EFFICACY AND SAFETY OF NALFURAFINE FOR REFRACTORY PRURITUS IN HEMODIALYSIS PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

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Abstract Title *

EFFICACY AND SAFETY OF NALFURAFINE FOR REFRACTORY PRURITUS IN HEMODIALYSIS PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

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Co-author 1

Hendra Perkasa dr.hendraperkasa@gmail.com Faculty of Medicine, University of Indonesia, Dr. Cipto Mangunkusumo National General Hospital Internal Medicine Jakarta Indonesia *

Co-author 2

Pringgodigdo Nugroho pringgodigdo.nugroho@ui.ac.id Faculty of Medicine, University of Indonesia, Dr. Cipto Mangunkusumo National General Hospital Internal Medicine Jakarta Indonesia -

Co-author 3

Maruhum Bonar mbhmarbun@gmail.com Faculty of Medicine, University of Indonesia, Dr. Cipto Mangunkusumo National General Hospital Internal Medicine Jakarta Indonesia -

Co-author 4

Muhammad Irvan Almaqdisi irvanalmaqdisii@gmail.com Faculty of Medicine, University of Riau Internal Medicine Pekanbaru Indonesia -

Co-author 5

Jason Phowira jphowira@gmail.com Faculty of Medicine, University of Indonesia Internal Medicine Jakarta Indonesia -

Co-author 6

Ni Made Hustrini madekum99@gmail.com Faculty of Medicine, University of Indonesia, Dr. Cipto Mangunkusumo National General Hospital Internal Medicine Jakarta Indonesia -

Co-author 7

Co-author 8

Co-author 9

Co-author 10

Co-author 11

Co-author 12

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Introduction

Uremic pruritus, a prevalent and debilitating symptom in patients with chronic kidney disease receiving dialysis, significantly impairs quality of life and remains challenging to manage. Limited data available on the benefit and safety of nalfurafine, a selective kappa-opioid receptor agonist, in this population. Our systematic review and meta-analysis aims to evaluate the efficacy and safety of nalfurafine versus placebo for refractory pruritus in hemodialysis patients.

Methods

PubMed, Scopus, and Cochrane were systematically searched until July 2025 to identify relevant studies and outcomes were assessed using random-effect model. Quality assessment was conducted using the Cochrane RoB 2.0 tool. Results were reported as risk ratio (RR) and mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: (CRD420251102989).

Results

Three randomized controlled studies involving 701 eligible patients were included. Nalfurafine significantly reduced the mean visual analogue scale (VAS) compared to placebo (MD: 9.57; 95% confidence interval [CI]: 5.82, 13.32; p<0.00001). Safety analysis indicated no differences in incidence of adverse events (RR: 0.94; 95% CI: 0.80–1.11; p=0.49) and serious adverse events (RR:0.82; 95% CI: 0.29–2.30; p=0.70).

Conclusion

Nalfurafine is a safe and effective therapy for refractory uremic pruritus in hemodialysis patients, providing significant symptom relief without increasing adverse events. Its use may represent a valuable addition to current management strategies. Further studies should clarify the influence of dialysis adequacy and middle-molecule clearance on treatment response to optimize patient outcomes.

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