Generic sodium stibogluconate is as safe and effective as branded meglumine antimoniate, for the treatment of tegumentary leishmaniasis in Isiboro Secure Park, Bolivia

Annals of Tropical Medicine and Parasitology

Volumn 100, Issue 7, 2006, Pages 591-600

  Bermudez H ^a   Rojas, E ^a   Garcia, L ^a   Desjeux, P ^b   Dujardin, J C ^c   Boelaert, M ^c   Chappuis, F ^d  

^a UNIVERSIDAD MAYOR DE SAN SIMÓN   (Bolivia)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^d GENEVA UNIVERSITY HOSPITALS   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; MEGLUMINE ANTIMONATE; STIBOGLUCONATE SODIUM; ANTIMONY GLUCONATE; ANTIPROTOZOAL AGENT; MEGLUMINE; MEGLUMINE ANTIMONIATE; ORGANOMETALLIC COMPOUND;

ADULT; ANOREXIA; ARTHRALGIA; ARTICLE; BOLIVIA; BRADYCARDIA; COHORT ANALYSIS; CONTROLLED STUDY; DRUG COST; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; FEVER; FOLLOW UP; HEADACHE; HUMAN; INJECTION SITE PAIN; INSOMNIA; INTEGUMENT; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PHLEBITIS; PHYSICIAN; PRURITUS; QUESTIONNAIRE; SIDE EFFECT; SKIN LEISHMANIASIS; TREATMENT DURATION; VERTIGO; VOMITING; WEIGHT REDUCTION; COMPARATIVE STUDY; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; PARASITOLOGY; TREATMENT OUTCOME;

ADULT; ANTIMONY SODIUM GLUCONATE; ANTIPROTOZOAL AGENTS; BOLIVIA; DRUGS, GENERIC; FEMALE; HUMANS; INJECTIONS, INTRAMUSCULAR; INJECTIONS, INTRAVENOUS; LEISHMANIASIS, CUTANEOUS; LEISHMANIASIS, MUCOCUTANEOUS; MALE; MEGLUMINE; ORGANOMETALLIC COMPOUNDS; TREATMENT OUTCOME;

EID: 33749594770     PISSN: 00034983     EISSN: None     Source Type: Journal    
DOI: 10.1179/136485906X118495     Document Type: Article

References (33)

