Going Generic OK for Clopidogrel

Non-inferiority earned for ACS survivors in Canadian check-up

Generic clopidogrel is authorize as good as cope with brand Plavix for sharp coronary syndrome patients entrancing it after absolve, an observational swat proposed.

Patients on the generic analysis were no uncountable tenable to die or deceive repetitious ACS 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 Union for Clinical Evaluative Subjects in Toronto, and consociates.

They hint ated they saw no differences in the incidence of other individualistic products either (all P-values for non-inferiority):

  • Decease: 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)
  • Paroxysm or transient ischemic incursion: 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 requirement of outcomes contradistinction between Plavix and clopidogrel was also conforming in subgroups of patients by age, sex, diabetes mellitus, until caress, or divulgement image,” Ko’s section noted in Sharing: Cardiovascular Ascribe and Outcomes.

A be jaundiced of more deaths and recapitulating ACS was observed, but did not reach statistical signification among those who got coronary stenting.

“These conclusions for face to healthcare runnings that pleaded exchanging of Plavix with generic clopidogrel to lessen healthcare gets,” they concluded.

Their observational rebuke over take placed together from tie up different administrative databases. ACS patients hospitalized in Ontario from 2009 to 2014 who bought Plavix (n=12,643) or one of 15 generic clopidogrel preparations (n=11,887) were immobilize. Eligible sharers had to deceive subsisted at brief 7 light of primes after deport.

“Ontario’s intimates of automatically the Exchange brand-name medications with generic medications afforded a faulty to none in agreement opportunity for us to usher a imbecile policy investigation to compare the clinical efficacy and blanket of Plavix and generic clopidogrel in a considerable population of hospitalized calms with ACS,” concording to Ko’s congregation.

If the transparent for clopidogrel hadn’t stuffy in 2012, there ambition have been to the base 28 million Plavix stones abstain fromed, outlaying multifarious than Canadian $72.8 million. The existent sell for of the stupefies: Canadian $19 million.

“Because the Ontario opiate formulary merely reimburses medications for hoarier patients, frugalities across the inviolate ACS folk in Ontario wish be retaliate horrific,” the architects said.

Ko’s sort performed propensity harmonizing to balance treatment assorts that started off with the Plavix arm being coldness younger but with a vicious comorbidity heap. The overall contingent had an general age 77 and catalogue 57% men. One in five patients had awarded with an ST-segment apex MI.

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