Comparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya.

Hdl Handle:
http://hdl.handle.net/10144/17263
Title:
Comparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya.
Authors:
Moore, E; O'Flaherty, D; Heuvelmans, H; Seaman, J; Veeken, H; de Wit, S; Davidson, R N
Journal:
Bulletin of the World Health Organization
Abstract:
OBJECTIVE: To compare the use of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis (kala-azar). METHODS: A total of 102 patients with confirmed kala-azar were treated in a mission hospital in West Pokot region, Kenya, with sodium stibogluconate (20 mg/kg/day for 30 days)--either as Pentostam (PSM) or generic sodium stibogluconate (SSG); 51 patients were allocated alternately to each treatment group. FINDINGS: There were no significant differences in baseline demographic characteristics or disease severity, or in events during treatment. There were 3 deaths in the PSM group and 1 in the SSG group; 2 patients defaulted in each group. Only 1 out of 80 test-of-cure splenic aspirates was positive for Leishmania spp.; this patient was in the SSG group. Follow-up after > or = 6 months showed that 6 out of 58 patients had relapsed, 5 in the SSG group and 1 in the PSM group. No outcome variable was significantly different between the two groups. CONCLUSION: The availability of cheaper generic sodium stibogluconate, subject to rigid quality controls, now makes it possible for the health authorities in kala-azar endemic areas to provide treatment to many more patients in Africa.
Affiliation:
Médecins Sans Frontières-Holland (MSF-H) Kala-azar Programme, South Sudan/Kenya.
Publisher:
Published by WHO
Issue Date:
2001
URI:
http://hdl.handle.net/10144/17263
PubMed ID:
11417033
Additional Links:
http://www.who.int/bulletin/en
Language:
en
ISSN:
0042-9686
Appears in Collections:
Leishmaniasis/Kala Azar

Full metadata record

DC FieldValue Language
dc.contributor.authorMoore, E-
dc.contributor.authorO'Flaherty, D-
dc.contributor.authorHeuvelmans, H-
dc.contributor.authorSeaman, J-
dc.contributor.authorVeeken, H-
dc.contributor.authorde Wit, S-
dc.contributor.authorDavidson, R N-
dc.date.accessioned2008-01-31T15:53:46Z-
dc.date.available2008-01-31T15:53:46Z-
dc.date.issued2001-
dc.identifier.citationComparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya. 2001, 79 (5):388-93 Bull. World Health Organ.-
dc.identifier.issn0042-9686-
dc.identifier.pmid11417033-
dc.identifier.urihttp://hdl.handle.net/10144/17263-
dc.description.abstractOBJECTIVE: To compare the use of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis (kala-azar). METHODS: A total of 102 patients with confirmed kala-azar were treated in a mission hospital in West Pokot region, Kenya, with sodium stibogluconate (20 mg/kg/day for 30 days)--either as Pentostam (PSM) or generic sodium stibogluconate (SSG); 51 patients were allocated alternately to each treatment group. FINDINGS: There were no significant differences in baseline demographic characteristics or disease severity, or in events during treatment. There were 3 deaths in the PSM group and 1 in the SSG group; 2 patients defaulted in each group. Only 1 out of 80 test-of-cure splenic aspirates was positive for Leishmania spp.; this patient was in the SSG group. Follow-up after > or = 6 months showed that 6 out of 58 patients had relapsed, 5 in the SSG group and 1 in the PSM group. No outcome variable was significantly different between the two groups. CONCLUSION: The availability of cheaper generic sodium stibogluconate, subject to rigid quality controls, now makes it possible for the health authorities in kala-azar endemic areas to provide treatment to many more patients in Africa.-
dc.language.isoen-
dc.publisherPublished by WHO-
dc.relation.urlhttp://www.who.int/bulletin/en-
dc.rightsArchived on this site with permission of WHOen_GB
dc.subject.meshAdolescent-
dc.subject.meshAdult-
dc.subject.meshAntimony Sodium Gluconate-
dc.subject.meshAntiprotozoal Agents-
dc.subject.meshChild-
dc.subject.meshChild, Preschool-
dc.subject.meshDrug Evaluation-
dc.subject.meshDrugs, Generic-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshKenya-
dc.subject.meshLeishmaniasis, Visceral-
dc.subject.meshMale-
dc.subject.meshTreatment Outcome-
dc.titleComparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya.-
dc.contributor.departmentMédecins Sans Frontières-Holland (MSF-H) Kala-azar Programme, South Sudan/Kenya.-
dc.identifier.journalBulletin of the World Health Organization-
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