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pubmed-article:21734127pubmed:abstractTextMiltefosine (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.lld:pubmed
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pubmed-article:21734127pubmed:year2011lld:pubmed
pubmed-article:21734127pubmed:articleTitlePhase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh.lld:pubmed
pubmed-article:21734127pubmed:affiliationInstitute Of Epidemiology, Disease Control and Research, Dhaka, Bangladesh. mrahman@citechco.netlld:pubmed
pubmed-article:21734127pubmed:publicationTypeJournal Articlelld:pubmed
pubmed-article:21734127pubmed:publicationTypeResearch Support, Non-U.S. Gov'tlld:pubmed
pubmed-article:21734127pubmed:publicationTypeClinical Trial, Phase IVlld:pubmed