EMPACT-MI Phase 3 Clinical Trial Data. Presented at the 2024 American College of Cardiology meeting. New England Medical Journalfound that empagliflozin (Jardiance, Boehringer Ingelheim) compared with placebo had a 10% relative risk reduction in the primary composite endpoint of first hospitalization for heart failure, but this was not statistically significant. did not reach significance.¹

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Empagliflozin is a once-daily, orally administered, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. Notably, it is the first type 2 diabetes drug in several countries to include cardiovascular mortality risk reduction data on the label for individuals with type 2 diabetes and cardiovascular disease.²

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

“These results add to the body of evidence across six clinical trials that have tested empagliflozin’s potential to achieve reductions in hospitalizations for heart failure in a wide range of populations, including patients with chronic heart failure, chronic kidney disease, and/or type 2 diabetes. ,” Karinne Brouillon, head of human medicine at Boehringer Ingelheim, said in a news release. “We remain committed to improving outcomes for people and their families affected by interconnected cardiovascular, renal and metabolic diseases.”²

Specifically, heart failure occurs when the heart cannot provide enough circulation to the body, or when it requires an increase in blood volume, causing congestion in the lungs and peripheral tissues. Heart failure affects more than 15 million people in Europe and Europe and more than 60 million people worldwide, and this number is expected to increase as the population ages. Approximately half of people with heart failure do not have diabetes, but it is highly prevalent in people with diabetes.²

The EMPACT-MI study compared empagliflozin 10 mg, given once a day in addition to standard treatment, to a placebo in more than 6,500 adults who had been hospitalized for a heart attack within 14 days. The primary endpoint was a composite of time to first hospitalization for heart failure or all-cause mortality up to 26 months. Individuals enrolled in this study had no chronic medical history 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, for an incidence of 5.9 and 6.6. Met. each per 100 patient-years. First hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and 153 patients (4.7%) in the placebo group (hazard ratio 0.77, 95% CI, 0.60-0.98) and was due to any cause. There were 169 deaths. 178 (5.2%) and 178 (5.5%), respectively (HR 0.96, 95% CI, 0.78-1.19).¹

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

Despite EMPACT-MI’s primary composite endpoint not meeting statistical significance, researchers said they remained positive about the EMPOWER clinical program overall.

“Despite remarkable advances in treatment, heart attack remains the most common cause of heart failure,” Jeff Emick, MD, Lilly senior vice president of product development, said in a 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, for adults with chronic heart failure, empagliflozin can reduce the risk of cardiovascular death and heart failure.” It has proven to be an important treatment that reduces the risk of hospitalization and has the potential to meet the needs of millions of people around the world.”²

References

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

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