Safety of Statins During Pregnancy

Dyslipidemic disorders represent a significant risk factor for the development of cardiovascular complications, particularly among middle-aged and elderly individuals. Nevertheless, genetic predisposition and physiological alterations can accelerate the onset of hyperlipidaemia and hypertriglyceridemia in young individuals, particularly during pregnancy. Currently, the primary hypolipidemic medications are statins; however, the potential use of these drugs during pregnancy in women remains a topic of debate. The aim of this review was to analyse the literature data regarding the potential risks to the foetus associated with the use of statins during pregnancy. Both the physicochemical and pharmacokinetic characteristics of these drugs were considered. Key factors such as lipophilicity, degree of binding to serum proteins, time to maximum blood concentration, half-life, degree of bioavailability, metabolic pathways and excretion are discussed in detail. The results of retrospective and prospective clinical studies in pregnant women and the results of preclinical studies are reviewed. This article provides information on the classification of modern statins (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin) based on the teratogenicity risk classifications proposed by Briggs et al. (2022) and the Australian Drug Evaluation Committee (ADEC). Analysis of the literature data indicates that statins are unlikely to significantly increase the risk of congenital malformations in humans. In addition, there is evidence to suggest that statins may offer potential benefits in the treatment of pre-eclampsia and dyslipidaemia in pregnancy. However, it should be noted that there is an increased risk of preterm delivery and low birth weight.