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

Details

Serval ID
serval:BIB_76900E4385FF
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Pregnancy outcome following maternal exposure to statins: a multicentre prospective study.
Journal
BJOG
Author(s)
Winterfeld U., Allignol A., Panchaud A., Rothuizen L.E., Merlob P., Cuppers-Maarschalkerweerd B., Vial T., Stephens S., Clementi M., De Santis M., Pistelli A., Berlin M., Eleftheriou G., Maňáková E., Buclin T.
ISSN
1471-0528 (Electronic)
ISSN-L
1470-0328
Publication state
Published
Issued date
2013
Peer-reviewed
Oui
Volume
120
Number
4
Pages
463-471
Language
english
Notes
Publication types: Journal Article ; Multicenter StudyPublication Status: ppublish
Abstract
OBJECTIVE: This contribution addresses the risk associated with exposure to statins during pregnancy.
DESIGN: Multicentre observational prospective controlled study.
SETTING: European Network of Teratology Information Services.
POPULATION: Pregnant women who contacted one of 11 participating centres, seeking advice about exposure to statins during pregnancy, or to agents known to be nonteratogenic.
METHODS: Pregnancies exposed during first trimester to statins were followed up prospectively, and their outcomes were compared with a matched control group.
MAIN OUTCOME MEASURES: Rates of major birth defects, live births, miscarriages, elective terminations, preterm deliveries and gestational age and birthweight at delivery.
RESULTS: We 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.
CONCLUSIONS: This study did not detect a teratogenic effect of statins. Its statistical power remains insufficient to challenge current recommendations of treatment discontinuation during pregnancy.
Keywords
Abnormalities, Drug-Induced/epidemiology, Abortion, Induced/statistics & numerical data, Abortion, Spontaneous/epidemiology, Adult, Birth Rate, Case-Control Studies, Europe/epidemiology, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects, Infant, Newborn, Infant, Newborn, Diseases/epidemiology, Maternal Age, Maternal Exposure/adverse effects, Pregnancy, Pregnancy Outcome/epidemiology, Pregnancy Trimester, First, Premature Birth/epidemiology, Prospective Studies, Risk Factors, Teratogens
Pubmed
Web of science
Open Access
Yes
Create date
07/03/2013 18:12
Last modification date
20/08/2019 14:33
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