A global study led by Mount Sinai researchers reveals that the SGLT2 inhibitor empagliflozin is safe and effective for patients hospitalized with acute myocardial infarction (MI), offering kidney-protective benefits. The findings, a secondary analysis of the EMPACT-MI trial, were presented at the European Society of Cardiology Congress and address concerns about using SGLT2 inhibitors in post-MI patients due to potential kidney injury risks.
Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital, emphasized the importance of this research, noting that approximately 40% of acute MI patients have chronic kidney disease. The study demonstrates that empagliflozin not only reduces heart failure events but also protects kidney function, as indicated by a reduced decline in eGFR compared to placebo.
EMPACT-MI Trial Details
The EMPACT-MI trial involved 6,522 patients with acute MI and increased heart failure risk. Participants were randomized to receive either empagliflozin 10 mg or a placebo, in addition to standard care, within 14 days of hospital admission for a heart attack. The trial excluded patients with a history of chronic heart failure but included those with type 2 diabetes and chronic kidney disease.
Key Findings on Kidney Function
Researchers found that empagliflozin exhibited kidney-protective effects by reducing the decline in eGFR (estimated glomerular filtration rate) compared to placebo. At 24 months, patients receiving empagliflozin showed stable eGFR compared to baseline, while the placebo group experienced a decline. This benefit was consistent regardless of the patient's initial kidney function.
Impact on Heart Failure Outcomes
While the trial showed no difference in the risk of death, empagliflozin significantly reduced the risk of hospitalization for heart failure and adverse heart failure events. These risk reductions were consistent across varying levels of baseline kidney function.
Safety Profile
The study also addressed safety concerns, revealing that adverse event rates were similar between the empagliflozin and placebo groups within 30 days of the initial drug intake. These rates remained consistent irrespective of baseline kidney function, systolic blood pressure, and concomitant medical therapies affecting kidney function.
Clinical Implications
Dr. Bhatt stated that the EMPACT-MI trial fills a crucial gap in understanding the clinical use of SGLT2 inhibitors in post-heart attack patients. By confirming the safety and efficacy of empagliflozin early after a heart attack, the findings have significant implications for treating a vulnerable population of cardiovascular disease patients worldwide.
The EMPACT-MI clinical trial was conducted, analyzed, and reported by Boehringer Ingelheim in partnership with the Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim and Lilly providing funding. The primary results of the EMPACT-MI trial had been presented at the Annual Scientific Session of American College of Cardiology, Apr 06-08, 2024, Atlanta and published in The New England Journal of Medicine.
