Enalapril Prescription to Women of Childbearing Age as Risk Factor for Congenital Defects in the Argentine Primary Care Level

pp 111-116

Abstract

Background
Use of angiotensin-converting enzyme inhibitors (ACEIs) during the first trimester of pregnancy is associated with a 2.71-fold increase in the risk of major congenital malformations (MCMs), a matter of care as ACEIs are one of the most frequent medications prescribed.

Objective
To quantify the prescription of enalapril –an ACEI– provided by the Remediar Program in women of childbearing age, and to think about the possible number of MCMs that could be prevented.

Material and Methods
The study has two designs: 1. Ecological study with cross comparisons of diagnoses, prescriptions and beneficiaries of the prescriptions of the Remediar Program (secondary sources). Target population: women between 15 to 49 years, treated at 6000 health care centers in Argentina from 2005 to 2006, with diagnosis of hypertension and/or prescription of enalapril. 2. Evaluation of a counterfactual approach of the impact following the reduction of exposure to ACEIs in such population.

Results
From a total of 15,001,041 R-Forms recorded during the year of the study, 2,085,338 women of childbearing age were identified; 5.5% of them received enalapril. Thus, considering that the number of MCMs expected using another medication would be 214 (95% CI 199-229) and the use of enalapril would increase the number of events to 579 (95% CI 296-863), the reduction of the exposure would prevent about 365 (95% CI 97-634) cases of MCD/year in the population covered by the Remediar Program.

Conclusions
Prescription of ACEIs in women of childbearing age is frequent. A significant number of cases of MCMs would be prevented avoiding the prescription and use of ACEIs in this population. More evidence is needed to evaluate this risk.