[Monotherapy with gabapentin ++]

Gabapentin is an anti-epileptic drug approved in the USA in December 1993 as an additional treatment for patients with crises of partial onset. Recently it has been approved for use as monotherapy. We review the characteristics of this molecule as an anti-epileptic drug and the clinical trials which have permitted approval of the current indications.

We review the particular difficulties of designing trials using monotherapy, both for ethical reasons (problems with the use of a placebo) and for technical reasons and those of interpretation (problems comparing two drugs with equivalent results) and analyze the trials in which attempts were made to overcome these difficulties. A trial designed to replace polytherapy in drug-resistant patients by monotherapy did not show conclusive results, although they were suggestive. A trial of patients admitted for pre-surgical studies permitted verification of the efficacy and safety of higher doses (3,600 mg/day) than those previously used (800-2,400 mg/day). Another trial, this time of newly diagnosed patients, permitted verification of the efficacy and safety of gabapentin used in different dosages.

Gabapentin is effective when used as monotherapy. The dose recommended for the initial treatment of newly-diagnosed patients is 900 mg/day. It has a better safety profile than carbamazepine and is indicated in simple and complex partial crises with or without secondary generalization.