TY - JOUR
T1 - A systematic review and an individual patient data meta-analysis of ivermectin use in children weighing less than fifteen kilograms: Is it time to reconsider the current contraindication?
T2 - Is it time to reconsider the current contraindication?
AU - Jittamala, Podjanee
AU - Monteiro, Wuelton
AU - Smit, Menno R.
AU - Pedrique, Belen
AU - Specht, Sabine
AU - Chaccour, Carlos J.
AU - Dard, C. line
AU - del Giudice, Pascal
AU - Khieu, Virak
AU - Maruani, Annabel
AU - Failoc-Rojas, Virgilio E.
AU - Sáez-de-Ocariz, Marimar
AU - Soriano-Arandes, Antoni
AU - Piquero-Casals, Jaime
AU - Faisant, Anne
AU - Brenier-Pinchart, Marie-Pierre
AU - Wimmersberger, David
AU - Coulibaly, Jean T.
AU - Keiser, Jennifer
AU - Boralevi, Franck
AU - Sokana, Oliver
AU - Marks, Michael
AU - Engelman, Daniel
AU - Romani, Lucia
AU - Steer, Andrew C.
AU - von Seidlein, Lorenz
AU - White, Nicholas J.
AU - Harriss, Eli
AU - Stepniewska, Kasia
AU - Humphreys, Georgina S.
AU - Kennon, Kalynn
AU - Guerin, Philippe J.
AU - Kobylinski, Kevin C.
N1 - Funding Information:
KCK was supported in part by a Fellowship from the US National Research Council. WM is supported in part by a Fellowship from the National Council for Scientific and Technological Development (CNPq) and by Fapem (Pr?-Estado). BP and SS are supported by the Drugs for Neglected Diseases initiative (DNDi). A full list of DNDi?s donors can be found at http://www.dndi. org/donors/donors/. The Infectious Disease Data Observatory and WorldWide Antimalarial Research Network are supported by the Bill & Melinda Gates Foundation and the Exxon Mobil Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2021 Jittamala et al.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3/1
Y1 - 2021/3/1
N2 - BACKGROUND: Oral ivermectin is a safe broad spectrum anthelminthic used for treating several neglected tropical diseases (NTDs). Currently, ivermectin use is contraindicated in children weighing less than 15 kg, restricting access to this drug for the treatment of NTDs. Here we provide an updated systematic review of the literature and we conducted an individual-level patient data (IPD) meta-analysis describing the safety of ivermectin in children weighing less than 15 kg. METHODOLOGY/PRINCIPAL FINDINGS: A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for IPD guidelines by searching MEDLINE via PubMed, Web of Science, Ovid Embase, LILACS, Cochrane Database of Systematic Reviews, TOXLINE for all clinical trials, case series, case reports, and database entries for reports on the use of ivermectin in children weighing less than 15 kg that were published between 1 January 1980 to 25 October 2019. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42017056515. A total of 3,730 publications were identified, 97 were selected for potential inclusion, but only 17 sources describing 15 studies met the minimum criteria which consisted of known weights of children less than 15 kg linked to possible adverse events, and provided comprehensive IPD. A total of 1,088 children weighing less than 15 kg were administered oral ivermectin for one of the following indications: scabies, mass drug administration for scabies control, crusted scabies, cutaneous larva migrans, myiasis, pthiriasis, strongyloidiasis, trichuriasis, and parasitic disease of unknown origin. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported. CONCLUSIONS/SIGNIFICANCE: Existing limited data suggest that oral ivermectin in children weighing less than 15 kilograms is safe. Data from well-designed clinical trials are needed to provide further assurance.
AB - BACKGROUND: Oral ivermectin is a safe broad spectrum anthelminthic used for treating several neglected tropical diseases (NTDs). Currently, ivermectin use is contraindicated in children weighing less than 15 kg, restricting access to this drug for the treatment of NTDs. Here we provide an updated systematic review of the literature and we conducted an individual-level patient data (IPD) meta-analysis describing the safety of ivermectin in children weighing less than 15 kg. METHODOLOGY/PRINCIPAL FINDINGS: A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for IPD guidelines by searching MEDLINE via PubMed, Web of Science, Ovid Embase, LILACS, Cochrane Database of Systematic Reviews, TOXLINE for all clinical trials, case series, case reports, and database entries for reports on the use of ivermectin in children weighing less than 15 kg that were published between 1 January 1980 to 25 October 2019. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42017056515. A total of 3,730 publications were identified, 97 were selected for potential inclusion, but only 17 sources describing 15 studies met the minimum criteria which consisted of known weights of children less than 15 kg linked to possible adverse events, and provided comprehensive IPD. A total of 1,088 children weighing less than 15 kg were administered oral ivermectin for one of the following indications: scabies, mass drug administration for scabies control, crusted scabies, cutaneous larva migrans, myiasis, pthiriasis, strongyloidiasis, trichuriasis, and parasitic disease of unknown origin. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported. CONCLUSIONS/SIGNIFICANCE: Existing limited data suggest that oral ivermectin in children weighing less than 15 kilograms is safe. Data from well-designed clinical trials are needed to provide further assurance.
UR - https://www.scopus.com/pages/publications/85103144168
U2 - 10.1371/journal.pntd.0009144
DO - 10.1371/journal.pntd.0009144
M3 - Article
C2 - 33730099
SN - 1935-2727
VL - 15
SP - e0009144
JO - PLoS neglected tropical diseases
JF - PLoS neglected tropical diseases
IS - 3
M1 - e0009144
ER -
SDG 3 Good Health and Well-being