via ip, maior proteção aos camundongos (menor taxa de óbito em 48 horas do que quando foi administrado, em parte, por via im, no local da inoculação do veneno (pThe efficacy of the Crotalus durissus terrificus antivenom administration by intramuscular (im injection at the same place of the im inoculation, of the C. d. terrificus venom was evaluated in mice. In three experiments two DL50 of the venom were inoculated and the antivenom was administered in three differents ways: half of the ED50 by intraperitoneal (ip administration and half by injection, at the same place, immediatelly after the venom inoculation and thirty minutes after the im venom inoculation; four fifth of ED50 by ip administration and one fifth by injection, at the same place and thirty minutes after the venom inoculation. The antivenom that was administred by intraperitoneal route provided a higher protection to mice (a lower death rate in a 48 hours period than when it was administred in parts, by intramuscular injection, at the same place of the venom inoculation (p<0,05. Therefore, it is concluded that this should not be used in human beings bitten by snakes.

Lindioneza Adriano Ribeiro

1993-02-01

312

Avaliação em camundongo da eficácia do antiveneno administrado no local da inoculação intramuscular do veneno de Crotalus durissus terrificus / Evaluation in mice, of the antivenom efficacy injected at the same place of the intramuscular inoculation of the Crotalus durissus terrificus venom  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese A eficácia do antiveneno crotálico por via intramuscular (im) no local da inoculação, também im, do veneno de Crotalus durissus terrificus foi avaliada em camundongos. Em três experimentos inocularam-se duas DLSO do veneno por via im e administrou-se o antiveneno de três formas: metade da DE50 por v [...] ia intraperitoneal (ip) e metade por via im, no mesmo local, imediatamente após (1º) e 30' após (2º) a inoculação do veneno; quatro quintos de DE50 por via ip e um quinto por via im, no mesmo local e 30' após a inoculação do veneno (3º). O antiveneno ofereceu, por via ip, maior proteção aos camundongos (menor taxa de óbito em 48 horas) do que quando foi administrado, em parte, por via im, no local da inoculação do veneno (p Abstract in english The efficacy of the Crotalus durissus terrificus antivenom administration by intramuscular (im) injection at the same place of the im inoculation, of the C. d. terrificus venom was evaluated in mice. In three experiments two DL50 of the venom were inoculated and the antivenom was administered in thr [...] ee differents ways: half of the ED50 by intraperitoneal (ip) administration and half by injection, at the same place, immediatelly after the venom inoculation and thirty minutes after the im venom inoculation; four fifth of ED50 by ip administration and one fifth by injection, at the same place and thirty minutes after the venom inoculation. The antivenom that was administred by intraperitoneal route provided a higher protection to mice (a lower death rate in a 48 hours period) than when it was administred in parts, by intramuscular injection, at the same place of the venom inoculation (p

Lindioneza Adriano, Ribeiro; Carla Lilian Agostini, Utescher; Silvia Lucia Paro, Vieira; Sara, Fensterseifer; Helena, Mukuno; Miguel Tanús, Jorge.

313

LEP injection  

International Nuclear Information System (INIS)

Studies have commenced of an injector for LEP (Billinge et al, 'Design Concept for a 100 GeV e+e- Storage Ring,' Proceedings of 1977 Particle Accelerator Conference, Chicago), the CERN 100 GeV e+e- storage ring design. The minimum energy for injection is 20 GeV, and a synchrotron injector is chosen in preference to a linac for cost reasons and to obtain faster ring filling. Factors involved in the design of the injector synchrotron are discussed and 2 alternative schemes are outlined for the filling of the 32 e+ and 32 e- LEP bunches. (author)

314

Priapismo secundario a antipsicóticos: a propósito de un caso asociado a risperidona Priapism associated with risperidone use: Report of one case  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Background: The use of drugs with ?-adrenergic antagonistic effect is one of the most prominent etiologies of priapism. We report a 32-year-old schizophrenic male in treatment with risperidone who consulted in the emergency room for a painful priapism. A low flow priapism was diagnosed. Medical treatment was unsuccessful and the patient was subjected to a proximal corporo-spongiosal shunt (Quackels technique), with good results. The patient was discharged in good...

Lizardo Cruzado; Vallejos, Ce?sar E.

2012-01-01

315

Priapismo secundario a antipsicóticos: a propósito de un caso asociado a risperidona Priapism associated with risperidone use: Report of one case  

Directory of Open Access Journals (Sweden)

Full Text Available Background: The use of drugs with ?-adrenergic antagonistic effect is one of the most prominent etiologies of priapism. We report a 32-year-old schizophrenic male in treatment with risperidone who consulted in the emergency room for a painful priapism. A low flow priapism was diagnosed. Medical treatment was unsuccessful and the patient was subjected to a proximal corporo-spongiosal shunt (Quackels technique, with good results. The patient was discharged in good conditions.

