Abstract Details

Title Evaluation of Long-Term Treatment with Lacosamide for Partial-Onset Seizures in the Elderly

Topic Epilepsy

Presentation(s) P04 - (-)

Poster/Presentation
Number 210

Objective

Background BACKGROUND: Epilepsy treatment in the elderly can be challenging due to comorbid conditions and concomitant medications. Long-term safety and efficacy of adjunctive lacosamide, an anti-epileptic drug for partial-onset seizures (POS), has been assessed in three open-label extension (OLE) trials that included elderly patients.

Design/Methods DESIGN/METHODS: Data were pooled from OLE trials (SP615[NCT00522275], SP756[NCT00552305], SP774[NCT00515619]) in adults with POS who completed a lead-in trial of adjunctive lacosamide. Outcomes for patients ?65 years were evaluated.

Results RESULTS: Of 1,054 patients who initiated OL lacosamide treatment, 13(1.2%) were ?65 years at study entry, 33(3.1%) were ?65 years by study end. Of 33 elderly patients by study end, 21(63.6%) completed the trial and 18/21(85.7%) continued to commercial lacosamide. Mean and maximum lacosamide treatment durations were 1563.2 and 2790.0 days; median modal dose was 400mg/day. At >1, >3, and >5 years OL treatment, 90.9%, 75.8%, and 42.4% of elderly patients remained in the trial. All patients had the opportunity to complete ?3 years OL treatment. Discontinuations were primarily due to adverse events (n=4, 12.1%), lack of efficacy (n=3, 9.1%), and consent withdrawal (n=2, 6.1%). Common treatment-emergent adverse events (n?5 [?15%]) were dizziness (n=12, 36.4%), fall (n=9, 27.3%), contusion or sinusitis (n=7 each, 21.2%), cognitive disorder, tremor, headache, depression, or cough (n=6 each, 18.2%), and urinary tract infection, nausea, diplopia, vision blurred, convulsion, balance disorder, or pain in extremity (n=5 each, 15.2%). Median percent reduction in seizure frequency from Baseline for 1-, 3- and 5-year completers was 62.5%, 58.2% and 66.6%; ?50% responder rates were 63.3%, 68.0% and 64.3%.

Conclusions CONCLUSIONS: In this small population of elderly patients, long-term OL lacosamide treatment (up to 8 years) was generally well tolerated and was associated with a reduction in seizure frequency and maintenance of efficacy similar to the overall OLE patient pool.

Authors/Disclosures
William E. Rosenfeld, MD, FAAN (Comprehensive Epilepsy Care Center for Children and Adults) PRESENTER	The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for SK Life Science.
Cindy McShea	No disclosure on file
Rishi Gupta, MD	No disclosure on file
Pamela Doty, PhD	No disclosure on file
Catherine Lubetzki (Hopital De La Salpetriere)	Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ROCHE. Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MERCK SERONO. Catherine Lubetzki has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for REWIND.

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