Epilepsia Open (Mar 2021)
Efficacy and safety of adjunctive perampanel in patients with focal seizures or generalized tonic‐clonic seizures: Post hoc analysis of Phase II and Phase III double‐blind and open‐label extension studies in India
Abstract
Abstract Objective This post hoc analysis assessed the efficacy and safety of adjunctive perampanel in patients (aged ≥ 12 years) with focal seizures (FS), with/without focal to bilateral tonic‐clonic seizures (FBTCS), or generalized tonic‐clonic seizures (GTCS) in India. Methods Centers in India were identified from six double‐blind, randomized, Phase II and Phase III studies of adjunctive perampanel (2–12 mg/day) and their open‐label extensions (OLEx). Efficacy assessments included median percent change in seizure frequency per 28 days, 50% and 75% responder and seizure‐freedom rates. Treatment‐emergent adverse events (TEAEs) were monitored. Results Overall, 128 patients (placebo, n = 39; perampanel, n = 89) were included in the double‐blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21]; GTCS, n = 13 [placebo, n = 6; perampanel, n = 7]) comprised the Full Analysis Set. Median percent reductions in seizure frequency per 28 days for placebo vs perampanel for Indian patients were as follows: 34.8% vs 49.8% (FS; not significant [NS]) and 43.1% vs 60.5% (FBTCS; NS) at 4–12 mg/day, respectively, and −22.4% vs 8.2% (GTCS; NS) at 8 mg/day, respectively. Fifty‐percent responder rates were 37.5% vs 55.1% (FS; NS), 42.9% vs 60.0% (FBTCS; NS), and 16.7% vs 42.9% (GTCS; NS), respectively; seizure‐freedom rates were 0.0% vs 5.8%, 7.1% vs 10.0%, and 0.0% vs 14.3%, respectively (all NS). Overall, 110 patients entered OLEx studies (FS, n = 99; GTCS, n = 11). Perampanel was efficacious for up to four years for FS and FBTCS and two years for GTCS. Across double‐blind and OLEx studies, TEAEs occurred in 58.4% and 83.6% of Indian perampanel‐treated patients, respectively; dizziness was most common. Efficacy and safety outcomes were generally similar overall between Indian and non‐Indian patients. Significance These data suggest adjunctive perampanel (up to 12 mg/day) may be a suitable anti‐seizure medication for patients (aged ≥ 12 years) with FS, with/without FBTCS, or GTCS in India.
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