DON’T TAKE PLAVIX (CLOPIDOGREL)--two articles.
In 2006 48 million American’s were taking it daily
Besides going after aspirin,
they sometimes recommend the
use of aspirin in combination with other drugs.
Such often isn’t warranted on the basis of journal articles which have
been shown consistently to have a very significant positive bias (what else
would you expect for research run by market departments). In the landmark study below Plavix
(Clopidogrel) and aspirin failed to be significantly better than aspirin and
placebo (and very likely the combination was worse because of
marketing bias. When reading journal
articles remember that (a) the editors do not see the raw data, and (b) that
the drug companies provide over 90% of the advertising revenue for that
journal. For my library on aspirin: http://healthfully.org/aspirin/index.html
The disconcerting
fact is that the sales persons for Bristol-Myers will be telling receptive
doctors that the combination is better than Plavix alone when the difference is
only insignificant. They will tell these
care givers that they should give Plavix to their patients who are on aspirin
(they won’t tell them that the patient who are on Plavix to add aspirin). Secondly they won’t tell the patient
of the
modest increase in gastrointestinal bleeds (which in other study come out much
higher) or that Plavix greatly increase the risk of a hemorrhagic stroke—which was
conveniently not included in this study.
Generic drug name:
clopidogrel (kloh PID oh grel)
Brand name(s): PLAVIX
(Bristol-Myers Squibb Company)
FAMILY: Adenosine
Diphosphate Blockers, Blood-clotting Inhibitors
Landmark study fails to show
a significant benefit for taking Plavix with Aspirin
http://www.nejm.org/doi/pdf/10.1056/NEJMoa060989
New England Journal of Medicine 3/12/2006 at 354:1706.17
Clopidogrel and Aspirin versus Aspirin Alone
for the Prevention of Atherothrombotic Events
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 {blood clot of a coronary
artery that supplies oxygen to the heart muscle}.
Method:
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.)
COMMENT
BY JK:
Very
likely the results would be
much better if the aspirin given with the placebo was the standard dose of 325
mg. I have strongly recommended this
higher does because of the ability to very significantly reduce cancer risk and
increase cancer survival, which is dose related. The method by which aspirin accomplishes
this is through the body’s mechanism of apoptosis (the destruction of abnormal
cells) which it enhances.
The
difference between the two
groups is a 0.5% lower incidence during the period of the study (28 months) of
major atherothrombotic event. This translates into 1 less atherothrombotic
event for every 200 taking the combination therapy. Moreover in another study there was an
increased major bleeding event (requiring a transfusion of 2 or more pints of
blood) 1% of those on Plavix compared to aspirin alone. SIDE EFFECTS AND COST MAKE IT CLEAR THAT
ASPIRIN ALONE IS THE PREFERRED TREATMENT.
The
marketing department of Bristol-Myers Squibb runs with what every positive crumb they
can find, such as
that in one study Plavix was slightly superior for aspirin for the first 30
day, but not thereafter,
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