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Sample records for boehringer ingelheim promeco

  1. Boehringer Ingelheim Promeco contemplates the benefits of cogeneration in its new plant; Boehringer Ingelheim Promeco contempla beneficios de la cogeneracion para su nueva planta

    Energy Technology Data Exchange (ETDEWEB)

    Ruiz Esparza, R. [Instituto de Investigaciones Electricas, Cuernavaca (Mexico); Khouri Solis, A. [Boehringer Ingelheim Promeco, Mexico, D. F. (Mexico)

    1997-12-31

    This paper presents the results of the feasibility study performed in BOEHRINGER INGELHEIM PROMECO to determine the benefits that a cogeneration system could render in satisfying the energy demand of its plant currently being expanded. The results showed that in accordance with the operation mode of the already expanded plant, the highest benefits could be obtained of a cogeneration system with a capacity of 1,600 Kw that would partially satisfy the thermal and electrical demands of BOEHRINGER INGELHEIM PROMECO. [Espanol] El presente articulo presenta los resultados de factibilidad que se realizo en Boehringer Ingelheim Promeco para determinar los beneficios que podria rendir un sistema de cogeneracion al satisfacer las demandas energeticas de su planta actualmente en ampliacion. Los resultados mostraron que de acuerdo al modo de operacion de la planta ya ampliada, los beneficios mas altos se obtendrian de un sistema de cogeneracion con capacidad de 1,600 kW que satisfaria parcialmente las demandas termicas y electricas de Boehringer Ingelheim Promeco.

  2. 78 FR 64018 - Manufacturer of Controlled Substances; Notice of Registration; Boehringer Ingelheim Chemicals, Inc.

    Science.gov (United States)

    2013-10-25

    ...; Notice of Registration; Boehringer Ingelheim Chemicals, Inc. By Notice dated June 18, 2013, and published in the Federal Register on July 1, 2013, 78 FR 39340, Boehringer Ingelheim Chemicals, Inc., 2820 N... 21 U.S.C. 823(a) and determined that the registration of Boehringer Ingelheim Chemicals, Inc., to...

  3. 78 FR 64016 - Importer of Controlled Substances, Notice of Registration, Boehringer Ingelheim Chemicals

    Science.gov (United States)

    2013-10-25

    ... Registration, Boehringer Ingelheim Chemicals By Notice dated June 18, 2013, and published in the Federal Register on July 1, 2013, 78 FR 39337, Boehringer Ingelheim Chemicals, 2820 N. Normandy Drive, Petersburg...) and determined that the registration of Boehringer Ingelheim Chemicals is consistent with the public...

  4. 77 FR 67397 - Importer Of Controlled Substances; Notice of Registration; Boehringer Ingelheim Chemicals, Inc.

    Science.gov (United States)

    2012-11-09

    ... Registration; Boehringer Ingelheim Chemicals, Inc. By Notice dated July 17, 2012, and published in the Federal Register on July 26, 2012, 77 FR 43861, Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive...), and determined that the registration of Boehringer Ingelheim Chemicals, Inc., to import the basic...

  5. 77 FR 70188 - Manufacturer of Controlled Substances; Notice of Registration; Boehringer Ingelheim Chemicals, Inc.

    Science.gov (United States)

    2012-11-23

    ...; Notice of Registration; Boehringer Ingelheim Chemicals, Inc. By Notice dated July 17, 2012, and published in the Federal Register on July 26, 2012, 77 FR 43863, Boehringer Ingelheim Chemicals, Inc., 2820 N... has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Boehringer...

  6. 78 FR 39337 - Importer of Controlled Substances, Notice of Application, Boehringer Ingelheim Chemicals

    Science.gov (United States)

    2013-07-01

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Application, Boehringer Ingelheim Chemicals Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on May 31, 2013, Boehringer Ingelheim Chemicals, 2820 N. Normandy Drive, Petersburg...

  7. 77 FR 43863 - Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals Inc.

    Science.gov (United States)

    2012-07-26

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 8, 2012, Boehringer Ingelheim Chemicals...

  8. 77 FR 43861 - Importer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals

    Science.gov (United States)

    2012-07-26

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on June 8, 2012, Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive...

  9. 78 FR 39340 - Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc.

    Science.gov (United States)

    2013-07-01

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 31, 2013, Boehringer Ingelheim Chemicals...

  10. Computer-aided drug design at Boehringer Ingelheim

    Science.gov (United States)

    Muegge, Ingo; Bergner, Andreas; Kriegl, Jan M.

    2017-03-01

    Computer-Aided Drug Design (CADD) is an integral part of the drug discovery endeavor at Boehringer Ingelheim (BI). CADD contributes to the evaluation of new therapeutic concepts, identifies small molecule starting points for drug discovery, and develops strategies for optimizing hit and lead compounds. The CADD scientists at BI benefit from the global use and development of both software platforms and computational services. A number of computational techniques developed in-house have significantly changed the way early drug discovery is carried out at BI. In particular, virtual screening in vast chemical spaces, which can be accessed by combinatorial chemistry, has added a new option for the identification of hits in many projects. Recently, a new framework has been implemented allowing fast, interactive predictions of relevant on and off target endpoints and other optimization parameters. In addition to the introduction of this new framework at BI, CADD has been focusing on the enablement of medicinal chemists to independently perform an increasing amount of molecular modeling and design work. This is made possible through the deployment of MOE as a global modeling platform, allowing computational and medicinal chemists to freely share ideas and modeling results. Furthermore, a central communication layer called the computational chemistry framework provides broad access to predictive models and other computational services.

  11. The Boehringer Ingelheim employee study (Part 2): 10-year cardiovascular diseases risk estimation.

    Science.gov (United States)

    Kempf, K; Martin, S; Döhring, C; Dugi, K; Haastert, B; Schneider, M

    2016-10-01

    Cardiovascular disease (CVD) may cause an economic burden to companies, but CVD risk estimations specific to working populations are lacking. To estimate the 10-year CVD risk in the Boehringer Ingelheim (BI) employee cohort and analyse the potential effect of hypothetical risk reduction interventions. We estimated CVD risk using the Framingham (FRS), PROCAM (PRS) and Reynolds (RRS) risk scores, using cross-sectional baseline data on BI Pharma employees collected from 2005 to 2011. Results were compared using Fisher's exact and Wilcoxon tests. The predictive ability of the score estimates was assessed using receiver-operating characteristics analyses. Among the 4005 study subjects, we estimated 10-year CVD risks of 35% (FRS), 9% (PRS) and 6% (RRS) for men and 10% (FRS), 4% (PRS) and 1% (RRS) for women. One hundred and thirty-four (6%) men and 111 (6%) women employees had current CVD. The best predictors of prevalent CVD were the FRS and the RRS for men [area-under-the-curve 0.62 (0.57-0.67) for both]. A hypothetical intervention that would improve systolic blood pressure, HbA1c (for diabetes), C-reactive protein, triglycerides and total and high-density lipoprotein cholesterol by 10% each would potentially reduce expected CVD cases by 36-41% in men and 30-45% in women, and if smoking cessation is incorporated, by 39-45% and 30-55%, respectively, depending on the pre-intervention risk score. There was a substantial risk of developing CVD in this working cohort. Occupational health programmes with lifestyle interventions for high-risk individuals may be an effective risk reduction measure. © The Author 2016. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. The Epidemiological Boehringer Ingelheim Employee Study—Part I: Impact of Overweight and Obesity on Cardiometabolic Risk

    Directory of Open Access Journals (Sweden)

    Kerstin Kempf

    2013-01-01

    Full Text Available Objective. Obesity-dependent diseases cause economic burden to companies. Large-scale data for working populations are lacking. Prevalence of overweight and obesity in the Boehringer Ingelheim (BI Employee cohort and the relationship between body mass index (BMI and cardiometabolic risk factors and diseases were estimated. Design and Methods. Employees (≥38 years, employed in Ingelheim ≥2 years; n=3151 of BI Pharma GmbH & Co. KG were invited by the medical corporate department to participate in intensive health checkups. Cross-sectional analysis of baseline data collected through 2006–2011 was performed. Results. 90% of eligible subjects participated (n=2849. Prevalences of overweight and obesity were 40% and 18% and significantly higher in men and participants ≥50 years. Cardiometabolic risk factor levels and prevalences of cardiometabolic diseases significantly increased with BMI and were higher in overweight and obese participants. Cut-points for increased risk estimated from ROC curves were ≈25 kg/m2 for hypertension, hypercholesterolemia, arteriosclerosis, and hypertriglyceridemia and 26.7–28.0 kg/m2 for the metabolic syndrome, insulin resistance, hyperinsulinemia, increased intima media thickness, and type 2 diabetes. Conclusion. This is the first large-scale occupational health care cohort from a single company. Cardiometabolic risk factors and diseases accumulate with increasing BMI. Occupational weight reduction programs seem to be reasonable strategies.

  13. The epidemiological Boehringer Ingelheim Employee study--part I: impact of overweight and obesity on cardiometabolic risk.

    Science.gov (United States)

    Kempf, Kerstin; Martin, Stephan; Döhring, Carmen; Dugi, Klaus; Wolfram von Wolmar, Carolin; Haastert, Burkhard; Schneider, Michael

    2013-01-01

    Obesity-dependent diseases cause economic burden to companies. Large-scale data for working populations are lacking. Prevalence of overweight and obesity in the Boehringer Ingelheim (BI) Employee cohort and the relationship between body mass index (BMI) and cardiometabolic risk factors and diseases were estimated. Employees (≥38 years, employed in Ingelheim ≥2 years; n = 3151) of BI Pharma GmbH & Co. KG were invited by the medical corporate department to participate in intensive health checkups. Cross-sectional analysis of baseline data collected through 2006-2011 was performed. 90% of eligible subjects participated (n = 2849). Prevalences of overweight and obesity were 40% and 18% and significantly higher in men and participants ≥50 years. Cardiometabolic risk factor levels and prevalences of cardiometabolic diseases significantly increased with BMI and were higher in overweight and obese participants. Cut-points for increased risk estimated from ROC curves were ≈ 25 kg/m(2) for hypertension, hypercholesterolemia, arteriosclerosis, and hypertriglyceridemia and 26.7-28.0 kg/m(2) for the metabolic syndrome, insulin resistance, hyperinsulinemia, increased intima media thickness, and type 2 diabetes. This is the first large-scale occupational health care cohort from a single company. Cardiometabolic risk factors and diseases accumulate with increasing BMI. Occupational weight reduction programs seem to be reasonable strategies.

  14. The Epidemiological Boehringer Ingelheim Employee Study—Part I: Impact of Overweight and Obesity on Cardiometabolic Risk

    Science.gov (United States)

    Martin, Stephan; Döhring, Carmen; Dugi, Klaus; Wolfram von Wolmar, Carolin; Haastert, Burkhard; Schneider, Michael

    2013-01-01

    Objective. Obesity-dependent diseases cause economic burden to companies. Large-scale data for working populations are lacking. Prevalence of overweight and obesity in the Boehringer Ingelheim (BI) Employee cohort and the relationship between body mass index (BMI) and cardiometabolic risk factors and diseases were estimated. Design and Methods. Employees (≥38 years, employed in Ingelheim ≥2 years; n = 3151) of BI Pharma GmbH & Co. KG were invited by the medical corporate department to participate in intensive health checkups. Cross-sectional analysis of baseline data collected through 2006–2011 was performed. Results. 90% of eligible subjects participated (n = 2849). Prevalences of overweight and obesity were 40% and 18% and significantly higher in men and participants ≥50 years. Cardiometabolic risk factor levels and prevalences of cardiometabolic diseases significantly increased with BMI and were higher in overweight and obese participants. Cut-points for increased risk estimated from ROC curves were ≈25 kg/m2 for hypertension, hypercholesterolemia, arteriosclerosis, and hypertriglyceridemia and 26.7–28.0 kg/m2 for the metabolic syndrome, insulin resistance, hyperinsulinemia, increased intima media thickness, and type 2 diabetes. Conclusion. This is the first large-scale occupational health care cohort from a single company. Cardiometabolic risk factors and diseases accumulate with increasing BMI. Occupational weight reduction programs seem to be reasonable strategies. PMID:23997947

  15. 2 obras de F. J. Barba Corsini: Edificio de los Laboratorios Boehringer Sohn Ingelheim, S. A. B., en San Juan Despí, Barcelona; Cine Victoria, en Hospitalet de Llobregat

    Directory of Open Access Journals (Sweden)

    Barba Corsini, F. J.

    1967-11-01

    Full Text Available Building for the Boehringer Sohn Ingelheim, S. A. E. Laboratories, at San Juan Despí – Barcelona The semibasement houses the services, including dressing rooms, dining hall, central air conditioning, stores, and other technical services. The ground floor comprises the main entrance hall and also some of the laboratories, whilst the rest of the building is mostly devoted to the functional purpose of the firm, i. e., laboratory work. The manager's office and council chamber are located on the second floor. The external aspect of the building reflects its function and is an outstanding example of impressive simplicity. Victoria Cinema, at Hospitalet de Llobregat – Barcelona The design of the building takes specifically into account the poor features of the site, the greater cost efficiency of reinforced concrete and the saving in construction time associated with metallic construction. Hence a compound design was adopted. All the external walls are built with unfaced brick, and «Durisol» has been adopted for the ceilings. The choice of illumination and colouring give the walls a fine quality, and emphasize their plastic texture. A restful quality and an indication of its commercial purpose are the fundamental features reflected by the external aspect of the building.Edificio de los Laboratorios Boehringer Sohn Ingelheim, S. A. E., en San Juan Despí- Barcelona La planta semisótano del edificio está dedicada a servicios: vestuario, comedor, central de acondicionamiento de aire, almacenes de utillaje, y servicios técnicos en general. En la planta baja se ha dispuesto el vestíbulo principal de acceso; y tanto en el resto de esta planta como en las superiores, se desarrollan todas las funciones de laboratorios. En la planta segunda se han instalado los despachos de Dirección, Sala de Juntas, etc. La expresión arquitectónica exterior del edificio responde a su utilidad y resalta por su elegante sencillez. Cine Victoria, en Hospitalet de

  16. Boehringer Ingleheim's selective glucocorticoid receptor agonist development candidate: evaluation of WO2010141331, WO2010141332 and WO2010141333.

    Science.gov (United States)

    Norman, Peter

    2011-07-01

    Three applications from Boehringer Ingelheim all relate to the preparation of non-steroidal glucocorticoid receptor agonists useful in the treatment of inflammatory respiratory diseases. The first two applications claim chiral processes for the preparation of these compounds or intermediates useful therein. These provide two alternative routes, respectively, using achiral and chiral reagents. The third application relates to the preparation of a crystalline salt of the preferred compound on a multi-kilogram scale in micronised form.

  17. "The molecular basis of aging": the Boehringer Ingelheim Fonds 95th International Titisee Conference.

    Science.gov (United States)

    Garinis, George A; Patil, Christopher K; Schumacher, Björn

    2007-01-01

    Nearly 20 years ago, researchers discovered that lifespan can be extended by single-gene mutations in the nematode worm Caenorhabditis elegans. Further studies revealed that the mechanisms governing aging in the smallest organisms have been evolutionarily conserved and may operate in human beings. Since then, the field of biogerontology has expanded considerably, learning from - and contributing to - such disparate fields as cell signaling, metabolism, endocrinology, and a wide range of human diseases including cancer. To date, newly discovered connections and novel interdisciplinary approaches gradually unify what once seemed unrelated observations between seemingly disparate research areas. While this unification is far from complete, several overlapping themes have clearly emerged. At the 95th International Titisee Conference, devoted to "The Molecular Basis of Aging," 60 of the world's pre-eminent biogerontologists shared their most recent findings in the biology of aging, and discussed interdisciplinary connections between diverse fields.

  18. [Screening for colorectal cancer: a cost benefit analysis on a health prevention programme at the Boehringer Ingelheim Company].

    Science.gov (United States)

    Schneider, M; Häck, H-J

    2011-05-01

    In Germany, approximately 70.000 people are diagnosed with colorectal cancer every year. With early diagnosis the recovery rates are over 90 % and early intervention can significantly reduce the costs of medical treatment as well as the economic losses from worker productivity. We here present the organisational procedure for bowel cancer screening and have weighed the costs against benefits to employees, the company and the healthcare system. The screening costs are compared with economic benefits. The target group for the study consisted of all 11.536 employees at the company's site in Germany. Volunteers were given a standardized questionnaire about the risk factors for colorectal cancers and an immunological fecal occult blood test (IFOBT). If risk factors for development of colorectal cancer were present or if the test result was positive, a colonoscopy was recommended in accordance with DGVS guidelines (German Society of Digestive and Metabolic diseases). A total of 4.287 employees (37.2 %) indicated an interest in undergoing screening; at the end of the period 3.958 complete datasets (2.296 men and 1.662 women, mean age 51.2 years) were available for evaluation. A colonoscopy was performed on 114 persons. Six cases of overt cancer were detected with three in the 36 - 50 age group and three in the 51 - 65 age group. Five of the six cases were stage T1 or T2. Adenomatous polyps were found and removed in 29 persons. The calculated cost benefit ratio was 1:2 for the company and 1:35 for the public health system. Using the example of colorectal screening, this study represents a cost benefit analysis of this preventative health measure in a company environment. The results show that even while taking into account the financial and personal commitment required, the cost benefit ratio is positive both for the company and for the healthcare system. © Georg Thieme Verlag KG Stuttgart · New York.

  19. 76 FR 62448 - Importer of Controlled Substances, Notice of Registration

    Science.gov (United States)

    2011-10-07

    ..., Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805, made application by... Boehringer Ingelheim Chemicals, Inc. to import the basic class of controlled [[Page 62449

  20. 76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

    Science.gov (United States)

    2011-08-09

    ... wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc. DATES: This rule is... dosage form products containing moxidectin to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt...

  1. Heart Failure Society of America

    Science.gov (United States)

    ... 2 Diabetes and Heart Disease in Partnership with Boehringer Ingelheim and Eli Lilly and Company November 16, ... announced a first-of-its-kind partnership with Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)... ...

  2. 76 FR 49649 - Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine

    Science.gov (United States)

    2011-08-11

    ... of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc. DATES: This rule is effective August 11...-018, 055-039, 065-071, and 065-440) to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway...

  3. 75 FR 69462 - Importer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2010-11-12

    ... 36683), Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805, made... registration of Boehringer Ingelheim Chemicals, Inc. to import the basic class of controlled substance is..., conventions, or protocols in effect on [[Page 69463

  4. 75 FR 71016 - Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine

    Science.gov (United States)

    2010-11-22

    ... drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplement provides for minor... INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has...

  5. 76 FR 72976 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2011-11-28

    ..., 2011, 76 FR 36577, Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia... Boehringer Ingelheim Chemicals, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Boehringer Ingelheim Chemicals, Inc...

  6. 75 FR 10165 - New Animal Drugs; Change of Sponsor

    Science.gov (United States)

    2010-03-05

    ... subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc. (Boehringer). In addition, FDA is... Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to Boehringer. DATES... 18 approved NADAs and 1 approved ANADA to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt...

  7. Boehringer immunoinhibition procedure for creatine kinase-MB evaluated and compared with column ion-exchange chromatography

    NARCIS (Netherlands)

    ter Welle, H. F.; Baartscheer, T.; Fiolet, J. W.

    1983-01-01

    In determination of creatine kinase isoenzyme MB (CK-MB), the Boehringer immunoinhibition method gives a high and variable blank activity as compared with column-chromatography. Thus a correction must be applied. Furthermore, a second correction of 1% of total creatine kinase activity is necessary

  8. Silent Revolution in the Library: Electronic Media Replace Printed Products. Official Pharmacopoeias: An Example from the Boehringer Mannheim Central Library.

    Science.gov (United States)

    Gretz, Marianne; And Others

    1996-01-01

    The Boehringer Mannheim Library (Germany) switched its loose-leaf pharmacopoeias from printed versions to electronic media. Discusses the decision-making and implementation process, and considers costs, technical requirements, availability of databases, user acceptance, installation, maintenance, and skills needed. Found that electronic media…

  9. 75 FR 75498 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2010-12-03

    ..., (75 FR 32506), Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia... has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Boehringer... with the public interest at this time. DEA has investigated Boehringer Ingelheim Chemicals, Inc. to...

  10. Evaluation of In vitro and In vivo Performance of Granisetron In situ ...

    African Journals Online (AJOL)

    lactide-co-glycolide. (Resomer RG 504H, Boehringer Ingelheim GmbH,. Ingelheim, Germany); ketamine hydrochloride. (Ketalar®, Pfizer, Turkey); dimethylsulphoxide, disodium hydrogenphosphate, potassium dihydrogenphosphate, sodium ...

  11. Sandra Boehringer, L'Homosexualité féminine dans l'Antiquité grecque et romaine

    Directory of Open Access Journals (Sweden)

    Rostom Mesli

    2008-07-01

    Full Text Available La publication de L’Homosexualité féminine dans l’Antiquité grecque et romaine de Sandra Boehringer est, à plusieurs titres, une excellente nouvelle.Sur le plan universitaire et éditorial, d’abord, ce livre vient confirmer qu’après de longues années de chape de plomb, les départements de lettres classiques et d’histoire ancienne sont en train de s’ouvrir aux recherches sur la sexualité. L’université française ne s’est mise – c’est le moins que l’on puisse dire – que très lentement aux recherc...

  12. The inherent dangers of using computable general equilibrium models as a single integrated modelling framework for sustainability impact assessment. A critical note on Boehringer and Loeschel (2006)

    International Nuclear Information System (INIS)

    Scrieciu, S. Serban

    2007-01-01

    The search for methods of assessment that best evaluate and integrate the trade-offs and interactions between the economic, environmental and social components of development has been receiving a new impetus due to the requirement that sustainability concerns be incorporated into the policy formulation process. A paper forthcoming in Ecological Economics (Boehringer, C., Loeschel, A., in press. Computable general equilibrium models for sustainability impact assessment: status quo and prospects, Ecological Economics.) claims that Computable General Equilibrium (CGE) models may potentially represent the much needed 'back-bone' tool to carry out reliable integrated quantitative Sustainability Impact Assessments (SIAs). While acknowledging the usefulness of CGE models for some dimensions of SIA, this commentary questions the legitimacy of employing this particular economic modelling tool as a single integrating modelling framework for a comprehensive evaluation of the multi-dimensional, dynamic and complex interactions between policy and sustainability. It discusses several inherent dangers associated with the advocated prospects for the CGE modelling approach to contribute to comprehensive and reliable sustainability impact assessments. The paper warns that this reductionist viewpoint may seriously infringe upon the basic values underpinning the SIA process, namely a transparent, heterogeneous, balanced, inter-disciplinary, consultative and participatory take to policy evaluation and building of the evidence-base. (author)

  13. Optical detectors for integration into a low cost radiometric device for in-water applications: A feasibility study

    CSIR Research Space (South Africa)

    Ramkilowan, A

    2013-04-01

    Full Text Available . 2009 22. Hamamatsu. Ultra compact mini-spectrometer integrating MEMS and image sensor technologies. Japan. 2011. 23. Boehringer Ingelheim. Monolithic microspectrometer (OEM) for spectral sensing applications. Germany. 2005 24. Kohler D D R...

  14. Atrial fibrillation and vascular disease-a bad combination

    DEFF Research Database (Denmark)

    Bjerring Olesen, Jonas; Gislason, Gunnar Hilmar; Torp-Pedersen, Christian

    2012-01-01

    management in patients with atrial fibrillation, several stroke and bleeding risk prediction schemes have been developed. Clin. Cardiol. 2012 DOI: 10.1002/clc.20955 Dr. Olesen received an honorarium through an educational grant from Sanofi Aventis for time and expertise spent writing this article. Dr Lip has...... served as a consultant for Bayer, Astellas, Merck, AstraZeneca, Sanofi, BMS/Pfizer, Biotronik, Portola and Boehringer Ingelheim and has been on the speakers bureau for Bayer, BMS/Pfizer, Boehringer Ingelheim, and Sanofi-Aventis. Drs. Gislason and Torp-Pedersen disclose no conflicts of interest....

  15. Availability, affordability, and consumption of fruits and vegetables in 18 countries across income levels: findings from the Prospective Urban Rural Epidemiology (PURE study

    Directory of Open Access Journals (Sweden)

    Victoria Miller, BSc

    2016-10-01

    Funding: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada, Sanofi-Aventis (France and Canada, Boehringer Ingelheim (Germany and Canada, Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.

  16. Ettevõttel lasub ühiskondlik vastutus / Karen Schmidt

    Index Scriptorium Estoniae

    Schmidt, Karen

    2011-01-01

    Terve Eesti SA algatusel Eesti ettevõtete poolt moodustatud koalitsioonist "Ettevõtted HIV vastu", kuhu kuuluvad Hill & Knowlton, Nordecon, Swedbank, TNS Emor, Coca-Cola, Johnson & Johnson, Rimi Eesti Food, DHL Estonia, Boehringer Ingelheim, Radisson BLU Hotell Tallinn ja TBWA/Guvatrak. Koalitsiooni töös osales kolm aastat ka Statoil

  17. Stroke and recurrent haemorrhage associated with antithrombotic treatment after gastrointestinal bleeding in patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Staerk, Laila; Lip, Gregory Y H; Olesen, Jonas B

    2015-01-01

    with better outcomes for all cause mortality and thromboembolism compared with patients who did not resume treatment. This was despite an increased longitudinal associated risk of bleeding. FUNDING, COMPETING INTERESTS, DATA SHARING: This study was supported by a grant from Boehringer-Ingelheim. Competing...

  18. Ipratropium bromide delivered by metered-dose aerosol to infant ...

    African Journals Online (AJOL)

    1990-08-21

    Aug 21, 1990 ... Two methods of administration of ipratropium bromide. (Atrovent; Boehringer Ingelheim) to wheezing children'< 25 months of age were compared: (I) the conventional nebulisa- tion (15 children); and (iI) a metered-dose aerosol plus spacer and mask (MDA group, 17 children). The drug induced a significant ...

  19. Withdrawal of inhaled glucocorticoids and exacerbations of COPD

    DEFF Research Database (Denmark)

    Magnussen, Helgo; Disse, Bernd; Rodriguez-Roisin, Roberto

    2014-01-01

    exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy. However, there was a greater decrease in lung function during the final step of glucocorticoid withdrawal. (Funded by Boehringer Ingelheim Pharma; WISDOM ClinicalTrials.gov number, NCT...

  20. Evidence for Enhanced Intestinal Absorption of Digoxin by P ...

    African Journals Online (AJOL)

    Digoxin (Boehringer Ingelheim, Germany), as well as erythromycin and clarithromycin. (Elder Pharmaceutical Ltd, India) were kindly provided by Zahravi Pharmaceutical. Company. Acetonitril and methanol were of high performance liquid chromatography. (HPLC) grade and obtained from Merck. (Germany). Phenol red ...

  1. Verslag symposium : "M€€r welzijn zonder pijn"

    NARCIS (Netherlands)

    Driesse, M.; Kluivers-Poodt, M.

    2010-01-01

    Op 27 april 2010 hield men in Lelystad het symposium 'Meer welzijn zonder pijn' over het thema welzijn bij landbouwhuisdieren, georganiseerd door Wageningen UR Livestock Research in samenwerking met Boehringer Ingelheim. Hoewel het symposium primair bedoeld was voor rundvee- en varkensdierenartsen,

  2. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms

    DEFF Research Database (Denmark)

    Vrijlandt, Elianne J L E; El Azzi, Georges; Vandewalker, Mark

    2018-01-01

    BACKGROUND: Few studies have assessed the safety and efficacy of potential asthma medications in children younger than 5 years. We descriptively assessed the safety and efficacy of tiotropium, a long-acting anticholinergic drug, in children aged 1-5 years with persistent asthmatic symptoms. METHO...... are needed to further assess the safety and efficacy of tiotropium in young children. FUNDING: Boehringer Ingelheim....

  3. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial

    DEFF Research Database (Denmark)

    NN, NN; Yusuf, S; Teo, K

    2008-01-01

    BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors reduce major cardiovascular events, but are not tolerated by about 20% of patients. We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular...... of cardiovascular death, myocardial infarction, or stroke. FUNDING: Boehringer Ingelheim....

  4. Diffusion-weighted magnetic resonance imaging in ileocolonic Crohn's disease

    DEFF Research Database (Denmark)

    Juel, Mie A; Rafaelsen, Søren Rafael; Nathan, Torben

    protocol contained coronal e-thrive and SShT2 with free-breathing and a factor b fixed at 800 s/mm2. Patients were examined in the prone position before and after intravenous administration of 20 mg Hyoscin Butylbromide (Buscopan®, Boehringer Ingelheim, Basel, Switzerland). Ileocolonoscopy with Simple...

  5. 76 FR 36577 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2011-06-22

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 4, 2011, Boehringer Ingelheim Chemicals Inc., 2820 N. Normandy Drive...

  6. "Partners in Science": A Model Cooperative Program Introducing High School Teachers and Students to Leading-Edge Pharmaceutical Science

    Science.gov (United States)

    Woska, Joseph R., Jr.; Collins, Danielle M.; Canney, Brian J.; Arcario, Erin L.; Reilly, Patricia L.

    2005-01-01

    "Partners in Science" is a cooperative program between Boehringer Ingelheim Pharmaceuticals, Inc. and area high schools in the community surrounding our Connecticut campus. It is a two-phase program that introduces high school students and teachers to the world of drug discovery and leading-edge pharmaceutical research. Phase 1 involves…

  7. Ipratropium bromide delivered by metered-dose aerosol to infant ...

    African Journals Online (AJOL)

    Two methods of administration of ipratropium bromide (Atrovent; Boehringer Ingelheim) to wheezing children'< 25 months of age were compared: (i) the conventional nebulisation (15 children); and (ii) a metered-dose aerosol plus spacer and mask (MDA group, 17 children). The drug induced a significant and similar fall in ...

  8. 75 FR 32506 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2010-06-08

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 12, 2010, Boehringer Ingelheim Chemicals Inc., 2820 N. Normandy Drive...

  9. Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data

    Directory of Open Access Journals (Sweden)

    Marjan W Attaei, MA

    2017-09-01

    Funding: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, the Ontario Ministry of Health and Long-Term Care, pharmaceutical companies (with major contributions from AstraZeneca [Canada], Sanofi Aventis [France and Canada], Boehringer Ingelheim [Germany amd Canada], Servier, and GlaxoSmithKline, Novartis and King Pharma, and national or local organisations in participating countries.

