heartdiseasefacts.com
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April 6, 2024
4 minute read
Important points:
- In patients with acute myocardial infarction, empagliflozin did not reduce the risk of death or heart failure hospitalization, the primary endpoint.
- The risk of certain heart failure-related outcomes was reduced in the empagliflozin group.
ATLANTA — In the EMPACT-MI trial, empagliflozin treatment immediately after acute MI did not significantly reduce the risk of HF hospitalization or death from any cause compared with placebo in patients at increased risk for HF. Ta.
Although the trial did not meet its primary endpoint, patients assigned empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) were at increased risk of certain outcomes directly related to heart failure, according to the researchers. It was said to be low.
Presented research results at an academic session of the American College of Cardiology. Javed Butler, MD, MPH, MBA, FACC, FAHA, FESC, Director of the Baylor Scott & White Institute, senior vice president of Baylor Scott & White Health, and distinguished professor of medicine at the University of Mississippi, Dr. reported a 10% reduction in the relative risk of death from any cause. The trial compared patients assigned daily empagliflozin with a placebo within 14 days of hospitalization for acute myocardial infarction, but said it did not reach statistical significance.
During approximately 18 months of follow-up, hospitalization for heart failure or death from any cause occurred in 8.2% of patients assigned empagliflozin and 9.1% of patients assigned placebo (HR = 0.9; 95% CI, 0.76-1.06; P = .21), according to the latest clinical trial results.
Main results
Despite advances in the management of acute myocardial infarction, many patients remain at high risk of developing heart failure. During his presentation, Butler said the prognosis is particularly poor for patients who develop congestion and left ventricular dysfunction after an acute MI. Previous studies have demonstrated that SGLT2 inhibitors can reduce CV outcomes in patients with heart failure, type 2 diabetes and high CV risk, chronic kidney disease. However, the safety and effectiveness of empagliflozin after MI was unclear, according to the researchers.
EMPACT-MI is a large-scale clinical trial conducted at 451 sites in 22 countries. Researchers randomly assigned 6,522 patients hospitalized with acute myocardial infarction and at risk for heart failure to receive empagliflozin 10 mg or a placebo daily in addition to standard care within 14 days of admission. Ta. High risk of heart failure was defined as signs or symptoms of congestion requiring treatment (57% of patients) or new-onset left ventricular ejection fraction <45% (78.4% of patients) . None of the patients had been previously diagnosed with chronic heart failure.
Most patients were male (75%), white (83%), older than 65 years (50%), and had a STEMI (74.3%). One third had type 2 diabetes and 13% had a previous myocardial infarction. Most patients (89.3%) underwent revascularization.
javed buttler
“While empagliflozin did not reduce mortality after a heart attack, it did reduce the risk of heart failure after a heart attack,” Butler said in an ACC press release. “While 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. ”
When researchers considered the individual components of the primary endpoint, there was no significant difference between empagliflozin and placebo for all-cause mortality (HR = 0.96, 95% CI, 0.78-1.19); The time to first death was significantly shortened. Hospital admissions for heart failure that selected empagliflozin (HR = 0.77; 95% CI, 0.6-0.98; P = .03), according to Mr. Butler.
Other important findings include:
- Total hospitalizations or all-cause mortality for heart failure: RR = 0.87 (95% CI, 0.68-1.1). P = .twenty four
- Total or all-cause mortality for non-elective CV hospitalizations: RR = 0.92; 95% CI, 0.78-1.07); P = .29
- Total nonelective all-cause hospitalizations or all-cause deaths: RR = 0.87; 95% CI, 0.77-1); P = .046
- Total myocardial infarction hospitalizations or all-cause mortality: RR = 1.06 (95% CI, 0.83-1.35). P = .63)
- Total number of hospitalizations for heart failure: RR = 0.67 (95% CI, 0.51-0.89). P = .006)
- Total number of adverse events in HF: RR = 0.63 (95% CI, 0.5-0.79). P < .001)
- Total number of adverse events for heart failure or all-cause mortality: RR = 0.79 (95% CI, 0.63-0.98). P = .031)
“Empagliflozin demonstrated a 23% and 33% relative risk reduction in first hospitalization for heart failure and total number of hospitalizations for heart failure as components of the primary endpoint and the first key secondary endpoint, respectively. Professor Butler said during his presentation. Additionally, he emphasized that in terms of heart failure adverse events, including outpatients, the relative risk of overall heart failure events was reduced by 37%.
