Tiotropium Respimat(®) vs. HandiHaler(®): real-life usage and TIOSPIR trial generalizability.
OBJECTIVE
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.
Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.|Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
Sven
S
Schmiedl
Pneumologische Praxis Muenchen - Pasing, Munich, Germany.
Rainald
R
Fischer
Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.|Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain.
Luisa
L
Ibanez
Novartis Farmaceutica S.A., Barcelona, Spain.
Joan
J
Fortuny
Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.|Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
Petra
P
Thürmann
Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Elena
E
Ballarin
Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Pili
P
Ferrer
Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Monica
M
Sabaté
Institute of Health Economics and Management, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.|Helmholtz Zentrum Muenchen - German Research Center for Environmental Health, Member of the German Center for Lung Research, Neuherberg, Germany.
Dominik
D
Rottenkolber
National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
Roman
R
Gerlach
National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
Martin
M
Tauscher
Pfizer, New York, NY, USA.
Robert
R
Reynolds
Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Joerg
J
Hasford
Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Marietta
M
Rottenkolber
D000280:Administration, Inhalation; D000368:Aged; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D004363:Drug Utilization / Q000706:statistics & numerical data; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D056687:Off-Label Use / Q000706:statistics & numerical data; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D000069447:Tiotropium Bromide / Q000008:administration & dosage* / Q000627:therapeutic use
D018680:Cholinergic Antagonists; D000069447:Tiotropium Bromide
COPD; TIOSPIR trial; real-life usage; secondary data analysis; tiotropium