Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial

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 (SbV) in a phase II pilot clinical trial in localised cutaneous leishmaniasis patients. Methods A randomise...

Full description

Saved in:
Bibliographic Details
Published in:Tropical medicine & international health 2018-09, Vol.23 (9), p.936-942
Main Authors: Machado, Paulo R. L., Ribeiro, Camila S., França‐Costa, Jaqueline, Dourado, Mayra E.F., Trinconi, Cristiana T., Yokoyama‐Yasunaka, Jenicer K. U., Malta‐Santos, Hayna, Borges, Valéria M., Carvalho, Edgar M., Uliana, Silvia R. B.
Format: Article
Language:English
Subjects:
Administration, Oral
Administration, Topical
Adult
antimoniés pentavalents
Antiprotozoal Agents - administration & dosage
Antiprotozoal Agents - therapeutic use
Citric acid
Clinical trials
Control methods
Cutaneous leishmaniasis
Drug Therapy, Combination
Effectiveness
Female
Humans
Leishmaniasis, Cutaneous - drug therapy
leishmaniose cutanée
Lesions
Male
Meglumine antimoniate
Meglumine Antimoniate - administration & dosage
Meglumine Antimoniate - therapeutic use
Middle Aged
Motivation
oral
Parasitic diseases
Patients
pentavalent antimonials
Pilot Projects
Randomization
Selective Estrogen Receptor Modulators - administration & dosage
Selective Estrogen Receptor Modulators - therapeutic use
Statistical analysis
Tamoxifen
Tamoxifen - administration & dosage
Tamoxifen - therapeutic use
Tamoxifen citrate
tamoxifène
topical
topique
traitement
treatment
Treatment Outcome
Vector-borne diseases
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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 (SbV) 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 SbV/kg/day for 20 days) vs. a standard SbV 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 SbV and 23 with the combination of tamoxifen and SbV. 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 SbV scheme, and 36.4% and 58%, respectively, for groups treated with SbV plus topical or oral tamoxifen. Conclusions In the doses and schemes used in this study, co‐administration of oral tamoxifen and SbV resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels. Objectifs Il y a un besoin évident de nouvelles stratégies de traitement de la leishmaniose. Ce travail a été mené pour évaluer l'efficacité de l'administration concomitante de tamoxifène et d'antimoniate de méglumine (SbV) dans un essai clinique pilote de phase II chez des patients atteints de leishmaniose cutanée localisée. Méthodes Un essai clinique pilote contrôlé randomisé a été mené pour évaluer l'efficacité et la sécurité du tamoxifène oral (40 mg/jour pendant 20 jours) ou topique (citrate de tamoxifène à 0.1% pendant 20 jours) combiné avec l'antimoniate de méglumine (20 mg SbV/kg/jour pendant 20 jours) par rapport à un protocole standard (20 mg SbV/kg/jour pendant 20 jours) pour le traitement de la leishmaniose cutanée. Le résultat principal était l’épithélisation complète de la lésion 6 mois après la fin du traitemen
ISSN:1360-2276
1365-3156
DOI:10.1111/tmi.13119