Ethiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome.

Hdl Handle:
http://hdl.handle.net/10144/17269
Title:
Ethiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome.
Authors:
Ritmeijer, K; Veeken, H; Melaku, Y; Leal, G; Amsalu, R; Seaman, J; Davidson, R N
Journal:
Transactions of the Royal Society of Tropical Medicine and Hygiene
Abstract:
We evaluated generic sodium stibogluconate (SSG) (International Dispensary Association, Amsterdam) versus Pentostam (sodium stibogluconate, GlaxoWellcome, London) under field conditions in Ethiopian patients with visceral leishmaniasis (VL; kala-azar). The 199 patients were randomly assigned to Pentostam (n = 104) or SSG (n = 95) in 1998/99; both drugs were given at 20 mg/kg intra-muscularly for 30 days. A clinical cure after 30-days treatment was achieved in 70.2% (Pentostam) and 81.1% (SSG). There were no significant differences between the 2 drugs for the following parameters: frequency of intercurrent events (vomiting, diarrhoea, bleeding or pneumonia) or main outcome (death during treatment and death after 6-month follow-up; relapse or post kala-azar dermal leishmaniasis at 6-months follow-up). Twenty-seven patients had confirmed co-infection with HIV. On admission, HIV co-infected VL patients were clinically indistinguishable from HIV-negative VL patients. The HIV co-infected VL patients had a higher mortality during treatment (33.3% vs 3.6%). At 6-month follow-up, HIV-positive patients had a higher relapse rate (16.7% vs 1.2%), a higher death rate during the follow-up period (14.3% vs 2.4%), and more frequent moderate or severe post kala-azar dermal leishmaniasis (27.3% vs 13.3%). Only 43.5% of the HIV-positive patients were considered cured at 6-months follow-up vs 92.1% of the HIV-negative patients. HIV-positive patients relapsing with VL could become a reservoir of antimonial-resistant Leishmania donovani.
Affiliation:
Médecins sans Frontières-Holland, P.O. Box 10014, 1001 EA Amsterdam, The Netherlands. koert_ritmeijer@amsterdam.msf.org
Publisher:
Elsevier
Issue Date:
31-Jan-2008
URI:
http://hdl.handle.net/10144/17269
PubMed ID:
11816442
Additional Links:
http://www.sciencedirect.com/science/journal/00359203
Language:
en
ISSN:
0035-9203
Appears in Collections:
Leishmaniasis/Kala Azar

Full metadata record

DC FieldValue Language
dc.contributor.authorRitmeijer, K-
dc.contributor.authorVeeken, H-
dc.contributor.authorMelaku, Y-
dc.contributor.authorLeal, G-
dc.contributor.authorAmsalu, R-
dc.contributor.authorSeaman, J-
dc.contributor.authorDavidson, R N-
dc.date.accessioned2008-01-31T16:35:43Z-
dc.date.available2008-01-31T16:35:43Z-
dc.date.issued2008-01-31T16:35:43Z-
dc.identifier.citationEthiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome., 95 (6):668-72 Trans. R. Soc. Trop. Med. Hyg.en
dc.identifier.issn0035-9203-
dc.identifier.pmid11816442-
dc.identifier.urihttp://hdl.handle.net/10144/17269-
dc.description.abstractWe evaluated generic sodium stibogluconate (SSG) (International Dispensary Association, Amsterdam) versus Pentostam (sodium stibogluconate, GlaxoWellcome, London) under field conditions in Ethiopian patients with visceral leishmaniasis (VL; kala-azar). The 199 patients were randomly assigned to Pentostam (n = 104) or SSG (n = 95) in 1998/99; both drugs were given at 20 mg/kg intra-muscularly for 30 days. A clinical cure after 30-days treatment was achieved in 70.2% (Pentostam) and 81.1% (SSG). There were no significant differences between the 2 drugs for the following parameters: frequency of intercurrent events (vomiting, diarrhoea, bleeding or pneumonia) or main outcome (death during treatment and death after 6-month follow-up; relapse or post kala-azar dermal leishmaniasis at 6-months follow-up). Twenty-seven patients had confirmed co-infection with HIV. On admission, HIV co-infected VL patients were clinically indistinguishable from HIV-negative VL patients. The HIV co-infected VL patients had a higher mortality during treatment (33.3% vs 3.6%). At 6-month follow-up, HIV-positive patients had a higher relapse rate (16.7% vs 1.2%), a higher death rate during the follow-up period (14.3% vs 2.4%), and more frequent moderate or severe post kala-azar dermal leishmaniasis (27.3% vs 13.3%). Only 43.5% of the HIV-positive patients were considered cured at 6-months follow-up vs 92.1% of the HIV-negative patients. HIV-positive patients relapsing with VL could become a reservoir of antimonial-resistant Leishmania donovani.en
dc.language.isoenen
dc.publisherElsevier-
dc.relation.urlhttp://www.sciencedirect.com/science/journal/00359203-
dc.rightsArchived on this site with the kind permission of Elsevier Ltd. and the Royal Society of Tropical Medicine and Hygiene, http://www.rstmh.org/transactions.aspen
dc.subject.meshAIDS-Related Opportunistic Infectionsen
dc.subject.meshAdulten
dc.subject.meshAntimony Sodium Gluconateen
dc.subject.meshAntiprotozoal Agentsen
dc.subject.meshDrugs, Genericen
dc.subject.meshFemaleen
dc.subject.meshFollow-Up Studiesen
dc.subject.meshHumansen
dc.subject.meshInjections, Intramuscularen
dc.subject.meshLeishmaniasis, Visceralen
dc.subject.meshMaleen
dc.subject.meshRecurrenceen
dc.subject.meshTreatment Outcomeen
dc.titleEthiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome.en
dc.contributor.departmentMédecins sans Frontières-Holland, P.O. Box 10014, 1001 EA Amsterdam, The Netherlands. koert_ritmeijer@amsterdam.msf.orgen
dc.identifier.journalTransactions of the Royal Society of Tropical Medicine and Hygieneen
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