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Use of Semaglutide After Acute Coronary Syndrome - Design and rationale of a retrospective observational study

Biasin, M.

2025-08-01 cardiovascular medicine
10.1101/2025.07.31.25332452 medRxiv
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RationaleSemaglutide, a glucagon like peptide 1 receptor agonist (GLP1 RA), has shown significant cardiovascular benefit in patients with type 2 diabetes mellitus (T2DM) and established atherosclerotic cardiovascular disease (ASCVD). However, its initiation in the immediate phase following an acute coronary syndrome (ACS) has not been systematically investigated. The current study aims to evaluate the early real world use of semaglutide following hospital discharge after ACS, a clinically relevant yet underexplored therapeutic window. ObjectivesThe primary objective is to assess the real world feasibility and tolerability of semaglutide therapy, either oral or subcutaneous, when initiated at hospital discharge in patients with T2DM after ACS. Secondary objectives include the characterization of clinical and metabolic profiles of treated patients, evaluation of treatment persistence and reasons for discontinuation, documentation of adverse events, and assessment of cardiovascular outcomes during follow up. MethodsThis is a retrospective, observational, multicenter study including adult patients with T2DM who were hospitalized for ACS, such as ST elevation myocardial infarction (STEMI), non ST elevation myocardial infarction (NSTEMI), or unstable angina, and were discharged with a documented recommendation to initiate semaglutide. Clinical data will be extracted from electronic medical records for patients treated between January 2021 and January 2025. Collected data will include baseline demographics, ACS characteristics, cardiometabolic parameters, semaglutide formulation and dosing, as well as follow up outcomes such as treatment continuation, adverse events, laboratory parameters, and major cardiovascular events. Ethics and DisseminationThis study involves retrospective analysis of anonymized clinical data. Ethical approval will be obtained in accordance with national and institutional requirements. Study results will be disseminated through peer reviewed publications and conference presentations. Trial RegistrationNot applicable. This is a non interventional retrospective study based on routinely collected data

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