Impact of rosiglitazone safety alerts on oral antidiabetic sales trends: a country-wide study in Portugal

Study identification

• EU PAS number:
  EUPAS12872
• Study ID:
  28116
• Official title and acronym:
  Impact of rosiglitazone safety alerts on oral antidiabetic sales trends: a country-wide study in Portugal
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  To assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral antidiabetic drugs. It was conducted an ecological study, using temporally aggregated data and linking safety alerts to country-wide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Medical Sciences Institute of Biomedicine, University of Aveiro

Portugal

Study timelines

Date when funding contract was signed

Planned: 17/09/2012

Actual: 17/09/2013

Study start date

Planned: 07/01/2013

Actual: 04/02/2013

Date of final study report

Planned: 31/12/2016

Actual: 30/01/2016

Sources of funding

Other

More details on funding

Internal funding

Regulatory

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