Randomized trial of two after-dialysis gabapentin regimens for severe uremic pruritus in hemodialysis patients
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Uremic pruritus (UP) has an overall reported incidence of ~ 46% in patients on hemodialysis, and is a relevant issue in the management of CKD [1, 2]. Gabapentin seems to be the best available treatment option, but since it is mainly eliminated by the kidneys, neurotoxicity is a concern, and sleepiness is the most frequently reported adverse reaction in clinical trials .
In this randomized, double-blind, placebo-controlled trial of gabapentin in hemodialysis patients with UP, we sought to determine the efficacy of two fixed-dose, after-dialysis drug regimens versus placebo.
Patients on thrice-weekly hemodialysis who met the following criteria were included: (1) age above 18 years; (2) history of itch for more than 6 weeks as per the definition of chronic itch by the International Forum for the Study of Itch ; (3) female subjects had to be willing to use adequate contraception; (4) a negative serum pregnancy test at initial screening of female subjects with childbearing potential.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Compliance with ethical standards
Conflict of interest
On behalf of all authors, the corresponding author states that there is no conflict of interest.
Statement of human and animal rights
All procedures were approved by the Azienda Ospedaliera S. Maria Nuova of Reggio Emilia Ethical Committee, and were compliant with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.
All participants provided informed consent prior to their participation.
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