Empagliflozin Shows 10% Relative Risk Reduction in Time to First Hospitalization Due to Heart Failure

Data from the EMPACT-MI phase 3 clinical trial, presented at the 2024 American College of Cardiology meeting and published in The New England Journal of Medicine, found that empagliflozin (Jardiance; Boehringer Ingelheim) showed a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure compared with placebo, although this did not reach statistical significance.¹

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Empagliflozin is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. Notably, it is the first type 2 diabetes medication that includes cardiovascular death risk reduction data for individuals with type 2 diabetes and cardiovascular disease in its label in several countries.²

The EMPACT-MI trial is part of the EMPOWER program, which is investigating empagliflozin on major patient outcomes in cardiovascular, rental, and metabolic diseases including type 2 diabetes, chronic heart failure, heart attack, and chronic kidney disease. Cumulatively, more than 1 billion individually worldwide live with these conditions, which are a leading cause of death.²

“These results add to the body of evidence, across 6 clinical trials, which examined empagliflozin’s potential to achieve reductions in hospitalization due to heart failure in a broad population, including those with chronic heart failure, chronic kidney disease, and/or type 2 diabetes,” said Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim, in a news release. “We continue to be fully committed to improving outcomes for people and families impacted by interconnected cardiovascular, renal, and metabolic diseases.”²

Heart failure, specifically, occurs when the heart cannot supply enough circulation to the body, or when doing so requires increased blood volume and leads to congestion in the lungs and peripheral tissues. Heart failure impacts more than 15 million individuals and Europe and more than 60 million patients worldwide and is expected to increase as the population ages. It is highly prevalent in individuals with diabetes, although approximately half of patients with heart failure do not have diabetes.²

The EMPACT-MI trial investigated empagliflozin 10 mg compared with placebo, administered once daily in addition to standard of care, in more than 6500 adults within 14 days of hospital admission for heart attack. The primary endpoint was the composite of time to first hospitalization due to heart failure or all-cause mortality up to 26 months. Individuals enrolled in the study had no history of chronic history failure and were eligible regardless of type 2 diabetes and chronic kidney disease status.¹

During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 8.2% of patients in the empagliflozin group, compared with 9.1% in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years. A first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and 153 patients (4.7%) in the placebo group (HR 0.77; 95% CI, 0.60-0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (HR 0.96; 95% CI, 0.78-1.19).¹

Adverse events were consistent with the known safety profile of empagliflozin. They were similar in both the empagliflozin and placebo groups.¹

Despite its failure to meet statistical significance in the primary composite endpoint in EMPACT-MI, investigators said they remain positive about the overall EMPOWER clinical program.

“Despite remarkable advances in treatment, heart attack remains the most common cause of heart failure,” said Jeff Emmick, MD, PhD, senior vice president of Product Development and Lilly, in the news release. “There is still an unmet need to reduce the risk of new onset heart failure and other common complications after a heart attack. However, in adults who have chronic heart failure, empagliflozin has proven to be an important therapy for reducing the risk of cardiovascular death and heart failure hospitalizations, and has the potential to meet the needs of millions of people worldwide.”²

References

1. Butler J, Jones WS, Udell JA, Anker SD, et al. Empagliflozin after acute myocardial infarction. N Engl J Med. 2024. doi:10.1056/NEJMoa2314051

2. Results announced from EMPACT-MI phase 3 trial investigating the effect of Jardiance (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack. News release. Boehringer Ingelheim. April 6, 2024. Accessed April 8, 2024. https://www.boehringer-ingelheim.com/human-health/heart-diseases/results-jardiance-empact-mi-phase-iii-trial