Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial

Steven P. Marso, Neil R. Poulter, Steven E. Nissen, Michael A. Nauck, Bernard Zinman, Gilbert H. Daniels, Stuart Pocock, William M. Steinberg, Richard M. Bergenstal, Johannes F E Mann, Lasse Steen Ravn, Kirstine Brown Frandsen, Alan C. Moses, John B. Buse

Research output: Contribution to journalArticle

128 Citations (Scopus)

Abstract

Background Diabetes is a multisystem disorder associated with a nearly twofold excess risk for a broad range of adverse cardiovascular outcomes including coronary heart disease, stroke, and cardiovascular death. Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with type 2 diabetes mellitus (T2DM). Study Design To formally assess the cardiovascular safety of liraglutide, the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial was commenced in 2010. LEADER is a phase 3B, multicenter, international, randomized, double-blind, placebo-controlled clinical trial with long-term follow-up. Patients with T2DM at high risk for cardiovascular disease (CVD) who were either drug naive or treated with oral antihyperglycemic agents or selected insulin regimens (human NPH, long-acting analog, or premixed) alone or in combination with oral antihyperglycemics were eligible for inclusion. Randomized patients are being followed for up to 5 years. The primary end point is the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Conclusions LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.

Original languageEnglish (US)
JournalAmerican Heart Journal
Volume166
Issue number5
DOIs
StatePublished - Nov 2013

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Type 2 Diabetes Mellitus
Cardiovascular Diseases
Hypoglycemic Agents
Myocardial Infarction
Safety
Controlled Clinical Trials
Standard of Care
Random Allocation
Liraglutide
Coronary Disease
Body Mass Index
Stroke
Placebos
Pharmaceutical Preparations
Population
Glucagon-Like Peptide Receptors
Human Isophane Insulin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Design of the liraglutide effect and action in diabetes : Evaluation of cardiovascular outcome results (LEADER) trial. / Marso, Steven P.; Poulter, Neil R.; Nissen, Steven E.; Nauck, Michael A.; Zinman, Bernard; Daniels, Gilbert H.; Pocock, Stuart; Steinberg, William M.; Bergenstal, Richard M.; Mann, Johannes F E; Ravn, Lasse Steen; Frandsen, Kirstine Brown; Moses, Alan C.; Buse, John B.

In: American Heart Journal, Vol. 166, No. 5, 11.2013.

Research output: Contribution to journalArticle

Marso, SP, Poulter, NR, Nissen, SE, Nauck, MA, Zinman, B, Daniels, GH, Pocock, S, Steinberg, WM, Bergenstal, RM, Mann, JFE, Ravn, LS, Frandsen, KB, Moses, AC & Buse, JB 2013, 'Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial', American Heart Journal, vol. 166, no. 5. https://doi.org/10.1016/j.ahj.2013.07.012
Marso, Steven P. ; Poulter, Neil R. ; Nissen, Steven E. ; Nauck, Michael A. ; Zinman, Bernard ; Daniels, Gilbert H. ; Pocock, Stuart ; Steinberg, William M. ; Bergenstal, Richard M. ; Mann, Johannes F E ; Ravn, Lasse Steen ; Frandsen, Kirstine Brown ; Moses, Alan C. ; Buse, John B. / Design of the liraglutide effect and action in diabetes : Evaluation of cardiovascular outcome results (LEADER) trial. In: American Heart Journal. 2013 ; Vol. 166, No. 5.
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abstract = "Background Diabetes is a multisystem disorder associated with a nearly twofold excess risk for a broad range of adverse cardiovascular outcomes including coronary heart disease, stroke, and cardiovascular death. Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with type 2 diabetes mellitus (T2DM). Study Design To formally assess the cardiovascular safety of liraglutide, the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial was commenced in 2010. LEADER is a phase 3B, multicenter, international, randomized, double-blind, placebo-controlled clinical trial with long-term follow-up. Patients with T2DM at high risk for cardiovascular disease (CVD) who were either drug naive or treated with oral antihyperglycemic agents or selected insulin regimens (human NPH, long-acting analog, or premixed) alone or in combination with oral antihyperglycemics were eligible for inclusion. Randomized patients are being followed for up to 5 years. The primary end point is the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Conclusions LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3{\%} were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3{\%}) patients with prior CVD and 1,748 (18.7{\%}) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.",
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AB - Background Diabetes is a multisystem disorder associated with a nearly twofold excess risk for a broad range of adverse cardiovascular outcomes including coronary heart disease, stroke, and cardiovascular death. Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with type 2 diabetes mellitus (T2DM). Study Design To formally assess the cardiovascular safety of liraglutide, the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial was commenced in 2010. LEADER is a phase 3B, multicenter, international, randomized, double-blind, placebo-controlled clinical trial with long-term follow-up. Patients with T2DM at high risk for cardiovascular disease (CVD) who were either drug naive or treated with oral antihyperglycemic agents or selected insulin regimens (human NPH, long-acting analog, or premixed) alone or in combination with oral antihyperglycemics were eligible for inclusion. Randomized patients are being followed for up to 5 years. The primary end point is the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Conclusions LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.

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