Evidence map›Paper›PMID 31293700›Full record

ArticleJournal of arrhythmia2019

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study.

Hiroshi Inoue, Michiaki Umeyama, Takako Yamada, Hiroyuki Hashimoto, Akira Komoto, Masahiro Yasaka

Abstract read
In one paragraph

Article in Journal of arrhythmia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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

16 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Observational
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
  16. 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.

Hiroshi InoueSaiseikai Toyama Hospital Toyama Japan.ORCID https://orcid.org/0000-0002-0775-8936
Michiaki UmeyamaBristol-Myers Squibb K.K. Tokyo Japan.
Takako YamadaBristol-Myers Squibb K.K. Tokyo Japan.
Hiroyuki HashimotoPfizer Japan Inc. Tokyo Japan.
Akira KomotoBristol-Myers Squibb K.K. Tokyo Japan.
Masahiro YasakaNational Hospital Organization Kyushu Medical Center Fukuoka Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApixaban, a non-vitamin K oral anticoagulant (NOAC), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF). However, the safety and effectiveness of apixaban in clinical practice have not yet been elucidated thoroughly among Japanese NVAF patients.

methodsA postmarketing surveillance study was conducted to determine the safety and effectiveness of apixaban. Patients were followed-up for 104 weeks. Outcome events included adverse drug reactions (ADRs), hemorrhages, and thromboembolic events (ischemic stroke, systemic embolism [SE], and transient ischemic attack [TIA]).

resultsAmong 6306 NVAF patients in the safety analysis set (age, 74.5 ± 10.1 years; women, 41.1%; and CHADS

conclusionsNo new safety signals of apixaban were identified in Japanese NVAF patients. Safety and effectiveness of apixaban were consistent with those in the ARISTOTLE study.

Indexed as

apixabanatrial fibrillationpostmarketing surveillancesafety

Identifiers

PMID31293700
PMCPMC6595349

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.