Study identification

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

Contact details

Per Sindahl

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Copenhagen Center of Regulatory Science
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable