Evaluation of pentamidine for the treatment of cutaneous leishmaniasis in Colombia.

Ninety-two patients in Colombia with cutaneous leishmaniasis were randomly assigned to groups to be treated with meglumine antimonate (infected control subjects; 10 mg of antimony/kg intramuscularly, twice a day for 20 days), pentamidine (2 mg/kg every other day intramuscularly, for a total of seven injections), or itraconazole (200 mg orally, twice a day for 28 days) or to receive no treatment (negative control subjects). In the group treated with meglumine antimonate, 21 of 23 patients healed by the first follow-up visit, 1.5 months after the end of therapy, and did not relapse (91% cure rate). In the pentamidine-treated group, 23 of 24 patients healed and did not relapse (96%). Four of the 23 pentamidine-treated patients who ultimately were cured had terminated therapy prematurely (after receiving 4-6 injections) because of hypotension (2 patients), hypoglycemia (1 patient), or headache and myalgias (1 patient). In a subsequent group of 19 patients who were administered 2 mg of pentamidine/kg every other day for a total of only four injections, 14 healed without relapse (74% cure rate). The itraconazole-treated group was similar to the no-treatment control group in terms of the number of patients for whom therapy failed (75% and 64%, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes