Premium
Oxcarbazepine in painful diabetic neuropathy: results of a dose‐ranging study
Author(s) -
Beydoun A.,
Shaibani A.,
Hopwood M.,
Wan Y.
Publication year - 2006
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.2006.00631.x
Subject(s) - oxcarbazepine , medicine , placebo , visual analogue scale , statistical significance , dose ranging study , diabetic neuropathy , anesthesia , randomized controlled trial , double blind , diabetes mellitus , epilepsy , carbamazepine , endocrinology , alternative medicine , pathology , psychiatry
Objectives – To evaluate the efficacy and safety of oxcarbazepine in patients with diabetic neuropathy in a multicenter, double‐blind, placebo‐controlled, dose‐ranging 16‐week study. Methods – A total of 347 patients were randomized to oxcarbazepine 600 mg/day ( n = 83), 1,200 mg/day ( n = 87), 1,800 mg/day ( n = 88), or placebo ( n = 89). The primary efficacy variable was change in mean visual analog scale (VAS) score from baseline to the last week of the study. Results – No difference between any oxcarbazepine group and the placebo group was noted for the primary efficacy variable. Both the 1,200‐ and 1,800‐mg/day groups showed a trend toward statistical significance ( P = 0.101, P = 0.096, respectively). Statistically significant differences were found between the oxcarbazepine 1,200‐mg/day ( P = 0.038) and 1,800‐mg/day ( P = 0.005) groups and placebo in the overall mean weekly VAS scores for the entire double‐blind treatment phase. Conclusions – Although the primary efficacy variable did not reach statistical significance, patients taking oxcarbazepine 1,200 and 1,800 mg/day showed improvements in VAS scores compared with placebo. Oxcarbazepine may provide clinically meaningful pain relief in patients with painful diabetic neuropathy.