Topiramate vs placebo in painful diabetic neuropathy: Analgesic and metabolic effects

Philip Raskin, P. D. Donofrio, N. R. Rosenthal, D. J. Hewitt, D. M. Jordan, J. Xiang, A. I. Vinik

Research output: Contribution to journalArticle

202 Scopus citations

Abstract

Background: Using identical methods, three simultaneous placebo-controlled trials of topiramate for painful diabetic neuropathy (PDN) did not reach significance. This independent yet concurrent placebo-controlled trial used different methods to assess topiramate efficacy and tolerability in PDN. Methods: This 12-week, multicenter, randomized, double-blind trial included 323 subjects with PDN and pain visual analog (PVA) score of at least 40 on a scale from 0 (no pain) to 100 (worst possible pain). Topiramate (n = 214) or placebo (n = 109) was titrated to 400 mg daily or maximum tolerated dose. Short-acting rescue analgesics were permitted only during the first 6 weeks. Results: Baseline characteristics were comparable between groups except for mean body weight (topiramate, 101.4 kg; placebo, 95.7 kg; p = 0.028). Twelve weeks of topiramate treatment reduced PVA scale score (from 68.0 to 46.2 mm) more effectively than placebo (from 69.1 to 54.0 mm; p = 0.038). Fifty percent of topiramate-treated subjects and 34% of placebo-treated subjects responded to treatment, defined as >30% reduction in PVA scale score (p = 0.004). Topiramate monotherapy also reduced worst pain intensity (p = 0.003 vs placebo) and sleep disruption (p = 0.020 vs placebo). Diarrhea, loss of appetite, and somnolence were the most commonly reported adverse events in the topiramate group. Topiramate reduced body weight (-2.6 vs +0.2 kg for placebo; p < 0.001) without disrupting glycemic control. Conclusions: Topiramate monotherapy reduced pain and body weight more effectively than placebo in patients with painful diabetic neuropathy.

Original languageEnglish (US)
Pages (from-to)865-873
Number of pages9
JournalNeurology
Volume63
Issue number5
DOIs
StatePublished - Sep 14 2004

ASJC Scopus subject areas

  • Clinical Neurology

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    Raskin, P., Donofrio, P. D., Rosenthal, N. R., Hewitt, D. J., Jordan, D. M., Xiang, J., & Vinik, A. I. (2004). Topiramate vs placebo in painful diabetic neuropathy: Analgesic and metabolic effects. Neurology, 63(5), 865-873. https://doi.org/10.1212/01.WNL.0000137341.89781.14