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Fixed-dose drug combination non-inferior to loose pills for tuberculosis
Four-drug therapy (RIPE) requires high patient commitment and imposes logistical demands on health systems in developing countries. Lienhardt et al report that a fixed-drug combination (FDC) of rifampin, isoniazid, pyrazinamide, and ethambutol was noninferior in producing negative cultures at 18 months compared to taking the drugs separately (both arms ~94% cure rate) in Africa, Asia and Latin America. Adverse events were roughly equal, but could be addressed more discriminately in the conventional group (i.e., stop one drug rather than all four at once). Patients in the FDC group took at most 3 or 4 pills a day, compared to the usual 9 to 16. (n=1,585). JAMA 2011;305:1415-1423.