title: Safety and efficacy of high-dose infusions of a preformed amphotericin B fat emulsion for treatment of Indian visceral leishmaniasis.
abstract: Amphotericin B deoxycholate is used as a first-line drug for visceral leishmaniasis (VL) in India. Its major drawbacks are prolonged hospitalization of treated patients and toxicity. An open label phase II study with pre-formed amphotericin B lipid emulsion (ABLE) was conducted to evaluate safety and efficacy of four regimens of 15 mg/kg each administered in 1-2 doses. Regimen 1 was 7.5 mg/kg/day on day 1 and day 3, and regimen 4 was a single bolus infusion of 15 mg/kg. The safety profile was excellent with mild infusion reactions seen in 38% of the patients. Definitive cure was achieved in 100% of the patients treated with regimen 4. The overall cure rate was 87% (95% confidence interval = 75-94%). In this study, ABLE was safe and had excellent efficacy when given as a bolus of 15 mg/kg. More studies with larger number of patients and higher doses are needed to establish acceptable, safe and efficacious regimen.
authors.affiliation: Kala-Azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drshyamsundar@hotmail.com
authors.forename: S
authors.initials: S
authors.lastname: Sundar
authors.forename: A
authors.initials: A
authors.lastname: Singh
authors.forename: D
authors.initials: D
authors.lastname: Agarwal
authors.forename: M
authors.initials: M
authors.lastname: Rai
authors.forename: N
authors.initials: N
authors.lastname: Agrawal
authors.forename: J
authors.initials: J
authors.lastname: Chakravarty
mesh_terms: D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004655:Emulsions; D005260:Female; D006801:Humans; D007194:India; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008055:Lipids / Q000737:chemistry; D008297:Male; D055815:Young Adult
chemical_list: D004655:Emulsions; D008055:Lipids; D000666:Amphotericin B