CONFERENCE UPDATE: ESC 2023

Dapagliflozin demonstrated long-term efficacy and safety among HF patients with deteriorating kidney functions: Post-hoc analysis of DAPA-HF and DELIVER trial

CARDIOLOGY
17 Nov 2023

STUDY DESIGN

Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, was proven to be safe and effective in chronic heart failure (HF) patients with an estimated glomerular filtration rate (eGFR) of 30mL/min/1.73m2 and 25mL/min/1.73m2 in the DAPA-HF and DELIVER trial respectively.1 A Post-hoc analysis was conducted among chronic HF patients in these 2 trials to determine the prognostic implications of deterioration of reduced kidney function (eGFR <25mL/min/1.73m2) and the clinical outcomes of dapagliflozin on this particular patient subgroup.1

This post-hoc analysis involved 11,007 randomized patients with chronic HF from the DAPA-HF and DELIVER trials, of which 50% of patients were categorized into the dapagliflozin cohort (n=5,504).1 Throughout the study period, 3.2% of patients experienced a deterioration of kidney function below eGFR <25mL/min/1.73m2 with a median time to deterioration of 121 days, while 74.4% and 73.5% of patients remained on their assigned study drug in the dapagliflozin and placebo cohorts respectively.1 The primary endpoints of this post-hoc analysis were the incidence of worsening HF events or  cardiovascular (CV) death among the patient cohorts and the safety outcomes of dapagliflozin.1

FINDINGS

Primary endpoint:
  • The primary endpoints of this study were the incidence of CV death or HF worsening event (hospitalization due to HF or urgent HF visit requiring intravenous therapies) among the patient population1
  • Patients who experienced a deterioration in kidney function (eGFR <25mL/min/1.73m2) had an 87% higher risk of CV death or HF worsening event (HR=1.87; 95% CI: 1.48-2.35; p<0.001)1
  • The incidence of CV death or HF worsening event was lower among patients treated with dapagliflozin compared to placebo, regardless of whether patients experienced (HR=0.53; 95% CI: 0.33-0.83) or did not experience (HR=0.78; 95% CI: 0.72-0.86) deterioration in kidney function (pinteraction=0.17)1
Safety:
  • Overall, the safety profile of dapagliflozin was consistent among patients with and without deterioration in kidney function1
  • The incidence rate of serious adverse events (SAEs), drug interruption and drug discontinuation remained similar between the dapagliflozin and placebo cohorts, regardless of the presence of deterioration in patients’ kidney function1

 

“Dapagliflozin was associated with more desirable outcomes regardless of deterioration of eGFR to 25mL/min/1.73m2. This benefit-to-risk ratio may favor continued treatment of dapagliflozin in patients with HF and progressively deteriorating kidney function”  

Dr. Scott D. Solomon
Brigham and Women’s Hospital,
Boston, Massachusetts,
United States

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