Abstracts

Rationale: Lacosamide (LCM) is a newly approved antiepileptic medication (AED) with a novel anticonvulsant activity. The efficacy of LCM has been well demonstrated in patients with refractory epilepsy through the pivotal trials, and LCM is now available in more than 12 countries following the approval by the European Commission in August 2008 and the U.S. Food and Drug Administration in October 2008. However, post-approval experiences are quite limited in real clinical practices where less refractory patients are seen. We evaluate the efficacy of LCM in our clinic population at the Barrow Neurological Institute in order to assess the usefulness of LCM in an outpatient practice setting. Methods: We identified clinic patients who are taking LCM for partial epilepsy by reviewing clinic records at the Barrow Neurological Institute. The data included patient s gender, age, seizure type, concurrent AEDs, LCM dosages, duration of therapy, and efficacy of LCM. To minimize bias, we excluded patients who had participated in the phase II or III LCM clinical trials in the past. Last observed efficacy information was used to report the efficacy of LCM. The efficacy of LCM was evaluated as responder rates (seizure reduction ?50% during treatment), and responders were further evaluated whether they had reached 75% or greater seizure reduction. Results: We identified 185 patients who started taking LCM on or after June 3, 2009. The median age of patients was 40.6 years, and 55.7% were female. The mean follow-up duration of patients was 28.9 weeks (median 30 weeks) when efficacy was evaluated. Approximately 66% of patients had tried more than 5 AEDs in the past when LCM was added. LCM was used as monotherapy in 6 patients, and 76.8% of patients were taking 1 or 2 AEDs. Out of 185 patients, efficacy information was available in 152 patients. Overall, 50% responder rate was 53.2% (81/152) and 75% responder rate was 29.6% (45/152). Seizure freedom for more than 6 months was achieved in 6 patients (3.9%). Remaining 43.8% of patients reported less than 50% of seizure improvement. The dosage of LCM was ranged from 100 mg to 400 mg per day with a daily median dosage of 200 mg. Conclusions: The efficacy of LCM in this study was comparable to the previously reported results in pivotal trials. However, our patient population was somewhat less refractory than previous studies, which may have resulted in higher 50% responder rate. This consistent efficacy result, combined with a favorable pharmacokinetic profile, suggests that LCM is a useful new AED as an adjunctive treatment in patients with partial-onset seizures.