Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies.

ABSTRACT:

Objective

To assess the efficacy and safety of eslicarbazepine acetate (ESL) monotherapy.

Methods

This post hoc pooled analysis of 2 randomized double-blind studies (093-045 and -046) included adults with partial-onset seizures medically uncontrolled by 1 or 2 antiepileptic drugs (AEDs). Following the baseline period (8 weeks), eligible patients were randomized 2:1 to receive ESL 1,600 mg or 1,200 mg once daily for 18 weeks; the primary endpoint was study exit by meeting predefined exit criteria (signifying worsening seizure control). In each study, treatment was considered effective if the upper 95% confidence limit for exit rate was lower than the historical control threshold (65.3%).

Results

Pooled exit rates were as follows: ESL 1,600 mg = 20.6% (95% confidence in

SUBMITTER: Sperling MR 

PROVIDER: S-EPMC4826334 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature