Drug utilization post-authorization safety study on aclidinium bromide
- Aclidinium bromide (Eklira®/Bretaris® Genuair®) is a new long-acting anticholinergic that was approved for the long-term treatment of adults with chronic obstructive pulmonary disease (COPD) in Germany in October 2012.
In a risk management plan, the European Medicines Agency (EMA) requested safety studies after market approval (Post-Authorization Studies, PASS) from the Marketing Authorization Holder AstraZeneca that should be conducted in different countries in which aclidinium bromide is available. In a first step, the PASS program includes a drug utilization study on the use of aclidinium bromide under every-day conditions.
Based on the data from the German Pharmacoepidemiological Research Database (GePaRD) from 2012 to 2014 courses of treatment with aclidinium bromide and other COPD medication will be analyzed and the users will be characterized and compared in terms of potential indications, comorbidity and comedication in a cohort study. In addition, the use of aclidinium bromide beyond its indication COPD (“off-label-use”), e.g. in pregnant woman or children will be investigated. Another aim of this study is the analysis of various subgroups for whom there is missing information in the risk management plan, such as persons with renal or hepatic impairment. For future safety studies, a cohort of new users of aclidinium bromide will be established.
The study is organized by the non-profit organization RTI Health Solutions and also conducted in further databases in the UK and Denmark.
- Begin: July 2014
End: December 2018
- Nadine Wentzell
Selected project-related publications
Contributions to books and proceedings
- Fröhlich N, Schink T. Aclidinium- oder Tiotropiumbromid? Untersuchung von Prädiktoren einer Aclidiniumbromidneuverordnung auf Basis von Routinedaten der DAK-Gesundheit. In: Rebscher H, editors. AMNOG-Report 2016. Nutzenbewertung von Arzneimitteln in Deutschland. Heidelberg: medhochzwei. 2016. S. 223-236