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

Winterfeld, Ursula; Allignol, Arthur; Panchaud, Alice; Rothuizen, Laura E.; Merlob, Paul; Cuppers-Maarschalkerweerd, Benedikte; Vial, Thierry; Stephens, Sally; Clementi, Maurizio; Santis, Marco De; Pistelli, Alessandra; Berlin, Maya; Eleftheriou, Georgios; Maňáková, Eva; Buclin, Thierry

doi:10.1111/1471-0528.12066

Cited by 100 publications

(105 citation statements)

References 26 publications

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“…235 The magnitude of risk is likely to be small. 236 Of note, the National Institutes of Health is currently sponsoring a trial of pravastatin during pregnancy for preeclampsia prevention.…”

Section: Statinsmentioning

confidence: 99%

Sex Differences in the Cardiovascular Consequences of Diabetes Mellitus

et al. 2015

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Currently, ≈1 in 13 people living in the United States has DM, and 90% to 95% of these individuals have type 2 DM (T2DM).2 Overall, the prevalence of T2DM is similar in women and men. In the United States, ≈12.6 million women (10.8%) and 13 million men (11.8%) ≥20 years of age are currently estimated to have T2DM. 2 Among individuals with T2DM, cardiovascular disease (CVD) is the leading cause of morbidity and mortality and accounts for >75% of hospitalizations and >50% of all deaths.3 Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of T2DM. 4,5 The reasons for this advantage are not entirely clear but are likely multifactorial with contributions from inherent physiological differences, including the impact of the sex hormones, differences in cardiovascular risk factors, and differences between the sexes in the diagnosis and treatment of DM and CVD. 6 In addition, there are racial and ethnic factors to consider because women of ethnic minority backgrounds have a higher prevalence of DM than non-Hispanic white (NHW) women.This scientific statement was designed to provide the current state of knowledge about sex differences in the cardiovascular consequences of DM, and it will identify areas that would benefit from further research because much is still unknown about sex differences in DM and CVD. Areas that are discussed include hormonal differences between the sexes and their possible effects on the interaction between DM and CVD, sex differences in epidemiology, ethnic and racial differences and risk factors for CVD in DM across the life span, sex differences in various types of CVD and heart failure, and sex differences in the effects of treatments for DM, including both medications and lifestyle. In addition, there is discussion about risk factors that are specific to women, including gestational diabetes mellitus (GDM) and polycystic ovarian syndrome (PCOS), which affect CVD risk. Table 1 focuses on sex differences in CVD risk factors and outcomes in DM, and Table 2 provides information about sex differences in CVD treatments and interventions in DM. Table 3 contains some of the important ideas for research in sex differences in the cardiovascular consequences of DM. The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on July 31, 2015, and the American Heart Association Executive Committee on September 5, 2015. A copy of the document is available at http://my.americanheart.org/statements by selecting either the "By...

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Section: Statinsmentioning

confidence: 99%

Sex Differences in the Cardiovascular Consequences of Diabetes Mellitus

et al. 2015

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“…However, the occurrence of three pregnancies during the study highlights the importance of appropriate counseling and follow-up when prescribing potentially teratogenic medications to female patients of childbearing age. Recent studies suggest minimal teratogenicity of statins during pregnancy (36,37), although statins remain pregnancy category X drugs as labeled by the US FDA. ACEIs and angiotensin receptor blockers are associated with an increased risk of fetal birth defects (38), although risk with use in early pregnancy is comparable to that of other antihypertensive medications (39,40).…”

Section: Discussionmentioning

confidence: 99%

Effect of Pravastatin on Total Kidney Volume, Left Ventricular Mass Index, and Microalbuminuria in Pediatric Autosomal Dominant Polycystic Kidney Disease

Cadnapaphornchai

George

McFann

et al. 2014

Clinical Journal of the American Society of Nephrology

151

101

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Background and objectives In autosomal dominant polycystic kidney disease (ADPKD), progressive kidney cyst formation commonly leads to ESRD. Because important manifestations of ADPKD may be evident in childhood, early intervention may have the largest effect on long-term outcome. Statins are known to slow progressive nephropathy in animal models of ADPKD. This randomized double-blind placebo-controlled phase III clinical trial was conducted from 2007 to 2012 to assess the effect of pravastatin on height-corrected total kidney volume (HtTKV) and left ventricular mass index (LVMI) by magnetic resonance imaging (MRI) and urine microalbumin excretion (UAE) in children and young adults with ADPKD.Designs, setting, participants, & measurements There were 110 pediatric participants with ADPKD and normal kidney function receiving lisinopril who were randomized to treatment with pravastatin or placebo for a 3-year period with evaluation at 0, 18, and 36 months. The primary outcome variable was a $20% change in HtTKV, LVMI, or UAE over the study period.Results Ninety-one participants completed the 3-year study (83%). Fewer participants receiving pravastatin achieved the primary endpoint compared with participants receiving placebo (69% versus 88%; P=0.03). This was due primarily to a lower proportion reaching the increase in HtTKV (46% versus 68%; P=0.03), with similar findings observed between study groups for LVMI (25% versus 38%; P=0.18) and UAE (47% versus 39%; P=0.50). The percent change in HtTKV adjusted for age, sex, and hypertension status over the 3-year period was significantly decreased with pravastatin (23%63% versus 31%63%; P=0.02).Conclusions Pravastatin is an effective agent to slow progression of structural kidney disease in children and young adults with ADPKD. These findings support a role for early intervention with pravastatin in this condition.

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“…ACEI inhibitors and statins have been associated with foetal toxicity [25], and they are not recommended during pregnancy. However, more recent reviews suggest that the risk associated with statins may be overestimated [26,27].…”

Section: Medical Therapymentioning

confidence: 99%