Lizardo Cruzado

2012-11-01

316

Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno / A comparative bioavailability study of two formulations of risperidone available in the Chilean market  

Scientific Electronic Library Online (English)

Full Text Available SciELO Chile | Language: Spanish Abstract in spanish [...] Abstract in english Background: Bioavailability of a particular drug can vary according to the formulation used. Therefore, studies of comparative bioavailability of different formulations of a same drug are worthwhile. Aim: To compare the bioavailability of two risperidone formulations available in the Chilean market. [...] Material and methods: The bioavailability of a local risperidone formulation (Spiron®) was compared with the original formulation of the drug (Risperdal®) in 12 healthy volunteers, aged 19±1 years. A single dose of 3 mg was given orally, using a randomized double blind protocol in two periods. Fifteen blood samples were obtained at regular intervals, until 24 h after drug administration. Risperidone plasma levels were measured by high pressure liquid chromatography. Pharmacokinetic parameters were calculated using a computer program that is independent of compartmental analysis. Results: The area under the curve of plasma concentration versus time, from 0 to infinite (ABC0-?) and from 0 to 24 h (ABC0-24), early exposure (ABC from 0 to maximal time) and maximal plasma concentrations were significantly lower for Spiron®. Half life time and time to achieve the maximal concentration were similar for the two formulations. Conclusions: According to bioequivalence tests suggested by the Food and Drug Administration (FDA) of the United States (90% confidence interval for the difference of log transformed mean pharmacokinetic parameters), the formulations Risperdal® and Spiron®, cannot be considered interchangeable (Rev Méd Chile 2003; 131: 527-34).

Leonardo E, Gaete; Jaime, Solís G; Pablo, Venegas F; Mitzy J, Carrillo C; Oscar, Schatloff B; Iván, Saavedra S.

2003-05-01

317

Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno A comparative bioavailability study of two formulations of risperidone available in the Chilean market  

Directory of Open Access Journals (Sweden)

Full Text Available Background: Bioavailability of a particular drug can vary according to the formulation used. Therefore, studies of comparative bioavailability of different formulations of a same drug are worthwhile. Aim: To compare the bioavailability of two risperidone formulations available in the Chilean market. Material and methods: The bioavailability of a local risperidone formulation (Spiron® was compared with the original formulation of the drug (Risperdal® in 12 healthy volunteers, aged 19±1 years. A single dose of 3 mg was given orally, using a randomized double blind protocol in two periods. Fifteen blood samples were obtained at regular intervals, until 24 h after drug administration. Risperidone plasma levels were measured by high pressure liquid chromatography. Pharmacokinetic parameters were calculated using a computer program that is independent of compartmental analysis. Results: The area under the curve of plasma concentration versus time, from 0 to infinite (ABC0-? and from 0 to 24 h (ABC0-24, early exposure (ABC from 0 to maximal time and maximal plasma concentrations were significantly lower for Spiron®. Half life time and time to achieve the maximal concentration were similar for the two formulations. Conclusions: According to bioequivalence tests suggested by the Food and Drug Administration (FDA of the United States (90% confidence interval for the difference of log transformed mean pharmacokinetic parameters, the formulations Risperdal® and Spiron®, cannot be considered interchangeable (Rev Méd Chile 2003; 131: 527-34.

Leonardo E Gaete

2003-05-01

318

Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno / A comparative bioavailability study of two formulations of risperidone available in the Chilean market  

Scientific Electronic Library Online (English)

Full Text Available SciELO Chile | Language: Spanish Abstract in spanish [...] Abstract in english Background: Bioavailability of a particular drug can vary according to the formulation used. Therefore, studies of comparative bioavailability of different formulations of a same drug are worthwhile. Aim: To compare the bioavailability of two risperidone formulations available in the Chilean market. [...] Material and methods: The bioavailability of a local risperidone formulation (Spiron®) was compared with the original formulation of the drug (Risperdal®) in 12 healthy volunteers, aged 19±1 years. A single dose of 3 mg was given orally, using a randomized double blind protocol in two periods. Fifteen blood samples were obtained at regular intervals, until 24 h after drug administration. Risperidone plasma levels were measured by high pressure liquid chromatography. Pharmacokinetic parameters were calculated using a computer program that is independent of compartmental analysis. Results: The area under the curve of plasma concentration versus time, from 0 to infinite (ABC0-?) and from 0 to 24 h (ABC0-24), early exposure (ABC from 0 to maximal time) and maximal plasma concentrations were significantly lower for Spiron®. Half life time and time to achieve the maximal concentration were similar for the two formulations. Conclusions: According to bioequivalence tests suggested by the Food and Drug Administration (FDA) of the United States (90% confidence interval for the difference of log transformed mean pharmacokinetic parameters), the formulations Risperdal® and Spiron®, cannot be considered interchangeable (Rev Méd Chile 2003; 131: 527-34).

Leonardo E, Gaete; Jaime, Solís G; Pablo, Venegas F; Mitzy J, Carrillo C; Oscar, Schatloff B; Iván, Saavedra S.

319

Comparison of somnolence associated with asenapine, olanzapine, risperidone, and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder  

Directory of Open Access Journals (Sweden)

Full Text Available Keming Gao,1 Mary Mackle,2 Pilar Cazorla,2 Jun Zhao,2 Armin Szegedi2 1Department of Psychiatry, Mood and Anxiety Clinic in the Mood Disorders Program, Case Western Reserve University, School of Medicine, Cleveland, OH, USA; 2Merck, Rahway, NJ, USA Background: Patients with schizophrenia or bipolar disorder (BPD may be differentially sensitive to antipsychotics. This study assessed the median time to onset, duration, and rate of somnolence associated with asenapine and other antipsychotics in both indications. Methods: Ten clinical trials (n = 4786 were analyzed as five cohorts pooled according to indication and study design. Results: In the short-term schizophrenia cohort, the incidence of somnolence was 13.1%, 19.1%, 8.5% 5.2%, and 6.9% with asenapine, olanzapine, risperidone, haloperidol, and placebo, respectively. Median time to onset of somnolence was 2 days for asenapine and olanzapine, and 6, 3, and 7 days for risperidone, haloperidol, and placebo, respectively. Median duration was 15 days for asenapine and olanzapine, and 3, 22.5, and 4.5 days for risperidone, haloperidol, and placebo, respectively. In the long-term schizophrenia cohort, the incidence, time to onset, and duration of somnolence with asenapine and olanzapine were 18.4% versus 19.6%, 9.0 days versus 12 days, and 22 days versus 21 days, respectively. In schizophrenia with persistent negative symptoms, the incidence, median time to onset, and duration of somnolence with asenapine and olanzapine were 18.5% versus 21.1%, 9.0 days versus 7.5 days, and 25.0 days versus 41.5 days, respectively. In the monotherapy for BPD cohort, the incidence of somnolence with asenapine, olanzapine, and placebo was 23.8%, 26.4%, and 6.4%, respectively. Median time to onset and duration of somnolence with asenapine, olanzapine, and placebo were 1, 2, and 2 days, respectively, and 7, 8.5, and 5 days. In the adjunctive therapy for BPD cohort, the incidence, median time to onset, and duration of somnolence with asenapine and placebo were 24.0% versus 10.2%, 1.5 days versus 2 days, and 12.5 days versus 7 days, respectively. Conclusion: In the short-term schizophrenia cohort, time to onset and duration of somnolence with asenapine was similar to that with olanzapine and haloperidol. Only asenapine and olanzapine had significantly higher rates of somnolence relative to placebo. The time to onset, duration, and incidence of somnolence with asenapine and olanzapine was similar in patients with long-term schizophrenia and those with BPD. Patients with BPD were more sensitive than those with schizophrenia to asenapine and olanzapine. Keywords: asenapine, somnolence, sedation, schizophrenia, bipolar disorder

Gao K

2013-08-01

320

Efficacy of different Anthelmintic formulations against Helminth Infestation in Sheep  

Directory of Open Access Journals (Sweden)

Full Text Available A study of comparative efficacy of six different commercial anthelmintic formulations against natural helminth infestations in sheep was conducted. Pre and post-treatment EPG (eggs per gram values were recorded and efficacies compared. Results showed that a combination of Ivermectin and Clorsulon in injectable form gave the overall highest curative rate against the parasites studied.

S. Nasreen, M. R. Khan, S. Peerzada and S. A. Andrabia

2008-07-01

 
 
 
 
321

Adolescent Risperidone treatment alters protein expression associated with protein trafficking and cellular metabolism in the adult rat prefrontal cortex.  

Science.gov (United States)

The prefrontal cortex (PFC) is associated with mental health illnesses including schizophrenia, depression, bipolar disorder, and autism spectrum disorders. It richly expresses neuroreceptors which are the target for antipsychotics. However, as the precise mechanism of action of antipsychotic medications is not known, proteomic studies of the effects of antipsychotic drugs on the brain are warranted. In the current study, we aimed to characterize protein expression in the adult rodent PFC (n = 5 per group) following low-dose treatment with Risperidone or saline in adolescence (postnatal days 34-47). The PFC was examined by triplicate 1 h runs of label-free LC-MS/MS. The raw mass spectral data were analyzed with the MaxQuant(TM) software. Statistical analysis was carried out using SAS® Version 9.1. Pathway and functional analysis was performed with IngenuityPathway Analysis and in the Database for Annotation, Visualization and Integrated Discovery (DAVID), respectively, the most implicated pathways were found to be related to mitochondrial function, protein trafficking, and the cytoskeleton. This report adds to the current repertoire of data available concerning the effects of antipsychotic drugs on the brain and sheds light on their biological mechanisms. The MS data have been deposited with the ProteomeXchange Consortium with dataset identifier PXD000480. PMID:24733778

Farrelly, Lorna A; Dicker, Patrick; Wynne, Kieran; English, Jane; Cagney, Gerard; Föcking, Melanie; Cotter, David R

2014-06-01

322

Self-Efficacy  

Science.gov (United States)

This is a comprehensive summary of the topic written by one of its pioneers. The site provides a definition of self-efficacy, characteristics of efficacious people, and a description of how self-efficacy can be developed or undermined. The author describes self-efficacy in social, family and school settings and in various stages of life. There is also a short bibliography.

Bandura, Albert; University, Stanford

323

Priapismo secundario a antipsicóticos: a propósito de un caso asociado a risperidona / Priapism associated with risperidone use: Report of one case  

Scientific Electronic Library Online (English)

Full Text Available SciELO Chile | Language: Spanish Abstract in spanish [...] Abstract in english Background: The use of drugs with ?-adrenergic antagonistic effect is one of the most prominent etiologies of priapism. We report a 32-year-old schizophrenic male in treatment with risperidone who consulted in the emergency room for a painful priapism. A low flow priapism was diagnosed. Medical trea [...] tment was unsuccessful and the patient was subjected to a proximal corporo-spongiosal shunt (Quackels technique), with good results. The patient was discharged in good conditions.

Lizardo, Cruzado; César E, Vallejos.

1445-14-01

324

Unilateral versus bilateral thyroarytenoid Botulinum toxin injections in adductor spasmodic dysphonia: a prospective study  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Objectives In this preliminary prospective study, we compared unilateral and bilateral thyroarytenoid muscle injections of Botulinum toxin (Dysport) in 31 patients with adductor spasmodic dysphonia, who had undergone more than 5 consecutive Dysport injections (either unilateral or bilateral) and had completed 5 concomitant self-rated efficacy and complication scores questionnaires related to the previous injections. We also developed a Neurophysiological Scoring (NPS...

