title: Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis.
abstract: Post-kala-azar dermal leishmaniasis (PKDL) is a chronic dermatosis that generally occurs after apparent cure of visceral leishmaniasis caused by Leishmania donovani. In view of the prolonged treatment regimens necessary for PKDL, noncompliance is a major limitation; an optimal regimen is yet to be defined, but 12 weeks of therapy with miltefosine is generally recommended. We performed a single-arm open-label trial of miltefosine administered daily for 16 weeks in 27 patients in Kolkata with PKDL. After 4 weeks of treatment, nine patients were lost to follow-up because of unacceptable side effects, including severe abdominal pain, nausea, and vomiting. Of the 18 remaining patients, seven completed 12 weeks of therapy and 11 completed 16 weeks of therapy. Three of the seven who received 12 weeks of therapy and none of the 11 who received 16 weeks of therapy experienced disease relapse. Our results suggest that a 16-week course of miltefosine is required for reliable cure of PKDL. Further, the study highlighted the urgent need for a multicentric randomized controlled trial of 12 versus 16 weeks of treatment with miltefosine for PKDL so as to achieve the goal of elimination of leishmaniasis in south Asia.
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Susmita
authors.initials: S
authors.lastname: Ghosh
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Nilay Kanti
authors.initials: NK
authors.lastname: Das
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Shibabrata
authors.initials: S
authors.lastname: Mukherjee
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Debanjan
authors.initials: D
authors.lastname: Mukhopadhyay
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Jayashree Nath
authors.initials: JN
authors.lastname: Barbhuiya
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India.
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India; Department of Dermatology, Medical College, Kolkata, West Bengal, India; Department of Dermatology, School of Tropical Medicine, Kolkata, West Bengal, India ilatim@vsnl.net.
authors.forename: Mitali
authors.initials: M
authors.lastname: Chatterjee
mesh_terms: D000293:Adolescent; D000328:Adult; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007893:Leishmania donovani; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine