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). This study demonstrates that pentamidine (2 mg/kg every other day for a total of seven injections) will cure virtually all of the patients who complete therapy (80%, in this study) and 75% of those who prematurely terminate therapy (20%, in this study), for a total cure rate of 95%; this rate is comparable with that achieved with a 20-day course of standard therapy (with meglumine antimonate). Pentamidine administered at the aforementioned dosage is an effective alternative to pentavalent antimony for the treatment of cutaneous leishmaniasis in the New World.