Dapagliflozin in Patients With Myocardial Infarction - DAPA-MI

Nov 11, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
AstraZeneca
Date Presented:
11/11/2023
Date Published:
11/11/2023
Original Posted Date:
11/11/2023
References

Contribution To Literature:

The DAPA-MI trial showed that dapagliflozin use among patients with acute MI without a history of DM or chronic HF has better cardiometabolic outcomes compared with placebo, with no difference in cardiovascular outcomes.

Description:

The goal of the trial was to assess the safety and efficacy of dapagliflozin in improving cardiometabolic outcomes among patients with acute myocardial infarction (MI) without heart failure (HF) or diabetes mellitus (DM).

Study Design

Clinically stable and eligible patients were randomized in a 1:1 fashion to either dapagliflozin 10 mg daily (n = 2,019) or placebo (n = 1,998). Usual care was pursued in both arms.

  • Total number of enrollees: 4,017
  • Duration of follow-up: 24 months
  • Mean patient age: 63 years
  • Percentage female: 20%

Inclusion criteria:

  • MI (non–ST-segment elevation MI [NSTEMI] or STEMI) <10 days
  • Impaired left ventricular (LV) systolic function or Q-wave MI
  • Hemodynamically stable

Exclusion criteria:

  • Type 1 or type 2 DM
  • Chronic symptomatic HF with a prior HF hospitalization within the last year and known reduced ejection fraction (EF) (LVEF ≤40%)
  • Estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2

Other salient features/characteristics:

  • Mean eGFR: 83.5 mL/min/1.73 m2
  • Baseline LVEF: <30%, 6.5%; 30-49%, 67%
  • Medications: angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker: 92%; beta-blocker: 89%
  • STEMI: 72%
  • Baseline glycated hemoglobin: 5.7%

Principal Findings:

The primary endpoint (hierarchical composite of death, HF hospitalization, nonfatal MI, atrial fibrillation/flutter event, type 2 DM, New York Heart Association [NYHA] class, weight decrease of ≥5%) for dapagliflozin vs. placebo, was: win ratio 1.34, 95% confidence interval [CI] 1.20-1.50 (p < 0.001).

Secondary outcomes for dapagliflozin vs. placebo:

  • Key secondary endpoint (hierarchical composite of death, HF hospitalization, nonfatal MI, atrial fibrillation/flutter event, type 2 DM, NYHA class): win ratio 1.20, 95% CI 1.04-1.40 (p = 0.015)
  • Major adverse cardiovascular events (MI, stroke, death): 3.4% vs. 3.6% (p > 0.05)
  • Cardiovascular death/hospitalization for HF/MI: 4.1% vs. 4.3% (p > 0.05)
  • All-cause mortality: 2.0% vs. 1.7% (p > 0.05)
  • New diagnosis of type 2 DM: 2.1% vs. 3.9%, hazard ratio 0.53, 95% CI 0.36-0.77
  • Change in body weight: –1.65 kg, 95% CI –2.12 to –1.18

Interpretation:

The results of this trial indicate that dapagliflozin use among patients with acute MI without a history of DM or chronic HF has better cardiometabolic outcomes compared with placebo. Cardiovascular outcomes including hospitalization for HF were similar but patients on dapagliflozin were less likely to develop diabetes and experienced a weight loss of 1.65 kg over approximately 2 years of follow-up. This is despite approximately 75% of the population having an EF of <50% in the acute setting. These are helpful findings and extend previous findings from SGLT2 inhibitor use among patients with HF or chronic kidney disease (with or without DM). Based on this trial, in an acute coronary syndrome population, the cardiovascular benefits appear limited.

References:

James S, Erlinge D, Storey RF, et al., on behalf of the DAPA-MI Investigators. Dapagliflozin in Myocardial Infarction Without Diabetes or Heart Failure. NEJM Evid 2023;Nov 11:[Epub ahead of print].

Presented by Dr. Stefan James at the American Heart Association Scientific Sessions, Philadelphia, PA, November 11, 2023.

Clinical Topics: Acute Coronary Syndromes

Keywords: Acute Coronary Syndrome, AHA23, GLP-1 Receptor


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