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Am. J. Trop. Med. Hyg., 71(5), 2004, pp. 577-581
Copyright © 2004 by The American Society of Tropical Medicine and Hygiene

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COMPARISON OF GENERIC TO BRANDED PENTAVALENT ANTIMONY FOR TREATMENT OF NEW WORLD CUTANEOUS LEISHMANIASIS

J. SOTO, L. VALDA-RODRIQUEZ, J. TOLEDO, L. VERA-NAVARRO, M. LUZ, H. MONASTERIOS-TORRICO, J. VEGA, AND J. BERMAN
Consorcio de Investigaciones Bioclínicas, Bogota, Colombia; Fundación Fader, Bogota, Colombia; Hospital de Clinicas, La Paz, Bolivia; North Bethesda, Maryland

The cost of generic pentavalent antimony (generic stibogluconate) is approximately one-sixth that of branded pentavalent antimony (stibogluconate in the form of Pentostam® or meglumine antimoniate in the form of Glucantime®). We compared generic stibogluconate to Pentostam and Glucantime for the treatment of cutaneous leishmaniasis patients in Bolivia and Colombia. For all 114 patients, the per-protocol cure rates were 83–91% and the intent-to-treat cure rates were 75–83%. The highest values were in the generic stibogluconate group. The incidence of pancreatic enzyme abnormalities was 48–88% and the incidence of liver enzyme abnormalities was 48–87%. The lowest incidences were in the generic stibogluconate group. The efficacy and tolerance of inexpensive generic stibogluconate appears comparable to branded formulations for the treatment of cutaneous leishmaniasis in these endemic regions.

Received March 26, 2004. Accepted for publication May 21, 2004.

Financial support: This study was supported by the AB Foundation.

Authors’ addresses: J. Soto, J. Toledo, and M. Luz, Consorcio de Investigaciones Bioclínicas, Calle 60 A 5-54, Suite 201, Bogota, Colombia, Telephone: 57-1-348-2171, Fax: 57-1-347-6093, E-mail: Jaime.Soto{at}cable.net.co. L. Valda-Rodriquez, L. Vera-Navarro, and H. Monasterios-Torrico, Hospital de Clinicas, La Paz, Bolivia. J. Vega, Fundación Fader, Bogota, Colombia. J. Berman, 6205 Poindexter Lane, North Bethesda, MD 20852, Telephone: 301-230-7138, Fax: 301-230-0427, E-mail: JBe9320457{at}aol.com.

Reprint requests: J. Soto, Consorcio de Investigaciones Bioclínicas, Calle 60 A 5-54, Suite 201, Bogota, Colombia.






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Copyright © 2004 by the American Society of Tropical Medicine and Hygiene.