کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5628152 | 1579818 | 2017 | 7 صفحه PDF | دانلود رایگان |
- Hostility- and aggression-related TEAEs reported with perampanel treatment.
- Concomitant levetiracetam did not increase hostility- or aggression-related TEAEs.
- Concomitant topiramate did not increase hostility- or aggression-related TEAEs.
In 4 Phase III registration trials (3 in patients with partial seizures, NÂ =Â 1480; 1 in patients with PGTCS, NÂ =Â 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 (NÂ =Â 340) compared to those not receiving levetiracetam (NÂ =Â 779); b) receiving topiramate (NÂ =Â 223) compared to those not receiving topiramate (NÂ =Â 896); and c) receiving both levetiracetam and topiramate (NÂ =Â 47) compared to those not receiving levetiracetam and topiramate (NÂ =Â 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.
Journal: Epilepsy & Behavior - Volume 75, October 2017, Pages 79-85