Sven Schmiedl1,2, Rainald Fischer3, Luisa Ibanez4,5, Joan Fortuny6, Petra Thürmann1,2, Elena Ballarin4, Pili Ferrer4, Monica Sabaté4, Dominik Rottenkolber7,8, Roman Gerlach9, Martin Tauscher9, Robert Reynolds10, Joerg Hasford11, Marietta Rottenkolber11. 1. Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. 2. Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany. 3. Pneumologische Praxis Muenchen - Pasing, Munich, Germany. 4. Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. 5. Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain. 6. Novartis Farmaceutica S.A., Barcelona, Spain. 7. Institute of Health Economics and Management, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany. 8. Helmholtz Zentrum Muenchen - German Research Center for Environmental Health, Member of the German Center for Lung Research, Neuherberg, Germany. 9. National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany. 10. Pfizer, New York, NY, USA. 11. Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Abstract
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.
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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