Objective: To evaluate bodyweight gain during pregabalin therapy for epilepsy and the utility of a short counseling program to prevent this side effect.
Methods: Randomized controlled trial on the effects of extended versus standard patient counseling on the risk of bodyweight gain with 3- and 6-month follow-up including a consecutive sample of adult outpatients with epilepsy eligible for pregabalin add-on treatment (N=98).
Results: The seizure response rate was about 30%, the seizure freedom rate was 5% at the 6-month follow-up (intent-to-treat sample, N=98). The median bodyweight gain for the according-to-protocol sample (N=62) was 4.0 kg with no effect of extended counseling. Bodyweight gain was correlated with number of anticonvulsant drugs (r=.32, p<.05).
Conclusions: Pregabalin treatment is associated with a high risk for bodyweight gain which in part depends on total anticonvulsant drug load. This side effect cannot be prevented by extended patient counseling within a standard clinical setting.