TY - JOUR
T1 - Adverse effects with semaglutide
T2 - a protocol for a systematic review with meta-analysis and trial sequential analysis
AU - Sillassen, Christina Dam Bjerregaard
AU - Kamp, Caroline Barkholt
AU - Petersen, Johanne Juul
AU - Faltermeier, Pascal
AU - Siddiqui, Faiza
AU - Grand, Johannes
AU - Dominguez, Helena
AU - Frølich, Anne
AU - Gæde, Peter Haulund
AU - Gluud, Christian
AU - Mathiesen, Ole
AU - Jakobsen, Janus
N1 - © 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.
PY - 2024/6/21
Y1 - 2024/6/21
N2 - 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.
AB - 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.
KW - Humans
KW - Systematic Reviews as Topic
KW - Glucagon-Like Peptides/therapeutic use
KW - Meta-Analysis as Topic
KW - Hypoglycemic Agents/therapeutic use
KW - Diabetes Mellitus, Type 2/drug therapy
KW - Research Design
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85196873884&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-084190
DO - 10.1136/bmjopen-2024-084190
M3 - Journal article
C2 - 38908837
SN - 2044-6055
VL - 14
SP - e084190
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e084190
ER -