ABSTRACT
Background: Dual antiplatelet therapy with clopidogrel plus low-dose aspirin has not been studied in a broad population of patients at high risk for atherothrombotic events.
Methods: We randomly assigned 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin and followed them for a median of 28 months. The primary efficacy end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes.
Results:The rate of the primary efficacy end point was 6.8 percent with clopidogrel plus aspirin and 7.3 percent with placebo plus aspirin (relative risk, 0.93; 95 percent confidence interval, 0.83 to 1.05; P=0.22). The respective rate of the principal secondary efficacy end point, which included hospitalizations for ischemic events, was 16.7 percent and 17.9 percent (relative risk, 0.92; 95 percent confidence interval, 0.86 to 0.995; P=0.04), and the rate of severe bleeding was 1.7 percent and 1.3 percent (relative risk, 1.25; 95 percent confidence interval, 0.97 to 1.61 percent; P=0.09). The rate of the primary end point among patients with multiple risk factors was 6.6 percent with clopidogrel and 5.5 percent with placebo (relative risk, 1.2; 95 percent confidence interval, 0.91 to 1.59; P=0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (3.9 percent vs. 2.2 percent, P=0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo (relative risk, 0.88; 95 percent confidence interval, 0.77 to 0.998; P=0.046).
Conclusions:In this trial, there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes. (ClinicalTrials.gov number, NCT00050817
New England Journal of Medicine; March 26, 2006
Yesterday when I went to the store to pick up my Plavix the cost was $390.00 for three months. I didn’t pick it up. This was shocking; in other years my medical expenses have been so high that the medication was covered; this year I haven’t met the deductible, so I am paying full price. This an absurdly high cost. Big Pharma is making a killing off of this drug. I spent this morning reviewing research on Plavix (www.bestheartsites.com). Still haven’t come to any conclusions about how safe discontinuing is. Part of the problem is that no research has been done for taking Plavix long term (this is my fourth year). And, as this research shows, it is not statistically more useful than aspirin . Hmm.
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Hi Steve
There is one very important line in this study’s abstract that should be highlighted:
“In the subgroup with clinically evident atherothrombosis, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo.”
That’s a statistically significant heart attack risk for those who have already been diagnosed with coronary artery disease and stent(s) implanted (a blockage that’s visible via angiography for example) as opposed to those with just “multiple risk factors” that could include diabetes, obesity, family history. etc.
I don’t think that this study is saying that “it is not statistically more useful than aspirin” – it’s saying that this MAY be true for SOME patients who just have certain risk factors, not a diagnosed cardiac condition.
I suspect that quitting Plavix is not even an option for those patients with implanted stents – at least within the first year – without permission from medical experts! The so-called “stent failure” is an unfortunately common danger for those who stop clopidogrel or other anti-platelet meds. I have met many survivors whose docs have indicated Plavix “for life”.
I cringe when I read studies like this whose headlines seem to suggest one thing (about Plavix being essentially useless as preventive meds in otherwise stent-less people!) yet when you read the fine print, the suggestion FOR US is entirely opposite!
Drug makers, bless their little pointy heads, all offer free or low-cost drugs to those who qualify. Just visit the website for the “Prescription Partnership” links.
Nonsense – the Plavix vs aspirin “non-advantage” has been proven many times. Plavix offers no real difference.
This is kind of like the argument of “well, so you bled to death – at least you didn’t have a stroke” regarding anti-coagulants. (5% possiblity of stoke, but a 6.5 percent of having a major bleeding caused death or Intracerebral Hemorrhage from the meds.