Background
Trials with SGLT2 inhibitors have been designed to investigate the effects of SGLT2 inhibitors on time to first worsening HF event or CV death as primary outcome, and HF hospitalization as secondary outcome [1-4]. An investigation in the treatment effect of dapagliflozin on the total burden of HF, that is first and subsequent HF hospitalizations or urgent visits for HF and CV death in HFpEF and HFmrEF, is still lacking.
Aim of the study
The authors investigated the effects of dapagliflozin on total HF events in patients with HFmrEF and HFpEF.
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Methods
This was a prespecified analysis of the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial. The DELIVER trial was a double-blind, event-driven, randomized clinical trial, in which 6263 patients with symptomatic HFmrEF/HFpEF (NYHA class II–IV HF symptoms, LVEF >40%, elevated NT-proBNP levels) were randomized to 10 mg dapagliflozin once daily or placebo. Patients were followed for a median period of 2.3 years. Two statistical methods were used to analyze total HF-events: the LWYY model and the joint frailty model.
Outcomes
The predefined outcome was total (first and repeated) worsening episodes of HF and CV death. In the DELIVER trial, the primary outcome was a composite of time to first worsening HF or CV death.
Dapagliflozin reduced the risk of total HF events (first and repeated events) compared with placebo in patients with HFmrEF and HFpEF. This benefit was consistent across different subgroups of patients, including across the spectrum of EF.
1. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008. doi:10.1056/NEJMoa1911303
2. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2022;387(12):1089-1098. doi:10.1056/NEJMoa2206286
3. Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020; 383(15):1413-1424. doi:10.1056/NEJMoa2022190
4. Anker SD, Butler J, Filippatos G, et al. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16): 1451-1461. doi:10.1056/NEJMoa2107038
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