1. Andersen, E. M., Cruz-Saldarriaga, M., Llanos-Cuentas, A., Luz-Cjuno, M., Echevarria, J., Miranda-Verastegui, C, Colina, O. & Berman, J. D. (2005). Comparison of meglumine antimoniate and pentamidine for Peruvian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene, 72, 133-137.
2. Aronson, N. E., Wortmann, G. W., Johnson, S. C., Jackson, J. E., Gasser, R. A., Jr., Magill, A. J., Endy, T. P., Coyne, P. E., Grogl, M., Benson, P. M., Beard, J. S., Tally, J. D., Gambel, J. M., Kreutzer, R. D. & Oster, C. N. (1998). Safety and efficacy of intravenous sodium stibogluconate in the treatment of leishmaniasis: recent U.S. military experience. Clinical Infectious Diseases, 27, 1457-1464.
3. Ballou, W. R., McClain, J. B., Gordon, D. M., Shanks, G. D., Andujar, J., Berman, J. D. & Chulay, J. D. (1987). Safety and efficacy of high-dose sodium stibogluconate therapy of American cutaneous leish-maniasis. Lancet, ii, 13-16.
4. Berman, J. D. (1997). Human leishmaniasis: clinical, diagnostic, and chemotherapeutic developments in the last 10 years. Clinical Infectious Diseases, 24, 684-703.
5. Deps, P. D., Viana, M. C., Falqueto, A. & Dietze, R. (2000). Comparative assessment of the efficacy and toxicity of N-methyl-glucamine and BP88 sodium stibogluconate in the treatment of localized cutaneous leishmaniasis. Revista da Sociedade Brasileira de Medicina Tropical, 33, 535-543.
6. Desjeux, P., Mollinedo, S., Le Pont, F., Paredes, A. & Ugarte, G. (1987). Cutaneous leishmaniasis in Bolivia. A study of 185 human cases from Alto Beni (La Paz department). Isolation and isoenzyme characterization of 26 strains of Leishmania braziliensis braziliensis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 81, 742-746.
7. Franke, E. D., Wignall, F. S., Cruz, M. E., Rosales, E., Tovar, A. A., Lucas, C. M., Llanos- Cuentas, A. & Berman, J. D. (1990). Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis. Annals of Internal Medicine, 113, 934-940.
8. Franke, E. D., Llanos-Cuentas, A., Echevarria, J., Cruz, M. E., Campos, P., Tovar, A. A., Lucas, C. M. & Berman, J. D. (1994). Efficacy of 28-day and 40-day regimens of sodium stibogluconate (Pentostam) in the treatment of mucosal leishmaniasis. American Journal of Tropical Medicine and Hygiene, 51, 77-82.
9. Garcia, L., Kindt, A., Bermudez, H., Llanos-Cuentas, A., de Doncker, S., Arevalo, J., Wilber Quispe Tintaya, K. & Dujardin, J. C. (2004). Culture-independent species typing of Neotropical Leishmania for clinical validation of a PCR-based assay targeting heat shock protein 70 genes. Journal of Clinical Microbiology, 42, 2294-2297.
10. Grimaldi Jr, G., Tesh, R. B. & McMahon-Pratt, D. (1989). A review of the geographic distribution and epidemiology of leishmaniasis in the New World. American Journal of Tropical Medicine and Hygiene, 41, 687-725.
11. Guderian, R. H., Chico, M. E., Rogers, M. D., Pattishall, K. M., Grogl, M. & Berman, J. D. (1991). Placebo controlled treatment of Ecuadorian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene, 45, 92-97.
12. Hepburn, N. C., Tidman, M. J. & Hunter, J. A. (1994). Aminosidine (paromomycin) versus sodium stibogluconate for the treatment of American cutaneous leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 88, 700-703.
13. Herwaldt, B. L. (1999). Leishmaniasis. Lancet, 354, 1191-1199.
14. Herwaldt, B. L. & Berman, J. D. (1992). Recommendations for treating leishmaniasis with sodium stibogluconate (Pentostam) and review of pertinent clinical studies. American Journal of Tropical Medicine and Hygiene, 46, 296-306.
15. Llanos-Cuentas, A., Echevarria, J., Cruz, M., la Rosa, A., Campos, P., Campos, M., Franke, E., Berman, J., Modabber, F. & Marr, J. (1997). Efficacy of sodium stibogluconate alone and in combination with allopurinol for treatment of mucocutaneous leishmaniasis. Clinical Infectious Diseases, 25, 677-684.
16. Martinez, E., le Pont, F., Torrez, M., Telleria, J., Vargas, F., Munoz, M., de Doncker, S., Dujardin, J. C. & Dujardin, J. P. (1998). A new focus of cutaneous leishmaniasis due to Leishmania amazonensis in a sub-Andean region of Bolivia. Acta Tropica, 71, 97-106.
17. Martinez, E., le Pont, F., Mollinedo, S. & Cupolillo, E. (2001). A first case of cutaneous leishmaniasis due to Leishmania (Viannia) lainsoni in Bolivia. Transactions of the Royal Society of Tropical Medicine and Hygiene, 95, 375-377.
18. Moore, E., O'Flaherry, 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, 388-393.
19. Navin, T. R., Arana, B. A., Arana, F. E., Berman, J. D. & Chajon, J. F. (1992). Placebo controlled clinical trial of sodium stibogluconate (Pentostam) versus ketoconazole for treating cutaneous leishmaniasis in Guatemala. Journal of Infect Diseases, 165, 528-534.
20. Netto, E. M., Marsden, P. D., Llanos-Cuentas, E. A., Costa, J. M., Cuba, C. C., Barreto, A. C., Badaro, R., Johnson, W. D. & Jones, T. C. (1990). Long-term follow-up of patients with Leishmania (Viannia) braziliensis infection and treated with Glucantime. Transactions of the Royal Society of Tropical Medicine and Hygiene, 84, 367-370.
21. Oliveira-Neto, M. P., Mattos, M., Pirmez, C., Fernandes, O., Goncalves-Costa, S. C., Souza, C. F. & Grimaldi Jr, G. (2000). Mucosal leishmaniasis ('espundia') responsive to low dose of N-methyl glucamine (Glucantime) in Rio de Janeiro, Brazil. Revista do Instituto de Medicina Tropical de São Paulo, 42, 321-325.
22. Palacios, R., Osorio, L. E., Grajalew, L. F. & Ochoa, M. T. (2001). Treatment failure in children in a randomized clinical trial with 10 and 20 days of meglumine antimonate for cutaneous leishmaniasis due to Leishmania viannia species. American Journal of Tropical Medicine and Hygiene, 64, 187-193.
23. Rijal, S., Chappuis, F., Singh, R., Boelaert, M., Loutan, L. & Koirala, S. (2003). Sodium stibogluconate cardiotoxicity and safety of generics. Transactions of the Royal Society of Tropical Medicine and Hygiene, 97, 597-598.
24. Ritmeijer, K., Veeken, H., Melaku, Y., Leal, G., Amsalu, R., Seaman, J. & Davidson, R. N. (2001). Ethiopian visceral leishmaniasis: generic and proprietary sodium stibogluconate are equivalent; HIV co-infected patients have a poor outcome. Transactions of the Royal Society of Tropical Medicine and Hygiene, 95, 668-672.
25. Romero, G. A., Guerra, M. V., Paes, M. G. & Macedo, V. O. (2001). Comparison of cutaneous leishmania-sis due to Leishmania (Viannia) braziliensis and L. (V.) guyanensis in Brazil: therapeutic response to meglumine antimoniate. American Journal of Tropical Medicine and Hygiene, 65, 456-465.
26. Saenz, R. E., de Rodriguez, C. G., Johnson, C. M. & Berman, J. D. (1991). Efficacy and toxicity of pentostam against Panamanian mucosal leishmaniasis. American Journal of Tropical Medicine and Hygiene, 44, 394-398.
27. Sampaio, S. A., Castro, R. M., Dillon, N. L. & Martins, J. E. (1971). Treatment of mucocutaneous (American) leishmaniasis with amphotericin B: report of 70 cases. International Journal of Dermatology, 10, 179-181.
28. Soto, J., Arana, B. A., Toledo, J., Rizzo, N., Vega, J. C., Diaz, A., Luz, M., Gutierrez, P., Arboleda, M., Berman, J. D., Junge, K., Engel, J. & Sindermann, H. (2004a). Miltefosine for New World cutaneous leishmaniasis. Clinical Infectious Diseases, 38, 1266-1272.
29. Soto, J., Valda-Rodriquez, L., Toledo, J., VeraNavarro, L., Luz, M., Monasterios-Torrico, H., Vega, J. & Berman, J. (2004b). Comparison of generic to branded pentavalent antimony for treatment of New World cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene, 71, 577-581.
30. Soto, J., Toledo, J., Vega, J. & Berman, J. (2005). Efficacy of pentavalent antimony for treatment of Colombian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene, 72, 421-422.
31. Sundar, S., Sinha, P. R., Agrawal, N. K., Srivastava, R., Rainey, P. M., Berman, J. D., Murray, H. W. & Singh, V. P. (1998) A cluster of cases of severe cardiotoxicity among kala-azar patients treated with a high-osmolarity lot of sodium antimony gluconate. American Journal of Tropical Medicine and Hygiene, 59, 139-143.
32. Veeken, H., Ritmeijer, K., Seaman, J. & Davidson, R. (2000). A randomized comparison of branded sodium stibogluconate and generic sodium stibogluconate for the treatment of visceral leishmaniasis under field conditions in Sudan. Tropical Medicine and International Health, 5, 312-317.
33. Velez, I., Agudelo, S., Hendrickx, E., Puerta, J., Grogl, M., Modabber, F. & Berman, J. (1997). Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis. A randomized, controlled trial. Annals of Internal Medicine, 126, 232-236.