title: Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years.
abstract: Long-term (up to 8 years of exposure) safety and efficacy of the antiepileptic drug lacosamide was evaluated in this open-label extension trial (SP615 [ClinicalTrials.gov identifier: NCT00552305]). Patients were enrolled following participation in a double-blind trial or one of two open-label trials of adjunctive lacosamide for partial-onset seizures. Dosage adjustments of lacosamide (100-800 mg/day) and/or concomitant antiepileptic drugs were allowed to optimize tolerability and seizure reduction. Of the 370 enrolled patients, 77%, 51%, and 39% had >1, >3, or >5 years of lacosamide exposure, respectively. Median lacosamide modal dose was 400mg/day. Common treatment-emergent adverse events (TEAEs) were dizziness (39.7%), headache (20.8%), nausea (17.3%), diplopia (17.0%), fatigue (16.5%), upper respiratory tract infection (16.5%), nasopharyngitis (16.2%), and contusion (15.4%). Dizziness (2.2%) was the only TEAE that led to discontinuation in >2% of patients. Ranges for median percent reductions in seizure frequency were 47-65%, and those for ≥ 50% responder rates were 49-63% for 1-, 3-, and 5-year completer cohorts. Exposure to lacosamide for up to 8 years was generally well tolerated, with a safety profile similar to previous double-blind trials, and efficacy was maintained.
authors.affiliation: Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield, MO 63017, USA. Electronic address: werosenfeld@msn.com.
authors.forename: William
authors.initials: W
authors.lastname: Rosenfeld
authors.affiliation: University of Virginia School of Medicine, Charlottesville, VA 22908, USA.
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Fountain
authors.affiliation: Faculty of Medicine, Clinic of Neurology and Neurosurgery, Vilnius University, Vilnius, Lithuania.
authors.forename: Gintaras
authors.initials: G
authors.lastname: Kaubrys
authors.affiliation: Institute of Clinical Neurosciences, Division of Neurology, Sahlgrenska Academy, Göteborg University, Göteborg, Sweden.
authors.forename: Elinor
authors.initials: E
authors.lastname: Ben-Menachem
authors.affiliation: UCB Pharma, Raleigh, NC 27617, USA.
authors.forename: Cindy
authors.initials: C
authors.lastname: McShea
authors.affiliation: UCB Pharma, Raleigh, NC 27617, USA.
authors.forename: Jouko
authors.initials: J
authors.lastname: Isojarvi
authors.affiliation: UCB Pharma, Raleigh, NC 27617, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Doty
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D012640:Seizures / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Antiepileptic drug; Epilepsy; Lacosamide; Partial-onset seizures