The clinical outcomes of dapagliflozin in patients with acute heart failure: A randomized controlled trial (DAPA-RESPONSE-AHF)

Eur J Pharmacol. 2023 Dec 15:961:176179. doi: 10.1016/j.ejphar.2023.176179. Epub 2023 Nov 2.

Abstract

Aims: Dapagliflozin may confer additional decongestive and natriuretic benefits to patients with acute heart failure (AHF). Nonetheless, this hypothesis was not clinically examined. This study aimed primarily to investigate the effect of dapagliflozin on symptomatic relief in those patients.

Methods: This was a randomized, double-blind study that included 87 patients with AHF presenting with dyspnea. Within 24 h of admission, patients were randomized to receive either dapagliflozin (10 mg/day, N = 45) or placebo (N = 42) for 30 days. The primary outcome was the difference between the two groups in the area under the curve (AUC) of visual analogue scale (VAS) dyspnea score over the first 4 days. Secondary endpoints included urinary sodium (Na) after 2 h of randomization, percent change in NT-proBNP, cumulative urine output (UOP), and differences in mortality and hospital readmission rates.

Results: The results showed that dapagliflozin significantly reduced the AUC of VAS dyspnea score compared to placebo (3192.2 ± 1631.9 mm × h vs 4713.1 ± 1714.9 mm × h, P < 0.001). The relative change of NT-proBNP compared to its baseline was also larger with dapagliflozin (-34.89% vs -10.085%, P = 0.001). Additionally, higher cumulative UOP was found at day 4 (18600 ml in dapagliflozin vs 13700 in placebo, P = 0.031). Dapagliflozin decreased rehospitalization rates within 30 days after discharge, while it did not affect the spot urinary Na concentration, incidence of worsening of heart failure, or mortality rates.

Conclusion: Dapagliflozin may provide symptomatic relief and improve diuresis in patients with AHF. Further studies are needed to confirm these findings. https://clinicaltrials.gov/study/NCT05406505.

Keywords: Congestion; Diuresis; Dyspnea; NT-proBNP; Patient reported outcomes; Placebo; Sodium-glucose co-transporter 2.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Benzhydryl Compounds / therapeutic use
  • Double-Blind Method
  • Dyspnea / complications
  • Dyspnea / drug therapy
  • Glucosides / therapeutic use
  • Heart Failure* / complications
  • Humans
  • Stroke Volume

Substances

  • Benzhydryl Compounds
  • dapagliflozin
  • Glucosides

Associated data

  • ClinicalTrials.gov/NCT05406505