麻豆传媒

Generic clopidogrel is just as good as name brand Plavix for acute coronary syndrome patients taking it after discharge, an observational study suggested.

Patients on the generic version were no more likely to at 1 year (17.6% Plavix versus 17.9% generic clopidogrel, HR 1.02, 95% CI 0.96-1.08, P=0.005 for non-inferiority), according to Dennis Ko, MD, of the Institute for Clinical Evaluative Sciences in Toronto, and colleagues.

They said they saw no differences in the incidence of other individual outcomes either (all P-values for non-inferiority):

• Death: 10.5% versus 11.2% (HR 1.07, 95% CI 0.99-1.15, P=0.210)
• All-cause readmission: 39.4% versus 39.8% (HR 1.02, 95% CI 0.97-1.06, P<0.001)
• ACS: 9.7% versus 9.2% (HR 0.94, 95% CI 0.87-1.03, P<0.001)
• Stroke or transient ischemic attack: 1.5% versus 1.4% (HR 0.92, 95% CI 0.74-1.15, P=0.056)
• Bleeding: 2.3% versus 2.7% (HR 1.17, 95% CI 0.99-1.39, P=0.772)

"The lack of outcomes difference between Plavix and clopidogrel was also consistent in subgroups of patients by age, sex, diabetes mellitus, prior stroke, or admission presentation," Ko's group noted in Circulation: Cardiovascular Quality and Outcomes.

A trend of more deaths and recurring ACS was observed, but did not reach statistical significance among those who got coronary stenting.

"These results lend support to healthcare policies that advocated substitution of Plavix with generic clopidogrel to reduce healthcare costs," they concluded.

Their observational study came together from linking several administrative databases. ACS patients hospitalized in Ontario from 2009 to 2014 who received Plavix (n=12,643) or one of 15 generic clopidogrel preparations (n=11,887) were included. Eligible participants had to have survived at least 7 days after discharge.

"Ontario's policy of automatically switching brand-name medications with generic medications afforded a unique opportunity for us to conduct a natural experiment to compare the clinical efficacy and safety of Plavix and generic clopidogrel in a large population of hospitalized patients with ACS," according to Ko's group.

If the patent for clopidogrel hadn't expired in 2012, there would have been over 28 million Plavix tablets dispensed, costing more than Canadian $72.8 million. The actual cost of the drugs: Canadian $19 million.

"Because the Ontario drug formulary only reimburses medications for older patients, savings across the entire ACS population in Ontario would be even greater," the authors said.

Ko's group performed propensity matching to balance treatment groups that started off with the Plavix arm being slightly younger but with a higher comorbidity burden. The overall cohort had an average age 77 and included 57% men. One in five patients had presented with an ST-segment elevation MI.

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