title: Revaluation of clopidogrel: let the data speak for themselves.
abstract: 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.
authors.affiliation: Institute of Clinical Pharmacology, Department of Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, and Department of Radiology, Renmin Hospital, Wuhan, 430030, China. LLsunrising@126.com
authors.forename: Li
authors.initials: L
authors.lastname: Liu
authors.forename: Fandian
authors.initials: F
authors.lastname: Zeng
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Zeng
authors.forename: Qingmei
authors.initials: Q
authors.lastname: Xue
authors.forename: Shaoping
authors.initials: S
authors.lastname: Nie
authors.forename: Cailian
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authors.lastname: Kang
authors.forename: Jianhong
authors.initials: J
authors.lastname: Wu
authors.forename: Qingyun
authors.initials: Q
authors.lastname: Kang
authors.forename: Xingao
authors.initials: X
authors.lastname: Wang
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Liu
authors.forename: Tao
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authors.lastname: Li
authors.forename: Jun
authors.initials: J
authors.lastname: Chen
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.forename: Rong
authors.initials: R
authors.lastname: Xu
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Yang
authors.forename: Hui
authors.initials: H
authors.lastname: Kang
authors.forename: Fagang
authors.initials: F
authors.lastname: Jiang
authors.forename: Zongtao
authors.initials: Z
authors.lastname: Li
authors.forename: Xuwu
authors.initials: X
authors.lastname: Wang
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Yu
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authors.lastname: Long
mesh_terms: D001157:Arterial Occlusive Diseases / Q000188:drug therapy* / Q000517:prevention & control; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin