Topiramate Decreased Pain and Sleep Disruption in Painful Diabetic Neuropathy

This 12-week, multicenter, randomized double-blind clinical trial included 323 subjects with painful diabetic neuropathy (PDN). Patients were given either Topiramate (214 patients) or placebo (109 patients) at a dosage of up to 400 mg daily or the maximum tolerated dose. Twelve weeks of topiramate treatment reduced pain scores more effectively than placebo. Fifty percent of topiramate-treated subjects and 34% of placebo-treated subjects responded to treatment, defined as a greater than 30% reduction in pain scores. Topiramate also reduced worst pain intensity and sleep disruption. Diarrhea, loss of appetite, and drowsiness were the most commonly reported adverse events in the topiramate group. Topiramate reduced body weight without disrupting glycemic control. Raskin P, Donofrio PD, Rosenthal NR, et al. Neurology. 63(5):865-73, 2004.