Efficacy and safety of lacosamide as first add-on or later adjunctive treatment for uncontrolled partial-onset seizures: A multicentre open-label trial
Por:
Zadeh, WW, Escartin, A, Byrnes, W, Tennigkeit, F, Borghs, S, Li, T, Dedeken, P, De Backer, M
Publicada:
1 sep 2015
Resumen:
Purpose: To evaluate the efficacy and safety of lacosamide administered as either first add-on or later add-on antiepileptic drug (AED) therapy for patients with uncontrolled partial-onset seizures (POS).
Methods: In this open-label, multicentre trial, patients with POS initiated oral lacosamide (titrated to 400 mg/day) either as add-on to first AED monotherapy, or as later add-on to 1-3 concomitant AEDs after >= 2 previous AEDs. The primary efficacy variable was the proportion of patients achieving seizure freedom for the first 12 weeks of the 24-week Maintenance Phase.
Results: 456 patients received >= 1 dose of lacosamide (96 as first add-on, 360 as later add-on). In the first add-on cohort, 27/72 (37.5%) patients completed 12 weeks treatment and remained seizure-free; 18/68 (26.5%) remained seizure-free after 24 weeks. 64/91 (70.3%) patients achieved >= 50% reduction in seizure frequency during maintenance treatment. This was accompanied by a mean 7.1 +/- 16.00 point improvement from Baseline in the Quality of Life Inventory in Epilepsy (QOLIE-31-P) total score for 24-week completers, with improvement reported in all subscales. Most common treatment-emergent adverse events (TEAEs) were dizziness (31.3%) and headache (13.5%). In the later add-on cohort, 39/261 (14.9%) and 29/249 (11.6%) patients remained seizure-free after completing 12 and 24 weeks' treatment, respectively. 178/353 (50.4%) patients achieved >= 50% reduction in seizure frequency during maintenance treatment. Mean change in QOLIE-31-P total score was 4.8 +/- 14.74 points among 24-week completers. Common TEAEs were dizziness (33.6%), somnolence (15.0%) and headache (11.4%).
Conclusions: Lacosamide initiated as first add-on treatment was efficacious and well tolerated in patients with uncontrolled POS. (C) 2015 The Authors. ISDN. Published by Elsevier Ltd.
Filiaciones:
Zadeh, WW:
Broadlawns Med Ctr, Des Moines, IA 50314 USA
Escartin, A:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona 08025, Spain
Byrnes, W:
UCB Pharma, Raleigh, NC 27617 USA
Tennigkeit, F:
UCB Pharma, D-40789 Monheim, Germany
Borghs, S:
UCB Pharma, Slough SL1 3WE, Berks, England
Li, T:
UCB Pharma, Raleigh, NC 27617 USA
Dedeken, P:
UCB Pharma, B-1070 Brussels, Belgium
De Backer, M:
UCB Pharma, B-1070 Brussels, Belgium
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