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Clinical Trial
. 2015 Nov-Dec;90(6):807-13.
doi: 10.1590/abd1806-4841.20153956.

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

Ellen Priscilla Nunes Gadelha  1 , Sinésio Talhari  1 , Jorge Augusto de Oliveira Guerra  1 , Leandro Ourives Neves  1 , Carolina Talhari  1 , Bernardo Gontijo  1 , Roberto Moreira da Silva Junior  1 , Anette Chrusciak Talhari  1
Affiliations
Clinical Trial

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

Ellen Priscilla Nunes Gadelha et al. An Bras Dermatol. 2015 Nov-Dec.

Abstract

Background: There have been few studies on pentamidine in the Americas; and there is no consensus regarding the dose that should be applied.

Objectives: To evaluate the use of pentamidine in a single dose to treat cutaneous leishmaniasis.

Methods: Clinical 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.

Results: there 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.

Conclusions: Clinical 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.

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Conflict of interest statement

Conflict of Interest: None

Figures

Figure 1
Figure 1
Capillary glucose levels before and 30 minutes after treatment
Figure 2
Figure 2
Patients cured. Patient who was cured. Before treatment (A), a month after (B), two months after (C) and six months after the end of treatment (D)
Figure 3
Figure 3
Patient with clinical failure. Before treatment (A), a week after (B), a month (C) and two months after the end of treatment (D)
See this image and copyright information in PMC

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