Key Points
- There was a mean 2.5-point decrease in pain scores from the start to the end of treatment in the 285 lacosamide-treated patients
compared with a 1.80-point decrease in the 188 placebo-treated patients, a significant difference (P=.0006).
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.
There was a mean 2.5-point decrease in pain scores from the start to the end of treatment in the 285 lacosamide-treated patients
compared with a 1.80-point decrease in the 188 placebo-treated patients, a significant difference (P=.0006). Overall, approximately one-third of the patients who received lacosamide reported ≥50% pain reduction. "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.
