Safety of GLP-1 Receptor Agonists and Other Second-Line Antidiabetics in Early Pregnancy
Authors' conclusion
Use of second-line noninsulin ADMs is rapidly increasing for treatment of T2D and other indications, resulting in an increasing number of exposed pregnancies. Although some estimates were imprecise, results did not indicate a large increased risk of MCMs above the risk conferred by maternal T2D requiring second-line treatment. Although reassuring, confirmation from other studies is needed, and continuous monitoring will provide more precise estimates as data accumulate.
Study context
- Population
- Pregnant women with T2D and their live-born infants followed up to 1 year after birth; 4 Nordic countries (2009–2020), US MarketScan (2012–2021), Israeli Maccabi (2009–2020)infants of women with T2D
- Participants
- 51,826 women
- Exposure
- Periconceptional second-line noninsulin antidiabetic medication (ADMs) vs insulin
- Sulfonylureasn = 1,362
- DPP-4 inhibitorsn = 687
- GLP-1 receptor agonistsn = 938
- SGLT2 inhibitorsn = 335
- Insulinn = 5,078reference
- Outcome
- Major congenital malformations (MCMs) in the infant; adjusted relative risks (RRs) from log-binomial regression, meta-analyzed
- Follow-up
- Up to 1 year after birth
Methodological detailsobservational, multinational (4 Nordic countries, US MarketScan, Israeli Maccabi), active comparator (insulin)
- Observational
- Multinational (4 Nordic countries, US MarketScan, Israeli Maccabi)
- Active comparator (insulin)
Main finding
As reported in the abstract
Observational data: associations, not effects.
Further findings
Standardized prevalence of major congenital malformations (MCMs), all infants and infants of women with T2D
- All infants (n = 3 514 865)
- 3.7%
- Infants born to women with T2D (n = 51 826)
- 5.3%
Periconceptional exposure to second-line noninsulin ADMs
- Nordics, per 100 000 pregnancies
- 32
- US, per 100 000 pregnancies
- 295
- Israel, per 100 000 pregnancies
- 73
- Exposure increased over the study period, especially in the US
Original publication
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