Oral pentoxifylline combined with pentavalent antimony: A randomized trial for mucosal leishmaniasis

Background. Mucosal leishmaniasis is associated with intense tissue damage and high tumor necrosis factor a 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-alpha (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 Sbv 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.