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. 2016 Mar-Apr;48(2):186-91.
doi: 10.4103/0253-7613.178839.

Bedaquiline versus placebo for management of multiple drug-resistant tuberculosis: A systematic review

Jaykaran Charan  1 , Tea Reljic  2 , Ambuj Kumar  2
Affiliations

Bedaquiline versus placebo for management of multiple drug-resistant tuberculosis: A systematic review

Jaykaran Charan et al. Indian J Pharmacol. 2016 Mar-Apr.

Abstract

Background: Multidrug-resistant tuberculosis (MDR-TB) is associated with significant morbidity and mortality. Bedaquiline is the first drug approved for treating MDR-TB.

Objectives: We performed a systematic review and meta-analysis to summarize the totality of all available evidence on the efficacy of bedaquiline for the management of MDR-TB.

Materials and methods: We searched the following PubMed and Cochrane Registry of Clinical Trials. Randomized controlled trials (RCTs) with a parallel design comparing bedaquiline versus any treatment for the management of MDR-TB in adults were eligible for inclusion. Data were pooled under a random effects model.

Results: Two trials published as three manuscripts with a total of 207 patients were included. As per the Cochrane risk of bias tool, majority of parameter were labeled as high or unclear risk of bias. Bedaquiline compared with placebo was associated with a statistically significant decrease in time to conversion of positive sputum culture to negative at 8 and 24 weeks with a significant increase in mortality on long-term follow-up. There was no difference in completion rates between bedaquiline and placebo.

Conclusion: Bedaquiline is an effective treatment modality for MDR-TB but needs to be balanced against significant mortality. Future Phase 3 RCTs are needed to make a conclusive recommendation.

Keywords: Bedaquiline; multidrug resistance; sputum conversion; tuberculosis.

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Figures

Figure 1
Figure 1
Flow diagram illustrating the selection process of included studies
Figure 2
Figure 2
Summary of risk of bias in the trials included in the systematic review
Figure 3
Figure 3
Forest plot for the comparison of “time to conversion of positive sputum to negative at 24 weeks” between bedaquiline and placebo
Figure 4
Figure 4
Forest plot for the comparison of mortality between bedaquiline and placebo
Figure 5
Figure 5
Forest plot for the comparison of “number of subjects completed the treatment” between bedaquline and placebo
See this image and copyright information in PMC

References

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