Medical Training & Development Manager EMEA European Knowledge Centre, Eisai Europe Ltd, Hatfield, Hertfordshire, UK
Rationale: Perampanel (PER) is a once-daily oral antiepileptic drug indicated in the U.S. for the treatment of focal-onset seizures in patients aged ≥ 4 years, and as adjunctive therapy in the treatment of generalized-onset tonic-clonic seizures in patients aged ≥ 12 years. Elderly patients are often excluded from clinical trials and consequently there is limited information about the effects of PER in this population. We conducted a pooled analysis of real-world studies to evaluate the effectiveness and safety profile of PER in epilepsy patients aged ≥ 65 years treated in clinical practice. Methods: Using databases from centers across Europe, Asia, the Americas and Australia, an interim pooled analysis was conducted of studies that collected clinical practice data on patients treated with PER for focal or generalized seizures. The primary assessment was retention rate (proportion of patients remaining on PER after treatment initiation). Efficacy assessments included seizure freedom rate (no reported seizures since at least the prior visit) and responder rate (≥ 50% reduction in seizure frequency) at the last visit. Tolerability was assessed by evaluating adverse events (AEs) and AEs leading to discontinuation. A subanalysis of data from patients aged ≥ 65 years was conducted to assess PER in this population. Results: Overall, 18 studies/work groups were included in this study. Of the 3,496 patients included in the interim pooled analysis, 256 were aged ≥ 65 years (50.8% female; mean age 72.4 years; mean number of previous antiepileptic drugs [AEDs], 4.6). The majority of patients (77.4%) had focal seizures only; 6.7% had generalized seizures only and 6.0% had both focal and generalized seizures. At treatment initiation the majority of patients were on one or two concomitant AEDs (1.2% initiated PER as monotherapy). The mean (standard deviation) PER dosage was 2.6 (1.4) mg/day at baseline and 5.7 (2.5) mg/day at last visit. Retention rates at 3, 6, and 12 months were 87.6% (190/217), 74.1% (160/216) and 58.4% (118/202), respectively. The main reasons for discontinuation were AEs (20.7%), lack of efficacy (6.0%) and both (2.3%). The efficacy population (defined as patients who initiated PER treatment and had ≥ 1 efficacy measurement available) consisted of 212 patients. At the last visit, seizure freedom rates in patients with focal and generalized seizures were 35.0% and 42.9%, respectively; the corresponding values for 50% responder rates were 68.7% and 83.3%, respectively (Figure 1). The safety population (defined as patients who initiated PER treatment for whom safety data were available) consisted of 221 patients. AEs were experienced by 52.0% of patients (Table 1) and the most common AEs were dizziness/vertigo (16.3%), somnolence (11.3%) and behavioral AEs (10.4%). Conclusions: PER was effective for both focal and generalized seizures and was generally well tolerated when used to treat elderly patients in clinical practice. Funding: Please list any funding that was received in support of this abstract.: Study supported by Eisai. Click here to view image/table
