Dapagliflozin in acute myocardial infarction with type 2 diabetes: a randomized clinical trial.

INTRODUCTION AND

OBJECTIVES

Dapagliflozin does not impact heart failure events in patients with myocardial infarction who do not have type 2 diabetes. However, its effects on patients with diabetes remain unexamined. Therefore, the main goal of this study was to assess the effect of dapagliflozin added to post-acute myocardial infarction (AMI) therapy on the occurrence of major adverse cardiovascular events (MACE), including heart failure (HF), cardiovascular death, stroke, and new acute myocardial infarction in patients with type 2 diabetes. Secondary endpoints included changes in left ventricular ejection fraction (LVEF).

METHODS

In a double-blind controlled clinical trial with an 18-month follow-up, we randomly assigned 181 patients with AMI to receive 10 mg of dapagliflozin or placebo once daily, along with standardized management. Risk analysis was conducted using both intention-to-treat and per-protocol analyses.

RESULTS

At the 18-month follow-up, the total number of heart failure events was higher in the placebo group (26 events; 29.5%) than in the dapagliflozin group (5 events; 5.3%) (HR 0.18; 95% CI, 0.40-0.85; p < 0.001). Final LVEF increased by 1.56% in the dapagliflozin group compared to placebo (p = 0.03).

CONCLUSIONS

Early initiation of dapagliflozin as part of the standard treatment for patients with acute myocardial infarction and type 2 diabetes decreases the risk of heart failure events at 18 months, improves LVEF, and remains safe even when combined with current optimal medical therapy. (ClinicalTrials.gov NCT04717986).