  10. Pharmacokinetics and safety of olodaterol administered with the Respimat Soft Mist inhaler in subjects with impaired hepatic or renal function

    Directory of Open Access Journals (Sweden)

    Kunz C

    2016-03-01

    Full Text Available Christina Kunz,1 Doreen Luedtke,1 Anna Unseld,2 Alan Hamilton,3 Atef Halabi,4 Martina Wein,5 Stephan Formella6 1Translational Medicine and Clinical Pharmacology, 2Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, Germany; 3Boehringer Ingelheim, Burlington, ON, Canada; 4CRS Clinical Research Services Kiel GmbH, Kiel, 5Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, 6Medicine Coordination, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany Purpose: In two trials, the influences of hepatic and renal impairment on the pharmacokinetics of olodaterol, a novel long-acting inhaled β2-agonist for treatment of COPD, were investigated.Subjects and methods: The first trial included eight subjects with mild hepatic function impairment (Child–Pugh A, eight subjects with moderate impairment (Child–Pugh B, and 16 matched healthy subjects with normal hepatic function. The second trial included eight subjects with severe renal impairment (creatinine clearance <30 mL·min-1 and 14 matched healthy subjects with normal renal function. Subjects received single doses of 20 or 30 µg olodaterol administered with the Respimat Soft Mist inhaler.Results: Olodaterol was well tolerated in all subjects. The geometric mean ratios and 90% confidence intervals of dose-normalized area under the plasma concentration-time curve from time zero to 4 hours (AUC0–4 for subjects with mild and moderate hepatic impairment compared to healthy subjects were 97% (75%–125% and 105% (79%–140%, respectively. Corresponding values for dose-normalized maximum concentration (Cmax were 112% (84%–151% (mild impairment and 99% (73%–135% (moderate impairment. The geometric mean ratio (90% confidence interval of AUC0–4 for subjects with severe renal impairment compared to healthy subjects was 135% (94%–195%, and for Cmax was 137% (84%–222%. There was no significant relationship

  11. The impact of data integrity on decision making in early lead discovery.

    Science.gov (United States)

    Beck, Bernd; Seeliger, Daniel; Kriegl, Jan M

    2015-09-01

    Data driven decision making is a key element of today's pharmaceutical research, including early drug discovery. It comprises questions like which target to pursue, which chemical series to pursue, which compound to make next, or which compound to select for advanced profiling and promotion to pre-clinical development. In the following paper we will exemplify how data integrity, i.e. the context data is generated in and auxiliary information that is provided for individual result records, can influence decision making in early lead discovery programs. In addition we will describe some approaches which we pursue at Boehringer Ingelheim to reduce the risk for getting misguided.

  12. The impact of data integrity on decision making in early lead discovery

    Science.gov (United States)

    Beck, Bernd; Seeliger, Daniel; Kriegl, Jan M.

    2015-09-01

    Data driven decision making is a key element of today's pharmaceutical research, including early drug discovery. It comprises questions like which target to pursue, which chemical series to pursue, which compound to make next, or which compound to select for advanced profiling and promotion to pre-clinical development. In the following paper we will exemplify how data integrity, i.e. the context data is generated in and auxiliary information that is provided for individual result records, can influence decision making in early lead discovery programs. In addition we will describe some approaches which we pursue at Boehringer Ingelheim to reduce the risk for getting misguided.

  13. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids

    DEFF Research Database (Denmark)

    Watz, Henrik; Tetzlaff, Kay; Wouters, Emiel F M

    2016-01-01

    BACKGROUND: Blood eosinophil counts might predict response to inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. We used data from the WISDOM trial to assess whether patients with COPD with higher blood eosinophil counts wou...... of exacerbations. Our data suggest that counts of 4% or greater or 300 cells per μL or more might identify a deleterious effect of ICS withdrawal, an effect not seen in most patients with eosinophil counts below these thresholds. FUNDING: Boehringer Ingelheim....

  14. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol

    Directory of Open Access Journals (Sweden)

    Roskell NS

    2014-07-01

    Full Text Available Neil S Roskell,1 Antonio Anzueto,2 Alan Hamilton,3 Bernd Disse,4 Karin Becker5 1Statistics, Bresmed Health Solutions Ltd, Sheffield, UK; 2School of Medicine, University of Texas Health Science Center, San Antonio, TX, USA; 3Medical Department, Boehringer Ingelheim (Canada Ltd, Burlington, ON, Canada; 4Medical Department, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany; 5Global Health Economics and Outcomes Research, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany Purpose: In the absence of head-to-head clinical trials comparing the once-daily, long-acting beta2-agonists olodaterol and indacaterol for the treatment of chronic obstructive pulmonary disease (COPD, an indirect treatment comparison by systematic review and synthesis of the available clinical evidence was conducted. Methods: A systematic literature review of randomized, controlled clinical trials in patients with COPD was performed to evaluate the efficacy and safety of olodaterol and indacaterol. Network meta-analysis and adjusted indirect comparison methods were employed to evaluate treatment efficacy, using outcomes based on trough forced expiratory volume in 1 second (FEV1, Transition Dyspnea Index, St George’s Respiratory Questionnaire total score and response, rescue medication use, and proportion of patients with exacerbations. Results: Eighteen trials were identified for meta-analysis (eight, olodaterol; ten, indacaterol. Olodaterol trials included patients of all severities, whilst indacaterol trials excluded patients with very severe COPD. Concomitant maintenance bronchodilator use was allowed in most olodaterol trials, but not in indacaterol trials. When similarly designed trials/data were analyzed for change from baseline in trough FEV1 (liters, the following mean differences (95% confidence interval were observed: trials excluding concomitant bronchodilator: indacaterol 75 mcg versus olodaterol 5 mcg, –0.005 (–0.077 to 0.067, and indacaterol 150 mcg

  15. Conception through build of an automated liquids processing system for compound management in a low-humidity environment.

    Science.gov (United States)

    Belval, Richard; Alamir, Ab; Corte, Christopher; DiValentino, Justin; Fernandes, James; Frerking, Stuart; Jenkins, Derek; Rogers, George; Sanville-Ross, Mary; Sledziona, Cindy; Taylor, Paul

    2012-12-01

    Boehringer Ingelheim's Automated Liquids Processing System (ALPS) in Ridgefield, Connecticut, was built to accommodate all compound solution-based operations following dissolution in neat DMSO. Process analysis resulted in the design of two nearly identical conveyor-based subsystems, each capable of executing 1400 × 384-well plate or punch tube replicates per batch. Two parallel-positioned subsystems are capable of independent execution or alternatively executed as a unified system for more complex or higher throughput processes. Primary ALPS functions include creation of high-throughput screening plates, concentration-response plates, and reformatted master stock plates (e.g., 384-well plates from 96-well plates). Integrated operations included centrifugation, unsealing/piercing, broadcast diluent addition, barcode print/application, compound transfer/mix via disposable pipette tips, and plate sealing. ALPS key features included instrument pooling for increased capacity or fail-over situations, programming constructs to associate one source plate to an array of replicate plates, and stacked collation of completed plates. Due to the hygroscopic nature of DMSO, ALPS was designed to operate within a 10% relativity humidity environment. The activities described are the collaborative efforts that contributed to the specification, build, delivery, and acceptance testing between Boehringer Ingelheim Pharmaceuticals, Inc. and the automation integration vendor, Thermo Scientific Laboratory Automation (Burlington, ON, Canada).

  16. VizieR Online Data Catalog: REFLEX Galaxy Cluster Survey catalogue (Boehringer+, 2004)

    Science.gov (United States)

    Boehringer, H.; Schuecker, P.; Guzzo, L.; Collins, C. A.; Voges, W.; Cruddace, R. G.; Ortiz-Gil, A.; Chincarini, G.; de Grandi, S.; Edge, A. C.; MacGillivray, H. T.; Neumann, D. M.; Schindler, S.; Shaver, P.

    2004-05-01

    The following tables provide the catalogue as well as several data files necessary to reproduce the sample preparation. These files are also required for the cosmological modeling of these observations in e.g. the study of the statistics of the large-scale structure of the matter distribution in the Universe and related cosmological tests. (13 data files).

  17. VizieR Online Data Catalog: REFLEX II. Properties of the survey (Boehringer+ 2013)

    Science.gov (United States)

    Boehringer, H.; Chon, G.; Collins, C. A.; Guzzo, L.; Nowak, N.; Bobrovskyi, S.

    2013-06-01

    Like REFLEX I, the extended survey covers the southern sky outside the band of the Milky Way (|bII|>=20°) with regions around the Magellanic clouds excised (3 in LMC, 3 in SMC). The total survey area after this excision amounts to 4.24 steradian (or 13924°2) which corresponds to 33.75% of the sky. Different from REFLEX I, we use the refined RASS product RASS III (Voges et al. 1999, Cat. IX/10). (2 data files).

  18. Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Ichinose M

    2015-08-01

    Full Text Available Masakazu Ichinose,1 Ayako Takizawa,2 Toshiyasu Izumoto,2 Yusuke Tadayasu,2 Alan L Hamilton,3 Christina Kunz,4 Yoshinosuke Fukuchi51Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 2Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany; 5Juntendo University School of Medicine, Tokyo, JapanBackground: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD.Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1 after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC0–3, peak FEV1 from 0 hour to 3 hours (peak FEV1, and corresponding forced vital capacity (FVC responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001. Mean increases in peak FEV1 and FEV1 AUC0–3 compared to placebo were also significant (P<0.0001. A clear dose–response relationship was observed across all treatment groups. FVC responses (trough

  19. Precautions to be taken by radiologists and radiographers when prescribing hyoscine-N-butylbromide

    International Nuclear Information System (INIS)

    Dyde, R.; Chapman, A.H.; Gale, R.; Mackintosh, A.; Tolan, D.J.M.

    2008-01-01

    Hyoscine-N-butylbromide (Buscopan, Boehringer Ingelheim) is a widely used antispasmodic in radiological practice. There seems to be no consensus as to best practice within radiology regarding the precautions that need to be taken when prescribing Buscopan. We have performed a thorough review of the available literature and make the following recommendations to those administering Buscopan: (1) enquire whether there is an allergic history; (2) ensure patient literature warns that 'in the rare event that following the examination you develop painful, blurred vision in one or both eyes, you must attend hospital immediately for assessment'; (3) warn patients to expect blurred vision and not to drive until this has worn off; (4) remind clinicians that special consideration needs to be given as to the method of investigating patients with cardiac instability, such as those recently admitted with acute coronary syndrome, recurrent cardiac pain at rest, uncontrolled left ventricular failure and recent ventricular arrhythmias

  20. Precautions to be taken by radiologists and radiographers when prescribing hyoscine-N-butylbromide

    Energy Technology Data Exchange (ETDEWEB)

    Dyde, R. [Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds (United Kingdom); Chapman, A.H. [Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds (United Kingdom)], E-mail: tony_chapman@ntlworld.com; Gale, R. [Department of Opthalmology, University of Leeds, Leeds (United Kingdom); Mackintosh, A. [Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds (United Kingdom); Tolan, D.J.M. [Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds (United Kingdom)

    2008-07-15

    Hyoscine-N-butylbromide (Buscopan, Boehringer Ingelheim) is a widely used antispasmodic in radiological practice. There seems to be no consensus as to best practice within radiology regarding the precautions that need to be taken when prescribing Buscopan. We have performed a thorough review of the available literature and make the following recommendations to those administering Buscopan: (1) enquire whether there is an allergic history; (2) ensure patient literature warns that 'in the rare event that following the examination you develop painful, blurred vision in one or both eyes, you must attend hospital immediately for assessment'; (3) warn patients to expect blurred vision and not to drive until this has worn off; (4) remind clinicians that special consideration needs to be given as to the method of investigating patients with cardiac instability, such as those recently admitted with acute coronary syndrome, recurrent cardiac pain at rest, uncontrolled left ventricular failure and recent ventricular arrhythmias.

  1. A Systematic Review of the Role of Dysfunctional Wound Healing in the Pathogenesis and Treatment of Idiopathic Pulmonary Fibrosis

    Directory of Open Access Journals (Sweden)

    Alan Betensley

    2016-12-01

    Full Text Available Idiopathic pulmonary fibrosis (IPF is a chronic, progressive interstitial lung disorder showcasing an interaction between genetic predisposition and environmental risks. This usually involves the coaction of a mixture of cell types associated with abnormal wound healing, leading to structural distortion and loss of gas exchange function. IPF bears fatal prognosis due to respiratory failure, revealing a median survival of approximately 2 to 3 years. This review showcases the ongoing progress in understanding the complex pathophysiology of IPF and it highlights the latest potential clinical treatments. In IPF, various components of the immune system, particularly clotting cascade and shortened telomeres, are highly involved in disease pathobiology and progression. This review also illustrates two US Food and Drug Administration (FDA-approved drugs, nintedanib (OFEV, Boehringer Ingelheim, Ingelheim am Rhein, Germany and pirfenidone (Esbriet, Roche, Basel, Switzerland, that slow IPF progression, but unfortunately neither drug can reverse the course of the disease. Although the mechanisms underlying IPF remain poorly understood, this review unveils the past and current advances that encourage the detection of new IPF pathogenic pathways and the development of effective treatment methods for the near future.

  2. Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain – a randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Blahova Z

    2016-12-01

    Full Text Available Zuzana Blahova,1 Janina Claudia Holm,1 Thomas Weiser,2 Erika Richter,2 Matthias Trampisch,2 Elena Akarachkova3 1Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria; 2Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany; 3I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation Background/objective: Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC of nonivamide (a capsaicinoid and nicoboxil (a nicotinic acid ester cream in the treatment of acute nonspecific low back pain.Materials and methods: This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon® cream in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.Results: Patients (n=138, 21–65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0–10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points; p<0.0001. On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points; p<0.0001. Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363], p<0.0001. At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199], p<0.0001. Both treatments were tolerated well. No serious adverse events were reported.Conclusion: Nicoboxil

  3. Study Design of VESUTO®: Efficacy of Tiotropium/Olodaterol on Lung Hyperinflation, Exercise Capacity, and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease.

    Science.gov (United States)

    Ichinose, Masakazu; Minakata, Yoshiaki; Motegi, Takashi; Ueki, Jun; Seki, Tetsuo; Anzai, Tatsuhiko; Takizawa, Ayako; Grönke, Lars; Hirata, Kazuto

    2017-07-01

    The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD. A protocol is developed for the VESUTO ® study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD. A total of 180 Japanese patients with COPD, aged ≥40 years will be enrolled into the double-blind, multicenter, active-controlled, crossover study (NCT02629965) and will be randomized to receive either tiotropium/olodaterol FDC or tiotropium for 6 weeks each [two puffs via RESPIMAT ® (Boehringer Ingelheim, Ingelheim, Germany) inhaler in the morning]. The primary endpoint is IC at rest measured at 60 min post-dose after 6 weeks treatment. The secondary endpoints include the 6-min walk distance (6MWD) at 90 min post-dose and physical activity measured by the activity monitor in the last 2 weeks of the 6-week treatment periods. Lung function tests will also be assessed after 6 weeks treatment. A mixed-effects model repeated measures approach will be used for the primary and secondary endpoints. The VESUTO ® study is the first randomized interventional study to investigate exercise capacity (6MWD) and physical activity measured by a 3-axis accelerometer in Japanese patients with COPD. The study could provide additional evidence of long-acting muscarinic antagonist (LAMA) + long-acting β 2 -agonist (LABA) combination therapy on patients' physical activities as well as lung

  4. Daily home-based spirometry during withdrawal of inhaled corticosteroid in severe to very severe chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Rodriguez-Roisin R

    2016-08-01

    Full Text Available Roberto Rodriguez-Roisin,1 Kay Tetzlaff,2,3 Henrik Watz,4 Emiel FM Wouters,5 Bernd Disse,2 Helen Finnigan,6 Helgo Magnussen,4 Peter MA Calverley7 1Respiratory Institute, Servei de Pneumologia, Hospital Clínic IDIBAPS-CIBERES, Universitat de Barcelona, Barcelona, Spain; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 3Department of Sports Medicine, University of Tübingen, Tübingen, Germany; 4Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; 5Department of Respiratory Medicine, University Hospital Maastricht, Maastricht University, Maastricht, the Netherlands; 6Department of Biostatistics and Data Sciences, Boehringer Ingelheim, Bracknell, UK; 7Institute of Ageing and Chronic Disease, Aintree University Hospital, Liverpool, UK Abstract: The WISDOM study (NCT00975195 reported a change in lung function following withdrawal of fluticasone propionate in patients with severe to very severe COPD treated with tiotropium and salmeterol. However, little is known about the validity of home-based spirometry measurements of lung function in COPD. Therefore, as part of this study, following suitable training, patients recorded daily home-based spirometry measurements in addition to undergoing periodic in-clinic spirometric testing throughout the study duration. We subsequently determined the validity of home-based spirometry for detecting changes in lung function by comparing in-clinic and home-based forced expiratory volume in 1 second in patients who underwent stepwise fluticasone propionate withdrawal over 12 weeks versus patients remaining on fluticasone propionate for 52 weeks. Bland–Altman analysis of these data confirmed good agreement between in-clinic and home-based measurements, both across all visits and at the individual visits at study weeks 6, 12, 18, and 52. There was a measurable difference between the forced expiratory volume

  5. Treatment of exacerbations as a predictor of subsequent outcomes in patients with COPD

    Directory of Open Access Journals (Sweden)

    Calverley PMA

    2018-04-01

    Full Text Available Peter MA Calverley,1 Antonio R Anzueto,2 Daniel Dusser,3 Achim Mueller,4 Norbert Metzdorf,5 Robert A Wise6 1Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK; 2Pulmonary/Critical Care, University of Texas and South Texas Veterans Health Care System, San Antonio, TX, USA; 3Department of Pneumology, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 4Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany; 5Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA Rationale: Exacerbations of COPD are managed differently, but whether treatment of one exacerbation predicts the likelihood of subsequent events is unknown. Objective: We examined whether the treatment given for exacerbations predicted subsequent outcomes. Methods: This was a post-hoc analysis of 17,135 patients with COPD from TIOtropium Safety and Performance In Respimat® (TIOSPIR®. Patients treated with tiotropium with one or more moderate to severe exacerbations on study were analyzed using descriptive statistics, logistic and Cox regression analysis, and Kaplan–Meier plots. Results: Of 8,061 patients with moderate to severe exacerbation(s, demographics were similar across patients with exacerbations treated with antibiotics and/or steroids or hospitalization. Exacerbations treated with systemic corticosteroids alone or in combination with antibiotics had the highest risk of subsequent exacerbation (HR: 1.21, P=0.0004 and HR: 1.33, P<0.0001, respectively, and a greater risk of having a hospitalized (severe exacerbation (HR: 1.59 and 1.63, P<0.0001, respectively or death (HR: 1.50, P=0.0059 and HR: 1.47, P=0.0002, respectively compared with exacerbations treated

  6. The efficacy and safety of combined tiotropium and olodaterol via the Respimat® inhaler in patients with COPD: results from the Japanese sub-population of the Tonado® studies

    Directory of Open Access Journals (Sweden)

    Ichinose M

    2016-08-01

    Full Text Available Masakazu Ichinose,1 Hiroyuki Taniguchi,2 Ayako Takizawa,3 Lars Grönke,4 Lazaro Loaiza,4 Florian Voß,4 Yihua Zhao,5 Yoshinosuke Fukuchi61Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 2Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan; 3Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA; 6Juntendo University School of Medicine, Tokyo, JapanBackground: The efficacy and safety of once-daily tiotropium + olodaterol (T+O maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonad® 1 (NCT01431274 and 2 (NCT01431287 studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD.Methods: In this Tondao® subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants.Results: Versus the overall population, the 413 Japanese patients randomized and treated were slightly older, with more men, lower body mass index, lower baseline St George’s Respiratory Questionnaire (SGRQ scores, fewer current smokers, but with higher pack-year smoking history. A lower proportion of Japanese patients used inhaled corticosteroids, short-acting muscarinic antagonists, or short- or long-acting β-adrenergic agonists at baseline, but use of long-acting muscarinic antagonists was higher. At Week 24, mean improvements with T+O 5/5 µg in forced expiratory volume in 1 second area under the curve from 0–3 hours response were 151 mL versus olodaterol and 134 mL versus tiotropium 5 µg; mean improvements with T+O 2.5/5 µg were 87 mL versus olodaterol and 70 mL versus tiotropium 2.5 µg. Mean improvements with T+O 5/5 µg in trough forced expiratory volume in 1 second were 131 mL versus

  7. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Miravitlles M

    2015-03-01

    Full Text Available Marc Miravitlles,1 David Price,2 Klaus F Rabe,3,7 Hendrik Schmidt,4 Norbert Metzdorf,5 Bartolome Celli6 1Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 2Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Department of Medicine, Christian-Albrechts-Universität zu Kiel (CAU, Großhansdorf, Germany; 4Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 6Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA; 7LungenClinic Grosshansdorf, Großhansdorf, Germany Background: There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD seen in real-life clinical settings are represented in randomized controlled trials (RCTs of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors.Methods: We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0, patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies.Results: We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our

  8. Epidemiology of chronic obstructive pulmonary disease: a literature review

    Directory of Open Access Journals (Sweden)

    Rycroft CE

    2012-07-01

    Full Text Available Catherine E Rycroft,1 Anne Heyes,1 Lee Lanza,2 Karin Becker31Market Access and Outcomes Strategy, RTI Health Solutions, Manchester, United Kingdom; 2Epidemiology, RTI Health Solutions, Waltham, MA, USA; 3Global Health Economics and Outcomes Research, Boehringer Ingelheim GmbH, Ingelheim, GermanyAbstract: The aim of this study is to quantify the burden of chronic obstructive pulmonary disease (COPD – incidence, prevalence, and mortality – and identify trends in Australia, Canada, France, Germany, Italy, Japan, The Netherlands, Spain, Sweden, the United Kingdom, and the United States of America. A structured literature search was performed (January 2000 to September 2010 of PubMed and EMBASE, identifying English-language articles reporting COPD prevalence, incidence, or mortality. Of 2838 articles identified, 299 full-text articles were reviewed, and data were extracted from 133 publications. Prevalence data were extracted from 80 articles, incidence data from 15 articles, and mortality data from 58 articles. Prevalence ranged from 0.2%–37%, but varied widely across countries and populations, and by COPD diagnosis and classification methods. Prevalence and incidence were greatest in men and those aged 75 years and older. Mortality ranged from 3–111 deaths per 100,000 population. Mortality increased in the last 30–40 years; more recently, mortality decreased in men in several countries, while increasing or stabilizing in women. Although COPD mortality increased over time, rates declined more recently, likely indicating improvements in COPD management. In many countries, COPD mortality has increased in women but decreased in men. This may be explained by differences in smoking patterns and a greater vulnerability in women to the adverse effects of smoking.Keywords: COPD, incidence, literature review, mortality, prevalence

  9. Impact and prevention of severe exacerbations of COPD: a review of the evidence

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    Halpin DMG

    2017-10-01

    Full Text Available David MG Halpin,1 Marc Miravitlles,2 Norbert Metzdorf,3 Bartolomé Celli4 1Department of Respiratory Medicine, Royal Devon and Exeter Hospital, Exeter, UK; 2Pneumology Department, Hospital Universitari Vall d’Hebron, CIBER de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 3Respiratory Medicine, Boehringer Ingelheim Pharma GmBH & Co KG, Ingelheim am Rhein, Germany; 4Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA Abstract: Severe exacerbations of COPD, ie, those leading to hospitalization, have profound clinical implications for patients and significant economic consequences for society. The prevalence and burden of severe COPD exacerbations remain high, despite recognition of the importance of exacerbation prevention and the availability of new treatment options. Severe COPD exacerbations are associated with high mortality, have negative impact on quality of life, are linked to cardiovascular complications, and are a significant burden on the health-care system. This review identified risk factors that contribute to the development of severe exacerbations, treatment options (bronchodilators, antibiotics, corticosteroids [CSs], oxygen therapy, and ventilator support to manage severe exacerbations, and strategies to prevent readmission to hospital. Risk factors that are amenable to change have been highlighted. A number of bronchodilators have demonstrated successful reduction in risk of severe exacerbations, including long-acting muscarinic antagonist or long-acting β2-agonist mono- or combination therapies, in addition to vaccination, mucolytic and antibiotic therapy, and nonpharmacological interventions, such as pulmonary rehabilitation. Recognition of the importance of severe exacerbations is an essential step in improving outcomes for patients with COPD. Evidence-based approaches to prevent and manage severe exacerbations should be implemented as part of targeted strategies for disease management. Keywords

  10. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

    Directory of Open Access Journals (Sweden)

    Koch A

    2014-07-01

    Full Text Available Andrea Koch,1 Emilio Pizzichini,2 Alan Hamilton,3 Lorna Hart,3 Lawrence Korducki,4 Maria Cristina De Salvo,5 Pierluigi Paggiaro6 1Medical Clinic III for Pneumology, Allergology, Sleep and Respiratory Medicine, University Hospital Bochum-Bergmannsheil, Bochum, Germany; 2NUPAIVA (Asthma Research Center, Universidade Federal de Santa Catarina, Santa Catarina, Brazil; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 5Centro Médico Dra. De Salvo, Fundación Respirar, Buenos Aires, Argentina; 6Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy Abstract: Two replicate, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III studies investigated the long-term efficacy and safety of once-daily olodaterol via Respimat® versus placebo and formoterol over 48 weeks in patients with moderate to very severe chronic obstructive pulmonary disease receiving usual-care background therapy. Patients received once-daily olodaterol 5 or 10 µg, twice-daily formoterol 12 µg, or placebo. Co-primary end points were forced expiratory volume in 1 second (FEV1 area under the curve from 0–3 hours response, FEV1 trough response, and Mahler transition dyspnea index total score after 24 weeks; secondary end points included St George's Respiratory Questionnaire. Overall, 904 (Study 1222.13 and 934 (Study 1222.14 patients received treatment. Olodaterol significantly improved FEV1 area under the curve from 0–3 hours versus placebo in both studies (with olodaterol 5 µg, 0.151 L and 0.129 L; with olodaterol 10 µg, 0.165 L and 0.154 L; for all comparisons P<0.0001 and FEV1 trough responses versus placebo (0.053–0.085 L; P<0.01, as did formoterol. Primary analysis revealed no significant difference in transition dyspnea index focal score for any active treatment versus placebo. Post hoc analysis using pattern mixture modeling (accounting for

  11. Cardiac safety strategies. 25-26 October 2005, the Radisson SAS Hotel, Nice, France.

    Science.gov (United States)

    Hanton, Gilles; Tilbury, Lorraine

    2006-03-01

    This meeting was organised by IIR Life Sciences. It was chaired by Brian Guth, (head of General Pharmacology at Boehringer Ingelheim Pharma) and brought together scientists and clinicians from the pharmaceutical industry, university and regulatory agencies. The meeting presented emerging trends in cardiac safety, including its regulatory context pertaining to ICH S7A, S7B and E14. ICH S7A and S7B highlight the importance of the hERG test and telemetric studies in non-rodents. ICH E14 describes the clinical 'thorough QT study' that is required by the FDA for any new drug. Marked physiological variability in QT interval over time can be observed, partly as a result of fluctuation in autonomic tone. Beat-to-beat QT variability and T-wave morphology should be considered as a part of an integrated estimate of proarrhythmic risk. A case study illustrated the predictivity of preclinical data for proarrhythmic risk in humans, showing the importance of evaluating QT effects in patients to establish a safety margin.

  12. Donated chemical probes for open science.

    Science.gov (United States)

    Müller, Susanne; Ackloo, Suzanne; Arrowsmith, Cheryl H; Bauser, Marcus; Baryza, Jeremy L; Blagg, Julian; Böttcher, Jark; Bountra, Chas; Brown, Peter J; Bunnage, Mark E; Carter, Adrian J; Damerell, David; Dötsch, Volker; Drewry, David H; Edwards, Aled M; Edwards, James; Elkins, Jon M; Fischer, Christian; Frye, Stephen V; Gollner, Andreas; Grimshaw, Charles E; IJzerman, Adriaan; Hanke, Thomas; Hartung, Ingo V; Hitchcock, Steve; Howe, Trevor; Hughes, Terry V; Laufer, Stefan; Li, Volkhart Mj; Liras, Spiros; Marsden, Brian D; Matsui, Hisanori; Mathias, John; O'Hagan, Ronan C; Owen, Dafydd R; Pande, Vineet; Rauh, Daniel; Rosenberg, Saul H; Roth, Bryan L; Schneider, Natalie S; Scholten, Cora; Singh Saikatendu, Kumar; Simeonov, Anton; Takizawa, Masayuki; Tse, Chris; Thompson, Paul R; Treiber, Daniel K; Viana, Amélia Yi; Wells, Carrow I; Willson, Timothy M; Zuercher, William J; Knapp, Stefan; Mueller-Fahrnow, Anke

    2018-04-20

    Potent, selective and broadly characterized small molecule modulators of protein function (chemical probes) are powerful research reagents. The pharmaceutical industry has generated many high-quality chemical probes and several of these have been made available to academia. However, probe-associated data and control compounds, such as inactive structurally related molecules and their associated data, are generally not accessible. The lack of data and guidance makes it difficult for researchers to decide which chemical tools to choose. Several pharmaceutical companies (AbbVie, Bayer, Boehringer Ingelheim, Janssen, MSD, Pfizer, and Takeda) have therefore entered into a pre-competitive collaboration to make available a large number of innovative high-quality probes, including all probe-associated data, control compounds and recommendations on use (https://openscienceprobes.sgc-frankfurt.de">https://openscienceprobes.sgc-frankfurt.dehttps://openscienceprobes.sgc-frankfurt.de/">/). Here we describe the chemical tools and target-related knowledge that have been made available, and encourage others to join the project. © 2018, Müller et al.

  13. Inhaled albuterol/salbutamol and ipratropium bromide and their combination in the treatment of chronic obstructive pulmonary disease.

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    Gordon, Joshiah; Panos, Ralph J

    2010-03-01

    Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality throughout the world. Combination therapy with albuterol and ipratropium bromide was approved > 15 years ago for the treatment of COPD. We review the mechanism of action, clinical efficacy, and safety of albuterol, ipratropium and combined albuterol-ipratropium therapy. We conducted a PubMed literature search using the keywords COPD, albuterol, ipratropium bromide and Combivent (Boehringer Ingelheim Corp., Ridgefield, CT, USA); pertinent references within the identified citations are included in the review. Data from the manufacturers are also evaluated. At the time of its approval, albuterol/ipratropium bromide was an innovative combination of existing medications for the treatment of COPD. The combined formulation provides better improvement in airflow than either component alone and, by reducing the number of separate inhalers, simplifies therapy and improves compliance compared with the individual components. The recent development and approval of longer acting and more potent beta agonists, anticholinergics and newer combination treatments have surpassed many of the advantages of combined albuterol-ipratropium for the treatment of patients with stable COPD.

  14. AMCP Partnership Forum: Navigating Innovations in Diabetes Care.

    Science.gov (United States)

    2016-12-01

    New developments that provide opportunities to enhance cost-effective diabetes care include advances in the pharmacologic treatment of diabetes, new drug delivery devices, innovations in patient management strategies, contracting strategies that incentivize effective interventions, and mobile health technologies. Payers must carefully consider the utility of these advances when making coverage decisions and designing benefits. To engage national stakeholders in a discussion about how to utilize innovations in diabetes care to optimize patient outcomes, the Academy of Managed Care Pharmacy organized the Partnership Forum on Navigating Innovations in Diabetes Care in Arlington, Virginia, on July 19-20, 2016. The forum explored current trends and advances in diabetes treatments and engaged in discussions about how organizations can leverage these emerging options to develop strategies that improve coordination of care and patient outcomes, while managing limited health resources. Additionally, stakeholders were tasked with identifying gaps in evidence that hinder decision making around novel therapies and other advances that are of direct relevance to managed care organizations. The AMCP Partnership Forum on Navigating Innovations in Diabetes Care and the development of this proceedings document were supported by Boehringer Ingelheim, Lilly, Dexcom, Insulet Corporation, Intarcia Therapeutics, and Merck.

