Abstract
Introduction
Japanese guidelines recommend aspirin 160–300 mg/day, starting within 48 h, for patients with acute cerebral infarction. However, there are few reports evaluated in Japanese patients. Our objective was to examine the safety and efficacy of enteric-coated aspirin, compared with other oral antiplatelet drugs, in Japanese patients with acute ischemic stroke.
Methods
We performed a prospective, non-randomized, observational and multicenter study between June 2005 and December 2007. Patients with symptomatic acute ischemic stroke, including transient ischemic attack (TIA), who started enteric-coated aspirin or other antiplatelet drugs within 7 days of hospitalization were registered. Outcome measures evaluated within 3 months were incidence of cerebral and non-cerebral hemorrhagic events, recurrence of ischemic stroke or TIA, non-cerebral ischemic events and death from any cause.
Results
Overall, 2,548 and 830 patients treated with enteric-coated aspirin (100–300 mg/day) or other antiplatelet drugs, respectively, were registered; approximately 60% were male, mean age was 70 years, 85% had pre-existing cardiovascular disease or other complications. Enteric-coated aspirin of 100 mg was mainly prescribed, and only approximately half of the patients were started on it within 48 h after onset of ischemic stroke. Safety and efficacy population excluded patients without follow-up data were 2,521 in enteric-coated aspirin and 807 in other antiplatelets. Hemorrhagic events occurred in 46 (1.8%) in the enteric-coated aspirin group and in 13 (1.6%) in the other antiplatelet drugs group, there was not significant. Recurrent ischemic stroke or TIA occurred in 39 (1.5%) of the enteric-coated aspirin and in 18 (2.2%) of other antiplatelet drugs, and there were any-cause death in 16 (0.6%) and 8 (1.0%). Incidences were slightly lower in the enteric-coated aspirin group compared with the other antiplatelet drugs group, but not statistically significant.
Conclusion
It seems that these results showed the safety and efficacy of the enteric-coated aspirin in acute stroke care in Japanese patients. Incidence of hemorrhagic events was comparable between the enteric-coated aspirin group and the other antiplatelet drugs group.
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Acknowledgments
Sponsorship and article processing charges for this study were funded by Bayer. Will Medical Communications assisted the authors with the submission process and this assistance was funded by Bayer. Dr Shunichi Takahashi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. The funding source was involved in the study design, the collection, analysis and interpretation of data, the writing of the report, and the decision to submit the paper for publication. The funding source had no influence over any treatment decisions.
Conflict of interest
Shunichi Takahashi is an employee of Bayer.
Osamu Mizuno is an employee of Bayer.
Toshiaki Sakaguchi is an employee of Bayer.
Takashi Yamada is an employee of Bayer.
Lyo Inuyama is an employee of Bayer.
Compliance with ethics guidelines
All study procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national), the Helsinki Declaration of 1975, as revised in 2000 and 2008, and the principles of Good Post-marketing Study Practice. The institutional review board of each participating institution approved the study protocol. Informed consent was not obtained, as Japanese law does not require informed consent for this type of observational study.
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Takahashi, S., Mizuno, O., Sakaguchi, T. et al. Enteric-Coated Aspirin Versus Other Antiplatelet Drugs in Acute Non-Cardioembolic Ischemic Stroke: Post-marketing Study in Japan. Adv Ther 31, 118–129 (2014). https://doi.org/10.1007/s12325-013-0089-1
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DOI: https://doi.org/10.1007/s12325-013-0089-1