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Clinical Trial
. 2023 Jan;31(1):111-122.
doi: 10.1002/oby.23621. Epub 2022 Dec 10.

Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics

Ildiko Lingvay  1 , Kirstine Brown-Frandsen  2 , Helen M Colhoun  3 , John Deanfield  4 , Scott S Emerson  5 , Sille Esbjerg  2 , Søren Hardt-Lindberg  2 , G Kees Hovingh  2 , Steven E Kahn  6 , Robert F Kushner  7 , A Michael Lincoff  8 , Steven P Marso  9 , Tea Monk Fries  2 , Jorge Plutzky  10 , Donna H Ryan  11 ; SELECT Study Group
Affiliations
Clinical Trial

Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics

Ildiko Lingvay et al. Obesity (Silver Spring). 2023 Jan.

Abstract

Objective: This paper describes the baseline characteristics of the Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) study, one of the largest cardiovascular (CV) outcome studies in the field of obesity, which evaluates the effect of semaglutide versus placebo on major CV events.

Methods: SELECT enrolled individuals with overweight or obesity without diabetes, with prior myocardial infarction, stroke, and/or peripheral artery disease. This study reports participants' baseline characteristics in the full study population and subgroups defined by baseline glycated hemoglobin (HbA1c ; <5.7%, ≥5.7 to <6.0%, ≥6.0 to <6.5%), baseline waist to height ratio tertile, and qualifying prior CV event or condition.

Results: The study enrolled 17,605 participants (72.5% male) with an average (SD) age of 61.6 (8.9) years and BMI of 33.34 (5.04) kg/m2 . The most common prior CV event was myocardial infarction (76.3% of participants), followed by stroke (23.3%) and peripheral artery disease (8.6%). Furthermore, 24.3% had a heart failure diagnosis. Two-thirds of participants (66%) had HbA1c in the prediabetes range (5.7%-6.4%). Across groups of increasing HbA1c , prevalence of all CV risk factors increased.

Conclusions: The enrolled population in SELECT includes participants across a broad range of relevant risk categories. This will allow the study to garner information about the CV benefits of semaglutide across these relevant clinical subgroups.

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Conflict of interest statement

Ildiko Lingvay received research funding (paid to institution) from Boehringer Ingelheim, Merck, Mylan, Novo Nordisk A/S, Pfizer, and Sanofi and advisory/consulting fees and/or other support from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly and Company, GI Dynamics, Intarcia, Intercept, Janssen, Mannkind, Merck, Mylan, Novartis, Novo Nordisk A/S, Pfizer, Sanofi, Shionogi, TARGETPharma, Valeritas, and Zealand Pharma. A. Michael Lincoff received research funding from AbbVie, AstraZeneca, CSL Behring, Eli Lilly and Company, Esperion, and Novartis and consulting fees from Akebia, Becton‐Dickson, Eli Lilly and Company, Endologix, Fibrogen, GlaxoSmithKline, Novo Nordisk A/S, and Provention Bio. Donna H. Ryan received consulting fees from Altimmune, Amgen, Boehringer Ingelheim, Calibrate, Epitomee, Gila, Ifa Celtic, Janssen, Eli Lilly and Company, Novo Nordisk A/S, Real Appeal (UnitedHealthcare), Roman Scientific Intake, Wondr Health, Xeno Bioscience, Ysopia, and Zealand; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Novo Nordisk A/S; payment for expert testimony from Simmons and Simmons; participated in a data safety monitoring board and/or advisory board for IQVIA and Rhythm Pharmaceuticals; and holds stock options in Calibrate, Epitomee, Roman, and Scientific Intake. Helen M. Colhoun received research support from AstraZeneca LP, Eli Lilly and Company, Novo Nordisk A/S, Pfizer, and Public Health Scotland; honoraria from Eli Lilly and Company, Novartis Pharmaceuticals, and Regeneron; served as board member/advisory panel member for Eli Lilly and Company, Novartis Pharmaceuticals, Novo Nordisk A/S, Regeneron, and Sanofi Aventis; and holds stocks/shares in Bayer AG and Roche Pharmaceuticals. John Deanfield received consulting fees from GENinCode UK Ltd; received CME honoraria and/or consulting fees from Aegerion, Amgen, Bayer, Boehringer Ingelheim, Merck, Novartis, Novo Nordisk A/S, Pfizer, Sanofi, and Takeda; and holds the following unpaid positions: Chief Medical Advisor for Our Future Health, senior advisor for Cardiovascular Disease Prevention for Public Health England, and Chair of the NHS Healthcheck Expert Scientific and Clinical Advisory Panel (ESCAP) and Review of the National Health Check Programme for Public Health England. Jorge Plutzky received consulting fees from Alnylam, Altimmune, Amgen, Esperion (clinical trial steering committee), Merck, MJ Health Lifesciences, and Novo Nordisk A/S (clinical trial steering committee) and received grant support from Boehringer Ingelheim and Novartis. Robert F. Kushner is a member of a medical advisory board for Novo Nordisk A/S. G. Kees Hobingh, Kirstine Brown‐Frandsen, Sille Esbjerg, Søren Hardt‐Lindberg, and Tea Monk Fries are employees of Novo Nordisk A/S and own stocks in the company. G. Kees Hovingh is also employed part‐time by Amsterdam UMC. Steven E. Kahn received advisory/consulting fees from Bayer, Boehringer Ingelheim, Casma Therapeutics, Eli Lilly and Company, Intarcia, Merck, Novo Nordisk A/S, Pfizer, and Third Rock Ventures. Steven P. Marso received consulting and/or honoraria from Boston Scientific, Change Healthcare, Novo Nordisk A/S, and Population Health Partners. Scott S. Emerson received consulting fees from Novo Nordisk A/S.

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