  15. Partners in Science: A Model Cooperative Program Introducing High School Teachers and Students to Leading-Edge Pharmaceutical Science

    Science.gov (United States)

    Woska, Joseph R., Jr.; Collins, Danielle M.; Canney, Brian J.; Arcario, Erin L.; Reilly, Patricia L.

    2005-12-01

    Partners in Science is a cooperative program between Boehringer Ingelheim Pharmaceuticals, Inc. and area high schools in the community surrounding our Connecticut campus. It is a two-phase program that introduces high school students and teachers to the world of drug discovery and leading-edge pharmaceutical research. Phase 1 involves a series of lectures, tours, and demonstrations given by scientists within our research and development division (R&D). Phase 2 involves the selection of a small group of participants to intern for the summer in a research laboratory, working side by side with a scientist within R&D. In this manuscript, the specific aims, goals, and development of the Partners in Science program are described, as well as the syllabus/agenda, the logistics surrounding the operation of the program, and our shared personal experiences with students and teachers who have participated. Some of the pitfalls/problems associated with the program will be presented, and finally, the future direction of the program including areas of improvement and expansion are described.

  16. Development and Evaluation of a Rapid Antigen Detection and Serotyping Lateral Flow Antigen Detection System for Foot-and-Mouth Disease Virus.

    Directory of Open Access Journals (Sweden)

    Kazuki Morioka

    Full Text Available We developed a lateral flow strip using monoclonal antibodies (MAbs which allows for rapid antigen detection and serotyping of foot-and-mouth disease virus (FMDV. This FMDV serotyping strip was able to detect all 7 serotypes and distinguish serotypes O, A, C and Asia1. Its sensitivities ranged from 10(3 to 10(4 of a 50% tissue culture infectious dose of each FMDV stain; this is equal to those of the commercial product Svanodip (Boehringer Ingelheim Svanova, Uppsala, Sweden, which can detect all seven serotypes of FMDV, but does not distinguish them. Our evaluation of the FMDV serotyping strip using a total of 118 clinical samples (vesicular fluids, vesicular epithelial emulsions and oral and/or nasal swabs showed highly sensitive antigen detection and accuracy in serotyping in accordance with ELISA or RT-PCR. To the best of our knowledge, this is the first report on any FMDV serotyping strip that provides both rapid antigen detection and serotyping of FMDV at the same time on one strip without extra devices. This method will be useful in both FMD-free countries and FMD-infected countries, especially where laboratory diagnosis cannot be carried out.

  17. Saline lavage with substitution of bovine surfactant in term neonates with meconium aspiration syndrome (MAS) transferred for extracorporeal membrane oxygenation (ECMO): a pilot study

    Science.gov (United States)

    Möller, Jens C; Kohl, Martina; Reiss, Irwin; Diederich, Wiebke; Nitsche, Esther M; Göpel, Wolfgang; Gortner, Ludwig

    1999-01-01

    Background: Meconium aspiration syndrome (MAS) is still a condition associated with a high mortality, and many patients require extracorporeal membrane oxygenation (ECMO) as rescue therapy. Beneficial effects of surfactant and perflubron lavage have been reported. However, pure surfactant supplementation has not been proven to be beneficial in the most severe forms of MAS. This study was performed to demonstrate an improvement in oxygenation in neonates transferred for ECMO and fulfilling ECMO criteria with a saline lavage and surfactant resupplementation. Methods: Twelve newborns with MAS [gestational age 36–40 weeks, mean birth weight 3200 g, age 4–16 h, oxygenation index (OI) > 40] transferred for ECMO therapy were treated with saline lavage (5–10 cm3/kg body weight, as long as green colored retrieval was observed) and resupplementation with bovine surfactant (Alveofact, Boehringer, Ingelheim, Germany). The OI at admission and 3 h after this procedure was compared using the t-test for paired samples. ECMO was available as rescue therapy at all times. Results: The OI decreased from 49.4 (SD ± 13.3) to 27.4 (SD ± 7.3), P meconium by extensive lavage is feasible as long as 16 h after birth even in infants considered for ECMO therapy; it might reduce the necessity of ECMO. PMID:11056719

  18. A new approach to characterise pharmaceutical aerosols: measurement of aerosol from a single dose aqueous inhaler with an optical particle counter.

    Science.gov (United States)

    Kuhli, Maren; Weiss, Maximilian; Steckel, Hartwig

    2010-01-31

    An in-line sampling system with dilution units for aqueous droplet aerosols from single dose inhalers (Berodual Respimat, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany) for an optical particle counter is described. The device has been designed to interface with a white light aerosol spectrometer (welas digital 2100, Palas GmbH, Germany) that allows the time-resolved measurement of highly concentrated aerosols. Performance of the sampling system with regard to the measured particle size distribution (PSD) is compared to Next Generation Impactor (NGI) and to laser diffraction measurements (Sympatec Inhaler and open bench). Optimal settings of the sampling system lead to PSDs that correspond well to those measured by the evaporation minimising NGI approach (15 L/min, cooled) and laser diffraction. The better accuracy of the new dilution unit in presence of an additional aerosol sampling filter in comparison to a previously described aerosol sampling system is shown for different settings of the sampling system. This allows a more precise quantification of the delivered drug amount which is also well correlated to the aerosol volume measured by the welas system. In addition, using time-resolved welas measurements provides insight into droplet size, evaporation and size changes of aerosol clouds delivered by liquid inhalers. Copyright 2009 Elsevier B.V. All rights reserved.

  19. Evaluation of a 20year old porcine reproductive and respiratory syndrome (PRRS) modified live vaccine (Ingelvac(®) PRRS MLV) against two recent type 2 PRRS virus isolates in South Korea.

    Science.gov (United States)

    Jeong, Jiwoon; Choi, Kyuhyung; Kang, Ikjae; Park, Changhoon; Chae, Chanhee

    2016-08-30

    Type 2 porcine reproductive and respiratory syndrome (PRRS) virus (PRRSV) was first isolated in Korea in 1994. The commercial PRRS modified live vaccine (Ingelvac(®) PRRS MLV, Boehringer Ingelheim Vetmedica Inc., St. Joseph, Missouri, USA) based on type 2 PRRSV, was first licensed for use in 3- to 18-week-old pigs in Korea in 1996. The objective of the present study was to evaluate the efficacy of this 20year old commercial PRRS modified live vaccine (MLV) against two recent PRRSV isolates. Two genetically distant type 2 PRRSV strains (SNUVR150004 for lineage 1 and SNUVR150324 for lineage 5), isolated in 2015, were used as challenge virus. Regardless of the challenge virus, vaccination of pigs effectively reduced the level of viremia, the lung lesions, and of the PRRSV antigen within the lung lesions. The induction of virus-specific interferon-γ secreting cells by the PRRS vaccine produced a protective immune response, leading to the reduction of PRRSV viremia. There were no significant differences in efficacy against the two recently isolated viruses by the PRRS MLV based on virological results, immunological responses, and pathological outcomes. This study demonstrates that the PRRS MLV used in this study is still effective against recently isolated heterologous type 2 PRRSV strains even after 20 years of use in over 35 million pigs. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Optimization of the Büchi B-90 spray drying process using central composite design for preparation of solid dispersions.

    Science.gov (United States)

    Gu, Bing; Linehan, Brian; Tseng, Yin-Chao

    2015-08-01

    A central composite design approach was applied to study the effect of polymer concentration, inlet temperature and air flow rate on the spray drying process of the Büchi B-90 nano spray dryer (B-90). Hypromellose acetate succinate-LF was used for the Design of Experiment (DoE) study. Statistically significant models to predict the yield, spray rate, and drying efficiency were generated from the study. The spray drying conditions were optimized according to the models to maximize the yield and efficiency of the process. The models were further validated using a poorly water-soluble investigational compound (BI064) from Boehringer Ingelheim Pharmaceuticals. The polymer/drug ratio ranged from 1/1 to 3/1w/w. The spray dried formulations were amorphous determined by differential scanning calorimetry and X-ray powder diffraction. The particle size of the spray dried formulations was 2-10 μm under polarized light microscopy. All the formulations were physically stable for at least 3h when suspended in an aqueous vehicle composed of 1% methyl cellulose. This study demonstrates that DoE is a useful tool to optimize the spray drying process, and the B-90 can be used to efficiently produce amorphous solid dispersions with a limited quantity of drug substance available during drug discovery stages. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Bai C

    2017-11-01

    Full Text Available Chunxue Bai,1 Masakazu Ichinose,2 Sang Haak Lee,3 Kwan Ho Lee,4 Olaf Jöns,5 Ulrich Bothner,6 Yihua Zhao,7 Roland Buhl8 1Department of Pulmonary Medicine, Shanghai Respiratory Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China; 2Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 3Department of Internal Medicine, St Paul’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea; 4Department of Internal Medicine, Yeungnam University Medical Center, Daegu, South Korea; 5Department of Medicine TA Respiratory Diseases, 6Department of Pharmacovigilance, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 7Department of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 8Pulmonary Department, Mainz University Hospital, Mainz, Germany Background and purpose: While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials.Materials and methods: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1 area under the curve from 0 to 3 hours (AUC0–3 response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 µg, tiotropium 5 µg, and olodaterol 5 µg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days

  2. In vitro dose comparison of Respimat® inhaler with dry powder inhalers for COPD maintenance therapy

    Directory of Open Access Journals (Sweden)

    Ciciliani A

    2017-05-01

    Full Text Available Anna-Maria Ciciliani,1,2 Peter Langguth,1 Herbert Wachtel2 1Institute of Pharmacy and Biochemistry, Faculty 09 (Chemistry, Pharmaceutics and Geosciences, Johannes Gutenberg University, Mainz, 2Analytical Development Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany Background: Combining in vitro mouth–throat deposition measurements, cascade impactor data and computational fluid dynamics (CFD simulations, four different inhalers were compared which are indicated for chronic obstructive pulmonary disease (COPD treatment.Methods: The Respimat inhaler, the Breezhaler, the Genuair, and the Ellipta were coupled to the idealized Alberta throat model. The modeled dose to the lung (mDTL was collected downstream of the Alberta throat model using either a filter or a next generation impactor (NGI. Idealized breathing patterns from COPD patient groups – moderate and very severe COPD – were applied. Theoretical lung deposition patterns were assessed by an individual path model.Results and conclusion: For the Respimat the mDTL was found to be 59% (SD 5% for the moderate COPD breathing pattern and 67% (SD 5% for very severe COPD breathing pattern. The percentages refer to nominal dose (ND in vitro. This is in the range of 44%–63% in vivo in COPD patients who display large individual variability. Breezhaler showed a mDTL of 43% (SD 2% for moderate disease simulation and 51% (SD 2% for very severe simulation. The corresponding results for Genuair are mDTL of 32% (SD 2% for moderate and 42% (SD 1% for very severe disease. Ellipta vilanterol particles showed a mDTL of 49% (SD 3% for moderate and 55% (SD 2% for very severe disease simulation, and Ellipta fluticasone particles showed a mDTL of 33% (SD 3% and 41% (SD 2%, respectively for the two breathing patterns. Based on the throat output and average flows of the different inhalers, CFD simulations were performed. Laminar and turbulent steady flow calculations indicated that

  3. Prevalence of hypertension and obesity in patients with type 2 diabetes mellitus in observational studies: a systematic literature review

    Directory of Open Access Journals (Sweden)

    Colosia AD

    2013-09-01

    Full Text Available Ann D Colosia,1 Roberto Palencia,2 Shahnaz Khan1 1RTI Health Solutions, Research Triangle Park, NC, USA; 2Boehringer Ingelheim GmbH, Ingelheim, Germany Background: Hypertension and obesity are known to contribute, directly or indirectly, to the development of long-term complications of type 2 diabetes mellitus (T2DM. Knowing the prevalence of these comorbidities is important for determining the size of the population that may benefit from strategies that reduce blood pressure and weight while controlling blood glucose. Methods: In this systematic literature review, electronic searches of PubMed, Embase, and the Cochrane Library were conducted to identify observational studies of hypertension and/or obesity prevalence in patients with T2DM throughout the world. The searches were limited to studies reported in English from January 1, 2001 to February 16, 2012. Results: From a total of 2,688 studies, 92 observational studies provided prevalence rates for hypertension and/or obesity specifically in adults with T2DM. Fifteen studies of specific subtypes of hypertension or subpopulations with T2DM were subsequently excluded, leaving 78 studies (in 77 articles for inclusion in this article. Of these, 61 studies reported hypertension prevalence, 44 reported obesity prevalence, and 12 reported the prevalence of hypertension with obesity. Most studies had a low risk of bias regarding diagnosis of T2DM (70/78, hypertension (59/69, or obesity (45/47. The continental regions with the most observational studies of hypertension or obesity prevalence were Europe (n = 30 and Asia (n = 26. Hypertension rates typically were high in all regions; most studies presented rates above 50%, and many presented rates above 75%. Obesity rates exceeded 30% in 38 of 44 studies and 50% in 14 of 44 studies, especially those assessing central obesity (based on waist circumference. Among obese adults, hypertension rates were at or above 70% in Asia and above 80% in Europe; rates

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

    Directory of Open Access Journals (Sweden)

    Ampudia-Blasco FJ

    2017-01-01

    Full Text Available Francisco Javier Ampudia‑Blasco,1 Irene Romera,2 Bernat Ariño,3 Ramón Gomis4 1Endocrinology and Nutrition Department, Clinic University Hospital Valencia, Valencia, Spain; 2Eli Lilly and Company España, Madrid, Spain; 3Boehringer Ingelheim España, Barcelona, Spain; 4Endocrinology Department, Hospital Clinic Barcelona, Barcelona, Spain Background: The recently published cardiovascular outcomes data for the first sodium–glucose cotransporter 2 (SGLT2 inhibitor, empagliflozin, have shown cardiovascular safety and additional benefits in patients with type 2 diabetes and established cardiovascular disease. Empagliflozin showed lower rates of death from cardiovascular causes or from any causes and lower hospitalization rates from heart failure compared with placebo, both in addition to standard care. This commentary discusses the existence of a possible class effect considering the available evidence described for other SGLT2 inhibitors. Main text: Empagliflozin, dapagliflozin and canagliflozin share the same mechanism of action, and it is a plausible hypothesis that some of the benefits of empagliflozin treatment could also be expected from other SGLT2 inhibitors. However, the rapid and persistent occurrence of cardiovascular benefits observed with empagliflozin and the different results shown by the three inhibitors in meta-analyses of some of their respective Phase II and III trials might suggest another possible mechanism of action, perhaps related to the different selectivity to inhibit SGLT-2 and other SGLT family members that these compounds present. Conclusion: There is still lack of evidence to answer whether the cardiovascular benefits observed with empagliflozin in the EMPA-REG OUTCOME study could be seen as a “class effect”, which is also attributable to dapagliflozin and canagliflozin. Keywords: cardiovascular, outcome studies, SGLT2 inhibitors, empagliflozin, dapagliflozin, canagliflozin

  5. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study.

    Science.gov (United States)

    Kadowaki, Takashi; Haneda, Masakazu; Inagaki, Nobuya; Terauchi, Yasuo; Taniguchi, Atsushi; Koiwai, Kazuki; Rattunde, Henning; Woerle, Hans J; Broedl, Uli C

    2015-04-01

    The aim of this randomized, double-blind, parallel-group study was to investigate the safety and efficacy of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes (T2DM). In a 12-week dose-finding period, patients [N = 547; mean baseline glycosylated hemoglobin (HbA1c) 7.92-8.02%] received empagliflozin (5, 10, 25, or 50 mg) or placebo. In a 40-week extension period, patients on empagliflozin 10 or 25 mg continued the same treatment and patients on other doses were reallocated to empagliflozin 10 or 25 mg. Outcomes at week 52 included changes from baseline in HbA1c, fasting plasma glucose (FPG), weight and blood pressure (BP) in patients who received empagliflozin 10 or 25 mg in both the initial 12 weeks and the extension and safety in patients treated with ≥1 dose of empagliflozin 10 or 25 mg. Adjusted mean ± SE changes in HbA1c from baseline at week 52 were -0.67 ± 0.09% and -0.86 ± 0.09%, in FPG were -24.7 ± 3.2 mg/dL and -31.3 ± 3.4 mg/dL, and in body weight were -3.1 ± 0.4 kg and -3.1 ± 0.4 kg, with empagliflozin 10 and 25 mg, respectively. Both doses reduced systolic and diastolic BP. Adverse events were reported in 70.8% and 66.8% of patients on empagliflozin 10 and 25 mg, respectively. Confirmed hypoglycemic adverse events (plasma glucose ≤70 mg/dL and/or requiring assistance) were reported in one patient per group. Empagliflozin monotherapy for 52 weeks led to sustained reductions in HbA1c, FPG, weight and BP and was well tolerated in Japanese patients with T2DM. Boehringer Ingelheim and Eli Lilly and Company.

  6. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD

    Directory of Open Access Journals (Sweden)

    Hodder R

    2011-04-01

    Full Text Available Rick Hodder1, Demetri Pavia2, Angela Lee2, Eric Bateman31Divisions of Pulmonary and Critical Care, University of Ottawa, Ottawa, ON, Canada; 2Boehringer Ingelheim Limited, Bracknell, England, UK; 3Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South AfricaAbstract: Bronchoconstriction has been reported in asthma and chronic obstructive pulmonary disease (COPD patients after administration of some aqueous inhalation solutions. We investigated the incidence of this event during long-term clinical trials of tiotropium delivered via Respimat® Soft Mist™ Inhaler (SMI. We retrospectively analyzed pooled data from two identical Phase III clinical trials, in which 1990 patients with COPD received 48 weeks' treatment with once-daily tiotropium (5 or 10 µg or placebo inhaled via Respimat® SMI. We recorded the incidence of bronchospasm and of a range of respiratory events that could suggest bronchoconstriction during the first 30 minutes after inhalation of study treatment on each of the eight test days. No patients reported bronchospasm. Six patients (0.3% reported a combination of at least two events suggestive of bronchoconstriction, and 21 (1.1% reported either rescue medication use or a respiratory adverse event. Asymptomatic falls in forced expiratory volume in one second (FEV1 of ≥15% were recorded on all test days, with no change in incidence over time, and affected 8.2% of those in the tiotropium groups and 14.5% of those on placebo. In COPD patients receiving long-term treatment with tiotropium 5 or 10 µg via Respimat® SMI, no bronchospasm was recorded, and the number of events possibly indicative of paradoxical bronchoconstriction was very low.Keywords: inhalation device, bronchoconstriction, COPD, tiotropium

  7. Assessment of the insecticidal activity of afoxolaner against Aedes aegypti in dogs treated with NexGard®.

    Science.gov (United States)

    Liebenberg, Julian; Fourie, Josephus; Lebon, Wilfried; Larsen, Diane; Halos, Lenaïg; Beugnet, Frédéric

    2017-01-01

    Twelve healthy dogs were studied in this parallel group, blinded, randomised, and negative controlled efficacy study. On Day -1, the 12 dogs included were ranked within sex in descending order of individual pre-treatment (Day -5) fed mosquito counts and randomly allocated by blocks of two dogs to the untreated control group or the afoxolaner-treated group. NexGard ® (Merial, now part of Boehringer Ingelheim Animal Health) was administered orally on Day 0 in accordance with the European label instructions. On Days 1, 7, 14, 21 and 28, all dogs were exposed for a duration of 1 hour to 50 ± 5 unfed Aedes aegypti females. After each exposure, mosquitoes were collected after 1 hour and assessed for viability during collection and at 24 ± 2 hours. The arithmetic (and geometric) mean values of live fed mosquito counts at 24 hours after the exposure periods for the negative control group ranged from 33.7 (32.3) to 49.8 (49.7), indicating that this was a vigorous mosquito strain. There was no significant difference between control and treated groups in the number of live and fed mosquitoes at each 1 hour post-exposure collection time. Based on arithmetic and geometric mean values at 24 hours after each exposure, significantly fewer live fed mosquitoes were recorded in the treated group, compared to the negative control group, throughout the study (p afoxolaner insecticidal efficacy against A. aegypti varied from 98% (Day 2) to 75.3% (Day 29) based on arithmetic means, and 98.7% (Day 2) to 89.8% (Day 29) based on geometric means. © J. Liebenberg et al., published by EDP Sciences, 2017.

  8. Comorbidity in chronic obstructive pulmonary disease. Related to disease severity?

    Directory of Open Access Journals (Sweden)

    Echave-Sustaeta JM

    2014-11-01

    Full Text Available Jose M Echave-Sustaeta,1 Lorena Comeche Casanova,1 Borja G Cosio,2 Juan Jose Soler-Cataluña,3 Ricardo Garcia-Lujan,1 Xavier Ribera41Respiratory Department, Hospital Universitario Quirón Madrid, Madrid, Spain; 2Respiratory Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain; 3Respiratory Department, Hospital Arnau de Vilanova, Valencia, Spain; 4Medical Deparment, Boehringer Ingelheim, Barcelona, SpainBackground and objective: Several diseases commonly co-exist with chronic obstructive pulmonary disease (COPD, especially in elderly patients. This study aimed to investigate whether there is an association between COPD severity and the frequency of comorbidities in stable COPD patients.Patients and methods: In this multicenter, cross-sectional study, patients with spirometric diagnosis of COPD attended to by internal medicine departments throughout Spain were consecutively recruited by 225 internal medicine specialists. The severity of airflow obstruction was graded using the Global Initiative for Chronic Obstructive Lung Disease (GOLD and data on demographics, smoking history, comorbidities, and dyspnea were collected. The Charlson comorbidity score was calculated.Results: Eight hundred and sixty-six patients were analyzed: male 93%, mean age 69.8 (standard deviation [SD] 9.7 years and forced vital capacity in 1 second 42.1 (SD 17.7%. Even, the mean (SD Charlson score was 2.2 (2.2 for stage I, 2.3 (1.5 for stage II, 2.5 (1.6 for stage III, and 2.7 (1.8 for stage IV (P=0.013 between stage I and IV groups, independent predictors of Charlson score in the multivariate analysis were age, smoking history (pack-years, the hemoglobin level, and dyspnea, but not GOLD stage.Conclusion: COPD patients attended to in internal medicine departments show high scores of comorbidity. However, GOLD stage was not an independent predictor of comorbidity.Keywords: Charlson, comorbidity, COPD

  9. Time to Angiographic Reperfusion and Clinical Outcome after Acute Ischemic Stroke in the Interventional Management of Stroke Phase III (IMS III) Trial: A Validation Study

    Science.gov (United States)

    Khatri, Pooja; Yeatts, Sharon D.; Mazighi, Mikael; Broderick, Joseph P.; Liebeskind, David S.; Demchuk, Andrew M.; Amarenco, Pierre; Carrozzella, Janice; Spilker, Judith; Foster, Lydia D.; Goyal, Mayank; Hill, Michael D.; Palesch, Yuko Y.; Jauch, Edward C.; Haley, E. Clarke; Vagal, Achala; Tomsick, Thomas A.

    2014-01-01

    BACKGROUND The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. METHODS The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. FINDINGS Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). INTERPRETATION We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support). PMID:24784550

  10. Essential rules and requirements for global clinical trials in rare lung diseases: a sponsor's standpoint.

    Science.gov (United States)

    Kuerner, Thomas

    2015-01-01

    International multicenter trials have the advantage of being able to recruit many patients within a short period. This is particularly useful for rare diseases. Ideally, conclusions drawn from the results of a global clinical trial apply to all study centers and countries involved, potentially expediting drug development and facilitating approval in foreign markets. However, several challenges must be overcome to ensure optimal trial conduct and coordinate trial sites working under different regulations and technical and cultural conditions. Thus, standardizing these trial elements is essential and may include training courses for the medical and technical staff at the study sites. Considering a rare disease, such as idiopathic pulmonary fibrosis (IPF), it is the trial sponsor's responsibility to seek consensus among clinical experts and regulatory agencies about fundamental questions, including a consistent diagnosis. In cross-cultural studies, it is important to use hard (objective) efficacy endpoints rather than patient-reported (subjective) measures, such as quality of life. A quality assurance program should be implemented, including the central review of diagnostic findings. Careful safety monitoring and an external independent data monitoring committee that periodically assesses a study treatment's risk-benefit ratio are required to protect trial patients from potential harm. Over the past few years, Boehringer Ingelheim has conducted two large-scale global clinical trials for the treatment of IPF (INPULSIS™-1 and INPULSIS™-2). These studies have just been completed and, as a result of careful planning, have successfully complied with the standards and needs of an international, cross-cultural study. Copyright © 2014 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  11. Assessment of the insecticidal activity of afoxolaner against Aedes aegypti in dogs treated with NexGard®

    Directory of Open Access Journals (Sweden)

    Liebenberg Julian

    2017-01-01

    Full Text Available Twelve healthy dogs were studied in this parallel group, blinded, randomised, and negative controlled efficacy study. On Day -1, the 12 dogs included were ranked within sex in descending order of individual pre-treatment (Day -5 fed mosquito counts and randomly allocated by blocks of two dogs to the untreated control group or the afoxolaner-treated group. NexGard® (Merial, now part of Boehringer Ingelheim Animal Health was administered orally on Day 0 in accordance with the European label instructions. On Days 1, 7, 14, 21 and 28, all dogs were exposed for a duration of 1 hour to 50 ± 5 unfed Aedes aegypti females. After each exposure, mosquitoes were collected after 1 hour and assessed for viability during collection and at 24 ± 2 hours. The arithmetic (and geometric mean values of live fed mosquito counts at 24 hours after the exposure periods for the negative control group ranged from 33.7 (32.3 to 49.8 (49.7, indicating that this was a vigorous mosquito strain. There was no significant difference between control and treated groups in the number of live and fed mosquitoes at each 1 hour post-exposure collection time. Based on arithmetic and geometric mean values at 24 hours after each exposure, significantly fewer live fed mosquitoes were recorded in the treated group, compared to the negative control group, throughout the study (p < 0.001. The afoxolaner insecticidal efficacy against A. aegypti varied from 98% (Day 2 to 75.3% (Day 29 based on arithmetic means, and 98.7% (Day 2 to 89.8% (Day 29 based on geometric means.

  12. Economic assessment of Ostertagia ostertagi and Fasciola hepatica infections in dairy cattle herds in Germany using Paracalc®.

    Science.gov (United States)

    Fanke, Jane; Charlier, Johannes; Steppin, Torsten; von Samson-Himmelstjerna, Georg; Vercruysse, Jozef; Demeler, Janina

    2017-06-15

    The aim of the current study was to estimate economic costs of Ostertagia ostertagi and Fasciola hepatica infections in dairy cattle herds in Germany using the online calculation programme Paracalc ® . Following a questionnaire, survey data were available from 464 farms in 14 federal states. On those farms bulk tank milk (BTM) samples and additionally up to six serum samples collected from first season grazing calves were analysed, using a commercially available ELISA (Boehringer Ingelheim SVANOVA Biotech AB, Uppsala, Sweden), an in-house ELISA (F. hepatica) and an in-house serum pepsinogen test. In total, samples obtained from 344 farms were included in the analysis since those were the only farms with complete questionnaires. Median costs per farm and year were estimated for gastrointestinal (GI) nematode infections (€721.38) and F. hepatica infection (€565.61). Decreases in milk yield in multiparous cows were the major reason for annual production losses due to GI nematodes (€13.33 per cow) and F. hepatica infections (€7.95 per cow), which was followed by annual costs for anthelmintic treatment against GI nematode infections in adult cows (€10.00 per cow) and F. hepatica infection associated annual costs due to repeated artificial insemination (€10.13 per cow) and prolonged calving intervals (€9.40 per cow). The study demonstrated that if all required information is provided, the Paracalc ® tool can assist to identify productions losses in dairy cattle herds due to helminth infections and to optimise farm economics in Germany. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

    Directory of Open Access Journals (Sweden)

    van Dijk Arie PJ

    2008-12-01

    Full Text Available Abstract Background - Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. Methods/design - In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse® Boehringer Ingelheim GmbH, a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year. The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. Discussion - The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage

  14. Combination of the sodium-glucose cotransporter-2 inhibitor empagliflozin with orlistat or sibutramine further improves the body-weight reduction and glucose homeostasis of obese rats fed a cafeteria diet

    Directory of Open Access Journals (Sweden)

    Vickers SP

    2014-07-01

    Full Text Available Steven P Vickers,1 Sharon C Cheetham,1 Katie R Headland,1 Keith Dickinson,1 Rolf Grempler,2 Eric Mayoux,2 Michael Mark,2 Thomas Klein2 1RenaSci, BioCity Nottingham, Nottingham, UK; 2Boehringer Ingelheim Pharma, Biberach an der Riss, Germany Abstract: The present study assessed the potential of the sodium glucose-linked transporter (SGLT-2 inhibitor empagliflozin to decrease body weight when administered alone or in combination with the clinically effective weight-loss agents orlistat and sibutramine in obese rats fed a cafeteria diet. Female Wistar rats were exposed to a cafeteria diet to induce obesity. Empagliflozin was dosed once daily (10, 30, and 60 mg/kg for 28 days. Combination studies were subsequently performed using a submaximal empagliflozin dose (10 mg/kg with either sibutramine or orlistat. Body weight, food, and water intake were recorded daily. The effect of drug treatment on glucose tolerance, relevant plasma parameters, and carcass composition was determined. Empagliflozin dose-dependently reduced body weight, plasma leptin, and body fat though increased urinary glucose excretion. The combination of empagliflozin and orlistat significantly reduced body weight compared to animals treated with either drug alone, and significantly improved glucose tolerance, plasma insulin, and leptin compared to vehicle-treated controls. The effect of sibutramine to improve glycemic control in an oral glucose-tolerance test was also significantly increased, with empagliflozin and combination treatment leading to a reduction in carcass fat greater than that observed with either drug alone. These data demonstrate that empagliflozin reduces body weight in cafeteria-fed obese rats. In combination studies, empagliflozin further improved the body-weight or body-fat loss of animals in comparison to orlistat or sibutramine alone. Such studies may indicate improved strategies for the treatment of obese patients with prediabetes or type 2 diabetes. Keywords

  15. Dynamics and evolution of porcine reproductive and respiratory syndrome virus (PRRSV) ORF5 following modified live PRRSV vaccination in a PRRSV-infected herd.

    Science.gov (United States)

    Nilubol, Dachrit; Tripipat, Thitima; Hoonsuwan, Tawatchai; Tipsombatboon, Pavita; Piriyapongsa, Jittima

    2014-01-01

    The objective of this study was to investigate the dynamics and evolution of porcine reproductive and respiratory syndrome virus (PRRSV) ORF5 following the use of a modified live PRRSV (MLV) vaccine. A PRRSV-positive farm with coexistence of types 1 and 2 and no history of MLV vaccination was investigated. Vaccination with a type 2 MLV (Ingelvac PRRS MLV, Boehringer Ingelheim, USA) was implemented. All sows were vaccinated at monthly intervals for two consecutive months and then every third month. Piglets were vaccinated once at 7-10 days of age and weaned to nursery facilities at 21-23 days of age. Serum samples were collected monthly before and after vaccination from four population groups, including replacement gilts and suckling, nursery and finishing pigs, and assayed by PCR. After a year of blood collection, amplified products were sequenced, resulting in 277 complete ORF5 gene sequences from 145 type 1 and 132 type 2 isolates. Prior to and following vaccination, both type 1 and type 2 PRRSV were isolated and found to coexist in an individual pig. Each genotype evolved separately without influencing the strain development of the other. Although the substitution rates of both genotypes were relatively similar, MLV vaccination appears to increase the heterogenicity of type 2 PRRSV, resulting in the emergence of three novel type 2 PRRSV clusters in the herd, including an MLV-like cluster, which disappeared within the month following whole-herd vaccination. Two additional clusters included one related to the MLV vaccine and one related to the endemic cluster of the herd.

