| Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. | |
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MedLine Citation:
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PMID: 23194157 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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U Winterfeld; A Allignol; A Panchaud; LE 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:
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Type: JOURNAL ARTICLE Date: 2012-11-30 |
Journal Detail:
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Title: BJOG : an international journal of obstetrics and gynaecology Volume: - ISSN: 1471-0528 ISO Abbreviation: BJOG Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-11-30 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100935741 Medline TA: BJOG Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG. |
Affiliation:
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STIS and Division of Clinical Pharmacology, University Hospital, Lausanne, Switzerland. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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