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Pfizer $100 million study to prove NSAIDís and Celebrex Safe


December 18, 2005

Pfizer $100 million study to prove NSAIDís and Celebrex Safe

Celebrex Cox-2 Inhibitor

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 heart problems.

Sincer Merkís 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 Vioxx.

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By Nicole Wilson
Best Syndication Staff Writer

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Copyright 2005 Best Syndication                                            Last Updated Saturday, July 10, 2010 09:46 PM