Journal
EPILEPSY & BEHAVIOR
Volume 75, Issue -, Pages 79-85Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yebeh.2017.06.038
Keywords
Perampanel; Levetiracetam; Topiramate; Epilepsy; Aggression; Hostility
Categories
Funding
- Eisai Inc
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In 4 Phase III registration trials (3 in patients with partial seizures, N = 1480; 1 in patients with PGTCS, N = 163), perampanel administered to patients already receiving 1-3 concomitant antiepileptic drugs (AEDS) demonstrated statistically superior efficacy compared to placebo in reducing seizure frequency. However, use of perampanel in these studies was associated with a risk of psychiatric and behavioral adverse reactions, including aggression, hostility, irritability, anger, and homicidal ideation and threats. The present study is a post hoc analysis of pooled data from these 4 trials to determine if concomitant treatment with levetiracetam and/or topiramate increased the risk of hostility- and aggression-related AEs. Treatment-emergent AEs (TEAEs) were determined using a Narrow & Broad search based on the Medical Dictionary for Regulatory Activities (MedDRA) standard MedDRA query (SMQ) for hostility- and aggression-related events. The rate of hostility- and aggression-related TEAEs was observed to be similar among perampanel-treated patients: a) receiving levetiracetam (N = 340) compared to those not receiving levetiracetam (N = 779); b) receiving topiramate (N = 223) compared to those not receiving topiramate (N = 896); and c) receiving both levetiracetam and topiramate (N = 47) compared to those not receiving levetiracetam and topiramate (N = 1072). Severe and serious TEAEs related to hostility and aggression were rare and occurred at a similar rate regardless of concomitant levetiracetam and/or topiramate therapy. Taken together, these results suggest that concomitant treatment with levetiracetam and/or topiramate has no appreciable effect on the occurrence of hostility- or aggression-related TEAEs in patients receiving perampanel. (C) 2017 The Authors. Published by Elsevier Inc.
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