October 8, 2007. 9:07 a.m.
Celebrex Increases the Risk of Cardiovascular Disease
(Don't Let them Tell You Otherwise).
Tomorrow there will be a hearing in Federal Court in San Francisco ("Pfizer's Risky Legal Bet on Celebrex") where lawyers for Pfizer will argue to have experts for the plaintiff's involved in
cases on Celebrex (celecoxib) and cardiovascular side effects excluded.
Reading their motion to exclude the plaintiff's experts reminds me
of Aristophanes description of Athenian Socratics, that they can take any argument and turn it
around on its head. Their arguments that mechanisms by which COX-2 inhibitors increase
clotting are just a speculation, or that a 2 fold increase in risk doesn't matter,
are patently absurd. In fact there is good evidence in the literature that
Celebrex increases cardiovascular risk.
Vioxx Could Indeed Leave You Skating on Thin Ice
The CLASS study of 2000 looked at one year of treatment with celecoxib (Celebrex),
but only the results found after six months were published. Based on data released to the FDA,
it was later discovered that in the second six months there was an increase in heart attack risk
with Celebrex.
The editor of the journal, Catherine DeAngelis, MD, was understandably perturbed when told
about this after the fact, as she expressed in an editorial in her journal.
APC, published in 2005, a cancer prevention trial, randomized 2035
patients to two doses of celecoxib or placebo. Patients on celecoxib showed a 2.3 fold
increased risk of stroke, heart attack or heart failure with 400 mg of Celebrex a day,
and a 3.4 fold increase with 800 mg of Celebrex a day. There was also a 3-fold
increase in death from heart disease or stroke at the highest dose. This study showed
that there is a dose response effect, i.e. the higher the dose the greater the risk.
Another cancer prevention trial published in 2006 was
PreSAP. In this study 1561 patients who had an adenoma removed
from their colon and were at high risk of recurrence were assigned celecoxib or
placebo for three years. There was a significant reduction in recurrence of polyps
at three years in the celecoxib group versus placebo (34% v 49%). There were 30%
more cardiovascular events with celecoxib, an increase that was not statistically significant.
However there was a significant doubling of cardiovascular
events in patients on celecoxib who were not taking aspirin.
And these drugs are not better than NSAIDs at treating arthritis
pain. Who wants to double their risk of having a heart attack? Not me.
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