Abstracts

Rationale: Lacosamide (LCM) is a newer anti-epileptic drug (AED). Non-inferiority of monotherapy compared to carbamazepine has been shown in a multicenter, historical controlled, double blind study. LCM monotherapy license is applied for in Europe. We report a retrospective cross sectional, multicenter study of lacosamide monotherapy off-label use. Methods: 11 centers in Austria participated. Identification of patients from databases or in clinical settings. Data were collected semi-anonymized in a database. Descriptive statistical analysis was performed. Results: 31 patients from 7 centers were included. 4 centers did not provide data. Patient characteristic were 12 males, median age 40 years (95% CI: 26,00 - 52,24) with a median disease duration of 14 years (95% CI 9,18 - 19,83) and a mean of 3.53 prior AEDs (95% CI 2,64 - 4,43). In 6% LCM was started as monotherapy. Reasons of reduction of previous additional AEDs were uncontrolled seizures in 39% and adverse events in 58%. Mean maintenance dose was 325 mg (95% CI 285 – 367 mg) with a mean duration of 27,23 month (95% CI 21,61 - 32,85mg). 21 patients were more then 12 month seizure free. Complex partial seizures were reduced by 46% and GTCS by 26%. Adverse events were noted in 16% (somnolence, dizziness, high blood pressure, left bundle branch block). Conclusions: LCM monotherapy showed a stable seizure control with good safety data. Reverse to monotherapy was well tolerated. These data confirm the outcome of the previous trial in clinical practice. Funding: This study was supported by an academic grant of UCB pharma, Vienna.