The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.

Gerstein HC, Hart R, Colhoun HM, Diaz R, Lakshmanan M, Botros FT, Probstfield J, Riddle MC, Rydén L, Atisso CM, Dyal L, Hall S and 17 more

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Avezum A, Basile J, Conget I, Cushman WC, Hancu N, Hanefeld M, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Muñoz EGC, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T

The lancet. Diabetes & endocrinology7 Jan 2020Cited by 96 (Europe PMC)

PMID31924562DOI10.1016/s2213-8587(19)30423-1PepBankPUB-31924562

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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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and cardiovascular risk factors, dulaglutide reduced stroke risk versus placebo.
In plain wordsIn patients with diabetes and cardiovascular risk factors, dulaglutide reduced stroke risk compared with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseStroke
Study
n = 9,901
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
0.76 ratio
stroke, dulaglutide versus placebo
Stroke events
158 participants
dulaglutide
Stroke events
205 participants
placebo
Stroke incidence
3.2%
dulaglutide
Stroke incidence
4.1%
placebo
Source sentences
Summary
158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62-0·94; p=0·010).
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456201
02HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and cardiovascular risk factors, dulaglutide reduced ischaemic stroke risk versus placebo.
In plain wordsIn patients with diabetes and cardiovascular risk factors, dulaglutide reduced blocked-vessel stroke risk compared with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseIschaemic stroke
Study
n = 9,901
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
0.75 ratio
ischaemic stroke
Source sentences
Summary
Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456202
03HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and cardiovascular risk factors, dulaglutide did not affect haemorrhagic stroke risk versus placebo.
In plain wordsIn patients with diabetes and cardiovascular risk factors, dulaglutide did not change bleeding stroke risk compared with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeHaemorrhagic stroke
Study
n = 9,901
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
1.05 ratio
haemorrhagic stroke
Source sentences
Summary
Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456203
04HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and cardiovascular risk factors, dulaglutide reduced non-fatal stroke or all-cause death versus placebo.
In plain wordsIn patients with diabetes and cardiovascular risk factors, dulaglutide reduced non-fatal stroke or death compared with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseNon-fatal stroke or all-cause death
Study
n = 9,901
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
0.88 ratio
composite
Source sentences
Summary
Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79-0·98; p=0·017) and disabling stroke (0·74, 0·56-0·99; p=0·042).
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456204
05HumanRandomized controlled trialEfficacy outcome
In patients with diabetes and cardiovascular risk factors, dulaglutide reduced disabling stroke risk versus placebo.
In plain wordsIn patients with diabetes and cardiovascular risk factors, dulaglutide reduced disabling stroke risk compared with placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDisabling stroke
Study
n = 9,901
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Measurements
Hazard ratio
0.74 ratio
disabling stroke
Source sentences
Summary
Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79-0·98; p=0·017) and disabling stroke (0·74, 0·56-0·99; p=0·042).
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456205
06HumanRandomized controlled trialEfficacy outcome
In patients with diabetes who had stroke, disability did not differ between dulaglutide and placebo groups.
In plain wordsIn patients with diabetes who had stroke, disability was similar with dulaglutide and placebo.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeDisability after stroke
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
1.5 mg weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The degree of disability after stroke did not differ by treatment group.
4 context sentences(design, population, supporting numbers)
Summary · context
REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries.
Summary · context
Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide).
Summary · context
Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952).
Summary · context
During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated.
Report a problemFND-3192456206

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 page ClinicalTrials.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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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