Gestational diabetes & diabetes in pregnancy
Safety of glucagon-like peptide-1 receptor agonists and other new-generation glucose-lowering agents for the management of type 2 diabetes in pregnancy: a French nationwide population-based study
Authors' conclusion
In this largest study to date on the use of glucose-lowering agents in pregnancy, first-trimester exposure to second-line glucose-lowering agents was not associated with an increased risk of major congenital malformations when compared with insulin-only use. However, a small increased risk of cardiac defects associated with first-trimester exposure to GLP-1RA and sulfonylureas is possible, and thus teratogenicity cannot be excluded.
Study context
- Population
- Singleton infants born after pregnancies >22 weeks in women aged 18 to 50 years with pregestational, pharmacologically treated T2D, France, January 2011 to August 2024
- Participants
- 19,092 eligible pregnancies
- Exposure
- First-trimester exposure to second-line glucose-lowering agents vs insulin alone
- Outcome
- Major congenital malformations (overall and organ-specific), ICD-10 codes per EUROCAT guidelines
- Follow-up
- During the delivery stay and up to 1 year after birth
Methodological detailsnationwide, French National Health Data System
- Nationwide
- French National Health Data System
Main finding
As reported in the abstract
- First-trimester exposure to second-line agents vs insulin-only use was not associated with an increased risk of overall or organ-specific major congenital malformations
- Adjusted RRs (Poisson regression with GEE); BMI and HbA1c unavailable, proxies of diabetes severity used
Observational data: associations, not effects.
Further findings
Cardiac malformations, sensitivity analyses with stricter exposure definitions
- Possible small increased risk of cardiac malformations after first-trimester exposure to GLP-1 RA and sulfonylureas
Original publication
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