Abstract Details

Title Long-Term Treatment of Partial-Onset Seizures in Adults Exposed Only to Approved Lacosamide Doses: Pooled Analysis of Three Open-Label Extension Studies

Topic Epilepsy

Presentation(s) P07 - (-)

Poster/Presentation
Number 170

Objective

Background BACKGROUND: The long-term safety and efficacy of adjunctive lacosamide (100-800mg/day) has been assessed in three open-label extension (OLE) trials.

Design/Methods DESIGN/METHODS: Data were pooled from trials SP615(NCT00522275), SP756(NCT00552305), and SP774(NCT00515619) in adults with POS who completed a primary trial of adjunctive lacosamide. Dosage adjustments of lacosamide and/or concomitant AEDs were allowed to optimize tolerability and seizure control. Outcomes from the OLE studies were evaluated for patients exposed only to ?400mg/day lacosamide during primary and OLE trials.

Results RESULTS: Of 1,054 patients who initiated OL lacosamide treatment, 34.4% (n=363) were exposed only to lacosamide ?400mg/day; 33.3% (121/363) completed the OLE trial and 89.3% (108/121) of completers continued to commercial lacosamide. A total of 66.7% (n=242) discontinued prior to the end of the exposure period (up to 8 years) mostly for lack of efficacy (24.0%), adverse events (16.8%), and consent withdrawal (17.6%). The estimated percentage of patients retained on lacosamide (Kaplan-Meier analysis) at 1, 3 and 5 years was 64.2%, 41.1% and 34.5%. As all patients had an opportunity to complete ?3 years of open-label treatment, lower retention rates after 3 years is attributed to study closure as well as premature discontinuations. The most commonly (?10%) reported treatment-emergent adverse events were dizziness (21.5%), headache (14.0%), and nasopharyngitis (10.7%). For 1-, 3-, and 5-year completer cohorts, the median percent reduction from Baseline in POS frequency per 28 days was 59.4%, 67.9%, and 71.0%. The ?50% responder rates for the 1-, 3-, and 5-year completer cohorts were 60.2%, 68.0%, and 70.2%; ?75% responder rates were 36.8%, 42.7%, and 49.1%.

Conclusions CONCLUSIONS: In patients exposed only to approved doses (up to 400mg/day), long-term adjunctive lacosamide was generally well tolerated and associated with reduction in seizure frequency and maintenance of efficacy.

Authors/Disclosures
O'Neill D'Cruz, MD, MBA, FAAN (OD Consulting and Neurological Services, PLLC) PRESENTER	No disclosure on file
Pamela Doty, PhD	No disclosure on file
	No disclosure on file
Cindy McShea	No disclosure on file
	No disclosure on file
Marc De Backer, MD, FBCPM, MBA	No disclosure on file

��ɫ��

��ɫ��