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Dulaglutide and cardiovascular and heart failure outcomes in patients with and without heart failure: a post-hoc
Kelley R H Branch1, Gilles R Dagenais2, Alvaro Avezum3
1University of Washington Heart Institute, Seattle, WA, USA.
Insights
Dulaglutide did not reduce heart failure events in people with type 2 diabetes. This glucagon-like peptide-1 agonist showed no significant benefit for cardiovascular outcomes in the REWIND trial.
Area of Science:
- Cardiology
- Endocrinology
- Diabetes Mellitus Research
Background:
- People with diabetes face a high risk of cardiovascular events, including heart failure (HF).
- Glucagon-like peptide-1 (GLP-1) agonists are used to manage type 2 diabetes and have shown cardiovascular benefits.
- The REWIND trial investigated the effects of dulaglutide on cardiovascular outcomes in patients with type 2 diabetes.
Purpose of the Study:
- To evaluate the efficacy of dulaglutide in preventing incident heart failure (HF) events.
- To assess the impact of dulaglutide on major adverse cardiovascular events (MACE) and HF in patients with and without pre-existing HF.
- To analyze cardiovascular outcomes in the context of type 2 diabetes management with dulaglutide.
Main Methods:
- A post-hoc analysis of the randomized, placebo-controlled REWIND trial involving 9901 participants.
- Dulaglutide treatment was compared against placebo over a median follow-up of 5.4 years.
- Heart failure events were defined as adjudicated hospitalizations or urgent evaluations for HF; MACE included non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death.
Main Results:
- No significant reduction in HF events was observed with dulaglutide compared to placebo (HR 0.93, 95% CI 0.77-1.12; p=0.456).
- Dulaglutide did not alter MACE or HF events in participants with baseline HF compared to those without (p=0.44 and p=0.19 for interaction).
- A marginal reduction in combined cardiovascular death and HF events was noted (HR 0.88, 95% CI 0.78-1.00; p=0.050), but this was not significant based on baseline HF status.
Conclusions:
- Dulaglutide treatment did not demonstrate a significant reduction in heart failure events in patients with type 2 diabetes over 5.4 years.
- The effect of dulaglutide on HF events was consistent regardless of whether participants had pre-existing heart failure.
- The study suggests dulaglutide may not be a primary intervention for preventing incident heart failure in this population.
Aims:
People with diabetes are at high risk for cardiovascular events including heart failure (HF). We examined the effect of the glucagon-like peptide 1 agonist dulaglutide on incident HF events and other cardiovascular outcomes in those with or without prior HF in the randomized placebo-controlled Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
Methods And Results:
The REWIND major adverse cardiovascular event (MACE) outcome was the first occurrence of a composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes). In this post-hoc analysis, a HF event was defined as an adjudication-confirmed hospitalization or urgent evaluation for HF. Of the 9901 participants studied over a median follow-up of 5.4 years, 213/4949 (4.3%) randomly assigned to dulaglutide and 226/4952 (4.6%) participants assigned to placebo experienced a HF event (hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.77-1.12; p = 0.456). In the 853 (8.6%) participants with HF at baseline, there was no change in either MACE or HF events with dulaglutide as compared to participants without HF (p = 0.44 and 0.19 for interaction, respectively). Combined cardiovascular death and HF events were marginally reduced with dulaglutide compared to placebo (HR 0.88, 95% CI 0.78-1.00; p = 0.050) but unchanged in patients with and without HF at baseline (p = 0.31).
Conclusions:
Dulaglutide was not associated with a reduction in HF events in patients with type 2 diabetes regardless of baseline HF status over 5.4 years of follow-up.
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