Empagliflozin did not reduce mortality for HF after MI regardless of T2D status

A subtype analysis of the EMPACT-MI trial showed that patients with type 2 diabetes (T2D) face a higher risk of all-cause mortality at 3 months following acute myocardial infarction (MI). Empagliflozin did not reduce mortality when started after acute MI but was associated with lower rates of heart failure (HF) hospitalisation, irrespective of T2D status. There were no unexpected safety signals.

In the double-blind, placebo-controlled EMPACT-MI trial (NCT04509674), participants with acute non-STEMI or non-STEMI at high risk of HF, defined as signs or symptoms of congestion requiring treatment during hospitalisation or a new reduction in left ventricular ejection fraction to <45%, and at least 1 HF risk factor were randomised to the SGLT2 inhibitor empagliflozin (n=3,260) or placebo (n=3,262) [1]. Over 17.9 months, the primary endpoint of HF hospitalisation or death from any cause occurred in 8.2% of the empagliflozin group and 9.1% of the placebo group with no significant difference between groups (HR 0.90; 95% CI 0.76–1.06). However, empagliflozin was associated with a lower rate of HF hospitalisations compared with placebo (3.6% vs 4.7%, respectively; HR 0.77; 95% CI 0.60–0.98) as a hypothesis generating outcome despite the overall neutral primary endpoint. There was no significant treatment effect for all-cause mortality (HR 0.96; 95% CI 0.78­–1.19).

The pre-specified subtype analysis of the EMPACT-MI data presented by Prof. Javed Butler (University of Mississippi, MI, USA) evaluated whether T2D status influences the risk of HF hospitalisation or overall survival following MI [2]. For participants with T2D (n=1,085) in the placebo group, this risk was found to be elevated versus those without T2D (n=999) at 3 months post-MI (HR 1.44; 95% CI 1.06–1.95; see Figure). The risk of all-cause mortality was significantly higher in the T2D group: HR 1.70 (95% CI 1.13–2.56). The risk for first HF hospitalisation was elevated in the T2D group (HR 1.22; 95% CI 0.82–1.83), but the difference was not significant. The heightened mortality risk in T2D patients became apparent after 3 months, and the increased risk of HF hospitalisation was apparent at 6 months.

Figure: Time to first HF hospitalisation or all-cause mortality [2]



*Versus no T2D.CI, confidence interval; HR, hazard ratio; T2D, type 2 diabetes.

Empagliflozin did not reduce mortality when initiated after acute MI, irrespective of T2D status. Empagliflozin reduced HF hospitalisation following acute MI regardless of T2D status. There were no unexpected safety signals in patients with T2D.

1. 
   
   1. Butler J, et al. N Engl J Med 2024;390:1455–66.
   2. Butler J, et al. The effect of empagliflozin after acute myocardial infarction in patients with and without diabetes: a pre-specified analysis of the EMPACT-MI trial. Late breaking clinical trials: drugs and disease management, Heart Failure 2024, 11–14 May, Lisbon, Portugal.

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Posted on 16 July 202416 July 2024