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- W3021532783 abstract "The aim of the study was to evaluate efficacy and safety of pregabalin given BID for relief of neuropathic pain in patients with postherpetic neuralgia (PHN). 370 PHN patients with pain for ≥3 months after skin rash healing were randomized in a multicenter, 13-week, double-blind, placebo-controlled study. Of the ITT population (n=368), 90 received pregabalin 300/600 mg/d BID, 98 received 300 mg/d BID, 87 received 150 mg/d BID, and 93 received placebo. The primary efficacy parameter was endpoint mean pain score derived from daily pain diaries. Weekly mean pain scores were also assessed. Safety evaluations included adverse events (AEs), physical and neurologic examinations, 12-lead ECG, vital signs, and clinical laboratory testing. Compared with placebo, all dosages of pregabalin were significantly superior (P<0.01) at relieving pain. Weekly mean pain scores in each pregabalin group were also significantly improved compared with placebo by Week 1, and improvement was maintained through Week 13. Most AEs were mild or moderate, and only 13% of patients treated with pregabalin (the greatest number of whom were from the 300/600 mg/d group) and 4% of patients in the placebo group withdrew because of treatment-related AEs. Among pregabalin-treated patients, AEs that most frequently led to discontinuation were dizziness (16 patients), somnolence (8), and ataxia (7). 75% of patients continued in the study's open-label follow-on arm. Pregabalin dosed BID was efficacious and well tolerated as treatment of neuropathic pain associated with PHN. Pregabalin's analgesic effect began by Week 1 and was sustained throughout the study's 13 weeks. This study was supported by Pfizer, Inc." @default.
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- W3021532783 date "2004-04-01" @default.
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- W3021532783 title "Novel therapeutic agents" @default.
- W3021532783 doi "https://doi.org/10.1016/j.jpain.2004.02.200" @default.
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