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Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design

Joaquim Barreto1, Marilia Martins1, Mauro Pascoa2

  • 1Laboratory of Atherosclerosis and Vascular Biology (Aterolab), Faculty of Medical Sciences, University of Campinas (Unicamp), Campinas, Brazil.

Expert Opinion on Drug Safety
|October 8, 2024
PubMed
Abstract

Insights

This study investigates if dapagliflozin benefits heart function in dialysis patients, extending previous findings in chronic kidney disease. Results may support using SGLT2 inhibitors in end-stage kidney disease.

Area of Science:

  • Cardiology
  • Nephrology
  • Pharmacology

Background:

  • Dapagliflozin demonstrates efficacy in preventing myocardial dysfunction in chronic kidney disease (CKD) patients.
  • This protective effect is observed irrespective of residual kidney function.
  • The study hypothesizes that these benefits extend to patients undergoing dialysis.

Purpose of the Study:

  • To evaluate the impact of dapagliflozin on myocardial function and structure in dialysis patients.
  • To assess changes in NT-proBNP levels as the primary endpoint.
  • To explore secondary endpoints including cardiac imaging parameters, functional capacity, and symptoms.

Main Methods:

  • The DARE-ESKD-2 trial is an ongoing, single-center, open-label randomized clinical trial.
  • 80 adult patients on dialysis for over 3 months were randomized 1:1 to receive dapagliflozin or standard treatment for 24 weeks.
  • Exclusion criteria included pregnancy, liver failure, drug allergy, and prior SGLT2 inhibitor use.

Main Results:

  • Patient enrollment is complete with 80 participants.
  • All participants are currently undergoing the 24-week follow-up period.
  • Primary and secondary outcome data are pending analysis.

Conclusions:

  • This trial will offer new insights into the myocardial effects of SGLT2 inhibitors in end-stage kidney disease (ESKD) patients on dialysis.
  • Findings may support the expanded use of SGLT2 inhibitors in the ESKD population.
  • The study aims to provide evidence-based recommendations for cardiovascular risk management in dialysis patients.
Keywords:
Chronic kidney diseasedapagliflozindialysisheart failuremyocardium

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