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Study · Randomized controlled trial · 2020

8 results

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

Marso SP, Baeres FMM, Bain SC, Goldman B, Husain M, Nauck MA, Poulter NR, Pratley RE, Thomsen AB, Buse JB

Journal of the American College of Cardiology1 Mar 2020Cited by 90 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and a history of heart failure, liraglutide did not significantly reduce major adverse cardiovascular events versus placebo (HR 0.81, 95% CI 0.65 to 1.02).

    In plain wordsIn people with type 2 diabetes and heart failure, liraglutide did not clearly lower major heart events compared with placebo.

    Outcome
    No significant changeMACE, with heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.81 HR
    with heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and no history of heart failure, the hazard ratio for major adverse cardiovascular events with liraglutide versus placebo was 0.88 (95% CI 0.78 to 1.00), a borderline result.

    In plain wordsIn people with type 2 diabetes and no heart failure, liraglutide gave a borderline lower risk of major heart events than placebo.

    Outcome
    No significant changeMACE, without heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.88 HR
    without heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and a history of heart failure, fewer deaths were observed with liraglutide than placebo, but the difference was not significant (HR 0.89, 95% CI 0.70 to 1.14).

    In plain wordsIn people with type 2 diabetes and heart failure, there were fewer deaths with liraglutide than with placebo, but the difference was not clear.

    Outcome
    No significant changeDeaths, with heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.89 HR
    with heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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.
    1 context sentence
    Summary · context
    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.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and no history of heart failure, liraglutide was linked to fewer deaths than placebo (HR 0.83, 95% CI 0.70 to 0.97).

    In plain wordsIn people with type 2 diabetes and no heart failure, liraglutide was linked to fewer deaths than placebo.

    Outcome
    DecreaseDeaths, without heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.83 HR
    without heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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.
    1 context sentence
    Summary · context
    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.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes and a history of heart failure, liraglutide did not increase the risk of heart failure hospitalization versus placebo (HR 0.98, 95% CI 0.75 to 1.28).

    In plain wordsIn people with type 2 diabetes and heart failure, liraglutide did not raise the risk of hospital stays for heart failure compared with placebo.

    Outcome
    No significant changeHeart failure hospitalization, with heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.98 HR
    with heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes and no history of heart failure, liraglutide did not increase the risk of heart failure hospitalization versus placebo (HR 0.78, 95% CI 0.61 to 1.00).

    In plain wordsIn people with type 2 diabetes and no heart failure, liraglutide did not raise the risk of hospital stays for heart failure compared with placebo.

    Outcome
    No significant changeHeart failure hospitalization, without heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.78 HR
    without heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and a history of heart failure, liraglutide did not significantly reduce the composite of heart failure hospitalization or cardiovascular death versus placebo (HR 0.92, 95% CI 0.74 to 1.15).

    In plain wordsIn people with type 2 diabetes and heart failure, liraglutide did not clearly lower heart failure hospital stays or heart deaths compared with placebo.

    Outcome
    No significant changeHeart failure hospitalization or cardiovascular death, with heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.92 HR
    with heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes and no history of heart failure, liraglutide was linked to a lower risk of heart failure hospitalization or cardiovascular death than placebo (HR 0.77, 95% CI 0.65 to 0.91).

    In plain wordsIn people with type 2 diabetes and no heart failure, liraglutide was linked to fewer heart failure hospital stays or heart deaths than placebo.

    Outcome
    DecreaseHeart failure hospitalization or cardiovascular death, without heart failure history
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.8 mg daily or maximum tolerated dose up to 1.8 mg daily · 3.5 to 5 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.77 HR
    without heart failure history, liraglutide vs placebo

    Source sentences

    Summary
    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).
    1 context sentence
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01179048

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

Novo Nordisk A/Sn = 9,34131 Aug 2010 to 17 Dec 2015

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 17 Jul 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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