TY  - JOUR
PY  - 2017//
TI  - Perampanel with concomitant levetiracetam and topiramate: post hoc analysis of adverse events related to hostility and aggression
JO  - Epilepsy and behavior
A1  - Chung, Steve
A1  - Williams, Betsy
A1  - Dobrinsky, Cindy
A1  - Patten, Anna
A1  - Yang, Haichen
A1  - Laurenza, Antonio
SP  - 79
EP  - 85
VL  - 75
IS  - 
N2  - 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.<br><br>Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.<p />  <p>Language: en</p>
LA  - en
SN  - 1525-5050
UR  - http://dx.doi.org/10.1016/j.yebeh.2017.06.038
ID  - ref1
ER  -