Toxicity related to the treatment of pulmonary tuberculosis

Introduction: The incidence and nature of toxicity related to tuberculosis (TB) treatment, who is most commonly affected and what is the true impact on treatment is predominantly characterised through retrospective or observational studies; with varying definitions for toxicity and estimates of the incidence or patient groups at highest risk. REMoxTB was a randomised, controlled, phase III pulmonary TB clinical trial with stringent collection of efficacy and safety data. Methods: A total of 639 patients received standard TB therapy as a control arm for the trial, with 655 patients and 636 patients allocated to the ~isoniazid~ and ~ethambutol~ arms. Related grade 3 and 4 adverse events were used to investigate the general toxicity observed during treatment and the liver biochemical tests collected were described in detail separately. Regression techniques investigated the association between patient demographics and toxicity. Lastly, the incidence of adverse events and the longitudinal pattern of clinical and laboratory data was described for HIV positive patients. Results: Approximately 10% of patients experienced clinically significant toxicity attributed to their drug therapy. Older patients, female patients, ... (continues)