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Title: Topiramate Shows Neuroprotective Effect in Diabetic Patients: Presented at IDF

"Topiramate Shows Neuroprotective Effect in Diabetic Patients: Presented at IDF"

By Jill Stein PARIS, FRANCE -- August 25, 2003 -- Topiramate may reverse the cytotoxic effects of sera and improve/restore neuronal function in patients with diabetic neuropathy. This finding was reported on today at the Eighteenth International Diabetes Federation Congress. Dr. Aaron Vinik, with the Strelitz Diabetes Institute in Norfolk, Virginia, United States, presented the results of an open-label trial in 11 patients with type 2 diabetes and C-fibre neuropathy. Because standard neuropathy tests cannot quantify C-fibre dysfunction, the study used quantitative sensory testing and neuropathy symptom scores, focusing on those aspects with the highest sensitivity for C-fibre dysfunction. To assess topiramate's effects on C-fibre structure, skin biopsies were taken to measure the density of unmyelinated nerve fibres, using immunohistochemistry with PGP-9.5 as a neuronal marker for C fibres. After a 4-week baseline phase, topiramate was started at 25 mg/d and increased to a target dose of 100 mg/d or maximum tolerated dose over 6 weeks; the dosage was maintained for the duration of the 18-week study. After 8 weeks of treatment, topiramate significantly increased intra-epidermal nerve fibre density (p < 0.04), dendrite length (p < 0.04), and conduction amplitude (p < 0.04), and improved symptoms of C- fibre dysfunction (p=0.04). Topiramate treatment also improved metabolic parameters, with significant decreases in diastolic blood pressure, haemoglobin A1 C, and total cholesterol. Side effects were consistent with clinical experience, and no serious side effects were reported. "Although our findings need to be validated by other investigators and in controlled clinical trials, the observations that topiramate may block neurotoxic factors present in diabetic neuropathy, stimulate neuronal regeneration, and improve neuronal function, while normalizing components of the dysmetabolic syndrome, suggest a potential role for topiramate in modifying the outcomes of diabetic neuropathy," Dr. Vinik said. Topiramate is a novel neurotherapeutic with clinical uses in various neuropsychiatric disorders, including epilepsy, migraine, and certain impulse control disorders. [Study title: Neuroprotective effects of novel neurotherapeutic topiramate in diabetic patients. Abstract 918]

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