KANSAS CITY, MO – While sodium-glucose cotransporter 2 inhibitors (SGLT2), initially used to treat type 2 diabetes, have been shown to improve health status in chronic heart failure, their effect in acute heart failure has not been as clear, according to a new study.
The report in Circulation pointed out that hospitalized acute heart failure patients tend to have poor health status, with many symptoms and physical limitations, and overall poor quality of life.
An international study team led by Saint Luke’s Mid America Heart Institute and including participation from the Tennessee Valley and San Francisco VA Healthcare System looked at the effects of the SGLT2 inhibitor empagliflozin on symptoms, physical limitations, and quality of life in those patients. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used for the study, the EMPULSE trial (Empagliflozin in Patients Hospitalized With Acute Heart Failure Who Have Been Stabilized).
For the trial, patients hospitalized for acute heart failure were randomized to empagliflozin 10 mg daily or placebo for 90 days. The KCCQ was used for assessment at randomization and 15, 30, and 90 days.
The researchers examined post hoc the effects of empagliflozin on the primary endpoint of clinical benefit — hierarchical composite of all-cause death, heart failure events, and a 5-point or greater difference in KCCQ Total Symptom Score [TSS] change from baseline to 90 days. Overall, 530 patients were randomized, 265 in each arm. Baseline KCCQ-TSS was low overall (mean [SD], 40.8 [24.0] points) at randomization.
Results indicated that empagliflozin-treated patients experienced greater clinical benefit across the range of KCCQ-TSS, with no treatment effect heterogeneity (win ratio [95% CIs] from lowest to highest tertile: 1.49 [1.01-2.20], 1.37 [0.94-1.99], and 1.48 [1.00-2.20], respectively; P for interaction=0.94).
“Beneficial effects of empagliflozin on health status were observed as early as 15 days,” according to the authors, “and persisted through 90 days, at which point empagliflozin-treated patients experienced a greater improvement in KCCQ TSS, physical limitations, quality of life, clinical summary, and overall summary (placebo-adjusted mean differences [95% CI]: 4.45 [95% CI, 0.32-8.59], P=0.03; 4.80 [95% CI, 0.00-9.61], P=0.05; 4.66 [95% CI, 0.32-9.01], P=0.04; 4.85 [95% CI, 0.77-8.92], P=0.02; and 4.40 points [95% CI, 0.33-8.48], P=0.03, respectively).”
Researchers concluded that initiation of empagliflozin in patients hospitalized for acute heart failure produced clinical benefits across the range of symptomatic impairment at baseline. Improvement in symptoms, physical limitations, and quality of life was observed as early as 15 days after drug initiation and maintained through 90 days.
The findings potentially extend the health status benefits of SGLT2 inhibitors to patients hospitalized with acute heart failure regardless of ejection fraction, de novo versus chronic decompensated heart failure status and degree of symptomatic impairment at baseline, the authors pointed out.
- Empagliflozin on Symptoms, Physical Limitations, and Quality of Life in Patients Hospitalized for Acute Heart Failure: Results From the EMPULSE Trial. 2022 Jul 26;146(4):279-288. doi: 10.1161/CIRCULATIONAHA.122.059725. Epub 2022 Apr 4. PMID: 35377706.
