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Randomized trial of two after-dialysis gabapentin regimens for severe uremic pruritus in hemodialysis patients

  • Giovanni Maria Rossi
  • Mattia Corradini
  • Valentina Blanco
  • Silvia Mattei
  • Enrico Fiaccadori
  • Augusto Vaglio
  • Lucio ManentiEmail author
CE - Research Letter to the Editor
  • 28 Downloads

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 [2].

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]; (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.

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Notes

Funding

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.

Informed consent

All participants provided informed consent prior to their participation.

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Copyright information

© Società Italiana di Medicina Interna (SIMI) 2019

Authors and Affiliations

  • Giovanni Maria Rossi
    • 1
  • Mattia Corradini
    • 2
  • Valentina Blanco
    • 3
  • Silvia Mattei
    • 2
  • Enrico Fiaccadori
    • 1
  • Augusto Vaglio
    • 4
    • 5
  • Lucio Manenti
    • 1
    Email author
  1. 1.U.O. Nefrologia, Dipartimento di Medicina Generale e SpecialisticaAzienda Ospedaliero-Universitaria di ParmaParmaItaly
  2. 2.Nephrology and Dialysis UnitAzienda USL-IRCCS di Reggio EmiliaReggio EmiliaItaly
  3. 3.Renal Unit, Nephrology and Dialysis DepartmentSant’Andrea HospitalLa SpeziaItaly
  4. 4.Department of Biomedical Clinical and Experimental Sciences “Mario Serio”University of FirenzeFlorenceItaly
  5. 5.Meyer Children’s HospitalFlorenceItaly

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