Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder

Study identification

• EU PAS number:
  EUPAS8441
• Study ID:
  29376
• Official title and acronym:
  Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Mirabegron is a first in class therapeutic agent, with a mechanism of action distinct from that of antimuscarinic agents indicated for the treatment of overactive bladder (OAB). This is a retrospective cohort study of new users of individual antimuscarinic drugs: oxybutynin, tolterodine, darifenacin, solifenacin, trospium, and fesoterodine. The objectives are: to describe drug-use patterns, to describe the availability of potential confounders, and to calculate background rates of cardiovascular (CV) and cancer outcomes among antimuscarinic drug users in the Danish National Databases, in collaboration with the University of Southern Denmark (SDU). Results will help to refine the study size and statistical power assessment for the post-marketing safety studies of Mirabegron, to be conducted, among other datasources, in the Danish Databases.The study period is January 2004 through December 2012. The study will calculate incidence rates of the following endpoints: - CV: including acute myocardial infarction, stroke, all-cause mortality, a MACE composite endpoint, and CV mortality.- Neoplasm endpoint: The study will focus on a composite of the 10 most commonly occurring malignancies. For cancer analyses only the first incident targeted cancer is considered.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Pharmacoepi center, University of Southern Denmark

Denmark

Study timelines

Date when funding contract was signed

Planned:15/09/2014

Actual:10/10/2014

Study start date

Planned:31/10/2014

Actual:31/10/2014

Data analysis start date

Planned:31/01/2015

Actual:31/01/2015

Date of final study report

Planned:29/03/2015

Actual:26/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)