Lacosamide may be useful for reducing diabetic neuropathy pain
MedWire News: Lacosamide reduces pain associated with diabetic neuropathy more than placebo and is well tolerated, report researchers.
However, in this study the benefits of lacosamide were not statistically significantly greater than placebo, they add.
Dan Ziegler (Heinrich Heine University, Düsseldorf, Germany) and colleagues randomly assigned 246 diabetic patients (Type 1 and Type 2) with moderate-to-severe neuropathic pain to receive placebo or oral lacosamide 400 or 600 mg/day in a 1:2:2 fashion.
The patients completed a 1-week washout period, followed by a 6-week titration period to the dose in question, and then a 12-week maintenance period.
The primary efficacy outcome of the study was intra-individual change in average daily pain score from baseline to the mean score over the last 4 weeks of the maintenance period.
Writing in the journal Diabetes Care, the team reports that the primary efficacy outcome was not met, as pain reduction was numerically, but not statistically greater with lacosamide treatment (400/600 mg/day) compared with placebo.
Both doses of the drug were significantly more effective than placebo over the titration, maintenance, and whole treatment period. At 18 weeks the mean reduction in pain score from baseline was 1.35, 1.50, and 1.70 points in the placebo, lacosamide 400 and 600 mg/day groups, respectively.
The authors say that “high placebo responses are not unusual in neuropathic pain studies” and suggest that an increased placebo response over the last 4 weeks of the study could explain the nonsignificant primary endpoint results.
Lacosamide was generally well tolerated, but at least 5% of the participants treated with lacosamide did experience adverse effects such as dizziness, fatigue, nausea, vertigo, headache, and vomiting, most of which appeared to be dose related.
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By Helen Albert