Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34999
• EU PAS number:
  EUPAS16282
• Study ID:
  34999
• Official title and acronym:
  Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Sweden

  United Kingdom

  United States
• 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 post authorization safety study (PASS, or post marketing requirement (PMR) in the US) is designed to generate additional evidence to help evaluate the results observed in the clinical trials. To implement the program, we selected data sources from 5 research centers. The investigators are from RTI Health Solutions, Optum, University of Southern Denmark, Centre for Pharmacoepidemiology at Karolinska Institute, and Comprehensive Health Insights.The study population will include patients observed in each of the 5 databases, providing a wide array of patient characteristics, drug utilization and medical practice patterns, which will enhance the generalizability of the study findings to the population of mirabegron users in real world practice, beyond clinical trials.This will be a cohort study comparing the incidence of commonly occurring cardiovascular events among new users of mirabegron and new users of any comparator antimuscarinic medication (as a group) used in the treatment of OAB. To provide a sufficiently large patient population within which to evaluate the safety of mirabegron, the study will be conducted within multiple databases. Each of these populations will be studied according to the same Core protocol, although operational details will vary across sites due to the specifics of the data environments. In addition to data source-specific analyses, estimates obtained from all data sources will be analyzed using a meta-analysis approach. Overall, the study period includes October 2012 (first observed use of mirabegron in US data) through June 2019 (submission of final study report).
• Study status:
  Finalised

Research institutions and networks

Institutions

Optum

Germany

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

University of Southern Denmark Odense C. Denmark, Comprehensive Health Insights Louisville, KY USA

Study timelines

Date when funding contract was signed

Planned: 10/08/2015

Actual: 22/09/2015

Study start date

Planned: 09/01/2017

Actual: 06/09/2016

Data analysis start date

Planned: 20/02/2017

Date of interim report, if expected

Planned: 29/06/2018

Date of final study report

Planned: 28/06/2019

Actual: 15/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Study protocol

Initial protocol

178-CL-114_Protocol Version 9.0_For EnCepp Reg

Updated protocol

178-cl-114-clp-10-reissue-v11-en-final-02

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)