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Revaluation of Clopidogrel: Let the Data Speak for Themselves

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机构: [1]Huazhong Univ Sci & Technol, Dept Pharmacol, Inst Clin Pharmacol, Tongji Med Coll, Wuhan 430030, Peoples R China; [2]Wuhan Gen Hosp, Dept Radiol, Guangzhou Mil Command, Wuhan 430070, Peoples R China; [3]Nanjing Univ, Sch Business, Nanjing 210093, Peoples R China; [4]Beijing Anzhen Hosp, Dept Cardiol, Beijing 100029, Peoples R China; [5]State Food Drug Adm China, Ctr Drug Evaluat, Beijing 100038, Peoples R China; [6]Cent S Univ, Xiangya Hosp 3, Dept Neurol, Changsha 410013, Peoples R China; [7]Beijing Tiantan Hosp, Dept Neurol, Beijing 100050, Peoples R China; [8]Capital Univ Med Sci, Chaoyang Hosp, Ctr Cardiol, Beijing 100020, Peoples R China; [9]Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Hlth Toxicol, MOE Key Lab Environm & Hlth, Wuhan 430030, Peoples R China; [10]Wuhan Univ, Renmin Hosp, Dept Radiol, Wuhan 430060, Peoples R China; [11]Shanxi Med Univ, Hosp 1, Dept Pharm, Taiyuan 030001, Peoples R China; [12]Wuhan Gen Hosp, Dept Orthoped, Guangzhou Mil Command, Wuhan 430070, Peoples R China; [13]Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Ophthalmol, Union Hosp, Wuhan 430022, Peoples R China; [14]Wuhan Univ, Coll Pharm, Wuhan 430072, Peoples R China; [15]Peoples Liberat Army Gen Hosp, Dept Otorhinolaryngol, Beijing 100853, Peoples R China; [16]Guangzhou Univ Tradit Chinese Med, Affiliated Hosp 2, Dept Radiol, Guangzhou 510120, Guangdong, Peoples R China
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关键词: clopidogrel aspirin antiplatelet therapy randomized blinded trial sample size power confidence interval

摘要:
Clopidogrel was believed to be superior to aspirin by the well-known CAPRIE trial. However, no other large clinical trials demonstrated the same results, but all focused on the combination use of clopidogrel with aspirin, and combination therapy in CREDO was called the "Emperor's New Clothes". However, no one overturned the results of these clinical trials by quantitatively analyzing them. We reviewed ten large-scale clinical trials about clopidogrel. On the basis of results of CAPRIE, CREDO and CHARISMA trials, we re-estimated their minimal sample sizes and their powers by three well-established statistical methodologies. From the results of CAPRIE, we inferred that the minimal sample size should be 85 086 or 84 968 but its power was only 30.70%. A huge gap existed. The same was also true of CREDO and CHARISMA trials. Moreover, in CAPRIE trial, 0 was included in the 95% confidence interval and 1 was included in the 95% confidence interval for the relative risk. There were some paradoxical data in CAPRIE trial. We are led to conclude that the results in CAPRIE, CREDO, and from the subgroup analysis in CHARISMA trials were questionable. These results failed to demonstrate that clopidogrel was superior to aspirin or that clopidogrel used in combination with aspirin was better than aspirin alone. The cost-effectiveness analyses by some previous studies were not reliable.

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影响因子: 最新[2023版] 最新五年平均 出版当年[2008版] 出版当年五年平均 出版前一年[2007版] 出版后一年[2009版]

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第一作者机构: [1]Huazhong Univ Sci & Technol, Dept Pharmacol, Inst Clin Pharmacol, Tongji Med Coll, Wuhan 430030, Peoples R China;
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通讯机构: [1]Huazhong Univ Sci & Technol, Dept Pharmacol, Inst Clin Pharmacol, Tongji Med Coll, Wuhan 430030, Peoples R China;
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