  16. Comparison of Aerodynamic Particle Size Distribution Between a Next Generation Impactor and a Cascade Impactor at a Range of Flow Rates.

    Science.gov (United States)

    Yoshida, Hiroyuki; Kuwana, Akemi; Shibata, Hiroko; Izutsu, Ken-Ichi; Goda, Yukihiro

    2017-04-01

    Wide variation in respiratory flow rates between patients emphasizes the importance of evaluating the aerodynamic particle size distribution (APSD) of dry powder inhaler (DPI) using a multi-stage impactor at different flow rates. US Pharmacopeia recently listed modified configurations of the Andersen cascade impactor (ACI) and new sets of cut-off diameter specifications for the operation at flow rates of 60 and 90 L/min. The purpose of this study was to clarify the effect of these changes on the APSD of DPI products at varied flow rates. We obtained APSD profiles of four DPIs and device combinations, Relenza®-Diskhaler® (GlaxoSmithKline Co.), Seebri®-Breezhaler® (Novartis Pharma Co.), Pulmicort®-Turbuhaler® (Astrazeneca Co.), and Spiriva®-Handihaler® (Nippon Boehringer Ingelheim Co.) using Next Generation Impactors (NGIs) and ACIs at flow rates from 28.3 to 90 L/min to evaluate the difference in the use of previous and new sets of cut-off diameter specifications. Processing the data using the new specifications for ACI apparently reduced large differences in APSD obtained by NGI and ACI with the previous specifications at low and high flow rates in all the DPIs. Selecting the appropriate configuration of ACI corresponding to the flow rate provided comparable APSD profiles of Pulmicort®-Turbuhaler® to those using NGIs at varied flow rates. The results confirmed the relevance of the current US Pharmacopeia specifications for ACI analysis in obtaining APSD profiles of DPI products at wide flow rates.

  17. Expert Panel Recommendations for the Identification and Management of Hyperkalemia and Role of Patiromer in Patients with Chronic Kidney Disease and Heart Failure.

    Science.gov (United States)

    Rafique, Zubaid; Weir, Matthew R; Onuigbo, Macaulay; Pitt, Bertram; Lafayette, Richard; Butler, Javed; Lopes, Maria; Farnum, Carolyn; Peacock, W Frank

    2017-04-01

    Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population. The panel noted that hyperkalemia is a serious condition that can lead to life-threatening complications, yet the treatment paradigm for hyperkalemia has remained without major advances for approximately 50 years, until the approval of patiromer. A number of issues still exist in the management of this patient population, including the lack of uniform treatment guidelines and consensus regarding the approach to treatment. As part of its effort, the panel developed an algorithm, the Proposed Diagnostic Algorithm for Hyperkalemia Treatment in the Acute Care Setting/Chronic Care. The panel agreed that patiromer appears to be a viable option for the management of hyperkalemia in patients with chronic kidney disease and/or heart failure and in patients who experience chronic hyperkalemia. This panel discussion was funded by Relypsa and facilitated by Magellan Rx Management. Rafique is a principal investigator for Relypsa and serves as a consultant for Instrumentation Laboratory, Magellan Health, Relypsa, and ZS-Pharma. Butler serves as consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, CardioCell, Janssen, Merck, Novartis, Relypsa, and ZS-Pharma. Lopes and Farnum are employed by Magellan Rx Management. Rafique designed the management protocol for this panel discussion and contributed to the writing and editing of this report document. The other authors report no conflicting interests. Relypsa

  18. 77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

    Science.gov (United States)

    2012-03-19

    ... regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer...., Rockville, MD 20855, 240-276-8336, email: [email protected] . SUPPLEMENTARY INFORMATION: Boehringer...

  19. Efficacy and tolerability of a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg according to age, gender, race, hypertension severity, and previous antihypertensive use: planned analyses of a randomized trial

    Directory of Open Access Journals (Sweden)

    Zhu D

    2013-04-01

    Full Text Available Dingliang Zhu,1 Harold Bays,2 Pingjin Gao,1 Michaela Mattheus,3 Birgit Voelker,3 Luis M Ruilope4 1Shanghai Ruijin Hospital, Shanghai, People’s Republic of China; 2Louisville Metabolic and Atherosclerosis Research Center Inc, Louisville, KY, USA; 3Boehringer Ingelheim International GmbH, Ingelheim, Germany; 4Hospital 12 de Octubre, Madrid, Spain Background: The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25 single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 100 mmHg in specific patient subpopulations. Methods: This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ≥ 65 years versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP 30 mmHg and >40 mmHg. Results: Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of >30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ≥65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients

  20. Impact of tiotropium + olodaterol on physical functioning in COPD: results of an open-label observational study

    Directory of Open Access Journals (Sweden)

    Sauer R

    2016-04-01

    Full Text Available Rüdiger Sauer,1 Michaela Hänsel,2 Roland Buhl,3 Roman A Rubin,4 Marcel Frey,5 Thomas Glaab2,3 1Lung Centre Ulm, Ulm, Germany; 2Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 3Pulmonary Department, Mainz University Hospital, Mainz, Germany; 4Pulmonary Specialist Practice, Wiesbaden, Germany; 5Biometrics, Alcedis GmbH, Gießen, Germany Background: Maintaining and improving physical functioning is key to mitigating the cycle of deconditioning associated with chronic obstructive pulmonary disease (COPD. We evaluated the impact of free combination of the long-acting anticholinergic tiotropium plus the long-acting β2-agonist olodaterol on physical functioning in a real-world clinical setting. Methods: In this open-label noninterventional study, Global initiative for chronic Obstructive Lung Disease (GOLD B–D patients with COPD aged ≥40 years were treated for 4–6 weeks with either tiotropium 5 µg + olodaterol 5 µg (both via Respimat® inhaler or tiotropium 18 µg (HandiHaler® + olodaterol 5 µg (Respimat® once daily. Physical functioning was assessed by the self-reported 10-item Physical Functioning Questionnaire (PF-10. The primary end point was the percentage of patients achieving therapeutic success, defined as a 10-point increase in the PF-10 between baseline (visit 1 and weeks 4–6 (visit 2. Secondary end points included absolute PF-10 scores, Physicians’ Global Evaluation, satisfaction with Respimat® and adverse events. Results: A total of 1,858 patients were treated: 1,298 (69.9% with tiotropium 5 µg + olodaterol 5 µg and 560 (30.1% with tiotropium 18 µg + olodaterol 5 µg. At study end, 1,683 (92.6% and 1,556 patients (85.6% continued using tiotropium and olodaterol, respectively; 48.9% (95% confidence interval: 46.5, 51.3 achieved the primary end point. Therapeutic success rates were significantly higher for maintenance-naïve patients compared to those who had received prior therapy (59.1% vs 44.5%; P<0

  1. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

    Science.gov (United States)

    Zinman, Bernard; Wanner, Christoph; Lachin, John M; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Mattheus, Michaela; Devins, Theresa; Johansen, Odd Erik; Woerle, Hans J; Broedl, Uli C; Inzucchi, Silvio E

    2015-11-26

    The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number

  2. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials.

    Science.gov (United States)

    Kohler, Sven; Zeller, Cordula; Iliev, Hristo; Kaspers, Stefan

    2017-07-01

    benefit-risk profile of empagliflozin in patients with T2DM. Boehringer Ingelheim Pharma GmbH.

  3. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.

    Science.gov (United States)

    Wanner, Christoph; Inzucchi, Silvio E; Lachin, John M; Fitchett, David; von Eynatten, Maximilian; Mattheus, Michaela; Johansen, Odd Erik; Woerle, Hans J; Broedl, Uli C; Zinman, Bernard

    2016-07-28

    . (Funded by the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

  4. Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes.

    Science.gov (United States)

    Yasui, Atsutaka; Lee, Ganghyuck; Hirase, Tetsuaki; Kaneko, Tatsuroh; Kaspers, Stefan; von Eynatten, Maximilian; Okamura, Tomoo

    2018-04-01

    Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, ameliorates hyperglycemia in patients with type 2 diabetes (T2D) by inducing sustained glucosuria. Empagliflozin treatment was previously associated with a transient increase in 24-h urine volume in Caucasian patients with T2D, however comparable evidence in Japanese T2D individuals is scarce. We therefore assessed acute and chronic changes in 24-h urine volume and fluid intake with empagliflozin in Japanese patients with T2D. In this randomized, double-blind, placebo-controlled, parallel-group, multiple-dose, 4-week trial, 100 Japanese patients with T2D were randomized to receive either 1, 5, 10, or 25 mg empagliflozin or placebo once-daily. Changes from baseline in 24-h urine volume and fluid intake were assessed at days 1, 27, and 28 after the initiation of empagliflozin. The 24-h urine volume and fluid intake were comparable across all treatment groups at baseline. Patients treated with either 10 or 25 mg empagliflozin (i.e., the licensed doses in Japan) showed a significant increase in 24-h urine volume compared to placebo at day 1 (mean change from baseline: + 0.83, + 1.08, and + 0.29 L/day in the empagliflozin 10 and 25 mg groups and the placebo group, respectively; both p empagliflozin groups were comparable to placebo at day 27 and 28 (differences vs placebo  0.05). The 24-h fluid intake was comparable across all study groups throughout the entire study period. No events consistent with dehydration were reported during empagliflozin treatment. Treatment initiation with empagliflozin in Japanese patients with T2D was associated with transient diuresis; however, overall urine volume returned towards baseline levels within 4 weeks of treatment. These findings are consistent with a physiological, adaptive mechanism of the kidney to maintain overall body fluid balance in response to treatment initiation with a SGLT2 inhibitor. NCT00885118. Nippon Boehringer Ingelheim Co., Ltd.

  5. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Ferguson GT

    2013-03-01

    Full Text Available Gary T Ferguson,1 Mo Ghafouri,2 Luyan Dai,2 Leonard J Dunn31Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Clinical Research of West Florida, Inc, Clearwater, FL, USABackground: Ipratropium bromide/albuterol Respimat inhaler (CVT-R was developed as an environmentally friendly alternative to ipratropium bromide/albuterol metered-dose inhaler (CVT-MDI, which uses a chlorofluorocarbon propellant.Objective: The objective of this study was to evaluate patient satisfaction, device usage, and long-term safety of CVT-R compared to CVT-MDI, and to the simultaneous administration of ipratropium bromide hydrofluoroalkane (HFA; I and albuterol HFA (A metered-dose inhalers as dual monotherapies (I + A.Design: This is a 48-week, open-label, randomized, active-controlled, parallel-group study (n = 470 comparing CVT-R to CVT-MDI and to I + A.Participants: Patients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD, and current or exsmokers.Interventions: Patients were randomized to receive: (1 CVT-R, one inhalation four times daily (QID; or (2 CVT-MDI, two inhalations QID; or (3 I + A two inhalations of each inhaler QID.Main measures: Patient Satisfaction and Preference Questionnaire (PASAPQ performance score (primary endpoint and adverse events.Key results: PASAPQ performance score was significantly higher (CVT-R versus CVT-MDI, 9.6; and CVT-R versus I + A, 6.2; both P < 0.001 when using CVT-R compared to CVT-MDI or I + A at all visits starting from week 3, while CVT-MDI and I + A treatment groups were similar. Time to first COPD exacerbation was slightly longer in the CVT-R group compared to the other treatment groups, although it did not reach statistical significance (CVT-R versus CVT-MDI, P = 0.57; CVT-R versus I + A, P = 0.22. Rates of withdrawal and patient refusal to continue treatment were lower in CVT-R compared with CVT

  6. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): an open-label randomised controlled trial.

    Science.gov (United States)

    Wachter, Rolf; Gröschel, Klaus; Gelbrich, Götz; Hamann, Gerhard F; Kermer, Pawel; Liman, Jan; Seegers, Joachim; Wasser, Katrin; Schulte, Anna; Jürries, Falko; Messerschmid, Anna; Behnke, Nico; Gröschel, Sonja; Uphaus, Timo; Grings, Anne; Ibis, Tugba; Klimpe, Sven; Wagner-Heck, Michaela; Arnold, Magdalena; Protsenko, Evgeny; Heuschmann, Peter U; Conen, David; Weber-Krüger, Mark

    2017-04-01

    months, we detected atrial fibrillation in 14% of 200 patients in the enhanced and prolonged monitoring group (27 patients) versus 5% in the control group (nine of 198 patients, absolute difference 9·0%; 95% CI 3·4-14·5, p=0·002; number needed to screen 11). Enhanced and prolonged monitoring initiated early in patients with acute ischaemic stroke aged 60 years or older was better than standard care for the detection of atrial fibrillation. These findings support the consideration of all patients aged 60 years or older with stroke for prolonged monitoring if the detection of atrial fibrillation would result in a change in medical management (eg, initiation of anticoagulation). Boehringer Ingelheim. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Intramuscular Immunization of Mice with the Live-Attenuated Herpes Simplex Virus 1 Vaccine Strain VC2 Expressing Equine Herpesvirus 1 (EHV-1) Glycoprotein D Generates Anti-EHV-1 Immune Responses in Mice.

    Science.gov (United States)

    Liu, Shiliang A; Stanfield, Brent A; Chouljenko, Vladimir N; Naidu, Shan; Langohr, Ingeborg; Del Piero, Fabio; Ferracone, Jacqueline; Roy, Alma A; Kousoulas, Konstantin G

    2017-06-15

    Vaccination remains the best option to combat equine herpesvirus 1 (EHV-1) infection, and several different strategies of vaccination have been investigated and developed over the past few decades. Herein, we report that the live-attenuated herpes simplex virus 1 (HSV-1) VC2 vaccine strain, which has been shown to be unable to enter into neurons and establish latency in mice, can be utilized as a vector for the heterologous expression of EHV-1 glycoprotein D (gD) and that the intramuscular immunization of mice results in strong antiviral humoral and cellular immune responses. The VC2-EHV-1-gD recombinant virus was constructed by inserting an EHV-1 gD expression cassette under the control of the cytomegalovirus immediate early promoter into the VC2 vector in place of the HSV-1 thymidine kinase (UL23) gene. The vaccines were introduced into mice through intramuscular injection. Vaccination with both the VC2-EHV-1-gD vaccine and the commercially available vaccine Vetera EHV XP 1/4 (Vetera; Boehringer Ingelheim Vetmedica) resulted in the production of neutralizing antibodies, the levels of which were significantly higher in comparison to those in VC2- and mock-vaccinated animals ( P vaccination with the VC2-EHV-1-gD vaccine stimulated robust IgG1 and IgG2a antibodies after three vaccinations ( P vaccinated mice produced significantly higher levels of IgM than mice in the other groups before and after challenge ( P Vaccination with VC2-EHV-1-gD stimulated strong cellular immune responses, characterized by the upregulation of both interferon- and tumor necrosis factor-positive CD4 + T cells and CD8 + T cells. Overall, the data suggest that the HSV-1 VC2 vaccine strain may be used as a viral vector for the vaccination of horses as well as, potentially, for the vaccination of other economically important animals. IMPORTANCE A novel virus-vectored VC2-EHV-1-gD vaccine was constructed using the live-attenuated HSV-1 VC2 vaccine strain. This vaccine stimulated strong humoral

  8. Three-minute constant rate step test for detecting exertional dyspnea relief after bronchodilation in COPD

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    Borel B

    2016-11-01

    Full Text Available Benoit Borel,1,2 Courtney A Wilkinson-Maitland,3 Alan Hamilton,4 Jean Bourbeau,5 Hélène Perrault,6 Dennis Jensen,3,5,7 François Maltais2 1Laboratoire HAVAE, Université de Limoges, Limoges, France; 2Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, 3Clinical Exercise and Respiratory Physiology Laboratory, Department of Kinesiology and Physical Education, McGill University, Montréal, QC, 4Boehringer Ingelheim (Canada Limited, Burlington, ON, 5Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Center, Montreal, QC, 6Faculty of Health Sciences, University of Ottawa, Ottawa, ON, 7Translational Research in Respiratory Diseases Program, Research Institute of the McGill University Health Centre, Montreal, QC, Canada Background: The aim of this study was to evaluate the responsiveness of the 3-minute constant rate step test (3-MST to detect the relief of exertional dyspnea (respiratory discomfort after acute bronchodilation in COPD patients. Patients and methods: A total of 40 patients with moderate-to-severe COPD (mean forced expiratory volume in 1 second: 45.7 (±14.7, % predicted performed four 3-MSTs at randomly assigned stepping rates of 14, 16, 20 and 24 steps/min after inhalation of nebulized ipratropium bromide (500 µg/salbutamol (2.5 mg and saline placebo, which were randomized to order. Patients rated their intensity of perceived dyspnea at the end of each 3-MST using Borg 0–10 category ratio scale. Results: A total of 37 (92.5%, 36 (90%, 34 (85% and 27 (67.5% patients completed all 3 minutes of exercise at 14, 16, 20 and 24 steps/min under both treatment conditions, respectively. Compared with placebo, ipratropium bromide/salbutamol significantly decreased dyspnea at the end of the third minute of exercise at 14 steps/min (by 0.6±1.0 Borg 0–10 scale units, P<0.01 and 16 steps/min (by 0.7±1.3 Borg 0–10 scale

  9. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation.

    Science.gov (United States)

    Cannon, Christopher P; Bhatt, Deepak L; Oldgren, Jonas; Lip, Gregory Y H; Ellis, Stephen G; Kimura, Takeshi; Maeng, Michael; Merkely, Bela; Zeymer, Uwe; Gropper, Savion; Nordaby, Matias; Kleine, Eva; Harper, Ruth; Manassie, Jenny; Januzzi, James L; Ten Berg, Jurrien M; Steg, P Gabriel; Hohnloser, Stefan H

    2017-10-19

    lower among those who received dual therapy with dabigatran and a P2Y 12 inhibitor than among those who received triple therapy with warfarin, a P2Y 12 inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864 .).

  10. Initiation of triple therapy maintenance treatment among patients with COPD in the US

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    Simeone JC

    2016-12-01

    Full Text Available Jason C Simeone,1 Rakesh Luthra,2 Shuchita Kaila,2 Xiaoyun Pan,1 Tarun D Bhagnani,1 Jieruo Liu,1 Teresa K Wilcox1 1Real-World Evidence, Evidera, Waltham, MA, 2HEOR Value Demonstration Team, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD recommends triple therapy (long-acting muscarinic receptor antagonists, long-acting beta-2 agonists, and inhaled corticosteroids for patients with only the most severe COPD. Data on the proportion of COPD patients on triple therapy and their characteristics are sparse and dated. Objective 1 of this study was to estimate the proportion of all, and all treated, COPD patients receiving triple therapy. Objective 2 was to characterize those on triple therapy and assess the concordance of triple therapy use with GOLD guidelines. Patients and methods: This retrospective study used claims from the IMS PharMetrics Plus database from 2009 to 2013. Cohort 1 was selected to assess Objective 1 only; descriptive analyses were conducted in Cohort 2 to answer Objective 2. A validated claims-based algorithm and severity and frequency of exacerbations were used as proxies for COPD severity. Results: Of all 199,678 patients with COPD in Cohort 1, 7.5% received triple therapy after diagnosis, and 25.5% of all treated patients received triple therapy. In Cohort 2, 30,493 COPD patients (mean age =64.7 years who initiated triple therapy were identified. Using the claims-based algorithm, 34.5% of Cohort 2 patients were classified as having mild disease (GOLD 1, 40.8% moderate (GOLD 2, 22.5% severe (GOLD 3, and 2.3% very severe (GOLD 4. Using exacerbation severity and frequency, 60.6% of patients were classified as GOLD 1/2 and 39.4% as GOLD 3/4. Conclusion: In this large US claims database study, one-quarter of all treated COPD patients received triple therapy. Although triple therapy is recommended for the most severe COPD patients

  11. Assessment of safety and reproductive performance after vaccination with a modified live-virus PRRS genotype 1 vaccine in pregnant sows at various stages of gestation.

    Science.gov (United States)

    Stadler, Julia; Zoels, Susanne; Eddicks, Matthias; Kraft, Christian; Ritzmann, Mathias; Ladinig, Andrea

    2016-07-19

    The objective of the present study was to assess safety and efficacy of a new modified live-virus porcine reproductive and respiratory syndrome (PRRS) genotype 1 vaccine in pregnant sows at various stages of gestation under field conditions. A total of 505 sows and gilts were allocated to two treatment groups and maintained in separate facilities. Animals of group 1 were vaccinated with a commercial modified live genotype 1 PRRSV vaccine (control product, CP), while animals of group 2 were immunized with a new modified live genotype 1 PRRSV vaccine (investigational veterinary product, IVP) (ReproCyc® PRRS EU, Boehringer Ingelheim Vetmedica GmbH). Injection site reactions were noted to be significantly less frequent in the IVP group compared to the CP group for pain (p=0.039), redness (p=0.030), heat (p=0.016) and swelling (p=0.002). The mean total number of piglets alive at weaning did not differ significantly between both study groups (10.6 vs. 11.0, p=0.375). However, pre-weaning mortality was significantly higher (p=0.005) in piglets from the CP group (14.1% vs. 10.9%). Analyses of reproductive performance data for both groups did not result in statistically significant differences between CP group and IVP group for number of piglets alive (12.7 and 12.6, respectively), healthy live (11.9 and 11.8), weak (0.7 and 0.5), stillborn (1.0 and 0.8) and mummified piglets (0.3 and 0.2) per litter. No differences were detected between both groups for piglet birth weights, while body weights at weaning (7.2kg vs. 6.6kg, p=0.026) and average daily gain (0.2445kg vs. 0.2211kg, p=0.037) were significantly higher in piglets from the IVP group. In conclusion, the administration of a single dose of ReproCyc® PRRS EU to sows and gilts at various stages of gestation confirmed non-inferiority to a commercial PRRS vaccine regarding safety and efficacy parameters under field conditions. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. The burden of chronic obstructive pulmonary disease associated with maintenance monotherapy in the UK

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    Edwards SC

    2016-11-01

    Full Text Available Susan C Edwards,1 Sian E Fairbrother,2 Anna Scowcroft,3 Gavin Chiu,4 Andrew Ternouth,3 Brian J Lipworth5 1Department of Market Access Pricing & Outcomes Research, 2Department of Medical Affairs - Respiratory, 3Department of Market Access, 4Department of Prescription Medicine - Respiratory, Boehringer Ingelheim, Bracknell, UK; 5Asthma and Allergy Research Group, Division of Cardiovascular and Diabetes Medicine, Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK Background: This study characterized a cohort of chronic obstructive pulmonary disease (COPD patients on maintenance bronchodilator monotherapy for ≥6 months to establish their disease burden, measured by health care utilization.Methods: Data were extracted from the UK Clinical Practice Research Datalink and linked to Hospital Episode Statistics. The monotherapy period spanned the first prescription of a long-acting β2-adrenergic agonist or a long-acting muscarinic antagonist until the end of the study (December 31, 2013 or until step up to dual/triple therapy, for example, addition of another long-acting bronchodilator, an inhaled corticosteroid, or both. A minimum of four consecutive prescriptions and 6 months on continuous monotherapy were required. Patients <50 years old at first COPD diagnosis or with another significant respiratory disease before starting monotherapy were excluded. Disease burden was evaluated by measuring patients’ rate of face-to-face interactions with a health care professional (HCP, COPD-related exacerbations, hospitalizations, and referrals.Results: A cohort of 8,811 COPD patients (95% Global initiative for chronic Obstructive Lung Disease stage A/B on maintenance monotherapy was identified between 2002 and 2013; 45% of these patients were still on monotherapy by the end of the study. Median time from first COPD diagnosis to first monotherapy prescription was 56 days, while the median time on

  13. The use of imepitoin (Pexion™) on fear and anxiety related problems in dogs - a case series.

    Science.gov (United States)

    McPeake, Kevin J; Mills, Daniel S

    2017-06-13

    Fear and anxiety based problems are common in dogs. Alongside behaviour modification programmes, a range of psychopharmacological agents may be recommended to treat such problems, but few are licensed for use in dogs and the onset of action of some can be delayed. The low affinity partial benzodiazepine receptor agonist imepitoin (Pexion™, Boehringer Ingelheim) is licensed for treating canine epilepsy, has a fast onset of action in dogs and has demonstrated anxiolytic properties in rodent models. This case series reports on the use of imepitoin in a group of dogs identified as having fear/anxiety based problems. Twenty dogs were enrolled into the study, attended a behaviour consultation and underwent routine laboratory evaluation. Nineteen dogs proceeded to be treated with imepitoin orally twice daily (starting dose approximately 10 mg/kg, with alterations as required to a maximum 30 mg/kg) alongside a patient-specific behaviour modification plan for a period of 11-19 weeks. Progress was monitored via owner report through daily diary entries and telephone follow-up every two weeks. A Positive and Negative Activation Scale (PANAS) of temperament was also completed by owners during baseline and at the end of the study. The primary outcome measure was average weekly global scores (AWG) from the owner diaries. Average weekly reaction scores (AWR) for each type of eliciting context was used as a secondary outcome. Seventeen dogs completed the trial. Treatment with imepitoin alongside a behaviour modification programme resulted in owner reported improvement with reduced AWG and reduced AWR for anxiety across a range of social and non-social eliciting contexts including noise sensitivities. Significant improvement was apparent within the first week of treatment, and further improvements seen at the 11 week review point. There was a significant reduction in negative activation (PANAS) with 76.5% of owners opting to continue imepitoin at their own expense after

  14. Association between adherence to medications for COPD and medications for other chronic conditions in COPD patients

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    Dhamane AD

    2016-12-01

    Full Text Available Amol D Dhamane,1 Phil Schwab,2 Sari Hopson,2 Chad Moretz,2 Srinivas Annavarapu,2 Kate Burslem,1 Andrew Renda,3 Shuchita Kaila1 1Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, 2Comprehensive Health Insights Inc, Louisville, 3Humana Inc, Louisville, KY, USA Background: Patients with COPD often have multiple comorbidities requiring use of multiple medications, and adherence rates for maintenance COPD (mCOPD medications are already known to be suboptimal. Presence of comorbidities in COPD patients, and use of medications used to treat those comorbidities (non-COPD medications, may have an adverse impact on adherence to mCOPD medications. Objective: The objective of the study was to evaluate the association between non-adherence to mCOPD medications and non-COPD medications in COPD patients. Methods: COPD patients were identified using a large administrative claims database. Selected patients were 40–89 years old and continuously enrolled for 12 months prior to and 24 months after the first identified COPD diagnosis (index date during January 1, 2009 to December 31, 2010. Patients were required to have ≥1 prescription for a mCOPD medication within 365 days of the index date and ≥1 prescription for one of 12 non-COPD medication classes within ±30 days of the first COPD prescription. Adherence (proportion of days covered [PDC] was measured during 365 days following the first COPD prescription. The association between non-adherence (PDC <0.8 to mCOPD and non-adherence to non-COPD medications was determined using logistic regression, controlling for baseline patient characteristics. Results: A total of 14,117 patients, with a mean age of 69.9 years, met study criteria. Of these, 40.9% were males and 79.2% were non-adherent to mCOPD medications with a mean PDC of 0.47. Non-adherence to mCOPD medications was associated with non-adherence to 10 of 12 non-COPD medication classes (odds ratio 1.38–1

  15. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

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    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  16. Disability related to COPD tool (DIRECT: towards an assessment of COPD-related disability in routine practice

    Directory of Open Access Journals (Sweden)

    Aguilaniu B

    2011-07-01

    Full Text Available B Aguilaniu1, J Gonzalez-Bermejo2, A Regnault3, C Dias Barbosa3, B Arnould3, M Mueser4, G Granet5, M Bonnefoy6, T Similowski2,71HYLAB, Physiologie Clinique, Grenoble, France; 2Assistance Publique – Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Service de Pneumologie et Réanimation, Paris, France; 3Mapi Values, Lyon, France; 4Formerly Boehringer Ingelheim, Paris, France; 5General Practitioner, Sainte-Foy-lès-Lyon, Paris, France; 6Centre Hospitalier Lyon Sud, Lyon, France; 7Université Paris 6 Pierre et Marie Curie, ER10, Paris, FranceBackground: Chronic Obstructive Pulmonary Disease (COPD is a worldwide public health concern. It is also a major source of disability that is often overlooked, depriving patients of effective treatments. This study describes the development and validation of a questionnaire specifically assessing COPD-related disability.Methods: The DIsability RElated to COPD Tool (DIRECT was developed according to reference methods, including literature review, patient and clinician interviews and test in a pilot study. A 12-item questionnaire was included for finalization and validation in an observational cross-sectional study conducted by 60 French pulmonologists, who recruited 275 COPD patients of stage II, III and IV according to the GOLD classification. Rasch modeling was conducted and psychometric properties were assessed (internal consistency reliability; concurrent and clinical validity.Results: The DIRECT score was built from the 10 items retained in the Rasch model. Their internal consistency reliability was excellent (Cronbach's alpha = 0.95. The score was highly correlated with the Saint George's Respiratory Questionnaire Activity score (r = 0.83 and the London Handicap Scale (r = –0.70, a generic disability measure. It was highly statistically significantly associated to four clinical parameters (P < 0.001: GOLD classification, BODE index, FEV1 and 6-minute walk distance.Conclusion: DIRECT is a

  17. New approaches to the modulation of inflammatory processes in airway disease models: ATS 2001, May 18-23, San Francisco

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    Hele David J

    2001-07-01

    Full Text Available Abstract The 97th American Thoracic Society meeting proved to be an excellent meeting, providing a wealth of new information on inflammatory diseases of the airways. Once again there appeared to be an increased emphasis on chronic obstructive pulmonary disease (COPD with most of the major drug companies concentrating a large part of their efforts in this field. An assessment of the new British Thoracic Society guidelines, which are designed to promote better management of COPD, was also presented at the meeting. Potential new treatments for inflammatory diseases of the airways including COPD were described, ranging from phase III trial data with GlaxoSmithKline's PDE4 inhibitor, Cilomilast (Ariflo® to the development of AstraZeneca's novel dual dopamine D2-receptor/β2-adrenoreceptor agonist, Viozan™. Of particular interest was Byk Gulden's Ciclesonide, a new corticosteroid with equivalent efficacy to the market leaders but with an improved safety profile. The same company also presented data on their PDE4 inhibitor, Roflumilast, which is now in phase II/III. Bayer presented data on their PDE4 inhibitor, BAY 19-8004, in a smoking animal model and claimed greater anti-inflammatory efficacy than with a steroid. Asta Medica (now known as Elbion also described a new potent PDE4 inhibitor, AWD 12-281, with anti-inflammatory activity. In the bronchodilator field, an analysis of data from a one-year trial with Boehringer Ingelheim's Tiotropium revealed a possible improvement in lung function in COPD patients; this needs to be confirmed in a specifically designed study. Inhibitors of p38 (c-Jun NH2-terminal kinase and syk kinase were also discussed as anti-inflammatory agents with potential in the treatment of COPD and asthma. GlaxoSmithKline's p38 kinase inhibitor, SB 239063, appeared to be the most advanced of these with clinical data expected in two to three years. Lyn kinase was also discussed as a novel target for inflammatory airway diseases.

