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.

Autor:	Dao K; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Shechtman S; The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel., Weber-Schoendorfer C; Charité - Universitätsmedizin Berlin, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany., Diav-Citrin O; The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel.; The Hebrew University and Hadassah Medical School, Jerusalem, Israel., Murad RH; The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel., Berlin M; Clinical Pharmacology and Toxicology Unit, Drug Consultation Center, Zerifin TIS, affiliated with the Faculty of Medicine, Tel Aviv University, Shamir Medical Center Assaf Harofeh, Tzrifin, Central, Israel., Hazan A; Clinical Pharmacology and Toxicology Unit, Drug Consultation Center, Zerifin TIS, affiliated with the Faculty of Medicine, Tel Aviv University, Shamir Medical Center Assaf Harofeh, Tzrifin, Central, Israel., Richardson JL; The UK Teratology Information Service, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Eleftheriou G; Poison Control Center, Hospital ASST Papa Giovanni XXIII, Bergamo, Italy., Rousson V; Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland., Diezi L; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Haefliger D; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Simões-Wüst AP; Department of Obstetrics, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Addor MC; Department of Woman-Mother-Child, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland., Baud D; Materno-Fetal and Obstetrics Research Unit, Department Woman-Mother-Child, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Lamine F; Endocrinology, Diabetes and Metabolism Service, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.; Endocrinology and Diabetes Unit. Internal Medicine Service, Hôpital Riviera-Chablais, Rennaz, Switzerland., Panchaud A; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.; Service of Pharmacy, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland., Buclin T; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Girardin FR; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland., Winterfeld U; Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland ursula.winterfeld@chuv.ch.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Apr 24; Vol. 14 (4), pp. e083550. Date of Electronic Publication: 2024 Apr 24.
DOI:	10.1136/bmjopen-2023-083550
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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