1. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy.
- Author
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Trinka E, Marson AG, Van Paesschen W, Kälviäinen R, Marovac J, Duncan B, Buyle S, Hallström Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, and Pohlmann-Eden B
- Subjects
- Adult, Anticonvulsants adverse effects, Carbamazepine adverse effects, Delayed-Action Preparations, Dose-Response Relationship, Drug, Drug Administration Schedule, Electroencephalography drug effects, Epilepsies, Partial diagnosis, Epilepsy, Generalized diagnosis, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Levetiracetam, Male, Middle Aged, Patient Dropouts, Piracetam adverse effects, Piracetam therapeutic use, Quality of Life, Signal Processing, Computer-Assisted, Valproic Acid adverse effects, Anticonvulsants therapeutic use, Carbamazepine therapeutic use, Epilepsies, Partial drug therapy, Epilepsy, Generalized drug therapy, Piracetam analogs & derivatives, Valproic Acid therapeutic use
- Abstract
Objective: To compare the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients with newly diagnosed epilepsy., Methods: This unblinded, randomised, 52-week superiority trial (NCT00175903) recruited patients (≥16 years of age) with ≥2 unprovoked seizures in the previous 2 years and ≥1 in the previous 6 months. The physician chose VPA or CBZ as preferred standard treatment; each patient was randomised to standard treatment or LEV. The primary outcome was time to treatment withdrawal (LEV vs standard antiepileptic drugs (AEDs)). Analyses also compared LEV with VPA-ER, and LEV with CBZ-CR., Findings: 1688 patients (mean age 41 years; 44% female) were randomised to LEV (n=841) or standard AEDs (n=847). Time to treatment withdrawal was not significantly different between LEV and standard AEDs: HR (95% CI) 0.90 (0.74 to 1.08). Time to treatment withdrawal (HR (95% CI)) was 1.02 (0.74 to 1.41) for LEV/VPA-ER and 0.84 (0.66 to 1.07) for LEV/CBZ-CR. Time to first seizure (HR, 95% CI) was significantly longer for standard AEDs, 1.20 (1.03 to 1.39), being 1.19 (0.93 to 1.54) for LEV/VPA-ER and 1.20 (0.99 to 1.46) for LEV/CBZ-CR. Estimated 12-month seizure freedom rates from randomisation: 58.7% LEV versus 64.5% VPA-ER; 50.5% LEV versus 56.7% CBZ-CR. Similar proportions of patients within each stratum reported at least one adverse event: 66.1% LEV versus 62.0% VPA-ER; 73.4% LEV versus 72.5% CBZ-CR., Conclusions: LEV monotherapy was not superior to standard AEDs for the global outcome, namely time to treatment withdrawal, in patients with newly diagnosed focal or generalised seizures.
- Published
- 2013
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