Abiola Jesuloba; Kafas Panagiotis; Prasad Vyas; Jerjes Waseem; Elmiyeh Behrad; Upile Tahwinder; Youl Bryan; Epstein Ruth; Hopper Colin; Sudhoff Holger; Rubin John

2009-01-01

325

Hiperprolactinemia y disfunción sexual en el primer episodio psicótico tratado con risperidona / Hiperprolactinaemia and sexual disfunction in first psychotic episode treated with risperidone  

Scientific Electronic Library Online (English)

Full Text Available SciELO Chile | Language: Spanish Abstract in spanish La hiperprolactinemia y las disfunciones sexuales son complicaciones frecuentes, pero poco estudiadas del tratamiento con risperidona. Objetivos: Determinar la prevalencia de hiperprolactinemia y disfunciones sexuales en un grupo de personas jóvenes con esquizofrenia, tratadas con risperidona. Métod [...] os: Un total de 40 pacientes (19 mujeres, edad promedio: 27 años) completaron el Cuestionario de Funcionamiento Sexual del Hospital General de Massachussets y el Cuestionario sobre Calidad de Vida: Satisfacción y Placer. Todos los pacientes fueron evaluados con las escalas PANSS y UKU y se determinó su nivel plasmático de prolactina. Resultados: El 90% de los pacientes presenta hiperprolactinemia, con valores significativamente más altos para las mujeres. El 62,5% de los pacientes, informó padecer alguna disfunción sexual, sin diferencias con la contraparte no afectada, en cuanto a género, edad ni tiempo de tratamiento. Aunque no se encontró relación con la prolactinemia, ni con la dosis de risperidona, quienes reportaron alguna disfunción sexual obtuvieron mayores puntajes de efectos adversos psíquicos y neurológicos en la escala UKU. Las disfunciones sexuales se asociaron con los síntomas negativos y generales de la PANSS y con menores puntajes en las subescalas de salud física y ánimo del Cuestionario sobre Calidad de Vida: Satisfacción y Placer. Conclusiones: Los resultados confirman la elevada frecuencia de disfunciones sexuales e hiperprolactinemia en las personas enfermas de esquizofrenia. Nuevos estudios se requieren para clarificar, en la práctica clínica habitual, la asociación entre disfunción sexual y el empleo de la risperidona, y su impacto en la calidad de vida de los pacientes. Abstract in english Hyperprolactinemia and Sexual dysfunction arefrequent, yetseldom studied, complications of the use of risperidone Objectives: To determine the prevalence and clinical correlates of sexual dysfunctions and hyperprolactinemia in a sample of youngpeople with schizophrenia treated with risperidone Metho [...] ds: 40 outpatients (19females; mean age: 27years) with schizophrenia treated with risperidone, participated in the study Sexual dysfunction and quality oflife were assessed with the Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), respectively Allpatients were evaluated with the Positive and Negative Syndrome Scale and the UKU side effect rating scale. Blood samples were analyzed for prolactine. Results: Hyperprolactinemia was found in 90% ofpatients, with levéis significantly higher in women. Sexual dysfunctions occurred in 25 (62.5%) patients. Patients with and without sexual dysfunction, did not significantly differ in gender, age or years of treatment. Although no association was found with prolactinemia or the dose of risperidone, patients with sexual dysfunction reported more psychic and neurologic side effects, and had higher scores in the negative symptoms and general psychopatology subscales ofthe PANSS and lower scores in the physical health and mood items of the Q-LES-Q. Conclusions: Results confirm the high prevalence of hyperprolactinemia and sexual dysfunctions in people with schizophrenia. Further study is warranted in order to clarify the association between sexual dysfunction and risperidone treatment in clinical practice and its impact in the quality oflife ofthe patients.

Alvaro, Cavieres F.

2008-06-01

326

Hiperprolactinemia y disfunción sexual en el primer episodio psicótico tratado con risperidona Hiperprolactinaemia and sexual disfunction in first psychotic episode treated with risperidone  

Directory of Open Access Journals (Sweden)

Full Text Available La hiperprolactinemia y las disfunciones sexuales son complicaciones frecuentes, pero poco estudiadas del tratamiento con risperidona. Objetivos: Determinar la prevalencia de hiperprolactinemia y disfunciones sexuales en un grupo de personas jóvenes con esquizofrenia, tratadas con risperidona. Métodos: Un total de 40 pacientes (19 mujeres, edad promedio: 27 años completaron el Cuestionario de Funcionamiento Sexual del Hospital General de Massachussets y el Cuestionario sobre Calidad de Vida: Satisfacción y Placer. Todos los pacientes fueron evaluados con las escalas PANSS y UKU y se determinó su nivel plasmático de prolactina. Resultados: El 90% de los pacientes presenta hiperprolactinemia, con valores significativamente más altos para las mujeres. El 62,5% de los pacientes, informó padecer alguna disfunción sexual, sin diferencias con la contraparte no afectada, en cuanto a género, edad ni tiempo de tratamiento. Aunque no se encontró relación con la prolactinemia, ni con la dosis de risperidona, quienes reportaron alguna disfunción sexual obtuvieron mayores puntajes de efectos adversos psíquicos y neurológicos en la escala UKU. Las disfunciones sexuales se asociaron con los síntomas negativos y generales de la PANSS y con menores puntajes en las subescalas de salud física y ánimo del Cuestionario sobre Calidad de Vida: Satisfacción y Placer. Conclusiones: Los resultados confirman la elevada frecuencia de disfunciones sexuales e hiperprolactinemia en las personas enfermas de esquizofrenia. Nuevos estudios se requieren para clarificar, en la práctica clínica habitual, la asociación entre disfunción sexual y el empleo de la risperidona, y su impacto en la calidad de vida de los pacientes.Hyperprolactinemia and Sexual dysfunction arefrequent, yetseldom studied, complications of the use of risperidone Objectives: To determine the prevalence and clinical correlates of sexual dysfunctions and hyperprolactinemia in a sample of youngpeople with schizophrenia treated with risperidone Methods: 40 outpatients (19females; mean age: 27years with schizophrenia treated with risperidone, participated in the study Sexual dysfunction and quality oflife were assessed with the Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q, respectively Allpatients were evaluated with the Positive and Negative Syndrome Scale and the UKU side effect rating scale. Blood samples were analyzed for prolactine. Results: Hyperprolactinemia was found in 90% ofpatients, with levéis significantly higher in women. Sexual dysfunctions occurred in 25 (62.5% patients. Patients with and without sexual dysfunction, did not significantly differ in gender, age or years of treatment. Although no association was found with prolactinemia or the dose of risperidone, patients with sexual dysfunction reported more psychic and neurologic side effects, and had higher scores in the negative symptoms and general psychopatology subscales ofthe PANSS and lower scores in the physical health and mood items of the Q-LES-Q. Conclusions: Results confirm the high prevalence of hyperprolactinemia and sexual dysfunctions in people with schizophrenia. Further study is warranted in order to clarify the association between sexual dysfunction and risperidone treatment in clinical practice and its impact in the quality oflife ofthe patients.

Alvaro Cavieres F

2008-06-01

327

Avaliação da eficácia do antiveneno botrópico administrado no local da inoculação intramuscular do veneno de Bothrops jararaca: estudo experimental em camundongos Assessment of the efficacy of antivenom injection at the site of the intramuscular inoculation of Bothrops jararaca venom in mice  

Directory of Open Access Journals (Sweden)

Full Text Available Foi determinada, em camundongos de 18 a 20 g, a dose efetiva 50% do antiveneno botrópico, por via intraperitoneal (ip, imediatamente (DE50 Oh e 30 minutos (DE50 30' após a inoculação de 2 DL50 do veneno de B. jararaca, por via intramuscular (im. A DE50 30' foi três vezes maior do que a DE50 Oh. A eficácia do antiveneno administrado no local da inoculação do veneno foi avaliada inoculando-se duas DL50 do veneno, por via im, e administrando-se a DE50 do antiveneno imediatamente (DE50 Oh e 30 minutos após (DE50 30', de duas formas a saber: totalmente por via ip (1ª e metade por via ip e metade por via im (2ª, no mesmo local da inoculação do veneno. O antiveneno ofereceu, por via ip, maior proteção aos camundongos (menor taxa de óbito em 48 horas do que quando metade do mesmo foi administrado, por via im, no local da inoculação do veneno. Conclui-se que, neste modelo experimental, quando se inicia o tratamento tardiamente há necessidade de maior dose de antiveneno botrópico e que não há benefício em administrá-lo no local da picada.The 50% effective intraperitoneal (ip dose of Bothrops jararaca antivenom (ED50 was assessed in mice immediately (ED50 Oh and thirty minutes (ED50 30' after the intramuscular (im injection of two 50% lethal dose (LD50 of Bothrops jararaca venom. The efficacy of the antivenom injected at the venom inoculation site was assessed by the inoculation of two LD50 of the venom by im route, followed immediately (ED50 Oh and 30 minutes later (ED50 30' by administration of the ED50 of the antivenom either entirely by the ip route or 50 percent ip plus 50 percent im, at the same inoculation site. It was shown that the ED50 30' was 3 times greater, than the ED50 Oh and that the antivenom was more protective to mice (lower death rate in 48 hours when given entirely ip. It was concluded that, in this experimental model, a higher dose of bothropic antivenom is needed when the treatment is started lately, and that there is no benefit in its administration at the venom inoculation site.

Carla Lilian Agostini Utescher

1994-06-01

328

UNDERGROUND INJECTION CONTROL (UIC) SHALLOW INJECTION WELLS  

Science.gov (United States)

This point coverage represents shallow Underground Injection Control (UIC) wells located in California. A shallow injection well is any subsurface disposal system such as a septic system, drywell, or seepage pit which conveys liquid waste from the surface of the ground to soil. ...