  18. SU-E-J-266: Cone Beam Computed Tomography (CBCT) Inter-Scan and Inter-Observer Tumor Volume Variability Assessment in Patients Treated with Stereotactic Body Radiation Therapy (SBRT) for Early Stage Non-Small Cell Lung Cancer (NSCLC)

    International Nuclear Information System (INIS)

    Hou, Y; Aileen, C; Kozono, D; Killoran, J; Wagar, M; Lee, S; Hacker, F; Aerts, H; Lewis, J; Mak, R

    2015-01-01

    award; Disclosure/Conflict of interest: Raymond H. Mak: Stock ownership: Celgene, Inc. Consulting: Boehringer-Ingelheim, Inc

  19. Impact of comorbid conditions in COPD patients on health care resource utilization and costs in a predominantly Medicare population

    Directory of Open Access Journals (Sweden)

    Schwab P

    2017-02-01

    Full Text Available Phil Schwab,1 Amol D Dhamane,2 Sari D Hopson,1 Chad Moretz,1 Srinivas Annavarapu,1 Kate Burslem,2 Andrew Renda,3 Shuchita Kaila2 1Comprehensive Health Insights Inc., Louisville, KY, 2Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 3Humana Inc., Louisville, KY, USA Background: Patients with chronic obstructive pulmonary disease (COPD often have multiple underlying comorbidities, which may lead to increased health care resource utilization (HCRU and costs.Objective: To describe the comorbidity profiles of COPD patients and examine the associations between the presence of comorbidities and HCRU or health care costs.Methods: A retrospective cohort study utilizing data from a large US national health plan with a predominantly Medicare population was conducted. COPD patients aged 40–89 years and continuously enrolled for 12 months prior to and 24 months after the first COPD diagnosis during the period of January 01, 2009, through December 31, 2010, were selected. Eleven comorbidities of interest were identified 12 months prior through 12 months after COPD diagnosis. All-cause and COPD-related hospitalizations and costs were assessed 24 months after diagnosis, and the associations with comorbidities were determined using multivariate statistical models.Results: Ninety-two percent of 52,643 COPD patients identified had at least one of the 11 comorbidities. Congestive heart failure (CHF, coronary artery disease, and cerebrovascular disease (CVA had the strongest associations with all-cause hospitalizations (mean ratio: 1.56, 1.32, and 1.30, respectively; P<0.0001; other comorbidities examined had moderate associations. CHF, anxiety, and sleep apnea had the strongest associations with COPD-related hospitalizations (mean ratio: 2.01, 1.32, and 1.21, respectively; P<0.0001; other comorbidities examined (except chronic kidney disease [CKD], obesity, and osteoarthritis had moderate associations. All

  20. SU-E-J-266: Cone Beam Computed Tomography (CBCT) Inter-Scan and Inter-Observer Tumor Volume Variability Assessment in Patients Treated with Stereotactic Body Radiation Therapy (SBRT) for Early Stage Non-Small Cell Lung Cancer (NSCLC)

    Energy Technology Data Exchange (ETDEWEB)

    Hou, Y; Aileen, C; Kozono, D; Killoran, J; Wagar, M; Lee, S; Hacker, F; Aerts, H; Lewis, J; Mak, R [Brigham and Women’s Hospital, Boston, MA (United States)

    2015-06-15

    award; Disclosure/Conflict of interest: Raymond H. Mak: Stock ownership: Celgene, Inc. Consulting: Boehringer-Ingelheim, Inc.

  1. Aversion to ambiguity and willingness to take risks affect therapeutic decisions in managing atrial fibrillation for stroke prevention: results of a pilot study in family physicians

    Directory of Open Access Journals (Sweden)

    Raptis S

    2017-09-01

    Full Text Available Stavroula Raptis,1,* Jia Ning Chen,2,* Florencia Saposnik,2 Roman Pelyavskyy,2 Andrew Liuni,3 Gustavo Saposnik2,4 On behalf of the Stroke Outcomes Research Canada Working Group (SORCan- www.sorcan.ca 1Applied Health Research Centre, Li Ka Shing Knowledge Institute, 2Stroke Outcomes and Decision Neuroscience Research Unit, Department of Medicine, St. Michael’s Hospital, University of Toronto, Toronto, 3Medical Department, Boehringer Ingelheim (Canada Ltd., Burlington, ON, Canada; 4Neuroeconomics and Decision Neuroscience, Department of Economics, University of Zurich, Zurich, Switzerland *These authors contributed equally to this work Background: Anticoagulation is the therapeutic paradigm for stroke prevention in patients with atrial fibrillation (AF. It is unknown how physicians make treatment decisions in primary stroke prevention for patients with AF. Objectives: To evaluate the association between family physicians’ risk preferences (aversion risk and ambiguity and therapeutic recommendations (anticoagulation in the management of AF for primary stroke prevention by applying concepts from behavioral economics. Methods: Overall, 73 family physicians participated and completed the study. Our study comprised seven simulated case vignettes, three behavioral experiments, and two validated surveys. Behavioral experiments and surveys incorporated an economic framework to determine risk preferences and biases (e.g., ambiguity aversion, willingness to take risks. The primary outcome was making the correct decision of anticoagulation therapy. Secondary outcomes included medical errors in the management of AF for stroke prevention. Results: Overall, 23.3% (17/73 of the family physicians elected not to escalate the therapy from antiplatelets to anticoagulation when recommended by best practice guidelines. A total of 67.1% of physicians selected the correct therapeutic options in two or more of the three simulated case vignettes. Multivariate

  2. Restenosis after coronary angioplasty.

    Science.gov (United States)

    Anderson, H V; Vignale, S J; Benedict, C R; Willerson, J T

    1993-09-01

    evidence of ischemia by thallium-201 scintigraphy, will not have angiographic restenosis. Numerous clinical trials have been performed in order to reduce or prevent restenosis. Almost all have been disappointing, while a few have been encouraging. Studies of antiplatelet agents such as aspirin, dipyridamole (Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA), and Ticlopidine (Syntex, Humgcao, Puerto Rico) have not shown efficacy, yet studies of an inhibitor of platelet-derived growth factor have been provocatively encouraging. No reduction in restenosis rates was found with the anticoagulants Coumadin (Du Pont Pharmaceuticals, Wilmington, DE, USA) and Heparin (Wyeth-Ayerst, Philadelphia, PA, USA). Fish oils (omega fatty acids) have been found in several clinical trials to provide modest, but encouraging, reductions in restenosis, but await further confirmation.(ABSTRACT TRUNCATED AT 400 WORDS)

  3. A simple semipaced 3-minute chair rise test for routine exercise tolerance testing in COPD

    Directory of Open Access Journals (Sweden)

    Aguilaniu B

    2014-09-01

    Full Text Available Bernard Aguilaniu,1,2 Hubert Roth,3 Jesus Gonzalez-Bermejo,4 Marie Jondot,5 Jocelyne Maitre,5 François Denis,6 Thomas Similowski4,7 1Medicine Faculty, Université Joseph Fourier, Grenoble, France; 2McGill University, Montreal, Canada; 3Centre de Recherche en Nutrition Humaine Rhône-Alpes, CHU Grenoble, France; 4Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Respiratory and Intensive Care Medicine, Paris, France; 5Clinique Universitaire de Pneumologie, CHU Grenoble, France, Grenoble, France; 6Boehringer Ingelheim, 7Université Paris, Paris, France Abstract: The functional work capacity of chronic obstructive pulmonary disease (COPD patients is usually assessed with walk tests such as the 6-minute walk test (6MWT or the shuttle test. Because these exercise modalities require a controlled environment which limits their use by pulmonologists and severely restricts their use among general practitioners, different modalities of a short (1 minute or less sit-to-stand test were recently proposed. In this study, we evaluated a new modality of a semipaced 3-minute chair rise test (3CRT in 40 patients with COPD, and compared the reproducibility of physiological responses and symptoms during the 3CRT and their interchangeability with the 6MWT. The results demonstrate that physiological variables, heart rate, pulse oxygen saturation, work done, and symptoms (Borg dyspnea and fatigue scores, during the 3CRT were highly reproducible, and that the physiological responses and symptoms obtained during the 3CRT and the 6MWT were interchangeable for most patients. Moreover, these preliminary data suggest that patients able to perform more than 50 rises during 3 minutes had no significant disability. The simplicity and ease of execution of the 3CRT will facilitate the assessment of exercise symptoms and disability in COPD patients during routine consultations with pulmonologists and general practitioners, and will thus contribute

  4. Increase in skeletal muscle protein content by the ß-2 selective adrenergic agonist clenbuterol exacerbates hypoalbuminemia in rats fed a low-protein diet

    Directory of Open Access Journals (Sweden)

    A.L. Sawaya

    1998-06-01

    Full Text Available This investigation examined how the nutritional status of rats fed a low-protein diet was affected when the animals were treated with the ß-2 selective agonist clenbuterol (CL. Males (4 weeks old from an inbred, specific-pathogen-free strain of hooded rats maintained at the Dunn Nutritional Laboratory were used in the experiments (N = 6 rats per group. CL treatment (Ventipulmin, Boehringer-Ingelheim Ltd., 3.2 mg/kg diet for 2 weeks caused an exacerbation of the symptoms associated with protein deficiency in rats. Plasma albumin concentrations, already low in rats fed a low-protein diet (group A, were further reduced in CL rats (A = 25.05 ± 0.31 vs CL = 23.64 ± 0.30 g/l, P<0.05. Total liver protein decreased below the level seen in either pair-fed animals (group P or animals with free access to the low-protein diet (A = 736.56 ± 26 vs CL = 535.41 ± 54 mg, P<0.05, whereas gastrocnemius muscle protein was higher than the values normally described for control (C animals (C = 210.88 ± 3.2 vs CL = 227.14 ± 1.7 mg/g, P<0.05. Clenbuterol-treated rats also showed a reduction in growth when compared to P rats (P = 3.2 ± 1.1 vs CL = -10.2 ± 1.9 g, P<0.05. This was associated with a marked decrease in fat stores (P = 5.35 ± 0.81 vs CL = 2.02 ± 0.16 g, P<0.05. Brown adipose tissue (BAT cytochrome oxidase activity, although slightly lower than in P rats (P = 469.96 ± 16.20 vs CL = 414.48 ± 11.32 U/BAT x kg body weight, P<0.05, was still much higher than in control rats (C = 159.55 ± 11.54 vs CL = 414.48 ± 11.32 U/BAT x kg body weight, P<0.05. The present findings support the hypothesis that an increased muscle protein content due to clenbuterol stimulation worsened amino acid availability to the liver and further reduced albumin synthesis causing exacerbation of hypoalbuminemia in rats fed a low-protein diet.

  5. Effect of dietary molybdenum and sulphur on the copper status of ...

    African Journals Online (AJOL)

    blood were performed using an electronic particle counter. Plasma AST and alkaline phosphatase (AP; EC 3.1.3.1) levels were estimated using Boehringer Mannheim standard kits. (Boehringer Mannheim GmbH Diagnostica, West Germany) and caeruloplasmin (ferroxidase; Cp; EC 1.16.3.1) activity in plasma as described ...

  6. Hypercholesterolaemia in a rural white population and its ...

    African Journals Online (AJOL)

    1990-07-21

    Jul 21, 1990 ... reference standards (Ortho Diagnostics and Boehringer Pre- cilip) were included in each run. Inter- and intra-run variation was less than 3%. The remaining serum was analysed for uric acid (BoehringerUric Acid Uricaquant method). Other measurements included blood pressure, height, weight and a.

  7. Estudo comparativo do manuseamento dos vários dispositivos de inalação utilizados em Portugal** Trabalho concotTente ao Premia Thome Villar/Boehringer Ingelhcim, 1999 (Secção A

    Directory of Open Access Journals (Sweden)

    António Morais

    2001-01-01

    Full Text Available RESUMO: A terapêutica inalatória tern urn papel fundamental no tratamento das doençs respiratórias. Esta importância deve-se à administração directa do fármaco na area em tratamento, o que leva à necessidade de menores doses de farmaco, com menores efeitos secundários, um mais rápido início de acção e uma maior eficácia terapêutica do mesmo. Quando prescrevemos urn inalador, temos que ter em conta as varias caracteristicas quer do farmaco, quer do inalador, nomeadamente a facilidade com que este ultimo pode ser manuseado.O objectivo deste estudo foi o de pesquisar o grau de dificuldade exigido na realização da manobra inalat6ria dos vários inaladores existentes em Portugal, alem das preferencias em relação aos mesmos por parte da população estudada. Uma população de 80 individuos, com media de idades de 45 anos (24-78, sendo 49 (61,2% homens e 31 (38,8% mulhercs, sem anterior contacto com inaladores, apos a aprcsentação de 6 inaladores frequentementc utilizados em Portugal (MDI e os DPI's Rotahaler, Turbohaler, Diskus, Diskhaler e Aerolizer, escolhiam qual delcs eque achavam ser esteticamentc o mais c o menos atractivo. Seguidamente cram instruldos sobre a maneira correcta de inalar com os aparelhos de inalação incluidos no estudo. Apos a instrução de cada inalador, tinham 3 tentativas para inalar de forma correcta com o mcsmo. Após as manobras inalat6rias com os 6 inaladorcs, os individuos CSCOlhiam qual deles e que tinha sido o mais fáicil co mais difícil de manusear, e em caso de terem de efectuar terapêutica inalatória qual deles é que escolheriam é qual deles é que rejeitariam.O Disk us - 22 (27,5 % e o Aerolizer - 21 (26,2 % foram considerados os mais atractivos enquanto o Turbuhaler foi considcrado o menos atraente-18 (22,5 %. 0 Turbuhaler- 25 (31,2%, foi considerado como o mais facil de ser manuseado versus o MDI - 36 (45% considerado o mais diflcil. O Turbuhaler seguido pelo Diskus foram aqueles que se revelaram de mais facil manuseamento, enquanto o MDI foi o que provocou mais dificuldades, com 38 (47,5% dos individuos a serem capazes de o manusear de forma correcta nas 3 tentativas dadas. 0 Turbuhaler - 25 (31,2% foi o inalador mais escolhido, seguido pelo Disk us - 23 (28,7%, sendo o MDI- 38 (47,5 % o inalador mais rejeitado. Em relação a algumas características da população, verificou-se que o Turbulzaler foi mais escolhido pelo sexo feminino e pelo grupo com estudos universitarios, enquanto que o Diskus foi o mais preferido pelos homens e pelos individuos com menores habilitações litenirias.Os autores concluem que o Turbuhaler se apresenta como o inalador de mais facil manuseamento, ao contn1rio do MDI que foi o que se associou a maiores dificuldades na realização da sua manobra inalat6ria. A escolha do inalador foi determinada especialmente pelo grau de facilidade na realização·da manobra inalat6ria. Existcm diferen.;as na prefcrencia dos inaladores por parte dos indivlduos que participaram nestc estudo tendo em conta algumas das suas caracteristicas, nomeadamente o scxo e as habilitações literarias.REV PORT PNEU 2001; VII (NōESPECIAT/BRASlL: 9-24 ABSTRACT: The inhalation therapy has a fundamental role in the treatment of respiratory diseases. This importance is related to several facts: through this therapy, the drug has a direct action in the area under treatment, smaller amounts of the drug are needed, there are less side effects and there is a faster efficient result at beginning of the drug's action. When prescribing an inhaler, the physician has to consider several variables, namely their ability to be easily handled.The aim of this work is the study of the individual adjustment to each of the inhalation devices available in Portugal, the difficulty degree detected in the individual use of devices and their preferences about them.The population was constituted by eighty individuals, 49 (61,2% males and 31 (38,8% females, with ages ranging from 24 to 78 (mean 45 years, who never had contact with an inhaler before. After the presentation of the studied inhalers (MDI and the DPI's Rotahaler, Turbulzaler, Diskus, Diskhaler e Aerolizer, each of the individuals chooses the most and the least attractive. Then they were instructed how to handle each of the inhalers properly. They had three chances to handle each inhaler successfully after instruction. After the inhaling act, each individual had to select which inhaler were the easiest and the most difficult to handle and which one he/she would choose and would reject.The Diskus - 22 (27,5 % and Aerolizer - 21 (26,2 % were considered the most attractive; the Turbuhaler - 18 (22,5% was considered the least attractive. The Turbuhaler followed by Diskus were the easiest to handle; on the contrary the MDI was the most difficult to handle. The Turbuhaler - 25 (31,2% was elected as the easiest to handle; the MDI- 36 (45% was selected as the most difficult to use. The Turbuhaler -25 (31,2% followed by Diskus - 23 (28,7% was the inhaler most chosen and the MDI - 38 (47,5% was the most rejected. The study of the inhalers preferences according to some population characteristics showed us that the Turbuhaler is chosen preferentially by females and individuals with university grade while Diskus is chosen predominantly by males and individuals with less academic qualifications.The authors conclude that the Turbuhaler was the easiest to usc and the MDI was the most difficult. The choice of the inhaler was determined mainly by the easiness of the inhalation. There are some differences related to the inhalers preferences according to some population characteristics, namely sex and academic qualilications.REV PORT PNEU 2001; VII (:Nō ESPECIAI/BRASIL: 9-24 Palavras-chave: inaladorcs, manuscamento, manobra inalatória, prefcrências, Key-words: inhalers, handling, inhaling, preferences

  8. Pingevabalt / Priidu Beier

    Index Scriptorium Estoniae

    Beier, Priidu, 1957-

    1995-01-01

    Arvustus: Vee, Elo. Ingelheim. Tln.: Eesti Raamat, 1995. Vastukaja : Viiding, Elo. Kirjaniku nimest ja veest // Kultuurileht. - 1995. - 10.nov. - Lk.17; Kivisildnik, Sven. Intuitiivne geneetika ja ustavuse piirid // Postimees. - 1996. - 4.märts. - Lk.18

  9. AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.

    Science.gov (United States)

    2018-03-01

    manufacturers should engage key stakeholders early and throughout the drug development process to ensure the most valid and representative PROs and patient populations will be included. To streamline the PRO collection process, participants suggested engaging pharmacists and other providers who may have more frequent interaction with patients. Participants also recommended that PRO collection and analysis should use common technology platforms, streamline components of clinician care to reduce workflow, and be integrated with claims data to provider payers a better understanding of patient health in real time. Finally, additional work should be done to develop patient-reported outcome measures that contain relevant measures for all healthcare stakeholders. While significant challenges remain in PRO development and adoption, participants agreed that greater use can only be achieved through collaboration and patient-centered care. The AMCP Partnership Forum titled "Improving Quality, Value, and Outcomes with Patient-Reported Outcomes" and the development of this proceedings report were supported by Amgen, Boehringer Ingelheim Pharmaceuticals, Genentech, GlaxoSmithKline, Novartis Pharmaceuticals, Novo Nordisk, Precision for Value, Premier, Sanofi, Takeda Pharmaceuticals USA, and Xcenda.

  10. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial.

    Science.gov (United States)

    Cherney, David Z I; Zinman, Bernard; Inzucchi, Silvio E; Koitka-Weber, Audrey; Mattheus, Michaela; von Eynatten, Maximilian; Wanner, Christoph

    2017-08-01

    and 1338 assigned to empagliflozin) had microalbuminuria, and 769 (11%; 260 assigned to placebo and 509 assigned to empagliflozin) had macroalbuminuria. Median treatment duration was 2·6 years (IQR 2·0-3·4; 136 weeks) and median observation time was 3·1 years (2·2-3·6; 164 weeks). After short-term treatment at week 12, the placebo-adjusted geometric mean ratio of UACR change from baseline with empagliflozin was -7% (95% CI -12 to -2; p=0·013) in patients with normoalbuminuria, -25% (-31 to -19; pempagliflozin in all three groups compared with placebo during long-term treatment when measured at 164 weeks. At follow-up, after cessation of treatment for a median of 34 or 35 days, UACR was lower in the empagliflozin versus placebo group in those with baseline microalbuminuria (placebo-corrected adjusted geometric mean ratio of relative change from baseline with empagliflozin: -22%, 95% CI -32 to -11; p=0·0003) or macroalbuminuria (-29%, -44 to -10; p=0·0048), but not for patients with baseline normoalbuminuria (1%, -8 to 10; p=0·8911). Patients treated with empagliflozin were more likely to experience a sustained improvement from microalbuminuria to normoalbuminuria (hazard ratio [HR] 1·43, 95% CI 1·22 to 1·67; pempagliflozin than placebo in all subgroups by UACR status. These results support short-term and long-term benefits of empagliflozin on urinary albumin excretion, irrespective of patients' albuminuria status at baseline. Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

    Science.gov (United States)

    Khatib, Rasha; McKee, Martin; Shannon, Harry; Chow, Clara; Rangarajan, Sumathy; Teo, Koon; Wei, Li; Mony, Prem; Mohan, Viswanathan; Gupta, Rajeev; Kumar, Rajesh; Vijayakumar, Krishnapillai; Lear, Scott A; Diaz, Rafael; Avezum, Alvaro; Lopez-Jaramillo, Patricio; Lanas, Fernando; Yusoff, Khalid; Ismail, Noorhassim; Kazmi, Khawar; Rahman, Omar; Rosengren, Annika; Monsef, Nahed; Kelishadi, Roya; Kruger, Annamarie; Puoane, Thandi; Szuba, Andrzej; Chifamba, Jephat; Temizhan, Ahmet; Dagenais, Gilles; Gafni, Amiram; Yusuf, Salim

    2016-01-02

    cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04-0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04-0·55). Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025. Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Analysis of pramipexole dose–response relationships in Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Wang Y

    2016-12-01

    Full Text Available Ying Wang,1 Sheng-Gang Sun,2 Sui-Qiang Zhu,3 Chun-Feng Liu,4 Yi-Ming Liu,5 Qing Di,6 Hui-Fang Shang,7 Yan Ren,8 Wei Xiang,9 Sheng-Di Chen1 1Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 2Department of Neurology, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 3Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 4Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, 5Department of Neurology, Qilu Hospital Affiliated to Shandong University, Jinan, 6Department of Neurology, Nanjing Brain Hospital, Nanjing, 7Department of Neurology, West China Hospital Affiliated to Sichuan University, Chengdu, 8Department of Neurology, First Affiliated Hospital of China Medical University, Shenyang, 9Medical Department, Boehringer Ingelheim (China Investment Co., Ltd., Shanghai, People’s Republic of China Background: Pramipexole (PPX, a non-ergot dopamine receptor agonist, is a first-line treatment for Parkinson’s disease (PD. A critical dose level above which a better benefit-to-harm ratio exists has not been examined.Methods: Chinese PD patients (n=464 were retrospectively analyzed by PPX maintenance dose, PD stage, combined levodopa dose, and baseline tremor contribution. The sum score of Baseline Activities of Daily Living (part II and Motor Examination (III of the Unified Parkinson’s Disease Rating Scale (UPDRS II+III was used as a covariate for final score adjustment.Results: Sustained-release (SR and immediate-release (IR PPX showed similar efficacy based on score changes at 18 weeks, with comparable tolerability. Approximately two-third of patients received PPX at ≥1.5 mg/d, and one fourth of patients had ≥20% tremor contribution to UPDRS II+III. After treatment, patients receiving PPX ≥1.5 mg/d showed

  13. AMCP Partnership Forum: FDAMA Section 114-Improving the Exchange of Health Care Economic Data.

    Science.gov (United States)

    2016-07-01

    harbor by using the consensus recommendations developed during the forum. Speakers, panelists, and attendees focused on 4 terms in Section 114 that remain open to interpretation by companies and enforcement bodies: (1) the scope of HCEI, (2) the scope of "formulary committee or similar entity," (3) the definition of "competent and reliable scientific evidence (CRSE)," and (4) the parameters of how information "directly relates to an approved indication." Based on the forum results, it was recommended that the safe harbor for companies' proactive dissemination of information under Section 114 should include health care decision makers beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations. Recommendations also suggested expansion to organizations that evaluate HCEI or develop value frameworks and compendia and individuals in such organizations. Forum participants also recommended that HCEI be truthful, and not misleading, and be based on the expertise of professionals in the relevant area. HCEI must also be developed and disclosed in a transparent, reproducible, and accurate manner. Forum participants also discussed and agreed on the types of information, format, and processes by which managed care pharmacy and other health care decision makers seek to receive HCEI from biopharmaceutical companies. Finally, participants encouraged the FDA, Congress, and other stakeholders to find ways to ensure that patients or their representative organizations have appropriate access to a full range of information about their medications and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner. The AMCP Partnership Forum on FDAMA Section 114-Improving the Exchange of Pharmacoeconomic Data and the development of this proceedings document were supported by AbbVie, Amgen, Boehringer Ingelheim Pharmaceuticals, Merck

  14. Stroke treatment with alteplase given 3.0-4.5 h after onset of acute ischaemic stroke (ECASS III): additional outcomes and subgroup analysis of a randomised controlled trial.

    Science.gov (United States)

    Bluhmki, Erich; Chamorro, Angel; Dávalos, Antoni; Machnig, Thomas; Sauce, Christophe; Wahlgren, Nils; Wardlaw, Joanna; Hacke, Werner

    2009-12-01

    -210 min: 1.62, 0.26-10.25; 211-240 min: 1.97, 0.82-4.76; 241-270 min: 3.15, 1.01-9.79; p=0.761), but not of age dichotomised at 65 years ( or =65 years: 5.79, 2.18-15.39; p=0.004). Our results support the use of alteplase up to 4.5 h after the onset of stroke symptoms across a broad range of subgroups of patients who meet the requirements of the European product label but miss the approved treatment window of 0-3 h. Boehringer Ingelheim.

  15. Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study.

    Science.gov (United States)

    Wahlgren, Nils; Ahmed, Niaz; Dávalos, Antoni; Hacke, Werner; Millán, Mónica; Muir, Keith; Roine, Risto O; Toni, Danilo; Lees, Kennedy R

    2008-10-11

    .18). Alteplase remains safe when given at 3-4.5 h after ischaemic stroke, offering an opportunity for patients who cannot be treated within the standard 3-h timeframe. Boehringer-Ingelheim, European Union Public Health Executive Authority.

  16. Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: A NICE single technology appraisal.

    Science.gov (United States)

    Faria, Rita; Spackman, Eldon; Burch, Jane; Corbacho, Belen; Todd, Derick; Pepper, Chris; Woolacott, Nerys; Palmer, Stephen

    2013-07-01

    The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dabigatran etexilate (Boehringer Ingelheim Ltd, UK) to submit evidence for the clinical and cost-effectiveness of this drug for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) as part of the NICE single technology appraisal process. The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the evidence review group (ERG). This article presents a summary of the manufacturer's submission, the ERG report and the subsequent development of NICE guidance for the use of dabigatran within the UK National Health Service. Dabigatran was granted marketing authorisation by the European Medicines Agency for a sequential dosing regimen (DBG sequential), in which patients under 80 years are treated with dabigatran 150 mg twice daily (DBG150) and patients 80 years and over are given dabigatran 110 mg twice daily (DBG110). NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the committee was whether the DBG sequential regimen was effective and cost-effective compared with warfarin or aspirin for patients with non-valvular AF and one or more risk factors. The RE-LY trial, a large multi-centre non-inferiority randomised clinical trial, was the primary source of clinical evidence. DBG150 was shown to be non-inferior, and subsequently superior to warfarin, for the primary outcome of all stroke/systemic embolism. DBG110 was found to be non-inferior to warfarin. Results were presented for a post hoc subgroup analysis for patients under and over 80 years of age, where DBG110 showed a statistically significant reduction of haemorrhagic stroke and intracranial haemorrhage in comparison to warfarin in patients over 80 years of age. This post hoc subgroup analysis by age was the basis for the licensed DBG sequential regimen

  17. Guideline for the management of chronic obstructive pulmonary disease--2011 update.

    Science.gov (United States)

    Abdool-Gaffar, M S; Ambaram, A; Ainslie, G M; Bolliger, C T; Feldman, C; Geffen, L; Irusen, E M; Joubert, J; Lalloo, U G; Mabaso, T T; Nyamande, K; O'Brien, J; Otto, W; Raine, R; Richards, G; Smith, C; Stickells, D; Venter, A; Visser, S; Wong, M

    2011-01-01

    lung co-morbidity and drug availability and cost. Holistic management utilising pharmacological and nonpharmacological options are put in perspective. Working groups of clinicians and clinical researchers following detailed literature review, particularly of studies performed in South Africa, and the GOLD guidelines. BENEFITS, HARMS AND COSTS. The guideline pays particular attention to cost-effectiveness in South Africa, and promotes the initial use of less costly options. It promotes smoking cessation and selection of treatment based on objective evidence of benefit. It also rejects a nihilistic or punitive approach, even in those who are unable to break the smoking addiction. These include primary and secondary prevention; early diagnosis, staging of severity, use of bronchodilators and other forms of treatment, rehabilitation, and treatment of complications. Advice is provided on the management of acute exacerbations and the approach to air travel, prescribing long-term oxygen and lung surgery including lung volume reduction surgery. The COPD Working Group comprised experienced pulmonologists representing all university departments in South Africa and some from private practice, and general practitioners. Most contributed to the development of the previous version of the South African guideline. GUIDELINE SPONSOR: The meeting of the Working Group of the South African Thoracic Society was sponsored by an unrestricted educational grant from Boehringer Ingelheim and Glaxo-Smith-Kline.

  18. Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis.

