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

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.Adults with > or =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.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 > or =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.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.