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Schmiedl, S.* ; Fischer, R.* ; Ibáñez, L.* ; Fortuny, J.* ; Thuermann, P.A.* ; Ballarin, E.* ; Ferrer, P.* ; Sabaté, M.* ; Rottenkolber, D. ; Gerlach, R.* ; Tauscher, M.* ; Reynolds, R.* ; Hasford, J.* ; Rottenkolber, M.*

Tiotropium Respimat© vs. HandiHaler©: Real-life usage and TIOSPIR trial generalizability.

Br. J. Clin. Pharmacol. 81, 379-388 (2016)
Verlagsversion DOI
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Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.
Aim: Two inhaler devices (Respimat (R) and HandiHaler (R)) 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. MethodsPatients aged 18years 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. ResultsBetween 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10000 persons for HandiHaler (R) and between 1.5 and 9.3 per 10000 persons for Respimat (R). Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler (R) 32.1%, Respimat (R) 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial. ConclusionsComparing 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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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Copd ; Real-life Usage ; Secondary Data Analysis ; Tiospir Trial ; Tiotropium; Obstructive Pulmonary-disease; Randomized Controlled-trials; Inhaler Devices; Copd Patients; Asthma; Mortality; Risk; Practitioners; Metaanalysis; Population
ISSN (print) / ISBN 0306-5251
e-ISSN 1365-2125
Zeitschrift British Journal of Clinical Pharmacology
Quellenangaben Band: 81, Heft: 2, Seiten: 379-388 Artikelnummer: , Supplement: ,
Verlag Wiley
Verlagsort Oxford
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Health Economics and Health Care Management (IGM)