    Science.gov (United States)

    Hollis, Chris; Pennant, Mary; Cuenca, José; Glazebrook, Cris; Kendall, Tim; Whittington, Craig; Stockton, Sarah; Larsson, Linnéa; Bunton, Penny; Dobson, Suzanne; Groom, Madeleine; Hedderly, Tammy; Heyman, Isobel; Jackson, Georgina M; Jackson, Stephen; Murphy, Tara; Rickards, Hugh; Robertson, Mary; Stern, Jeremy

    2016-01-01

    in the UK. For part 1, 70 studies were included in the quantitative systematic review. The evidence suggested that for treating tics in children and young people with TS, antipsychotic drugs [standardised mean difference (SMD) -0.74, 95% confidence interval (CI) -1.08 to -0.41; n = 75] and noradrenergic agents [clonidine (Dixarit(®), Boehringer Ingelheim) and guanfacine: SMD -0.72, 95% CI -1.03 to -0.40; n = 164] are effective in the short term. There was little difference among antipsychotics in terms of benefits, but adverse effect profiles do differ. Habit reversal training (HRT)/comprehensive behavioural intervention for tics (CBIT) was also shown to be effective (SMD -0.64, 95% CI -0.99 to -0.29; n = 133). For part 2, 295 parents/carers of children and young people with TS contributed useable survey data. Forty young people with TS participated in in-depth interviews. Four studies were in the qualitative review. Key themes were difficulties in accessing specialist care and behavioural interventions, delay in diagnosis, importance of anxiety and emotional symptoms, lack of provision of information to schools and inadequate information regarding medication and adverse effects. The number and quality of clinical trials is low and this downgrades the strength of the evidence and conclusions. Antipsychotics, noradrenergic agents and HRT/CBIT are effective in reducing tics in children and young people with TS. The balance of benefits and harms favours the most commonly used medications: risperidone (Risperdal(®), Janssen), clonidine and aripiprazole (Abilify(®), Otsuka). Larger and better-conducted trials addressing important clinical uncertainties are required. Further research is needed into widening access to behavioural interventions through use of technology including mobile applications ('apps') and video consultation. This study is registered as PROSPERO CRD42012002059. The National Institute for Health Research Health Technology Assessment

  19. Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

    Science.gov (United States)

    Attaei, Marjan W; Khatib, Rasha; McKee, Martin; Lear, Scott; Dagenais, Gilles; Igumbor, Ehimario U; AlHabib, Khalid F; Kaur, Manmeet; Kruger, Lanthe; Teo, Koon; Lanas, Fernando; Yusoff, Khalid; Oguz, Aytekin; Gupta, Rajeev; Yusufali, Afzalhussein M; Bahonar, Ahmad; Kutty, Raman; Rosengren, Annika; Mohan, Viswanathan; Avezum, Alvaro; Yusuf, Rita; Szuba, Andrzej; Rangarajan, Sumathy; Chow, Clara; Yusuf, Salim

    2017-09-01

    all four drug classes available were more likely to use at least one blood pressure-lowering medicine (adjusted odds ratio [OR] 2·23, 95% CI 1·59-3·12); pmedicines were not available. Participants with known hypertension from households able to afford four blood pressure-lowering drug classes were more likely to use at least one blood pressure-lowering medicine (adjusted OR 1·42, 95% CI 1·25-1·62; pmedicines. A large proportion of communities in low-income and middle-income countries do not have access to more than one blood pressure-lowering medicine and, when available, they are often not affordable. These factors are associated with poor blood pressure control. Ensuring access to affordable blood pressure-lowering medicines is essential for control of hypertension in low-income and middle-income countries. Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, the Ontario Ministry of Health and Long-Term Care, pharmaceutical companies (with major contributions from AstraZeneca [Canada], Sanofi Aventis [France and Canada], Boehringer Ingelheim [Germany amd Canada], Servier, and GlaxoSmithKline), Novartis and King Pharma, and national or local organisations in participating countries. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

  20. Effects of telmisartan on office and 24-hour ambulatory blood pressure: an observational study in hypertensive patients managed in primary care

    Directory of Open Access Journals (Sweden)

    Frederic Kontny

    2010-01-01

    Full Text Available Frederic Kontny1, Terje Risanger2, Arne Bye3, Øyvind Arnesen4, Odd Erik Johansen4 for the TELMIMORE Study Investigators51Dept of Cardiology, Volvat Medical Centre, Oslo, Norway; 2Prinsdal Health Centre, Oslo, Norway; 3Frosta Health Centre, Frosta, Norway; 4Medical Department, Boehringer-Ingelheim Norway KS, Asker, Norway; 5The TELMIMORE Study Investigators are listed at the end of the paperPurpose: Although elevated blood pressure (BP predicts future cardiovascular events, recommended BP targets often is not reached in the general community. In a clinical real-life setting we evaluated BP impact and tolerability of the angiotensin-II receptor blocker telmisartan in patients with essential hypertension.Patients and methods: Patients in this observational study not at target BP started or switched to telmisartan monotherapy (40 or 80 mg or a fixed-dose combination of telmisartan and hydrochlorothiazide (HCT 80 mg/12.5 mg. Office and 24-hour ambulatory BP (AMBP were measured before and after 8 weeks of treatment and physicians reported perceived drug efficacy and tolerability as “Very good”, “Good”, “Moderate” or “Bad”.Results: 100 patients (34% female, 60 years, BMI 29.4 kg/m2, mean office BP 159/92 mmHg of whom 38% were treatment naïve and 30%, 17%, 9% and 6% respectively were on 1, 2, 3 or 4 BP-lowering drugs, completed 8 weeks of treatment. The proportion of patients with office BP < 140/90 mmHg increased from 3% to 54% for systolic (P < 0.001, 38% to 75% for diastolic (P < 0.001, and 2% to 45% for systolic and diastolic BP (P < 0.001. A significant effect on BP levels was seen in patients being either treatment naïve or on 1 to 3 BP-lowering drugs at study entry, whereas no BP improvement occurred in those who switched from 4 drugs. Overall, mean 24-hour AMBP was reduced from 141/85 to 131/79 mmHg (P < 0.001. Drug efficacy and tolerability were perceived as “Very good” or “Good” by 44%/34% and 66%/27%, respectively

  1. Characteristics and Medication Use of Psoriasis Patients Who May or May Not Qualify for Randomized Controlled Trials.

    Science.gov (United States)

    Malatestinic, William; Nordstrom, Beth; Wu, Jashin J; Goldblum, Orin; Solotkin, Kathleen; Lin, Chen-Yen; Kistler, Kristin; Fraeman, Kathy; Johnston, Joseph; Hawley, Lcdr Lesley; Sicignano, Nicholas; Araujo, Andre

    2017-03-01

    .g., comorbidities, prior treatments) from their trial-eligible counterparts. Regardless of their differences at baseline, adherence, persistence, and switching of biologic medications are largely similar, with few differences noted among groups. Financial support for this study was provided by Lilly USA. Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries, and he is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Malatestinic, Goldblum, Solotkin, Lin, Johnston, and Araujo are employees and/or stock owners of Lilly. Nordstrom, Kistler, and Fraeman are employees of Evidera, which received funding from Lilly to conduct this study. LCDR Hawley is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that "copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a U.S. government work as a work prepared by a military service member or employee of the U.S. government as part of that person's official duties. Research data were derived from an approved Naval Medical Center, Portsmouth, Virginia, institutional review board protocol. The views expressed in this work are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government. Study concept and design were contributed by Malatestinic and Araujo, along with the other authors. Nordstrom, Kistler, Fraeman, and Sicignano collected the data, and data interpretation was performed by Wu, Lin, and Hawley, along with Malatestinic, Nordstrom, Solotkin, and Araujo. The manuscript was written by Johnston, Malatestinic, Kistler, Wu, and Araujo, along with Nordstrom, Goldblum, Solotkin, Hawley, and

  2. Economic Impact of Above-Label Dosing with Etanercept, Adalimumab, or Ustekinumab in Patients with Psoriasis.

    Science.gov (United States)

    Feldman, Steven R; Zhao, Yang; Zhou, Huanxue; Herrera, Vivian; Tian, Haijun; Li, Yunfeng

    2017-05-01

    above-label use were $19,458 for etanercept, $18,972 for adalimumab, and $21,045 for ustekinumab. Total additional annual costs were $5,623,362 for etanercept, $701,964 for adalimumab, and $1,304,790 for ustekinumab. Psoriasis patients treated with etanercept, adalimumab, or ustekinumab had extensive above-label use over the 12-month follow-up period, which subsequently led to higher costs. Novartis Pharmaceuticals Corporation sponsored this study and the resultant publication. BioScience Communications provided medical writing and editorial support, which was also funded by Novartis Pharmaceuticals Corporation. Feldman was engaged by Novartis Pharmaceuticals as a paid clinical expert and scientific advisor for this study. He has received research support and speaking and/or consulting fees from AbbVie, Advance Medical, Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Caremark, Celgene, Eli Lilly, Galderma, GSK/Stiefel, Informa, Janssen, LEO Pharma, Merck, Merz, Mylan, National Biological, National Psoriasis Foundation, Pfizer, Qurient, Suncare Research, UpToDate, and Valeant; is the founder and majority owner of www.DrScore.com ; and is founder and part owner of Causa Research. Zhao, Herrera, Tian, and Li are employees of Novartis Pharmaceuticals. Zhou is a paid consultant for Novartis Pharmaceuticals and is an employee of KMK Consulting. Study concept and design were contributed by Feldman, Zhao, Herrera, and Li. Zhou and Li were responsible for data collection. Data were interpreted by Feldman and Zhao, with assistance from Zhou, Herrera, Tian, and Li. The manuscript was written primarily by Feldman and Zhao, with assistance from Zhou and Li. The manuscript was revised by Feldman and Zhao, assisted by Zhou, Herrera, Tian, and Li. Portions of this work were presented at the 34th Anniversary Fall Clinical Dermatology Conference in Las Vegas, Nevada, October 1-4, 2015.

  3. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study.

    Science.gov (United States)

    O'Donnell, Martin J; Chin, Siu Lim; Rangarajan, Sumathy; Xavier, Denis; Liu, Lisheng; Zhang, Hongye; Rao-Melacini, Purnima; Zhang, Xiaohe; Pais, Prem; Agapay, Steven; Lopez-Jaramillo, Patricio; Damasceno, Albertino; Langhorne, Peter; McQueen, Matthew J; Rosengren, Annika; Dehghan, Mahshid; Hankey, Graeme J; Dans, Antonio L; Elsayed, Ahmed; Avezum, Alvaro; Mondo, Charles; Diener, Hans-Christoph; Ryglewicz, Danuta; Czlonkowska, Anna; Pogosova, Nana; Weimar, Christian; Iqbal, Romaina; Diaz, Rafael; Yusoff, Khalid; Yusufali, Afzalhussein; Oguz, Aytekin; Wang, Xingyu; Penaherrera, Ernesto; Lanas, Fernando; Ogah, Okechukwu S; Ogunniyi, Adesola; Iversen, Helle K; Malaga, German; Rumboldt, Zvonko; Oveisgharan, Shahram; Al Hussain, Fawaz; Magazi, Daliwonga; Nilanont, Yongchai; Ferguson, John; Pare, Guillaume; Yusuf, Salim

    2016-08-20

    -2·67 for high or heavy episodic intake vs never or former drinker; 5·8%, 3·4-9·7 for current alcohol drinker vs never or former drinker), and diabetes mellitus (1·16, 1·05-1·30; 3·9%, 1·9-7·6) were associated with all stroke. Collectively, these risk factors accounted for 90·7% of the PAR for all stroke worldwide (91·5% for ischaemic stroke, 87·1% for intracerebral haemorrhage), and were consistent across regions (ranging from 82·7% in Africa to 97·4% in southeast Asia), sex (90·6% in men and in women), and age groups (92·2% in patients aged ≤55 years, 90·0% in patients aged >55 years). We observed regional variations in the importance of individual risk factors, which were related to variations in the magnitude of ORs (rather than direction, which we observed for diet) and differences in prevalence of risk factors among regions. Hypertension was more associated with intracerebral haemorrhage than with ischaemic stroke, whereas current smoking, diabetes, apolipoproteins, and cardiac causes were more associated with ischaemic stroke (prisk factors are collectively associated with about 90% of the PAR of stroke in each major region of the world, among ethnic groups, in men and women, and in all ages. However, we found important regional variations in the relative importance of most individual risk factors for stroke, which could contribute to worldwide variations in frequency and case-mix of stroke. Our findings support developing both global and region-specific programmes to prevent stroke. Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Network, Health Research Board Ireland, Swedish Research Council, Swedish Heart and Lung Foundation, The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland (Sweden), AstraZeneca, Boehringer Ingelheim (Canada), Pfizer (Canada), MSD, Chest, Heart and Stroke Scotland, and The Stroke Association, with support from The UK Stroke

  4. Extracellular cAMP activates molecular signalling pathways associated with sperm capacitation in bovines.

    Science.gov (United States)

    Alonso, Carlos Agustín I; Osycka-Salut, Claudia E; Castellano, Luciana; Cesari, Andreína; Di Siervi, Nicolás; Mutto, Adrián; Johannisson, Anders; Morrell, Jane M; Davio, Carlos; Perez-Martinez, Silvina

    2017-08-01

    -AM (intracellular Ca2+ chelator, 50 μM), EGTA (10 μM) and Probenecid (MRPs general inhibitor, 500 μM). In addition, assays for binding to oviductal epithelial cells and IVF were carried out to test the effect of cAMP compared with other known capacitant agents such as heparin (60 μg/ml) and bicarbonate (40 mM). Straws of frozen bovine semen (20-25 × 106 spermatozoa/ml) were kindly provided by Las Lilas, CIALE and CIAVT Artificial Insemination Centers. The methods used in this work include western blot, immunohistochemistry, flow cytometry, computer-assisted semen analysis, live imaging of Ca2+ and fluorescence scanning. At least three independent assays with bull samples of proven fertility were carried. In the present study, we elucidate the molecular events induced by extracellular cAMP. Our results showed that external cAMP induces sperm capacitation, depending upon the action of PLC. Downstream, this enzyme increased ERK1-2 activation through PKC and elicited a rise in sperm Ca2+ levels (P rate compared to control conditions (P us to hypothesize that cAMP is a self-produced autocrine/paracrine factor, and supports the emerging paradigm that spermatozoa do not compete but, in fact, communicate with each other. A precise understanding of the functional competence of mammalian spermatozoa is essential to generate clinical advances in the treatment of infertility and the development of novel contraceptive strategies. This work was supported by Consejo Nacional de Investigaciones Científicas y Técnicas [PIP0 496 to S.P.-M.], Agencia Nacional de Promoción Científica y Tecológica [PICT 2012-1195 and PICT2014-2325 to S.P.-M., and PICT 2013-2050 to C.D.], Boehringer Ingelheim Funds, and the Swedish Farmers Foundation [SLF-H13300339 to J.M.]. The authors declare there are no conflicts of interests. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email

  5. The Quorum-Sensing Regulon of Vibriofischeri: Novel Components of the Autoinducer/LuxR Regulatory Circuit

    Science.gov (United States)

    1999-06-01

    obvious parallel between virulence factors and symbiosis factors, non-lux genetic loci that are transcriptionally regulated by autoinducer/luxR have not...from several unlinked genetic loci to control multiple functions [4]. Pseudomonas aeruginosa, for example, controls the production of elastase...Southern (55) hybridization analyses, the Genius nonradioactive DNA labelling and detection kit (Boehringer Mannheim Biochemicals, India- napolis

  6. ·The clinical and biochemical effects of two combination oral ...

    African Journals Online (AJOL)

    1991-04-06

    Apr 6, 1991 ... a commercial kit (Boehringer-Mannheim CHOD-PAP High. Performance kit) and triglyceride was similarly determined. (Clinical Colorimetric Enzymatic Method, Carlo Erba, Milan). HDL-C was measured after precipitation of the low-density lipoprotein (LDL), and very low-density lipoprotein (VLDL).

  7. Molecular characterisation of Mycovellosiella koepki, the causal ...

    African Journals Online (AJOL)

    KEN

    2007-02-05

    Feb 5, 2007 ... then annealing at 52°C for 1 min and finally 72°C for primer extension. The final primer elongation segment of the run was extended to 10 min at 72°C. Amplified products were digested with restriction enzymes according to the manufacturer's instructions. (Boehringer Mannheim). Digested DNA fragments ...

  8. standards of diabetic care - successes and failures of a patient ...

    African Journals Online (AJOL)

    3.5 - 6.0%). Satisfactory control was defined as HbAlC ,,; 9.5%. Total cholesterol and triglycerides were measured by automated enzymatic methods (Hitachi Analyzers; reagents from Boehringer Mannheim GmbH Diagnostics, Germany). Hypercholesterolaemia and hypertriglyceridaemia requiring pharmacological treatment ...

  9. Increase energy efficiency in the cold production; Steigerung der Energieeffizienz in der Kaelteerzeugung

    Energy Technology Data Exchange (ETDEWEB)

    Paatzsch, Rene [Institut fuer Luft- und Kaeltetechnik gGmbH, Dresden (Germany). Hauptbereich Kaelte- und Waermepumpentechnik; Berg, Hans-Peter [Boehringer Ingelheim Pharma GmbH und Co. KG, Ingelheim (Germany)

    2011-12-15

    According to a study by ILK Dresden the cold production in the field of pharmaceutical manufacturing at Boehringer has been adjusted. By installing a turbo chiller and the sliding control of the cooling water temperature depending on the wet bulb temperature the COP of the cold production was improved of 3.1 to 4.5 currently. (orig.)

  10. 2012 edition JMBR - CORRECTION.cdr

    African Journals Online (AJOL)

    FinePrint

    Boehringer spectrophometer 4010) at appropriate wavelengths. The concentration of plasma low density lipoprotein cholesterol (LDLc) was. 1 estimated according to Okwusidi (1988) as the difference between TPC and HDLc to obtain summed LDLc + VLDLc; with subsequent adjustment for determined. TRG concentration ...

  11. Effect of hypoxia-inducible factor 1-alpha (HIF-1α) on proliferation ...

    African Journals Online (AJOL)

    Jane

    2011-07-25

    , rabbit anti-mouse HIF-1α polyclonal antibody, mouse specific HIF-1α-siRNA and mock siRNA (Sigma-Aldrich,. USA), Annexin V-FITC apoptosis detection kit (BD, USA) and. TUNEL assay kit (Boehringer Mannheim, Germany) ...

  12. 128 - 131 Abdu Anticholinester

    African Journals Online (AJOL)

    DR. AMIN

    shown in the equation below (Boehringer, 1991). The study was set out to investigate the effect of the leaves extract of Anogeisus leiocarpus on the cholinesterase enzyme which serves as an indicator system whose analysis always correspond to the bioluminescence Mycobacterium aurum or tuberculosis expressing firefly.

  13. Sluggish glucose tolerance in tuberculosis patients | Bell | South ...

    African Journals Online (AJOL)

    Standard oral glucose tolerance tests (OGTTs) were performed in both groups in the morning after an overnight fast. Anticoagulant-treated blood was analysed for glucose and insulin using Peridochrome Glucose (Boehringer Mannheim, Mannheim, Germany) and radioimmunoassay (RIA) (Diagnostic Products Corporation, ...

  14. GB virus C epidemiology in Denmark

    DEFF Research Database (Denmark)

    Christensen, Peer B; Fisker, Niels; Mygind, Lone H

    2003-01-01

    children, 9 and 15 years of age (n = 901), blood donors (n = 5,203), hospital employees (n = 1,432), and prisoners and injecting drug users (n = 447). In-house RT-PCR for GBV-CRNA was used together with a commercial ELISA for anti-E2 (Boehringer, Germany). In addition, questionnaires for risk factors...

  15. Redhead (Rubiaceae)

    African Journals Online (AJOL)

    Erah

    15. Schmidt E, Schmidt FW. Manuel d'enzymologie. Clinique. Serie Boehringer Mannheim. Diagnostica, 1973; p 76. 16. Medirabbit.com. Valeurs de référence de biochimie sanguine,. 2004http:// www.medirabbit.com/FR/Hematologie/biochimi e/blood chemistry fr.htm. 17. Founzegue AC, Adama C, N'Guessan JD, Koffi GK,.

  16. Biodegradation of 2,4-dichlorophenol originating from ...

    African Journals Online (AJOL)

    STORAGESEVER

    2009-06-03

    Jun 3, 2009 ... of high concentration of chlorophenols. Appl. Microbiol. Biotechnol. 59: 599-604. Louie TM, Webster CM, Xun L (2002). Genetic and biochemical characterization of a 2,4,6- trichlorophenol degradation pathway in. Ralstonia eutropha JMP 134. J. Bacteriol. 184: 3492-3500. Lysetska M, Knoll A, Boehringer D ...

  17. Elucidating the Role of cAb1 and the Abi-Family of cAB1 Target Proteins in Cancer Development and Progression

    Science.gov (United States)

    2000-07-01

    Photoshop 5.0. Photography of some lower mag- cut on a Reichert Jung cryostat, mounted on CSS-100 nification images was performed with a Wild Photo...4 Schools marked " advertisement " in accordance with 18 U.S.C. section 1734. Physician-Scientist Program, sponsored by the Lucille P. Markey Charitable...Boehringer payment of page charges. This article must therefore be hereby suended, 5marked " advertisement " in accordance with 18 USC section Mannheim), 5

  18. Characterisation of penA and tetM resistance genes of Neisseria ...

    African Journals Online (AJOL)

    20 mM EDTA, pH 7,4) containing 25 IJg of lysozyme. After 10 minutes at room temperature 0,5 ml of 2% Triton-X 100 and. 12,5 IJg of Proteinase K (Boehringer) were added. ... the exception that 4 IJg of mutanolysin (Sigma) and 10 IJg lysozyme (Sigma) were added to aid lysis. Plasmid. Volume 85 No. 8 August 1995 SAMJ ...

  19. Assessment of genomic relationship between Oryza sativa and ...

    African Journals Online (AJOL)

    STORAGESEVER

    2010-03-01

    Mar 1, 2010 ... bovine serum albumin (BSA) in 4xSSct (4xSSC + 0.05% Tween-. 20), was dropped on each slide, covered with cover slip and incubated for 5 min at 37°C. An aliquot of 70 µl, fluorescein isothio- cynate (FITC)-Avidin (Boehringer Mannheim), in 1% BSA/4xSSct was layered on the slides and incubated for 60 ...

  20. Monitoring paneer for Listeria monocytogenes- A high risk food ...

    African Journals Online (AJOL)

    Dr.Batish

    2012-05-15

    May 15, 2012 ... Taq DNA polymerase (Boehringer Mannheim). Appropriate positive and negative controls with each reaction were also set up. The PCR parametres included initial denaturation at 95°C for 4 min followed by. 25 cycles of denaturation at 95°C for 30 s, annealing at 60°C for 30 s, extension at 72°C for 30 s ...

  1. Comparative studies on the determination of alphafetoprotein by enzyme immunoassay and by radioimmunoassay

    International Nuclear Information System (INIS)

    Haller, G.; Linneke, P.; Voss, P.; Jeske, W.

    1987-01-01

    Alphafetoprotein (AFP) was determined in serum of pregnant women in the tenth till sixteenth week of pregnancy by means of two enzyme immunoassays (Enzymun-Test AFP, Boehringer Mannheim, FRG and AFP EIA 'Dessau' 1000, Research Institute for Vaccine Dessau, GDR) and a radioimmunoassay (Radioimmunoassay Kit, AFP-PR, CIS, France). Parallel determinations in sera of 438 patients, who had come to surveillance for the first consultation were estimated. A comparison between the methods showed a good correlation. (author)

  2. A simplified radioimmunoassay for digoxin determination using a 125-I-labelled solid-phase kit

    International Nuclear Information System (INIS)

    Doering, W.; Bluemel, E.

    1978-01-01

    Our experience with a commercially available kit (Radioimmunoassay DIGOXIN, Boehringer, Mannheim) using ( 125 J)-labelled digoxin and antibody-coated tubes is reported. This simplified method requires only two pipetting steps per sample and results can be obtained in 70 min. The intra- and interassay coefficient of variation ranged between 7% and 8%. The specific digoxin antibody antibody gave no clinical relevant cross-reactions with spironolactone or prednisone ( [de

  3. Model-independent X-ray Mass Determinations for Clusters of Galaxies

    Science.gov (United States)

    Nulsen, Paul

    2005-09-01

    We propose to use high quality X-ray data from the Chandra archive to determine the mass distributions of about 60 clusters of galaxies over the largest possible range of radii. By avoiding unwarranted assumptions, model-independent methods make best use of high quality data. We will employ two model-independent methods. That used by Nulsen & Boehringer (1995) to determine the mass of the Virgo Cluster and a new method, that will be developed as part of the project. The new method will fit a general mass model directly to the X-ray spectra, making best possible use of the fitting errors to constrain mass profiles.

  4. A combined approach of DNA probe and RFLP for family and species identification of larval stages of commercially important aquatic species: A study on the surfclam Spisula solidissima

    Digital Repository Service at National Institute of Oceanography (India)

    Achuthankutty, C.T.

    /T ATTACCGCGGC G/T GCTG- 3'))- In 100 ?l reactions, the reagent con- centrations used were as follows. Each reaction contained, 1-2 ?l of template DNA, 10 ?l of l0x PCR buffer (Boehringer Mannheim, Germany), 0.2 mM dNTP, 0.2 (M of each primer, 40 ?g of bovine...- nal extension at 72? C for 7 m. The pres- ence of PCR products was confirmed by electrophoresis on a 2% agarose gel con- taining ethidium bromide. Probe Hybridization PCR products from the larvae and controls were tested with mactrid-spe- cific...

  5. Comparison of serum copper determination by colorimetric and atomic absorption spectrometric methods in seven different laboratories. The S.F.B.C. (Société Française de Biologie Clinique) Trace Element Group.

    Science.gov (United States)

    Arnaud, J; Chappuis, P; Zawislak, R; Houot, O; Jaudon, M C; Bienvenu, F; Bureau, F

    1993-02-01

    An interlaboratory collaborative trial was conducted on the determination of serum copper using two different methods, based on colorimetry (test combination Copper, Boehringer Mannheim, Mannheim, Germany) and flame atomic absorption spectrometry (FAAS). The general performance of the colorimetric method was below that of FAAS, except for sensitivity and linear range, as assessed by detection limit (0.44 versus 1.32 mumol/L) and upper limit of linearity (150 versus 50 mumol/L). The range of the between-run CVs and the recovery of standard additions were, respectively, 2.3-11.9% and 92-127% for the colorimetric method and 1.1-6.0% and 93-101% for the FAAS method. Interferences were minimal with both methods. The two techniques correlated satisfactorily (the correlation coefficients ranged from 0.945-0.970 among laboratories) but the colorimetric assay exhibited slightly higher results than the FAAS method. Each method was transferable among laboratories.

  6. PDT-induced apoptosis in bladder carcinoma cells

    Science.gov (United States)

    Bachor, Ruediger; Reich, Ella D.; Kleinschmidt, Klaus; Repassy, Denes; Hautmann, Richard E.

    1999-02-01

    Photodynamic therapy (PDT) is a highly efficient inducer of apoptosis in EY-28 bladder carcinoma cells, resulting in extensive DNA fragmentation. Bladder carcinoma cells EY-28 (Tumorbank Heidelberg, Germany) were incubated for 1 h with 1 (mu) g AamTPPn/ml or 2 (mu) g AamTPPn/ml. After incubation cells were refed with complete medium and irradiated with 0.75 J/cm2. To identify apoptotic cells, a in situ cell death detection kit POD (Boehringer Mannheim, Germany) was used. The chromatin condensation characteristic to apoptotic cells was detected by transmission electron microscopy. Using 1 (mu) g AamTPPn/ml and 2 (mu) g AamTPPn/ml (9-Acetamido-2,7,12,17- tetra-n-Porpylporphycene), respectively, and irradiation at 0.75 J/cm2, a percentage of 36.9% and 54.7%, respectively, of apoptotic cells was detected.

  7. Effect of gamma radiation on the concentration of pyruvate and lactate in erythrocytes of healthy men after submaximal physical exercise

    International Nuclear Information System (INIS)

    Zagorski, T.; Dudek, I.; Berkan, L.; Chmielewski, H.; Kedziora, J.

    1993-01-01

    The aim of this work was to study the effect of gamma radiation and submaximal physical exercise on the concentration of final products of anaerobic glycolytic pathway in erythrocytes of healthy men. Twenty one men aged 20-22 were examined. They underwent physical exercise at doses of 2 w/kg body weight for 15 min. Erythrocytes were taken in the rest and after physical exercise and were exposed to gamma radiation (500 Gy doses) from 60 Co source. The concentration of pyruvate was estimated by Fermognost tests and the concentration of lactate by Boehringer Mannheim tests. The submaximal physical exercise was found to cause a significantly increased concentration of pyruvate and lactate in the non-radiated and irradiated erythrocytes. Gamma radiation at 500 Gy dose was found to increase concentration of pyruvate in erythrocytes (in the rest and after physical exercise) with simultaneous decrease of lactate concentration. (author). 17 refs, 1 tab

  8. Studies of Interactions of Positive Helium Ions with Small Neutrals at Temperatures Below 50K

    Science.gov (United States)

    Schauer, Martin Michael

    1990-01-01

    Interactions of He^+ ions with small neutrals are important because of their fundamental nature and applicability to other areas of research. In the past, very little work has been done on such systems at very low temperatures (T Boehringer and Arnold (1986) and Johnsen, Chen, and Biondi (1980). A new method of detecting the ions in the trap was also developed and implemented. The Fourier Transform Ion Z-resonance (FTIZR) technique took advantage of an induced coherence in the oscillations of the ions in the trap. This method allowed for measurement of faster ion -neutral reactions. This method was demonstrated by studying the non -resonant charge transfer process ^3He ^+{+}^4He{toatop >=ts}^3He{+}^4He^+. These measurements confirmed that the forward reaction is endothermic by about 1.1 meV.

  9. Determination of serum digosin. A comparison between RIA and EIA

    International Nuclear Information System (INIS)

    Spitz, J.; Braun, J.S.; Schmidt, M.; Krankenhausstiftung Bamberg

    1979-01-01

    The results of two radioimmunoassays (RIA, precipitating technique), of a homogenous (EMIT) and a heterogenous (ELISA) enzyme immunoassay (EIA) for ascertaining the amounts of digoxin showed a good correlation in precision and a reasonably AK satisfying correlation in the recovery. However, there was a clear discrepancy in the amounts of digoxin concentrate in the serum of patients. Only the RIA of Abbott and the EIA of Boehringer showed no significant differences. Particularly noticeable was the tendency towards lower values in the EMIT-technique as well as its liability to unspecific serum changes (lipaemia etc.), which often made the detection of digoxin impossible. The routine use of this technique appears problematic. The need for establishing one's own laboratory and test-specific therapeutical range is pointed out. (orig.) [de

  10. Effect of gamma radiation on levels of adenine nucleotides in erythrocytes of healthy individuals after submaximum physical exertion

    International Nuclear Information System (INIS)

    Zagorski, T.; Dudek, I.; Mazurek, M.; Berkan, L.; Chmielewski, H.; Kedziora, J.

    1994-01-01

    The authors studied the effect of gamma radiation and submaximum physical exercise on adenosine-5'-triphosphate (ATP), adenosine-5'-diphosphate (ADP) and adenosine-5'-monophosphate (AMP) contents in erythrocytes of healthy males. Twenty one men aged 20-22 years were examined. They underwent physical exercise at doses of 2 w/kg body weight for 15 min. Erythrocytes were exposed to gamma radiation (500 Gy doses) from 60 Co source. The concentration of adenine nucleotides in erythrocytes was measured by the Boehringer Mannheim tests. The submaximum physical exercise was found to decrease ATP content and to increase ADP and AMP in erythrocytes. Gamma radiation at 500 Gy dose was found to decrease ATP concentration in erythrocytes both at rest and after submaximum exercise and to increase AD content. It was revealed that AMP content increased at rest and decreased after submaximum exercise in irradiated erythrocytes. (author). 20 refs, 1 tab

  11. A Maximum Power Point Tracking Control Method of a Photovoltaic Power Generator with Consideration of Dynamic Characteristics of Solar Cells

    Science.gov (United States)

    Watanabe, Takashi; Yoshida, Toshiya; Ohniwa, Katsumi

    This paper discusses a new control strategy for photovoltaic power generation systems with consideration of dynamic characteristics of the photovoltaic cells. The controller estimates internal currents of an equivalent circuit for the cells. This estimated, or the virtual current and the actual voltage of the cells are fed to a conventional Maximum-Power-Point-Tracking (MPPT) controller. Consequently, this MPPT controller still tracks the optimum point even though it is so designed that the seeking speed of the operating point is extremely high. This system may suit for applications, which are installed in rapidly changeable insolation and temperature-conditions e.g. automobiles, trains, and airplanes. The proposed method is verified by experiment with a combination of this estimating function and the modified Boehringer's MPPT algorithm.

