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.
基金:
We are indebted to Mr. Xinhui HU at Department of Geotechnical Engineering, Southwest Jiaotong University, Chengdu, China, for his help on the calculation programs. We also thank Prof. Liangping HU, Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Prof. Qijun SHENG in Medical College of Ningbo University, Prof. Ping YIN, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Prof. Cihua LIU, School of Mathematics and Statistics Huazhong University of Science and Technology, Prof. Chuanhua YU, School of Public Health, Wuhan University, and Prof. Hongping YU, Department of Epidemiology and Statistics, School of Public Health,Guangxi Medical University for help in Statistics.
第一作者机构:[1]Huazhong Univ Sci & Technol, Dept Pharmacol, Inst Clin Pharmacol, Tongji Med Coll, Wuhan 430030, Peoples R China;
通讯作者:
通讯机构:[1]Huazhong Univ Sci & Technol, Dept Pharmacol, Inst Clin Pharmacol, Tongji Med Coll, Wuhan 430030, Peoples R China;
推荐引用方式(GB/T 7714):
Liu Li,Zeng Fandian,Zeng Xiaohua,et al.Revaluation of Clopidogrel: Let the Data Speak for Themselves[J].JOURNAL OF HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY-MEDICAL SCIENCES.2010,30(3):299-306.doi:10.1007/s11596-010-0346-3.
APA:
Liu, Li,Zeng, Fandian,Zeng, Xiaohua,Xue, Qingmei,Nie, Shaoping...&Long, Yu.(2010).Revaluation of Clopidogrel: Let the Data Speak for Themselves.JOURNAL OF HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY-MEDICAL SCIENCES,30,(3)
MLA:
Liu, Li,et al."Revaluation of Clopidogrel: Let the Data Speak for Themselves".JOURNAL OF HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY-MEDICAL SCIENCES 30..3(2010):299-306