Perampanel beneficial to both Asian, non-Asian patients with refractory focal seizures
Perampanel is safe and effective for treating refractory focal seizures in both Asian and non‐Asian populations, a study has found.
The present analysis included data from four randomized, placebo‐controlled phase III studies involving patients aged ≥12 years who had focal seizures with or without focal to bilateral tonic‐clonic (FBTC) seizures. These patients received perampanel at a dose of 2, 4, 8 or 12 mg or placebo in two phases: 6‐week baseline period (during which perampanel doses were titrated by 2 mg/wk until randomized dose or maximum tolerated dose was reached) and maintenance phase (another 13 weeks).
A total of 2,187 randomized patients were included in the intention-to-treat population, among whom 935 were Asian and 1,247 were non‐Asian. Efficacy endpoints included median percent change in seizure frequency per 28 days, and 50-percent and seizure‐freedom responder rates relative to baseline.
The median percent change in seizure frequency per 28 days was significantly greater with perampanel vs placebo: 8-mg (−31.1 percent; p<0.0001) and 12-mg doses (−38.1 percent; p<0.0001) in the Asian population, and the 4-mg (−21.1 percent; p=0.0001), 8-mg (−26.3 percent; p<0.0001) and 12-mg doses (−27.7 percent; p=0.0001) in the non‐Asian population.
Perampanel was also superior to placebo in terms of the 50-percent responder rate, particularly the 8-mg (40.1 percent; p<0.0001) and 12-mg doses (43.8 percent; p<0.0001) in the Asian population, and the 4-mg (29.4 percent; p=0.0002), 8-mg (32.8 percent; p<0.0001) and 12-mg doses (34.5 percent; p=0.0001) in the non‐Asian population.
Seizure‐freedom rate among all patients ranged from 4.9–11.7 percent with perampanel 2, 4, 8 and 12 mg.
Dizziness, somnolence, irritability, headache and fatigue were the most frequently reported treatment‐emergent adverse events (TEAEs) across Asian and non-Asian populations. Meanwhile, the most common psychiatric TEAEs were aggression and irritability.
The present data show that perampanel has a favourable and similar risk‐benefit profile in both Asian and non‐Asian populations with refractory focal seizures, researchers said.