Merck Withdraws Vioxx Due to Cardiovascular Risk
Not a Complete Surprise to InfoPOEMs Subscribers
Merck &. Co., Inc. recently announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication. The company's decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial.
This news does not come as a complete surprise to the institutional subscribers of InfoPOEMs. In 2001, evidence suggested that the new COX-2 inhibitors, including Vioxx, could increase the risk of a major cardiovascular event. The two InfoPOEMs excerpted below foreshadowed these developments almost three years ago. We're happy to know that our subscribers have been ahead of the curve due to timely exposure to the best evidence-based research available.
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For more information on these developments, see one of the articles covering the story, or refer directly to the announcement from Merck.
Evidence that Matters
In November of 2001, we made our subscribers aware of the potential risks of Vioxx and other COX-2 inhibitors.
COX-2 may increase CV risk
Clinical question
Do selective COX-2 inhibitors, such as Celebrex and Vioxx,
increase the risk of a cardiovascular event?
Bottom line
The new COX-2 inhibitors, rofecoxib (Vioxx)
and celecoxib (Celebrex), may increase the risk of a major
cardiovascular event. Further study needs to be performed to confirm
whether these results are true. With evidence also surfacing that
these drugs may not be as "gentle" on the GI tract as marketing
efforts purport, we need to keep a look out for further research in
this area. (LOE = 2a).
For many, this risk did not outweigh the slight benefit that Vioxx was found to provide over naproxen in a study earlier that year.
Rofecoxib no safer than naproxen in daily use
Clinical question
Is rofecoxib safer than naproxen when used daily, and if so,
how much safer?
Bottom line
For patients who take an anti-inflammatory
every day, the risk of GI events is slightly lower with
rofecoxib. The small absolute reduction in risk has to be balanced
against higher cost and a higher risk of adverse cardiovascular
events. Remember that these patients had rheumatoid arthritis and
were taking the drugs daily - one would have to write a lot of
scripts for Vioxx to the sore weekend warrior to prevent one GI
event, while costing them a lot of money and increasing their risk
of CV events. (LOE =
1b).
And of course these InfoPOEMs are included in one of the seven databases within InfoRetriever, our decision support tool, and are readily available each time a search is performed for information on COX-2 inhibitors, or Stroke, or Vioxx, or ....
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