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Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review

BACKGROUND: Tafenoquine is an 8-aminoquinoline anti-malarial drug recently approved as a single-dose (300 mg) therapy for Plasmodium vivax relapse prevention, when co-administered with 3-days of chloroquine or other blood schizonticide. Tafenoquine 200 mg weekly after a loading dose is also approved...

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Autores principales: Duparc, Stephan, Chalon, Stephan, Miller, Scott, Richardson, Naomi, Toovey, Stephen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7071640/
https://www.ncbi.nlm.nih.gov/pubmed/32169086
http://dx.doi.org/10.1186/s12936-020-03184-x
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author Duparc, Stephan
Chalon, Stephan
Miller, Scott
Richardson, Naomi
Toovey, Stephen
author_facet Duparc, Stephan
Chalon, Stephan
Miller, Scott
Richardson, Naomi
Toovey, Stephen
author_sort Duparc, Stephan
collection PubMed
description BACKGROUND: Tafenoquine is an 8-aminoquinoline anti-malarial drug recently approved as a single-dose (300 mg) therapy for Plasmodium vivax relapse prevention, when co-administered with 3-days of chloroquine or other blood schizonticide. Tafenoquine 200 mg weekly after a loading dose is also approved as travellers’ prophylaxis. The development of tafenoquine has been conducted over many years, using various dosing regimens in diverse populations. METHODS: This review brings together all the preclinical and clinical data concerning tafenoquine central nervous system safety. Data were assembled from published sources. The risk of neuropsychiatric adverse events (NPAEs) with single-dose tafenoquine (300 mg) in combination with chloroquine to achieve P. vivax relapse prevention is particularly examined. RESULTS: There was no evidence of neurotoxicity with tafenoquine in preclinical animal models. In clinical studies in P. vivax relapse prevention, nervous system adverse events, mainly headache and dizziness, occurred in 11.4% (36/317) of patients with tafenoquine (300 mg)/chloroquine versus 10.2% (19/187) with placebo/chloroquine; and in 15.5% (75/483) of patients with tafenoquine/chloroquine versus 13.3% (35/264) with primaquine (15 mg/day for 14 days)/chloroquine. Psychiatric adverse events, mainly insomnia, occurred in 3.8% (12/317) of patients with tafenoquine/chloroquine versus 2.7% (5/187) with placebo/chloroquine; and in 2.9% (14/483) of patients with tafenoquine/chloroquine versus 3.4% (9/264) for primaquine/chloroquine. There were no serious or severe NPAEs observed with tafenoquine (300 mg)/chloroquine in these studies. CONCLUSIONS: The risk:benefit of single-dose tafenoquine/chloroquine in P. vivax relapse prevention is favourable in the presence of malaria, with a low risk of NPAEs, similar to that seen with chloroquine alone or primaquine/chloroquine.
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spelling pubmed-70716402020-03-18 Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review Duparc, Stephan Chalon, Stephan Miller, Scott Richardson, Naomi Toovey, Stephen Malar J Review BACKGROUND: Tafenoquine is an 8-aminoquinoline anti-malarial drug recently approved as a single-dose (300 mg) therapy for Plasmodium vivax relapse prevention, when co-administered with 3-days of chloroquine or other blood schizonticide. Tafenoquine 200 mg weekly after a loading dose is also approved as travellers’ prophylaxis. The development of tafenoquine has been conducted over many years, using various dosing regimens in diverse populations. METHODS: This review brings together all the preclinical and clinical data concerning tafenoquine central nervous system safety. Data were assembled from published sources. The risk of neuropsychiatric adverse events (NPAEs) with single-dose tafenoquine (300 mg) in combination with chloroquine to achieve P. vivax relapse prevention is particularly examined. RESULTS: There was no evidence of neurotoxicity with tafenoquine in preclinical animal models. In clinical studies in P. vivax relapse prevention, nervous system adverse events, mainly headache and dizziness, occurred in 11.4% (36/317) of patients with tafenoquine (300 mg)/chloroquine versus 10.2% (19/187) with placebo/chloroquine; and in 15.5% (75/483) of patients with tafenoquine/chloroquine versus 13.3% (35/264) with primaquine (15 mg/day for 14 days)/chloroquine. Psychiatric adverse events, mainly insomnia, occurred in 3.8% (12/317) of patients with tafenoquine/chloroquine versus 2.7% (5/187) with placebo/chloroquine; and in 2.9% (14/483) of patients with tafenoquine/chloroquine versus 3.4% (9/264) for primaquine/chloroquine. There were no serious or severe NPAEs observed with tafenoquine (300 mg)/chloroquine in these studies. CONCLUSIONS: The risk:benefit of single-dose tafenoquine/chloroquine in P. vivax relapse prevention is favourable in the presence of malaria, with a low risk of NPAEs, similar to that seen with chloroquine alone or primaquine/chloroquine. BioMed Central 2020-03-14 /pmc/articles/PMC7071640/ /pubmed/32169086 http://dx.doi.org/10.1186/s12936-020-03184-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Review
Duparc, Stephan
Chalon, Stephan
Miller, Scott
Richardson, Naomi
Toovey, Stephen
Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title_full Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title_fullStr Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title_full_unstemmed Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title_short Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
title_sort neurological and psychiatric safety of tafenoquine in plasmodium vivax relapse prevention: a review
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7071640/
https://www.ncbi.nlm.nih.gov/pubmed/32169086
http://dx.doi.org/10.1186/s12936-020-03184-x
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