329

Eficácia e segurança dos antipsicóticos atípicos nas demências: uma revisão sistemática / Efficacy and safety of atypical antipsychotics in dementia: a sistematic review  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese OBJETIVO: O emprego de antipsicóticos atípicos (AA) no tratamento de sintomas psicológicos e comportamentais das demências (SPCD) tem sido alvo de discussão em relação à eficácia e à segurança. O objetivo deste artigo é propiciar atualização sobre o tema. MÉTODOS: Revisão da literatura publicada nos [...] últimos dez anos com ênfase em metanálises e ensaios clínicos randomizados (ECR) controlados com placebo. RESULTADOS: Três metanálises e nove ensaios clínicos foram analisados. Há evidências de eficácia clínica para risperidona (1mg/dia), olanzapina (5 a 10mg/dia) e aripiprazol (2 a 15mg/dia) no tratamento de agressividade e/ou SPCD em geral, e para risperidona (1mg/dia) no tratamento de sintomas psicóticos associados à demência. Os eventos adversos comuns com o uso de AA foram sonolência, sintomas extrapiramidais (SEP), incontinência ou infecção do trato urinário e alterações de marcha. O tratamento com AA associou-se a maior risco de eventos cerebrovasculares e de mortalidade em idosos com demência. CONCLUSÃO: Baixas dosagens de risperidona, olanzapina e aripiprazol são eficazes na redução de agressividade e/ou SPCD globais; risperidona é eficaz na redução de sintomas psicóticos associados à demência. Em virtude de esses tratamentos associarem-se a pequeno aumento no risco de eventos cerebrovasculares e mortalidade, seu uso deve ser reservado para sintomatologia moderada/grave. Abstract in english OBJECTIVE: Concerns have been raised about efficacy and adverse events of atypical antipsychotics in the treatment of behavioural and psychological symptoms of dementia (BPSD). This paper is an update on current evidence of this theme. METHODS: Review of published meta-analysis and randomized placeb [...] o-controlled trials (RCTs) in the last ten years. RESULTS: Three meta-analysis and nine RCTs were evaluated. Evidence suggests that risperidone (1mg/day), olanzapine (5 to 10mg/day), and aripiprazole (2 to 15mg/day) are effective in treating aggression and/or BPSD overall; risperidone (1mg/day) reduces psychosis. Adverse events were mainly somnolence, extrapyramidal symptoms, urinary tract infection or incontinence, and abnormal gait with drug treatment. Atypical antipsychotics were associated with increased risk for cerebrovascular adverse events and mortality in elderly patients with dementia. CONCLUSION: Low doses of risperidone, olanzapine, and aripiprazole are effective in treating aggression and/or BPSD overall, and risperidone reduces psychosis associated with dementia. In view of the increased risk of cerebrovascular adverse events and mortality, the use of atypical antipsychotics in individuals with dementia should be reserved for patients with moderate/severe behavioural symptoms.

Melissa Guarieiro, Ramos; Fábio Lopes, Rocha.

330

Eficácia e segurança dos antipsicóticos atípicos nas demências: uma revisão sistemática Efficacy and safety of atypical antipsychotics in dementia: a sistematic review  

Directory of Open Access Journals (Sweden)

Full Text Available OBJETIVO: O emprego de antipsicóticos atípicos (AA no tratamento de sintomas psicológicos e comportamentais das demências (SPCD tem sido alvo de discussão em relação à eficácia e à segurança. O objetivo deste artigo é propiciar atualização sobre o tema. MÉTODOS: Revisão da literatura publicada nos últimos dez anos com ênfase em metanálises e ensaios clínicos randomizados (ECR controlados com placebo. RESULTADOS: Três metanálises e nove ensaios clínicos foram analisados. Há evidências de eficácia clínica para risperidona (1mg/dia, olanzapina (5 a 10mg/dia e aripiprazol (2 a 15mg/dia no tratamento de agressividade e/ou SPCD em geral, e para risperidona (1mg/dia no tratamento de sintomas psicóticos associados à demência. Os eventos adversos comuns com o uso de AA foram sonolência, sintomas extrapiramidais (SEP, incontinência ou infecção do trato urinário e alterações de marcha. O tratamento com AA associou-se a maior risco de eventos cerebrovasculares e de mortalidade em idosos com demência. CONCLUSÃO: Baixas dosagens de risperidona, olanzapina e aripiprazol são eficazes na redução de agressividade e/ou SPCD globais; risperidona é eficaz na redução de sintomas psicóticos associados à demência. Em virtude de esses tratamentos associarem-se a pequeno aumento no risco de eventos cerebrovasculares e mortalidade, seu uso deve ser reservado para sintomatologia moderada/grave.OBJECTIVE: Concerns have been raised about efficacy and adverse events of atypical antipsychotics in the treatment of behavioural and psychological symptoms of dementia (BPSD. This paper is an update on current evidence of this theme. METHODS: Review of published meta-analysis and randomized placebo-controlled trials (RCTs in the last ten years. RESULTS: Three meta-analysis and nine RCTs were evaluated. Evidence suggests that risperidone (1mg/day, olanzapine (5 to 10mg/day, and aripiprazole (2 to 15mg/day are effective in treating aggression and/or BPSD overall; risperidone (1mg/day reduces psychosis. Adverse events were mainly somnolence, extrapyramidal symptoms, urinary tract infection or incontinence, and abnormal gait with drug treatment. Atypical antipsychotics were associated with increased risk for cerebrovascular adverse events and mortality in elderly patients with dementia. CONCLUSION: Low doses of risperidone, olanzapine, and aripiprazole are effective in treating aggression and/or BPSD overall, and risperidone reduces psychosis associated with dementia. In view of the increased risk of cerebrovascular adverse events and mortality, the use of atypical antipsychotics in individuals with dementia should be reserved for patients with moderate/severe behavioural symptoms.

Melissa Guarieiro Ramos

2006-01-01

331

The staying safe intervention: training people who inject drugs in strategies to avoid injection-related HCV and HIV infection.  

