Pioglitazone Use and Risk of Bladder Cancer: a Systematic Review and Meta-Analysis of Observational Studies

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18799
• EU PAS number:
  EUPAS16082
• Study ID:
  18799
• Official title and acronym:
  Pioglitazone Use and Risk of Bladder Cancer: a Systematic Review and Meta-Analysis of Observational Studies
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The primary research question is whether type 2 diabetes mellitus patients treated with pioglitazone are at a higher risk of bladder cancer compared to type 2 diabetes mellitus patients who are not treated with pioglitazone. The secondary research question is whether the risk of bladder cancer is increased by cumulative exposure duration or cumulative dose of pioglitazone.This meta-analysis will be based on a systematic and comprehensive literature review that will be conducted to identify eligible observational studies from peer-reviewed scientific journals.
• Study status:
  Finalised

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Planned: 02/08/2016

Actual: 02/08/2016

Study start date

Planned: 28/10/2016

Actual: 28/10/2016

Date of final study report

Planned: 31/12/2016

Actual: 18/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Development Centre Europe Ltd

Study protocol

Initial protocol

ER-9531 TAKEDA Pioglitazone meta-analysis study protocol v1.2 20161104_clean

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable