Enteric-Coated Aspirin Versus Other Antiplatelet Drugs in Acute Non-Cardioembolic Ischemic Stroke: Post-marketing Study in Japan

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• 作者：Shunichi Takahashi (1)
  Osamu Mizuno (1)
  Toshiaki Sakaguchi (1)
  Takashi Yamada (1)
  Lyo Inuyama (1)
  
• 关键词：Acute cerebral infarction ; Acute ischemic stroke ; Antiplatelet drugs ; Enteric ; coated aspirin ; Post ; marketing surveillance study
• 刊名：Advances in Therapy
• 出版年：2014
• 出版时间：January 2014
• 年：2014
• 卷：31
• 期：1
• 页码：118-129
• 全文大小：473 KB
• 作者单位：Shunichi Takahashi (1)
  Osamu Mizuno (1)
  Toshiaki Sakaguchi (1)
  Takashi Yamada (1)
  Lyo Inuyama (1)
  
  1. Medical Affairs, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-ku, Osaka, 530-0001, Japan
  
• ISSN：1865-8652

文摘

Introduction Japanese guidelines recommend aspirin 160-00?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 (100-00?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.