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| |  Investigational Lacosamide Reduces Diabetic Neuropathic Pain: Presented at AAN By Ed Susman CHICAGO -- April 17, 2008 -- The antiepileptic drug lacosamide appears to offer substantial pain relief to a majority of diabetic patients with neuropathic pain, according to results of a pooled analysis of four phase 2 and 3 studies involving more than 1,200 patients. "These studies show that lacosamide has long-term pain relief benefits for individuals with diabetic neuropathy," said Aziz Shaibani, MD, Clinical Assistant Professor of Medicine, Baylor College of Medicine, Houston, Texas. In his poster presentation on April 15 at the American Academy of Neurology (AAN) 60th Annual Meeting, Dr. Shaibani said that 3 of the studies scrutinised outcomes of diabetic patients treated for neuropathic pain after 20 weeks of therapy. Most trials of diabetic neuropathic pain are only performed for 8 weeks, so Dr. Shaibani said these studies with lacosamide show that the efficacy of the drug can be maintained for a longer period of time. Dr. Shaibani and his colleagues reviewed data on the 400-mg dose of lacosamide and compared results with placebo in the double-blind studies of the drug. "This analysis of phase 2 and 3, placebo-controlled, clinical trials suggests that 400 mg/day lacosamide is consistently effective and well tolerated in the treatment of diabetic neuropathic pain," he said. In the pooled trials, the mean reduction of pain from baseline to the end of the trials as measured on the Likert Pain Scores was 1.8 points for the 188 patients assigned to placebo compared with 2.5 points among the 285 patients on the 400-mg dose of lacosamide (P < .001), Dr. Shaibani said. About 13.6% of patients assigned to lacosamide and 5.2% of placebo patients experienced dizziness as the major adverse event, he said. Dr. Shaibani said that severe dizziness was reported by 1 patient taking lacosamide 400 mg a day. Serious adverse events involving the cardiac and nervous systems were few and occurred at about the same rate in placebo patients as among those on the active drug. Locasomide is undergoing regulatory review in the United States and Europe. Funding for the studies were provided by Schwartz Biosciences Inc, a member of the UCB Group. [Presentation title: Evaluation of Lacosamide in Diabetic Neuropathic Pain Trials. Abstract P03.158]
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