  12. Transluminal laser angioplasty

    Science.gov (United States)

    Otto, Wlodzimierz

    1996-03-01

    Twenty seven patients with femoral artery occlusion were treated by transluminal Nd:YAG laser angioplasty, in 16 patients the procedure was combined with intraarterial infusion of rTPA (actilyse-Boehringer Ing). In 5 out of 11 patients from the initial group recanalization was not successful. In 16 patients from the rTPA group satisfactory immediate results were achieved in all cases. In long time observations ranging from 9 to 24 months all patients remained free from symptoms, although in 4 of them angiography and Doppler ultrasound examination reveal no flow in the femoral artery. In the remaining 12 patients (75%), the previously occluded artery is patent. No complications of laser angioplasty nor intraarterial infusion of rTPA were noted in this series.

  13. Brightest Cluster Galaxies in REXCESS Clusters

    Science.gov (United States)

    Haarsma, Deborah B.; Leisman, L.; Bruch, S.; Donahue, M.

    2009-01-01

    Most galaxy clusters contain a Brightest Cluster Galaxy (BCG) which is larger than the other cluster ellipticals and has a more extended profile. In the hierarchical model, the BCG forms through many galaxy mergers in the crowded center of the cluster, and thus its properties give insight into the assembly of the cluster as a whole. In this project, we are working with the Representative XMM-Newton Cluster Structure Survey (REXCESS) team (Boehringer et al 2007) to study BCGs in 33 X-ray luminous galaxy clusters, 0.055 < z < 0.183. We are imaging the BCGs in R band at the Southern Observatory for Astrophysical Research (SOAR) in Chile. In this poster, we discuss our methods and give preliminary measurements of the BCG magnitudes, morphology, and stellar mass. We compare these BCG properties with the properties of their host clusters, particularly of the X-ray emitting gas.

  14. Biosensor technology for the detection of illegal drugs I: objectives, preparatory work, and drug enrichment

    Science.gov (United States)

    Hilpert, Reinhold; Binder, Florian; Grol, Michael; Hallermayer, Klaus; Josel, Hans-Peter; Klein, Christian; Maier, Josef; Oberpriller, Helmut; Ritter, Josef; Scheller, Frieder W.

    1994-10-01

    In a joint project of Deutsche Aerospace, Boehringer Mannheim and the University of Potsdam portable devices for the detection of illegal drugs, based on biosensor technology, are being developed. The concept enrichment of the drug from the gas phase and detection by immunological means. This publication covers the description of our objectives, preparatory work and results concerning enrichment of drugs from the gas phase. Vapor pressures of cocaine and cannabinoids have been determined. A test gas generator has been constructed which allows for reproducible preparation of cocaine concentrations between 2 ng/l and 2 pg/l. Coupling of a thermodesorption unit with GC/MS has been established for reference analysis. As another analytical tool, an ELISA with a lower detection limit of about 0,5 pg cocaine/assay has been developed. Applying fleece-type adsorbers, enrichment factors for cocaine in the range of 105 have been realized. No significant interference was found with potentially disturbing substances.

  15. Determination of triiodothyronine in serum by enzyme- and radioimmunoassay

    International Nuclear Information System (INIS)

    Oellerich, M.; Haindl, H.; Medizinische Hochschule Hannover

    1981-01-01

    An evaluation of a heterogeneous enzyme immunoassay for determination of triiodothyronine in serum (Enzymun-Test T 3 , Boehringer Mannheim) is presented. The enzyme immunoassay was compared with the laboratory routine radioimmunoassay. The precision of both assays was satisfactory at triiodothyronine concentrations between 1.0 and 8.0 nmol/l (coefficients of variation from day to day 3 from 96-104% and with the radioimmunoassay from 88-111%. A comparison of the results obtained by Enzymun-Test T 3 and the radioimmunoassay in a series of 103 patients showed a good correlation between both methods. L-thyroxine did not cause a relevant cross-reaction in the enzyme immunoassay. About 20 unknown samples can be analyzed in triplicate by Enzymun-Test T 3 within 260 minutes. (orig.) [de

  16. Comparison of telomere length and telomerase activation between breast fibroadenoma and infiltrating ductal carcinoma in Malaysian women.

    Science.gov (United States)

    Looi, Lai-Meng; Cheah, Phaik-Leng; Ng, Min-Hwei; Yip, Cheng-Har; Mun, Kein-Seong; Rahman, Nazarina Abdul

    2010-01-01

    A study was initiated to explore possible differences in handling telomere attrition in the most common lignant and benign tumours of the breast in Malaysian women. Infiltrating ductal carcinoma (IDC) and fibroadenoma (FA) represented the malignant and benign prototypes respectively. 29 IDC, 28 FA and 22 benign non-lesional control (BNL) breast tissue samples were analysed for telomerase activation using a Telomerase PCR ELISA kit (Boehringer Mannheim). In addition, 23 IDC, 12 FA and 14 BNL were subjected to telomere length determination with a TeloTAGGG Telomere Length Assay Kit (Roche Diagnostic GmbH, Germany), following digestion of genomic DNA by frequently cutting restriction enzymes RsaI and HinfI. Mean telomerase activity in IDC (A450nm=0.3338), but not FA (A450nm=0.0003) was significantly raised (pbreast and may be important for targeted therapy.

  17. A critical appraisal of a further three new commercial digoxin radioimmunoassay kits with reference to cross-reacting substances

    International Nuclear Information System (INIS)

    Wood, W.G.; Wachter, C.

    1979-01-01

    A further 3 digoxin radioimmunoassay (RIA) kits have been evaluated for performance and cross-reaction with digitoxin, spironolactone, canrenone and furosemide (Lasix-Hoechst). Effects of serum protein concentrations have also been tested. The kits tested were from the following manufacturers: A) Diagnostic Products Corporation Digoxin RIA Kit. B) Byk-Mallinckrodt SPAC Digoxin Kit. C) Boehringer-Mannheim Digoxin RIA Kit. All kits used a 125 I-labelled tracer. Kit A used a conventional liquid phase system using double-antibody separation for bound and free drug. Kits B and C used a solid-phase antibody coated tube method. All kits showed a lower cross-reaction to digitoxin than quoted by the manufacturer. Cross-reaction to spironolactone (Aldactone - Boehringer-Mannheim) was less than 1.50 nmol/l at a serum concentration of 125 mg/l Aldactone in all 3 kits. The cross-reaction to canrenone was somewhat higher, 5.2 nmol/l 'digoxin' being measured in one kit at a serum canrenone concentration of 125 mg/l. There was no cross-reaction with furosemide in any kit, even at a serum concentration of 5 g/l. The coated-tube assays were affected by serum albumin and globulin concentration changes, one kit showing a difference of over 50% binding in the range 1-20% albumin. The double-antibody kit did not show dependence on the concentration of these proteins. All kits measured digoxin with good reproducibility in the range 0.40-10.0 nmol/l. (orig.) [de

  18. Labelled antibody assays for measuring free triiodothyronine: evaluation and comparison with a labelled analog method

    International Nuclear Information System (INIS)

    Sapin, R.; Gasser, F.; Schlienger, J.L.; Chambron, J.

    1993-01-01

    We evaluated analytically and clinically two new one-step labelled antibody assays for measuring free triiodothyronine (FT3): the first, radiolabelled with 125 I, Amerlex-MAB (MAB) from Kodak diagnostic, and the second, labelled with peroxidase, Enzymum-test FT3 (BM) from Boehringer Mannheim adapted for the Boehringer ES 600 analyzer. The clinical results were compared with those obtained with a radiolabelled analog tracer kit, Amerlex-M (M) from Kodak diagnostic. The latter kit is known to give low FT3 results in sera with low albumin concentrations. Analytical performances of the automated method (BM) were better than those obtained with the manual method (MAB): intra-assay reproducibility (CV<3% vs CV about 5%), inter-assay reproducibility (CV<4% vs CV between 4 and 8%) and mean drift (+1.25% vs -4.3%). The detection limit was low for both kits (<1 pmol/l). In the euthyroid reference group (n = 98) we observed a significant difference between outpatient and hospitalized patient FT3 concentrations as measured with the M kit only. Clinical sensitivity for hyperthyroidism (n = 38) was better for the MAB (92%) than for the BM kit (76%). Specificity in euthyroid L-thyroxine (T4) treated patients (n = 26) was good for both kits (MAB: 92%; BM: 88%) . Hypoalbuminemia (n = 8) decreased FT3 results as follows: M, very significantly; BM, significantly; MAB, only slightly. In patients treated with amiodarone (n = 5), a drug known to lower the metabolic conversion of T4 to T3, the increase of the MAB FT3 results contrasted with the decrease of the BM and M results. In conclusion, results of the two new kits were not strongly influenced by hypoalbuminemia. The MAB results showing lack of decrease in patients with non-thyroidal illness without hypoalbuminemia and in amiodarone-treated patients were unexpected

  19. Vol. 4 in the series: Site profiles of persistent chlorinated hydrocarbons - cause-oriented monitoring in aquatic media; Pestizide aus der Reihe der persistenten chlorierten Kohlenwasserstoffe in Gewaessern der Rhein-Region - Ergebnisse nachhaltiger Steuerungen von Wirtschaft und Politik. Bd. 4 der Reihe: Standortprofile persistenter chlorierter Kohlenwasserstoffe - ursachenorientiertes Monitoring in aquatischen Medien

    Energy Technology Data Exchange (ETDEWEB)

    Heinisch, E.; Kettrup, A.; Bergheim, W.; Wenzel, S.

    2003-07-01

    Evaluating the analytical data of DDT and its metabolites, the isomers of HCH as well as (sometimes) of aldrin and dieldrin in surface water, suspended matter, eels, breams and roaches from the rivers Rhine, Neckar, Kocher, Enz, Main (upto km 360), Weschnitz, Modau, Schwarzbach, Hengstbach, Grundbach, Nidda, Rodau, Kinzig, Werra, Diemel, Lahn, Nahe, Mosel, Sauer, Saar, Ahr, Kyll, Sieg and Laacher See distance profiles (partly from Konstanz till Markermeer) and time series (partly from 1984-2001) were elaborated. The primary data come from about 15 mainly regional investigation departments, the IKSR and the Environmental Specimen Bank. The chemical enterprises in Rheinfelden, Grenzach, Ludwigshafen, Lampertheim, Gernsheim, Darmstadt, Hoechst, Kelsterbach, Offenbach, Ingelheim, Loelsdorf, Leverkusen, Elberfeld, Krefeld-Uerdingen and Huels could partly be made transparent by the course of the sDDT and sHCH values and the profiles of the constituents and isomers, resp., in the distance profiles (especially from the river Rhine) mainly from 1990/92. The corresponding graph for the year 2000 shows that there is no longer a human and ecotoxicological relevance of the compounds to be expected. (orig.)

  20. Mg,Ca-ATPase activity under irradiation

    International Nuclear Information System (INIS)

    Ladutin, V.V.; Orlova, V.V.; Lob, P.A.; Gerasiminko, I.V.; Mack, E.I.

    2003-01-01

    Full text: The influence of different doses irradiation at the Mg,Ca-ATPase activity at the rat brain has been investigated. The analyses were made at the apparatus of LKB and Carl-Ceis-Jena firm with help of reagents of Sigma and Boehringer firm. Rats decapitated after 1, 3, 6, 24 and 48 h after action of irradiation. Dose 0.206 C/kg. Erythrocytes. 1 and 3h after irradiation influence- decrease of Mg,Ca-ATPase activity to 86-87% relatively control level, 24 and 48 h - increase of activity to the control level. Dose 0.312 C/kg. Large hemispheres. 1h - decrease of ATPase activity to 90% relatively control, 3h - increase to control level, 24h - fall to 86%, after 48h small increase to 93% relatively control. Dose 9.287 C/kg. Large hemispheres. 1h - sharp fall of Mg, Ca-ATPase activity to 67 % relatively control, increase of activity to 96% after 3h and sharp fall of activity to 64% 6h after action of irradiation. Dose 9.287 C/kg. Cerebellum. 1h - sharp decrease of ATPase activity to 80%. After 3h -sharp increase to 160% relatively control level and sharp fall of ATPase activity to 47% relatively control after 6h. The mechanism of radiation pathology of active ion transport has been discussed

  1. [Effects of balneotherapy on the reactants of acute inflammation phase in ankylosing spondylitis].

    Science.gov (United States)

    2009-01-01

    Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects sacroiliac joints, spinal column and peripheral joints. Beside medication therapy, physical and balneotherapy play an important role in its complex treatment. The aim of the research was to establish serum concentrations of C-reactive protein (CRP), alpha 1-acid glycoprotein (alpha 1-AGP), ceruloplasmine (CP) and erythrocyte sedimentation rate (SE) before and after the balneotherapy in ankylosing spondylitis. The research included 50 AS patients according to the revised New York criteria, of mean age 43 years, who were treated for 14 days on the average at the Clinic for Rheumatology of the Institute "Niska Banja". All the patients received medications and balneotherapy (radioactive oligomineral baths, peloid, massage, kinesitherapy); the serum concentrations of CRP, al-AGP, CP and SE were measured before and after balneotherapy. Serum proteins were determined using original Nor Partigen plates Boehringer. Erythrocyte sedimentation rate was measured by Westergreen method. Balneotherapy was applied individually, intensively or mildly, depending on the AS stage and activity phase. After dosed balneotherapy, a significant decrease in the concentrations of CP (p acute phase reactants is important in the evaluation of dosed balneotherapy efficiency in the treatment of ankylosing spondylitis.

  2. VizieR Online Data Catalog: Cool-core clusters with Chandra obs. (Andrade-Santos+, 2017)

    Science.gov (United States)

    Andrade-Santos, F.; Jones, C.; Forman, W. R.; Lovisari, L.; Vikhlinin, A.; van Weeren, R. J.; Murray, S. S.; Arnaud, M.; Pratt, G. W.; Democles, J.; Kraft, R.; Mazzotta, P.; Bohringer, H.; Chon, G.; Giacintucci, S.; Clarke, T. E.; Borgani, S.; David, L.; Douspis, M.; Pointecouteau, E.; Dahle, H.; Brown, S.; Aghanim, N.; Rasia, E.

    2018-02-01

    The main goal of this work is to compare the fraction of cool-core (CC) clusters in X-ray-selected and SZ-selected samples. The first catalog of 189 SZ clusters detected by the Planck mission was released in early 2011 (Planck Collaboration 2011, VIII/88/esz). A Chandra XVP (X-ray Visionary Program--PI: Jones) and HRC Guaranteed Time Observations (PI: Murray) combined to form the Chandra-Planck Legacy Program for Massive Clusters of Galaxies. For each of the 164 ESZ Planck clusters at z<=0.35, we obtained Chandra exposures sufficient to collect at least 10000 source counts. The X-ray sample used here is an extension of the Voevodkin & Vikhlinin (2004ApJ...601..610V) sample. This sample contains 100 clusters and has an effective redshift depth of z<0.3. All have Chandra observations. Of the 100 X-ray-selected clusters, 49 are also in the ESZ sample, and 47 are in the HIFLUGCS (Reiprich & Boehringer 2002ApJ...567..716R) catalog. (2 data files).

  3. [Evaluation of the test strip Reflotron ALP (alkaline phosphatase) for blood samples of dogs and cats].

    Science.gov (United States)

    Hirschberger, J; Dietz, J; Baumeister, C; Kraft, M

    1998-09-01

    The test strip Reflotron ALP (alcaline phosphatase) was evaluated for use in canine and feline heparinized blood samples. The within-run and the day-to-day precision of blood and plasma samples was excellent. A haematocrit up to 60% of canine blood and up to 50% of feline blood had no influence on the measurements. Reflotron ALP was compared with ALP on Hitachi 717 (Boehringer Mannheim, Mannheim, Germany). The correlation of both methods was good for canine and feline blood samples. Reflotron ALP was higher than Hitachi ALP in both species. Despite an enormous deviation between Reflotron ALP and the reference method of canine and feline blood samples within the reference range, Reflotron ALP is a suited test for the detection of elevated ALP activity in canine and feline blood samples. Differences of the ALP activity might be caused by ALP isoenzymes. The activity of ALP isoenzymes depends on the method. The buffer systems of Reflotron ALP and Hitachi ALP are different. Significant exceeding of the reference range was reliably detected. In this investigation the study results for heparinized whole blood, heparinized plasma and serum are approximately the same.

  4. Effect of Low Dose Gamma Radiation on Some Biochemical Indicators in the Blood Plasma of Chickens

    International Nuclear Information System (INIS)

    Kraljevic, P.; Simpraga, M.; Vilic, M.; Miljanic, S.

    2001-01-01

    Full text: An attempt was made to determine the effect of irradiation of eggs by low dose ionising radiation before incubation on concentration of total protein, glucose and cholesterol in the blood plasma of chickens hatched from irradiated eggs. The eggs of heavy breeding chickens were irradiated by dose of 0.15 Gy gamma radiation ( 60 Co) before incubation. Along with the chickens which were hatched from irradiated eggs, there was the control group of chickens hatched from nonirradiated eggs. All other conditions were the same for the both groups. After hatching, blood samples were taken from the wing vein on days 1, 3, 5, 7, 10, 20, 30 and 42. The concentration of all three parameters was determined spectrophotometrically using Boehringer Mannheim GmbH optimized kits. The concentration of total protein was significantly decreased in the blood plasma of chickens hatched from irradiated eggs on days 3, 7 and 30 and increased only on day 5. The concentration of glucose in the blood plasma was increased in the same chickens on days 1 and 30. The concentration of the cholesterol was decreased in the same chickens on day 7, and increased on day 10. Obtained results indicate that low-dose of gamma radiation has effects on some metabolic processes in the chickens hatched from eggs irradiated before incubation. (author)

  5. Enhanced throughput for infrared automated DNA sequencing

    Science.gov (United States)

    Middendorf, Lyle R.; Gartside, Bill O.; Humphrey, Pat G.; Roemer, Stephen C.; Sorensen, David R.; Steffens, David L.; Sutter, Scott L.

    1995-04-01

    Several enhancements have been developed and applied to infrared automated DNA sequencing resulting in significantly higher throughput. A 41 cm sequencing gel (31 cm well- to-read distance) combines high resolution of DNA sequencing fragments with optimized run times yielding two runs per day of 500 bases per sample. A 66 cm sequencing gel (56 cm well-to-read distance) produces sequence read lengths of up to 1000 bases for ds and ss templates using either T7 polymerase or cycle-sequencing protocols. Using a multichannel syringe to load 64 lanes allows 16 samples (compatible with 96-well format) to be visualized for each run. The 41 cm gel configuration allows 16,000 bases per day (16 samples X 500 bases/sample X 2 ten hour runs/day) to be sequenced with the advantages of infrared technology. Enhancements to internal labeling techniques using an infrared-labeled dATP molecule (Boehringer Mannheim GmbH, Penzberg, Germany; Sequenase (U.S. Biochemical) have also been made. The inclusion of glycerol in the sequencing reactions yields greatly improved results for some primer and template combinations. The inclusion of (alpha) -Thio-dNTP's in the labeling reaction increases signal intensity two- to three-fold.

  6. Faraday Rotation Measure Study of Cluster Magnetic Fields

    Science.gov (United States)

    Frankel, M. M.; Clarke, T. E.

    2001-12-01

    Magnetic fields are thought to play an important role in galaxy cluster evolution. To this end in this study, we looked at polarized radio sources viewed at small impact parameters to the cores of non-cooling flow clusters. By looking at non-cooling flow clusters we hoped to establish what magnetic fields of clusters look like in the absence of the compressed central magnetic fields of the cooling-flow cores. Clarke, Kronberg and Boehringer (2001) examined Faraday rotation measures of radio probes at relatively large impact parameters to the cores of galaxy clusters. The current study is an extension of the Clarke et al. analysis to probe the magnetic fields in the cores of galaxy clusters. We looked at the Faraday rotation of electromagnetic waves from background or imbedded radio galaxies, which were observed with the VLA in A&B arrays. Our results are consistent with previous findings and exhibit a trend towards higher rotation measures and in turn higher magnetic fields at small impact parameters to cluster cores. This research was made possible through funding from the National Science Foundation.

  7. Sunyaev-Zeldovich Predictions for the Atacama Cosmology Telescope

    Science.gov (United States)

    Menanteau, Felipe; Hughes, J. P.; Jimenez, R.; Barkhouse, W.; Berta, Z.; Hansen, S.; Hernandez-Monteagudo, C.; Kosowsky, A.; Lin, Y. T.; Moodley, K.; Ngeow, C.; Roche, N.; Spergel, D.; Tucker, D.; Verde, L.

    2007-05-01

    We present predictions for the microwave sky in a low-extinction region centered near RA = 23:00 and Dec = -55:12, which will be surveyed in the coming year at 145 GHz by the Atacama Cosmology Telescope (ACT, PI: Lyman Page) and in the X-ray band by XMM-Newton (PI: Hans Boehringer). The predictions are based on Sunyaev-Zeldovich distortions drawn from optical data collected by the Blanco Cosmology Survey (BCS). We also compare the predictions with X-ray data from the ROSAT All Sky Survey. The BCS (PI: Joe Mohr) is a NOAO large, wide-field survey project that has been awarded 45 nights on the CTIO Blanco 4-meter telescope to image two 50 square-degree patches of the southern sky in four bands (griz). The survey began in 2005 and has completed two (out of three) years of data taking. A preliminary automated image reduction and analysis pipeline for the BCS data is briefly summarized. Financial support was provided by the NSF under the PIRE program (OISE-0530095).

  8. Stability of Seven Days Sample Storage of Erythrocyte’s SOD and Blood’s GPx

    Directory of Open Access Journals (Sweden)

    Miswar Fattah

    2012-12-01

    Full Text Available The research was about SOD erythrocyte activities at day 0, 1, 3, 5, and 7 which centrifuged at room temperature (22.5 0C and storage temperature (-80 0C, SOD activities at day-0 which centrifuged at 4 0C, SOD whole blood activities with one day incubated at 2-8 0C and GPx activities at day 0, 1, 3, 5, and 7 with 2–8 0C storage temperature. Laboratory analysis were performed by using reagent from Randox Laboratories, and Hitachi 917 analyzer from Boehringer Mannheim. SOD activities were measured at 505 nm absorbance meanwhile 340 nm absorbance is used to measure GPx. Data was analyzed by using t-test method and showed that SOD activities at day 0, 1, 3, 5, and 7 with room temperature centrifuged had no significant differences. Significant differences are found at day-0 with centrifuged at 4 0C and one day incubated whole blood at 2–8 0C. GPx activities at day- 3 had no significant differences. Significant differences are found at day-0,1, 5 and 7 after storage.

  9. Enzimatik Yöntemle Bazı Sebze ve Meyvelerde Nitrat Düzeyinin Belirlenmesi

    Directory of Open Access Journals (Sweden)

    Nevzat Artık

    2015-02-01

    Full Text Available Bu çalışmada Ankara ve çevresinde 2000 yılı içerisinde yetiştirilen bazı taze sebze ve meyve örnekleri materyal olarak kullanıldı. Bu örneklere ait nitrat miktarları enzimatik Boehringer Mannheim GmbH metodu ile belirlendi. Nitrat içeriğinin taze sebzelerde 0.00-3019.41 mg/kg, taze meyvelerde ise 0.00-126.19 mg/kg arasında değiştiği saptandı. Nitrat miktarı, kereviz (3667.40 mg/kg, roka (3019,41 mg/kg ve pazı (2621.79 mg/kg örneklerinde yüksek bulunurken, kavun (0.00-47.93 mg/kgt karpuz (47.21-126.19 mg/kg gibi meyveler ile havuç (0.00-47.71 mg/kg, domates (0.00-71.10 mg/kg gibi meyve benzeri sebzelerde düşük düzeyde bulundu.

  10. The influence of intravenous canrenoate on the determination of digoxin in serum by radio- and enzyme-immunoassay

    International Nuclear Information System (INIS)

    Rietbrock, N.; Lichey, J.; Borner, K.; Freie Univ. Berlin

    1979-01-01

    Ten patients were kept on a constant maintenance dose of digoxin. During a baseline period of 6 days, blood samples were taken daily for analysis of digoxin in serum. On the 6th day the maintenance dose of digoxin was withheld and a single intravenous dose of 200mg potassium-canrenoate (AldactoneR) was administered to all patients. Digoxin in serum was determined by a classical radioimmunoassay with 125 I-digoxin and solid phase technique (RIA-NEN) and partly by a heterogenous enzyme-immunoassay (EnzymunR-Digoxin, Boehringer, Mannheim). Results of the radioimmunoassay indicated a rise of apparent serum digoxin levels with an average maximum of 201% of the mean baseline value 30 min after injection of canrenoate and a gradual return to the baseline value within 6 to 10 hours. Contrary to the radioimmunoassay there was no interference when using the enzyme-immunoassay in a subgroup of identical serum samples: serum digoxin levels remained constant throughout the test. Interference of determinations of digoxin in serum by spironolactone and its metabolites appear to be related to two factors: 1. The mode of administration and the amount of interfering drug, 2. the specifity of the digoxin antibody used in the kit. (orig.) [de

  11. Effect of clonidine on 22Na clearance in the rabbit eye

    International Nuclear Information System (INIS)

    Obenberger, J.; Rozsival, P.; Babicky, A.

    1979-01-01

    Effects of clonidine on the intraocular hydrodynamics demonstrated themselves as changes of 22 Na-clearance. This test is based on the principle of the intraocular penetration of contactly applied radioisotope and on monitoring the decreasing ocular radioactivity by means of external gamma detectors. The half-times of 22 Na-clearance were significantly prolonged after the local application of 100 μl of 0.5% clonidine (Isoglaucon Boehringer) as compared with the control group. The control animals displayed a half-time of 38.0+-2.7 in comparison with the treated animals measured at intervals of 30 to 90 min and 90 to 150 min after drug instillation, where half-times were significantly prolonged to 49.3+-4.3 and 63.4+-3.8, respectively. In other groups of rabbits 22 Na-clearance was measured on the contralateral eyes of after the intravenous injection of clonidine (25 μg per kg). In both cases the half-times did not significantly differ from the values found in controls. The observed changes of ocular hydrodynamics caused by clonidine probably reflect the inhibitory influence of this drug on aqueous humour production. Results of present investigations point to the decisive role of the local action of clonidine on the eye. (author)

  12. Dynamic formulation of a top-down and bottom-up merging energy policy model

    International Nuclear Information System (INIS)

    Frei, Christoph W.; Haldi, P.-A.; Sarlos, G.Gerard

    2003-01-01

    The impact of energy policy measures is not restricted to the energy system and should therefore be analysed within an economy-wide framework, while keeping the essential details of the energy sector. The aim of this paper is to present new developments in the field of the consistent evaluation of indicators for the sustainability assessment of energy policy measures. Starting from the static concept of Boehringer (Energy Econ. 20 (1998) 233), this paper shows how the complementarity format can be used in computable general equilibrium (CGE) modelling for a dynamic formulation of bottom-up and top-down approach merging models. While a hybrid approach increases the credibility of CGE models in energy policy analysis by replacing the energy sector generic functional forms with a bottom-up activity analysis based on specific technologies, the endogenous formulation of investment decisions makes an explicit description of evolving specific capital stocks and technology mixes possible. Both features are essential when assessing effects of policy measures that may be affected by structural change--which is typically the case in the long-term assessment of energy policy measures

  13. Determination of Several Clinical Parameters of the Blood for the HealthyEvaluation of the Radiation Worker

    International Nuclear Information System (INIS)

    Yazid, M; Triyono; Aris-Bastianudin

    2000-01-01

    Determination of the several clinical parameters of the blood for healthyevaluation of the radiation worker has been done. This research was done forarrangement of the medical general check up of the radiation worker toobserve pathological indicator of several body organs. The blood sample wastaken from vena mediana cubiti and analyzed by reagent using standardprocedure from Boehringer Mainheim. That procedure is specific for eachclinical parameters. That clinical parameters concentration was measured byClinicon Photometer 4010. The clinical data of the radiation worker wascompared to the non radiation worker. The measurement results of 501patients, shown that total protein concentrations for all worker are > 8.00g%, the cholesterol concentration of 25 patient are > 260 mg%. The glucoseconcentration for fasting condition of 7 patients are > 200 mg/dl, the ureumconcentration of all patients are 7mg% and the creatinine of 112 patients are > 1.4 mg%. From those results canbe concluded that the most pathological indicator can be identified fromliver, heart and kidney function respectively. From the clinical aspects canbe seen that there is no significant difference between the health ofradiation worker and non radiation worker. (author)

  14. Biosensor technology for the detection of illegal drugs II: antibody development and detection techniques

    Science.gov (United States)

    Hilpert, Reinhold; Bauer, Christian; Binder, Florian; Grol, Michael; Hallermayer, Klaus; Josel, Hans-Peter; Klein, Christian; Maier, Josef; Makower, Alexander; Oberpriller, Helmut; Ritter, Josef

    1994-10-01

    In a joint project of Deutsche Aerospace, Boehringer Mannheim and the University of Potsdam portable devices for the detection of illegal drugs, based on biosensor technology, are being developed. The concept enrichment of the drug from the gas phase and detection by immunological means. This publication covers the development of specific antibodies and various detection procedures. Antibodies with a high affinity for cocaine have been developed with the aid of specially synthesized immunogens. A competitive detection procedure with biosensors based on optical grating couplers and applying particulate labels has been established, showing a lower detection limit of 10-10 mol/l for cocaine. Additionally, a combination of a displacement-immunoreactor and an enzymatically amplified electrode was investigated, which at present still suffers from insufficient sensitivity of the immunoreactor. An alternative, fleece-matrix based test procedure, where enrichment and detection steps are integrated in a single unit, is promising in terms of simplicity and sensitivity. A simple swab-test for the detection of cocaine at surfaces has been developed, which has a lower detection limit of about 10 ng and which can be performed within one minute.

