Adverse drug reactions associated with first-line anti-tuberculosis drug regimens
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.
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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