Jha, Tara K. ; Sundar, Shyam ; Thakur, Chandreshwar P. ; Mark Felton, J. ; Sabin, Antony J. ; Horton, John (2005) A phase II dose-ranging study of sitamaquine for the treatment of visceral leishmaniasis in India The American Journal of Tropical Medicine and Hygiene, 73 (6). pp. 1005-1011. ISSN 0002-9637
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Official URL: http://www.ajtmh.org/content/73/6/1005.abstract?si...
Abstract
This randomized, open label, multicenter study assessed the dose-response and safety profile for oral sitamaquine in 120 Indian subjects with visceral leishmaniasis (VL). Patients aged 5-64 years (mean age 21.2 years) received one of four sitamaquine doses (1.5, 1.75, 2.0, or 2.5 mg kg-1 day-1) daily for 28 days. At Day 180 in the intent-to-treat population, final cure (primary efficacy outcome) was achieved in 92 of 106 (87%) patients overall and 25 of 31 (81%), 24 of 27 (89%), 23 of 23 (100%), and 20 of 25 (80%) patients at doses of 1.5, 1.75, 2.0, or 2.5 mg kg-1 day-1 sitamaquine, respectively. Sitamaquine was generally well tolerated. The most common adverse events during the active treatment phase were vomiting (8% [10 of 120]), dyspepsia (8% [9 of 120]) and cyanosis (3% [4 of 120]). Nephrotic syndrome (3% [3 of 120]) and glomerulonephritis (2% [2 of 120]) were also reported and require further investigation. Oral sitamaquine demonstrated efficacy in Indian VL and was well tolerated.
Item Type: | Article |
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Source: | Copyright of this article belongs to American Society of Tropical Medicine and Hygiene. |
ID Code: | 71326 |
Deposited On: | 25 Nov 2011 07:04 |
Last Modified: | 25 Nov 2011 07:04 |
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