Unanswered questions on the safety of MDT-U - Reply^*

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.

• *
  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