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      Miltefosine: a review of its pharmacology and therapeutic efficacy in the treatment of leishmaniasis.

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          Abstract

          Miltefosine is an alkylphosphocholine drug with demonstrated activity against various parasite species and cancer cells as well as some pathogenic bacteria and fungi. For 10 years it has been licensed in India for the treatment of visceral leishmaniasis (VL), a fatal neglected parasitic disease. It is the first and still the only oral drug that can be used to treat VL and cutaneous leishmaniasis (CL). The standard 28 day miltefosine monotherapy regimen is well tolerated, except for mild gastrointestinal side effects, although its teratogenic potential severely hampers its general use in the clinic and roll-out in national elimination programmes. The pharmacokinetics of miltefosine are mainly characterized by its long residence time in the body, resulting in extensive drug accumulation during treatment and long elimination half-lives. At the moment, different combination therapy strategies encompassing miltefosine are being tested in multiple controlled clinical trials in various geographical areas of endemicity, both in South Asia and East Africa. We here review the most salient pre-clinical and clinical pharmacological aspects of miltefosine, its mechanism of action against Leishmania parasites and other pathogens, and provide a systematic overview of the efficacy and safety data from all clinical trials of miltefosine, either alone or in combination, in the treatment of VL and CL.

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          Author and article information

          Journal
          J Antimicrob Chemother
          The Journal of antimicrobial chemotherapy
          Oxford University Press (OUP)
          1460-2091
          0305-7453
          Nov 2012
          : 67
          : 11
          Affiliations
          [1 ] Center for Tropical Medicine and Travel Medicine, Division of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. thomasdorlo@gmail.com
          Article
          dks275
          10.1093/jac/dks275
          22833634
          81d09308-e93d-4445-ab22-72dc54d95429

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