Abstract 16378: Clinical Outcomes of Plavix and Generic Clopidogrel for Patients With Hospitalized With an Acute Coronary Syndrome
Background: Clopidogrel is one of the most commonly prescribed cardiac drugs because of its ability to improve clinical outcomes for cardiovascular conditions. After patent protection of Plavix® expired in 2012, many health care systems have adopted generic clopidogrel to reduce costs. However, there are limited data to demonstrate that generic clopidogrel can provide similar safety and effectiveness as compared with Plavix®.
Methods: We conducted a population-based observational study to determine whether generic clopidogrel was noninferior to Plavix® in Ontario, Canada. Patients who were hospitalized with an acute coronary syndrome (ACS) from 2009 to 2014, older than 65 years, survived at least 7 days after discharge, were eligible for inclusion. The noninferiority margin was prespecified as a relative difference of 10% in the hazard of the primary outcome. Inverse probability of treatment weighting using the propensity score was used to account for differences in baseline characteristics between the treatment groups. The primary outcome was a composite of death and recurrent ACS at 1 year. Secondary outcomes included the individual endpoints of death, hospitalization for ACS, stroke or transient ischemic attack, and bleeding.
Results: Our study included 12,643 patients who were prescribed Plavix and 11,887 patients prescribed generic clopidogrel. Their mean age was 77 years, 56% were male and 83% had a myocardial infarction. At 1-year, 17.7% of patients prescribed Plavix experienced the primary outcome as compared with 17.9% of patients prescribed generic clopidogrel (adjusted HR 1.02; 95% CI 0.96-1.08; p=0.005 for non-inferiority). There was no significant difference for 1-year mortality among patients prescribed Plavix at 10.5% vs. generic clopidogrel at 11.2% (HR 1.07; 95% CI 0.99-1.15, P value non-significant for non-inferiority or superiority). Similarly, there were no significant differences in rates of hospitalization for ACS, stroke or transient ischemic attack, and bleeding.
Conclusion: Generic clopidogrel is not inferior to Plavix with respect to the composite endpoint of death and recurrent hospitalization for ACS at 1 year, supporting the automatic substitution policy of Plavix to generic clopidogrel in older ACS patients.
Author Disclosures: D. Ko: None. J. Tu: None. H. Krumholz: Consultant/Advisory Board; Significant; United Health Care. P. Austin: None. T. Stukel: None. A. Chong: None. M. Koh: None. J. de Melo Junior: None. C. Jackevicius: None.
- © 2016 by American Heart Association, Inc.