The use of the sodium-glucose cotransporter 2 (SGLT-2) inhibitor empagliflozin after a heart attack reduces overall heart failure hospitalization and death from any cause, according to a study published in the annual scientific journal of the American College of Cardiology. It also showed no significant effect on reducing session. But researchers said the drug may help reduce the risk of heart failure, including hospitalization after a heart attack.

Despite not meeting its primary endpoint, results from the EMPACT-MI trial showed that people who took empagliflozin had fewer heart failure hospitalizations, including first hospitalization for heart failure, total hospitalization for heart failure, and combined hospitalization for heart failure. The risk of certain directly related outcomes was found to be significantly lower. We report rates of heart failure hospitalization and death without increasing the risk of adverse events.

We found that empagliflozin did not reduce mortality after a heart attack, but it did reduce the risk of heart failure after a heart attack. Although a 25% to 30% reduction in heart failure hospitalizations is clinically significant, when combined with all-cause mortality, the study was not positive for the primary endpoint. ”

Javed Butler, M.D., director of the Baylor Scott & White Research Institute in Dallas and distinguished professor at the University of Mississippi School of Medicine in Jackson, Mississippi, is the study’s lead author.

SGLT-2 inhibitors were initially approved to treat type 2 diabetes by lowering blood sugar levels. As increasing evidence points to the benefits of these drugs in reducing heart failure and other heart diseases, researchers are investigating whether these drugs can help prevent heart failure even in people without diabetes or chronic kidney disease. I’ve been trying to decide.

A heart attack can damage the heart muscle and, in some cases, cause heart failure, a condition in which the heart becomes too weak or hard to effectively pump blood throughout the body. The EMPACT-MI trial was designed to determine whether SGLT-2 inhibitors can safely help prevent heart failure and reduce mortality in people at high risk of heart failure after a heart attack.

The study enrolled 6,522 people treated for acute myocardial infarction at 451 centers in 22 countries. Participants had no history of heart failure but had at least one heart failure risk factor in addition to signs of underlying cardiac dysfunction indicated by a new decrease in left ventricular ejection fraction <45%. and/or had signs or symptoms of congestion that required treatment. Approximately 32% had type 2 diabetes. The average age of participants was 64 years, approximately 25% were female, and 84% were Caucasian.

Within 14 days of being hospitalized for a heart attack, half of the participants were randomly assigned to receive 10 mg of empagliflozin a day, and the other half received a placebo. Researchers followed the results for a median time of just under 18 months.

The study’s primary composite endpoint occurred in 8.2% of patients receiving empagliflozin and 9.1% of patients receiving placebo, but this difference was not statistically significant. There was also no difference in mortality from any cause, which occurred in 5.2% of patients treated with empagliflozin and 5.5% in the control group.

All secondary endpoints specifically related to heart failure outcomes were significantly reduced in patients receiving empagliflozin. For example, patients who received empagliflozin were 23% less likely to experience a first heart failure hospitalization and more likely to experience a heart failure hospitalization, including recurrent hospitalizations, compared to patients who received a placebo. % was low. The combined rate of heart failure hospitalization and heart failure death was also 31% lower in patients receiving empagliflozin.

Among patients who were not taking common heart failure medications such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNI) at the time of initial hospital discharge, patients taking empagliflozin patients were significantly less likely to start these treatments. Patients on treatment for 6 months or less compared to patients taking a placebo.

“In terms of heart failure outcomes, the data are not only strong, but consistent with what has been found in additional populations over the past decade,” Butler said. “This finding is fully consistent in both direction and magnitude with other studies of SGLT-2 inhibitors in populations with diabetes and chronic kidney disease.”

According to the researchers, the study had a pragmatic trial design to simplify trial procedures and reduce burden on both participants and sites, but it also had limitations that may have affected the results. It is said that there was. For example, outpatient heart failure events were not formally captured as part of the primary endpoint because outcomes were not adjudicated by independent reviewers. However, researchers said the heart failure outpatient data was collected as part of a study design to assess adverse events. Analysis of these events showed that participants receiving empagliflozin had significantly fewer outpatient visits due to heart failure compared to placebo.

Another limitation is the use of all-cause mortality as part of the primary endpoint, which does not include deaths unrelated to heart failure, even though the study drug is unlikely to have an effect. This means that these are also included in the evaluation items. Additionally, unusual circumstances, such as the COVID-19 pandemic and conflicts involving Russia, Ukraine, and Israel, all countries participating in the trial, may have affected both hospitalization and mortality rates. There were also some.

Finally, the researchers said the follow-up period may have been too short to fully capture differences in mortality associated with heart failure. People who develop heart failure after a heart attack usually do not start showing symptoms of heart failure until several months later, so a reduction in mortality is not expected until later.

“We don’t have long enough follow-up to see whether preventing heart failure translates into improved mortality, but if we’re preventing heart failure, that’s a good thing. It makes clinical sense,” Butler said. He said.

This research was funded by Boehringer Ingelheim and Eli Lilly.

The study was published online in the New England Journal of Medicine upon publication.

Mr. Butler will participate in a press conference for the media on Saturday, April 6, 2024 at 10:45 a.m. ET/2:45 a.m. UTC in Room B203.

Dr. Butler will present “Empagliflozin After Acute Myocardial Infarction: EMPACT” in the Hall B-1 main tent on Saturday, April 6, 2024 at 9:30 a.m. ET/13:30 p.m. UTC. -Results of the MI Examination” will be presented.