March 13, 2018
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Brand, generic clopidogrel confer similar outcomes

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Patients with ACS who were prescribed generic clopidogrel had similar rates of death and recurrent hospitalization compared with those prescribed the brand-name version, according to a study published in Circulation: Cardiovascular Quality and Outcomes.

“People can safely use generic clopidogrel,” Dennis T. Ko, MD, MSc, associate professor at the Institute for Clinical Evaluative Sciences in Toronto, said in a press release. “This large and real-world study should be reassuring to physicians and health care organizations who have been concerned about changing what is prescribed.”

In this population-based observational study, researchers analyzed data from 24,530 patients (mean age, 77 years; 57% men) who were hospitalized for ACS between 2009 and 2014 in Ontario, Canada. STEMI occurred in 21% of patients.

Patients were prescribed either brand-name clopidogrel (Plavix, Sanofi-Aventis; n = 12,643) or generic clopidogrel (n = 11,887) within 7 days of discharge from their hospitalization.

The primary outcome was a composite of recurrent hospitalization for ACS and all-cause death within 1 year. Secondary outcomes of interest were all-cause hospitalization, all-cause mortality, stroke or transient ischemic attack, bleeding and ACS.

At 1 year, the primary outcome occurred in 17.6% of patients in the brand-name group and 17.9% in the generic group (HR = 1.02; 95% CI, 0.96-1.08; P for noninferiority = .005).

Significant differences in the brand-name and generic groups were not seen for 1-year mortality (10.5% vs. 11.2%, respectively; HR = 1.07; 95% CI, 0.99-1.15), stroke or TIA hospitalization (1.5% vs. 1.4%; HR = 0.92; 95% CI, 0.74-1.15), bleeding hospitalization (2.3% vs. 2.7%; HR = 1.17; 95% CI, 0.99-1.39), ACS hospitalization (9.7% vs. 9.2%; HR = 0.94; 95% CI, 0.87-1.03) or all-cause hospitalization (41.2% vs. 41.7%; HR = 1.02; 95% CI, 0.98-1.06).

“Given the lack of clinical difference between Plavix and generic clopidogrel, health systems that continue to fund Plavix should consider substituting to the generic formulation to reduce health care resources,” Ko and colleagues wrote. – by Darlene Dobkowski

Disclosures: Ko reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.