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@article{1751483,
author = {Rektor, Ivan and Krauss, G.L. and Inoue, Y. and Kaneko, S. and Williams, B. and Patten, A. and Malhotra, M. and Laurenza, A. and Wechsler, R.T.},
article_location = {Hoboken},
article_number = {7},
doi = {http://dx.doi.org/10.1111/epi.16573},
keywords = {AMPA receptor antagonist; antiseizure medication; focal to bilateral tonic-clonic seizures; generalized tonic-clonic seizures},
language = {eng},
issn = {0013-9580},
journal = {Epilepsia},
title = {Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies},
url = {https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/epi.16573},
volume = {61},
year = {2020}
}
TY - JOUR
ID - 1751483
AU - Rektor, Ivan - Krauss, G.L. - Inoue, Y. - Kaneko, S. - Williams, B. - Patten, A. - Malhotra, M. - Laurenza, A. - Wechsler, R.T.
PY - 2020
TI - Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies
JF - Epilepsia
VL - 61
IS - 7
SP - 1491-1502
EP - 1491-1502
PB - Wiley-Blackwell
SN - 00139580
KW - AMPA receptor antagonist
KW - antiseizure medication
KW - focal to bilateral tonic-clonic seizures
KW - generalized tonic-clonic seizures
UR - https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/epi.16573
N2 - Objective This post hoc analysis evaluated long-term efficacy and safety in patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies to receive long-term adjunctive perampanel. Methods Patients aged 12 years and older who completed phase II or III randomized, double-blind, placebo-controlled studies could enter an OLEx study, each comprising a blinded conversion period followed by an open-label maintenance period (32-424 weeks; maximum perampanel dose = 12 mg/d). Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs) were analyzed. Results Baseline characteristics were generally balanced between patients with FBTCS (n = 720) and GTCS (n = 138). Mean (standard deviation) cumulative duration of perampanel exposure was 102.3 (70.3) weeks (FBTCS) and 83.9 (38.4) weeks (GTCS). Retention rates were 50.0% for up to 4 years (FBTCS) and 49.2% for up to 2 years (GTCS). Across OLEx treatment durations, median reductions in seizure frequency per 28 days were 66.7% (FBTCS) and 80.6% (GTCS). Fifty percent and 75% responder and seizure-freedom rates were 59.5%, 45.3%, and 18.4%, respectively (FBTCS), and 72.5%, 51.5%, and 16.7%, respectively (GTCS). Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts. TEAE incidence was highest during Year 1 (FBTCS, 85.3%; GTCS, 86.2%); most common were dizziness and somnolence. During Year 1, serious TEAEs were reported in 81 (11.3%; FBTCS) and 10 (7.2%; GTCS) patients. TEAEs were consistent with the known safety profile of perampanel; no new safety signals were identified with long-term treatment. Significance This post hoc analysis suggests long-term (up to 4 years) adjunctive perampanel (up to 12 mg/d) is efficacious and well tolerated in patients (aged 12 years and older) with FBTCS or GTCS.
ER -
REKTOR, Ivan, G.L. KRAUSS, Y. INOUE, S. KANEKO, B. WILLIAMS, A. PATTEN, M. MALHOTRA, A. LAURENZA and R.T. WECHSLER. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies. \textit{Epilepsia}. Hoboken: Wiley-Blackwell, 2020, vol.~61, No~7, p.~1491-1502. ISSN~0013-9580. Available from: https://dx.doi.org/10.1111/epi.16573.
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