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From the University of Texas Southwestern Medical Center at Dallas (Dr. Raskin), Dallas, TX; Bowman Gray School of Medicine (Dr. Donofrio), Winston-Salem, NC; Ortho-McNeil Pharmaceutical, Inc. (Drs. Rosenthal, Hewitt, and Xiang, D.M. Jordan), Raritan, NJ; and Eastern Virginia Medical School (Dr. Vinik), Norfolk, VA.
Address correspondence and reprint requests to Dr. Philip Raskin, Professor of Medicine, Clifton and Betsy Robinson Chair in Biomedical Research, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75390-8858; email: Philip.Raskin{at}UTSouthwestern.edu
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.
Received December 17, 2003. Accepted in final form May 14, 2004.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the September 14 issue to find the link for this article.
*See Appendix E-1 on the NeurologyWeb site.
Related Article
Neurology 2004 63: 766-767.
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