Document Detail

Pregnancy outcome following maternal exposure to statins: a multicentre prospective study.
MedLine Citation:
PMID:  23194157     Owner:  NLM     Status:  MEDLINE    
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.
U Winterfeld; A Allignol; A Panchaud; L E Rothuizen; P Merlob; B Cuppers-Maarschalkerweerd; T Vial; S Stephens; M Clementi; M De Santis; A Pistelli; M Berlin; G Eleftheriou; E Maňáková; T Buclin
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Publication Detail:
Type:  Journal Article; Multicenter Study     Date:  2012-11-30
Journal Detail:
Title:  BJOG : an international journal of obstetrics and gynaecology     Volume:  120     ISSN:  1471-0528     ISO Abbreviation:  BJOG     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-12     Completed Date:  2013-04-04     Revised Date:  2013-10-28    
Medline Journal Info:
Nlm Unique ID:  100935741     Medline TA:  BJOG     Country:  England    
Other Details:
Languages:  eng     Pagination:  463-71     Citation Subset:  AIM; IM    
Copyright Information:
© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.
STIS and Division of Clinical Pharmacology, University Hospital, Lausanne, Switzerland.
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MeSH Terms
Abnormalities, Drug-Induced / epidemiology
Abortion, Induced / statistics & numerical data
Abortion, Spontaneous / epidemiology
Birth Rate
Case-Control Studies
Europe / epidemiology
Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
Infant, Newborn
Infant, Newborn, Diseases / epidemiology
Maternal Age
Maternal Exposure / adverse effects*
Pregnancy Outcome / epidemiology*
Pregnancy Trimester, First
Premature Birth / epidemiology
Prospective Studies
Risk Factors
Reg. No./Substance:
0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Teratogens
Comment In:
BJOG. 2013 Oct;120(11):1439-40   [PMID:  24034522 ]
BJOG. 2013 Oct;120(11):1440   [PMID:  24034523 ]

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