Treatment of visceral leishmaniasis with injectable paromomycin (aminosidine). An open-label randomized phase-II clinical study

Thakur, C.P.; Kanyok, Thomas P.; Pandey, Avinash Kumar; Sinha, Geeta; Messick, Chad R.; Olliaro, Piero

doi:10.1016/s0035-9203(00)90131-7

Cited by 60 publications

(39 citation statements)

References 6 publications

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“…The drug has been used with interferon ␥, paromomycin (also known as aminosidine), or pentamidine either concomitantly or sequentially. 4,[12][13][14][15][16][17][28][29][30][31][32][33] We found 13 studies (eight comparative, three dose-finding, and two noncomparative) done between 1980 and 2001, enrolling 1562 patients in a total of 24 antimony study arms (table 3). Adequacy of allocation was difficult to assess, except for studies versus paromomycin.…”

Section: Pentavalent Antimonymentioning

confidence: 99%

“…[13][14][15][16][17][22][23][24] No significant benefit was achieved by combining antimony with interferon ␥. In all other cases, antimony was significantly less effective than the comparator regimen.…”

Section: Pentavalent Antimonymentioning

confidence: 99%

“…Information provided 12 Sundar et al 13 Thakur et al [14][15][16] Thakur and Narayan 17 Sundar et al 18,20 Amphotericin …”

Section: Amphotericin B and Its Lipid Formulationsmentioning

confidence: 99%

“…12,14,15,58,59 Three of them were comparative against antimony alone (20 mg/kg per day for 30 days), one dose-finding, and one non-comparative (table 7). All comparative and dose-finding studies used computer-generated randomisation; methods to conceal allocation were used in two.…”

Section: Paromomycinmentioning

confidence: 99%

See 3 more Smart Citations

Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004

Olliaro

Guérin

Gerstl

et al. 2005

The Lancet Infectious Diseases

204

181

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Section: Pentavalent Antimonymentioning

confidence: 99%

Section: Pentavalent Antimonymentioning

confidence: 99%

“…Information provided 12 Sundar et al 13 Thakur et al [14][15][16] Thakur and Narayan 17 Sundar et al 18,20 Amphotericin …”

Section: Amphotericin B and Its Lipid Formulationsmentioning

confidence: 99%

Section: Paromomycinmentioning

confidence: 99%

See 2 more Smart Citations

Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004

Olliaro

Guérin

Gerstl

et al. 2005

The Lancet Infectious Diseases

204

181

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“…However, since 1990s, increasing resistance to antimonials in Indian VL has been observed primarily in Bihar and adjacent territories. Randomized controlled trials with Indian patients with VL from 1992 to 2000 showed an efficacy of 36 to 69%, with an average of 50% [15][16][17][18] . As antimonials, ABD has been poorly evaluated in children with VL.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil

Borges

Pranchevicius

Noronha

et al. 2017

Rev. Soc. Bras. Med. Trop.

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Introduction: Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. Methods: This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/ kg/day for 20 days) or amphotericin B deoxycholate (1mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. Results: In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. Conclusions: N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL.

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Antiprotozoal/Antiparasitic Agents

Woster

2010

Burger's Medicinal Chemistry and Drug Discovery

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Collectively, diseases caused by parasitic protozoa, including human African trypanosomiasis ( HAT ), Chagas' disease and leishmaniasis, threaten more than 550 million people worldwide and cause nearly 150,000 deaths annually. The causative organisms for these diseases are unicellular trypanosomatid parasites of the genera Trypanosoma brucei , Trypanosoma cruzi , and Leishmania sp., respectively. Drug therapies available for these diseases have not changed significantly in the past 50 years, and currently used agents are far less than satisfactory due to extreme toxicity, and because resistant parasitic strains are becoming more prevalent. These diseases are confined to impoverished or rural areas of Mexico, Central America, South America, sub‐Saharan Africa, the Middle East, Indonesia, and India. As such, drug discovery efforts against trypanosomatid diseases are limited because patients in underdeveloped areas cannot afford therapy, and because the infected population is too small to justify the required research expenditures. In addition, antiparasitic research in Third World nations is often hampered by economic issues and political turmoil, virtually assuring that the world's most impoverished people will continue to bear the major burden of parasitic disease. Clearly, there is a need for new anti‐infective agents that are potent, nontoxic and inexpensive to manufacture. In this chapter, the etiology of these diseases and their current treatment are described. The chapter also deals with medicinal chemistry aspects of efforts to identify new drug targets for parasitic diseases, and to produce novel inhibitors of trypanosomatid growth for use as antiparasitic agents.

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Treatment of visceral leishmaniasis with injectable paromomycin (aminosidine). An open-label randomized phase-II clinical study

Cited by 60 publications

References 6 publications

Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004

Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004

Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil

Antiprotozoal/Antiparasitic Agents

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