Effectiveness and safety of clofazimine in multidrug-resistant tuberculosis: a nationwide report from Brazil
Effectiveness and safety of clofazimine in multidrug-resistant tuberculosis: a nationwide report from Brazil
Data
2017
Autores
Dalcolmo, Margareth
Gayoso, Regina
Sotgiu, Giovanni
D’Ambrosio, Lia
Rocha, Jorge L.
Borga, Liamar
Fandinho, Fatima
Braga, Jose U.
Galesi, Vera M.N.
Barreira, Draurio
Journal Title
Journal ISSN
Volume Title
Publisher
European Respiratory Journal
Resumo
Although clofazimine is used to treat multidrug-resistant tuberculosis (MDR-TB), there is
scant information on its effectiveness and safety. The aim of this retrospective, observational study was to
evaluate these factors as well as the tolerability of clofazimine in populations in Brazil, where it was
administered at a daily dose of 100 mg·day−1 (body weight ⩾45 kg) as part of a standardised MDR-TB
treatment regimen until 2006 (thereafter pyrazinamide was used).
All MDR-TB patients included in the Sistema de Informação de Tratamentos Especiais da Tuberculose
(SITETB) individual electronic register were analysed. The effectiveness of clofazimine was assessed by
comparing the treatment outcomes of patients undergoing clofazimine-containing regimens against those
undergoing clofazimine-free regimens and its safety by describing clofazimine-attributed adverse events.
A total of 1446 patients were treated with clofazimine-containing regimens and 1096 with pyrazinamide-
containing regimens.
Although success rates were similar in patients treated with clofazimine versus those treated with
pyrazinamide (880 out of 1446, 60.9%, versus 708 out of 1096, 64.6%; p=0.054), clofazimine-treated cases
exhibited higher death rates due to tuberculosis than pyrazinamide-treated ones (314 out of 1446, 21.7%,
versus 120 out of 1096, 10.9%) but fewer failures (78 out of 1446, 5.4%, versus 95 out of 1096, 8.7%) and less
loss to follow-up (144 out of 1446, 10.0%, versus 151 out of 1096, 13.8%). No relevant differences were
detected when comparing adverse events in patients treated with clofazimine-containing regimens to those
treated with clofazimine-free regimens. However, the incidence of side-effects was less than previously
reported (gastro-intestinal complaints: 10.5%; hyper-pigmentation: 50.2%; neurological disturbances: 9–13%).
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Citação
Dalcolmo M, Gayoso R, Sotgiu G, et al. Effectiveness and safety of clofazimine in multidrug-resistant tuberculosis: a nationwide report from Brazil. Eur Respir J 2017; 49: 1602445 doi: 10.1183/13993003.02445-2016.