Everolimus dosing recommendations for tuberous sclerosis complex-associated refractory seizures.

ABSTRACT:

Objective

The present analysis examined the exposure-response relationship by means of the predose everolimus concentration (C_min ) and the seizure response in patients with tuberous sclerosis complex-associated seizures in the EXIST-3 study. Recommendations have been made for the target C_min range of everolimus for therapeutic drug monitoring (TDM) and the doses necessary to achieve this target C_min .

Methods

A model-based approach was used to predict patients' daily C_min . Time-normalized C_min (TN-C_min ) was calculated as the average predicted C_min in a time interval. TN-C_min was used to link exposure to efficacy and safety end points via model-based approaches. A conditional logistic r

SUBMITTER: Franz DN 

PROVIDER: S-EPMC6033043 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature