Revaluation of Clopidogrel: Let the Data Speak for Themselves
10.1007/s11596-010-0346-3
- Author:
LIU LI
1
;
ZENG FANDIAN
;
ZENG XIAOHUA
;
XUE QINGMEI
;
NIE SHAOPING
;
KANG CAILIAN
;
WU JIANHONG
;
KANG QINGYUN
;
WANG XINGAO
;
LIU XIAOQING
;
LI TAO
;
CHEN JUN
;
LI QING
;
XU RONG
;
YANG XIAOYAN
;
KANG HUI
;
JIANG FAGANG
;
LI ZONGTAO
;
WANG XUWU
;
ZHANG LI
;
LONG YU
Author Information
1. Institute of Clinical Pharmacology, Department of Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
- Keywords:
clopidogrel;
aspirin;
antiplatelet therapy;
randomized blinded trial;
sample size;
power;
confidence interval
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2010;30(3):299-306
- CountryChina
- Language:Chinese
-
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 combina-tion 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 ana-lyzing 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 pre-vious studies were not reliable.
