| Full text | |
| Author(s): |
Machado, Paulo R. L.
;
Ribeiro, Camila S.
;
Franca-Costa, Jaqueline
;
Dourado, Mayra E. F.
;
Trinconi, Cristiana T.
;
Yokoyama-Yasunaka, Jenicer K. U.
;
Malta-Santos, Hayna
;
Borges, Valeria M.
;
Carvalho, Edgar M.
;
Uliana, Silvia R. B.
Total Authors: 10
|
| Document type: | Journal article |
| Source: | TROPICAL MEDICINE & INTERNATIONAL HEALTH; v. 23, n. 9, p. 7-pg., 2018-09-01. |
| Abstract | |
ObjectivesThere 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. MethodsA 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. ResultsA 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. ConclusionsIn 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. ObjectifsIl y a un besoin evident de nouvelles strategies de traitement de la leishmaniose. Ce travail a ete mene pour evaluer l'efficacite de l'administration concomitante de tamoxifene et d'antimoniate de meglumine (Sb-V) dans un essai clinique pilote de phase II chez des patients atteints de leishmaniose cutanee localisee. MethodesUn essai clinique pilote controle randomise a ete mene pour evaluer l'efficacite et la securite du tamoxifene oral (40mg/jour pendant 20 jours) ou topique (citrate de tamoxifene a 0.1% pendant 20 jours) combine avec l'antimoniate de meglumine (20mg Sb-V/kg/jour pendant 20 jours) par rapport a un protocole standard (20mg Sb-V/kg/jour pendant 20 jours) pour le traitement de la leishmaniose cutanee. Le resultat principal etait l'epithelisation complete de la lesion 6 mois apres la fin du traitement. Les resultats secondaires etaient la guerison des lesions 2 mois apres la fin du traitement et la frequence et la gravite des effets indesirables. ResultatsUn total de 38 sujets ont ete inclus dans l'essai; 15 ont ete traites avec le Sb-V standard et 23 avec la combinaison de tamoxifene et de Sb-V. Parmi les patients traites avec le schema de combinaison, 12 ont recu du tamoxifene par voie orale et 11 ont ete traites avec du tamoxifene topique. Le tamoxifene administre par voie orale ou topique etait bien tolere. Les taux de guerison 6 mois apres la fin du traitement, par intention de traiter, etait de 40% dans le groupe traite avec le schema standard Sb-V et 36.4% et 58%, respectivement, pour les groupes traites avec Sb-V plus tamoxifene topique ou orale. ConclusionsDans les doses et les schemas utilises dans cette etude, la co-administration par voie orale de tamoxifene et de Sb-V a entraine des taux de guerison plus eleves que le schema de traitement standard, mais pas a des niveaux statistiquement significatifs. (AU) | |
| FAPESP's process: | 15/09080-2 - Evaluation of candidate drugs for the treatment of Leishmaniasis in Brazil |
| Grantee: | Silvia Reni Bortolin Uliana |
| Support Opportunities: | Regular Research Grants |