Results presented at the 27th Annual Meeting of the American Pain Society
SMYRNA, Ga., May 8 /PRNewswire/ -- Patients treated with lacosamide demonstrated sustained pain relief from diabetic neuropathic pain (DNP), compared to placebo-treated patients, according to data presented at the 27th annual meeting of the American Pain Society (APS) in Tampa, Fla.
"This is the first placebo-controlled trial of a diabetic neuropathic pain treatment providing evidence of long-term efficacy for more than one year in a withdrawal setting," said Tibor Hidvegi, MD, Medical Department, Petz Aladar Hospital, Gyor, Hungary. "These results are promising because more treatment options are needed for DNP, a debilitating complication of diabetes that can leave patients in discomfort."
This placebo-controlled, withdrawal study was a sub-trial of an open- label, follow-on (SP746) to a Phase III, double-blind trial (SP743). Patients had been followed for at least 16 months (mean 20 months) before entering the sub-trial. Prior to any lacosamide treatment, patients had an average daily pain score of 6.5. After more than a year of open-label treatment, the mean pain score was 2.5, the baseline score of the withdrawal sub-trial.
A total of 106 patients treated with lacosamide (100-400 mg/day) participated in the withdrawal study. In a blinded fashion, lacosamide treatment was withdrawn (less than or equal to 28 days) and reintroduced to these patients.
The primary endpoint was the change in average daily pain score from baseline (seven days prior to randomization) to the last seven days of each period, using the 11-point Likert pain scale, which ranges from zero (no pain) to 10 (worst possible pain).
The difference in average daily pain scores between lacosamide and
placebo was statistically significant and favored lacosamide (p= 0.007). In
addition, average daily pa
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