Exposure to ACEi, ARB and statin drugs among women of child-bearing age in Denmark

Study identification

• EU PAS number:
  EUPAS106995
• Study ID:
  106996
• Official title and acronym:
  Exposure to ACEi, ARB and statin drugs among women of child-bearing age in Denmark
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Cardiometabolic disorders are common. Increasing prevalence among younger people of hypertension, type 2 diabetes and hyperlipidaemia has seen rising numbers of women of child-bearing age prescribed drugs that modulate the renin-angiotensin system (RAS) or that lower cholesterol levels. Among RAS-acting drugs, both angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are known teratogens when foetal exposure occurs in the second or third trimester. There is debate as to the teratogenicity risk associated with first trimester exposure. Statins, hydroxy methyl glutaryl Co-A (HMG-Co A) reductase enzyme inhibitors, are considered possibly teratogenic but epidemiological studies to date have not described convincing associations with foetal harm. In Denmark, ACEI and ARB have a ‘Do not use’ recommendation in pregnancy. A caveat with ACEIs is that first trimester teratogenic risk is interpreted as similar to the risk from hypertension itself (e.g., ramipril SPC) while second and third trimester exposure is considered teratogenic. Statins have a ‘should not be used’ in pregnancy recommendation owing to insufficient data on their effects. Despite their teratogenicity, studies in the UK and the US have reported that pregnancies have occurred among women prescribed ACEI and ARB drugs as well as prescription without concomitant contraception and/or without a record of having been advised about teratogenic risk. There are similar reports from European countries, Australia and Taiwan. To the best of our knowledge, no studies have investigated the situation in Denmark. This study examines prescribing of RAS-acting drugs and statins among women of child-bearing age in Denmark. It compares prescribing of the drugs among women of child-bearing age with that among men of similar ages.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 06/01/2023

Actual: 06/01/2023

Study start date

Planned: 15/06/2023

Actual: 15/06/2023

Date of final study report

Planned: 18/09/2024

Sources of funding

Other

More details on funding

Danish Cardiovascular Academy

Regulatory

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