SGLT2 Inhibitor Empagliflozin Treatment Stabilizes Kidney Function in Patients Who Have Had a Heart Attack
Mount Sinai-led study demonstrates kidney benefits of drug used in diabetes and heart failure
Journal: Nature Cardiovascular Research – June 13 Online Issue
Author: Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai
Title: Secondary analysis of the EMPACT-MI Trial Reveals Cardiovascular-Kidney Efficacy and Safety of Empagliflozin After Acute Myocardial Infarction
Bottom line of study: SGLT2 inhibitors have become a major drug used to treat diabetes, heart failure, and chronic kidney disease. However, there have been questions as to whether it is safe to use these drugs in patients after recent heart attack due to concerns about harming kidney function in potentially unstable patients.
This secondary analysis of the EMPACT-MI trial demonstrates the SGLT2 inhibitor empagliflozin preserved kidney function and was safe to initiate in heart attack patients. Researchers found that after heart attack patients were on the drug for two years, their kidney function was stable and unharmed, while patients on placebo had significant worsening of their kidney function.
Even in heart attack patients with poor kidney function, researchers found SGLT2 inhibitors reduced heart failure complications. This is important considering that drugs that are beneficial in patients without kidney disease sometimes don’t work for patients with kidney disease. This was not the case with empagliflozin.
Why this study is important: Many heart attack patients who could benefit from SGLT2 inhibitors do not currently receive these drugs because many doctors fear they could damage kidney function. Results from this study, the largest trial to date of an SGLT2 inhibitor in patients with heart attacks, may change this.
How the research was conducted: Researchers randomized 6,522 patients hospitalized with a heart attack to either an SGLT2 inhibitor or placebo, on average five days after the heart attack. Patients were followed for an average of a year and a half.
Study results: Empagliflozin reduced total hospitalizations for heart failure by 33 percent (2.4 events per 100 person-years in the empagliflozin group and 3.6 events per 100 person-years in the placebo group) with consistent effects according to kidney function. The difference in eGFR change (a measure of kidney function) between empagliflozin and placebo was 4.1 ml/min/1.73 m2), indicating significant worsening of kidney function in the placebo group after two years.
What the study means for clinicians and patients: Clinicians should be vigilant when it comes to treating patients who might benefit from SGLT2 inhibitors and not withhold therapy due to a recent heart attack or because of kidney disease, since these study results show these drugs will not impact kidney function.
Quotes: “SGLT2 inhibitors are underused in clinical practice. These data provide reassurance of the safety of using this class of drugs when indicated—even in patients after a recent heart attack and if the kidney function is impaired,” says lead investigator Dr. Bhatt.
About the EMPACT-MI trial: EMPACT-MI trial (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction, NCT04509674) is a multicenter, randomized, parallel-group, double-blind, placebo-controlled superiority trial investigating the effect of empagliflozin on all-cause mortality and hospitalization due to heart failure in adults who have had a heart attack. Participants had no history of chronic heart failure and were eligible regardless of type 2 diabetes and chronic kidney disease status. EMPACT-MI included more than 6,500 adults from 22 countries. Study participants were randomized to receive either empagliflozin 10 mg or placebo, once daily, both on top of standard of care within 14 days of hospital admission for heart attack. 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.
Funding: Boehringer Ingelheim funded the trial and these analyses
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Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across seven hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time—discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
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For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Instagram, LinkedIn, X, and YouTube.