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Rischi associati all’uso di statine durante la gravidanza

L'uso involontario delle statine durante la gravidanza è potenzialmente sempre più frequente: l'aumento dell'incidenza del diabete di tipo 2 in età più giovane da un lato e il crescente numero di donne che hanno figli più tardi nella vita dall'altro portano a un numero consistente di donne esposte alle statine prima del concepimento. Questo studio caso-controllo ha valutato le differenze riguardanti le interruzioni di gravidanza tra donne che assumono o meno statine durante la gravidanza. Circa il 25% di tutte le gravidanze potenzialmente esposte a una statina ha comportato l'interruzione spontanea rispetto al 21% in donne non esposte, con un aumento del rischio del 64%.

STATINS DURING PREGNANCY: A COHORT STUDY USING THE GENERAL PRACTICE RESEARCH DATABASE TO INVESTIGATE PREGNANCY LOSS

McGrogan A, Snowball J, Charlton RA

Pharmacoepidemiol Drug Saf 2017;26:843-852

PURPOSE: The aim of this study was to determine if there are any differences between the types of pregnancy loss experienced by women who have been prescribed a statin just before or early in pregnancy compared with those who have not.
METHODS: A retrospective cohort study using the General Practice Research Database was carried out. Women aged 10-49 years at pregnancy start who received a prescription for a statin in the 3 months before and/or during the first trimester of pregnancy were matched to up to 10 pregnancies on age at start date, diabetes and hypertension status before pregnancy. Pregnancies occurring between 1/1/1992 and 31/3/2009 were included. Pregnancy losses were identified and categorised as spontaneous (including miscarriage), induced for medical, other or unknown reasons. Freetext was used to determine the type of loss where this was not clear from the coded medical records.
RESULTS: Two hundred eighty-one pregnancies potentially exposed to statins were identified and matched to 2643 unexposed pregnancies. About 54.45% of pregnancies potentially exposed to a statin resulted in a delivery compared with 62.81% of those not exposed. 25.27% of all pregnancies potentially exposed to a statin resulted in a spontaneous loss compared with 20.81% in those not exposed. Using a time to event analysis with exposure as a time-dependent covariate gave an adjusted hazards ratio of 1.64 (95%CI 1.10 to 2.46) of spontaneous pregnancy loss in the statin exposed group.
CONCLUSIONS: This study is the first to report the differences in types of pregnancy loss following the potential exposure to a statin just before or early in pregnancy.

Pharmacoepidemiol Drug Saf 2017;26:843-852