Empagliflozin benefits acute HF regardless of baseline impairment: EMPULSE
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WASHINGTON — Patients with acute HF assigned the SGLT2 inhibitor empagliflozin saw a greater improvement in HF symptoms, physical limitations and quality of life measures vs. placebo, with benefit seen as early as 15 days, data show.
Presenting new analyses from the EMPULSE trial at the American College of Cardiology Scientific Session, Mikhail Kosiborod, MD, FACC, FAHA, cardiologist at Saint Luke’s Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City School of Medicine, said patients who received empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) derived benefit regardless of their baseline level of impairment.
“To date, there has been a lack of therapies with compelling benefit on outcomes in patients with acute HF, highlighting a critical unmet need,” Kosiborod said during a featured clinical research presentation. “EMPULSE fills a unique niche in HF trials of SGLT2 inhibitors because it specifically focuses on [patients with] acute HF who have been randomized in the hospital, it includes patients with both reduced and preserved ejection fraction, those with or without diabetes and, importantly, those with de novo or chronic decompensated HF.”
Assessing quality of life measures
As Healio previously reported, in the EMPULSE trial, adults hospitalized with acute HF who received empagliflozin were 36% more likely than those on placebo to have clinical benefit at 90 days, including prevention of death and readmissions. For the new analyses, researchers evaluated the effects of empagliflozin on the primary endpoint of total clinical benefit according to the degree of symptomatic impairment at baseline and examined the impact of empagliflozin on a broad range of outcomes measured by various domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
EMPULSE enrolled 530 patients hospitalized with a primary diagnosis of acute HF, defined as de novo or decompensated chronic HF, regardless of left ventricular ejection fraction and diabetes status. The mean age of patients was 69 years, 34% were women and 45.3% had type 2 diabetes. Mean baseline LVEF was 35.1%; 32% had an LVEF greater than 40%.
Researchers assigned patients to empagliflozin 10 mg daily or placebo for 90 days; KCCQ was assessed at baseline, 15, 30 and 90 days.
The findings were simultaneously published in Circulation.
Improvement observed early
Within the cohort, mean baseline KCCQ total symptom score was low overall at 40.8 points, consistent with acute HF, and improved substantially by 90 days, with a mean change of 36.2 for patients assigned empagliflozin (95% CI, 33.3-39.1) and 31.7 for those assigned placebo (95% CI, 28.8-34.7). The win ratios favored empagliflozin similarly across all tertiles of baseline KCCQ total symptom score (P for interaction = .94), according to the researchers.
Participants who received empagliflozin experienced greater improvement in KCCQ total symptom score (effect size = 4.5; 95% CI, 0.3-8.6; P = .035), physical limitations (effect size = 4.8; 95% CI, 0-9.6; P = .05), quality of life (effect size = 4.7; 95% CI, 0.3-9; P = .036), clinical summary score (effect size = 4.9; 95% CI, 0.8-8.9; P = .02) and overall summary score (effect size = 4.4; 95% CI, 0.3-8.5; P =.03) at day 90.
Benefits were evident at 15 days and maintained through 90 days, Kosiborod said. Results persisted regardless of baseline EF and KCCQ total symptom score.
“Treatment with empagliflozin produced total clinical benefit in patients hospitalized with acute HF across the entire range of KCCQ,” Kosiborod said. “This indicates the benefits of empagliflozin for this patient population are independent of symptomatic impairment at baseline.”
In discussion after the presentation, Deepak L. Bhatt, MD, MPH, executive director of interventional cardiology programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and Cardiology Today Intervention Section Editor, called the quality of life data impressive, noting the early benefit observed.
“This is a call to physicians, including cardiologists, to start prescribing these agents,” Bhatt said. “There is a bit of a penalty to simply saying, ‘I’ll wait until I see the patient in 2 weeks, or 1 month, or 3 months.’ These data support early initiation.”
Reference:
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Kosiborod M, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
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