Use of oral Semaglutide after Acute Coronary Syndrome - Design and rationale of a prospective observational study
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Rationale
Oral semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), has shown cardiovascular benefits in patients with type 2 diabetes mellitus (T2DM) and established atherosclerotic cardiovascular disease (ASCVD). However, its initiation in patients immediately following an acute coronary syndrome (ACS) has not been prospectively investigated. This study addresses this critical gap by evaluating the feasibility, tolerability, and clinical characteristics associated with prescribing oral semaglutide (Rybelsus) at hospital discharge in patients with T2DM admitted for ACS.
Objectives
The primary objective is to evaluate the proportion of patients discharged after ACS who successfully initiate and tolerate oral semaglutide within 30 days, without permanent discontinuation due to adverse events by 3 months. Secondary objectives include characterization and quantification of adverse events (with a focus on gastrointestinal intolerance, pancreatitis, and worsening renal function), assessment of treatment persistence and adherence, evaluation of metabolic parameter changes, documentation of cardiovascular outcomes during 12 months of follow-up, and exploration of clinical predictors for treatment discontinuation and adverse events.
Methods
This is a prospective, observational, multicenter study enrolling adult patients with T2DM admitted for ACS (STEMI, NSTEMI, or unstable angina), discharged from the coronary care unit with documented initiation of oral semaglutide (Rybelsus). Patient data will be systematically collected at baseline (hospital discharge), 3, 6, and 12 months, through standardized electronic case report forms during clinical visits and via electronic health records. Collected data includes demographics, ACS clinical presentation, metabolic parameters (HbA1c, BMI, eGFR), semaglutide dosing, adherence, adverse events, treatment continuation rates, and cardiovascular outcomes.
Ethics and Dissemination
Ethical approval will be obtained from institutional review boards in accordance with national regulations. All participants will provide informed consent. Findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.
Trial Registration
Not applicable. This is an observational, non-interventional study
