SIX MONTHS POSTMARKETING EXPERIENCE WITH LACOSAMIDE IN PATIENTS WITH PHARMACORESISTANT FOCAL EPILEPSY AT A TERTIARY EPILEPSY CENTER IN GERMANY
Abstract number :
1.209
Submission category :
7. Antiepileptic Drugs
Year :
2009
Submission ID :
9592
Source :
www.aesnet.org
Presentation date :
12/4/2009 12:00:00 AM
Published date :
Aug 26, 2009, 08:12 AM
Authors :
Tim Wehner, S. Bauer, H. Hamer, K. Hattemer, I. Immisch, S. Knake, M. Nowak, P. Reif, A. Strzelczyk and F. Rosenow
Rationale: Lacosamide (LCM) was approved in Germany as add-on therapy for pharmacoresistant focal epilepsy in September 2008. Here, we report our experience with LCM in the first 25 patients at our institution. Methods: Following approval by the German licensing authorities, we offered LCM to patients with pharmacoresistant focal epilepsy. We prospectively collected data on seizure rate, side effects, and management decisions at 3 and 6 months follow up. Results: 25 patients (12 male, age 13-65 years) with a minimum follow up of 6 months were included. The epilepsy syndrome had been defined by video-EEG monitoring in 22 (88%). Three patients (12%) had undergone prior resections, six (24%) had undergone vagus nerve stimulator placement, two (8%) were scheduled to undergo invasive video EEG monitoring or surgery, and two (8%) had been offered resective surgery but declined. All patients experienced 1 - 60 (mean 7) seizures per month despite being on 1-4 (mean 2) anticonvulsants. Patients had failed 1-14 (mean 6) anticonvulsants. Patients were titrated according to the schedule recommended by the manufacturer. Three patients (12%) had non-sustained periods of seizure freedom of one, four and five months. Eight patients (32%) reported a reduction in seizure frequency by more than 50%, three of these by more than 90%. No patient patient achieved complete seizure freedom. Thirteen patients (52%) experienced side effects during the titration, mostly dizziness, fatigue, nausea, and gait instability. In five patients (20%), these disappeared during the maintenance phase and/or with dose reduction. Two patients lost more than 10% of their body weight. No patient experienced significant adverse events. At six months follow up, 17 patients (68%) were still taking 200-600, mean 400mg LCM. The drug had been discontinued in 8 patients (32%), due to intolerable side effects in 4, due to inefficacy in 3. One patient had died of metastatic breast cancer. Conclusions: Our experience with LCM in highly pharmacoresistant patients with focal epilepsy yields results comparable to the approval studies. LCM seems to be a safe alternative in patients with pharmacoresistant focal epilepsy, with short term benefit in one third of patients. Substantial weight loss may occur.
Antiepileptic Drugs