Cited by 118Diabetes Treatment and ManagementHeart Failure Treatment and ManagementCardiovascular Function and Risk Factors

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Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure

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Marso, Steven P., Baeres, Florian M.M., Bain, Stephen C., Goldman, Bryan, Husain, Mansoor, Nauck, Michael A., Poulter, Neil R., Pratley, Richard E., Thomsen, Anne Bloch, Buse, John B.·2020·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2019.12.063

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Abstract

Background More data regarding effects of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes (T2D) and heart failure (HF) are required.Objectives The purpose of this study was to investigate the effects of liraglutide on cardiovascular events and mortality in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) participants, by HF history.Methods In the multinational, double-blind, randomized LEADER trial, 9,340 patients with T2D and high cardiovascular risk were assigned 1:1 to liraglutide (1.8 mg daily or maximum tolerated dose up to 1.8 mg daily) or placebo plus standard care, and followed for 3.5 to 5 years. New York Heart Association (NYHA) functional class IV HF was an exclusion criterion. The primary composite major adverse cardiovascular events outcome was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Post hoc Cox regression analyses of outcomes by baseline HF history were conducted.Results At baseline, 18% of patients had a history of NYHA functional class I to III HF (liraglutide: n = 835 of 4,668; placebo: n = 832 of 4,672). Effects of liraglutide versus placebo on major adverse cardiovascular events were consistent in patients with (hazard ratio [HR]: 0.81 [95% confidence interval (CI): 0.65 to 1.02]) and without (HR: 0.88 [95% CI: 0.78 to 1.00]) a history of HF (p interaction = 0.53). In both subgroups, fewer deaths were observed with liraglutide (HR: 0.89 [95% CI: 0.70 to 1.14] with HF; HR: 0.83 [95% CI: 0.70 to 0.97] without HF; p interaction = 0.63) versus placebo. No increased risk of HF hospitalization was observed with liraglutide, regardless of HF history (HR: 0.98 [95% CI: 0.75 to 1.28] with HF; HR: 0.78 [95% CI: 0.61 to 1.00] without HF; p interaction = 0.22). Effects of liraglutide on the composite of HF hospitalization or cardiovascular death were consistent in patients with (HR: 0.92 [95% CI: 0.74 to 1.15]) and without (HR: 0.77 [95% CI: 0.65 to 0.91]) a history of HF (p interaction = 0.19).Conclusions Based on these findings, liraglutide should be considered suitable for patients with T2D with or without a history of NYHA functional class I to III HF. (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]; NCT01179048).

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Authors: Marso, S. P., Baeres, F. M. M., Bain, S. C., Goldman, B., Husain, M., Nauck, M. A., Poulter, N. R., Pratley, R. E., Thomsen, A. B., & Buse, J. B.
Affiliations: HCA Midwest Division (US)
Novo Nordisk (Denmark) (DK)
Swansea University (GB)
Ted Rogers Centre for Heart Research (CA)
St. Josef-Hospital (DE)
Imperial College London (GB)
Translational Research Institute for Metabolism and Diabetes (US)
University of North Carolina at Chapel Hill (US)
Corresponding author: Marso, Steven P.
ORCID: Bain, Stephen C.
Husain, Mansoor
Nauck, Michael A.
Poulter, Neil R.
Pratley, Richard E.
Buse, John B.
Venue: Journal of the American College of Cardiology
Publisher: Elsevier BV
Published: 2020-03
Volume: 75
Issue: 10
Pages: 1128-1141
ISSN: 0735-1097 (ISSN-L)
DOI: 10.1016/j.jacc.2019.12.063
OpenAlex: W3009912045
Cited by: 118
References: 37
Citations by year: 2026: 17 · 2025: 22 · 2024: 25 · 2023: 17 · 2022: 12 · 2021: 17 · 2020: 8
FWCI: 10.18
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 381 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
Spiral (Imperial College London) (submittedVersion)
UNC Libraries
Funders: Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
GlaxoSmithKline
Sanofi
Boston Scientific Corporation
Cardiff University
Novo Nordisk
Servier
National Institutes of Health (UL1TR002489)
Abbott Vascular
National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108612, U54DK118612)
National Center for Advancing Translational Sciences
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
Keywords: liraglutide, GLP-1 receptor agonists, type 2 diabetes, heart failure, major adverse cardiovascular events, cardiovascular mortality, heart failure hospitalization, LEADER trial, subgroup analysis, cardiovascular risk, myocardial infarction, stroke, NYHA functional class, glycemic control, weight loss, blood pressure
MeSH terms: Liraglutide, Aged, Cardiovascular Diseases, Death, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Heart Failure, Hospitalization, Humans, Hypoglycemic Agents, Male, Middle Aged, Treatment Outcome, Internationality

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Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure

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