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

196 Citations (Scopus)

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
StatePublished - Sep 14 2004

Fingerprint

Diabetic Neuropathies
Analgesics
Placebos
Pain
Body Weight
Pain Measurement
Short-Acting Analgesics
topiramate
Maximum Tolerated Dose
Appetite
Diarrhea
Sleep

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

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.

Topiramate vs placebo in painful diabetic neuropathy : Analgesic and metabolic effects. / Raskin, Philip; Donofrio, P. D.; Rosenthal, N. R.; Hewitt, D. J.; Jordan, D. M.; Xiang, J.; Vinik, A. I.

In: Neurology, Vol. 63, No. 5, 14.09.2004, p. 865-873.

Research output: Contribution to journalArticle

Raskin, P, Donofrio, PD, Rosenthal, NR, Hewitt, DJ, Jordan, DM, Xiang, J & Vinik, AI 2004, 'Topiramate vs placebo in painful diabetic neuropathy: Analgesic and metabolic effects', Neurology, vol. 63, no. 5, pp. 865-873.
Raskin P, Donofrio PD, Rosenthal NR, Hewitt DJ, Jordan DM, Xiang J et al. Topiramate vs placebo in painful diabetic neuropathy: Analgesic and metabolic effects. Neurology. 2004 Sep 14;63(5):865-873.
Raskin, Philip ; Donofrio, P. D. ; Rosenthal, N. R. ; Hewitt, D. J. ; Jordan, D. M. ; Xiang, J. ; Vinik, A. I. / Topiramate vs placebo in painful diabetic neuropathy : Analgesic and metabolic effects. In: Neurology. 2004 ; Vol. 63, No. 5. pp. 865-873.
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AU - Hewitt, D. J.

AU - Jordan, D. M.

AU - Xiang, J.

AU - Vinik, A. I.

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N2 - 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.

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