Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study
Article Swipe
Hiroshi Inoue
,
Michiaki Umeyama
,
Takako Yamada
,
Hiroyuki Hashimoto
,
Akira Komoto
,
Masahiro Yasaka
·
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1002/joa3.12184
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1002/joa3.12184
Background Apixaban, 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. Methods A 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 ( ADR s), hemorrhages, and thromboembolic events (ischemic stroke, systemic embolism [ SE ], and transient ischemic attack [ TIA ]). Results Among 6306 NVAF patients in the safety analysis set (age, 74.5 ± 10.1 years; women, 41.1%; and CHADS 2 score, 2.0 ± 1.4), 3600 patients (57.1%) received the standard dose (5 mg twice daily) and 2694 (42.7%) received a reduced dose (2.5 mg twice daily) of apixaban. ADR s occurred in 604 patients (9.58%), with the most common being epistaxis (0.86%), subcutaneous hemorrhage (0.67%), and hematuria (0.57%). Incidence rate of any hemorrhages and major hemorrhage was 5.52% per year and 2.36% per year, respectively. Incidence rate of ischemic stroke/ SE / TIA was 1.00% per year among 6286 patients in the effectiveness analysis set. Among three subgroups (3106 apixaban initiators, 2038 patients switched from warfarin, and 1118 patients switched from other NOAC s), incidence rates of major hemorrhage ( P = 0.221 for trend) and ischemic stroke/ SE / TIA ( P = 0.686 for trend) were comparable. Conclusions No new safety signals of apixaban were identified in Japanese NVAF patients. Safety and effectiveness of apixaban were consistent with those in the ARISTOTLE study.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1002/joa3.12184
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/joa3.12184
- OA Status
- gold
- Cited By
- 25
- References
- 34
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2944592714
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2944592714Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1002/joa3.12184Digital Object Identifier
- Title
-
Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the
STANDARD studyWork title - Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2019Year of publication
- Publication date
-
2019-05-09Full publication date if available
- Authors
-
Hiroshi Inoue, Michiaki Umeyama, Takako Yamada, Hiroyuki Hashimoto, Akira Komoto, Masahiro YasakaList of authors in order
- Landing page
-
https://doi.org/10.1002/joa3.12184Publisher landing page
- PDF URL
-
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/joa3.12184Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/joa3.12184Direct OA link when available
- Concepts
-
Apixaban, Medicine, Atrial fibrillation, Incidence (geometry), Internal medicine, Stroke (engine), Rivaroxaban, Warfarin, Adverse effect, Postmarketing surveillance, Thromboembolic stroke, Mechanical engineering, Physics, Engineering, OpticsTop concepts (fields/topics) attached by OpenAlex
- Cited by
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25Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1, 2024: 2, 2023: 5, 2022: 2, 2021: 4Per-year citation counts (last 5 years)
- References (count)
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34Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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