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Tiotropium Respimat(®) vs. HandiHaler(®): real-life usage and TIOSPIR trial generalizability.
Schmiedl, Sven; Fischer, Rainald; Ibanez, Luisa; Fortuny, Joan; Thürmann, Petra; Ballarin, Elena; Ferrer, Pili; Sabaté, Monica; Rottenkolber, Dominik; Gerlach, Roman; Tauscher, Martin; Reynolds, Robert; Hasford, Joerg; Rottenkolber, Marietta.
Afiliación
  • Schmiedl S; Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
  • Fischer R; Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
  • Ibanez L; Pneumologische Praxis Muenchen - Pasing, Munich, Germany.
  • Fortuny J; Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Thürmann P; Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain.
  • Ballarin E; Novartis Farmaceutica S.A., Barcelona, Spain.
  • Ferrer P; Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
  • Sabaté M; Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
  • Rottenkolber D; Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Gerlach R; Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Tauscher M; Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Reynolds R; Institute of Health Economics and Management, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
  • Hasford J; Helmholtz Zentrum Muenchen - German Research Center for Environmental Health, Member of the German Center for Lung Research, Neuherberg, Germany.
  • Rottenkolber M; National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
Br J Clin Pharmacol ; 81(2): 379-88, 2016 Feb.
Article en En | MEDLINE | ID: mdl-26506314
AIM: Two inhaler devices (Respimat® and HandiHaler®) are available for tiotropium, a long acting anticholinergic agent. We aimed to analyze drug utilization, off-label usage and generalizability of the TIOSPIR trial results for both devices. METHODS: Patients aged ≥18 years exhibiting at least one documented prescription of tiotropium in the database of the Association of Statutory Health Insurance Physicians, Bavaria, Germany, were included (years 2004-2008). Annual period prevalence rates (PPRs) were calculated stratified by age, gender and inhaler devices. Off-label usage (patients lacking a chronic obstructive pulmonary disease (COPD) diagnosis) and the proportion of patients meeting the inclusion and exclusion criteria of the TIOSPIR trial were analyzed. RESULTS: Between 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10 000 persons for HandiHaler® and between 1.5 and 9.3 per 10 000 persons for Respimat®. Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler® 32.1%, Respimat® 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial. CONCLUSIONS: Comparing the two tiotropium devices, no clinically relevant differences regarding patient and prescribing characteristics were revealed. Results of the TIOSPIR trial were generalizable only to a minority of our study patients, underlining the need for real-life data.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antagonistas Colinérgicos / Enfermedad Pulmonar Obstructiva Crónica / Inhaladores de Dosis Medida / Inhaladores de Polvo Seco / Bromuro de Tiotropio Tipo de estudio: Risk_factors_studies Límite: Aged / Female / Humans / Male Idioma: En Revista: Br J Clin Pharmacol Año: 2016 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antagonistas Colinérgicos / Enfermedad Pulmonar Obstructiva Crónica / Inhaladores de Dosis Medida / Inhaladores de Polvo Seco / Bromuro de Tiotropio Tipo de estudio: Risk_factors_studies Límite: Aged / Female / Humans / Male Idioma: En Revista: Br J Clin Pharmacol Año: 2016 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido