Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients
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2017
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Background
Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes,
leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to
the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all
leprosy patients have been encouraged by the WHO, rendering disease classification
unnecessary.
Methodology and findings
An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil,
compared main outcomes (frequency of reactions, bacilloscopic index trend, disability pro gression and relapse rates) among MB patients treated with a uniform regimen/U-MDT
(dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dap sone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB
patients with high bacterial load were included. There was no statistically significant differ ence in Kaplan-Meyer survival function regarding reaction or disability progression among
patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both
groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both
groups and for interaction variables that included treatment group.
During active follow up, four patients in U-MDT group relapsed representing a relapse
rate of 2.6 per 1000 patients per year of active follow up (95% CI [0 81, 6 2] per 1000). Dur ing passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period
corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the
entire follow up period between 2 9- and 4 5 per 1000 people per year.
Conclusion
Our results on the first randomized and controlled study on U-MDT together with the results
from three previous studies performed in China, India and Bangladesh, support the hypothe sis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy
patients in the field worldwide.
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PENNA, Gerson Oliveira et al. Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): results of an open label, randomized and controlled clinical trial, among multibacillary patients. Plos Neglected Tropical Diseases, San Francisco, v. 11, n. 7, e0005725, 2017. DOI: 10.1371/journal.pntd.0005725. Disponível em: https://pmc.ncbi.nlm.nih.gov/articles/PMC5526599/. Acesso em: 12 fev. 2025.