Evidence map›Paper›PMID 33850579›Full record

ArticleJournal of arrhythmia2021

Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two-year postmarketing surveillance study (ETNA-AF-Japan).

Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai

Open access · goldAbstract read
In one paragraph

Article in Journal of arrhythmia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

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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

4 authors at 3 institutions in 1 country.

Takeshi YamashitaThe Cardiovascular Institute Tokyo Japan.ORCID https://orcid.org/0000-0002-2544-8464
Yukihiro KoretsuneNational Hospital Organization Osaka National Hospital Osaka Japan.
Tomoko NagaoPharmacoepidemiology & PMS Department Daiichi Sankyo Co. Ltd Tokyo Japan.ORCID https://orcid.org/0000-0001-9846-2729
Kazuhito ShiosakaiData Intelligence Department Daiichi Sankyo Co. Ltd Tokyo Japan.
Daiichi-Sankyo (Japan) · JPCardiovascular Institute Hospital · JPOsaka National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDirect oral anticoagulants (DOACs) are the recommended first-line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, the safety and effectiveness of edoxaban for this indication requires monitoring over the long term in real-world settings.

methodsETNA-AF-Japan (trial no. UMIN000017011) was a prospective, multicenter observational study (part of postmarketing surveillance in Japan). NVAF patients due to receive edoxaban to prevent ischemic stroke were enrolled between 13 April 2015 and 30 September 2017.

resultsA total of 11 569 patients were enrolled. For the 11 111 patients (female, 40.6%) whose data comprised the safety analysis set, age, body weight, creatinine clearance (CLcr), and CHADS

conclusionsThese results provide real-world evidence for the long-term good safety and effectiveness profile of edoxaban in Japanese NVAF patients under clinical practice.

Indexed as

anticoagulantatrial fibrillationdirect‐acting oral anticoagulantsedoxabanpostmarketing product surveillance

Identifiers

PMID33850579
PMCPMC8021991
OpenAlexW3131443479

What OpenQuestion holds

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LicenceCC BY
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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.