Abstract Details

Title Early Efficacy with Adjunctive Lacosamide Treatment in Patients with Uncontrolled Partial Seizures: Analysis of Mean Percentage of Seizure-Free Days Per Week

Topic Epilepsy

Presentation(s) P07 - (-)

Poster/Presentation
Number 172

Objective

Background BACKGROUND: Lacosamide is approved as adjunctive treatment for adults with partial-onset seizures. The onset of efficacy relative to placebo (assessed by the median percent reduction in seizure frequency and ?50% responder rates) was evident by the first week of treatment with adjunctive lacosamide (Chung et al, 2010, CNS Drugs).This post hoc analysis evaluated efficacy based on percentage of seizure-free days/week during the entire Treatment Period (4-6-week Titration + 12-week Maintenance).

Design/Methods DESIGN/METHODS: Data were pooled from 3 pivotal trials (SP667, SP754 [NCT00136019], SP755 [NCT00220415]) evaluating fixed doses of lacosamide 200, 400, 600mg/day and placebo. The mean percentage of seizure-free days over the entire Treatment Period and for each week of the Treatment Period was evaluated for lacosamide (all doses combined) and placebo. Generalized estimating equation models were used to perform pairwise comparisons of lacosamide versus placebo.

Results RESULTS: Overall, 935 lacosamide- and 359 placebo-randomized patients with at least one seizure diary entry were included in the analysis. For lacosamide, significant differences in the mean percentage of seizure-free days over the Treatment Period (P<0.001) and at each week (range P<0.001 to 0.020) were observed relative to placebo. Significant differences versus placebo were evident during Week 1 of actual lacosamide exposure, when patients in all three lacosamide treatment groups were receiving lacosamide 100mg/day (P=0.014). Mean percentage of seizure-free days/week with lacosamide treatment increased during dose titration and remained relatively constant during the 12-week Maintenance period.

Conclusions CONCLUSIONS: The results of this population-based analysis confirm the efficacy of lacosamide and further support previous post hoc analyses indicating a difference between lacosamide and placebo starting from the first week of actual exposure (100mg/day).

Authors/Disclosures
PRESENTER	No disclosure on file
Antonio Bertolotto, MD, FAAN (Ospedale Koelliker)	Dr. Bertolotto has nothing to disclose.
	No disclosure on file
	No disclosure on file
Pamela Doty, PhD	No disclosure on file
Marc De Backer, MD, FBCPM, MBA	No disclosure on file
Steve Chung, MD, FAAN (Banner University Medical Center)	The institution of Dr. Chung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ucb pharma. Dr. Chung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Life sciences. Dr. Chung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eisai. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for eisai. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for ucb. Dr. Chung has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for SK Life sciences. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for sunovion.

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