Plasma Concentration and Pharmacodynamics of Edoxaban in Patients with Nonvalvular Atrial Fibrillation and Acute Heart Failure View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-03-30

AUTHORS

Takeru Nabeta, Keisuke Kida, Miwa Ishida, Takaaki Shiono, Norio Suzuki, Shunichi Doi, Maya Tsukahara, Yuki Ohta, Tetsuya Kimura, Keita Yamaguchi, Atsushi Takita, Naoki Matsumoto, Yoshihiro J. Akashi, Junya Ako, Takayuki Inomata

ABSTRACT

ObjectiveThe objective of this study was to assess the pharmacokinetic and pharmacodynamic profiles and safety of edoxaban in patients with nonvalvular atrial fibrillation (NVAF) who were hospitalized with acute heart failure (AHF).MethodsThe trough plasma concentrations of edoxaban, and the coagulation biomarkers prothrombin fragments 1 and 2 (F1+2) and d-dimer, were determined. Twenty-six patients received edoxaban 60 mg (30 mg when dose adjustment was required) and blood samples were collected immediately before oral edoxaban administration for 7 consecutive days after hospitalization and on the day of discharge.ResultsThe mean observation period was 13 (range 7–46) days. Trough plasma concentrations of edoxaban were constant from day 2 onwards. On day 1, the variation was greater owing to the differing intervals between the last edoxaban dose and day 1 blood collection. Trough plasma concentrations were higher in patients with reduced creatinine clearance (≤ 50 mL/min). Median values for F1+2 and d-dimer remained within normal ranges throughout the study. There were no drug discontinuations, and no serious adverse events were reported.ConclusionsThis is the first study of edoxaban pharmacokinetics and pharmacodynamics in patients with NVAF and AHF, and shows that the pharmacokinetic and pharmacodynamic profiles of edoxaban were constant during hospitalization. Thus, even in patients with NVAF and AHF, edoxaban anticoagulation therapy with guided dose adjustment is considered to be a safe and appropriate intervention. In particular, patients with reduced creatinine clearance should adhere to dose adjustment criteria.Clinical Trial RegistrationjRCTs031190006 (Japan Registry of Clinical Trials), 5 April, 2019 retrospectively registered. More... »

PAGES

1061-1071

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40262-021-00999-y

DOI

http://dx.doi.org/10.1007/s40262-021-00999-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1136749759

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33782831


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20 schema:description ObjectiveThe objective of this study was to assess the pharmacokinetic and pharmacodynamic profiles and safety of edoxaban in patients with nonvalvular atrial fibrillation (NVAF) who were hospitalized with acute heart failure (AHF).MethodsThe trough plasma concentrations of edoxaban, and the coagulation biomarkers prothrombin fragments 1 and 2 (F1+2) and d-dimer, were determined. Twenty-six patients received edoxaban 60 mg (30 mg when dose adjustment was required) and blood samples were collected immediately before oral edoxaban administration for 7 consecutive days after hospitalization and on the day of discharge.ResultsThe mean observation period was 13 (range 7–46) days. Trough plasma concentrations of edoxaban were constant from day 2 onwards. On day 1, the variation was greater owing to the differing intervals between the last edoxaban dose and day 1 blood collection. Trough plasma concentrations were higher in patients with reduced creatinine clearance (≤ 50 mL/min). Median values for F1+2 and d-dimer remained within normal ranges throughout the study. There were no drug discontinuations, and no serious adverse events were reported.ConclusionsThis is the first study of edoxaban pharmacokinetics and pharmacodynamics in patients with NVAF and AHF, and shows that the pharmacokinetic and pharmacodynamic profiles of edoxaban were constant during hospitalization. Thus, even in patients with NVAF and AHF, edoxaban anticoagulation therapy with guided dose adjustment is considered to be a safe and appropriate intervention. In particular, patients with reduced creatinine clearance should adhere to dose adjustment criteria.Clinical Trial RegistrationjRCTs031190006 (Japan Registry of Clinical Trials), 5 April, 2019 retrospectively registered.
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27 D-dimer
28 F1
29 acute heart failure
30 adjustment
31 adjustment criteria
32 administration
33 adverse events
34 anticoagulation therapy
35 appropriate interventions
36 atrial fibrillation
37 blood collection
38 blood samples
39 clearance
40 collection
41 concentration
42 consecutive days
43 creatinine clearance
44 criteria
45 day 1
46 day 2
47 days
48 days of discharge
49 discharge
50 discontinuation
51 dose
52 dose adjustment
53 drug discontinuation
54 edoxaban
55 edoxaban administration
56 edoxaban dose
57 edoxaban pharmacokinetics
58 events
59 failure
60 fibrillation
61 first study
62 heart failure
63 hospitalization
64 interval
65 intervention
66 mean observation period
67 median value
68 nonvalvular atrial fibrillation
69 normal range
70 objective
71 observation period
72 patients
73 period
74 pharmacodynamic profile
75 pharmacodynamics
76 pharmacodynamics of edoxaban
77 pharmacokinetics
78 plasma concentrations
79 profile
80 prothrombin
81 range
82 safety
83 safety of edoxaban
84 samples
85 serious adverse events
86 study
87 therapy
88 trough plasma concentrations
89 values
90 variation
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