Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study
Article first published online: 4 MAY 2006
Acta Neurologica Scandinavica
Volume 113, Issue 6, pages 395–404, June 2006
How to Cite
Beydoun, A., Shaibani, A., Hopwood, M. and Wan, Y. (2006), Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study. Acta Neurologica Scandinavica, 113: 395–404. doi: 10.1111/j.1600-0404.2006.00631.x
- Issue published online: 4 MAY 2006
- Article first published online: 4 MAY 2006
- Accepted for publication February 1, 2006
- antiepileptic drug;
- diabetic neuropathy;
- neuropathic pain;
- randomized study
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.