02773nas a2200289   4500000000100000008004100001260001200042653001900054653001200073653001200085653003000097100001200127700001300139700001400152700001700166700001300183700001300196700001400209700002200223700001400245700001200259245011200271856015300383300000800536520192500544022001402469       2024                            d  c04/202410aClinical trial10aleprosy10aRelapse10aUniform multidrug therapy1 aPenna G1 aPontes M1 aTalhari S1 aGonçalves H1 aCortez C1 aPessoa A1 aPedroza V1 aBührer-Sékula S1 aStefani M1 aPenna M00aLate relapses in leprosy patients in Brazil: 10-year post-trial of uniform multidrug therapy (U-MDT/CT-BR).  uhttps://www.sciencedirect.com/science/article/pii/S141386702400028X/pdfft?md5=7d145991c7d7997f91f2ae5c746b7fcf&pid=1-s2.0-S141386702400028X-main.pdf  a1-83 a<p><strong>Background: </strong>Leprosy is a neglected dermato-neurologic, infectious disease caused by Mycobacterium leprae or M. lepromatosis. Leprosy is treatable and curable by multidrug therapy/MDT, consisting of 12 months rifampicin, dapsone and clofazimine for multibacillary/MB patients and for 6 months for paucibacillary/PB patients. The relapse rate is considered a crucial treatment outcome. A randomized Controlled Trial (U-MDT/CT-BR) conducted from 2007‒2012 compared clinical outcomes in MB patients after 12 months regular MDT/R-MDT and 6 months uniform MDT/U-MDT in two highly endemic Brazilian areas.</p>

<p><strong>Objectives: </strong>To estimate the 10 years relapse rate of MB patients treated with 6 months U-MDT.</p>

<p><strong>Methods: </strong>The statistical analyses treated the data as a case-control study, sampled from the cohort generated for the randomized trial. Analyses estimated univariate odds ratio and applied logistic regression for multivariate analysis, controlling the confounding variables.</p>

<p><strong>Results: </strong>The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and 3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced bias, underestimating the force of the association represented by the odds ratio.</p>

<p><strong>Conclusions: </strong>The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group supporting strong evidence that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy endemic countries worldwide.</p>

<p><strong>Trial Registration: </strong>ClinicalTrials.gov: NCT00669643.</p>
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