Refractory partial-onset seizures and secondarily generalized seizures: long-term safety of Perampanel


A study ( Study 307 ) has evaluated safety, tolerability, seizure frequency, and regional variations in treatment responses with the AMPA antagonist, Perampanel ( Fycompa ), in a large extension study during up to 3 years of treatment.

Patients greater than or equal to 12 years old with partial-onset seizures despite treatment with 1-3 antiepileptic drugs at baseline completed a Perampanel phase III trial and entered extension study 307.
Patients were titrated to 12 mg/day ( or their individual maximum tolerated dose ) during the blinded conversion period, followed by open-label maintenance. Exposure, safety ( adverse events, vital signs, weight, electrocardiography [ ECG ], laboratory values ) and seizure outcomes were analyzed; key measures were assessed by geographic regions.

Among 1,216 patients, median exposure was 1.5 years ( range 1 week to 3.3 years ), with 300 or more patients treated for 2 years or more. Treatment retention was 58.5% at cutoff.

Adverse effects reported in greater than or equal to 10% of patients were dizziness, somnolence, headache, fatigue, irritability, and weight increase. Only dizziness and irritability caused discontinuation in greater than 1% of patients ( 3.9% and 1.3%, respectively ).
The only serious adverse effect reported in greater than 1% of patients were epilepsy-related ( convulsion, 3.0%; status epilepticus, 1.1% ).
No clinically relevant changes in vital signs, ECG or laboratory parameters were seen.

After titration / conversion, responder rate and median percentage change from baseline in seizure frequency were stable: 46% for both measures at 9 months ( in 980 patients with greater than or equal to 9 months' exposure ) and 58% and 60%, respectively, at 2 years ( in the 337 patients with 2 years' exposure ).
Median percentage reduction in frequency of secondarily generalized seizures ranged from 77% at 9 months ( n= 422 ) to 90% at 2 years ( n= 141 ).
Among the 694 patients with maintenance data 1 year or more, 5.3% were seizure-free for the entire year.

In conclusion, no new safety signals emerged during up to 3 years of Perampanel exposure in 39 countries.
Seizure responses remained stable, with marked reductions, particularly in secondarily generalized seizures. ( Xagena )

Krauss GL et al, Epilepsia 2014; Epub ahead of print

XagenaMedicine_2014



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