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

BACKGROUND

There have been few studies on pentamidine in the Americas; and there isno consensus regarding the dose that should be applied.

OBJECTIVES

To evaluate the use of pentamidine in a single dose to treat cutaneousleishmaniasis.

METHODS

Clinical trial of phase II pilot study with 20 patients. Pentamidine wasused at a dose of 7 mg/kg, in a single dose. Safety and adverseeffects were also assessed. Patients were reviewed one, two, and sixmonths after the end of treatments.

RESULTS

there was no difference between the treatment groups in relation togender, age, number or location of the lesions. Pentamidine, appliedin a single dose, obtained an effectiveness of 55%. Mild adverseevents were reported by 17 (85%) patients, mainly transient pain atthe site of applications (85%), while nausea (5%), malaise (5%) anddizziness (5%) were reported in one patient. No patient had sterileabscess after taking medication at a single dose of 7mg/kg.

CONCLUSIONS

Clinical studies with larger samples of patients would enable a betterclinical response of pent amidine at a single dose of 7mg, allowingthe application of more powerful statistical tests, thus providingmore evidences of the decrease in the effectiveness of thatmedication. Hence, it is important to have larger studies with newdiagrams and/or new medications.