title: Levetiracetam extended release for the treatment of patients with partial-onset seizures: A long-term, open-label follow-up study.
abstract: This was an open-label study (N01281 [NCT00419393]) assessing the long-term safety of extended-release levetiracetam (LEV XR) in patients with partial-onset seizures (POS); the study was a follow-up to a double-blind, randomized, historical controlled, multicenter, conversion to monotherapy study (N01280 [NCT00419094]). Eligible patients initially received LEV XR 2000 mg/day; dose adjustments and the addition of other antiepileptic drugs (AEDs) were permitted. Overall, 190 patients were enrolled, 189 (99.5%) received LEV XR (safety and efficacy populations) and 166 patients (87.4%) completed the study. The study duration in completed patients was 5.5-24.6 months. Mean daily dose of LEV XR was 2131 mg/day. Treatment-emergent adverse events (TEAEs) occurred in 126 patients (66.7%); most were of mild or moderate severity. Five patients (2.6%) had a TEAE that led to treatment discontinuation. Treatment-emergent serious adverse events occurred in 22 patients (11.6%). Twenty-six patients (13.8%) experienced a psychiatric TEAE. The median 7-day normalized POS frequency was: 1.38 at N01280 study baseline; 0.50 at the first visit of N01281 (last visit of N01280); and 0.00-0.36 between all subsequent visits. Overall, 171 patients (90.5%) entered the N01281 study on LEV XR monotherapy; 65.3% (32/49) of patients remained on monotherapy for 12 months and 47.1% (8/17) for 18 months. While remaining on LEV XR monotherapy, 27/139 patients (19.4%) were seizure-free at 6 months and 8/49 (16.3%) at 12 months. In conclusion, LEV XR was well tolerated when administered as long-term monotherapy or in combination with other AEDs in patients with inadequately controlled POS.
authors.affiliation: Banner University Medical Center, 111 E. McDowell Road, Phoenix, AZ 85006, USA. Electronic address: Steve.Chung@bannerhealth.com.
authors.forename: Steve
authors.initials: S
authors.lastname: Chung
authors.affiliation: Pediatric Neurology Department, Hospital Civil de Guadalajara, Coronel Calderón 777, Col. El Retiro, Guadalajara, Jalisco, Mexico. Electronic address: Dr_Ceja@hotmail.com.
authors.forename: Hugo
authors.initials: H
authors.lastname: Ceja
authors.affiliation: Department of Neurology, Medical University of Lublin, Lublin, Poland. Electronic address: JGawlowicz@yahoo.com.
authors.forename: Jacek
authors.initials: J
authors.lastname: Gawłowicz
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Cindy.McShea@ucb.com.
authors.forename: Cindy
authors.initials: C
authors.lastname: McShea
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Jimmy.Schiemann@ucb.com.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Schiemann
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Sarah.h.Lu@gsk.com.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lu
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D012640:Seizures / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D000077287:Levetiracetam; D010889:Piracetam
keywords: Antiepileptic drug; Extended release; Levetiracetam; Long-term; Monotherapy; Partial-onset seizures