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

U Winterfeld*, A Allignol, A Panchaud, Le Rothuizen, P Merlob, B Cuppers Maarschalkerweerd, T Vial, S Stephens, M Clementi, Marco De Santis, A Pistelli, M Berlin, G Eleftheriou, E Maňáková, T. Buclin

*Autore corrispondente per questo lavoro

Risultato della ricerca: Contributo in rivistaArticolo

66 Citazioni (Scopus)

Abstract

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.
Lingua originaleInglese
pagine (da-a)463-471
Numero di pagine9
RivistaBJOG: An International Journal of Obstetrics and Gynaecology
Volume120
Numero di pubblicazione4
DOI
Stato di pubblicazionePubblicato - 2013

All Science Journal Classification (ASJC) codes

  • Ostetricia e Ginecologia

Keywords

  • Abnormalities
  • Abortion
  • Adult
  • Birth Rate
  • Case-Control Studies
  • Diseases
  • Drug-Induced
  • Europe
  • Female
  • First
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Induced
  • Infant
  • Maternal Age
  • Maternal Exposure
  • Newborn
  • Pregnancy
  • Pregnancy Outcome
  • Pregnancy Trimester
  • Premature Birth
  • Prospective Studies
  • Risk Factors
  • Spontaneous
  • Teratogens

Fingerprint

Entra nei temi di ricerca di 'Pregnancy outcome following maternal exposure to statins: a multicentre prospective study'. Insieme formano una fingerprint unica.

Cita questo