Lacosamide in patients with epilepsy of cerebrovascular etiology.

Abstract

OBJECTIVES:

To assess tolerability and efficacy of lacosamide in adults with cerebrovascular epilepsy etiology (CVEE).

MATERIALS AND METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Felix Rosenow, Christian Brandt, Ali Bozorg, Svetlana Dimova, Björn Steiniger-Brach, Ying Zhang, Bruno Ferrò, Gregory L Holmes, Reetta Kälviäinen
• Journal: Acta neurologica Scandinavica (Acta Neurol Scand) Vol. 141 Issue 6 Pg. 473-482 (Jun 2020) ISSN: 1600-0404 [Electronic] Denmark
• PMID: 32068241 (Publication Type: Clinical Trial, Phase III, Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial)
• Copyright: © 2020 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd.

Chemical References

• Anticonvulsants
• Carbamazepine
• Lacosamide

Topics

• Adolescent
• Adult
• Aged
• Anticonvulsants (therapeutic use)
• Carbamazepine (therapeutic use)
• Cerebrovascular Disorders (complications, diagnosis, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Epilepsy (diagnosis, drug therapy, etiology)
• Female
• Humans
• Lacosamide (therapeutic use)
• Male
• Middle Aged
• Treatment Outcome
• Young Adult