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Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries.
Bull World Health Organ. 1998; 76(1):25-32.BW

Abstract

Reported are the results of a study to determine the efficacy and safety of liposomal amphotericin B (AmBisome) for treating visceral leishmaniasis (kala-azar) in several developing countries where the disease is endemic (Brazil, India, and Kenya). At each study site, sequential cohorts of 10 patients each were treated with AmBisome at a dose of 2 mg.kg-1.day-1 (2 MKD). The first cohort received regimen 1:2 MKD on days 1-6 and day 10 (total dose: 14 mg/kg). If the efficacy with this regimen was satisfactory, a second cohort received regimen 2:2 MKD on days 1-4 and 10 (total dose: 10 mg/kg); and a third cohort received regimen 3:2 MKD on days 1, 5, and 10 (total dose: 6 mg/kg). In India, regimens 1, 2, and 3 (which were studied concurrently) each cured 100% of 10 patients. In Kenya, regimen 1 cured all 10 patients, regimen 2 cured 90% of 10 patients, but regimen 3 cured only 20% of 5 patients. In Brazil, regimen 1 was only partially curative: 5 of 13 patients (62%). Therefore, 15 patients were administered regimen 4 (2 MKD for 10 consecutive days; total dose, 20 mg/kg) and 13 patients were cured (83%). These results suggest that for the treatment of kala-azar the following doses of AmBisome should be administered: in India and Kenya, 2 mg/kg on days 1-4 and day 10; and in Brazil, 2 mg/kg on days 1-10.

Authors+Show Affiliations

Biology Department, Walter Reed Army Institute of Research, Washington, DC, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study

Language

eng

PubMed ID

9615494

Citation

Berman, J D., et al. "Efficacy and Safety of Liposomal Amphotericin B (AmBisome) for Visceral Leishmaniasis in Endemic Developing Countries." Bulletin of the World Health Organization, vol. 76, no. 1, 1998, pp. 25-32.
Berman JD, Badaro R, Thakur CP, et al. Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. Bull World Health Organ. 1998;76(1):25-32.
Berman, J. D., Badaro, R., Thakur, C. P., Wasunna, K. M., Behbehani, K., Davidson, R., Kuzoe, F., Pang, L., Weerasuriya, K., & Bryceson, A. D. (1998). Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. Bulletin of the World Health Organization, 76(1), 25-32.
Berman JD, et al. Efficacy and Safety of Liposomal Amphotericin B (AmBisome) for Visceral Leishmaniasis in Endemic Developing Countries. Bull World Health Organ. 1998;76(1):25-32. PubMed PMID: 9615494.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. AU - Berman,J D, AU - Badaro,R, AU - Thakur,C P, AU - Wasunna,K M, AU - Behbehani,K, AU - Davidson,R, AU - Kuzoe,F, AU - Pang,L, AU - Weerasuriya,K, AU - Bryceson,A D, PY - 1998/6/6/pubmed PY - 1998/6/6/medline PY - 1998/6/6/entrez KW - Africa KW - Africa South Of The Sahara KW - Americas KW - Asia KW - Brazil KW - Clinical Research KW - Developing Countries KW - Diseases KW - Drugs--administraction and dosage KW - Drugs--side effects KW - Eastern Africa KW - English Speaking Africa KW - Health KW - India KW - Kenya KW - Latin America KW - Leishmaniasis--prevention and control KW - Parasitic Diseases KW - Public Health KW - Research Methodology KW - Research Report KW - Safety KW - South America KW - Southern Asia KW - Treatment SP - 25 EP - 32 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 76 IS - 1 N2 - Reported are the results of a study to determine the efficacy and safety of liposomal amphotericin B (AmBisome) for treating visceral leishmaniasis (kala-azar) in several developing countries where the disease is endemic (Brazil, India, and Kenya). At each study site, sequential cohorts of 10 patients each were treated with AmBisome at a dose of 2 mg.kg-1.day-1 (2 MKD). The first cohort received regimen 1:2 MKD on days 1-6 and day 10 (total dose: 14 mg/kg). If the efficacy with this regimen was satisfactory, a second cohort received regimen 2:2 MKD on days 1-4 and 10 (total dose: 10 mg/kg); and a third cohort received regimen 3:2 MKD on days 1, 5, and 10 (total dose: 6 mg/kg). In India, regimens 1, 2, and 3 (which were studied concurrently) each cured 100% of 10 patients. In Kenya, regimen 1 cured all 10 patients, regimen 2 cured 90% of 10 patients, but regimen 3 cured only 20% of 5 patients. In Brazil, regimen 1 was only partially curative: 5 of 13 patients (62%). Therefore, 15 patients were administered regimen 4 (2 MKD for 10 consecutive days; total dose, 20 mg/kg) and 13 patients were cured (83%). These results suggest that for the treatment of kala-azar the following doses of AmBisome should be administered: in India and Kenya, 2 mg/kg on days 1-4 and day 10; and in Brazil, 2 mg/kg on days 1-10. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/9615494/Efficacy_and_safety_of_liposomal_amphotericin_B__AmBisome__for_visceral_leishmaniasis_in_endemic_developing_countries_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/9615494/ DB - PRIME DP - Unbound Medicine ER -