Comparison of efficacy and safety of fixed-dose combination regimen versus separate drugs for treatment of tuberculosis

<b>Introduction:</b> Tuberculosis is also a major cause of morbidity and mortality worldwide. Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti-tuberculosis treatment regimen. <b>Objective:</b> To determine whether the four-drug fixed-dose combination is safer or more effective than separate drugs for treatment of pulmonary tuberculosis. <b>Methods:</b> A retrospective study which includes 176 patients with pulmonary or extra-pulmonary tuberculosis. Two groups were compared: group1 (G1) including 102 patients who received separate drugs and group2 (G2) including 74 patients who received fixed-dose combination regimen. <b>Results:</b> The patients of the group 2 was characterized by a higher relapse rate of tuberculosis (6.7% vs 3.9%) with no statistically significant difference (p = 0,307). The adverse events were observed in 40 patients in group 1 and in 58 patients in group 2 with a statistically significant difference (p = 0,000). Group 2 was characterized by a higher frequency of adverse events (21.6% vs 3.9%) requiring discontinuation of treatment without statistically significant difference (p = 0.580). <b>Conclusion:</b> The reviewed studies showed that four-drug fixed-dose combination therapy provides greater patient comfort by reducing the number of pills as well as simplifying pharmaceutical management. However, the composition and dosage recommendations for fixed-dose combination formulations differ from those for separate formulations. Thus, questions about the effectiveness and side effects of combination formulations remain.