Key result
Dapagliflozin improves all KCCQ health status domains at 8 months in HFmrEF and HFpEF.
Why the study?
Patients with HFmrEF and HFpEF experience a high symptom burden and poor quality of life, making health status improvement a key management goal.
Does dapagliflozin improve health status measured by KCCQ in patients with symptomatic HFmrEF/HFpEF?
RCT
Does dapagliflozin improve health status measured by KCCQ in patients with symptomatic HFmrEF/HFpEF?
Dapagliflozin improves health status and reduces symptom deterioration in patients with HFmrEF and HFpEF, with benefits especially pronounced in those with greater baseline symptom impairment.
Answers are grounded in this paper and cite their sources.
Supports dapagliflozin for health status gains in HFmrEF/HFpEF; extends SGLT2i evidence beyond LVEF to KCCQ domains.
BACKGROUND: Patients with heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) experience a high burden of symptoms, physical limitations, and poor quality of life; improving health status is a key goal of management. OBJECTIVES: In a prespecified analysis of the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial, we examine effects of dapagliflozin on health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ). METHODS: The DELIVER trial randomized patients with symptomatic HFmrEF/HFpEF to dapagliflozin 10 mg or placebo. KCCQ was evaluated at randomization, 1, 4, and 8 months; KCCQ Total Symptom Score (TSS) was a key secondary endpoint. Patients were stratified by KCCQ-TSS tertiles; Cox models examined effects of dapagliflozin on clinical outcomes. We evaluated the effects of dapagliflozin on KCCQ-TSS, Physical Limitations (PLS), Clinical Summary (CSS), and Overall Summary (OSS) domains. Responder analyses compared proportions of dapagliflozin vs placebo-treated patients with clinically meaningful changes in KCCQ. Fewer dapagliflozin-treated patients had deterioration, and more had improvements in all KCCQ domains at 8 months. CONCLUSIONS: The clinical benefits of dapagliflozin in HFmrEF/HFpEF appear especially pronounced in those with greater baseline symptom impairment. Dapagliflozin improved all KCCQ domains and the proportion of patients experiencing clinically meaningful changes in health status. (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure [DELIVER]; NCT03619213).
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Kosiborod et al. (2022) conducted an RCT in Heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). Dapagliflozin vs. placebo was evaluated on KCCQ Total Symptom Score (TSS). Dapagliflozin reduced deterioration and increased improvements in all KCCQ domains at 8 months in patients with HFmrEF/HFpEF.
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