Oral Pentoxifylline Combined with Pentavalent Antimony: A Randomized Trial for Mucosal Leishmaniasis

Abstract

Background. Mucosal leishmaniasis is associated with intense tissue damage and high tumor necrosis factor–α production. Therapeutic failure occurs in up to 42% of cases; patients who experience treatment failure will require >1 pentavalent antimony (Sb^v) course or alternative drugs to achieve a cure. We previously showed that an inhibitor of tumor necrosis factor–α (pentoxifylline) combined with Sb^v cured 90% patients refractory to monotherapy with Sb^v. Methods. A double-blind, placebo-controlled trial involving 23 patients with mucosal leishmaniasis evaluated the efficacy of pentoxifylline when administered in association with Sb^v, compared with Sb^v treatment alone. Eleven patients were randomized to receive Sb^v plus oral pentoxifylline for 30 days, and 12 patients received Sb^v plus oral placebo. The criterion for cure was a complete healing of lesions. Results. All patients in the pentoxifylline group experienced a cure with 1 course of Sb^v, whereas 5 (41.6%) of 12 patients in the placebo group required a second course of Sb^v (P = .037). The healing time ± standard deviation in the pentoxifylline group was 83 ± 36 days, compared with 145 ± 99 days in the placebo group (P = .049). No relapses were documented in either group at the 2-year follow-up visit. Conclusions. The addition of pentoxifylline to Sb^v in mucosal leishmaniasis reduces the healing time significantly and prevents the need for further courses of Sb^v.