Safety and Short-Term Effects of Empagliflozin in Patients with Heart Failure and End-Stage Renal Disease
Abstract
Aim: Our aim was to evaluate the safety of empagliflozin in escalating doses among patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis who also have heart failure.
Methods: This single-arm, open-label, dose-escalation study enrolled patients with ESRD on maintenance hemodialysis with heart failure (reduced or preserved ejection fraction) from June to September 2023. Patients sequentially received empagliflozin at doses of 5 mg, 10 mg, and 25 mg daily for 4 weeks per dose, alongside standard care. Pre-dialysis vital signs, electrocardiograms, complete blood counts, and biochemical profiles were monitored weekly. Dose-dependent changes were assessed using linear mixed models.
Results: A total of 17 patients participated, without significant adverse events. Empagliflozin treatment was associated with a significant shortening of QRS duration (regression coefficient - 3.35 ms, P < 0.001), stable QT intervals, increased serum calcium (regression coefficient 0.02 mg/dL, P = 0.004), and decreased bicarbonate levels (regression coefficient - 0.27 mmol/L, P = 0.019). Additionally, diastolic blood pressures measured pre-dialysis significantly increased over time (regression coefficient 1.70 mmHg, P = 0.025).
Conclusion: Empagliflozin at doses of 5 mg, 10 mg, and 25 mg per day, administered sequentially for 4 weeks each, demonstrated a favorable safety profile in patients with ESRD undergoing maintenance hemodialysis. Further studies are warranted to explore…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 17 participants or records.
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