Lacosamide Added to Existing Monotherapy in Epilepsy Patients with Partial Onset Seizures: Second Interim Analysis of the VITOBA Study (P3.275)

OBJECTIVE: This prospective non-interventional study (NCT01098162) evaluated seizure control and tolerability of lacosamide in adults with partial-onset seizures receiving one antiepileptic drug (AED). BACKGROUND: Approval of lacosamide (up to 400mg/day) as adjunctive treatment of partial-onset seizures in adults was based on data from studies in treatment-resistant patients treated with up to three concomitant AEDs. DESIGN/METHODS: This 6-month study, conducted in clinical practice in Germany, was planned to enroll 500 evaluable patients. The current interim analysis reports data from 329 patients evaluable for seizure control and 367 patients evaluable for safety. Background AED monotherapy was based on the independent decision of the treating physician. Outcome variables included reduction in seizure frequency (蠅50% and 蠅75%), seizure freedom, and Clinical Global Impression of Change (CGIC) at last study visit (6 months) compared with 3-month retrospective baseline, as well as treatment-emergent adverse events (TEAEs). RESULTS: At the last visit, 40.7% were free from seizures for 蠅3 months (median lacosamide dose: 200mg/day [50-600mg/day]). 70.2% of patients showed a 蠅50% reduction and 59.9% showed a 蠅75% reduction in seizure frequency (during last 3 months of study). On the CGIC, physicians judged symptoms as “very much improved” in 26.5% or “much improved” in 36.9% of patients. Reduction in seizure frequency was greater for patients aged 蠅65 years (蠅50% responders 78.2%, seizure freedom 54.5%, n=55) vs 5 years; and patients who received lacosamide as first adjunctive treatment (蠅50% responders 81.3%, seizure freedom 55.4%, n=112) vs history of more AEDs. 12.5% of patients discontinued due to a TEAE. The most common TEAEs judged by physicians to be related to lacosamide were fatigue (10.1%, n=37), dizziness (8.7%, n=32), headache and nausea (2.2%, n=8 each). CONCLUSIONS: This interim analysis indicates improved seizure control, generally well tolerated when lacosamide was used as adjunctive treatment to AED monotherapy in routine clinical practice. Study Supported by: UCB Pharma Disclosure: Dr. Noack-Rink has received personal compensation for activities with UCB Pharma as an employee. Dr. Mayer has nothing to disclose. Dr. Arnold has received personal compensation for activities with UCB Pharma, Upsher-Smith, and Eisai Inc. as a consultant. Dr. Runge has received personal compensation for activities with Eisai Inc. and UCB Pharma. Dr. Runge has received research support from UCB Pharma.