Authors: Beydoun, A.¹; Shaibani, A.²; Hopwood, M.³; Wan, Y.⁴

Source: Acta Neurologica Scandinavica, Volume 113, Number 6, June 2006 , pp. 395-404(10)

Publisher: Wiley-Blackwell

Abstract:

Beydoun A, Shaibani A, Hopwood M, Wan Y. Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study.

Acta Neurol Scand 2006: 113: 395–404.

© 2006 The Authors Journal compilation © 2006 Blackwell Munksgaard. 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.

Keywords: antiepileptic drug; diabetic neuropathy; neuropathic pain; oxcarbazepine; randomized study

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1600-0404.2006.00631.x

Affiliations: 1: American University of Beirut, Beirut, Lebanon 2: St Lukes Medical Tower, Houston, TX, USA 3: Clinical Research and Development, Novartis Pharmaceuticals Inc, East Hanover, NJ, USA 4: Biostatistics and Statistical Reporting, Novartis Pharmaceuticals Inc, East Hanover, NJ, USA

Publication date: 2006-06-01

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