1. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy
- Author
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Brodie, M. J, Perucca, E, Ryvlin, P, Ben Menachem, E, Meencke, H. J, Van Landegem, W, Ossemann, M, Sadzot, B, Van Paesschen, W, Van Zandijcke, M, Hovorka, J, Marusic, P, Pazdera, L, Rektor, I, Stolcova, E, Tislerova, D, Kalviainen, R, Korpelainen, J, Peltola, J, Ranua, J, Geraud, G, Hirsch, E, Josien, E, Vercueil, L, Vespignani, H, Jeschke Rohrich, B, Keidel, M, Mattern, W, Ochs, G, Schmitz, B, Schumann, G, Balogh, A, Clemens, B, Czopf, J, Halasz, P, Rajna, P, Vecsei, L, Baruzzi, A, Beghi, A. E, Canevini, M. P, De Feo, M. R, Lamberti, P, Marciani, M. G, Marrosu, F, Mazza, Salvatore, Monaco, F, Mutani, R, Regesta, G, Zaccara, G, Drozdowski, W, Fryze, W, Jedrzejczak, J, Nowaki, P, Selmaj, K, Stelmasiak, Z, Wajgt, A, Bryer, A, Coetzee, C, Gardiner, J, Haug, P, Isaacs, M, Kelbe, C, Modi, G, Opperman, D, Shah, N, Wolberg, S, Arbizu, T, Forcadas, I, Macin Eiras, J. L, Martinez, M, Marti Masso, J. F, Molins, A, Serratosa, J. M, Borre, B, Kallen, K, Kumlien, E, Lindberger, M, Palm, R, Carpay, J. A, Sanders, E. A. C. M, Van Leusden, J. A, Vecht, C, Roberts, R. C, Smith, P, and Tidswell, P.
- Subjects
business.industry ,levetiracetam ,oxcarbazepine ,Carbamazepine ,medicine.disease ,law.invention ,Epilepsy ,Settore MED/26 - NEUROLOGIA ,Tolerability ,Randomized controlled trial ,law ,Anesthesia ,Clinical endpoint ,Medicine ,epilepsy ,Neurology (clinical) ,Levetiracetam ,business ,Adverse effect ,Oxcarbazepine ,medicine.drug - Abstract
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.
- Published
- 2007