Substituting or adding fluoroquinolones to established first-line antituberculous drug regimens gives no additional benefit or risks

Ziganshina LE, Squire SB

Published Online:

January 21, 2009

Fluoroquinolones have antituberculous activity, but are not one of the standard antituberculous medicines. Ciprofloxacin, ofloxacin, levofloxacin, sparfloxacin, and moxifloxacin have been tested in randomized controlled trials. Ciprofloxacin should not be used as a substitute drug in the standard antituberculous regimen as more people with drug-sensitive tuberculosis had relapses and it took longer for them to be cured. However, it was no different in terms of cure or number of adverse events. Sparfloxacin was no better than ofloxacin when added to antituberculous regimens in drug-resistant tuberculosis. Further trials are warranted.

Abstract (click to read)

Background:

Fluoroquinolones are sometimes used to treat multiple-drug-resistant and drug-sensitive tuberculosis. The effects of fluoroquinolones in tuberculosis regimens need to be assessed.

Objectives:

To assess fluoroquinolones as additional or substitute components to antituberculous drug regimens for drug-sensitive and drug-resistant tuberculosis.

Search strategy:

In July 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 3), MEDLINE, EMBASE, LILACS, Science Citation Index, Database of Russian Publications, and metaRegister of Controlled Trials. We also scanned reference lists of all identified studies and contacted researchers.

Selection criteria:

Randomized controlled trials of antituberculous regimens containing fluoroquinolones in people diagnosed with bacteriologically positive (sputum smear or culture) pulmonary tuberculosis.

Data collection and analysis:

Two authors independently applied inclusion criteria, assessed the risk of bias in the trials, and extracted data. We used risk ratio (RR) for dichotomous data, mean difference (MD) for continuous data (both with 95% confidence intervals (CI)), and the random-effects model if we detected heterogeneity and it was appropriate to combine data.

Main results:

Eleven trials (1514 participants) met the inclusion criteria. No statistically significant difference was found in trials substituting ciprofloxacin, ofloxacin or moxifloxacin for first-line drugs in relation to cure (416 participants, 3 trials), treatment failure (388 participants, 3 trials), or clinical or radiological improvement (216 participants, 2 trials). Substituting ciprofloxacin into first-line regimens in drug-sensitive tuberculosis led to a higher incidence of relapse (RR 7.17, 95% CI 1.33 to 38.58; 384 participants, 3 trials) and longer time to sputum culture conversion (MD 0.50 months, 95% CI 0.18 to 0.82; 168 participants, 1 trial), although this was confined to HIV-positive participants. Substituting for ethambutol in first-line regimens led to a higher incidence of total number of adverse events (RR 1.34, 95% CI 1.05 to 1.72; 492 participants, 2 trials). Adding or substituting levofloxacin to basic regimens in drug-resistant areas had no effect. A comparison of sparfloxacin versus ofloxacin added to regimens showed no statistically significant difference in cure (184 participants, 2 trials), treatment failure (149 participants, 2 trials), or the total number of adverse events (253 participants, 3 trials).

Authors' conclusions:

Only ciprofloxacin, ofloxacin, levofloxacin, sparfloxacin and moxifloxacin have been tested in randomized controlled trials for treating tuberculosis. We cannot recommend ciprofloxacin in treating tuberculosis. Trials of newer fluoroquinolones for treating tuberculosis are needed and are ongoing. No difference has been demonstrated between sparfloxacin and ofloxacin in drug-resistant tuberculosis.

This record should be cited as:

Ziganshina LE, Squire SB. Fluoroquinolones for treating tuberculosis. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD004795. DOI: 10.1002/14651858.CD004795.pub3

Assessed as up to date:

October 14, 2007

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Primary Review Group:

Infectious Diseases Group

Health topics:

Infectious disease > Tuberculosis > Treatment: drugs

Lungs & airways > Respiratory infections > Tuberculosis treatment: drugs

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Substituting or adding fluoroquinolones to established first-line antituberculous drug regimens gives no additional benefit or risks

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