Exposure to pioglitazone and the risk of prostate cancer: a nested case-control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48533
• EU PAS number:
  EUPAS11750
• Study ID:
  48533
• Official title and acronym:
  Exposure to pioglitazone and the risk of prostate cancer: a nested case-control study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Several previous epidemiological studies have investigated pioglitazone and risk of prostate cancer with conflicting results. This study aims to use CPRD GOLD to further investigate if there is an association between pioglitazone use and the development of prostate cancer, and to explore the possible reasons for such an association and whether this is unique to pioglitazone or seen also with other diabetic treatments. This nested case-control study will be set within a CPRD GOLD cohort of male type 2 diabetes mellitus (T2DM) patients, aged 40 years or over, who initiated first ever diabetic drug therapy on or after 01 January 2001 until the most recent date of the three databases. Cases of prostate cancer diagnosed after the start of first diabetic medication will be identified using linkage to Cancer Registration data, and hospital discharge diagnoses in the HES dataset. This observational study will estimate risk of prostate cancer in relation to ever having been exposed to pioglitazone and also with duration and cumulative dose of pioglitazone exposure. Conditional logistic regression analyses will be used to generate risk estimates while adjusting for potential confounding factors.
• Study status:
  Finalised

Research institution and networks

Institutions

ICON Commersialisation & Outcomes (MAPI-ICON), ICON

Germany

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 16/04/2015

Actual: 16/04/2015

Study start date

Planned: 15/01/2016

Actual: 15/01/2016

Data analysis start date

Planned: 05/02/2016

Actual: 05/02/2016

Date of final study report

Planned: 29/07/2016

Actual: 11/07/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

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