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- Title
Comparison of Clinical Efficacy and Safety of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients Undergoing Percutaneous Coronary Intervention.
- Authors
Park, Mahn-Won; Jeong, Seung; Her, Sung; Kim, Pum-Joon; Cho, Jung; Kim, Chan; Chung, Wook-Sung; Seung, Ki-Bae; Yim, Hyeon-Woo; Chang, Kiyuk
- Abstract
Objective: A new polymeric salt form of clopidogrel, clopidogrel resinate (CR), is a resinate complex of the (+)-clopidogrel optical isomer wherein the (+)-clopidogrel isomer binds to a water-soluble cation exchange resin via sulfonic acid groups. CR was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available regarding its impact on adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Methods: Clopidogrel bisulfate (CB) was used exclusively from January 2004 through April 2010, after which CR was exclusively administered from May 2010 through September 2011, in 8 centers. We categorized the overall population ( N = 10,487) into two groups according to the prescribed clopidogrel type: CB ( n = 9,127) or CR ( n = 1,360). To minimize the covariate imbalance and confounding in comparing CB and CR, we used a multivariable Cox proportional hazard regression model and the propensity score (PS) method to identify a 1:1 matched cohort ( n = 2,470). We compared cumulative adverse outcomes during a 1-year follow-up after PCI in the overall population and in the PS-matched cohort. Results: In the overall population, there is no difference in the 1-year cumulative event rates between the two groups (CB : CR) : composite of any death, nonfatal myocardial infarction or stroke (6.0 % vs. 6.0 %, adjusted HR, 0.82; 95 % CI, 0.61-1.11, p = 0.57), stent thrombosis (0.4 % vs. 0.2 %; adjusted HR, 0.40; 95 % CI, 0.09-1.72, p = 0.31), and bleeding (0.9 % vs. 0.6 %; adjusted HR, 0.67; 95 % CI, 0.28-1.58, p = 0.22). In the PS-matched cohort, the overall findings were consistent. Conclusions: In this large real-world PCI population, CR was as effective and as safe as CB in preventing adverse clinical outcomes.
- Subjects
CLOPIDOGREL; CARDIOVASCULAR disease treatment; ION exchange resins; PROPORTIONAL hazards models; COHORT analysis; THERAPEUTIC equivalency in drugs
- Publication
Cardiovascular Drugs & Therapy, 2013, Vol 27, Issue 5, p441
- ISSN
0920-3206
- Publication type
Article
- DOI
10.1007/s10557-013-6466-9