Lacosamide safely decreases pain scores in patients with painful diabetic neuropathy, according to a pooled efficacy and safety analysis presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago.
Lacosamide safely decreases pain scores in patients with painful diabetic neuropathy, according to a pooled efficacy and safety analysis presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago.
More than half of diabetic patients with neuropathy respond suboptimally to the best treatments presently available, said Aziz Shaibani, MD, clinical assistant professor of medicine at Baylor College of Medicine in Houston, and lead investigator of the analysis.
Included in the analysis were three phase 3 trials; these studies enrolled patients who had a 6-month to 5-year history of pain caused by diabetic neuropathy and an average baseline pain intensity of ≥4 on the 11-point Likert pain scale. Patients in the studies were treated with lacosamide 400 mg/d or placebo for 12 weeks.
"The findings are encouraging when you consider that approximately 72% of patients in the study had used prior medications for diabetic neuropathic pain, and roughly 70% of them had poor responses to the earlier treatments," Dr Shaibani said.
Common side effects that occurred more often with lacosamide than with placebo included dizziness (13.6% vs 4.1%), fatigue (7.7% vs 6.2%), nausea (6.8% vs 5.2%), and tremor (5.9% vs 4.1%).
Lacosamide did not prolong the QT interval and did not produce significant leg or foot edema or somnolence, all of which commonly occur with drugs that are typically used to treat diabetic neuropathic pain, Dr Shaibani said.
Lacosamide is currently under review by FDA for the treatment of diabetic neuropathic pain and as adjunctive therapy for partial-onset seizures.
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