Abstract
What is already known about this subjectCholesterol is known to be essential for fetal development.Statins, which inhibit cholesterol production, have therefore been considered as potential teratogens and are contraindicated in pregnancy.Data available thus far on the risks of congenital anomalies associated with statin therapy have come from non-analytic postmarketing surveillance studies.Given the increasing use of statins in women of childbearing age, there is a need for a population-based study on the risks of congenital anomalies associated with gestational statin use.What this study addsIn this pharmacoepidemiological study, we determined the risk of congenital anomalies in women who filled prescriptions for statins during the first trimester of pregnancy, compared with women who had stopped statins before pregnancy or those who used fibrates during pregnancy.We found no evidence of an increased risk of fetal anomalies among first-trimester statin users, or any discernable pattern of congenital anomalies among live births.However, in the absence of outcome data on nonlive births, conclusions remain uncertain.AimsEvidence from animal studies suggests that statin medications should not be taken during pregnancy. Our aim was to examine the association between the use of statins in early pregnancy and the incidence of congenital anomalies.MethodsA population-based pregnancy registry was built. Three study groups were assembled: women prescribed statins in the first trimester (group A), fibrate/nicotinic acid in the first trimester (group B) and statins between 1 year and 1 month before conception, but not during pregnancy (group C). Among live-born infants, we selected as cases infants with any congenital anomaly diagnosed in the first year of life. Controls were defined as infants with no congenital anomalies. The rate of congenital anomalies in the respective groups was calculated. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were also calculated.ResultsOur study group consisted of 288 pregnant women. Among women with a live birth, the rate of congenital anomalies was 3/64 (4.69%; 95% CI 1.00, 13.69) in group A, 3/14 in group B (21.43%; 95% CI 4.41, 62.57) and 7/67 in group C (10.45%; 95% CI 4.19, 21.53). The adjusted OR for congenital anomalies in group A compared with group C was 0.36 (95% CI 0.06, 2.18).ConclusionWe did not detect a pattern in fetal congenital anomalies or evidence of an increased risk in the live-born infants of women filling prescriptions for statins in the first trimester of pregnancy. Conclusions, however, remain uncertain in the absence of data from nonlive births.
Highlights
High blood cholesterol has been shown to be a risk factor for coronary heart disease (CHD) and cardiovascular death [1]
The adjusted odds ratios (OR) for congenital anomalies in group A compared with group C was 0.36
We did not detect a pattern in fetal congenital anomalies or evidence of an increased risk in the live-born infants of women filling prescriptions for statins in the first trimester of pregnancy
Summary
High blood cholesterol has been shown to be a risk factor for coronary heart disease (CHD) and cardiovascular death [1]. The incidence of HeFH in Quebec is about 2.5-fold higher than in the rest of Canada [5] Pregnant women or those likely to become pregnant clearly fall within the populations that might become targets for antilipaemic drug therapy. The recommendation is for lipid-lowering agents (especially statins) to be discontinued before conception, or even during the 5–10 years while women have children because of the uncertainty over their safety for the fetus [3, 6]. There is no evidence that given close obstetrical care, satisfactory outcomes for both mother and baby cannot be achieved [8,9,10]
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