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Vol. 94. Núm. 4.
Páginas 500 (1 julho 2019)
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Vol. 94. Núm. 4.
Páginas 500 (1 julho 2019)
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Unanswered questions on the safety of MDT-U - Reply*
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Gerson Oliveira Penna1,2, Heitor de Sá Gonçalves3, Maria Araci de Andrade Pontes3
1 Center for Tropical Medicine, Universidade de Brasília, Brasília, DF, Brazil.
2 Escola Fiocruz de Governo, Fundação Oswaldo Cruz, Brasília, DF, Brazil.
3 Dermatology Outpatient Clinic, Centro de Dermatologia Dona Libânia, Fortaleza, CE, Brazil.
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Dear Dr. Barve,

Thank you very much for your comments regarding our paper “Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach”.1

Let us clarify some points:

  • 1.

    Indeed, both pigmentation and xerosis are caused by clofazimine. We definitely did not imply that these were due to rifampicin and/or dapsone.

  • 2.

    It is clear that paucibacillary (PB) patients treated with R-MDT do not use clofazimine. However, as mentioned in reference 2, the inclusion of clofazimine in the treatment of PB patients did not lead to an increase in non-compliance when we used U-MDT.2

  • 3.

    Definitely, we cannot compare data from leprosy control programs with a randomized and controlled clinical trial.3 It would be a fundamental and serious mistake. However, it is very important to stress that only 24 patients had to interrupt treatment due to adverse effects (AE).1

  • 4.

    Despite your question about the moment of AE onset, for us it is clear and elementary that the shorter the treatment is, the less AE we are likely to find.

References
[1.]
Cruz RCS, Buhrer-Sékula S, Penna GO, Moraes MEA, Gonçalves HS, Stefani MMA, et al.
Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach..
An Bras Dermatol., 93 (2018), pp. 377-384
[2.]
Ferreira IP, Buhrer-Sékula S, De Oliveira MR, Gonçalves H de S, Pontes MA, Penna ML, et al.
Patient profile and treatment satisfaction of Brazilian leprosy patients in a clinical trial of uniform six-month multidrug therapy (U-MDT/CT-BR)..
Lepr Rev., 85 (2014), pp. 267-274
[3.]
Penna GO, Bührer-Sékula S, Kerr LRS, Stefani MMA, Rodrigues LC, de Araújo MG, 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 Negl Trop Dis., 11 (2017), pp. e0005725

Study conducted at the Centro de Dermatologia Dona Libânia and Fundação de Dermatologia Tropical e Venereologia “Alfredo da Matta,” Manaus (AM), Brazil.

Financial support: Department of Science and Technology (DECIT), Ministry of Health CNPq, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brasília, DF, Brazil.

Conflict of interest: None.

Copyright © 2019. Anais Brasileiros de Dermatologia
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