The following is a summary of “Effect of Dapagliflozin on Health Status in Patients With Preserved or Mildly Reduced Ejection Fraction,” published in the 2023 February issue of Cardiology by Kosiborod, et al.
Patients with heart failure with minimally reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF) have a significant burden of symptoms, physical limitations, and low quality of life; thus, one of the main therapeutic objectives is to improve health status. For a study, researchers sought to assess dapagliflozin’s impact on health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in a prespecified analysis of the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) study.
Dapagliflozin 10 mg or placebo was administered to individuals with symptomatic HFmrEF/HFpEF in the DELIVER study. KCCQ Total Symptom Score (TSS), a significant secondary objective, was assessed at randomization, 1, 4, and 8 months. Cox models examined how dapagliflozin affected clinical outcomes after stratifying patients based on KCCQ-TSS tertiles. Dapagliflozin’s impacts on the KCCQ-TSS, Physical Limitations (PLS), Clinical Summary (CSS), and Overall Summary (OSS) domains were assessed. In addition, the percentage of dapagliflozin vs. placebo-treated participants who experienced clinically significant KCCQ changes were compared in responder analyses.
KCCQ baseline data were available for 5,795 patients (median KCCQ-TSS 72.9). Patients with higher baseline symptom burden saw a bigger reduction in cardiovascular death/worsening of HF as a result of dapagliflozin (lowest-to-highest KCCQ-TSS tertile: HR: 0.70 [95% CI: 0.58-0.84]; 0.81 [95% CI: 0.65-1.01]; 1.07 [95% CI: 0.83-1.37]; Pinteraction = 0.026). At 8 months, dapagliflozin significantly increased the KCCQ-TSS, -PLS, -CSS, and -OSS (2.4, 1.9, 2.3, and 2.1 points higher vs. placebo; P< 0.001 for all). In addition, patients on dapagliflozin saw improvements in KCCQ-TSS independent of EF (Pinteraction = 0.85). At 8 months, fewer individuals on dapagliflozin had deterioration, and more showed improvements across all KCCQ areas.
The therapeutic advantages of dapagliflozin in HFmrEF/HFpEF are more notable in patients with more severe baseline symptom impairment. Each KCCQ domain and the percentage of patients who saw clinically significant improvements in their health status was enhanced by dapagliflozin.
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