Abstracts

RATIONALE:_ The ultimate goal in the treatment of epilepsy is cessation of seizures. However, few refractory patients become seizure-free during short-term clinical trials, reduction of events by at least 50% is considered a good response in this population. Never the less seizure free rates are important to report. The numbers of patients who achieved 100%, ?75% and ?50% reduction in seizures during levetiracetam (LEV) trials were calculated. METHODS:_ Data from three placebo-controlled clinical trials (N132, N051, N138) were further analyzed to determine 100% and ?75% response during the treatment period (titration + evaluation). LEV doses were 1000, 2000 & 3000 mg/day versus placebo added to standard treatments. RESULTS:_ Twenty-six patients (N=592) (4.4%; P=<0.001) became seizure-free taking LEV compared to one patient (N=312) (0.3%) taking placebo. By comparison, 102/589 patients (17.3%; P=<0.001) taking LEV achieved 75% seizure reduction compared to 8/310 patients (3.3%) taking placebo. Using the standard ?50% reduction definition, 206/589 LEV patients (35.0%; P=<0.001) and 29/310 placebo patients (9.4%) responded. Differences between LEV and placebo groups were 4.1%, 14.0% and 25.6%, respectively. CONCLUSIONS: _These analyses demonstrated that although the patients enrolled in the well controlled clinical trials had been poorly controlled on previous treatment regimens, addition of LEV provided a good response for many patients at doses of 1000, 2000 & 3000 mg/day.