THE EFFECT OF PERAMPANEL ON WEIGHT CHANGE IN ADOLESCENTS WITH REFRACTORY FOCAL EPILEPSY
Abstract number :
2.402
Submission category :
Year :
2014
Submission ID :
1868954
Source :
www.aesnet.org
Presentation date :
12/6/2014 12:00:00 AM
Published date :
Dec 4, 2014, 06:00 AM
Authors :
Lieven Lagae, Elena Belousova, Kevin Carroll, Antonio Laurenza, Parnia Geransar and Ailsa McLellan
Rationale: Perampanel has been associated with weight gain in adults and adolescents. There is uncertainty whether this effect in adolescents is above the normal growth expected in this population. Methods: Analysis of data from three Phase III studies (E2007-304, -305, -306) and one extension study (E2007-307) was done to compare observed versus expected weight for 12-<18-year-old adolescents receiving perampanel. Weight at baseline and at each study visit was compared to expected growth curves from Centers for Disease Control growth charts. Individual weight data and relevant baseline characteristics (including concomitant medications) were extracted for adolescents who had significant weight loss or gain, defined by crossing two percentile lines during treatment with perampanel. Results: There was no statistically significant difference between observed and expected weight in the total population (N=124) in the 12-<18-year age range (estimated difference observed vs. expected: 2.3 kg [5%]; P=0.3613 increase over the period 12 to 18 years of age; P=0.3613). Ten patients exhibited clinically significant weight change, defined as weight crossing 2 percentiles relative to their baseline percentile; 7 (6 female) experienced weight gain and 3 weight loss (all males). Of the females who demonstrated clinically significant weight gain, 5/6 had an initial low baseline weight <5th percentile and gained weight to reach the expected weight range for age, and 3/6 had intellectual disability or developmental delay. One female gained weight across 3 percentiles, but exhibited a complex medical history and was taking concomitant risperidone and zonisamide. The male who gained significant weight also increased height by 15 cm (2 percentiles). All 3 males who decreased weight across 2 percentiles were taking concomitant AEDs, and two had developmental abnormalities (cerebral palsy and autism). Conclusions: The average weight change observed in adolescents receiving perampanel is in line with expected weight change for the general adolescent population.