Abstract
There is limited evidence on the effect of DM co-morbidity in those undergoing treatment for MDR-TB. We report post-hoc analyses of participants from the STREAM Clinical Trial (Stage 1 and 2 combined). Participants who self-reported diabetes, had random blood glucose ≥200mg/dl at baseline, or reported taking concomitant medication for diabetes were classified as the DM group. In total, 896 (n=84 DM, n=812 non-DM) and 976 (n=87 DM, n=889 non-DM) participants were included respectively in the efficacy and safety analyses reported here. Summary statistics for efficacy and safety outcomes were calculated. Hazard ratios (HR) for time-to-event outcomes were estimated using Cox-proportional hazard models. Compared to the non-DM group, the DM group were significantly older, more likely to be male and had a higher BMI. The DM group experienced a significantly higher proportion of serious adverse events (SAEs) (41% vs. 22%, p<0.001) but was comparable to the non-DM group on all other safety (grade 3-5 adverse events, deaths, unscheduled visits) as well as all efficacy parameters (proportion with unfavourable outcome, proportion FoR, time to FoR and culture conversion) assessed. The STREAM clinical trial experience indicated that it is possible to achieve similar treatment outcomes in people with MDR-TB who have a DM co-morbidity. However, this sub-population experienced more SAEs, underscoring the importance of close monitoring to manage their impact and improve MDR-TB treatment outcomes.