Perinatal Outcomes After Statin Exposure During Pregnancy

Chang, Jui-Chun; Chen, Yen–Ju; Chen, I-Chien; Lin, Wei-Szu; Chen, Yiming; Lin, Ching‐Heng

doi:10.1001/jamanetworkopen.2021.41321

Cited by 38 publications

(24 citation statements)

References 40 publications

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“…Also, despite the high number of pregnancies (n = 822 071), in relatively few pregnancies (n = 298, 0.036 %), a prescription for a statin had been filled during first trimester. This is largely in line with data from other populations [15–19]. Although reassuring, the low frequency of statin exposure during pregnancy limits the power of drug safety analyses.…”

Section: Discussionsupporting

confidence: 77%

Use of statins and other lipid-modifying agents across pregnancy – a nationwide drug utilization study of 822 071 pregnancies in Norway in 2005-2018

Christensen

Bogsrud

Holven

et al. 2022

Preprint

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Background: Statins are becoming more widely used among women of reproductive age; however, nationwide data on statin use across pregnancy is scarce. We therefore aimed to describe the drug utilization patterns for statins and other lipid-modifying agents (LMAs) before, during, and after pregnancy, for all pregnancies in Norway from 2005 to 2018. Methods: We linked individual-level data from four nationwide electronic health care registries in Norway and characterized the prescription fills of statins and other LMAs across pregnancy. We also examined trends in pregnancy-related LMA use, and characterized women using statins and other LMAs on parameters of health status and co-morbidity. Results: In total 822 071 pregnancies for 503 723 women were included. The number of statin prescription fills decreased rapidly during first trimester and returned to pre-pregnancy levels about one year postpartum. Pregnancy-related statin use increased from 2005 (approx. 0.11 % of all pregnancies) to 2018 (approx. 0.29 % of all pregnancies); however, in total, few statin prescriptions were filled within any trimester of pregnancy (n = 331, 0.04 % of all pregnancies). Statin use was more common in women with higher age, higher weight, smoking, and comorbidities such as hypertension and diabetes mellitus; also, statin users often had co-medication pertinent to these conditions. Conclusions: Although statins and other LMAs were increasingly being used around the time of pregnancy among women in Norway, drug use was mostly discontinued during first trimester. Our results suggest that pregnancy-related statin use should be monitored, and that drug safety analyses for maternal and offspring health outcomes are needed.

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Section: Discussionsupporting

confidence: 77%

Use of statins and other lipid-modifying agents across pregnancy – a nationwide drug utilization study of 822 071 pregnancies in Norway in 2005-2018

Christensen

Bogsrud

Holven

et al. 2022

Preprint

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“…The studies were published between 2007 and 2021 and originated from the United States ( n = 4), Canada ( n = 2), United Kingdom ( n = 2), Indonesia ( n = 1), Greece ( n = 1), Taiwan ( n = 1) and multicentre over Europe ( n = 1). Four studies were RCT’s ( Costantine et al, 2016 ; Ahmed et al, 2020 ; Deviana et al, 2020 ), ( Costantine et al, 2021 ) and eight studies were cohort studies ( Lefkou et al, 2016 ; McGrogan et al, 2017 ; Lee et al, 2018 ; Chang et al, 2021 ; Winterfeld et al, 2013 ), ( Taguchi et al, 2008 ; Bateman et al, 2015 ), ( Ofori et al, 2007 ).…”

Section: Resultsmentioning

confidence: 99%

The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis

Hirsch

Ternovsky²,

Zwas³

et al. 2022

Front. Pharmacol.

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Objective: To assess the effect of statin exposure during pregnancy on congenital anomalies and spontaneous abortions.Data sources: Electronic databases were searched from inception to January 2022.Study Eligibility Criteria: Cohort studies and randomized controlled trials (RCTs) evaluate the effect of treatment with statins on congenital anomalies in general and cardiac malformations in particular. Studies evaluating spontaneous abortions were included as a secondary outcome.Study appraisal and synthesis methods: Pooled odds ratio was calculated using a random-effects model and meta-regression was utilized when applicable.Results: Twelve cohort studies and RCTs were included in the analysis. Pregnancy outcomes of 2,447 women that received statins during pregnancy were compared to 897,280 pregnant women who did not. Treatment with statins was not associated with a higher risk of overall congenital anomalies (Odd Ratio = 1.1, CI (0.9–1.3), p = 0.33, I2 = 0%). Yet, cardiac malformations were more prevalent among neonates born to statins users (OR = 1.4, CI (1.1–1.8), p = 0.02, I2 = 0%). The risk was higher when exposure occurred during the first trimester. This finding was statistically significant in cohort studies, but not in RCTs. Statin treatment was also associated with a higher rate of spontaneous abortions (OR = 1.5, CI (1.1–2.0), p = 0.005, I2 = 0%). In meta-regression analysis, no significant association between lipophilic statins and the rate of congenital anomalies was found.Conclusion: Overall, treatment with statins during pregnancy was not associated with an increased risk of congenital anomalies. A slight risk elevation for cardiac malformation and spontaneous abortions was seen in cohort studies but not in RCTs.Systematic Review Registration:clinicaltrials.gov, identifier [CRD42020165804 17/2/2020]The meta-analysis was presented online at 42nd annual meeting of SMFM. January 31-5 February 2022.

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“…A recent meta-analysis of 9 observational studies found no association between statin use and stillbirth (OR 1.30; 95% CI 0.56-3.0; p=0.54), induced abortion (OR 2.08; 95% CI; 0.81-5.36; p=0.129), or elective abortion (OR 1.37; 95% CI, 0.68-2.76; p=0.378) [5] but spontaneous abortion was more common (OR 1.36; 95% CI, 1.10-1.68; p=0.004). More recently, a retrospective cohort study of 469 statin-exposed pregnant women (vs. 4,690 matched controls) reported no increase in congenital anomalies (RR, 1.24; 95% CI 0.81-1.90 after adjustment for maternal age and comorbidities), although there was a greater risk of low birth weight (RR 1.51; 95% CI, 1.05-2.16) and preterm birth (RR 1.99; 95% CI, 1.46-2.71) [16].…”

mentioning

confidence: 92%

“…The apparently lower risk with hydrophilic statins may be due to a lower tendency to cross the placenta [17]. Unexpectedly, adverse neonatal outcomes were less likely in a subgroup of 174 women who continued statins throughout pregnancy compared to 395 women who discontinued statins after conception was confirmed [16].…”

mentioning

confidence: 98%

“…In conclusion, the FDA contraindication to statin use during pre-conception planning and pregnancy has been removed in light of considerable evidence pointing to the absence of excess teratogenic risk or other adverse pregnancy outcomes with inadvertent statin use [5,14,16]. Despite this change, the FDA still discourages the routine use of statins during pregnancy.…”

mentioning

confidence: 99%

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