Statin use in pregnancy and risk of congenital malformations: a Norwegian nationwide study
Authors' conclusion
In this large, nationwide study and updated meta-analysis, no significant association was observed between first-trimester exposure to statins or other LMAs and congenital malformations.
Study context
- Population
- All pregnant women in Norway, 2005–18
- Participants
- 283 / 1,255 / 803,830
- Comparison
- First-trimester statin exposure vs non-exposure
- Statin-exposedn = 283
- Statin-discontinuern = 1,255
- Statin non-exposedn = 803,830reference
- Outcome
- Congenital malformations in offspring
Methodological detailsmixed-effects logistic regression, adjusted analyses, Adjusted for age, parity, pre-pregnancy folate use, smoking in early pregnancy, comorbidity, co-medication
- Mixed-effects logistic regression
- Adjusted analyses
- Adjusted for age, parity, pre-pregnancy folate use, smoking in early pregnancy, comorbidity, co-medication
Pooled result
As reported in the abstract
Any congenital malformation
exposed vs non-exposedAdjusted odds ratio (95% CI)
Any malformation
1.30(.81-2.09)
Major malformation
1.15(.61-2.19)
Minor malformation
1.47(.75-2.89)
Further pooled results
| Outcome | Adjusted OR (95% CI) | |
|---|---|---|
| Malformations, statin-exposed vs discontinuerExposedvs discontinuerAny malformation | 1.01 (.59-1.72) | |
| Malformations, statin-exposed vs discontinuerExposedvs discontinuerMajor malformation | 1.08 (.52-2.25) | |
| Malformations, statin-exposed vs discontinuerExposedvs discontinuerMinor malformation | .94 (.44-2.00) | |
| 0.512Adjusted odds ratio (log scale) |
Updated meta-analysis: major and heart malformations
- No increased risk of major malformations, adjusted OR
- 1.06 (95% CI .86-1.31)
- No increased risk of heart malformations, adjusted OR
- 1.24 (95% CI .94-1.64)
Heart malformations, any LMA exposure
- No association, adjusted OR
- 1.22 (95% CI .50-3.01)
Original publication
Statin use in pregnancy and risk of congenital malformations: a Norwegian nationwide study. Eur Heart J. Published 21 August 2025. doi:10.
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