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Background and Aims: Statins are the drugs of choice for decreasing elevated low-density lipoprotein cholesterol. Based mostly on animal studies and case reports, they are forbidden to pregnant women and in the preconception period because of their possible teratogenic effects, for which causality has never been proven. The aim of this study was to systematically review the existing studies and to perform a meta-analysis on this topic., Methods: The databases PubMed/MEDLINE, Scopus, and Web of Science were searched since the inception until May 16, 2020. The risk of bias for each clinical trial was evaluated using the Cochrane handbook criteria for systematic reviews. The National Institutes of Health (NIH) quality assessment tool was used for the evaluation of cohort and cross-sectional studies. Meta-analysis was performed on the extracted data. Heterogeneity was assessed using I 2 measure and Cochrane's Q statistic. We calculated a pooled estimate of odds ratio (OR) and 95% confidence intervals (CI) using a random-effects model., Results: 23 studies (nine cohort studies, six case reports, six case series, one population-based case-referent study and one clinical trial) with 1,276,973 participants were included in the systematic review and 6 of them (n = 1,267,240 participants) were included in meta-analysis. The results of the critical review did not suggest a clear-cut answer to the question whether statin treatment during pregnancy is associated with an increased rate of birth defects or not, while the results of the meta-analysis indicated that statin use does not increase birth defects [OR (95%CI): 1.48 (0.90, 2.42), p = 0.509], including cardiac anomalies [2.53 (0.81, 7.93), p = 0.112] and other congenital anomalies [1.19 (0.70, 2.03), p = 0.509)]., Conclusions: We observed no significant increase of birth defects after statin therapy. Thus, there is still no undoubtful evidence that statin treatment during pregnancy is teratogenic, and this issue still needs to be investigated, especially there are more and more pregnant women at high CVD risk that could have benefited from the statin therapy., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose of Review: To compare the European and US guidelines for familial hypercholesterolaemia, but also all the European and US position/consensus papers on heterozygous and homozygous familial hypercholesterolaemia published recently., Recent Findings: It has been established that the prevalence of familial hypercholesterolaemia was previously markedly underestimated. The disease is characterized by a lifelong significant increase in LDL cholesterol (LDL-C) levels and therefore premature atherosclerotic cardiovascular disease. Recommendations on familial hypercholesterolaemia have been included as a special chapter in the recent European (European Society of Cardiology/European Atherosclerosis Society) guidelines on dyslipidaemia, whereas in the new US (American College of Cardiology/American Heart Association) lipid guidelines they have been included only generally and these guidelines avoid mentioning familial hypercholesterolaemia explicitly. Both of these guidelines recommend statins in high doses as the treatment option. However, in the American College of Cardiology/American Heart Association guidelines, there is no requirement to attain a specific LDL-C target which is different from the European Society of Cardiology/European Atherosclerosis Society guidelines. Although these two guidelines differ markedly in a number of aspects, they both stress the need to diagnose familial hypercholesterolaemia patients as early as possible and to treat them with intensive LDL-C-lowering therapy., Summary: All the guidelines and consensus papers stress that earlier diagnosis and effective treatment can markedly improve life expectancy among familial hypercholesterolaemia patients.

Atherosclerotic cardiovascular disease is the most important public health problem of our time in both Europe and the rest of the world, accounting for the greatest expenditure in most healthcare budgets. Achieving consistency of clinical care, incorporating new evidence and their synthesis into practical recommendations for clinicians is the task of various guideline committees throughout the world. Any change in a set of guidelines therefore can have far reaching consequences, particularly if they appear to be at variance with the existing guidelines. The present article discusses the recent American College of Cardiology (ACC)/American Heart Association (AHA) guidelines 2013 on the control of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults. When compared with the ESC/EAS guidelines on lipid modification in 2011, the ACC/AHA guidelines of 2013 differ markedly. Specifically, (i) the scope is limited to randomized trials only, which excludes a significant body of data and promotes essentially a statin centric approach only; (ii) the abolition of low-density lipoprotein cholesterol (LDL-C) targets in favour of specific statin regimens that produce a 30-50% reduction in LDL-C we believe will confuse many physicians and miss the opportunity for medication adherence and patient engagement in self-management; (iii) the absence of target LDL-C levels in very high-risk patients with high absolute risk or residual risk factors will discourage clinicians to consider the addition of lipid modification treatments and individualize patient care; (iv) a reduction in the threshold for treatment in primary prevention will result in a greater number of patients being prescribed statin therapy, which is potentially good in young patients with high life time risk, but will result in a very large number of older patients offered therapy; and (v) the mixed pool risk calculator used to asses CVD risk in the guidelines for primary prevention has not been fully evaluated. This article discusses the potential implications of adopting the ACC/AHA guidelines on patient care in Europe and beyond and concludes with the opinion that the ESC/EAS guidelines from 2011 seem to be the most wide ranging, pragmatic and appropriate choice for European countries.