Abstracts

Rationale: Rufinamide is a new antiepileptic drug recently approved by the FDA as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). It has a few specific attributes that make it an attractive option for an AED: few serious side effects, few drug interactions, and quick titration. To further extend the clinical knowledge of this new drug, the present chart review study was conducted to further examine the safety and efficacy of rufinamide adjunctive therapy in pediatric and young adult patients with a variety of seizure types. Methods: This chart review study included male and female pediatric and young adult patients receiving rufinamide for epilepsy between January and November 2009 at the Blue Bird Circle Clinic for Pediatric Neurology at Texas Children s Hospital, a comprehensive epilepsy center. Patients were regularly evaluated for seizure response and adverse events and classified according to subjective reports and seizure diaries. Responders were defined as patients who had a 50% or greater decrease in seizure frequency, with significant response defined as a 75% or greater decrease in seizure frequency. Results: Charts for 45 patients (26 M, 19 F) were reviewed. Mean patient age at the time of review was 9.5 years. 44 patients (97.8%) had received previous therapy with 1 or more AEDs (range, 0-9) prior to starting rufinamide. 43 patients (95.6%) were receiving concurrent AED drug therapy (mean AEDs 2.14, range, 0-4). Mean rufinamide dosage was 827.3 mg/day, or 30.1 mg/kg/day (range, 300-1800 mg/day or 6.7-57 mg/kg/day). Mean duration of rufinamide therapy was 21 weeks (range, 1-103 weeks). Patients experienced a broad spectrum of partial and generalized seizure/epilepsy types. 19 patients (46%) were determined to be responders, and 22 patients (54%) were non-responders. Of the non-responders, 15 patients (68%) stopped due to lack of efficacy, 5 patients (23%) stopped due to an increase in seizure frequency, and 2 patients (9%) stopped due to adverse effects. Of the patients who responded to therapy, 7 patients (37%) were classified to have significant response to rufinamide therapy, and 12 patients (63%) had mild-moderate responses. 17 patients (37.8%) stopped their trial of rufinamide prior to the end of the review period. Conclusions: The results of our study indicate that rufinamide is a helpful adjunct in the therapy of a variety of refractory seizure types both in children and in young adults. This is consistent with data from previous studies. 46% of our patients exhibited a reduction in seizure frequency, with 37% of the responders showing a more than 50% decline in seizure frequency. Rufinamide appeared to have had a relatively good safety profile, as only two patients stopped the medication due to adverse effects. However, 15 patients did not think that the medication helped them, and 5 actually had an increase in seizure frequency on rufinamide. Allowing for the limitation of small sample size and the retrospective nature of the study, our data shows promise that rufinamide therapy may be a relatively safe adjunct in the treatment of refractory epilepsy.