- Design
- Systematic review and meta-analysis of 3 observational cohorts
- Population
- 669 SGLT2 inhibitor-exposed pregnancies in women with type 2 diabetes
- Primary outcome
- Major congenital malformations versus insulin
- Effect
- RR 0.94 (95% CI 0.68–1.29); cardiac malformations RR 0.97 (0.64–1.48)
A systematic review in Endocrine pooled three observational cohorts with 669 pregnancies exposed to an SGLT2 inhibitor around conception or in early pregnancy, in women with type 2 diabetes, compared with women taking insulin or a sulfonylurea.
Against insulin, exposure was not associated with major congenital malformations (RR 0.94) or cardiac malformations (RR 0.97). Adding a sulfonylurea comparator gave a similar result. One Korean cohort found exposure in gestational weeks 4–10 associated with congenital heart defects (RR 2.79). The authors rated certainty low to very low.
Cardiologists increasingly prescribe SGLT2 inhibitors to younger women for heart failure and CKD, and many pregnancies are unplanned. These data are mildly reassuring for a woman who conceives on the drug, but the intervals are wide enough to miss a meaningful increase, and the weeks 4–10 signal needs replication.
The practical answer is unchanged: SGLT2 inhibitors are not recommended in pregnancy, so discuss contraception when starting one and stop it once pregnancy is recognised.
- Ask about pregnancy plans and contraception when starting an SGLT2 inhibitor in a woman of reproductive age
- Stop the SGLT2 inhibitor as soon as pregnancy is recognised and review heart failure treatment with obstetric input
- Reassure, cautiously, a woman exposed before pregnancy was known: no clear increase in major malformations has been shown
- Consider a detailed fetal anomaly scan, including the heart, after exposure in the first trimester
Why it matters
Cardiorenal prescribing has put SGLT2 inhibitors into a population where unplanned pregnancy is common.
Don't overread it
Few exposed pregnancies and wide intervals mean this cannot rule out a clinically important increase in risk.
The statistics, in plain English
An RR of 0.94 with an interval of 0.68 to 1.29 means the data fit anything from a 32% lower to a 29% higher risk. The Korean heart-defect RR of 2.79 comes from one cohort and one exposure window, so it is a signal to check, not a finding.
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