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From evidence to practice: Identifying candidates for semaglutide in chronic atherosclerotic disease
Aldo P Maggioni1, Francesco Orso1, Donata Lucci1
1ANMCO Research Center, HCF Fondazione ANMCO per il Tuo cuore ETS, Firenze, Italy.
Insights
Semaglutide, a GLP-1 receptor agonist, shows potential for cardiovascular risk reduction in patients with coronary artery disease. Over half of real-world patients met eligibility criteria, indicating a significant opportunity for secondary cardiovascular prevention.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Randomized trials (SELECT, SOUL) established semaglutide's efficacy in reducing atherothrombotic events and cardiovascular mortality in coronary artery disease (CAD) patients.
- Real-world patient populations may differ from clinical trial cohorts, necessitating an assessment of real-world eligibility for semaglutide therapy.
Purpose of the Study:
- To assess the proportion of patients with coronary artery disease (CAD) who meet eligibility criteria for semaglutide therapy based on regulatory guidelines derived from SELECT and SOUL trials.
- To evaluate the potential real-world application of semaglutide for secondary cardiovascular prevention in cardiology practice.
Main Methods:
- Utilized data from the START and BRING-UP prevention registries to identify patients comparable to SELECT and SOUL trial participants.
- Excluded 623 patients due to severe renal impairment or current GLP-1 receptor agonist use, analyzing a final cohort of 11,807 patients.
- Defined eligibility criteria based on regulatory authorities' guidelines informed by SELECT and SOUL trial results, differentiating between diabetic and non-diabetic patients.
Main Results:
- Among 11,807 patients, 8682 were non-diabetic and 3125 were diabetic.
- 42.5% of non-diabetic patients (SELECT-like criteria: overweight/obese with established CAD) and 97.9% of diabetic patients (SOUL-like criteria: aged ≥50 with cardiovascular disease) met criteria.
- Overall, 54.3% (6748/12,430) of the evaluated real-world cardiology patient population theoretically fulfilled eligibility criteria for semaglutide treatment.
Conclusions:
- A substantial proportion of patients with coronary artery disease managed in real-world cardiology settings are potentially eligible for semaglutide therapy.
- Identifying this eligible patient pool is crucial for estimating unmet clinical needs and assessing the feasibility of innovative secondary cardiovascular prevention strategies.
Background And Aim:
Randomised clinical trials (SELECT and SOUL) demonstrated that semaglutide, a GLP-1 receptor agonist, reduces the combined outcome measure of atherothrombotic events or cardiovascular mortality in patients with coronary artery disease, both with and without diabetes. Because real-world populations may differ from trial cohorts, we assessed the proportion of patients potentially eligible for semaglutide using the criteria set out by the regulatory authorities based on the SELECT and SOUL results.
Methods And Results:
Patients whose clinical characteristics were comparable to those of patients enrolled in the SELECT and SOUL trials were identified within the START and BRING-UP prevention registries. Among 12,430 patients, 623 were excluded because of severe renal impairment or ongoing GLP-1 receptor agonist therapy. The final population included 11,807 patients: 8682 without diabetes and 3125 with diabetes. Among non-diabetic patients, 3689 (42.5%) were SELECT-like, defined as overweight or obese individuals with established coronary disease. Among diabetic patients, 3059 (97.9%) were SOUL-like, defined as individuals aged ≥50 years with cardiovascular disease. Overall, 6748 of 12,430 patients (54.3%) theoretically fulfilled eligibility criteria for semaglutide treatment in real-world cardiology practice.
Conclusions:
According to the criteria set out by the regulatory authorities based on the SELECT and SOUL trial results, a large proportion of patients with coronary artery disease managed by cardiologists may be potentially eligible for semaglutide therapy. Identifying the target population for this therapeutic strategy may help clinicians and healthcare authorities estimate unmet clinical needs and evaluate the sustainability of innovative approaches for secondary cardiovascular prevention.
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