Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of PharmacologicalTreatments for Overactive Bladder

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29380
• EU PAS number:
  EUPAS8444
• Study ID:
  29380
• Official title and acronym:
  Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of PharmacologicalTreatments for Overactive Bladder
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• 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, and fesoterodine. The objectives are: to describe drug-use patterns, to describe the availability of potential confounders in the Swedish data resources, and to calculate background rates of cardiovascular (CV) and cancer outcomes among antimuscarinic drug users in the Swedish Prescription and Inpatient National Databases, in collaboration with the Karolinska Institutet (KI) Center for Pharmacoepidemiology (CPE). 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 data sources, in the Swedish Databases.The study period is July 1, 2005 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 institution and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Contact details

Alejandro Arana

Study contact

[e-mail]

Alejandro Arana

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 15/09/2014

Actual: 10/10/2014

Data collection

Planned: 05/01/2015

Actual: 05/01/2015

Date of interim report, if expected

Planned: 06/02/2015

Actual: 26/03/2015

Date of final study report

Planned: 29/02/2016

Actual: 16/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Study protocol

Initial protocol

178-cl-118-clp-02-reissue-en-v1dot1_Redacted

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)