Development and application of an aggregate adherence metric derived from population pharmacokinetics to inform clinical trial enrichment.

ABSTRACT: Nonadherence to prescribed medication is a common barrier to effective treatment, and current options to determine adherence are limited. This study describes development of an aggregate adherence measure based on population pharmacokinetics (PK), and its comparison to a subjective questionnaire, the Morisky 8-item medication adherence scale (MMAS8), in a trial of psychiatric patients on stable doses of oral aripiprazole. A comprehensive model was first built using plasma drug concentration data from 24 clinical studies comprising 448 patients with over 13,500 observations. Application of this model to independent patient profiles for a given drug-dosing regimen were used to generate the primary aggregate adherence metric, a ratio of observed versus expected plasma exposures at steady-stat

SUBMITTER: Knights J 

PROVIDER: S-EPMC4432109 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature