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Oral miltefosine for the treatment of Indian visceral leishmaniasis.
Trans R Soc Trop Med Hyg. 2006 Dec; 100 Suppl 1:S26-33.TR

Abstract

Large-scale antimony resistance in the treatment of visceral leishmaniasis (VL) in north Bihar, India, has led to the development of miltefosine as an alternative therapy. In a pilot study and later in three Phase II studies involving 249 patients, oral miltefosine, 100-150 mg/day for 28 days, was shown to cure approximately 90% patients with reasonable safety. In the pivotal Phase III trial, 299 patients were treated at three centres with amphotericin B as the comparator drug (99 patients). In this trial 38% and 20% patients had mild to moderate vomiting and diarrhoea respectively, similar to previous studies. Asymptomatic transient elevation of hepatic transaminases and mild renal dysfunction were observed in 15% and 10% patients respectively. The final cure rate was 94% with miltefosine and 97% with amphotericin B; based on these results, the drug was approved in India. Subsequently in two paediatric studies involving 119 patients in the age group of 2-11 years, the safety and efficacy of miltefosine (2.5 mg/kg daily for 28 days) was established with a cure rate (94%) similar to that seen in adults. Miltefosine is the first oral antileishmanial drug with a high degree of safety and efficacy for the treatment of VL.

Authors+Show Affiliations

Kala-azar Medical Research Center, Banaras Hindu University, Varanasi, India. drshyamsundar@dataone.inNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

16730038

Citation

Sundar, Shyam, et al. "Oral Miltefosine for the Treatment of Indian Visceral Leishmaniasis." Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 100 Suppl 1, 2006, pp. S26-33.
Sundar S, Jha TK, Thakur CP, et al. Oral miltefosine for the treatment of Indian visceral leishmaniasis. Trans R Soc Trop Med Hyg. 2006;100 Suppl 1:S26-33.
Sundar, S., Jha, T. K., Thakur, C. P., Bhattacharya, S. K., & Rai, M. (2006). Oral miltefosine for the treatment of Indian visceral leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 100 Suppl 1, S26-33.
Sundar S, et al. Oral Miltefosine for the Treatment of Indian Visceral Leishmaniasis. Trans R Soc Trop Med Hyg. 2006;100 Suppl 1:S26-33. PubMed PMID: 16730038.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral miltefosine for the treatment of Indian visceral leishmaniasis. AU - Sundar,Shyam, AU - Jha,T K, AU - Thakur,C P, AU - Bhattacharya,S K, AU - Rai,M, Y1 - 2006/05/26/ PY - 2005/12/02/received PY - 2006/01/31/revised PY - 2006/02/09/accepted PY - 2006/5/30/pubmed PY - 2007/6/23/medline PY - 2006/5/30/entrez SP - S26 EP - 33 JF - Transactions of the Royal Society of Tropical Medicine and Hygiene JO - Trans R Soc Trop Med Hyg VL - 100 Suppl 1 N2 - Large-scale antimony resistance in the treatment of visceral leishmaniasis (VL) in north Bihar, India, has led to the development of miltefosine as an alternative therapy. In a pilot study and later in three Phase II studies involving 249 patients, oral miltefosine, 100-150 mg/day for 28 days, was shown to cure approximately 90% patients with reasonable safety. In the pivotal Phase III trial, 299 patients were treated at three centres with amphotericin B as the comparator drug (99 patients). In this trial 38% and 20% patients had mild to moderate vomiting and diarrhoea respectively, similar to previous studies. Asymptomatic transient elevation of hepatic transaminases and mild renal dysfunction were observed in 15% and 10% patients respectively. The final cure rate was 94% with miltefosine and 97% with amphotericin B; based on these results, the drug was approved in India. Subsequently in two paediatric studies involving 119 patients in the age group of 2-11 years, the safety and efficacy of miltefosine (2.5 mg/kg daily for 28 days) was established with a cure rate (94%) similar to that seen in adults. Miltefosine is the first oral antileishmanial drug with a high degree of safety and efficacy for the treatment of VL. SN - 0035-9203 UR - https://www.unboundmedicine.com/medline/citation/16730038/Oral_miltefosine_for_the_treatment_of_Indian_visceral_leishmaniasis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0035-9203(06)00110-6 DB - PRIME DP - Unbound Medicine ER -