Abstract
Safety and Efficacy of Two Pregabalin Regimens for Add-on Treatment of Partial Epilepsy Beydoun A, Uthman BM, Kugler AR, Greiner MJ, Knapp LE, Garofalo EA; Pregabalin 1008-009 Study Group Neurology 2005;64:475–480 Objective To evaluate the efficacy, tolerability, and safety of two pregabalin regimens administered as adjunctive therapy to that of placebo in patients with medically refractory partial epilepsy. Methods A multicenter, double-blind, randomized, parallel-group, placebo-controlled trial was performed. After a prospective 8-week baseline phase, patients were randomized to 12 weeks of double-blind treatment with placebo or pregabalin, 600 mg/day, administered twice daily (BID) or 3 times daily (TID). Primary efficacy was measured as change in seizure frequency from baseline of either pregabalin regimen compared with placebo. Secondary efficacy comparisons included the proportion of patients experiencing ≥50% reduction in seizure frequency (responder rate) and median percentage change from baseline in seizure frequency. Safety/tolerability assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory evaluation. Efficacy and safety analyses were performed on the intent-to-treat (ITT) population. Results Pregabalin treatment resulted in seizure frequency reductions: 53% for pregabalin TID ( P ≤ 0.0001) and 44% for pregabalin BID ( P ≤ 0.0001) compared with a 1% increase for placebo. Responder rates were 49% for pregabalin TID and 43% for pregabalin BID compared with 9% for placebo ( P ≤ 0.001). Both pregabalin regimens were similar in efficacy and tolerability. The most common AEs were dizziness, somnolence, and ataxia. Conclusions Pregabalin administered at 600 mg/day is safe, generally well tolerated, and efficacious as adjunctive therapy for the treatment of patients with partial seizures, with or without secondary generalizations. This dose can be administered on a twice-daily or 3-times-daily schedule with similar efficacy and tolerability results.
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