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Oral miltefosine for Indian post‐kala‐azar dermal leishmaniasis: a randomised trial
Author(s) -
Sundar Shyam,
Sinha Prabat,
Jha T. K.,
Chakravarty Jaya,
Rai Madhukar,
Kumar Nawin,
Pandey Krishna,
Narain M. K.,
Verma N.,
Das V. N. R.,
Das P.,
Berman Jonathan,
Arana Byron
Publication year - 2013
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.12015
Subject(s) - miltefosine , medicine , visceral leishmaniasis , adverse effect , leishmaniasis , surgery , randomized controlled trial , clinical trial , immunology
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 .