Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23.
Continuing the theme from last week’s update on fixed-dose combinations (FDCs), we present a summary of this article by Christian Lienhardt (Leader of the Clinical Trial Capacity Subgroup, and affiliated with the Stop TB Partnership), et al., on the efficacy and safety of a 4-drug FDC when compared to a regimen of separately administered drugs. Key points from the article are:
- Results suggest that a 4-drug FDC is as good or efficacious as a regimen using separate drugs.
- The authors analyzed the data per protocol, intention-to-treat model based on analysis plan (model 1), and modified intention-to-treat model (model2); the per-protocol and model 2 analysis satisfied the criteria for non-inferiority defined in the protocol.
- Safety data showed there were few adverse events and similar frequency in both regimens.
- The study was a parallel-group, open-label, non-inferiority, randomized controlled trial conducted at 11 sites in Africa, Asia, Latin America, between 2003 ad 2008.
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Bio-IT World Announces the Winners of its 2011 Best Practices Awards Program