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Back to Cardiology Articles
Tuesday, 19th October 2004
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The class of drugs known as Cox-2 inhibitors is under scrutiny for increasing
the risk of heart disease and stroke.
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A few weeks after the withdrawal of the popular pain killer,
Vioxx from the market, Bextra is also found to increase the risk
of heart disease.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are a large group of drugs that include aspirin,
ibuprofen, Vioxx, Bextra and Celebrex. However, Vioxx, Bextra
and Celebrex belong to a class of
NSAIDs known as Cox-2 inhibitors, aslo known as second
generation
NSAIDs. All these drugs are effective in relieving arthritis
pain.
They work by reducing substances that cause inflammation,
pain, and fever in the body and is used to treat arthritis,
acute pain in adults, and pain that accompanies menstrual
cycles.
Vioxx and the risk of heart disease
Recently Merck, the company that manufactures Vioxx,
voluntarily withdrew Vioxx from the market after a clinical trial
confirmed that Vioxx increased patients' risk of heart attack
and stroke. Merck made this decision independent of input from
the FDA.
Merck's decision to withdraw Vioxx from the market is based
on new data from a trial called the APPROVe trial. In the
APPROVe trial, Vioxx was compared with placebo. The purpose of
the trial was to see if Vioxx at 25mg was effective in
preventing the recurrence of colon polyps. But the trial was
also designed to look at the drug's long-term safety. This trial
was stopped early because after 18 months on Vioxx, patients'
heart attack and stroke risks doubled from 7.5 out of 1,000 for
patients on placebo to 15 out of 1,000 for patients on Vioxx.
The threat posed by this finding is very serious when one considers that when
patients get into their 60s and 70s, arthritis and heart disease
run together.
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The safety of other Cox-2 inhibitors
Since then, there has been increased attention on Vioxx's
sister drugs, Bextra and Celebrex. Because they have the same
mechanism of action, it was feared that these drugs might also
increase heart risk.
Now Pfizer, which produces the other two drugs, Celebrex and
Bextra, has issued a warning that Bextra may cause rare skin and
heart side effects. To date, there is no evidence that Bextra
increases heart risk in arthritis patients without heart
disease. But studies of Bextra alone or in combination with
parecoxib, together with a study published in 2003, show an
increase in "cardiovascular events" in patients undergoing heart
bypass surgery. Pfizer also warns that Bextra may cause rare but
serious skin reactions more often than other Cox-2 inhibitors.
The risk of these skin reactions, Pfizer says, is greatest
during the first two weeks of Bextra treatment.
So far, there is no hard evidence that Celebrex increases
heart risk. On the contrary with Celebrex there is some evidence
that it is more heart-friendly than Vioxx or Bextra. Celebrex
doesn't raise blood pressure at high doses and there seems to be
no increase in heart disease events from the many studies
conducted.
European regulators said they were launching a
safety investigation into the entire class of Cox-2 inhibitors.
Also, an editorial in the New England Journal of Medicine raised
questions about the safety of these drugs.
Pfizer is currently considering initiating clinical trials to
test the safety of these drugs when used in the long term. In
the mean time, patients currently taking these drugs
should consult their physicians about whether to switch to a
different drug and what the risks of taking these drugs have on
them. If the only thing that works for a particular patient is a
Cox-2 drug, it is probably a good idea for that
patient to keep other risk factors for stroke or heart disease
low.
UPDATE: In December, 2004 the NIH suspended the APC colon
cancer prevention trial when findings suggested Celebrex more
than doubled heart deaths, heart attacks, and strokes in people
enrolled in the study (Full
Story).
References
Topol EJ. Failing the public health -- Rofecoxib, Merck,
and the FDA. N Engl J Med 2004 Oct 21; 351:1707-9.
FitzGerald GA. Coxibs and cardiovascular disease. N
Engl J Med 2004 Oct 21; 351:1709-11.
| Article reviewed by: |
Dr. Tamer Fouad, M.D.
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| Edited
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Dr. Russell Musthafa
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Reviewed
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Dr. Yasser Mokhtar, M.D.
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Theresa Jones (Registered Nurse).
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Carolyn Merritt (Licensed Practical Nurse).
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