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Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study
Article first published online: 4 MAY 2006
DOI: 10.1111/j.1600-0404.2006.00631.x
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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
Publication History
- Issue published online: 4 MAY 2006
- Article first published online: 4 MAY 2006
- Accepted for publication February 1, 2006
- Abstract
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Keywords:
- antiepileptic drug;
- diabetic neuropathy;
- neuropathic pain;
- oxcarbazepine;
- 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.