Oral miltefosine for Indian post-kala-azar dermal leishmaniasis: a randomised trial.
Trop Med Int Health
; 18(1): 96-100, 2013 Jan.
Article
em En
| MEDLINE
| ID: mdl-23136856
ABSTRACT
OBJECTIVE:
Standard treatment of Indian post-kala-azar dermal leishmaniasis (PKDL) is unsatisfactory because to achieve therapeutic effectiveness, heroic courses of parenteral and toxic agents have to be administered. Our objective was to evaluate oral miltefosine for its potential to provide effective as well as tolerable treatment for this disease.METHOD:
Open-label, randomised, parallel-group multicentric trial. Miltefosine, 100 mg/day to all but one patient, was administered for 12 weeks or 8 weeks, with a target of 18 patients in each treatment group. Key endpoints were tolerance during treatment and efficacy at 12 months of follow-up.RESULTS:
The ITT and per-protocol cure rates after 12 months of follow-up for patients receiving 12 weeks of therapy were 78% (14 of 18 patients 95% CI = 61-88%) and 93% (14 of 15 patients 95% CI = 71-95%), respectively, after 12 months of follow-up. The ITT and per-protocol cure rates for patients receiving 8 weeks of therapy were 76% (13 of 17 patients 95% CI = 53-90%) and 81% (13 of 16 patients 95% CI = 57-93%), respectively. Gastrointestinal and other adverse events were rare.CONCLUSIONS:
This study suggests that oral miltefosine for 2-3 months can be considered a treatment of choice for Indian PKDL.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fosforilcolina
/
Tripanossomicidas
/
Leishmaniose Cutânea
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
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Adult
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Female
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Humans
/
Male
Idioma:
En
Revista:
Trop Med Int Health
Assunto da revista:
MEDICINA TROPICAL
/
SAUDE PUBLICA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Índia