A PHARMO Study on the Utilization of Pioglitazone in Clinical Practice in The Netherlands with Regard to Diabetic Treatment Regimen and Co-morbidities

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28851
• EU PAS number:
  EUPAS10001
• Study ID:
  28851
• Official title and acronym:
  A PHARMO Study on the Utilization of Pioglitazone in Clinical Practice in The Netherlands with Regard to Diabetic Treatment Regimen and Co-morbidities
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  The goal of this study is to describe the prescription of pioglitazone in diabetic patients according to Summary of Product Characteristics (SmPC), and to evaluate the implementation of the risk minimization measures introduced in July 2011 regarding bladder cancer and heart failure and the need for regular review of the benefits of therapy. This drug utilization study will describe the pioglitazone users with regard to age, sex, concomitant drug use, and prevalent comorbidities at the time of their first pioglitazone prescription, specifically hypertension and ischemic heart disease.
• Study status:
  Finalised

Research institutions and networks

Institutions

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Study timelines

Date when funding contract was signed

Actual: 23/07/2012

Study start date

Actual: 01/08/2012

Data analysis start date

Actual: 01/09/2012

Date of final study report

Actual: 17/10/2012

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TDC Europe

Study protocol

Initial protocol

PHARMO_Protocol_Pioglitazone_DUS

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)