DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Amphotericin B colloidal dispersion for the treatment of Indian visceral leishmaniasis.

Author(s): Sundar S, Mehta H, Chhabra A, Singh V, Chauhan V, Desjeux P, Rai M

Affiliation(s): Kala-Azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drshyamsundar@dataone.in

Publication date & source: 2006-03-01, Clin Infect Dis., 42(5):608-13. Epub 2006 Jan 20.

Publication type: Randomized Controlled Trial

BACKGROUND: In Bihar, India, where visceral leishmaniasis (VL) is hyperendemic and refractory to antimony, amphotericin B is the most effective option for the treatment of VL. Lipid formulations of amphotericin B are able to circumvent the toxic effect of conventional amphotericin B, and the total dose of these formulations can be administered over a short duration. However, cost is a major constraint in the use of lipid formulations of amphotericin B. Amphotericin B colloidal dispersion (ABCD), which is a less expensive lipid formulation, has not been tested for the treatment of VL in India. METHODS: In an open-label, randomized clinical trial, we evaluated the efficacy and safety of a 6-day course of ABCD administered to 3 different dose groups (total dose: 7.5 mg/kg [group A], 10 mg/kg [group B], and 15 mg/kg [group C]), each of which included a cohort of 135 patients. RESULTS: Although infusion-related fever and chills occurred in 56%-68% of patients in the 3 different dose groups, 401 of 405 patients completed the treatment. All 135 patients in group A completed treatment, and the final cure rate for this group was 97%. In the group that received the highest dose of ABCD (group C), severe backache, an unusual side effect, was observed in 8 patients (5.92%). Serious adverse effects led to the withdrawal of 2 patients (1.48%) each from group B and group C. CONCLUSIONS: Although the cost of ABCD is prohibitive, the high level of efficacy associated with short-term treatment with low-dose ABCD provides another alternative for the treatment of VL, especially in regions where VL is antimony refractory.

Page last updated: 2006-11-04

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017