Abstracts

Rationale: Rufinamide is a triazole derivative, a novel antiepileptic drug (AED) Rufinamide acts prolonging the inactive state of voltage dependent sodium channels and limits sustained repetitive firing of sodium dependent action potentials in neurons. Rufinamide has been found to be effective in the treatment of drop attacks and partial seizures associated to Lennox - Gastaut Syndrome. Nevertheless efficacy of Rufinamide was demonstrated in five randomized placebo-controlled trials in patients with partial seizures. The aim of the study was to explore the efficacy of rufinamide as a second line adjunctive treatment of partial seizures in adult with focal epilepsy. Methods: This study was carried out in our Epilepsy Center. We describe 30 adults patients (mean age 28) with focal epilepsy , who developed drug resistant epilepsy to a second specific AED drug. Diagnosis of epilepsy was made according to the Commission on Classification and terminology of the International League against Epilepsy . Patients were interviewed, and general and neurological physical examination was performed. Patients with psychogenic seizures were excluded. Seizure diary was utilized to establish the base line type and frequency of seizures . All underwent to prolonged awake and sleep polygraphic video-electroenecephalography study and high quality brain MRI. Initial dosage and titration of Rufinamide were at discretion of epileptologist according to medical need and considering changes in the pharmacokinetics associated to concomitants AED. The total daily dose (TDD) was taken orally, half in the morning and half in the evening, starting at TDD of 400mg twice-daily, which was incremented to a target of 2400mg, according clinical needs. Blood examination was performed 20 days after RUF starting to monitor any detectable blood side effects. Results: 18/30 patients were responders . Four patients experienced a greater 65% seizure reduction. Six patients showed a 25% seizure reduction , three of them not showed modifications in seizures frequency and one showed a gather reduction , but no frequency reduction. The clinical impression on cognitive side effects was that no serious cognitive effect even in add-on treatment was associated to RUF, but otherwise neuropsychological test were not performed before and after drug administration. No major side effects were referred by patients and Rufinamide was generally well-tolerated. Conclusions: The 72% of our patients showed a seizures reduction greater of 65%. Our sample, althought small, was selected basing on epilepsy resistance to two first line AED drugs. Responder rates for patients with partial seizures was around 23% in the current opinions. But, the patient population examined in previous literature showed mostly severe drug resistant epilepsy. Our sample, was selected basing on epilepsy resistance to two first line AED drugs. This data address us to puzzle that Rufinamide used as off-label treatment in not severely affected drug-resistance epilepsy showed higher responder rate , ranging from 25 to 65%of seizures reduction. Further study are required to clearly define patient population that could benefit by Rufinamide and controlled trials are request to confirm this data. In addition the impression that no clinical cognitive effects were related to RUF provide us with a drug , in a clinical practise, to treat patients without inducing cognitive impairment. Funding: No funding was received