Efficacy and Tolerability of Perampanel Monotherapy in Focal and Generalized Tonic-Clonic Seizures in Clinical Practice. Preliminary Results From a Multicenter Spanish Study
Abstract number :
3.316
Submission category :
7. Antiepileptic Drugs / 7E. Other
Year :
2018
Submission ID :
501812
Source :
www.aesnet.org
Presentation date :
12/3/2018 1:55:12 PM
Published date :
Nov 5, 2018, 18:00 PM
Authors :
Rafael Toledano, Hospital Universitario Ramón y Cajal; Fernando Ayuga Loro, Virgen de la Salud Hospital; Beatriz Parejo, Hospital Universitario Clínico de San Carlos; Irene García-Morales, Hospital Universitario Clínico de San Carlos,
Rationale: Perampanel (PER) is an antiepileptic drug (AED) with a novel mechanism acting as a non-competitive antagonist of AMPA receptors of glutamate. It is approved for the treatment of focal seizures with or without secondary generalization and primary generalized tonic-clonic seizures. Perampanel has proven better efficacy and tolerability when used as early add on but there is still lack of evidence when it is used as monotherapy. Methods: Multicenter, observational and retrospective study of patients with focal or generalized epilepsy treated with PER monotherapy according to daily clinical practice in Spain. Patients treated with PER monotherapy were included. Efficacy and tolerability were analyzed at 3, 6 and 12 months after PER monotherapy. Here we present preliminary results. Results: In total, 33 patients have been included so far. Here we analyze the 28 patients that have at least 3 months follow up after PER monotherapy. Mean age was 51.5 years-old and 15 were women. The most frequent epilepsy type was focal (62.4%) and the mean duration of the pathology was 10.6 years. The most frequent seizure type was generalized tonic-clonic (GTCS), either primary or secondary, occurring in 23 patients (82.1%). Mean number of previous AEDs was 2.3. Most patients (71.4%) achieved PER monotherapy by reduction of concomitant AEDs (secondary monotherapy). Median PER dose at last visit was 4 mg/day [2, 8]. After 3 months of PER monotherapy seizure frequency was reduced by 67.5% for focal seizures and 91% for GTCS. 25 out of 33 patients had 6 months follow up after starting PER monotherapy and seizure frequency reduction was 70% for focal seizures and 100% for GTCS. After 12 months, 14 patients had follow up data and seizure frequency reduction was 50% for focal epilepsy and 49.3% for GTCS. Retention rate was 92.9% after 3 months, 92% after 6 months, 66.7% after 12 months and 64.3% for those patients who had more than 12 months follow up. In total, 14 patients (50%) reported adverse events (AEs) during PER monotherapy, however AEs only led to discontinuation in 3 patients (10.7%). The majority of AEs (73.3%) were considered mild and somnolence was the most frequent (21.42%). Conclusions: Our preliminary results showed that PER is an effective treatment when used as monotherapy by reducing seizure frequency at low doses. It has also shown a high retention rate and a good tolerability profile since most of the adverse events were mild. Accordingly, PER should be considered a good option for monotherapy in patients with focal and generalized seizures. Funding: None