New findings from a pre-specified analysis of DELIVER Phase III trial data show that AstraZeneca’s FARXIGA® (dapagliflozin) improved symptom burden and health-related quality of life in patients with heart failure (HF) and mildly reduced or preserved ejection fraction (EF) compared to placebo.1 The results were presented today at the American Heart Association (AHA) Scientific Sessions 2022 in Chicago, Illinois, US, and are currently in press in the Journal of the American College of Cardiology.
In addition to the greater risk of death and hospitalizations, patients with HF and mildly reduced or preserved EF experience an especially high burden of symptoms and physical limitations, and a poor quality of life, which is why improving health status is a key goal of management.1 In a prespecified analysis of the DELIVER Phase III trial, the Kansas City Cardiomyopathy Questionnaire (KCCQ) was utilized to examine the effects of FARXIGA on a broad range of health outcomes.1
In the analysis, FARXIGA, in addition to standard care compared with placebo, improved symptom burden, physical limitations and quality of life as measured by mean KCCQ scores, with benefits achieved as early as one month.1 Benefits were sustained at eight months, with mean improvement in total symptom score of 2.4 points, physical limitations 1.9 points, clinical summary 2.3 points and overall summary 2.1 points higher than placebo (all p <0.001).1 Also at eight months, fewer patients treated with FARXIGA compared to placebo had a significant deterioration, and more had at least small, moderate and large (at least 5-, at least 10- and at least 15-point, respectively) improvements in health status across evaluated KCCQ domains.1 The benefits of FARXIGA on cardiovascular (CV) death and worsening HF in patients with mildly reduced or preserved EF appeared especially pronounced in those with greater degree of symptomatic impairment at baseline.1