Efficacy and safety of lacosamide as first add-on or later adjunctive treatment for uncontrolled partial-onset seizures : A multicentre open-label trial
Zadeh, Wendy Waldman (Broadlawns Medical Center)
Escartín Siquier, Antonio E (Institut d'Investigació Biomèdica Sant Pau)
Byrnes, William (UCB Pharma)
Tennigkeit, Frank (UCB Pharma)
Borghs, Simon (UCB Pharma)
Li, Ting (UCB Pharma)
Dedeken, Peter (UCB Pharma)
De Backer, Marc (UCB Pharma)
Universitat Autònoma de Barcelona

Data:	2015
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Focal epilepsy ; Lacosamide ; Quality of life ; Seizure freedom
Publicat a:	Seizure, Vol. 31 (january 2015) , p. 72-79, ISSN 1532-2688

DOI: 10.1016/j.seizure.2015.07.001
PMID: 26362380

8 p, 494.3 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats