Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review

Objective: To evaluate the dosing, efficacy and safety of the main antileishmanial agents amphotericin B (conventional or liposomal), pentavalent antimonials, miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children. Methods: The efficacy and safety of visceral...

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Main Authors: Nirmitha L. De Silva, Manjula Hettiarachchi, Chandrika S. Ranasinghe, Thishan C. Yahathugoda, Shalindra Ranasinghe
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2025-06-01
Series:Asian Pacific Journal of Tropical Medicine
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Online Access:https://journals.lww.com/10.4103/apjtm.apjtm_685_24
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author Nirmitha L. De Silva
Manjula Hettiarachchi
Chandrika S. Ranasinghe
Thishan C. Yahathugoda
Shalindra Ranasinghe
author_facet Nirmitha L. De Silva
Manjula Hettiarachchi
Chandrika S. Ranasinghe
Thishan C. Yahathugoda
Shalindra Ranasinghe
author_sort Nirmitha L. De Silva
collection DOAJ
description Objective: To evaluate the dosing, efficacy and safety of the main antileishmanial agents amphotericin B (conventional or liposomal), pentavalent antimonials, miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children. Methods: The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed, Cochrane, clinicaltrials.gov, and Google Scholar, focusing on randomised trials with separate pediatric data (published from 2000-2024). The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2). Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist. Results: Of 1 186 records, only 7 were eligible for qualitative synthesis. Three trials exclusively included children. The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis. Most trial arms reported efficacies over 94% for children across different regimens. Miltefosine monotherapy showed the highest rate of late treatment failures, highlighting that allometric dosing is crucial to ensure proper drug exposure in children. Safety data for children were available in only three studies with varied reporting systems of adverse events. Although regimens in this review were generally considered to be safe in children, antimonial-related cardiac toxicity remains a threat. Conclusions: This review highlights the need for pediatric-specific trials, clear presentation of pediatric data, and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.
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spelling doaj-art-182db989a3ca405c9c065723df282c8f2025-08-20T02:43:28ZengWolters Kluwer Medknow PublicationsAsian Pacific Journal of Tropical Medicine2352-41462025-06-0118624325210.4103/apjtm.apjtm_685_24Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic reviewNirmitha L. De SilvaManjula HettiarachchiChandrika S. RanasingheThishan C. YahathugodaShalindra RanasingheObjective: To evaluate the dosing, efficacy and safety of the main antileishmanial agents amphotericin B (conventional or liposomal), pentavalent antimonials, miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children. Methods: The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed, Cochrane, clinicaltrials.gov, and Google Scholar, focusing on randomised trials with separate pediatric data (published from 2000-2024). The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2). Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist. Results: Of 1 186 records, only 7 were eligible for qualitative synthesis. Three trials exclusively included children. The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis. Most trial arms reported efficacies over 94% for children across different regimens. Miltefosine monotherapy showed the highest rate of late treatment failures, highlighting that allometric dosing is crucial to ensure proper drug exposure in children. Safety data for children were available in only three studies with varied reporting systems of adverse events. Although regimens in this review were generally considered to be safe in children, antimonial-related cardiac toxicity remains a threat. Conclusions: This review highlights the need for pediatric-specific trials, clear presentation of pediatric data, and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.https://journals.lww.com/10.4103/apjtm.apjtm_685_24visceral leishmaniasischildrentreatmentsefficacysafetysystematic review
spellingShingle Nirmitha L. De Silva
Manjula Hettiarachchi
Chandrika S. Ranasinghe
Thishan C. Yahathugoda
Shalindra Ranasinghe
Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
Asian Pacific Journal of Tropical Medicine
visceral leishmaniasis
children
treatments
efficacy
safety
systematic review
title Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
title_full Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
title_fullStr Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
title_full_unstemmed Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
title_short Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review
title_sort therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children a systematic review
topic visceral leishmaniasis
children
treatments
efficacy
safety
systematic review
url https://journals.lww.com/10.4103/apjtm.apjtm_685_24
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