Evidence map›Paper›PMID 31432451›Full record

Observational studyJournal of thrombosis and thrombolysis2019

Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings.

Takanori Ikeda, Satoshi Ogawa, Takanari Kitazono, Jyoji Nakagawara, Kazuo Minematsu, Susumu Miyamoto, Yuji Murakawa, Sanghun Iwashiro, Yoko Kidani, Yutaka Okayama and 3 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of thrombosis and thrombolysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 11 pooled it
–field-weighted citation impact
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

31 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  4. Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
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  11. An Updated Pooled Analysis of Off-Label Under and Over-Dosed Direct Oral Anticoagulants in Patients with Atrial Fibrillation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
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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

13 authors.

Takanori IkedaDepartment of Cardiovascular Medicine, Toho University Graduate School of Medicine, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan. takanori.ikeda@med.toho-u.ac.jp.
Satoshi OgawaInternational University of Health & Welfare Mita Hospital, Tokyo, Japan.
Takanari KitazonoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Jyoji NakagawaraOsaka Namba Clinic, Osaka, Japan.
Kazuo MinematsuNational Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
Susumu MiyamotoDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Yuji MurakawaThe 4th Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Kawasaki, Japan.
Sanghun IwashiroMedical Affairs Thrombosis, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
Yoko KidaniMedical Affairs Thrombosis, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
Yutaka OkayamaPharmacovigilance & Medical Governance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
Toshiyuki SunayaStatistics & Data Insights, Data Sciences & Analytics, Research & Development Japan, Bayer Yakuhin, Ltd., Osaka, Japan.
Shoichiro SatoPharmacovigilance & Medical Governance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
Satoshi YamanakaMedical Affairs Thrombosis, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The approved dose of oral anticoagulant rivaroxaban for patients with non-valvular atrial fibrillation (NVAF) in Japan is 15 mg once daily (od) in patients whose creatinine clearance is ≥ 50 mL/min, but recent real-world studies have demonstrated that these patients often received less than the recommended dose due to bleeding concerns. The effect of under-dosing on safety and effectiveness outcomes remains unclear. We used 1-year follow-up data from the XAPASS, a real-world Japanese prospective, single-arm, observational study. Of the 11,308 patients, 6521 patients who completed a 1-year follow-up and had a creatinine clearance ≥ 50 mL/min were included in this sub-analysis. Primary endpoints were any bleeding and a composite of stroke/non-central nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI). Among the 6521 patients, 4185 (64.2%; mean CHADS

Indexed as

AgedAtrial FibrillationDisease ManagementFactor Xa InhibitorsFemaleGuideline AdherenceHemorrhageHumansMaleMiddle AgedPractice Patterns, Physicians'RivaroxabanStrokeTreatment OutcomeFactor Xa InhibitorsRivaroxabanAnticoagulantsAtrial fibrillationRivaroxabanStroke preventionUnderdosing

Identifiers

PMID31432451
PMCPMC6800859

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.