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Clinical Trial
. 2004 Nov;71(5):577-81.

Comparison of generic to branded pentavalent antimony for treatment of new world cutaneous leishmaniasis

J Soto  1 , L Valda-Rodriquez, J Toledo, L Vera-Navarro, M Luz, H Monasterios-Torrico, J Vega, J Berman
Affiliations
  • PMID: 15569787
Clinical Trial

Comparison of generic to branded pentavalent antimony for treatment of new world cutaneous leishmaniasis

J Soto et al. Am J Trop Med Hyg. 2004 Nov.

Erratum in

  • Am J Trop Med Hyg. 2005 Mar;72(3):359

Abstract

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.

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