  15. Resultados cubanos del programa latinoamericano de educación a pacientes diabéticos no insulinodependientes (PEDNID-LA Results of the Latin American education program for non-insulin dependent patients (PEDNID-LA

    Directory of Open Access Journals (Sweden)

    Rosario García González

    2001-08-01

    Full Text Available Se muestran los resultados cubanos del Estudio Multicéntrico Latinoamericano de Educación en Diabetes para evaluar en forma prospectiva los cambios clínicos, bioquímicos y terapéuticos obtenidos en un grupo de personas con diabetes tipo 2, después de participar en un programa de educación grupal estructurado por la Asociación Latinoamericana de Diabetes y auspiciado por la Federación Internacional de Diabetes, la OMS y sus oficinas panamericanas y patrocinado por los Laboratorios Boehringer Mannheim. El proyecto central incluyó, por cada país, 30 - 40 pacientes no insulinodependientes, obesos y preferentemente de reciente inicio de la enfermedad, según el orden cronológico de su asistencia a la consulta ambulatoria. El programa constó de 4 sesiones teórico-prácticas semanales durante un mes y desarrolladas en forma de discusiones grupales y de un seguimiento trimestral en consulta durante 1 año. Los datos se procesaron según el programa Epi-Info y los resultados se compararon antes y un año después de la intervención educativa. Se encontró aumento significativo (p = 0,001 de los conocimientos sobre la enfermedad y disminución del peso corporal, de los síntomas clásicos de la enfermedad y de la dosis diaria de hipoglucemiantes orales. Los niveles medios de hemoglobina glucosilada, al final del estudio, habían mejorado significativamente (p=0,001, similar a lo encontrado en el resto de los países participantes. Se comprobó el impacto de la intervención educativa en la normalización de indicadores clínicos, bioquímicos y terapéuticos y se confirmó la posibilidad de que el continente pueda implementar programas de educación que refuercen y complementen el cuidado clínicoThe results of the Latin America Multicentered Study on Diabetes Education in Cuba are shown. This study was aimed at prospectively assessing the clinical, biochemical and therapeutical changes reached in a group of persons with type 2 diabetes

  16. Concentration of Proteins and Protein Fractions in Blood Plasma of Chickens Hatched from Eggs Irradiated with Low Level Gamma Rays

    International Nuclear Information System (INIS)

    Kraljevic, P.; Vilic, M.; Simpraga, M.; Matisic, D.; Miljanic, S.

    2011-01-01

    In literature there are many results which have shown that low dose radiation can stimulate many physiological processes of living organism. In our earlier paper it was shown that low dose of gamma radiation has a stimulative effect upon metabolic process in chickens hatched from eggs irradiated before incubation. This was proved by increase of body weight gain and body weight, as well as by increase of two enzymes activities in blood plasma (aspartate aminotransferase and alanine aminotransferase) which play an important role in protein metabolism. Therefore, an attempt was made to determine the effect of eggs irradiation by low dose gamma rays upon concentration of total proteins and protein fractions in the blood plasma of chickens hatched from irradiated eggs. The eggs of heavy breed chickens were irradiated with a dose of 0.15 Gy gamma radiation (60Co) before incubation. Along with the chickens which were hatched from irradiated eggs, there was a control group of chickens hatched from nonirradiated eggs. All other conditions were the same for both groups of chickens. Blood samples were taken from the right jugular vein on the 1 s t and 3 r d day, or from the wing vein on days 5 and 7 after hatching. The total proteins concentration in the blood plasma was determined by the biuret method using Boehringer Mannheim GmbH optimized kits. The protein fractions (albumin, α 1 -globulin, α 2 -globulin, β- and γ-globulins) were estimated electrophoretically on Cellogel strips. The total proteins concentration was significantly decreased in blood plasma of chickens hatched from irradiated eggs on days 3 (P t h day (P 2 -globulin was decreased on days 1 (P t h day of life. Obtained results indicate that low dose of gamma radiation has mostly inhibitory effect upon concentration of total proteins and protein fractions in the blood plasma of chickens hatched from irradiated eggs before incubation. (author)

  17. Radioimmunoassay of serum digoxin levels in digitalis intoxication

    International Nuclear Information System (INIS)

    Arendt, G.

    1981-01-01

    For 101 hospitalized patients where clinical symptoms of a glucosidine intoxication as a consequence of oral digoxin treatment were noted, serum digoxin levels were determined using a RIA kit of the Boehringer company (I-125 tracer, solid phase tube separation technique) on a fasted stomach prior to oral drug administration. An ECG was performed simultaneously and in addition kidney function parameters and electrolyte levels were determined. An anamnesis and clinical examination of the patients were also conducted. Interferences in the RIA method and gastro-intestinal illness resulting in changes in resorption behaviour were excluded. The group of patients showed collectively an average serum digoxin level of 2.9 +- 0.9 ng/ml with a range from 1.8 to 6.8 ng/ml, which was statistically significantly higher than the average value for 101 patients receiving long-term oral medication but without symptoms of glycosidine intoxication. According to the manufacture's specifications for the RIA kit, values > 2.0 ng/ml are considered as toxic, with values between 1.6 and 2.0 ng/mg falling into a ''grey zone''. A correlation was found between toxic serum values with changes in ECG pattern and subjective clinical symptoms of intoxication. A limitation of kidney function was responsible for the high serum glycoside levels in 62% of the patients. It was shown that the differing response of patients towards digitalis medication, above all in the case of long-term therapy, warrants an RIA determination of serum glycoside values in order to adjust the digoxin dose to individual requirements. (orig./MG) [de

  18. The L_X-M relation of Clusters of Galaxies

    Energy Technology Data Exchange (ETDEWEB)

    Rykoff, E.S.; Evrard, A.E.; McKay, T.A.; Becker, M.R.; Johnston, D.E.; Koester, B.P.; Nord, B.; Rozo, E.; Sheldon, E.S.; Stanek, R.; Wechsler, R.H.

    2008-05-16

    We present a new measurement of the scaling relation between X-ray luminosity and total mass for 17,000 galaxy clusters in the maxBCG cluster sample. Stacking sub-samples within fixed ranges of optical richness, N200, we measure the mean 0.1-2.4 keV X-ray luminosity, , from the ROSAT All-Sky Survey. The mean mass, , is measured from weak gravitational lensing of SDSS background galaxies (Johnston et al. 2007). For 9 {le} N{sub 200} < 200, the data are well fit by a power-law, /10{sup 42} h{sup -2} ergs{sup -1} = (12.6{sub -1.3}{sup +1.4}(stat) {+-} 1.6 (sys)) (/10{sup 14} h{sup -1} M{sub {circle_dot}}){sup 1.65{+-}0.13}. The slope agrees to within 10% with previous estimates based on X-ray selected catalogs, implying that the covariance in L{sub X} and N{sub 200} at fixed halo mass is not large. The luminosity intercept is 30%, or 2{sigma}, lower than determined from the X-ray flux-limited sample of Reiprich & Boehringer (2002), assuming hydrostatic equilibrium. This slight difference could arise from a combination of Malmquist bias and/or systematic error in hydrostatic mass estimates, both of which are expected. The intercept agrees with that derived by Stanek et al. (2006) using a model for the statistical correspondence between clusters and halos in a WMAP3 cosmology with power spectrum normalization {sigma}{sub 8} = 0.85. Similar exercises applied to future data sets will allow constraints on the covariance among optical and hot gas properties of clusters at fixed mass.

  19. Aminotransferases and Leucine Aminopeptidase Activity in Blood Plasma of Chickens

    International Nuclear Information System (INIS)

    Kraljevic, P.; Stojevic, Z.; Milinkovic-Tur, S.; Simpraga, M.; Miljanic, S.

    1998-01-01

    It has been reported that irradiation of mammals by gama-rays cause increase of some enzyme activity in their blood plasma (Miller and Gates 1949; Milch and Albaum 1959; Hughes 1958; Miholjcic et al. 1979). In our previous papers (Kraljevic et al., 1982; Kraljevic and Emanovic 1993) it has been shown that activities of some enzymes in the blood plasma of chickens after an intramuscular injection of radioactive isotope 32 P. In this paper an attempt has been made to investigate the influence of gamma-ray irradiation of the whole body of chickens upon activity of some enzymes in their blood plasma. We also wanted to investigate whether the activity of aspartate-aminotransferase (AST), alanine aminotransferase (ALT) and leucine-aminopeptidase (LAP) may serve as an additional test for functional liver damage in chickens caused by gamma-ray. Fifty day old hybrid male chickens of heavy Jata breeds were irradiated by gamma-ray in the dose of 7,23±0,95 Gy. Blood samples were taken from the wing vein on days 1, 3, 5, 7, 9 and 15 after irradiation. Activity of AST, ALT, and LAP in the blood plasma were determined spectrophotometrically using Boehringer Mannheim GmbH optimized kits. At the end of the experiment all birds were sacrificed and, as well as died birds were photomorphologically and histologically investigated. The obtained results showed decrease of activity of all three enzymes during the whole period of investigation, but significant decrease showed only AST and LAP. It seems that both enzymes may serve as additional test for functional liver damage in chickens by external gamma-rays. (author)

  20. Dynamics of ceruloplasmin amd of some blood parameters in piglets suffering from acute radiation disease

    International Nuclear Information System (INIS)

    Aladzhov, E.

    1987-01-01

    Changes in oxidase activity of ceruloplasmin (CP) were followed up after treatment with gamma rays of 60 Co with a dose of 4 Ey (dose power 0.68 Ey/min) in the blood serum of male piglets of an average life weight of 18+-3 kg. CP level from 217 E/l raised to 376 E/l on the 16th hour after radiation and on the 16th day decreased to 296 e/l. Moreover, serum copper increased from 25 μmol/l to 42.3 μmol/l on the 16th hour following irradiation but on the 14th day its level dropped to 32.5 μmol/l. Erythrocyte and leucocyte count decreased from 5.83x10 12 /l and 19.94x10 12 /l to 2.47x10 12 /l and 2.0x10 9 /l, respectively. Besides, serum albumin decreased, but α-and β-globulins increased. Examination of ailing piglets showed a paraclinical pattern of an inflammatory process by acute radiation disease. CP as an antioxidant participates in reactions with toxic radiacals on radiation. By the rising of its level on radiation it again was characterized as an acute-phase protein. Serum CP was determined according to the method of Ravin using as substrate P-phenylendiamine dihydrochloride; serum copper - by the test of Boehringer Mannheim; serum proteins were studied electrophoretically on agarose gels using veronal buffer, pH 8.6

  1. Studies on the comparability of the results from different methods for the radioimmunological determination of digoxin

    International Nuclear Information System (INIS)

    Dwenger, A.; Trautschold, I.

    1978-01-01

    Three iodine-125-digoxin radioimmunoassay kits (A Amersham Buchler; B Boehringer Mannheim; C Schwarz Mann/Becton Dickinson) were evaluated with respect to assay quality and comparability of the results. Intra- and interassay variances were calculated for the following types of samples: Three media (a pool serum; b artificial human serum; c buffer solution with albumin and globulin) containing pure digoxin, sera from a pharmacokinetic study, sera with different concentrations of proteins, a hemolytic serum and sera with digitoxin and metabolites of spironolactone. The intra-assay precision depended on the medium of the sample and was higher for samples with identical digoxin concentrations in an identical medium (e.g. CV for 2 μg/l in medium a for kit A: 4.3% for kit B: 7.0%; for kit C: 2.2%) than for samples with identical antigen concentrations in different media (CV for 2 μg/l in media a, b and c for kit A: 6.4%; for kit B: 9.1%; for kit C: 4.3%). The mean recovery in the range 0.5-4 μg/l depended on the kind of medium (a, b or c) and varied for kit A from 84.4% to 100.8%, for kit B from 112.0% to 119.6%, and for kit C from 98.0% to 104.5%. Decreasing serum protein concentrations to less than one half of the physiological concentration gave false negative results for kit A and fals positive results for kit C; for kit B this dependency was not be observed, but there was a decrease of reproducibility. (orig./AJ) [de

  2. Lactato sanguíneo em atletas de judô: relato da experiência de coleta durante combates sucessivos em uma competição oficial

    Directory of Open Access Journals (Sweden)

    Alexandre Velí Nunes

    1998-02-01

    Full Text Available Este artigo é um relato de experiência que faz parte de uma investigação sobre a avaliação de atletas de judô de elite. Seu objetivo é comunicar à comunidade científica a metodologia utilizada, assim como descrever os procedimentos e as dificuldades encontradas na execução dessa metodologia. Nessa experiência, foram feitas 155 coletas de lactato sanguíneo em atletas de judô que participaram de uma competição internacional realizada em Porto Alegre, em julho de 1997. Os atletas da seleção gaúcha de judô, previamente selecionados (n = 21, submeteram-se à coleta de sangue do lóbulo da orelha antes e logo após os combates. Além desses, todos os atletas que participaram das lutas finais das respectivas categorias foram incentivados a submeter-se à coleta ao final do combate. Também foi verificada a FC dos atletas através de palpação radial em 15s, no momento da coleta de sangue. Utilizou-se o analisador de lactato portátil AccusportTM (Boehringer Mannheim Corp., Mannheim, Alemanha com Test Strips BM Lactate e caneta com microlancetas descartáveis da mesma marca. Constatou-se que a utilização da metodologia e do equipamento acima descritos é apropriada para esse tipo de população e situação, e que os resultados encontrados podem contribuir para a avaliação da intensidade do esforço desses atletas.

  3. The dynamics of blood biochemical parameters in cosmonauts during long-term space flights

    Science.gov (United States)

    Markin, Andrei; Strogonova, Lubov; Balashov, Oleg; Polyakov, Valery; Tigner, Timoty

    Most of the previously obtained data on cosmonauts' metabolic state concerned certain stages of the postflight period. In this connection, all conclusions, as to metabolism peculiarities during the space flight, were to a large extent probabilistic. The purpose of this work was study of metabolism characteristics in cosmonauts directly during long-term space flights. In the capillary blood samples taken from a finger, by "Reflotron IV" biochemical analyzer, "Boehringer Mannheim" GmbH, Germany, adapted to weightlessness environments, the activity of GOT, GPT, CK, gamma-GT, total and pancreatic amylase, as well as concentration of hemoglobin, glucose, total bilirubin, uric acid, urea, creatinine, total, HDL- and LDL cholesterol, triglycerides had been determined. HDL/LDL-cholesterol ratio also was computed. The crewmembers of 6 main missions to the "Mir" orbital station, a total of 17 cosmonauts, were examined. Biochemical tests were carryed out 30-60 days before lounch, and in the flights different stages between the 25-th and the 423-rd days of flights. In cosmonauts during space flight had been found tendency to increase, in compare with basal level, GOT, GPT, total amylase activity, glucose and total cholesterol concentration, and tendency to decrease of CK activity, hemoglobin, HDL-cholesterol concentration, and HDL/LDL — cholesterol ratio. Some definite trends in variations of other determined biochemical parameters had not been found. The same trends of mentioned biochemical parameters alterations observed in majority of tested cosmonauts, allows to suppose existence of connection between noted metabolic alterations with influence of space flight conditions upon cosmonaut's body. Variations of other studied blood biochemical parameters depends on, probably, pure individual causes.

  4. Urinary secretory IgA after nutritional rehabilitation

    Directory of Open Access Journals (Sweden)

    M.R. Teodósio

    1999-04-01

    Full Text Available We studied the secretory IgA (sIgA response of the mucosal urinary tract of malnourished children before and after nutritional rehabilitation. sIgA concentration (mg/l was determined by ELISA in 187 children aged 3 months to 5 years. The children, who frequented a day care center, were divided into four groups, according to nutritional status: 57 were eutrophic, 49 were undergrown, 57 were moderately malnourished and 24 were severely malnourished. In addition, dip slide (Urotube, Roche and dip-stick (Combur 9-Boehringer tests showed that children had no bacteriuria or any other urinary abnormalities. Plasma albumin concentration (g/dl was significantly lower (P<0.005 in the severely malnourished group (mean 3.0 ± 0.3 SD than in the eutrophic group (mean 4.0 ± 0.5 SD. When each nutritional state was analyzed, no significant differences in the sIgA were found between the 0 |-| 1 and 1 -| 5 year age range. In the moderately and severely malnourished groups, sIgA (0.36 and 0.45, respectively was significantly lower than in the eutrophic (0.69 and undergrown (0.75 groups. Ninety-five children were included in the 8-month follow-up study; 30 children were excluded from the follow-up because 4 had bacteriuria, 11 had leukocyturia, 8 had proteinuria and 7 had hematuria. Among the malnourished children, 40% showed nutritional improvement (P<0.05 and significantly increased sIgA as compared to reference values for the eutrophic and undergrown groups. These data suggest that malnourished children have a significantly lower urinary sIgA than eutrophic children. After nutritional rehabilitation, they develop local immunity with a significant increase in sIgA.

  5. Transferases activity in blood plasma of chickens hatched from eggs irradiated during incubation by low dose gamma rays

    International Nuclear Information System (INIS)

    Kraljevic, P.; Vilic, M.; Miljanic, S.; Simpraga, M.

    2005-01-01

    In our earlier studies chickens hatched from eggs irradiated with 0.15 Gy gamma rays before incubation showed a significantly higher growth than controls during the fattening period (1-42 days). The activity of aspartate-aminotransferase (AST), alanine-aminotransferase (ALT) and plasma glucose in the same chickens were also significantly higher. These results suggested that low-dose gamma-radiation stimulated certain metabolic processes in chickens hatched from eggs irradiated before incubation. The goal of this study was to determine the effects of low-dose ionising radiation on AST and ALT activity in the blood plasma of chickens hatched from eggs irradiated during incubation. The eggs of heavy breeding chickens (Avian, line 34) were exposed to 0.15 Gy of gamma-radiation (6 0C o) on the seventh day of incubation, i.e. at the time when the organogenesis in chickens is completed. The control group of chickens hatched from non-irradiated eggs. All other conditions were the same for both groups. After hatching, blood samples were taken from the wing vein on days 1, 3, 5, 7, 10, 20, 32 and 42. The activity of both enzymes was determined spectrophotometrically using Boehringer Mannheim GmbH optimised kits. On day 10, AST and ALT activity were significantly higher in the blood plasma of chickens hatched from irradiated eggs, but it significantly dropped for both enzymes on day 20. Our results indicate that exposure of eggs to low-dose gamma-radiation on the seventh day of incubation affects AST and ALT activity in the blood plasma of chickens hatched from irradiated eggs. However, this effect is somewhat different from the effects of egg exposure to low-dose gamma radiation before incubation.(author)

  6. Concentration of total proteins in blood plasma of chickens hatched from irradiated eggs with low dose gamma radiation

    International Nuclear Information System (INIS)

    Vilic, M.; Kraljevic, P.; Miljanic, S.; Simpraga, M.

    2005-01-01

    It is known that low-dose ionising radiation may have stimulating effects on chickens. Low doses may also cause changes in the concentration of blood plasma total proteins, glucose and cholesterol in chickens. This study investigates the effects of low dose gamma-radiation on the concentration of total proteins in the blood plasma of chickens hatched from eggs irradiated with a dose of 0.15 Gy on incubation days 7 and 19. Results were compared with the control group (chickens hatched from non-irradiated eggs). After hatching, all other conditions were the same for both groups. Blood samples were drawn from the heart, and later from the wing vein on days 1, 3, 5, 7,10, 20, 30 and 42. The concentration of total proteins was determined spectrophotometrically using Boehringer Mannheim GmbH optimised kits. The concentration of total proteins in blood plasma in chickens hatched from eggs irradiated with 0.15 Gy on incubation day 7 showed a statistically significant decrease on the sampling day 3 (P less than 0.05) and 7 (P less than 0.01). The concentration of total proteins in blood plasma in chickens hatched from eggs irradiated with 0.15 Gy on incubation day 19 showed a statistically significant increase only on sampling day 1 (P less than 0.05). These results suggest that exposure of eggs to 0.15 Gy of gamma-radiation on the 7th and 19th day of incubation could produce different effects on the protein metabolism in chickens.(author)

  7. AMCP Partnership Forum: Biosimilars--Ready, Set, Launch.

    Science.gov (United States)

    2016-04-01

    technology infrastructure to support operations, contracting, billing, reimbursement, and reporting needs; and having appropriate active surveillance mechanisms to enable assessment of the clinical performance of biosimilars and their innovator products. Participants recommended guidance for AMCP to optimally support its membership and stakeholders with educational and training programs at multiple venues; a platform for regular communications and updates; and advocacy, community promotion, and education. The AMCP Partnership Forum entitled "Biosimilars-Ready, Set, Launch" and the development of this report were supported by Abbvie, Amgen, Apotex, Boehringer, Merck, Momenta, and Sandoz.

  8. Perfíl lipídico en una comunidad de Calarcá, Colombia

    Directory of Open Access Journals (Sweden)

    Andrea Arias

    1997-09-01

    Full Text Available Las enfermedades cardiovasculares (EC, en general, y la cardiopatía isquémica, en particular, constituyen un importante problema de salud pública por su alta mortalidad, morbilidad, costos médico-hospitalarios e impacto laboral por su poder incapacitante. Estas patologías constituyen la primera causa de muerte en la población adulta en Colombia después de las muertes por violencia. Dado que, en nuestro país, no se han determinado con exactitud parámetros propios del comportamiento de los Iípidos sanguíneos en la población, se hace necesaria su caracterización para que se puedan establecer politicas de intervención para la prevención y control de EC, tanto a nivel individual como poblacional. Este trabajo intenta contribuir al estudio poblacional del comportamiento de los niveles de Iípidos en poblaciones colombianas. Se determinaron los niveles de colesterol total (CT, colesterol en lipoproteínas de baja densidad (C-LDL, colesterol en lipoproteínas alta densidad (C-HDL y triglicéridos (TG, en sueros de 71 varones escogidos al azar con edades comprendidas entre 20 y 70 años. Se utilizaron métodos enzimáticos con reactivos Boehringer Manheinn. Los resultados de este estudio muestran que 21,1% de la población presenta colesterol mayor de 200 mgldL, 66,2% C-HDL menor de 35 mg/dL, 5,6% presentan C-LDL mayor de 150 mg/dL y 36,6 presenta TG mayor de 150 mg/dL. Estos datos indican que, para esta población, el factor protector para las EC (C-HDL está seriamente afectado y, además, presenta una zipertrigliceridemia aislada. Se encontró una alta incidencia sobre los valores del perfil lipídico de los factores de riesgo no lipídicos como son el índice de masa corporal, el fumar, los antecedentes familiares y la edad. Los resultados obtenidos en el presente estudio se semejan a los encontrados para poblaciones de países en desarrollo y los encontrados en estudios de poblaciones colombianas, por tal motivo deben iniciarse

  9. Effect of Low Dose Gamma Radiation Upon Phosphatase Activity in Blood Plasma of Chicken Hatched from Eggs Irradiated on the Seventh Day of Incubation

    International Nuclear Information System (INIS)

    Kraljevic, P.; Vilic, M.; Miljanic, S.; Simpraga, M.

    2008-01-01

    In our earlier studies chickens hatched from eggs irradiated with 0.15 Gy gamma rays before incubation showed a significantly higher growth than controls during the fattening period (1-42 days). The activity of aspartate-aminotransferase (AST), alanine-aminotransferase (ALT), acid phosphatase (ACP) and plasma glucose in the same chickens were also significantly higher. These results suggested that low-dose gamma-radiation stimulated certain metabolic processes in chickens hatched from eggs irradiated before incubation. Investigating the effect of low dose gamma radiation upon transferases activity in blood plasma of chickens hatched from eggs irradiated on the 7th day of incubation, i.e. in the time when organogenesis is completely finished, we found that on day 10, AST and ALT activity was significantly higher in the blood plasma of those chickens, whereas it significantly dropped for both enzymes on day 20. This time the goal of study was to determine the effect of low-dose gamma radiation on ACP and alkaline phosphatase (ALP) activity in the blood plasma of chickens hatched from eggs irradiated on the 7th day of incubation. The eggs of heavy breeding chickens (Avian, line 34) were exposed to 0.15 Gy of gamma radiation (60Co) on the seventh day of incubation. The control group included chickens hatched from non-irradiated eggs. All other conditions were the same for both groups. After hatching, blood samples were taken from the wing vein on days 1, 3, 5, 7, 10, 20, 32 and 42. The activity of both enzymes was determined spectrophotometrically using Boehringer Mannheim GmbH optimised kits. ACP activity was significantly lower in the blood plasma of chickens hatched from irradiated eggs on day 3 (P<0,01), 5 (P<0,05) and 10 (P<0,05). Throughout the experimental period ALP activity did not statistically significantly change. Our results indicate that exposure of eggs to low-dose gamma radiation on the seventh day of incubation reduces ACP activity in the blood plasma

  10. Estudo da correlação entre a velocidade de reação motora e o lactato sanguíneo, em diferentes tempos de luta no judô Estudio de la correlación entre la velocidad de reacción motora y el lactato sanguíneo en distintos tiempos de lucha en el judo Study of the correlation between the velocity of motor reaction and blood lactate in different times of combat in judo

    Directory of Open Access Journals (Sweden)

    Elessandro Váguino de Lima

    2004-10-01

    Full Text Available A velocidade de reação motora humana ou tempo de reação (TR é uma capacidade física importante para judocas, sendo observada na reação aos ataques ou pegadas do adversário, a fim de realizar um contragolpe ou uma esquiva. Durante uma luta de alta intensidade, há um aumento considerável na concentração de lactato sanguíneo (LS, relacionado à fadiga muscular, podendo interferir na capacidade de reação do atleta. Fisiologicamente, a fadiga pode ocorrer em diferentes níveis, desde a percepção do sinal externo, até a contração muscular. O objetivo deste trabalho foi de verificar a influência das concentração do LS, após estímulo de luta (Randori de 1min e 30s, 3min e 5min, no TR em atletas de judô de alto nível. Foram analisados 11 indivíduos masculinos, competidores, saudáveis, com idade média de 23,4 anos ± 2 anos. Para o registro do TR simples foi utilizado o sistema Cybex Reactor. Para os registros do LS foi utilizado um lactímetro Accusport®, com fitas Boehringer Mannheim®. A análise da variância (Kruskal-Wallis mostrou diferença significativa entre o LS antes e após a luta (p 0,05. Conclui-se que a concentração de LS não influencia a capacidade dos atletas de reagir rapidamente ao estímulo visual, mas faz com que haja uma diminuição na eficiência na tarefa de TR, provavelmente devido a diminuição na capacidade de concentração dos atletas de judô após condição fatigante de luta.La velocidad de reacción motora humana o el tiempo de reacción (TR es una capacidad física importante para luchadores de judo que se observa en la reacción a los ataques o golpes del adversario con contragolpeos o esquivos. Durante una lucha de alta intensidad, hay un aumento considerable en la concentración de lactato sanguíneo (LS que se relaciona a la fatiga muscular, pudiendo interferir con la capacidad de reacción del atleta. En términos fisiológicos, la fatiga puede ocurrir en niveles diferentes, desde

  11. A 90 minute soccer match decreases triglyceride and low density lipoprotein but not high-density lipoprotein and cholesterol levels

    Directory of Open Access Journals (Sweden)

    Nader - Rahnama

    2009-11-01

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    • BACKGROUND: The association between the lipid profiles level and the incidence and severity of coronary heart disease (CHD is very pronounced in epidemiological studies, and an inverse relation between physical fitness and the incidence of coronary heart disease has been observed in many studies. The aim of this study was to investigate the impact of a soccer match on lipid parameters of professional soccer players.
    • METHODS: Twenty two professional soccer players participated in the study. Blood (10ml for determination of lipid profiles was obtained at rest and immediately after a 90 minute soccer match. Lipid parameters were measured using Boehringer Mannheim kits and Clinilab and BioMerieux analyser.
    • RESULTS: The results of this study showed that the triglyceride was significantly higher before the match than afterwards (159.09 ± 58.2 vs. 88.63 ± 34.1 mg/dl, p < 0.001, whereas the low-density lipoprotein (LDL was lower before the match than after it (98.04 ± 28.9 vs. 112.31 ± 30.5 mg/dl. Moreover, there were no significant differences in cholesterol concentration (171.4 ± 30.28 mg/dl vs. 173.18 ± 32.75 mg/dl and high-density lipoprotein (HDL concentration (34.04 ± 5.58 mg/dl vs. 34.4 ± 4.6 mg/dl between before and after the match.
    • CONCLUSIONS: Although the soccer competitive match has no favourable acute effect on lipid

    • Title of paper: the induction of P-53 independent programmed cell death (apoptosis) with ionizing radiation and 5-fluorouracil (5-FU) in the HT-29 human colon carcinoma cell line

      International Nuclear Information System (INIS)

      Blackstock, A. Wm.; Gill, Misha; Hess, Suzanne M.; Fisher, Robert W.; Leadon, Steven A.; Tepper, Joel E.

      1996-01-01

      Purpose/Objective: The role of programmed cell death (apoptosis) as a cellular response to cancer therapy such as radiation or chemotherapy is the subject of much study, and manipulation of the apoptotic response in tumor cells may be valuable in the treatment of a variety of cancers. Both p53 dependent and independent apoptotic pathways have been identified; p53 is mutated in at least 50 % of human cancers and a majority of radiation resistant tumors contain p53 mutations. This study is designed to examine the induction of programmed cell death in a human colon carcinoma cell line that possesses two mutated p53 alleles. Ionizing radiation alone, or in combination with the chemotherapeutic drug 5-fluorouracil (5-FU), were used to elicit the apoptotic response. This study will focus on whether these treatments can induce a significant apoptotic response in cells that have mutated p53 alleles. Materials and Methods: HT-29 cells were assessed for clonogenic survival after being plated at a variety of densities, and treated with single graded doses of radiation (0, 1, 2, 4, 6, 8, 10 Gy) either alone or immediately prior to a 24 hour exposure to 5-FU (2 ug/ml). The extent of radiation and 5-FU-induced apoptosis was determined in the HT-29 cell line after single doses of 0, 2, 5, and 10 Gy either alone or immediately prior to a 24 hour incubation in 5-FU (2 ug/ml). Three separate assays were used to evaluate the apoptotic response. Cells undergoing apoptosis undergo gross morphological changes including a condensation of chromatin, membrane blebbing, and an eventual release of membrane bound cytoplasmic fragments. Hematoxylin and eosin staining were used to visualize some of these morphological changes. Another characteristic of the apoptotic response is the activation of an endonuclease that cleaves DNA into specific fragments. Accordingly, an ELISA cell death assay (Boehringer Mannheim, Indianapolis IN) was used to quantitate cytoplasmic histone-associated DNA

    • ROSAT Discovers Unique, Distant Cluster of Galaxies

      Science.gov (United States)

      1995-06-01

      measured (by obtaining spectra of the arcs and measuring their redshift). The masses of galaxy clusters are important for the determination, for instance of the mean density and distribution of matter in the universe. This is because these clusters are the most massive, clearly defined objects known and as such trace these parameters in the universe on very large scales. Another possibility to derive the cluster mass is offered by X-ray observations, because the distribution of the hot, X-ray emitting gas traces the gravitational field of the cluster. Recently, in some clusters there has been a discrepancy between the mass determined in this way and that found from gravitational lensing effects. The team of astronomers now hopes that follow-up X-ray observations of RXJ1347.5-1145 will help to solve this puzzle. Moreover, the combination of extremely high X-ray brightness and the possibility to perform a rather accurate mass determination by the gravitational lensing effect makes this particular cluster a truly unique object. In view of the exceptional X-ray brightness, a very high mass is expected. The exact determination will be possible, as soon as spectra have been obtained of the two arcs. Contrary to what is the case in other clusters, this will not be so difficult, due to their unusual brightness and their ideal geometrical configuration. [1] This is a joint Press Release of ESO and the Max-Planck-Society. It is accompanied by a B/W photo. [2] The investigation described in this Press Release is the subject of a Letter to the Editor which will soon appear in the European journal Astronomy & Astrophysics, with the following authors: Sabine Schindler (Max-Planck-Institut fuer Extraterrestrische Physik and Max-Planck-Institut fuer Astrophysik, Garching, Germany), Hans Boehringer, Doris M. Neumann and Ulrich G. Briel (Max-Planck-Institut fuer Extraterrestrische Physik, Garching, Germany), Luigi Guzzo (Osservatorio Astronomico di Brera, Merate, Italy), Guido Chincarini