Abstract
This study was designed to assess the efficacy and safety of pregabalin—a novel a2-d ligand with analgesic, anxiolytic, and anticonvulsant activity—for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, double-blind, placebo-controlled trial to receive 150 ðn 1⁄4 81Þ; 300 mg/day ðn 1⁄4 76Þ pregabalin, or placebo ðn 1⁄4 81Þ for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses $ 1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders ($ 50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study’s duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin treated patients than placebo-treated patients reported that they were ‘much improved’ or ‘very much improved’. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral edema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures.
q 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. Keywords: Post-herpetic neuralgia; Herpes zoster; Pregabalin; Neuropathic pain; Chronic pain; Sleep; Mood; Clinical trial
