Efficacy and Safety of Pregabalin for the Treatment of Neuropathic Pain in Patients Undergoing Hemodialysis

Abstract

Pregabalin is a gamma aminobutyric acid derivative administered for neuropathic pain. It binds to α2δ subunits of voltage-dependent calcium channels, and inhibits calcium inflow of synapses and the release of excitatory neurotransmitters. This study investigated the efficacy and safety of pregabalin in patients with peripheral neuropathic pain undergoing maintenance hemodialysis. This study was a prospective, open-label, single-arm, multi-center trial. Patients were treated with an initial dose of pregabalin at 25mg; this was then increased up to a maximum of 150mg depending on the patient during a 12-week study period. Visual Analog Scale, Eight-Item Short Form Health Survey (SF-8), and laboratory data were collected at baseline and the end of the study. A total of 45 patients with peripheral neuropathic pain were included, of whom 35 patients were analyzed. The final mean dose of pregabalin was 50.7mg daily. Mean Visual Analog Scale scores significantly decreased from 52.4mm at baseline to 34.1mm at the end of the study (p<0.0001). Scores for all eight categories of the SF-8 significantly increased compared with baseline (p<0.05). Both physical and mental component summary scores of the SF-8 also significantly increased (p<0.05). Ten patients were withdrawn from the study because of drowsiness, dizziness, and invalidity; however, no serious adverse drug reactions were recorded. If adverse effects are carefully monitored and the administered dosage prudently determined, pregabalin can be an effective treatment for peripheral neuropathic pain in patients undergoing hemodialysis. UMIN000023117.