Miltefosine for the treatment of American Tegumentary Leishmaniasis

American Tegumentary Leishmaniasis (ATL) is a major public health problem, especially in developing countries. There have been few pharmacological advances for ATL. Pentavalent antimonials require monitoring because they are cardiotoxic, hepatotoxic and nephrotoxic. One of the alternatives is miltefosine, an oral drug that has shown good effectiveness in some Leishmania species. Objective: To review the evidence for the efficacy and safety of miltefosine in monotherapy or in combination. Method: Preparation of a Technical-Scientific Opinion. Results: 6 studies were selected. The clinical trials showed cure rates at six months ranging from 58.6 to 87.9% in the miltefosine treatment group and from 53.3 to 93.7% in the meglumine group. Calculation of the RR of the studies showed a small association between miltefosine and the six-month cure rate (RR=1.02). Only one study showed a cure rate at three months of 67.6% and 78.3% in the miltefosine and meglumine groups, respectively. As for safety, miltefosine had less serious adverse events compared to meglumine, the most frequent being gastrointestinal symptoms.