Does empagliflozin improve the overall health of patients with heart failure with reduced LVEF?
A recently published secondary analysis of the EMPEROR-Reduced study is based mainly on the results of the KCCQ-23 questionnaire, which assesses the patient's health status from their perspective. Its goal was to verify whether the benefit of empagliflozin added to the treatment of heart failure with reduced left ventricular ejection fraction (HFrEF) depends on the initial health status and how it subsequently affects the health status of these patients over 1 year.
KCCQ-CSS Score
The KCCQ-23 questionnaire (Kansas City Cardiomyopathy Questionnaires) is a 23-item validated tool that specifically measures the impact of heart failure on patients' health status from their perspective. It is a reliable questionnaire sensitive to changes, with results that correlate with mortality, the number of hospitalizations, and treatment costs. The Clinical Summary Score (KCCQ-CSS) from this questionnaire includes the physical function and symptom domains and ranges from 0–100, with higher scores indicating better health status.
Evaluated Parameters
In this secondary analysis of the randomized double-blind placebo-controlled EMPEROR-Reduced study, the influence of the baseline KCCQ-CSS (when dividing patients into tertiles) on the effect of empagliflozin on the primary endpoint, including cardiovascular mortality and heart failure hospitalizations, was evaluated. The Cox proportional hazards model was used for the analysis. Additionally, the improvement or worsening of KCCQ-CSS depending on empagliflozin treatment was assessed.
Results
Among the 3705 enrolled participants, the evaluation showed that compared to placebo, empagliflozin reduced the risk of the primary endpoint regardless of the baseline KCCQ-CSS tertile: in patients with KCCQ-CSS < 62.5, the hazard ratio (HR) was 0.83 (95% confidence interval [CI] 0.68–1.02), for KCCQ-CSS 62.6–85.4, HR was 0.74 (95% CI 0.58–0.94), and for KCCQ-CSS ≥ 84.5, HR was 0.61 (95% CI 0.46–0.82) (p for trend = 0.10).
Furthermore, empagliflozin led to an improvement in the average KCCQ-CSS after 3, 8, and 12 months. Significantly more patients achieved an improvement of this score by at least 5 points, at least 10 points, and at least 15 points, and significantly fewer patients experienced a worsening of at least 5 points with empagliflozin than with placebo after 3 months of treatment. This benefit of empagliflozin persisted even after 8 and 12 months of treatment.
Conclusion
Based on the conclusions of this analysis, empagliflozin significantly improved cardiovascular outcomes across the entire range of initial KCCQ-23 domain scores and improved the health status of patients with HFrEF. Treatment with empagliflozin was associated with a higher probability of improvement and a lower probability of health status deterioration. These consistent findings regarding patient-assessed health from the EMPEROR-Reduced and DAPA-HF studies support the position of sodium-glucose cotransporter 2 inhibitors (SGLT2i, gliflozins) as one of the basic pillars in the treatment of HFrEF.
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Source: Butler J., Anker S. D., Filippatos G. et al.; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J 2021 Mar 31; 42 (13): 1203–1212, doi: 10.1093/eurheartj/ehaa1007.
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