Abstract
SETTING: Several recent trials evaluating 4-month fluoroquinolone (FQ) containing regimens found that none of the experimental regimens were non-inferior to standard 6-month therapy in treating patients with drugsusceptible pulmonary tuberculosis (PTB). OBJECTIVE: To answer whether FQ-containing duration-shortened regimens are non-inferior to standard therapy in the treatment of patients with non-cavitary PTB. DE S IGN: Systematic review of all randomized and quasi-randomized trials that substituted an FQ into standard therapy for less than 6 months' duration to treat drug-susceptible, non-cavitary PTB. Non-inferiority was based on a 6% margin of difference. RESULTS: Of 4594 total participants in the three trials that met the inclusion criteria, 1066 patients had noncavitary disease. The pooled difference in unfavorable outcomes was 5% (95%CI 3 to 13) in patients with non-cavitary disease treated with FQ-containing regimens vs. standard therapy. In subgroup analyses, the pooled difference in unfavorable outcomes was 1% (95%CI 3 to 5) when comparing the daily form of intervention regimen with standard therapy, and 1% (95%CI 5 to 4) between regimens replacing ethambutol (EMB) with an FQ and standard therapy. No difference in risk of adverse events was noted. CONCLUSION: Daily administered 4-month regimens with substitution of EMB by an FQ may be non-inferior to standard therapy in patients with culture-confirmed, non-cavitary, drug-susceptible PTB.
Original language | English (US) |
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Pages (from-to) | 1522-1528 |
Number of pages | 7 |
Journal | International Journal of Tuberculosis and Lung Disease |
Volume | 20 |
Issue number | 11 |
DOIs | |
State | Published - Nov 1 2016 |
Keywords
- Clinical trials
- Gatifloxacin
- Moxifloxacin
- Randomized controlled trial
- Systematic review
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Infectious Diseases