title: Phase IV trial of miltefosine in adults and children for treatment of visceral leishmaniasis (kala-azar) in Bangladesh.
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.
authors: Institute Of Epidemiology, Disease Control and Research, Dhaka, Bangladesh. mrahman@citechco.net
authors: Mahmudur
authors: M
authors: Rahman
authors: Be-Nazir
authors: BN
authors: Ahmed
authors: M Abul
authors: MA
authors: Faiz
authors: M Zafor Ullah
authors: MZ
authors: Chowdhury
authors: Quazi Tarikul
authors: QT
authors: Islam
authors: Rahman
authors: R
authors: Sayeedur
authors: M Ridwanur
authors: MR
authors: Rahman
authors: Moazzem
authors: M
authors: Hossain
authors: Abdul Mannan
authors: AM
authors: Bangali
authors: Ziauddin
authors: Z
authors: Ahmad
authors: M Nazrul
authors: MN
authors: Islam
authors: C G Nicholas
authors: CG
authors: Mascie-Taylor
authors: Jonathan
authors: J
authors: Berman
authors: Byron
authors: B
authors: Arana
mesh_terms: D000293:Adolescent; D000328:Adult; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D001459:Bangladesh; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine