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Study · Randomized controlled trial · n = 9,901 · 2020

2 results

Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis.

Dagenais GR, Rydén L, Leiter LA, Lakshmanan M, Dyal L, Probstfield JL, Atisso CM, Shaw JE, Conget I, Cushman WC, Lopez-Jaramillo P, Lanas F and 13 more

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Munoz EGC, Pirags V, Pogosova N, Basile J, Sheu WHH, Temelkova-Kurktschiev T, Raubenheimer PJ, Keltai M, Hall S, Pais P, Colhoun HM, Riddle MC, Gerstein HC

Cardiovascular diabetology25 Nov 2020Cited by 27 (Europe PMC)

PMID33239067 (opens in a new tab)PMCIDPMC7690176 (opens in a new tab)DOI10.1186/s12933-020-01179-1 (opens in a new tab)PepBankPUB-33239067
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Summary

BackgroundThe Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years. These findings were based on a time-to-first-event analysis and preclude relevant information on the burden of total major events occurring during the trial. This analysis reports on the total cardiovascular or fatal events in the REWIND participants METHODS: We compared the total incidence of MACE or non-cardiovascular deaths, and the total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization) or non-cardiovascular deaths between participants randomized to dulaglutide and those randomized to placebo. Incidences were expressed as number per 1000 person-years. Hazard ratios (HR) were calculated using the conditional time gap and proportional means models.ResultsParticipants had a mean age of 66.2 years, 46.3% were women and 31% had previous cardiovascular disease. During the trial there were 1972 MACE or non-cardiovascular deaths and 3673 expanded MACE or non-cardiovascular deaths. The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82-0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80-0.98) p = 0.022]. The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87-0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82-0.99) p = 0.028].ConclusionsThese findings suggest that weekly subcutaneous dulaglutide reduced total cardiovascular or fatal event burden in people with type 2 diabetes at moderate cardiovascular risk.Clinical trial registrationhttps://www.clinicaltrials.gouv . Unique Identifier NCT01394952).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In diabetes patients with cardiovascular risk, dulaglutide reduced total MACE or non-cardiovascular death incidence versus placebo.

    In plain wordsIn people with diabetes and cardiovascular risk, dulaglutide reduced combined major cardiovascular events or other deaths compared with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseTotal MACE or non-cardiovascular death
    Study

    n = 9,901

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · 5.4 yearsAs given in this study (human).

    Measurements

    Event incidence
    35.8 per 1000 person-years
    dulaglutide
    Event incidence
    40.3 per 1000 person-years
    placebo
    Absolute reduction
    4.5 per 1000 person-years
    dulaglutide versus placebo
    Conditional time gap HR
    0.9 ratio
    dulaglutide versus placebo
    Proportional means HR
    0.89 ratio
    dulaglutide versus placebo

    Source sentences

    Summary
    The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82-0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80-0.98) p = 0.022].
    1 context sentence
    Summary · context
    in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In diabetes patients with cardiovascular risk, dulaglutide reduced total expanded MACE or non-cardiovascular death incidence versus placebo.

    In plain wordsIn people with diabetes and cardiovascular risk, dulaglutide reduced combined expanded cardiovascular events or other deaths compared with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseTotal expanded MACE or non-cardiovascular death
    Study

    n = 9,901

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · 5.4 yearsAs given in this study (human).

    Measurements

    Event incidence
    67.1 per 1000 person-years
    dulaglutide
    Event incidence
    74.7 per 1000 person-years
    placebo
    Absolute reduction
    7.6 per 1000 person-years
    dulaglutide versus placebo
    Conditional time gap HR
    0.93 ratio
    dulaglutide versus placebo
    Proportional means HR
    0.9 ratio
    dulaglutide versus placebo

    Source sentences

    Summary
    The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87-0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82-0.99) p = 0.028].
    1 context sentence
    Summary · context
    in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 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 postedNCT01394952

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Eli Lilly and Companyn = 9,90122 Jul 2011 to 21 Aug 2018

Cardiovascular Disease · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 8 Oct 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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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