Evidence map›Paper›PMID 38641335›Full record

Trial reportThrombosis and haemostasis2024

Pharmacokinetics of Edoxaban 15 mg in Very Elderly Patients with Nonvalvular Atrial Fibrillation: A Subanalysis of the ELDERCARE-AF Study.

Takeshi Yamashita, Yoshiyuki Igawa, Masayuki Fukuzawa, Takuya Hayashi, Stefanie Hennig, Ken Okumura

Open access · hybridAbstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Thrombosis and haemostasis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Takeshi YamashitaDepartment of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.
Yoshiyuki IgawaQuantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Masayuki FukuzawaJapan Business Unit, Primary Medical Science Department, Cardiovascular Group, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Takuya HayashiData Analysis Group, Data Intelligence Department, Global DX, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Stefanie HennigCertara, Inc., Princeton, New Jersey, United States.
Ken OkumuraDivision of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
Daiichi-Sankyo (Japan) · JPCardiovascular Institute Hospital · JPIntegra LifeSciences (United States) · USSaiseikai Kumamoto Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the pharmacokinetics (PK) of low-dose (15 mg) edoxaban in very elderly patients (≥80 years) with nonvalvular atrial fibrillation (NVAF) and high bleeding risk.

methodsThis subanalysis of the phase 3, randomized, double-blind, placebo-controlled, multicenter ELDERCARE-AF study evaluated edoxaban plasma concentrations and compared them with the Japanese population of the ENGAGE AF-TIMI 48 and Japanese severe renal impairment (SRI) studies.

resultsThe PK analysis population included 451 patients, 53.8% of whom concomitantly used antiplatelet drugs, 41.0% had SRI, and 38.0% had low body weight. Edoxaban plasma concentrations at trough and 1 to 3 hours post-dose in ELDERCARE-AF were 17.3 ± 13.9 (

conclusionPK data support edoxaban 15 mg once daily for very elderly NVAF patients with high bleeding risk, with caution for patients with SRI and/or low body weight.

Indexed as

Atrial FibrillationFactor Xa InhibitorsHemorrhagePyridinesThiazolesAged, 80 and overAge FactorsDouble-Blind MethodFemaleHumansJapanMalePlatelet Aggregation InhibitorsRisk FactorsTreatment OutcomeedoxabanFactor Xa InhibitorsPlatelet Aggregation InhibitorsPyridinesThiazoles

Identifiers

PMID38641335
PMCPMC11349424
OpenAlexW4394978408

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.