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Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis.
Am J Trop Med Hyg. 2015 Oct; 93(4):767-9.AJ

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+Show Affiliations

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.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.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.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.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.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.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.

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26175030

Citation

Ghosh, Susmita, et al. "Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis." The American Journal of Tropical Medicine and Hygiene, vol. 93, no. 4, 2015, pp. 767-9.
Ghosh S, Das NK, Mukherjee S, et al. Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis. Am J Trop Med Hyg. 2015;93(4):767-9.
Ghosh, S., Das, N. K., Mukherjee, S., Mukhopadhyay, D., Barbhuiya, J. N., Hazra, A., & Chatterjee, M. (2015). Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis. The American Journal of Tropical Medicine and Hygiene, 93(4), 767-9. https://doi.org/10.4269/ajtmh.14-0721
Ghosh S, et al. Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis. Am J Trop Med Hyg. 2015;93(4):767-9. PubMed PMID: 26175030.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis. AU - Ghosh,Susmita, AU - Das,Nilay Kanti, AU - Mukherjee,Shibabrata, AU - Mukhopadhyay,Debanjan, AU - Barbhuiya,Jayashree Nath, AU - Hazra,Avijit, AU - Chatterjee,Mitali, Y1 - 2015/07/14/ PY - 2014/11/17/received PY - 2015/06/02/accepted PY - 2015/7/16/entrez PY - 2015/7/16/pubmed PY - 2016/2/3/medline SP - 767 EP - 9 JF - The American journal of tropical medicine and hygiene JO - Am J Trop Med Hyg VL - 93 IS - 4 N2 - 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. SN - 1476-1645 UR - https://www.unboundmedicine.com/medline/citation/26175030/Inadequacy_of_12_Week_Miltefosine_Treatment_for_Indian_Post_Kala_Azar_Dermal_Leishmaniasis_ L2 - https://ajtmh.org/doi/10.4269/ajtmh.14-0721 DB - PRIME DP - Unbound Medicine ER -