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Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial
Author(s) -
Machado Paulo R. L.,
Ribeiro Camila S.,
FrançaCosta Jaqueline,
Dourado Mayra E.F.,
Trinconi Cristiana T.,
YokoyamaYasunaka Jenicer K. U.,
MaltaSantos Hayna,
Borges Valéria M.,
Carvalho Edgar M.,
Uliana Silvia R. B.
Publication year - 2018
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/tmi.13119
Subject(s) - meglumine antimoniate , medicine , tamoxifen , adverse effect , cutaneous leishmaniasis , intention to treat analysis , surgery , leishmaniasis , breast cancer , cancer , pathology
Objectives There is a clear need for new strategies of leishmaniasis treatment. This work was conducted to evaluate the efficacy of the co‐administration of tamoxifen and meglumine antimoniate (Sb V ) in a phase II pilot clinical trial in localised cutaneous leishmaniasis patients. Methods A randomised controlled pilot clinical trial was conducted to evaluate the efficacy and safety of oral (40 mg/day for 20 days) or topical tamoxifen (0.1% tamoxifen citrate for 20 days) combined with meglumine antimoniate (20 mg Sb V /kg/day for 20 days) vs . a standard Sb V protocol (20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis. Primary outcome was complete epithelisation of the lesion 6 months after the end of treatment. Secondary outcomes were lesion healing 2 months after the end of treatment and frequency and severity of adverse events. Results A total of 38 subjects were included in the trial, 15 were treated with standard Sb V and 23 with the combination of tamoxifen and Sb V . Of the patients treated with the co‐administration scheme, 12 received tamoxifen orally and 11 were treated with topical tamoxifen. Tamoxifen administered by the oral or topical routes was well tolerated. Cure rates 6 months after the end of treatment per intention to treat were 40% in the group treated with the standard Sb V scheme, and 36.4% and 58%, respectively, for groups treated with Sb V plus topical or oral tamoxifen. Conclusions In the doses and schemes used in this study, co‐administration of oral tamoxifen and Sb V resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels.