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New Data Support Long-term Use of Antiepileptic Drug Vimpat(R) (Lacosamide) (C-V)
Date:12/7/2009

on of 700 days, or almost 2 years (minimum duration: 1 day; maximum duration: 2,437 days, or 6.7 years), were similar to those reported with short-term use. The dose most commonly used for the longest period of time was 400 mg/day.

  • There were no new types of TEAEs judged by researchers to be related to the drug that emerged with long-term use.
  • The most common TEAEs (greater than or equal to 10 percent) reported at any time during the double-blind and open-label extension trials were dizziness (45.6 percent), headache (20.6 percent), diplopia (18.5 percent), nausea (15.3 percent), nasopharyngitis (14.3 percent), vomiting (14.1 percent), fatigue (13.8 percent), abnormal coordination (12.5 percent), blurred vision (12.0 percent), tremor (11.5 percent), somnolence (11.5 percent), convulsion (11.4 percent), and contusion (10.4 percent).
  • Long-term lacosamide treatment was not associated with any clinically relevant changes in median or mean measurements for body weight, hematology, clinical chemistry, or vital signs. A small increase in mean PR interval was observed. There were no reports of higher-degree heart block (i.e., second or third-degree).

Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.231) W. Rosenfeld(1), F. Rosenow(2), J. Isojarvi(3), D. Hebert(3), P. Doty(3) (1)The Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri; (2)Interdisciplinary Epilepsy Center, Department of Neurology, Philipps-University, Marburg, Germany;(3)SCHWARZ BIOSCIENCES (a member of the UCB Group), Raleigh, North Carolina

Abstract: Preliminary Evaluation of the Risk of Cognitive Adverse Events in Lacosamide Clinical Trials for Adjunctive Treatment of Partial Onset Seizures

This preliminary analysis of spontaneously reported TEAEs potentially related to cognitive function showed
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