A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice

Abstract

Objective: to retrospectively assess the Russian experience with perampanel (PER) in everyday clinical practice as an adjunctive medication for the treatment of patients aged 12 years or older with focal epilepsy (FE).Patients and methods. A multicenter retrospective study was conducted, during which the physicians filled out standard questionnaires assessing the characteristics of the disease and the therapy performed. The maximum follow-up period was 12 months. Each patient was included in the study only once for the duration of the study. A total of 164 cases of pharmacoresistant FE were analyzed. The patients' mean age was 37.7 years; the male to female ratio was 1:1. The disease duration over 10 years was in 68.7% of patients; structural epilepsy was present in 68.2% (temporal and frontal lesions in 53.4 and 39.1%, respectively)Results and discussion. Most (26.6%) patients were prescribed PER after three previous lines of therapy; before PEP administration, there was a maximum of 2 (50.9%) and 3 (29.6%) drugs, respectively, in the combination. The initial frequency of all seizure types reached 9 [3; 34] per month; that of focal-onset bilateral tonic-clonic seizures was 3 [2; 6] per month. Combined therapy including PER could lead to the disappearance of seizures in 22.7% of cases; the responders (by all seizure types) were 52.8%, whereas the remission rate of bilateral tonic-clonic seizures was 60.8% of patients, the responder rate was 27,8%. At 12 months of follow-up, the therapy retention rate reached 80.7% (95% confidence interval, 72.3—89.1). Adverse events (AEs) were noted in 31.3% of patients; the most frequent AEs were drowsiness (10.4%), aggression (9.8%), irritability (6.7%); other AEs were observed in individual cases. The average dose of PER was 8 mg.Conclusion. PER was effective in patients with resistant PEs at a maximum follow-up of 12 months in routine clinical practice. Remission of all seizure types was achieved in 22.7% of cases, the decrease in the number of seizures >50% was seen in 52.8% of cases; the therapy retention rate was 80.7%. The drug had a therapeutic effect in all types of focal seizures and was most effective in focal-onset bilateral tonic-clonic seizures. Along with its good clinical effect, PER demonstrated a predictable safety profile.

Keywords

• perampanel
• pharmacoresistant focal epilepsy
• efficacy
• tolerance
• safety
• adverse events
• side effects
• therapy retention