Efficacy and safety of a single dose pentamidine (7mg/kg) for patients with cutaneous leishmaniasis caused by L. guyanensis: a pilot study

Abstract

BACKGROUNDThere have been few studies on pentamidine in the Americas; and there is no consensus regarding the dose that should be applied.OBJECTIVESTo evaluate the use of pentamidine in a single dose to treat cutaneous leishmaniasis.METHODSClinical trial of phase II pilot study with 20 patients. Pentamidine was used at a dose of 7 mg/kg, in a single dose. Safety and adverse effects were also assessed. Patients were reviewed one, two, and six months after the end of treatments.RESULTSthere was no difference between the treatment groups in relation to gender, age, number or location of the lesions. Pentamidine, applied in a single dose, obtained an effectiveness of 55%. Mild adverse events were reported by 17 (85%) patients, mainly transient pain at the site of applications (85%), while nausea (5%), malaise (5%) and dizziness (5%) were reported in one patient. No patient had sterile abscess after taking medication at a single dose of 7mg/kg.CONCLUSIONSClinical studies with larger samples of patients would enable a better clinical response of pent amidine at a single dose of 7mg, allowing the application of more powerful statistical tests, thus providing more evidences of the decrease in the effectiveness of that medication. Hence, it is important to have larger studies with new diagrams and/or new medications.

An open label randomized clinical trial comparing the safety and effectiveness of one, two or three weekly pentamidine isethionate doses (seven milligrams per kilogram) in the treatment of cutaneous leishmaniasis in the Amazon Region

“…guyanensis . [ 24 ] These results are similar to those in the standard regimen recommended by the BMH. [ 18 ]…”

American cutaneous leishmaniasis in infancy and childhood

“…Localized cutaneous leishmaniasis has, as an etiologic agent, any member of the neotropical subgenera Viannia and Leishmania, with L (V) braziliensis , as described by some authors, one of the most important parasites associated with this form . In the Brazilian Amazon region, L. guyanensis has been implicated as the main etiological agent of localized cutaneous leishmaniasis . In Ecuador L. panamensis and L. guyanensis have been linked to zoonotic cutaneous leishmaniasis, predominantly in the subtropical and tropical lowlands of the Pacific region, while L. amazonensis, L. equatorensis , and L. mexicana are known to be the main players involved in both the Andean and coastal regions .…”

“…22,[31][32][33] In the Brazilian Amazon region, L. guyanensis has been implicated as the main etiological agent of localized cutaneous leishmaniasis. 34,35 In Ecuador L. panamensis and L. guyanensis have been linked to zoonotic cutaneous leishmaniasis, predominantly in the subtropical and tropical lowlands of the Pacific region, while L. amazonensis, L. equatorensis, and L. mexicana are known to be the main players involved in both the Andean and coastal regions. [6][7][8][9][10] Mucocutaneous leishmaniasis has been mainly associated with infection by L. (V) braziliensis, 31,36,37 as well as in borderline disseminated cutaneous form, which also exhibit parasites belonging to the L. braziliensis complex 38 as well as other species from the Viannia subgenus.…”

“…106,107 Recently, a single dose of 7 mg/kg of pentamidine for cutaneous leishmaniasis due to L. guyanensis showed the same effectiveness as the regimen of three injections of 4 mg/kg (adults). 35 Amphotericin B deoxycholate is sometimes effective in patients unresponsive to antimonials 1 and is considered a drug of choice in cases with mucosal involvement at a dosage of 0,5-1 mg/kg IV daily or every other day for up to 8 weeks; 1,108,109 as well as in refractory cases of diffuse cutaneous leishmaniasis. 110 There is insufficient information on which to make confident recommendations for the lipid-associated amphotericin B compounds, and although there are case reports of failure 1,110 an increasing number of reports have started to demonstrate their good safety profile and efficacy, especially in cases of mucocutaneous leishmaniasis.…”

Nanotechnological Strategies for Treatment of Leishmaniasis—A Review

“…49 Only in South America, pentamidine, an aromatic diamine, has been used in the treatment of CL, 8 but severe adverse effects, including diabetes mellitus, hypoglycemia, shock, myocarditis and renal toxicity, limit its use. 50 Paromomycin is an aminoglycoside antibiotic with described leishmanicidal activity; however, this drug has been documented to have variable efficacy in different countries and is not commonly used or widely available outside Africa and the Indian subcontinent. 25 51 Miltefosine, registered in 2002, is the first, and remains the only, orally administered agent used for the treatment of all types of leishmaniasis, 38 45 52 even though gastrointestinal side-effects (anorexia, nausea, vomiting and diarrhea), hepatotoxicity and renal insufficiency have been reported.…”