Effects of liraglutide on cardiovascular outcomes in patients with diabetes with or without heart failure
Open accessAbstract
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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Data from an exploratory analysis of the AMPLITUDE-O trial suggest that the efficacy and safety of efpeglenatide was independent of concurrent SGLT2 inhibitor use, including heart failure hospitalization.
“Data from an exploratory analysis of the AMPLITUDE-O trial suggest that the efficacy and safety of efpeglenatide was independent of concurrent SGLT2 inhibitor use, including HF hospitalization.546”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [546]
The AMPLITUDE-O trial, comparing efpeglenatide with placebo, showed a nominally significant benefit on hospitalization for heart failure.
“The AMPLITUDE-O trial, comparing efpeglenatide with placebo, showed a nominally significant benefit on hospitalization for HF.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [546]
In the LEADER trial, participants with prevalent heart failure experienced consistent reduction in MACE and cardiovascular and all-cause death with liraglutide compared with participants in the non-HF subgroup and showed no excess risk of HF hospitalization.
“Participants with prevalent HF experienced consistent reduction in MACE and cardiovascular and all-cause death with liraglutide compared with participants in the non-HF subgroup and showed no excess risk of HF hospitalization.32”
From Use of Glucagon-Like Peptide-1 Receptor Agonists in Patients With Type 2 Diabetes and Cardiovascular Disease: A Review (2020) · cites this paper as [32]
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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
- 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)
- 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
- 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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