Butler said the reduced risk of hospitalization for heart failure was consistent in subgroup and sensitivity analyses.
Butler said the safety findings were consistent with empagliflozin’s known safety profile.
Adverse events occurred in approximately one-quarter of patients in both groups, and adverse events leading to permanent discontinuation occurred in 3.8% of both groups. There was no significant difference in the risk of kidney damage.
integrity of evidence
Taken together, Professor Butler said: “The combined evidence suggests a benefit for empagliflozin in reducing the risk of heart failure in patients following acute myocardial infarction who have never had heart failure.” The EMPACT-MI results are “consistent with the benefits demonstrated with empagliflozin in other trials in adjacent patient populations.”
The recent DAPA-MI trial also investigated the effects of SGLT2 inhibitors after acute MI, this time using dapagliflozin. (His full Healio article on DAPA-MI can be found here.) However, his DAPA-MI and his There are important differences between EMPACT-MI.
According to the researchers, the results of the EMPACT-MI trial “help fill a knowledge gap” regarding the effects of SGLT2 inhibitors after MI.
James L. Januzzi
During the discussion after the trial, Dr. James L. Januzzi, These are exciting results from a challenging study, said the Hutter family professor of medicine at Harvard Medical School, a cardiologist at Massachusetts General Hospital, and director of heart failure and biomarker testing at the Beim Clinical Institute in Boston. He said that there is.
“I view pharmacotherapy research in acute myocardial infarction as a ‘good news, bad news’ story, meaning that…as in the case of the EMPACT-MI trial, high-risk enrichments are included. Because of factors and increased sample size, we see a very low event rate overall. That’s good news. …but on the other hand, there’s still a risk for these patients. Despite excellent medical care in the cath lab and post-catheterization medical therapy, understanding who is at risk for developing heart failure symptoms remains something we all take very seriously. …When we looked at the results as trialists, we found that the primary endpoint was neutral, but then we had a series of very interesting secondary follow-up results. ” said Januzzi.
reference:
perspective
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Patrick T. O’Gara, MD, MACC
I believe that, overall, these drugs are safe and that SGLT2 inhibitors may have a role in reducing heart failure events in patients with acute myocardial infarction. I was particularly interested in the differences between non-STEMI patients and his STEMI patients, and whether he thought there were any signs of greater benefit if stratified by type of MI. That was the comment.
We need to learn more about risk scores that may allow this therapy to be applied to appropriate patients. As Dr. Butler mentioned, can we determine who is at higher risk and who is likely to benefit most from the use of these drugs? I think this is an ongoing effort. However, it is a safe intervention and may have benefits.
Patrick T. O’Gara, MD, MACC
director
Cardiology Department Strategic Plan
Brigham and Women’s Hospital
Watkins Family Cardiology Distinguished Chair Professor
Harvard Medical School
Former President of the American College of Cardiology
Disclosure: O’Gara does not report any relevant financial disclosures.
Information source/disclosure information
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Butler J et al. American College of Cardiology/Journal of the American College of Cardiology Latest clinical trials. Presentation location: American College of Cardiology Scientific Sessions. April 6-8, 2024. Atlanta.
Disclosure: The EMPACT-MI trial was funded by Boehringer Ingelheim and Eli Lilly. Mr. Butler is a member of Abbott, American Regent, Amgen, Applied Therapeutics, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardiac Dimensions, Cardiocel, Cardiol, and CSL. Bering, CVRx, Cytokinetics, Daxor, Edwards, Element Science, Faraday, Foundry, G3P, Innolife, Impulse Dynamics, Inbria, Inventiva, Ionis, Lexicon, Lilly, Livanova, Janssen, Regeneron, Lenibus, Roche, Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, Sol.
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