Pharmaceutical Technology

ACC 24: EMPACT-MI study fails to meet primary endpoint

Data from this study demonstrating improvement in HF hospitalisation rates is consistent with studies in populations using SGLT-2Is in T2D and CKD.

At the American College of Cardiology (ACC)’s 73rd Annual Scientific Session in April 2024, the results of Eli Lilly and Boehringer Ingelheim’s Phase III EMPACT-MI trial, which examined patients treated with sodium-glucose co-transporter-2 inhibitor (SGLT-2I) empagliflozin (Jardiance) following a heart attack, have been reported.

Butler and colleagues presented data from EMPACT-MI that investigated the safety and efficacy of empagliflozin in 6,000 patients with acute myocardial infarction (AMI). However, the treatment with empagliflozin did not impact the study’s primary endpoint of a combination of heart failure and hospitalisation and all-cause mortality. Empagliflozin has previously been identified to improve cardiovascular (CV) outcomes in patients with heart failure (HF), patients with type 2 diabetes (T2D) who have high CV risk, and patients with chronic kidney disease (CKD).

Key opinion leaders interviewed by GlobalData have increasingly stated the need for therapies that address both T2D and HF, and additional comorbidities such as CKD and SGLT-2I therapies have strong clinical data to support improved outcomes for patients with these cardio-metabolic disorders. It is likely that the market share for empagliflozin across the T2D, HF and CKD space will increase in direct competition with the other market-leading SGLT-2I, AstraZeneca’s dapagliflozin (Farxiga).

In EMPACT-MI, a total of 3,260 patients received empagliflozin and a further 3,262 were in the placebo group. The median follow-up period was 17.9 months, during which a first hospitalisation for HF or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events respectively per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; p=0.21). In reporting the individual components of the primary endpoint, Butler and colleagues stated that the first hospitalisation for HF occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19).

The potential for SGLT-2I therapies to treat HF remains significantly promising

For patients with an increased risk of HF after AMI, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalisation for HF or all-cause mortality (the primary endpoint). However, improvement was seen in HF hospitalisation rates when tracked individually, with patients 23% less likely to be hospitalised for HF for the first time and 33% less likely to experience any HF hospitalisation and all-cause mortality.

The potential for SGLT-2I therapies to treat HF with or without T2D remains significantly promising and the data from this study demonstrating improvement in HF hospitalisation rates is consistent with studies in populations using SGLT-2Is in T2D and CKD. An unmet need remains in the HF space, to reduce the risk of new-onset HF and other common complications after an MI and it has been found that in chronic HF, Jardiance reduces the risk of CV death and HF hospitalisation.