Japanese postmarketing surveillance of clopidogrel for patients with non-ST-segment-elevation acute coronary syndrome indicated for percutaneous coronary intervention (J-PLACE NSTE-ACS)

被引：3

作者：

Morino Y. ^{[1
]}

Ako J. ^{[2
]}

Kobayashi M. ^{[3
]}

Nakamura M. ^{[4
]}

机构：

[1] Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka

[2] Department of Cardiovascular Medicine, Kitasato University, Kanagawa

[3] Medical Operations, Tokyo, Sanofi K.K.

[4] Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo

来源：

Cardiovascular Intervention and Therapeutics | 2014年 / 29卷 / 2期

关键词：

Clopidogrel; NSTE-ACS; Postmarketing surveillance;

D O I：

10.1007/s12928-013-0229-1

中图分类号：

学科分类号：

摘要：

Clopidogrel in combination with aspirin has been a standard therapy for patients who have undergone percutaneous coronary intervention. The present study was conducted as a postmarketing surveillance, for the purpose of assessing the safety and efficacy of clopidogrel in real clinical practice in patients with non-ST-segment-elevation acute coronary syndrome (NSTE-ACS). Subjects were registered between March 2008 and December 2010, and as a result, patients not only with NSTE-ACS but also other types of ischemic heart diseases were enrolled. Data on off-label subjects were used only in safety evaluation. After excluding patients with inappropriate clinical report forms, 3,673 patients with non-ST-segment-elevation myocardial infarction, unstable angina, STEMI, stable angina, or old myocardial infarction were observed for safety evaluation. Efficacy was assessed in 2,562 of the 3,673 patients with NSTE-ACS. Aspirin was concomitantly prescribed to 3,615/3,673 (98.6 %) of the safety group, and 2,374/3,673 (64.6 %) received a loading dose of clopidogrel. During a maximum follow-up period of 12 months, 397 (10.8 %) of the 3,673 patients experienced adverse drug reactions (ADRs), of whom 145 (4.0 %) had serious conditions, as classified by the investigators. The most frequently observed ADRs were hepatobiliary and gastrointestinal disorders. Bleeding adverse events were observed in 138 patients (3.8 %) and 80 cases (2.2 %) were considered as serious. The 1-year cumulative incidence of major adverse cardiovascular events and major adverse cardiac and cerebrovascular events in the patients with NSTE-ACS were estimated to be 11.6 and 12.2 %, respectively. Serious AEs that substantially affect the safety profile of clopidogrel were not confirmed. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics.

引用

页码：123 / 133

页数：10

共 30 条

[21]

Huang C.C., Chen Y.C., Leu H.B., Chen T.J., Lin S.J., Chan W.L., Et al., Risk of adverse outcomes in Taiwan associated with concomitant use of clopidogrel and proton pump inhibitors in patients who received percutaneous coronary intervention, Am J Cardiol, 105, pp. 1705-1709, (2010)

[22]

Drug safety communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug

[23]

Kimura T., Morimoto T., Furukawa Y., Nakagawa Y., Kadota K., Iwabuchi M., Et al., Association of the use of proton pump inhibitors with adverse cardiovascular and bleeding outcomes after percutaneous coronary intervention in the Japanese real world clinical practice, Cardiovasc Interv Ther, 26, pp. 222-233, (2011)

[24]

Jiang Z., Wu H., Duan Z., Wang Z., Hu K., Ye F., Et al., Proton-pump inhibitors can decrease gastrointestinal bleeding after percutaneous coronary intervention, Clin Res Hepatol Gastroenterol, (2013)

[25]

Ohkubo K., Kobayashi Y., Nakamura Y., Miyazaki A., Incidence of side-effects of dual antiplatelet therapy with clopidogrel and aspirin after coronary stent implantation, Cardiovasc Interv Ther, 26, pp. 33-37, (2011)

[26]

Isshiki T., Kimura T., Ueno T., Nakamura M., Igarashi K., Yokoi H., Et al., Clopidogrel trial in patients with elective percutaneous coronary intervention for stable angina and old myocardial infarction (CLEAN): safety and efficacy study of clopidogrel compared to ticlopidine in Japanese patients, Int Heart J, 53, pp. 91-101, (2012)

[27]

Fukuuchi Y., Tohgi H., Okudera T., Ikeda Y., Miyanaga Y., Uchiyama S., Et al., A randomized, double-blind study comparing the safety and efficacy of clopidogrel versus ticlopidine in Japanese patients with noncardioembolic cerebral infarction, Cerebrovasc Dis, 25, pp. 40-49, (2008)

[28]

Uchiyama S., Fukuuchi Y., Yamaguchi T., The safety and efficacy of clopidogrel versus ticlopidine in Japanese stroke patients: combined results of two phase III, multicenter, randomized clinical trials, J Neurol, 256, pp. 888-897, (2009)

[29]

Shigematsu H., Komori K., Tanemoto K., Harada Y., Nakamura M., Clopidogrel for atherothrombotic event management in patients with peripheral arterial disease (COOPER) study: safety and efficacy of clopidogrel versus ticlopidine in Japanese patients, Ann Vasc Dis, 5, pp. 364-375, (2012)

[30]

Daida H., Miyauchi K., Ogawa H., Yokoi H., Matsumoto M., Kitakaze M., Et al., Management and two-year long-term clinical outcomes of patients with acute coronary syndrome in Japan: prevention of atherothrombotic incidents following ischemic coronary attack (PACIFIC) registry, Circ J, 77, pp. 934-943, (2013)

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