Background and aims

Statins are contraindicated in pregnancy, due to their potential teratogenicity. However, data are still inconsistent and some even suggest a potential benefit of statin use against pregnancy complications. We aimed to investigate the effects of statins on pregnancy outcomes, including stillbirth, fetal abortion, and preterm delivery, through a systematic review of the literature and a meta-analysis of the available clinical studies.

Methods

A literature search was performed through PubMed, Scopus, and Web of Science up to 16 May 2020. Data were extracted from 18 clinical studies (7 cohort studies, 2 clinical trials, 3 case reports, and 6 case series). Random effect meta-analyses were conducted using the restricted maximum likelihood method. The common effect sizes were calculated as odds ratios (ORs) and their 95% confidence interval (CI) for each main outcome.

Results

Finally, nine studies were included in the meta-analysis. There was no significant association between statin therapy and stillbirth [OR (95% CI) = 1.30 (0.56, 3.02), p=0.54; I² = 0%]. While statin exposure was significantly associated with increased rates of spontaneous abortion [OR (95% CI) = 1.36 (1.10–1.68), p=0.004, I² = 0%], it was non-significantly associated with increased rates of induced abortion [OR (95% CI) = 2.08 (0.81, 5.36), p=0.129, I² = 17.33%] and elective abortion [OR (95% CI) = 1.37 (0.68, 2.76), p=0.378, I² = 62.46%]. A non-significant numerically reduced rate of preterm delivery was observed in statin users [OR (95% CI) = 0.47 (0.06, 3.70), p=0.47, I² = 76.35%].

Conclusions

Statin therapy seems to be safe as it was not associated with stillbirth or induced and elective abortion rates. Significant increase after statin therapy was, however, observed for spontaneous abortion. These results need to be confirmed and validated in future studies.

中文翻译：

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他汀类药物对妊娠结局影响的系统评价和荟萃分析

背景和目标

由于其潜在的致畸性，妊娠期禁用他汀类药物。然而，数据仍然不一致，有些人甚至表明他汀类药物对妊娠并发症的潜在益处。我们旨在通过对文献的系统回顾和对现有临床研究的荟萃分析，研究他汀类药物对妊娠结局的影响，包括死产、胎儿流产和早产。

方法

通过 PubMed、Scopus 和 Web of Science 进行了截至 2020 年 5 月 16 日的文献检索。从 18 项临床研究（7 项队列研究、2 项临床试验、3 份病例报告和 6 份病例系列）中提取数据。使用限制最大似然法进行随机效应荟萃分析。共同效应大小计算为每个主要结果的优势比 (OR) 及其 95% 置信区间 (CI)。

结果

最后，9 项研究被纳入荟萃分析。他汀类药物治疗与死产之间没有显着关联 [OR (95% CI) = 1.30 (0.56, 3.02), p = 0.54; I ²  = 0%]。虽然他汀类药物暴露与自然流产率增加显着相关 [OR (95% CI) = 1.36 (1.10–1.68), p= 0.004, I ²  = 0%]，但与人工流产率增加无显着相关[OR (95% CI) = 2.08 (0.81, 5.36), p= 0.129, I ²  = 17.33%] 和选择性流产 [OR (95% CI) = 1.37 (0.68, 2.76), p= 0.378, I ² = 62.46%]。在他汀类药物使用者中观察到早产率在数值上没有显着降低 [OR (95% CI) = 0.47 (0.06, 3.70), p = 0.47, I ²  = 76.35%]。

结论

他汀类药物治疗似乎是安全的，因为它与死产或人工流产和选择性流产率无关。然而，观察到他汀类药物治疗后自然流产的显着增加。这些结果需要在未来的研究中得到证实和验证。