TY  - JOUR
PY  - 2016//
TI  - Analysis of falls in patients with epilepsy enrolled in the perampanel phase III randomized double-blind studies
JO  - Epilepsia
A1  - Leppik, Ilo E.
A1  - Yang, Haichen
A1  - Williams, Betsy
A1  - Zhou, Sharon
A1  - Fain, Randi
A1  - Patten, Anna
A1  - Bibbiani, Francesco
A1  - Laurenza, Antonio
SP  - 51
EP  - 59
VL  - 58
IS  - 1
N2  - OBJECTIVE: To analyze occurrence of falls among patients with partial seizures, with/without secondarily generalized seizures (SGS), and primary generalized tonic-clonic seizures (PGTCS) in the perampanel phase III clinical studies. <br><br>METHODS: Studies 304, 305, and 306 randomized subjects (≥12 years) with drug-resistant partial seizures (with/without SGS) to perampanel 2, 4, 8, or 12 mg or placebo for double-blind treatment. The adverse event (AE) of falls was analyzed in the Safety Analysis Set (N = 1480). Study 332 randomized subjects aged ≥12 years with a diagnosis of PGTCS into perampanel 8 mg or placebo groups for double-blind treatment. In a systematic review of reported falls in the study 332 Safety Analysis Set (N = 163), falls were queried to establish whether each was seizure related; subjects with falls resulting from a seizure were not included in this analysis. <br><br>RESULTS: For studies 304/305/306, treatment-emergent falls occurred in 5.1% perampanel-treated versus 3.4% placebo-treated subjects with partial seizures. Exposure-adjusted rate for falls (falls/subject-month of exposure) was greater for total perampanel than for placebo (0.0175 vs. 0.0093) and was dose related for those receiving perampanel. In subjects with SGS, incidence of treatment-emergent falls was 4.3% in perampanel and 4.0% in placebo groups. Exposure-adjusted rates were 0.0169 and 0.0097 falls per subject-month of exposure in perampanel and placebo, respectively. For study 332, 2.5% perampanel-treated and 1.2% placebo-treated subjects with PGTCS had treatment-emergent falls that were not part of a seizure. Exposure-adjusted rates were 0.0169 and 0.0032 falls per subject-month of exposure in perampanel and placebo, respectively. SIGNIFICANCE: Results of the perampanel studies suggest that patients with epilepsy should be monitored due to the common risk of falls.<br><br>Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.<p />  <p>Language: en</p>
LA  - en
SN  - 0013-9580
UR  - http://dx.doi.org/10.1111/epi.13600
ID  - ref1
ER  -