An Exploratory Analysis of Predictors of Minimum Sodium Level Related to Treatment with Adjunct Eslicarbazepine Acetate (P06.124)

Abstract

Objective: Evaluate predictors of hyponatremia (defined at different levels) in association with the use of eslicarbazepine acetate (ESL) 800 mg and 1200 mg as adjunct treatment to 1-3 concomitant anti-epileptic drugs (con-AEDs). Background Eslicarbazepine acetate is a novel sodium (Na + )-channel blocking antiepiletic drug (AED). Hyponatremia may develop during treatment with sodium channel AEDs. In two phase III clinical trials of ESL sodium levels + Design/Methods: Data from 790 subjects included in 2 Phase III trials were analyzed. For each subject the minimum post-dose Na + level was defined. Predicted values for log transformed minimum post-dose Na + levels were obtained from an ANCOVA model with treatment group, baseline Na + , con-AED, and the interaction of baseline Na + and con-AED as fixed effects. Probabilities of minimum post-dose Na + levels for ESL 800 mg and 1200 mg were calculated using the cumulative standard normal distribution: z=[log(x)-predicted value from model]/Sqrt MSE from model where x=125 mEq/L,130 mEq/L, 135 mEq/L. Results: Carbamazepine ([CBZ] n=467), lamotrigine ([LMT] n=186), valproic acid ([VPA] n=186) and levetiracetam ([LEV] n=96) were the most common con-AEDs. The combination of low baseline Na + and concomitant CBZ was associated with a higher probability of minimum post-treatment Na + + , the incidence of Na + Conclusions: The risk of developing hyponatremia (Na + + and those taking CBZ. Supported by: BIAL - Portela & Ca, SA. Data analysis and editorial support provided by Sunovion Pharmaceuticals Inc. Disclosure: Dr. Cheng has received personal compensation for activities with Sunovion Pharmaceuticals, Inc. Ms. Zummo has received personal compensation for activities with Sunovion Pharmaceuticals Inc. Dr. Sousa has received personal compensation for activities with BIAL as an employee. Dr. Versavel has received personal compensation for activities with Sunovion Pharmaceuticals Inc. as an employee. Dr. Blum has received personal compensation for activities with Sunovion Pharmaceuticals Inc as an emplyee. Dr. Blum holds stock and/or stock options in GlaxoSmithKline, which sponosred research in which Dr. Blum was involved as an investigator.