Phase III Trial Data Show Jardiance Falls Short of Statistical Significance in Reducing Risk of Heart Failure Hospitalization, Death Following Heart Attack
In the EMPACT-MI trial, Jardiance produced a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization for heart failure or all-cause mortality.
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Findings from the Phase III EMPACT-MI trial show that compared with placebo, patients administered Jardiance (empagliflozin; Boehringer Ingelheim and Eli Lilly and Company) achieved a 10% relative risk reduction in the trial’s primary composite endpoint of time to first hospitalization for heart failure (HF) or all-cause mortality, which did not reach statistical significance. Jardiance, a sodium glucose cotransporter-2 (SGLT2) inhibitor, has been shown to reduce the risk of cardiovascular death (CVD) or hospitalization for HF in patients with chronic HF with reduced left ventricular ejection fraction. Further, Jardiance has been found to reduce the risk of CVD or hospitalization for HF in patients with chronic HF with a preserved left ventricular ejection fraction.2
“These results add to our understanding of SGLT2 inhibitors and contribute to the body of evidence across six clinical studies examining the potential for Jardiance to impact major outcomes in a broad population of adults with heart failure, chronic kidney disease or type 2 diabetes,” Mohamed Eid, MD, MSc, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolic Medicine, Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “Building on this strong foundation, we remain committed to leading efforts aimed at increasing awareness, generating real-world evidence and advancing care for people affected by interconnected cardiovascular, renal and metabolic diseases.”1
Jardiance has previously been approved to lower the risk of CVD and hospitalization in adults with HF; to lower the risk of further worsening of kidney disease, end-stage kidney disease, death from CVD, and hospitalization in adults with chronic kidney disease; to lower the risk of CVD in adults with type 2 diabetes with known cardiovascular disease; and to reduce blood sugar in conjunction with diet and exercise in patients aged 10 years older with type 2 diabetes.
In the multicenter, randomized, parallel group, double-blind, placebo-controlled EMPACT-MI superiority trial, investigators evaluated Jardiance at a dose of 10 mg administered once daily along with standard of care, in more than 6,500 adult patients within 14 days of being admitted to the hospital for a heart attack. The trial’s primary endpoint was composite of time to first hospitalization for HF or all-cause mortality up to 26 months. Enrollment criteria included no history of chronic HF and eligibility regardless of type 2 diabetes and chronic kidney disease status.
Trial data show that compared to placebo, patients administered Jardiance had a relative risk reduction of 23% for time to first hospitalization for HF and 33% for total hospitalizations for HF.
"Despite remarkable advances in treatment, heart attack remains the most common cause of heart failure,” Jeff Emmick, MD, PhD, senior vice president, Product Development, Lilly, said in a press 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, Jardiance 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."1
References
1. Results announced from EMPACT-MI phase III trial investigating the effect of Jardiance® (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack. Eli Lilly. News release. April 6, 2024. Accessed April 8, 2024. https://investor.lilly.com/news-releases/news-release-details/results-announced-empact-mi-phase-iii-trial-investigating-effect
2. Kosiborod MN, Angermann CE, Collins SP, et al. Effects of empagliflozin on symptoms, physical limitations and quality of life in patients hospitalized for acute heart failure - results from the EMPULSE trial. Circulation. Published online April 4, 2022. Accessed April 8, 2024. doi:10.1161/ CIRCULATIONAHA.122.059725
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