Pregnancy outcome following maternal exposure to statins: a multicentre prospective study

OBJECTIVE:\r\nThis contribution addresses the risk associated with exposure to statins during pregnancy.\r\nDESIGN:\r\nMulticentre observational prospective controlled study.\r\nSETTING:\r\nEuropean Network of Teratology Information Services.\r\nPOPULATION:\r\nPregnant women who contacted one of 11 participating centres, seeking advice about exposure to statins during pregnancy, or to agents known to be nonteratogenic.\r\nMETHODS:\r\nPregnancies exposed during first trimester to statins were followed up prospectively, and their outcomes were compared with a matched control group.\r\nMAIN OUTCOME MEASURES:\r\nRates of major birth defects, live births, miscarriages, elective terminations, preterm deliveries and gestational age and birthweight at delivery.\r\nRESULTS:\r\nWe collected observations from 249 exposed pregnancies and 249 controls. The difference in the rate of major birth defects between the statin-exposed and the control groups was small and statistically nonsignificant (4.1% versus 2.7% odds ratio [OR] 1.5; 95% confidence interval [95% CI] 0.5-4.5, P = 0.43). In an adjusted Cox model, the difference between miscarriage rates was also small and not significant (hazard ratio 1.36, 95% CI 0.63-2.93, P = 0.43). Premature birth was more frequent in exposed pregnancies (16.1% versus 8.5%; OR 2.1, 95% CI 1.1-3.8, P = 0.019). Nonetheless, median gestational age at birth (39 weeks, interquartile range [IQR] 37-40 versus 39 weeks, IQR 38-40, P = 0.27) and birth weight (3280 g, IQR 2835-3590 versus 3250 g, IQR 2880-3630, P = 0.95) did not differ between exposed and non-exposed pregnancies.\r\nCONCLUSIONS:\r\nThis study did not detect a teratogenic effect of statins. Its statistical power remains insufficient to challenge current recommendations of treatment discontinuation during pregnancy.