Evaluating the impact of Dapagliflozin on outcomes in systolic heart failure.

Abstract

Objective: To determine the efficacy of dapagliflozin in reducing cardiovascular events and improving clinical outcomes in patients with systolic heart failure. Study Design: Randomized Controlled Trial. Settings: Department of Internal Medicine and Cardiology, PAF Hospital, Islamabad. Study Period: November 2022 to April 2024. Method: A total of 1470 systolic heart failure (HF) patients aged ≥ 18 years with symptoms of New York Heart Association class (NYHA) II, III or IV, ejection fraction ≤ 40% and raised levels of plasma pro-B-type natriuretic peptide (pro-BNP) were enrolled in the study and randomized in 2 equal groups of 735 patients each. In Group-A, patients received dapagliflozin 10 mg once daily while the patients in Group-B received a matching placebo, over a period of one year. The primary outcome was set as worsening of HF (unplanned consultation/hospitalization due to HF). The secondary outcome was a change in the Kansas City Cardiomyopathy Questionnaire (KCCQ). Results: The mean age of participants in this study was 64.81±7.98 years. The results showed that worsening of heart failure (19.05% Vs 26% respectively, p-value=0.001), unplanned hospital visits due to HF (10.34% Vs 14.1% respectively, p-value=0.031), hospitalization due to HF (8.84% Vs 12.65% respectively, p-Value=0.032) was significantly lower and statistically significant change in KCCQ score (5.2±17.6 Vs 3.1±18.4 respectively, p-value=0.026) was observed in Group-A compared to Group-B. Conclusion: In systolic heart failure patients with reduced ejection fraction, dapagliflozin lowered the risk of worsening of heart failure and improved the symptoms of heart failure.