Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents in Denmark: interrupted time series analysis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45122
• EU PAS number:
  EUPAS38752
• Study ID:
  45122
• Official title and acronym:
  Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents in Denmark: interrupted time series analysis
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Through a referral procedure in 2014, the European Medicines Agency recommended risk minimisation measures, including restrictions on the combined use of RAS-acting agents. The primary objective of this study was to assess the impact of the EMA referral on the co-prescribing of RAS-acting agents in Denmark by examining the trends in co-dispensing of Angiotensin-converting enzyme inhibitors (ACEis) and Angiotensin II receptor blockers (ARBs). A secondary objective was to describe the population in terms of demographics (age and sex) co-prescribed an ACEi and an ARB over time. The study included nationwide secondary data from the National Prescription Registry (NPR) covering all prescriptions dispensed by community pharmacies in Denmark from 2008 through 2018.
• Study status:
  Finalised

Research institutions and networks

Institutions

Data Analytic Center (DAC), Danish Medicine Agency

Denmark

Study timelines

Date when funding contract was signed

Planned: 01/01/1900

Actual: 01/01/1900

Study start date

Planned: 01/01/1900

Actual: 01/01/1900

Date of final study report

Planned: 01/06/2021

Actual: 01/06/2020

Sources of funding

Other

More details on funding

Copenhagen Center of Regulatory Science

Study protocol

Initial protocol

DUS of RAS-acting agents

Regulatory

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