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This pilot study explores the feasibility and preliminary efficacy of the Staying Safe Intervention, an innovative, strengths-based program to facilitate prevention of infection with the human immunodeficiency virus and with the hepatitis C virus among people who inject drugs (PWID). The authors explored changes in the intervention's two primary endpoints: (a) frequency and amount of drug intake, and (b) frequency of risky injection practices. We also explored changes in hypothesized mediators of intervention efficacy: planning skills, motivation/self-efficacy to inject safely, skills to avoid PWID-associated stigma, social support, drug-related withdrawal symptoms, and injection network size and risk norms. A 1-week, five-session intervention (10 hours total) was evaluated using a pre- versus 3-month posttest design. Fifty-one participants completed pre- and posttest assessments. Participants reported significant reductions in drug intake and injection-related risk behavior. Participants also reported significant increases in planning skills, motivation/self-efficacy, and stigma management strategies, while reducing their exposure to drug withdrawal episodes and risky injection networks. PMID:24694328

Mateu-Gelabert, Pedro; Gwadz, Marya Viorst; Guarino, Honoria; Sandoval, Milagros; Cleland, Charles M; Jordan, Ashly; Hagan, Holly; Lune, Howard; Friedman, Samuel R

2014-04-01

332

Comparative cardiovascular safety of risperidone and olanzapine, based on electrocardiographic parameters and blood pressure: A prospective open label observational study  

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Objective: To assess the cardiovascular safety of two commonly prescribed atypical antipsychotics risperidone (RSP) and olanzapine (OZP) in schizophrenic patients, using electrocardiography (ECG) and Blood Pressure (BP). Materials and Methods: This was a 10-week prospective open label, observational study, carried out in a newly diagnosed 64 schizophrenic patients receiving either RSP or OZP. RSP (n = 32) was started with dose of 2 mg/day and increased to 4 mg/day after 2 weeks, whereas OZP (n = 32) was started at a dose of 5 mg/day and was increased to 10 mg/day after 2 weeks. Heart rate (HR), ECG parameters (PR, RR, QRS, QT intervals and QTc and QTd) and BP (systolic and diastolic in supine and standing position) were recorded at baseline (before drug therapy)) and during follow-up visits at 2(I), 6(II) and 10(III) weeks. Results: In the RSP group, at II and III follow-ups, a significant increase in the HR (P = 0.018, P = 0.011 respectively) as well as in QTc (P = 0.025, P = 0.015, respectively) was observed when compared to the basal values. In the OZP group, diastolic BP was significantly decreased in standing position at II and III follow-ups (P = 0.045 and P = 0.024, respectively) compared to the basal values. When the two groups were compared with each other, no significant differences were observed in the changes of HR, PR, QRS, QT, RR, QT, QTd and SBP (supine and standing position); and DBP (supine position). However, DBP in standing position showed a significant decrease in the OZP group at II and III follow-up (P = 0.036 and P = 0.016, respectively) compared to the RSP group. Conclusions: Patients treated with OZP are at higher risk to develop postural hypotension as compared with RSP; hence RSP could be better tolerated by patients taking antihypertensive drugs as compared with OZP whereas OZP would have a safer cardiac profile.

Choure, Balwant Kisanrao; Gosavi, Devesh; Nanotkar, Sanjay

2014-01-01

333

Long-acting injectable formulations of new-generation antipsychotics: a review from a clinical perspective.  

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Antipsychotics are the mainstay of the long-term treatment of patients with schizophrenia. In this context, the evidence also supports the effectiveness of long-acting injections (LAIs) or depots of antipsychotics regarding their relapse-preventing properties. When a LAI formulation of risperidone was launched as the first second-generation depot, there was a renaissance of interest in these formulations. In the meantime, olanzapine, paliperidone, and aripiprazole have been approved by regulatory authorities as LAIs in various countries. All studies using the new-generation depots have shown a clear advantage over placebo regarding relapse prevention and symptom reduction. Safety profiles of the long-acting compounds are comparable to their oral formulations with the exception of olanzapine pamoate injections, which can sometimes lead to a post-injection delirium. Despite the fact that many treatment guidelines recommend LAI antipsychotics as an important treatment option for the long-term management of schizophrenia, they are still most frequently used in chronically ill patients with considerable compliance problems. It is imperative to overcome this indication bias in order to be able to utilize all available treatment options in the long-term management of schizophrenia. There is little evidence on comparisons between LAIs and their oral mother compounds, and even less concerning effectiveness comparisons between different depots. The purpose of this manuscript is to review the recent clinical evidence on new-generation depot antipsychotics. PMID:23780619

Rauch, Anna-Sophia; Fleischhacker, W Wolfgang

2013-08-01

334

Ferric Carboxymaltose Injection  

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Ferric carboxymaltose injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells ... stop working) who are not on dialysis. Ferric carboxymaltose injection is in a class of medications called ...

335

Iron Dextran Injection  

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Iron dextran injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells ... treated with iron supplements taken by mouth. Iron dextran injection is in a class of medications called ...

336

Iron Sucrose Injection  

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Iron sucrose injection is used treat iron-deficiency anemia (a lower than normal number of red blood cells due ... may cause the kidneys to stop working). Iron sucrose injection is in a class of medications called ...

337

Intramuscular injection angle: evidence for practice?  

