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Fluoroquinolones for Treating Tuberculosis (Presumed Drug- Sensitive) (Review)

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Fluoroquinolones for Treating Tuberculosis (Presumed Drug- Sensitive) (Review) Fluoroquinolones for treating tuberculosis (presumed drug- sensitive) (Review) Ziganshina LE, Titarenko AF, Davies GR This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 6 http://www.thecochranelibrary.com Fluoroquinolones for treating tuberculosis (presumed drug-sensitive) (Review) Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 3 BACKGROUND .................................... 5 OBJECTIVES ..................................... 6 METHODS ...................................... 6 RESULTS....................................... 9 Figure1. ..................................... 10 Figure2. ..................................... 12 ADDITIONALSUMMARYOFFINDINGS . 15 DISCUSSION ..................................... 20 Figure3. ..................................... 20 Figure4. ..................................... 21 AUTHORS’CONCLUSIONS . 23 ACKNOWLEDGEMENTS . 23 REFERENCES ..................................... 24 CHARACTERISTICSOFSTUDIES . 30 DATAANDANALYSES. 60 Analysis 1.1. Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome1Deathfromanycause. 61 Analysis 1.2. Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome2TB-relateddeath. 62 Analysis 1.3. Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 3 Sputum culture conversion at 8 weeks. ....... 62 Analysis 1.4. Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome4Seriousadverseevents. 63 Analysis 1.5. Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 5 Total number of people with adverse events. ............ 63 Analysis 2.1. Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome1Relapse. ............................... 64 Analysis 2.2. Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome2Deathfromanycause. 65 Analysis 2.3. Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome3TB-relateddeath. 66 Analysis 2.4. Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 4 Sputum culture conversion at 8 weeks. ....... 67 Analysis 2.5. Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome5Seriousadverseevents. 68 Analysis 3.1. Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome1Deathfromanycause. 69 Analysis 3.2. Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome2TB-relateddeath. 69 Analysis 3.3. Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome 3 Sputum culture conversion at 8 weeks. ....... 70 Analysis 3.4. Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome4Seriousadverseevents. 70 APPENDICES ..................................... 71 WHAT’SNEW..................................... 81 HISTORY....................................... 82 CONTRIBUTIONSOFAUTHORS . 82 Fluoroquinolones for treating tuberculosis (presumed drug-sensitive) (Review) i Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DECLARATIONSOFINTEREST . 82 SOURCESOFSUPPORT . 83 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 83 INDEXTERMS .................................... 83 Fluoroquinolones for treating tuberculosis (presumed drug-sensitive) (Review) ii Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Fluoroquinolones for treating tuberculosis (presumed drug- sensitive) Lilia E Ziganshina1, Albina F Titarenko1, Geraint R Davies2 1Department of Basic and Clinical Pharmacology, Kazan (Volga region) Federal University, Kazan, Russian Federation. 2Institute of Infection and Global Health, University of Liverpool, Liverpool, UK Contact address: Lilia E Ziganshina, Department of Basic and Clinical Pharmacology, Kazan (Volga region) Federal University, 18 Kremlevskaya Street, 420008, 14-15 Malaya Krasnaya Street, 420015, Kazan, Tatarstan, Russian Federation. [email protected]. [email protected]. Editorial group: Cochrane Infectious Diseases Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 6, 2013. Review content assessed as up-to-date: 4 March 2013. Citation: Ziganshina LE, Titarenko AF, Davies GR. Fluoroquinolones for treating tuberculosis (presumed drug-sensitive). Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD004795. DOI: 10.1002/14651858.CD004795.pub4. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Currently the World Health Organization only recommend fluoroquinolones for people with presumed drug-sensitive tuberculosis (TB) who cannot take standard first-line drugs. However, use of fluoroquinolones could shorten the length of treatment and improve other outcomes in these people. This review summarises the effects of fluoroquinolones in first-line regimens in people with presumed drug-sensitive TB. Objectives To assess fluoroquinolones as substitute or additional components in antituberculous drug regimens for drug-sensitive TB. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register; CENTRAL (The Cochrane Library 2013, Issue 1); MED- LINE; EMBASE; LILACS; Science Citation Index; Databases of Russian Publications; and metaRegister of Controlled Trials up to 6 March 2013. Selection criteria Randomized controlled trials (RCTs) of antituberculous regimens based on rifampicin and pyrazinamide and containing fluoro- quinolones in people with presumed drug-sensitive pulmonary TB. Data collection and analysis Two authors independently applied inclusion criteria, assessed the risk of bias in the trials, and extracted data. We used the risk ratio (RR) for dichotomous data and the fixed-effect model when it was appropriate to combine data and no heterogeneity was present. We assessed the quality of evidence using the GRADE approach. Fluoroquinolones for treating tuberculosis (presumed drug-sensitive) (Review) 1 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results We identified five RCTs (1330 participants) that met the inclusion criteria. None of the included trials examined regimens of less than six months duration. Fluoroquinolones added to standard regimens A single trial (174 participants) added levofloxacin to the standard first-line regimen. Relapse and treatment failure were not reported. For death, sputum conversion, and adverse events we are uncertain if there is an effect (one trial, 174 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for ethambutol in standard regimens Three trials (723 participants) substituted ethambutol with moxifloxacin, gatifloxacin, and ofloxacin into the standard first-line regimen. For relapse, we are uncertain if there is an effect (one trial, 170 participants, very low quality evidence). No trials reported on treatment failure. For death, sputum culture conversion at eight weeks, or serious adverse events we do not know if there was an effect (three trials, 723 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for isoniazid in standard regimens A single trial (433 participants) substituted moxifloxacin for isoniazid. Treatment failure and relapse were not reported. For death, sputum culture conversion, or serious adverse events the substitution may have little or no difference (one trial, 433 participants, low quality evidence for all three outcomes). Fluoroquinolines in four month regimens Six trials are currently in progress testing shorter regimens with fluoroquinolones. Authors’ conclusions Ofloxacin, levofloxacin, moxifloxacin, and gatifloxacin have been tested in RCTs of standard first-line regimens based on rifampicin and pyrazinamide for treating drug-sensitive TB. There is insufficient evidence to be clear whether addition or substitution of fluoro- quinolones for ethambutol or isoniazid in the first-line regimen reduces death or relapse, or increases culture conversion at eight weeks. Much larger trials with fluoroquinolones in short course regimens of four months are currently in progress. PLAIN LANGUAGE SUMMARY Substituting or adding fluoroquinolones to established first-line antituberculous drug regimens gives no additional benefit or risks Tuberculosis is an infectious disease caused by Mycobacterium tuberculosis bacteria. Over two billion people worldwide are believed to be latently infected with TB and approximately 10% of these people will develop active TB later in life. The World Health Organization currently only recommend treatment with fluoroquinolones for patients who cannot take standard first-line drugs. In this review, we examined the effect of including fluoroquinolones in first-line treatment regimens on people with presumed drug-sensitive tuberculosis.
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