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Oral miltefosine for Indian post-kala-azar dermal leishmaniasis: a randomised trial.
Trop Med Int Health. 2013 Jan; 18(1):96-100.TM

Abstract

OBJECTIVE

Standard treatment of Indian post-kala-azar dermal leishmaniasis (PKDL) is unsatisfactory because to achieve therapeutic effectiveness, heroic courses of parenteral and toxic agents have to be administered. Our objective was to evaluate oral miltefosine for its potential to provide effective as well as tolerable treatment for this disease.

METHOD

Open-label, randomised, parallel-group multicentric trial. Miltefosine, 100 mg/day to all but one patient, was administered for 12 weeks or 8 weeks, with a target of 18 patients in each treatment group. Key endpoints were tolerance during treatment and efficacy at 12 months of follow-up.

RESULTS

The ITT and per-protocol cure rates after 12 months of follow-up for patients receiving 12 weeks of therapy were 78% (14 of 18 patients: 95% CI = 61-88%) and 93% (14 of 15 patients: 95% CI = 71-95%), respectively, after 12 months of follow-up. The ITT and per-protocol cure rates for patients receiving 8 weeks of therapy were 76% (13 of 17 patients: 95% CI = 53-90%) and 81% (13 of 16 patients: 95% CI = 57-93%), respectively. Gastrointestinal and other adverse events were rare.

CONCLUSIONS

This study suggests that oral miltefosine for 2-3 months can be considered a treatment of choice for Indian PKDL.

Authors+Show Affiliations

Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drshyamsundar@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23136856

Citation

Sundar, Shyam, et al. "Oral Miltefosine for Indian Post-kala-azar Dermal Leishmaniasis: a Randomised Trial." Tropical Medicine & International Health : TM & IH, vol. 18, no. 1, 2013, pp. 96-100.
Sundar S, Sinha P, Jha TK, et al. Oral miltefosine for Indian post-kala-azar dermal leishmaniasis: a randomised trial. Trop Med Int Health. 2013;18(1):96-100.
Sundar, S., Sinha, P., Jha, T. K., Chakravarty, J., Rai, M., Kumar, N., Pandey, K., Narain, M. K., Verma, N., Das, V. N., Das, P., Berman, J., & Arana, B. (2013). Oral miltefosine for Indian post-kala-azar dermal leishmaniasis: a randomised trial. Tropical Medicine & International Health : TM & IH, 18(1), 96-100. https://doi.org/10.1111/tmi.12015
Sundar S, et al. Oral Miltefosine for Indian Post-kala-azar Dermal Leishmaniasis: a Randomised Trial. Trop Med Int Health. 2013;18(1):96-100. PubMed PMID: 23136856.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral miltefosine for Indian post-kala-azar dermal leishmaniasis: a randomised trial. AU - Sundar,Shyam, AU - Sinha,Prabat, AU - Jha,T K, AU - Chakravarty,Jaya, AU - Rai,Madhukar, AU - Kumar,Nawin, AU - Pandey,Krishna, AU - Narain,M K, AU - Verma,N, AU - Das,V N R, AU - Das,P, AU - Berman,Jonathan, AU - Arana,Byron, Y1 - 2012/11/08/ PY - 2012/11/10/entrez PY - 2012/11/10/pubmed PY - 2013/2/21/medline SP - 96 EP - 100 JF - Tropical medicine & international health : TM & IH JO - Trop Med Int Health VL - 18 IS - 1 N2 - OBJECTIVE: Standard treatment of Indian post-kala-azar dermal leishmaniasis (PKDL) is unsatisfactory because to achieve therapeutic effectiveness, heroic courses of parenteral and toxic agents have to be administered. Our objective was to evaluate oral miltefosine for its potential to provide effective as well as tolerable treatment for this disease. METHOD: Open-label, randomised, parallel-group multicentric trial. Miltefosine, 100 mg/day to all but one patient, was administered for 12 weeks or 8 weeks, with a target of 18 patients in each treatment group. Key endpoints were tolerance during treatment and efficacy at 12 months of follow-up. RESULTS: The ITT and per-protocol cure rates after 12 months of follow-up for patients receiving 12 weeks of therapy were 78% (14 of 18 patients: 95% CI = 61-88%) and 93% (14 of 15 patients: 95% CI = 71-95%), respectively, after 12 months of follow-up. The ITT and per-protocol cure rates for patients receiving 8 weeks of therapy were 76% (13 of 17 patients: 95% CI = 53-90%) and 81% (13 of 16 patients: 95% CI = 57-93%), respectively. Gastrointestinal and other adverse events were rare. CONCLUSIONS: This study suggests that oral miltefosine for 2-3 months can be considered a treatment of choice for Indian PKDL. SN - 1365-3156 UR - https://www.unboundmedicine.com/medline/citation/23136856/Oral_miltefosine_for_Indian_post_kala_azar_dermal_leishmaniasis:_a_randomised_trial_ L2 - https://doi.org/10.1111/tmi.12015 DB - PRIME DP - Unbound Medicine ER -