Trial of oral miltefosine for visceral leishmaniasis

Sundar, Shyam; Rosenkaimer, F; Makharia, M K; Goyal, Ashish; Mandal, Abhijit; Voß, Andreas; Hilgard, P.; Murray, Henry W.

doi:10.1016/s0140-6736(98)04367-0

Cited by 212 publications

(159 citation statements)

References 18 publications

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“…In India, where resistance to antimonial agents is very high, miltefosine has been used since 1998 for the treatment of Visceral Leishmaniasis (VL) produced by L. donovani 7,24 . This has motivated its evaluation for the treatment of other leishmaniasis 25 . In Colombia, two studies have been conducted for the treatment of CL.…”

Section: Introductionmentioning

confidence: 99%

Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

López

Cruz

Godoy

et al. 2013

Rev. Inst. Med. trop. S. Paulo

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SUMMARYIn Colombia, pentavalent antimonials and miltefosine are the drugs of choice for the treatment of cutaneous leishmaniasis; however, their toxicity, treatment duration, (treatment adherence problems), cost, and decreased parasite sensitivity make the search for alternative treatments of American cutaneous leishmaniasis necessary. Based on the results found in a controlled, open, randomized, phase III clinical trial, the efficacy and safety of miltefosine was compared to that of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia. Adult patients from the Colombian army participated in the study; they received either 50 mg of miltefosine three times per day for 28 days by the oral route (n = 145) or a thermotherapy (Thermomed ® ) application of 50 ºC for 30 seconds over the lesion and surrounding area (n = 149). Both groups were comparable with respect to their sociodemographic, clinical, and parasitological characteristics. The efficacy of miltefosine by protocol and by intention to treat was 70% (85/122 patients) and 69% (85/145 patients), respectively. The adverse effects were primarily gastrointestinal for miltefosine and pain at the lesion site after treatment for thermotherapy. No statistically significant difference was found in the efficacy analysis (intention to treat and protocol) between the two treatments. ClinicalTrials.gov: NCT00471705.

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Section: Introductionmentioning

confidence: 99%

Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

López

Cruz

Godoy

et al. 2013

Rev. Inst. Med. trop. S. Paulo

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“…Both in vitro and in vivo studies have shown that miltefosine is active against Leishmania (Leishmania) donovani (Croft et al 1996, Le Fichoux et al 1998. Clinical trials in India have demonstrated a cure rate of 97% among patients treated for visceral leishmaniasis with oral miltefosine at a dose of 2.5 mg/Kg/day for four weeks (Sundar et al 1998, Bhattacharya et al 2004). This drug has also been tested for the treatment of cutaneous leishmaniasis in South America.…”

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confidence: 99%

The in vitro leishmanicidal activity of hexadecylphosphocholine (miltefosine) against four medically relevant Leishmania species of Brazil

Morais-Teixeira

Damasceno

Galuppo

et al. 2011

Mem. Inst. Oswaldo Cruz

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The in vitro leishmanicidal activity of miltefosine® (Zentaris GmbH) was assessed against four medically relevant Leishmania species of Brazil: Leishmania (Leishmania) amazonensis, Leishmania (Viannia) braziliensis, Leishmania (Viannia) guyanensis and Leishmania (Leishmania) chagasi. The activity of miltefosine against these New World species was compared to its activity against the Old World strain, Leishmania (Leishmania) donovani, which is known to be sensitive to the effects of miltefosine. The IC50 and IC90 results suggested the New World species harboured similar in vitro susceptibilities to miltefosine; however, miltefosine was approximately 20 times more active against the Old World L. (L.) donovani than against the New World L. (L.) chagasi species. The selectivity index varied from 17.2-28.9 for the New World Leishmania species and up to 420.0 for L. (L.) donovani. The differences in susceptibility to miltefosine suggest that future clinical trials with this drug should include a laboratory pre-evaluation and a dose-defining step

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“…Miltefosine was then administered orally to BALB/c mice infected with L. donovani and L. infantum, and 95% parasite elimination was achieved with a dosage of 20 mg/kg bodyweight (Kuhlencord et al 1992). The results stimulated the creation of a clinical program for visceral leishmaniasis in India, where the first phase I/II study was completed in 1997 (Sundar et al 1998). In 2000 and 2001, it was demonstrated that miltefosine was effective in immunodeficient animals in contrast with the lack of activity of sodium stibogluconate (Murray 2000;Escobar et al 2001).…”

Section: Miltefosinementioning

confidence: 99%

Therapeutic switching in leishmania chemotherapy: a distinct approach towards unsatisfied treatment needs

2011

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Current drugs for the treatment of visceral leishmaniasis are inadequate. No novel compound is in the pipeline. Since economic returns on developing a new drug for neglected disease, leishmaniasis is so low that therapeutic switching represents the only realistic strategy. It refers to ''alternative drug use'' discoveries which differ from the original intent of the drug. Amphotericin B, paromomycin, miltefosine and many other drugs are very successful examples of ''new drugs from old''. This article reviews the discovery, growth and current status of these drugs and concluded that the potential of this approach (therapeutic switching) may use in the development of new antileishmanials in future also.

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Trial of oral miltefosine for visceral leishmaniasis

Cited by 212 publications

References 18 publications

Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

The in vitro leishmanicidal activity of hexadecylphosphocholine (miltefosine) against four medically relevant Leishmania species of Brazil

Therapeutic switching in leishmania chemotherapy: a distinct approach towards unsatisfied treatment needs

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