EMPULSE: Empagliflozin Yields QOL Benefits in Patients Hospitalized for Acute HF

Late breaking secondary analysis data from the EMPULSE trial revealed the initiation of empagliflozin in patients hospitalized for acute heart failure (AHF) improved symptoms, physical limitations (PLS), and quality of life (QOL), regardless of the degree of symptomatic impairment at baseline.

Findings, presented by Mikhail N. Kosiborod, MD, a cardiologist and vice president of Research at Saint Luke's Health System, also revealed benefits were seen after 15 days and were maintained at 90 days.

Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that was first approved for patients with type 2 diabetes in 2014, but recently gained FDA approval in February 2022 for a broader range of patients with heart failure, including those with preserved ejection fraction (HFpEF).

Individuals with AFH have a high burden of symptoms, researchers explained, and although the beneficial effects of SGLT2 inhibitors have been documented in patients with chronic HF, less is known with regard to AHF.

In the study, AHF was defined as de novo or decompensated chronic HF, regardless of ejection fraction or diabetes. Upon hospitalization, a total of 530 patients were randomized for 90 days to empagliflozin 10 mg daily (n=265) or placebo. Study participants also completed the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and after 15, 30 and 90 days.

Randomization took place at 118 centers, starting at least 24 hours after hospitalization and no later than 5 days following admission after stabilization was achieved.

At baseline, KCCQ total symptom score (TSS) was low overall with a mean (SD) score of 40.8 (24.0) points, a finding consistent with AHF. However, after 90 days, this score significantly improved among patients (mean change: placebo 31.7 [95% CI, 28.8-34.7]; empagliflozin 36.2 [95% CI, 33.3-39.1]).

Additional analyses revealed that empagliflozin-treated patients had a greater improvement in KCCQ TSS, PLS, QOL, clinical summary scores and overall summary scores at day 90 (effect sizes 4.5 [95% CI, 0.3-8.6], P= .035; 4.80 [95% CI, 90.0-9.6], P = .050; 4.7 [95% CI, 0.3-9.0], P = .036; 4.9 [95% CI, 0.8, 8.9], P = .02; and 4.4 [95% CI, 0.3-8.5], P = .03, respectively).

The observations “are of clinical relevance, as very few therapies have been shown to improve symptoms and functional status in the early post-discharge period in patients hospitalized with AHF,” authors wrote.

Researchers also hypothesize the findings may indicate initiation of SGLT2 inhibitors during hospitalization in this population could help improve the hospital-to-home transition, although more studies are needed in this area.

Based on the positive outcomes seen so early post-AHF hospitalization, panelists stressed the importance of empagliflozin initiation while a patient is still in the hospital as opposed to 1 to 2 weeks thereafter.

“If you don’t prescribe in the hospital, it’s unlikely to happen post-discharge,” Kosiborod said.

The post hoc nature of the analyses employed marks a limitation to this study while the follow-up period was relatively short.

Reference

Kosiborod M, Angermann CE, Collins S, et al. Effects of empagliflozin on symptoms, physical limiations, and quality of life in patients hospitalized for acute heart failure- results from the EMPULSE trial. Circulation. Published online April 4, 2022.