Early initiation of Empagliflozin Improves QoL in Acute HF Patients within 2 weeks: EMPULSE Trial
Introduction Patients hospitalized for acute heart failure (AHF) are at high risk for cardiovascular death and readmission, and also experience an especially high burden of heart failure (HF) related symptoms and physical limitations.
A recent study suggests that early initiation of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin improves physical limitations and quality of life (QoL) in patients hospitalized for acute heart failure. The study findings were published in the journal Circulation on April 04, 2022.
Previous studies have demonstrated that SGLT2 inhibitors improve health status in chronic HF, but their impact on these outcomes in AHF is not well characterized. Therefore, Dr Mikhail N. Kosiborod and his team investigated the effects of the SGLT2 inhibitor empagliflozin on symptoms, physical limitations and quality of life, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the EMPULSE trial.
In this study, the researchers randomized 530 hospitalized AHF patients to empagliflozin 10 mg daily or placebo for 90 days. They evaluated KCCQ at randomization and 15, 30 and 90 days. The primary composite endpoints assessed were time to death, frequency of HF events, time to first HF event, and change in QoL score from baseline. They further performed pre-specified analyses, to evaluate the changes (randomization to Day 90) in KCCQ domains, including Total Symptom Score (TSS), Physical Limitations (PLS), quality of life (QoL), clinical summary (CSS) and overall summary (OSS) scores using a repeated measures model. In general, patients had very poor health status at baseline.
Key findings of the study:
- Upon analysis, the researchers found that empagliflozin-treated patients experienced greater clinical benefit across the range of KCCQ-TSS, with no treatment effect heterogeneity (win ratio from lowest to highest tertile: 1.49, 1.37, and 1.48, respectively).
- They observed beneficial effects of empagliflozin on health status as early as 15 days and persisted through 90 days, at which point empagliflozin-treated patients experienced a greater improvement in KCCQ TSS, PLS, QoL, CSS and OSS (placebo-adjusted mean differences: 4.45, 4.80; 4.66; 4.85; and 4.40 points, respectively).
The authors concluded, "Initiation of empagliflozin in patients hospitalized for AHF produced clinical benefit regardless of the degree of symptomatic impairment at baseline; and improved symptoms, physical limitations and quality of life, with benefits seen as early as 15 days and maintained through 90 days."
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