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Revaluation of Clopidogrel: Let the Data Speak for Themselves

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机构: [1]Institute of Clinical Pharmacology, Department of Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China [2]Department of Radiology, Wuhan General Hospital, Guangzhou Military Command, Wuhan 430070, China [3]School of Business, University of Nanjing, Nanjing 210093, China [4]Department of Cardiology, Beijing Anzhen Hospital, Beijing 100029, China [5]The Center for Drug Evaluation, State Food and Drug Administration of China, Beijing100038, China [6]Department of Neurology, Xiangya Third Hospital, Central South University, Changsha 410013, China [7]Department of Neurology, Beijing Tiantan Hospital Beijing 100050, China [8]Cardiology Center, Chaoyang Hospital, Capital University of Medical Sciences, Beijing 100020, China [9]Department of Health Toxicology, MOE Key Laboratory of Environmental and Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China [10]Department of Radiology, Renmin Hospital of Wuhan University, Wuhan 430060, China [11]Department of Pharmacy, the First Hospital of Shanxi Medical University, Taiyuan 030001, China [12]Department of Orthopedics, Wuhan General Hospital, Guangzhou Military Command, Wuhan 430070, China [13]Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China [14]College of Pharmacy, Wuhan University, Wuhan 430072, China [15]Department of Otorhinolaryngology, PLA General Hospital, Beijing 100853, China [16]Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou510120, 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]Institute of Clinical Pharmacology, Department of Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
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