Science.gov (United States)

This article presents the findings of a search for evidence to support the 45-60 degree angle of insertion for intramuscular injection of vaccine which is recommended in New Zealand. With the objective of discovering the evidence base for an intramuscular injection angle which differs from that recommended by the World Health Organisation and the accepted practice experienced by the author in the UK, Canada, Malawi and the USA, a comprehensive library and internet literature search was undertaken. As well, information was sought by personal correspondence and contact with a range of immunisation specialists. Both the literature specifically on needle angle and that which includes needle angle within a wider investigation of technique is included. Overwhelmingly the evidence supports a 90 degree angle of needle insertion for intramuscular injection as being that most effective in terms of patient comfort, safety and efficacy of vaccine. PMID:12238797

Warren, Barbara L

2002-07-01

338

Treatment of posttraumatic stress disorder - related nightmares and other sleep disturbances with risperidone in combat veterans and victims of domestic and childhood abuse  

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Full Text Available Sleep disturbances including nightmares are often reported as hallmark of posttraumatic stress disorder (PTSD. The literature related to the pharmacological treatment of PTSD-related nightmares is sparse and inconclusive. After reviewing the literature it was obvious that currently a limited data on studies supporting the use of antipsychotic medications for the treatment of PTSD are published. Moreover, even more limited scientific evidence is now available to formulate evidence-based guidelines for the treatment of PTSD-related nightmares which are often reported as the most intrusive and disruptive symptom. Objective for this study is to review comprehensively the current research literature which reflects use of antipsychotic medication risperidone for the treatment of PTSD-related nightmares of different etiology.

Nina Khachiyants

2010-09-01

339

Treatment of posttraumatic stress disorder - related nightmares and other sleep disturbances with risperidone in combat veterans and victims of domestic and childhood abuse  

Directory of Open Access Journals (Sweden)

Full Text Available Sleep disturbances including nightmares are often reported as hallmark of posttraumatic stress disorder (PTSD. The literature related to the pharmacological treatment of PTSD-related nightmares is sparse and inconclusive. After reviewing the literature it was obvious that currently a limited data on studies supporting the use of antipsychotic medications for the treatment of PTSD are published. Moreover, even more limited scientific evidence is now available to formulate evidence-based guidelines for the treatment of PTSD-related nightmares which are often reported as the most intrusive and disruptive symptom. Objective for this study is to review comprehensively the current research literature which reflects use of antipsychotic medication risperidone for the treatment of PTSD-related nightmares of different etiology.

Nina Khachiyants

2010-08-01

340

Intravitreal gas injection for the treatment of diabetic macular edema  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Dominic McHugh, Bhaskar Gupta, Manzar Saeed King's College Hospital, Denmark Hill, London, England, UK Purpose: This study investigates the efficacy of an intravitreal gas injection in inducing a posterior vitreous detachment (PVD) in patients with clinically significant diabetic macular edema refractory to laser therapy. Methods: A local ethics committee-approved technique of an intravitreal injection of pure perfluoropropane gas (C3F8) was performed for all participants. After a per...

McHugh D; Gupta B; Saeed M

2011-01-01

 
 
 
 
341

Effects of risperidone and olanzapine dose reduction on cognitive function in stable patients with schizophrenia: an open-label, randomized, controlled, pilot study.  

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Impact of dose reduction of atypical antipsychotics on cognitive function has not been investigated in stable patients with schizophrenia. In this open-label, 28-week, randomized controlled trial, stable patients with schizophrenia treated with risperidone or olanzapine were randomly assigned to the reduction group (dose reduced by 50% in 4 weeks and then maintained) or maintenance group (dose kept constant). Assessments at baseline and week 28 included the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Positive and Negative Syndrome Scale (PANSS), and Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). Sixty-one patients were enrolled; 2 of 31 (6.5%) and 5 of 30 (16.7%) patients prematurely withdrew from the study in the reduction and maintenance groups, respectively. While no significant differences in change in the PANSS total score were observed between the 2 groups, the reduction group showed significantly greater improvements in the RBANS and DIEPSS total scores compared with the maintenance group (mean ± SD, +7.0±7.1 vs -0.1±8.0, P < .001; -0.9±1.7 vs +0.1±1.2, P = .010, respectively). This 6-month pilot study suggests that risperidone or olanzapine dose reduction of 50% can improve cognitive function for stable patients with schizophrenia. Due to the open-label design, small sample size, and short study duration, however, there is a need to confirm the finding through double-blind, larger scale trials with longer follow-up periods. Moreover, potential risks of relapse following antipsychotic dose reduction should be thoroughly investigated in longer term studies. PMID:23821768

Takeuchi, Hiroyoshi; Suzuki, Takefumi; Remington, Gary; Bies, Robert R; Abe, Takayuki; Graff-Guerrero, Ariel; Watanabe, Koichiro; Mimura, Masaru; Uchida, Hiroyuki

2013-09-01

342

Comparison between intraarticular triamcinolone acetonide and methylprednisolone acetate injections in treatment of frozen shoulder.  

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We conclude that triamcinolone acetonide is a good rescue for painful stiff shoulder particularly for resistant cases as with diabetes mellitus, and with long duration of illness. Also, its efficacy can be observed with less frequent injections.

Riyadh A. Sakeni

2007-05-01

343

Long-acting injectable aripiprazole: how might it fit in our tool box?  

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Schizophrenia is a severe mental illness with a lifetime prevalence of approximately one percent worldwide. Maintenance antipsychotic treatment has been effective in preventing relapses in long-term follow-up studies. Logically it can be proposed that long-acting injectable antipsychotics (LAI) might reduce both unintentional and intentional nonadherence. Long-acting injectable aripiprazole was approved for the treatment of schizophrenia by the U.S. FDA on 28th February 2013 and will be marketed under the name Abilify Maintena. Aripiprazole LAI (ALAI) is a lyophilized powder that needs to be reconstituted with sterile water to form an injectable suspension without affecting the original molecule. The monthly