Abstract
PurposeWe investigated the long-term efficacy and safety of perampanel as a first add-on therapy in patients with focal epilepsy. MethodsThis retrospective study represented the 3-year extension phase of a multicenter, open-label, phase 4, prospective study of perampanel as a first add-on therapy in patients with focal epilepsy. Seizure and safety outcomes were assessed annually from the start of the extension study, and the retention rate was calculated from the start of perampanel exposure in the original study. ResultsThe 50% responder and seizure freedom rates were 84.8% and 58.7%, respectively, during the third year and 71.7% and 32.6%, respectively, during the entire 3-year period of the extension study. The 1-, 2-, and 3-year retention rates were 62.5%, 53.1%, and 52.1%, respectively. Efficacies were higher in patients that were aged >55 years, male, and receiving ≤4 mg of perampanel. Perampanel was generally well tolerated; 47.3% of patients experienced at least one adverse event during the 3 years of extension (46 adverse events (AEs) in 35 patients). The most common AEs were dizziness (33.8%), somnolence (5.4%), anger (4.1%), and irritability (4.1%). AEs were resolved with perampanel dose reduction or discontinuation in 10 (13.5%) and 12 (16.2%) patients, respectively. ConclusionLong-term treatment with perampanel as a first add-on therapy did not raise new safety signals in patients with focal epilepsy. Especially at low perampanel doses (≤4 mg/day), sustained improvement in seizure control was achieved, which could potentially avoid adverse drug reactions.
Highlights
Epilepsy characterized by recurrent seizures is one of the most common chronic brain diseases affecting both sexes and all ages
In the 3-year extension study of the initial phase 4 prospective study [11], the long-term efficacy and tolerability of perampanel were retrospectively investigated as a first add-on therapy in patients with focal epilepsy who did not respond to Antiepileptic drugs (AEDs) monotherapy
We found that the 50% responder and seizure freedom rates were 76.4% and 43.6%, respectively, during the first year from the start of the extension study and 84.8% and 58.7%, respectively, during the third year of extension
Summary
Epilepsy characterized by recurrent seizures is one of the most common chronic brain diseases affecting both sexes and all ages. In a recent meta-analysis, the point prevalence of active epilepsy was 6.38 per 1000 people, indicating that there are more than 50 million patients with epilepsy worldwide [1]. Recurrent seizures in patients with epilepsy have substantial impacts on cognitive, psychological, and social functioning and may even cause sudden death [2,3]. Antiepileptic drugs (AEDs) represent the most important approach for treating epilepsy. Monotherapy with a single AED can produce seizure freedom for at least one year in 61% of. When seizure recurrence persists despite two or three trials with monotherapy, combining two or more AEDs with different mechanisms of action is required to control seizures [5,6]
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