Lacosamide in patients with epilepsy of cerebrovascular etiology.
antiepileptic drugs
elderly
epilepsy
lacosamide
seizures
stroke
Journal
Acta neurologica Scandinavica
ISSN: 1600-0404
Titre abrégé: Acta Neurol Scand
Pays: Denmark
ID NLM: 0370336
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
11
11
2019
revised:
28
01
2020
accepted:
14
02
2020
pubmed:
19
2
2020
medline:
1
9
2020
entrez:
19
2
2020
Statut:
ppublish
Résumé
To assess tolerability and efficacy of lacosamide in adults with cerebrovascular epilepsy etiology (CVEE). Exploratory post hoc analyses of a double-blind, initial monotherapy trial of lacosamide vs carbamazepine-controlled release (carbamazepine-CR) (SP0993; NCT01243177); a double-blind conversion to lacosamide monotherapy trial (SP0902; NCT00520741); and an observational study of adjunctive lacosamide added to one antiepileptic drug (SP0973 VITOBA; NCT01098162). Patients with CVEE were identified based on epilepsy etiology recorded at baseline. In the initial monotherapy trial, 61 patients had CVEE (lacosamide: 27; carbamazepine-CR: 34). 20 (74.1%) patients on lacosamide (27 [79.4%] on carbamazepine-CR) reported treatment-emergent adverse events (TEAEs), most commonly (≥10%) headache, dizziness, and fatigue (carbamazepine-CR: headache, dizziness). A numerically higher proportion of patients on lacosamide than carbamazepine-CR completed 6 months (22 [81.5%]; 20 [58.8%]) and 12 months (18 [66.7%]; 17 [50.0%]) treatment without seizure at last evaluated dose. In the conversion to monotherapy trial, 26/30 (86.7%) patients with CVEE reported TEAEs, most commonly (≥4 patients) dizziness, convulsion, fatigue, headache, somnolence, and cognitive disorder. During lacosamide monotherapy, 17 (56.7%) patients were 50% responders and six (20.0%) were seizure-free. In the observational study, 36/83 (43.4%) patients with CVEE reported TEAEs, most commonly (≥5%) fatigue and dizziness. Effectiveness was assessed for 75 patients. During the last 3 months, 60 (80%) were 50% responders and 42 (56.0%) were seizure-free. These exploratory post hoc analyses suggested lacosamide was generally well tolerated and effective in patients with CVEE, with data from the initial monotherapy trial suggesting numerically better efficacy than carbamazepine-CR.
Substances chimiques
Anticonvulsants
0
Carbamazepine
33CM23913M
Lacosamide
563KS2PQY5
Types de publication
Clinical Trial, Phase III
Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
473-482Subventions
Organisme : UCB Pharma
Informations de copyright
© 2020 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd.
Références
Forsgren L, Beghi E, Oun A, Sillanpää M. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005;12:245-253.
Hauser WA, Annegers JF, Kurland LT. Incidence of epilepsy and unprovoked seizures in Rochester, Minnesota: 1935-1984. Epilepsia. 1993;34:453-468.
Zelano J. Poststroke epilepsy: update and future directions. Ther Adv Neurol Disord. 2016;9:424-435.
Larsson D, Åsberg S, Kumlien E, Zelano J. Retention rate of first antiepileptic drug in poststroke epilepsy: a nationwide study. Seizure. 2019;64:29-33.
Gibson LM, Hanby MF, Al-Bachari SM, Parkes LM, Allan SM, Emsley HC. Late-onset epilepsy and occult cerebrovascular disease. J Cereb Blood Flow Metab. 2014;34:564-570.
Brigo F, Lattanzi S, Zelano J, et al. Randomized controlled trials of antiepileptic drugs for the treatment of post-stroke seizures: a systematic review with network meta-analysis. Seizure. 2018;61:57-62.
Holtkamp M, Beghi E, Benninger F, Kalviainen R, Rocamora R, Christensen H. European Stroke Organisation guidelines for the management of post-stroke seizures and epilepsy. Eur Stroke J. 2017;2:103-115.
UCB INC. Vimpat® (lacosamide) US Prescribing Information. UCB Inc; 2019.
UCB PHARMA SA. Vimpat® (lacosamide) summary of product characteristics. 2018.
Mazzocchetti P, Tantucci M, Bastioli G, et al. Lacosamide protects striatal and hippocampal neurons from in vitro ischemia without altering physiological synaptic plasticity. Neuropharmacology. 2018;135:424-430.
Ahn JY, Yan BC, Park JH, et al. Novel antiepileptic drug lacosamide exerts neuroprotective effects by decreasing glial activation in the hippocampus of a gerbil model of ischemic stroke. Exp Ther Med. 2015;10:2007-2014.
Kim GH, Byeon JH, Eun BL. Neuroprotective effect of lacosamide on hypoxic-ischemic brain injury in neonatal rats. J Clin Neurol. 2017;13:138-143.
Belcastro V, Vidale S, Pierguidi L, et al. Intravenous lacosamide as treatment option in post-stroke non convulsive status epilepticus in the elderly: a proof-of-concept, observational study. Seizure. 2013;22:905-907.
Baulac M, Rosenow F, Toledo M, et al. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017;16:43-54.
Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55:1088-1098.
Runge U, Arnold S, Brandt C, et al. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: the VITOBA study. Epilepsia. 2015;56:1921-1930.
Rudd GD, Haverkamp W, Mason JW, et al. Lacosamide cardiac safety: clinical trials in patients with partial-onset seizures. Acta Neurol Scand. 2015;132:355-363.
Isojärvi JI, Pakarinen AJ, Myllylä VV. Serum lipid levels during carbamazepine medication. A prospective study. Arch Neurol. 1993;50:590-593.
Brämswig S, Sudhop T, Luers C, von Bergmann K, Berthold HK. Lipoprotein(a) concentration increases during treatment with carbamazepine. Epilepsia. 2003;44:457-460.
Dimova S, Zhang Y, Steiniger-Brach B, et al. Lipid levels during lacosamide and controlled-release carbamazepinemonotherapy: post-hoc analysis of a prospective randomized double-blind trial. 71st Annual Meeting of the American Epilepsy Society. 2017:Abstract 1.284.
Elger CE, Rademacher M, Brandt C, et al. Changes in hormone and lipid levels in male patients with focal seizures when switched from carbamazepine to lacosamide as adjunctive treatment to levetiracetam: a small phase IIIb, prospective, multicenter, open-label trial. Epilepsy Behav. 2016;62:1-5.
Cawello W. Clinical pharmacokinetic and pharmacodynamic profile of lacosamide. Clin Pharmacokinet. 2015;54:901-914.
Cawello W, Stockis A, Andreas JO, Dimova S. Advances in epilepsy treatment: lacosamide pharmacokinetic profile. Ann N Y Acad Sci. 2014;1329:18-32.