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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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  S. Perry, P. Holt, and M. Benatar Levetiracetam Versus Carbamazepine Monotherapy for Partial Epilepsy in Children Less Than 16 Years of Age J Child Neurol, May 1, 2008; 23(5): 515 - 519. [Abstract] [PDF]
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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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 Levetiracetam Noninferior to Carbamazepine for Newly Diagnosed Epilepsy Journal Watch Neurology, May 22, 2007; 2007(522): 2 - 2. [Full Text]
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