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Comparison of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis in Kenya.
Bull World Health Organ. 2001; 79(5):388-93.BW

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.

Links

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Authors+Show Affiliations

Moore E
Médecins Sans Frontières-Holland (MSF-H) Kala-azar Programme, South Sudan/Kenya.
O'Flaherty D
No affiliation info available
Heuvelmans H
No affiliation info available
Seaman J
No affiliation info available
Veeken H
No affiliation info available
de Wit S
No affiliation info available
Davidson RN
No affiliation info available

MeSH

AdolescentAdultAntimony Sodium GluconateAntiprotozoal AgentsChildChild, PreschoolDrug EvaluationDrugs, GenericFemaleHumansKenyaLeishmaniasis, VisceralMaleTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

11417033

Citation

Moore, E, et al. "Comparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya." Bulletin of the World Health Organization, vol. 79, no. 5, 2001, pp. 388-93.
Moore E, O'Flaherty D, Heuvelmans H, et al. Comparison of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis in Kenya. Bull World Health Organ. 2001;79(5):388-93.
Moore, E., O'Flaherty, D., Heuvelmans, H., Seaman, J., Veeken, H., de Wit, S., & Davidson, R. N. (2001). Comparison of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis in Kenya. Bulletin of the World Health Organization, 79(5), 388-93.
Moore E, et al. Comparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya. Bull World Health Organ. 2001;79(5):388-93. PubMed PMID: 11417033.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis in Kenya. AU - Moore,E, AU - O'Flaherty,D, AU - Heuvelmans,H, AU - Seaman,J, AU - Veeken,H, AU - de Wit,S, AU - Davidson,R N, PY - 2001/6/22/pubmed PY - 2001/7/13/medline PY - 2001/6/22/entrez SP - 388 EP - 93 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 79 IS - 5 N2 - 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. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/11417033/Comparison_of_generic_and_proprietary_sodium_stibogluconate_for_the_treatment_of_visceral_leishmaniasis_in_Kenya_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/11417033/ DB - PRIME DP - Unbound Medicine ER -