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POSTER SESSION #4

(P173) ONCE-WEEKLY SEMAGLUTIDE IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION, OBESITY AND TYPE 2 DIABETES: MAIN RESULTS FROM THE STEP-HFPEF DM TRIAL

Friday, October 25, 2024
1:30 PM – 2:00 PM PT
Location: BOARD 70

    Presenting Author(s)

  • Justin Ezekowitz, MBBCh MSc

    Professor of Medicine, Division of Cardiology, University of Alberta
    UNIVERSITY OF ALBERTA
    University of Alberta
    Edmonton, Alberta, Canada

    • Co-Author(s)

  • MK

    Mikhail N. Kosiborod, n/a

    Department of Cardiovascular Disease, Saint Luke’s Mid America Heart Institute
    University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
    Kansas City, Missouri, United States

  • Mark C. Petrie, n/a

    School of Cardiovascular and Metabolic Health,
    University of Glasgow, Glasgow, UK
    University of Glasgow
    Glasgow, Scotland, United Kingdom

  • BB

    Barry A. Borlaug, n/a

    Department of Cardiovascular Medicine
    Mayo Clinic, 200 First Street SW, Rochester, MN 55902, USA
    Rochester, Minnesota, United States

  • JB

    Javed Butler, n/a

    Department of Medicine
    University of Mississippi, Jackson, MS, USA, Baylor Scott and White Research Institute, Dallas, TX,
    Jackson, Mississippi, United States

  • MD

    Melanie J. Davies, n/a

    Diabetes Research Centre
    University of Leicester, Leicester, UK; NIHR Leicester Biomedical Research Centre, Leicester, UK
    Leicester, England, United Kingdom

  • GH

    G Kees Hovingh, n/a

    Novo Nordisk A/S
    Søborg, Denmark
    Søborg, Hovedstaden, Denmark

  • DK

    Dalane W. Kitzman, n/a

    Department of Cardiovascular Medicine and Section on Geriatrics and Gerontology
    , Wake Forest School of Medicine, Winston-Salem, NC, USA
    Winston-Salem, North Carolina, United States

  • DV

    Daniél Vega Møller, n/a

    Novo Nordisk A/S,
    Søborg, Denmark
    Søborg, Hovedstaden, Denmark

  • MB

    Marianne Bach Treppendahl, n/a

    Novo Nordisk A/S
    Søborg, Denmark
    Søborg, Hovedstaden, Denmark

  • Subodh Verma, MD PhD FRCSC FAHA FCCS FCAHS (he/him/his)

    Cardiac Surgeon
    St. Michael's Hospital
    University of Toronto
    Toronto, Ontario, Canada

  • TJ

    Thomas Jon Jensen, n/a

    Novo Nordisk A/S
    Søborg, Denmark
    Søborg, Hovedstaden, Denmark

  • KL

    Karoline Liisberg, n/a

    Novo Nordisk A/S,
    Søborg, Denmark
    Søborg, Hovedstaden, Denmark

  • ML

    Marie L. Lindegaard, n/a

    Novo Nordisk A/S,
    Søborg, Denmark
    Søborg,, Hovedstaden, Denmark

  • SS

    Sanjiv J. Shah, n/a

    Division of Cardiology, Department of Medicine
    Northwestern University Feinberg School of Medicine, Chicago, IL, USA
    Chicago, Illinois, United States

Disclosure(s):
Justin Ezekowitz, MBBCh MSc: No relevant disclosure to display
Subodh Verma, MD PhD FRCSC FAHA FCCS FCAHS: No relevant disclosure to display


Background: Obesity and type 2 diabetes (T2D) are highly prevalent in people who have heart failure with preserved ejection fraction (HFpEF) and associated with an especially high burden of symptoms and functional impairment. There are no approved therapies that specifically target obesity-related HFpEF in people with T2D.

METHODS AND RESULTS: In this double-blind trial, we randomized 616 participants across 108 sites in 16 countries with HFpEF, body mass index (BMI) of ≥30 kg/m2, and T2D to once-weekly semaglutide 2.4 mg or placebo for 52 weeks. Dual primary endpoints were change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and body weight. Confirmatory secondary endpoints were change in 6-minute walk distance (6MWD), hierarchical composite (death, HF events, and change in KCCQ-CSS and 6MWD) and change in C-reactive protein. Exploratory endpoints included N-terminal pro-b-type natriuretic peptide (NT-proBNP) and adjudicated HF events. Overall, 44% were female, median age was 69 years, median BMI was 36.9 kg/m2, KCCQ-CSS 59.4 points, 6MWD 280 meters, NT-proBNP 493 pg/mL, and left ventricular ejection fraction (LVEF) 56%. Most participants were treated with diuretics; 32.5% received mineralocorticoids receptor antagonists (MRAs) and 32.8% sodium glucose cotransporter-2 inhibitors (SGLT2is) (Table). The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P< 0.001), and the mean percentage change in body weight was −9.8% with semaglutide and −3.4% with placebo (estimated difference, −6.4 percentage points; 95% CI, −7.6 to −5.2; P< 0.001) (Figure). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group.

Conclusion: STEP-HFpEF DM (Semaglutide Treatment Effect in Patients with Obesity and HFpEF with Diabetes) randomized people with obesity-related HFpEF and T2D who have marked symptomatic and functional impairment and will determine whether semaglutide can improve symptoms, physical limitations and exercise function in this group with a need for additional therapies.