million study to prove NSAIDís and Celebrex Safe
December 18, 2005
A Cleveland Clinic
will be in charge of the $100 million international study. Steve Nissen,
a Cleveland cardiologist will head the trial study to determine how safe
Celebrex, a Cox-2 inhibitor and other pain killers are for people with
Vioxx, also a Cox-2 inhibitor, was pulled from the Market and with the
lawsuits that have started with Vioxx, Celebrex sales have slowed more
than 40% plus they also could be entangled in lawsuits since it is also
a cox-2 inhibitor. Pfizerís Celebrex has a required safety warning on
its label now which doesnít give confidence in taking this prescription.
This four year
trial will include 20,000 participants that have had a heart problem
such as a heart attack, blocked arteries, or chronic chest pains,
diabetes, stroke or clogged vessels in the neck or legs. They with
randomly assign medication to the selected participants with one of the
following; Celebrex, Ibuprofen, or Naproxen and will also receive a drug
to prevent and stomach irritation.
"Since so many
arthritis patients are at risk for heart disease, it is critically
important to understand the cardiovascular safety of these drugs,"
Nissen said. "Currently available information is insufficient to
determine whether typical dosages of Celebrex and other popular pain
relievers are linked to an increased risk of heart disease."
One of the reasons
that Nissen was selected is that he served on the FDA panel and asked
for research on the heart risks for Celebrex and Vioxx in a 2001 study
before Vioxx and Bextra where taken of the market.
"The idea here is
if you know what happens in the highest risk individuals, you will know
how to use the drugs in people at lower risk," said Nissen. "We will
have 10 times the statistical power of any study ever done of these
drugs." If Celebrex test well with this study on the worst case
scenario, there will be renewed confiedence in the safety of taking
Cox-2 inhibitors, as well as help Pfizer prevent legal woes like Merckís
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