Prenatal statin exposure and adverse birth outcomes in Asian women: a systematic review and meta-analysis.
- 1Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006, China.
- 2Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006, China. [email protected].
- 3Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006, China. [email protected].
Abstract
Background
The safety of statin use during pregnancy remains controversial. We aimed to evaluate the association between prenatal statin exposure and pregnancy outcomes in Asian women, including low birth weight, preterm birth, and congenital anomalies.Methods
We conducted a PRISMA-compliant systematic review and meta-analysis of studies in Asian populations evaluating prenatal statin exposure. PubMed, Embase, the Cochrane Library, Web of Science, and trial registries were searched through January 31, 2026. Eligible randomized and observational studies included Asian populations and reported low birth weight, preterm birth, or congenital anomalies. Adjusted risk ratios were pooled using random-effects inverse-variance models, and risk of bias was assessed with standard tools.Results
Three nationwide observational cohort studies from Taiwan and South Korea were included in the quantitative synthesis, and one Indonesian randomized trial of pravastatin for preeclampsia prevention was reviewed qualitatively. Prenatal statin exposure was not associated with congenital anomalies (RR, 0.98; 95% CI, 0.89-1.08; I² = 0%), but was associated with low birth weight (RR, 1.27; 95% CI, 1.07-1.49; I² = 49%). The association with preterm birth was not statistically significant (RR, 1.24; 95% CI, 0.95-1.62; I² = 87%). Sensitivity analyses restricted to exposed versus unexposed comparisons yielded similar conclusions.Conclusions
The available Asian evidence, largely derived from nationwide East Asian cohorts, suggests no clear association between prenatal statin exposure or continuation and congenital anomalies. A modest association with low birth weight was observed, whereas evidence for preterm birth remained inconclusive. The low-birth-weight finding should be interpreted cautiously because of residual confounding, comparator heterogeneity, prematurity-related low birth weight, and pharmacological heterogeneity across statins.Systematic review registration
PROSPERO CRD420251235975.
Related
- Neurodevelopmental outcomes following prenatal cannabinoid exposure: a systematic review
- Prenatal antiseizure medication exposure and offspring structural and neurodevelopmental outcomes: an umbrella review of systematic reviews and meta-analyses
- Statin use and clinical outcomes in patients with head and neck cancer: a systematic review and meta-analysis
- Prenatal substance exposure and 5-year child protection outcomes among infants not reported at birth
- Association between Prenatal Adversity and Neonatal Outcomes in Infants with Prenatal Opioid Exposure
BibTeX
@article{ye2026prenatal,
title = {{Prenatal statin exposure and adverse birth outcomes in Asian women: a systematic review and meta-analysis.}},
author = {Shuya Ye and Fan Wu and Dongli Sun and Xiao Zhang and Li Wang and Meng Zhang and Caihong Zheng and Yue Chen},
journal = {BMC pediatrics},
year = {2026},
month = jul,
doi = {10.1186/s12887-026-07379-0},
url = {https://europepmc.org/article/MED/42902252},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Prenatal statin exposure and adverse birth outcomes in Asian women: a systematic review and meta-analysis.
AU - Shuya Ye
AU - Fan Wu
AU - Dongli Sun
AU - Xiao Zhang
AU - Li Wang
AU - Meng Zhang
AU - Caihong Zheng
AU - Yue Chen
PY - 2026
DA - 2026/07/01
JO - BMC pediatrics
DO - 10.1186/s12887-026-07379-0
UR - https://europepmc.org/article/MED/42902252
AB - Background The safety of statin use during pregnancy remains controversial. We aimed to evaluate the association between prenatal statin exposure and pregnancy outcomes in Asian women, including low birth weight, preterm birth, and congenital anomalies.Methods We conducted a PRISMA-compliant systematic review and meta-analysis of studies in Asian populations evaluating prenatal statin exposure. PubMed, Embase, the Cochrane Library, Web of Science, and trial registries were searched through January 31, 2026. Eligible randomized and observational studies included Asian populations and reported low birth weight, preterm birth, or congenital anomalies. Adjusted risk ratios were pooled using random-effects inverse-variance models, and risk of bias was assessed with standard tools.Results Three nationwide observational cohort studies from Taiwan and South Korea were included in the quantitative synthesis, and one Indonesian randomized trial of pravastatin for preeclampsia prevention was reviewed qualitatively. Prenatal statin exposure was not associated with congenital anomalies (RR, 0.98; 95% CI, 0.89-1.08; I² = 0%), but was associated with low birth weight (RR, 1.27; 95% CI, 1.07-1.49; I² = 49%). The association with preterm birth was not statistically significant (RR, 1.24; 95% CI, 0.95-1.62; I² = 87%). Sensitivity analyses restricted to exposed versus unexposed comparisons yielded similar conclusions.Conclusions The available Asian evidence, largely derived from nationwide East Asian cohorts, suggests no clear association between prenatal statin exposure or continuation and congenital anomalies. A modest association with low birth weight was observed, whereas evidence for preterm birth remained inconclusive. The low-birth-weight finding should be interpreted cautiously because of residual confounding, comparator heterogeneity, prematurity-related low birth weight, and pharmacological heterogeneity across statins.Systematic review registration PROSPERO CRD420251235975.
SN - 1471-2431
ER -