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Free Content Adverse drug reactions associated with first-line anti-tuberculosis drug regimens

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BACKGROUND: Standard treatment of active tuberculosis (TB) consists of isoniazid (INH), rifampin (RMP), pyrazinamide (PZA) and ethambutol (EMB). Although this regimen is effective in treating active TB, it is associated with many adverse drug reactions (ADRs) and poses a significant challenge to completion of treatment.

OBJECTIVES: To examine the incidence of major ADRs and risk factors associated with first-line anti-tuberculosis medications.

METHODS: This study evaluated patients receiving treatment for active TB from a population-based database (2000–2005). The nature of the ADRs, likelihood of association with the study medications and severity were evaluated.

RESULTS: A total of 1061 patients received treatment, of whom 318 (30%) had at least one major ADR. The overall incidence of all major ADRs was 7.3 events per 100 person-months (95%CI 7.2–7.5): 23.3 (95%CI 23.0–23.7) when on all four first-line drugs, 13.6 (95%CI 13.3–14.0) when on RMP, INH and PZA, and 2.4 (95%CI 2.3–2.6) when on INH and RMP. Adjusted hazard ratio (HR) revealed that combination regimens containing PZA, females, subjects aged 35–59 and ≥60 years, baseline aspartate aminotransferase ≥80 U/l and drug resistance were associated with any major event.

CONCLUSIONS: First-line anti-tuberculosis drugs are associated with significant ADRs. There are several risk factors associated with the development of ADRs, including exposure to regimens containing PZA.
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Keywords: adverse events; first-line medications; tuberculosis

Document Type: Regular Paper

Affiliations: 1: University of British Columbia, Vancouver, British Columbia, Canada; and BC Center for Disease Control, Vancouver, British Columbia, Canada 2: University of British Columbia, Vancouver, British Columbia, Canada; and Center for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada 3: University of British Columbia, Vancouver, British Columbia, Canada 4: BC Center for Disease Control, Vancouver, British Columbia, Canada 5: University of British Columbia, Vancouver, British Columbia, Canada; and Center for Clinical Epidemiology and Evaluation, Vancouver, British Columbia, Canada

Publication date: August 1, 2007

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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