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

201 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

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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 - Raskin, Philip

AU - Donofrio, P. D.

AU - Rosenthal, N. R.

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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