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: S Sundar, A Singh, D Agarwal, M Rai, N Agrawal, J Chakravarty
• Journal: The American journal of tropical medicine and hygiene (Am J Trop Med Hyg) Vol. 80 Issue 5 Pg. 700-3 (May 2009) ISSN: 1476-1645 [Electronic] United States
• PMID: 19407109 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Emulsions
• Lipids
• Amphotericin B

Topics

• Adult
• Amphotericin B (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Emulsions
• Female
• Humans
• India
• Leishmaniasis, Visceral (drug therapy)
• Lipids (chemistry)
• Male
• Young Adult