REWIND
Trial question
What is the role of dulaglutide in middle-aged and older patients with T2DM with either previous CVD or cardiovascular risk factors?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 9901
9901 patients (4589 female, 5312 male).
Inclusion criteria: patients aged ≥ 50 years with T2DM who had either a previous cardiovascular event or cardiovascular risk factors.
Key exclusion criteria: eGFR < 15 mL/min/1.73 m²; cancer in the previous 5 years; severe hypoglycemia in the previous year, life expectancy < 1 year; coronary or cerebrovascular event within the previous 2 months; plans for revascularization.
Interventions
N=4949 dulaglutide (weekly subcutaneous injection of 1.5 mg).
N=4952 placebo (matching placebo).
Primary outcome
First occurrence of nonfatal MI, nonfatal stroke, or CV death
12%
13.4%
13.4 %
10.1 %
6.7 %
3.4 %
0.0 %
Dulaglutide
Placebo
Significant
decrease ▼
NNT = 71
Significant decrease in first occurrence of nonfatal MI, nonfatal stroke, or CV death (12% vs. 13.4%; HR 0.88, 95% CI 0.79 to 0.99).
Secondary outcomes
No significant difference in MI (4.5% vs. 4.7%; HR 0.96, 96% CI 0.79 to 1.15).
Significant decrease in stroke (3.2% vs. 4.1%; HR 0.76, 95% CI 0.62 to 0.94).
No significant difference in all-cause mortality (10.8% vs. 12%; HR 0.9, 95% CI 0.8 to 1.01).
Safety outcomes
No significant differences in serious adverse events, serious gastrointestinal events, severe hypoglycemia, cancers, pancreatitis.
Significant difference in gastrointestinal adverse event during follow-up (47.4% vs. 34.1%).
Conclusion
In patients aged ≥ 50 years with T2DM who had either a previous cardiovascular event or cardiovascular risk factors, dulaglutide was superior to placebo with respect to first occurrence of nonfatal MI, nonfatal stroke, or CV death.
Reference
Hertzel C Gerstein, Helen M Colhoun, Gilles R Dagenais et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130.
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