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This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 68, Number 6, February 6, 2007 Italian Translation Italian Data Supplement Correspondence: Submit a response Correspondence: View responses Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Brodie, M. J. Search for Related Content PubMed PubMed Citation Articles by Brodie, M. J. Related Collections Parkinson's disease/Parkinsonism Surgery/Stimulation

Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy

From the Epilepsy Unit, Western Infirmary, Glasgow, Scotland (M.J.B.); Institute of Neurology, IRCCS C, Mondino Foundation and Clinical Pharmacology Unit, University of Pavia, Pavia, Italy (E.P.); Hospices Civils de Lyon, Lyon, France (P.R.); Sahlgren University Hospital, Göteborg, Sweden (E.B.-M.); and Epilepsy Centre of Berlin, Berlin, Germany (H.-J.M.).

Address correspondence and reprint requests to Dr. Martin J. Brodie, Epilepsy Unit, Western Infirmary, Glasgow, G11 6NT, Scotland, UK; e-mail: mjb2k{at}clinmed.gla.ac.uk

Objective: We report the results of a prospective study of the efficacy and tolerability of levetiracetam, a new antiepileptic drug with a unique mechanism of action, in comparison with controlled-release carbamazepine as first treatment in newly diagnosed epilepsy.

Methods: Adults with 2 partial or generalized tonic–clonic seizures in the previous year were randomly assigned to levetiracetam (500 mg twice daily, n = 288) or controlled-release carbamazepine (200 mg twice daily, n = 291) in a multicenter, double-blind, noninferiority, parallel-group trial. If a seizure occurred within 26 weeks of stabilization, dosage was increased incrementally to a maximum of levetiracetam 1,500 mg twice daily or carbamazepine 600 mg twice daily. Patients achieving the primary endpoint (6-month seizure freedom) continued on treatment for a further 6-month maintenance period.

Results: At per-protocol analysis, 73.0% (56.6%) of patients randomized to levetiracetam and 72.8% (58.5%) receiving controlled-release carbamazepine were seizure free at the last evaluated dose (adjusted absolute difference 0.2%, 95% CI –7.8% to 8.2%) for 6 months (1 year). Of all patients achieving 6-month (1-year) remission, 80.1% (86.0%) in the levetiracetam group and 85.4% (89.3%) in the carbamazepine group did so at the lowest dose level. Withdrawal rates for adverse events were 14.4% with levetiracetam and 19.2% with carbamazepine.

Conclusions: Levetiracetam and controlled-release carbamazepine produced equivalent seizure freedom rates in newly diagnosed epilepsy at optimal dosing in a setting mimicking clinical practice. This trial has confirmed in a randomized, double-blind setting previously uncontrolled observations that most people with epilepsy will respond to their first-ever antiepileptic drug at low dosage.

*See the appendix for the list of investigators.

Disclosure: This study was sponsored by UCB SA, who were involved in the design and conduct of the study; collection, management, and analysis of the data; and preparation and review of the manuscript. Drs. Brodie and Perucca have received grants from UCB Pharma exceeding $10,000. All authors have received honoraria from UCB SA.

Received June 2, 2006. Accepted in final form October 5, 2006.

This article has been cited by other articles:

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				N. K. Sethi, J. Torgovnick, E. Arsura, M .J. Brodie, E . Perucca, P . Ryvlin, E . Ben-Menachem, and H .-J. Meenche COMPARISON OF LEVETIRACETAM AND CONTROLLED-RELEASE CARBAMAZEPINE IN NEWLY DIAGNOSED EPILEPSY Neurology, August 28, 2007; 69(9): 937 - 938. [Full Text] [PDF]

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