Article ; Online: Use of GLP1 receptor agonists in early pregnancy and reproductive safety: a multicentre, observational, prospective cohort study based on the databases of six Teratology Information Services.
2024 Volume 14, Issue 4, Page(s) e083550
Abstract: Objectives: Glucagon-like peptide 1 receptor agonists (GLP1-RA) are indicated for the treatment of type 2 diabetes and more recently for weight loss. The aim of this study was to assess the risks associated with GLP1-RA exposure during early pregnancy.!# ...
| Abstract | Objectives: Glucagon-like peptide 1 receptor agonists (GLP1-RA) are indicated for the treatment of type 2 diabetes and more recently for weight loss. The aim of this study was to assess the risks associated with GLP1-RA exposure during early pregnancy. Design: This multicentre, observational prospective cohort study compared pregnancy outcomes in women exposed to GLP1-RA in early pregnancy either for diabetes or obesity treatment with those in two reference groups: (1) women with diabetes exposed to at least one non-GLP1-RA antidiabetic drug during the first trimester and (2) a reference group of overweight/obese women without diabetes, between 2009 and 2022. Setting: Data were collected from the databases of six Teratology Information Services. Participants: This study included 168 pregnancies of women exposed to GLP1-RA during the first trimester, alongside a reference group of 156 pregnancies of women with diabetes and 163 pregnancies of overweight/obese women. Results: Exposure to GLP1-RA in the first trimester was not associated with a risk of major birth defects when compared with diabetes (2.6% vs 2.3%; adjusted OR, 0.98 (95% CI, 0.16 to 5.82)) or to overweight/obese (2.6% vs 3.9%; adjusted OR 0.54 (0.11 to 2.75)). For the GLP1-RA group, cumulative incidence for live births, pregnancy losses and pregnancy terminations was 59%, 23% and 18%, respectively. In the diabetes reference group, corresponding estimates were 69%, 26% and 6%, while in the overweight/obese reference group, they were 63%, 29% and 8%, respectively. Cox proportional cause-specific hazard models indicated no increased risk of pregnancy losses in the GLP1-RA versus the diabetes and the overweight/obese reference groups, in both crude and adjusted analyses. Conclusions: This study offers reassurance in cases of inadvertent exposure to GLP1-RA during the first trimester of pregnancy. Due to the limited sample size, larger studies are required to validate these findings. |
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| MeSH term(s) | Humans ; Female ; Pregnancy ; Prospective Studies ; Adult ; Pregnancy Trimester, First ; Glucagon-Like Peptide-1 Receptor/agonists ; Hypoglycemic Agents/therapeutic use ; Hypoglycemic Agents/adverse effects ; Pregnancy Outcome/epidemiology ; Obesity/epidemiology ; Diabetes Mellitus, Type 2/drug therapy ; Abnormalities, Drug-Induced/epidemiology ; Pregnancy in Diabetics/drug therapy ; Databases, Factual ; Pregnancy Complications/drug therapy |
| Chemical Substances | Glucagon-Like Peptide-1 Receptor ; Hypoglycemic Agents |
| Language | English |
| Publishing date | 2024-04-24 |
| Publishing country | England |
| Document type | Journal Article ; Observational Study ; Multicenter Study ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2599832-8 |
| ISSN | 2044-6055 ; 2044-6055 |
| ISSN (online) | 2044-6055 |
| ISSN | 2044-6055 |
| DOI | 10.1136/bmjopen-2023-083550 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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