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Aim <p>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.</p> Methods <p>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.</p> Results <p>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, <i>P</i> &lt; 0.001), stable QT intervals, increased serum calcium (regression coefficient 0.02 mg/dL, <i>P</i> = 0.004), and decreased bicarbonate levels (regression coefficient − 0.27 mmol/L, <i>P</i> = 0.019). Additionally, diastolic blood pressures measured pre-dialysis significantly increased over time (regression coefficient 1.70 mmHg, <i>P</i> = 0.025).</p> Conclusion <p>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 clinical implications of the observed physiological changes. </p> Registration <p>This was a single-arm, open-label, dose-escalating safety study required by the institutional review board of the National Taiwan University Hospital before the commencement of two randomized controlled trials registered at ClinicalTrials.gov (EMPA-PRED [NCT06249945] and EMPA-RRED [NCT06249932]).</p>

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Safety and Short-Term Effects of Empagliflozin in Patients with Heart Failure and End-Stage Renal Disease

  • 期刊论文

  • 发表日期：

    2025年8月25日

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  • Donna Shu-Han Lin,
  • Hao-Yun Lo,
  • Chung-Wei Yang,
  • Chih-Cheng Wu

摘要

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 clinical implications of the observed physiological changes.

Registration

This was a single-arm, open-label, dose-escalating safety study required by the institutional review board of the National Taiwan University Hospital before the commencement of two randomized controlled trials registered at ClinicalTrials.gov (EMPA-PRED [NCT06249945] and EMPA-RRED [NCT06249932]).