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

that rates of these TEAEs among patients taking therapeutic doses of Vimpat® were dose-dependent. Researchers noted that these findings are preliminary, and should be confirmed with formal neuropsychological testing.

  • A retrospective analysis of pooled safety data from three lacosamide double-blind phase II/III studies was conducted to calculate the rates of spontaneously reported TEAEs potentially related to cognition
    • The analysis encompassed all treatment groups, i.e., patients taking lacosamide 200 mg/day to 600 mg/day; a total of 1,308 patients were included. (In the U.S. and Europe, doses above 400 mg/day are not approved doses.)
  • The incidence of cognition-related TEAEs among the combined 200 mg/day and 400 mg/day groups was 6.1 percent versus 4.7 percent for placebo (OR 1.3; 95 percent CI 0.7-2.3); the incidence rate for all lacosamide treatment groups was 7.7 percent (OR 1.6; 95 percent CI: 0.9-2.7).
  • The incidence of TEAEs potentially related to cognition appeared dose-related, occurring at 1.9 percent for the lacosamide 200 mg/day group (OR 0.4; 95 percent CI: 0.1-1.3), 8.5 percent for lacosamide 400 mg/day (OR 1.7; 95 percent CI: 1.0-3.2), and 13.8 percent at the unapproved 600 mg/day dose (OR 2.8; 95 percent CI 1.3-5.7).
  • The only individual TEAE potentially related to cognition occurring at an incidence of 2 percent or greater at approved doses was cognitive disorder (2.1 percent for lacosamide 400 mg/day versus 0.4 percent for lacosamide 200 mg/day and 0.3 percent for placebo); other spontaneously reported TEAEs included:
    • Memory impairment (1.5 percent for lacosamide 400 mg/day, 1.1 percent for lacosamide 200 mg/day and 1.6 percent for placebo).
    • Confusional state (1.5 percent, 0.0 percent and 0.8 percent, respectively).
    • Disturbance in attention (1.1 percent, 0.0 percent and 0.5 percent, respectively).

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