A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis.
Rev Soc Bras Med Trop
; 52: e20180292, 2019 Mar 28.
Article
in En
| MEDLINE
| ID: mdl-30942258
ABSTRACT
INTRODUCTION:
The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study.METHODS:
We performed a randomized clinical trial with two parallel groups. The tested intervention consisted of miltefosine 1.3-2 mg/kg/day (two capsules) for 28 days or intravenous 20 mg SbV/kg/day of meglumine antimoniate (N-MA) for 30 days. The final endpoint was defined as complete healing of the lesion four years after treatment. We also analyzed an early endpoint at 90 days after treatment.RESULTS:
Forty patients were included in this study each experimental group comprised 20 patients. Applying a multivariate model in an intention-to-treat analysis, we observed that patients treated with miltefosine had a cure probability 2.08 times greater (95% confidence interval [CI] = 1.03-4.18) than those treated with N-MA at 90 days after treatment. At the final endpoint, we observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33-1.32). With respect to adverse reactions, significant differences between groups were related to gastrointestinal effects, which were more frequent in the miltefosine group.CONCLUSIONS:
Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Phosphorylcholine
/
Leishmaniasis, Mucocutaneous
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Meglumine Antimoniate
/
Antiprotozoal Agents
Type of study:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
Limits:
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Rev Soc Bras Med Trop
Year:
2019
Document type:
Article
Affiliation country:
Brasil