Acessibilidade / Reportar erro

Unanswered questions on the safety of MDT-U - Reply* * Study conducted at the Centro de Dermatologia Dona Libânia and Fundação de Dermatologia Tropical e Venereologia “Alfredo da Matta,” Manaus (AM), Brazil.

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”.11 Cruz RCS, Bührer-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. 2018;93:377-84.

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.22 Ferreira IP, Bührer-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. 2014;85:267-74.

  3. Definitely, we cannot compare data from leprosy control programs with a randomized and controlled clinical trial.33 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. 2017;11:e0005725. 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).11 Cruz RCS, Bührer-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. 2018;93:377-84.

  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.

  • *
    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.

REFERENCES

  • 1
    Cruz RCS, Bührer-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. 2018;93:377-84.
  • 2
    Ferreira IP, Bührer-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. 2014;85:267-74.
  • 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. 2017;11:e0005725.

Publication Dates

  • Publication in this collection
    17 Oct 2019
  • Date of issue
    Jul-Aug 2019

History

  • Received
    03 Dec 2018
  • Accepted
    03 Apr 2019
Sociedade Brasileira de Dermatologia Av. Rio Branco, 39 18. and., 20090-003 Rio de Janeiro RJ, Tel./Fax: +55 21 2253-6747 - Rio de Janeiro - RJ - Brazil
E-mail: revista@sbd.org.br