Abstracts

Rationale: Lacosamide (LCM) has been approved in Taiwan for use as adjunctive therapy in the treatment of complex partial (focal impaired awareness) seizures and simple (focal awareness) or complex partial seizures with secondary generalization (focal to bilateral tonic-clonic) in patients aged ≥16 years. Previous clinical studies for regulatory approval were performed in patients with difficult-to-treat epilepsy in a highly controlled setting. Therefore, this trial was conducted to assess the safety and tolerability of LCM in real-world clinical practice in Taiwan. Effectiveness of LCM was also assessed as an exploratory objective. Methods: This was a multicenter, prospective, observational, non-interventional trial (EP0063). Patients aged ≥16 years with (1) complex partial seizures or (2) simple or complex partial seizures with secondary generalization were enrolled if they were taking ≥1 concomitant antiepileptic drug (AED), had ≥1 seizure in the 3 months prior to baseline and were prescribed LCM according to the approved label in Taiwan. The primary safety variable was treatment-emergent adverse events (TEAEs) spontaneously reported to, or observed by, the treating physician. Effectiveness variables included Clinical Global Impression of Change (CGIC), seizure-free status, and 28-day seizure frequency. Results: A total of 172 patients were screened and 171 were included in all analyses. Of these, 139 (81.3%) completed the 12-month trial period. Patient demographics and baseline characteristics are shown in Table 1. Patients were taking a mean (SD) of 2.8 (1.1) AEDs at baseline. Patients received LCM for a mean (SD) duration of 288.7 (111.9) days, and the mean (SD) daily dose of LCM was 205.0 (82.7) mg/day. Overall, 55.6% of patients reported at least 1 TEAE; a total of 355 TEAEs were reported (Table 2). The incidences of drug-related TEAEs and drug-related TEAEs leading to discontinuation of LCM were 43.3% and 8.2%, respectively. No new safety signals were observed. There were 2 deaths during the trial period, 2 cases of suicidal ideation, 1 suicide attempt, 4 patients with decreased appetite, 3 with loss of consciousness, and 1 pacemaker insertion; none was considered to be related to LCM. CGIC was very much improved in 15.2%, much improved in 21.6%, minimally improved in 26.9%, not changed in 31.6%, and minimally worse in 4.7% of patients. 12.3% of patients were seizure-free during the first 6 months of the trial, 21.6% in the last 6 months of the trial, and 8.2% for the full 12 months of the trial. At the end of 12 months, the median seizure frequency reduction was -0.30/28 days (range: -21.0, 92.5). Conclusions: The safety and tolerability profile of LCM adjunctive therapy in this Taiwanese patient group in real-world practice was consistent with the overall established safety profile of LCM. Effectiveness was also favorable and physicians rated more than 60% of patients as “improved” over the course of 12 months of treatment with LCM. Funding: UCB Pharma-sponsored