Adverse effects with semaglutide: a protocol for a systematic review with meta-analysis and trial sequential analysis.

Autor:	Sillassen CDB; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark christina.sillassen@ctu.dk.; Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Kamp CB; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Petersen JJ; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark., Faltermeier P; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.; MSH Medical School Hamburg University of Applied Sciences and Medical University, Hamburg, Germany., Siddiqui F; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark., Grand J; Amager-Hvidovre Hospital, Department of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark., Dominguez H; Bispebjerg and Frederiksberg Hospital, Department of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark.; Department of Biomedicine, Health Faculty, University of Copenhagen, Copenhagen, Denmark., Frølich A; Innovation and Research Centre for Multimorbidity, Slagelse Hospital, Slagelse, Denmark.; Section of General Practice, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark., Gæde PH; Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Gluud C; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Mathiesen O; Department of Anaesthesiology, Zealand University Hospital Koge Centre for Anaesthesiological Research, Koge, Denmark.; Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark., Jakobsen J; Centre for Clinical Intervention Research, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jun 21; Vol. 14 (6), pp. e084190. Date of Electronic Publication: 2024 Jun 21.
DOI:	10.1136/bmjopen-2024-084190
Abstrakt:	Introduction: Semaglutide is increasingly used for the treatment of type 2 diabetes mellitus, overweight and other conditions. It is well known that semaglutide lowers blood glucose levels and leads to significant weight loss. Still, a systematic review has yet to investigate the adverse effects with semaglutide for all patient groups. Methods and Analysis: We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medline, Embase, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index-Science) and clinical trial registries from their inception and onwards to identify relevant randomised clinical trials. We expect to conduct the literature search in July 2024. Two review authors will independently extract data and perform risk-of-bias assessments. We will include randomised clinical trials comparing oral or subcutaneous semaglutide versus placebo. Primary outcomes will be all-cause mortality and serious adverse events. Secondary outcomes will be myocardial infarction, stroke, all-cause hospitalisation and non-serious adverse events. Data will be synthesised by meta-analyses and trial sequential analysis; risk of bias will be assessed with Cochrane Risk of Bias tool-version 2, an eight-step procedure will be used to assess if the thresholds for statistical and clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations. Ethics and Dissemination: This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals. Prospero Registration Number: CRD42024499511. Competing Interests: Competing interests: PG has received lecture fees for Novo Nordisk, AstraZeneca, Eli Lilly, Bayer, MSD and has served in Advisory Boards for Novo Nordisk, AstraZeneca, Bayer. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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