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• W4283211472 abstract "The article in Journal of Clinical Pharmacology by Maldonado and Grundmann1 entitled “Drug-Drug Interactions of Artemisinin-Based Combination Therapies in Malaria Treatment” is highly misleading in its conclusions and specific examples. The Abstract states: “Based on known genotypes of cytochrome P450 (CYP) enzymes, CYP2B6 and CYP3A are primarily involved in the metabolism of artemisinin and its derivatives.” This is true only for artemisinin and artemether. For the therapeutically most important artemisinin derivatives, artesunate and dihydroartemisinin (DHA), the primary metabolic pathway is esterase-catalyzed hydrolysis and uridine diphosphate glucuronosyltransferase–mediated conjugation, respectively.2 Further, artemisinin is not recommended as a component of artemisinin-based combination therapies (ACTs) and is not clinically relevant regarding drug interactions with ACT therapy. The abstract goes on to state: “Reduced functions in these enzymes can lead to subtherapeutic concentrations of the active metabolite dihydroartemisinin that may cause treatment failure which has been shown in some studies with cardiovascular, antibiotic, and antiparasitic drugs.” ACTs are highly effective treatments for uncomplicated falciparum malaria, and the authors do not support this statement by citing a single example of antimalarial treatment failure in patients. Additionally, therapeutic concentrations of DHA have not been defined in the literature. In the Cardiovascular section (Pyronaridine-Artesunate subsection), the study of Morris, et al3 was mischaracterized, stating that “the size of the study population was very small.” The study was, in fact, appropriately powered to provide a statistical power of >90% for the study objective and concluded that “the magnitude of the drug-drug interaction effect observed in the present analysis appears to be sufficiently small, even for subjects with an EM phenotype, to allow for the coadministration of pyronaridine-artesunate with most CYP2D6 substrates under conditions of careful clinical monitoring.” This position is reflected in the current EMA approved labeling: “Caution is therefore advised when co-administering Pyramax with metoprolol given in cardiac failure, notably during the titration phase, and a possible dose adjustment may be required. This also applies to flecainide and propafenone, two antiarrhythmics exclusively metabolized by CYP2D6.” In the Antimalarial Section (Pyronaridine-Artesunate subheading), it should be noted there are a number of recent trials combining pyronaridine-artesunate with primaquine,4-7 all supporting the safety and efficacy of this combination. The EMA-approved labeling offers appropriate guidance: “The combination of Pyramax and primaquine has shown neither clinically relevant pharmacokinetic variations nor any impaired tolerance. If needed, the two antimalarial drugs may be co-administered.” In the Antimalarial Section (Artesunate subheading), there is a discussion on the combination of chlorproguanil, dapsone, and artesunate. This combination was investigational only and never received stringent regulatory approval or advancement to marketing. This section really has no clinical relevance in a discussion of ACTs. The main conclusion is also misleading, where it is stated: “In addition, artemisinin is a strong inhibitor of CYP1A2 and CYP2B6, while artemether strongly inhibits CYP2B6.” Regarding ACT therapy for treating uncomplicated falciparum malaria, artemisinin is not recommended as a component of ACTs and this statement applies only to artemether and not artesunate or DHA. We would advise for the inaccuracies we have highlighted to be corrected. This research was funded in part by Medicines for Malaria Venture (Geneva, Switzerland) and Shin Poong Pharmaceutical Co., Ltd. (Seoul, Korea)." @default.
• W4283211472 created "2022-06-22" @default.
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• W4283211472 date "2022-07-05" @default.
• W4283211472 modified "2023-09-27" @default.
• W4283211472 title "Misstatements in Artemisinin‐Based Combination Therapies in Malaria Treatment" @default.
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• W4283211472 doi "https://doi.org/10.1002/jcph.2113" @default.
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