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

Am J Trop Med Hyg. 2004 Nov;71(5):577-81.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antimony Sodium Gluconate / administration & dosage*
  • Antimony Sodium Gluconate / adverse effects
  • Antiprotozoal Agents / administration & dosage*
  • Antiprotozoal Agents / adverse effects
  • Bolivia
  • Colombia
  • Double-Blind Method
  • Drugs, Generic / administration & dosage
  • Drugs, Generic / adverse effects
  • Female
  • Humans
  • Leishmaniasis, Cutaneous / drug therapy*
  • Leishmaniasis, Cutaneous / pathology
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Antiprotozoal Agents
  • Drugs, Generic
  • Antimony Sodium Gluconate