Ethambutol Population Pharmacokinetics and Pharmacodynamics From a Phase 3 Confirmatory Trial for the Treatment of Tuberculosis.

ABSTRACT:

Background

Ethambutol, a longstanding treatment for tuberculosis (TB), lacks comprehensive pharmacokinetic (PK) data, particularly regarding covariates affecting exposure and their link to treatment outcomes. Using the largest data to date from Study 31/AIDS Clinical Trials Group A5349, we aimed to characterize ethambutol PKs, identify risk factors for lower exposure, quantify relationships between exposure and efficacy and safety outcomes, and explore dosing considerations that optimize risks and benefits.

Methods

We analyzed ethambutol PK data using nonlinear mixed-effect modeling. We evaluated the contribution of ethambutol exposure to efficacy outcomes using parametric time-to-event modeling and safety outcomes using logistic regression.

Results

In 1493 participan

SUBMITTER: Alkhafaji S 

PROVIDER: S-EPMC13629508 | biostudies-literature | 2026 Sep

REPOSITORIES: biostudies-literature