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Revaluation of clopidogrel: let the data speak for themselves

Authors
  • Liu, Li1
  • Zeng, Fandian1
  • Zeng, Xiaohua2
  • Xue, Qingmei3
  • Nie, Shaoping4
  • Kang, Cailian5
  • Wu, Jianhong1
  • Kang, Qingyun6
  • Wang, Xingao7
  • Liu, Xiaoqing8
  • Li, Tao9
  • Chen, Jun10
  • Li, Qing11
  • Xu, Rong1
  • Yang, Xiaoyan1
  • Kang, Hui12
  • Jiang, Fagang13
  • Li, Zongtao14
  • Wang, Xuwu15
  • Zhang, Li1
  • And 1 more
  • 1 Huazhong University of Science and Technology, Institute of Clinical Pharmacology, Department of Pharmacology, Tongji Medical College, Wuhan, 430030, China , Wuhan (China)
  • 2 Guangzhou Military Command, Department of Radiology, Wuhan General Hospital, Wuhan, 430070, China , Wuhan (China)
  • 3 University of Nanjing, School of Business, Nanjing, 210093, China , Nanjing (China)
  • 4 Beijing Anzhen Hospital, Department of Cardiology, Beijing, 100029, China , Beijing (China)
  • 5 State Food and Drug Administration of China, The Center for Drug Evaluation, Beijing, 100038, China , Beijing (China)
  • 6 Central South University, Department of Neurology, Xiangya Third Hospital, Changsha, 410013, China , Changsha (China)
  • 7 Beijing Tiantan Hospital, Department of Neurology, Beijing, 100050, China , Beijing (China)
  • 8 Capital University of Medical Sciences, Cardiology Center, Chaoyang Hospital, Beijing, 100020, China , Beijing (China)
  • 9 Huazhong University of Science and Technology, Department of Health Toxicology, MOE Key Laboratory of Environmental and Health, Tongji Medical College, Wuhan, 430030, China , Wuhan (China)
  • 10 Renmin Hospital of Wuhan University, Department of Radiology, Wuhan, 430060, China , Wuhan (China)
  • 11 the First Hospital of Shanxi Medical University, Department of Pharmacy, Taiyuan, 030001, China , Taiyuan (China)
  • 12 Guangzhou Military Command, Department of Orthopedics, Wuhan General Hospital, Wuhan, 430070, China , Wuhan (China)
  • 13 Huazhong University of Science and Technology, Department of Ophthalmology, Union Hospital, Tongji Medical College, Wuhan, 430022, China , Wuhan (China)
  • 14 Wuhan University, College of Pharmacy, Wuhan, 430072, China , Wuhan (China)
  • 15 PLA General Hospital, Department of Otorhinolaryngology, Beijing, 100853, China , Beijing (China)
  • 16 The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Department of Radiology, Guangzhou, 510120, China , Guangzhou (China)
Type
Published Article
Journal
Journal of Huazhong University of Science and Technology [Medical Sciences]
Publisher
Huazhong University of Science and Technology
Publication Date
Jun 17, 2010
Volume
30
Issue
3
Pages
299–306
Identifiers
DOI: 10.1007/s11596-010-0346-3
Source
Springer Nature
Keywords
License
Yellow

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.

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