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Am J Trop Med Hyg ; 85(1): 66-9, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21734127

ABSTRACT

Miltefosine (target dose of 2.5 mg/kg/day for 28 days) is the recommended treatment for visceral leishmaniasis (kala-azar) in Bangladesh on the basis of data from India. We evaluated miltefosine in a phase IV trial of 977 patients in Bangladesh. At the six-month final follow up, 701 were cured. 24 showed initial treatment failure, and 95 showed treatment failure at 6 months, although 73 of the 95 showed treatment failure solely by the criterion of low hemoglobin values. One hundred twenty-one patients were not assessable. With the conservative assumption that all low hemoglobin values represented treatment failure, the final per protocol cure rate was 85%. Of 13 severe adverse events, 6 led to treatment discontinuation and 7 resulted in deaths, but only 1 death (associated with diarrhea) could be attributed to drug. Nearly all non-serious adverse events were gastrointestinal: vomiting in 25% of patients and diarrhea in 8% of patients. Oral miltefosine is an attractive alternative to intramuscular antimony and intravenous amphotericin B for treatment of kala-azar in Bangladesh.


Subject(s)
Antiprotozoal Agents/therapeutic use , Leishmaniasis, Visceral/drug therapy , Phosphorylcholine/analogs & derivatives , Adolescent , Adult , Bangladesh , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Phosphorylcholine/therapeutic use , Treatment Outcome
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