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Studies Confirm Arthritis Drugs Raise Heart Attack Risk

Posted on: Sunday, 23 January 2005, 12:00 CST

WASHINGTON -- Two studies released this week have turned up new evidence that all of the popular arthritis painkillers known as cox- 2 inhibitors may put users at greater risk of heart attacks and strokes.

The first of the two papers published online by the journal Circulation found that patients who had had heart bypass surgery and were taking Pfizer Inc.'s Bextra, in combination with an experimental medication, were three times more likely to have strokes and heart attacks than patients taking a placebo. The statistically significant tripling of the risk showed up when researchers combined the results of two earlier studies involving more than 2,000 people in a statistical technique called a meta- analysis.

A second study found that when mice that are genetically prone to hardening of the arteries were treated with a cox-2 drug and an aspirin substitute, their condition worsened rather than improving, as researchers had anticipated.

Lead researcher Garret FitzGerald of the University of Pennsylvania said the two studies led him to conclude that the entire class of drugs poses a risk. He also said an upcoming clinical trial proposed by Pfizer, the maker of Celebrex, to test whether that drug may help patients with heart disease, should not go forward.

"The clear emergence of a cardiovascular hazard from cox-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill-advised," said FitzGerald, a longtime skeptic of widespread cox-2 use.

A Pfizer spokeswoman said Monday that company officials could not comment because they had not yet seen the studies.

The latest bad news for makers and users of cox-2 drugs comes a month before the Food and Drug Administration is scheduled to hold an unusual three-day hearing, Feb. 16-18, of two advisory panels to consider safety issues that have arisen around the class of drugs.

Planning for the meeting began in the fall after Merck & Co. took its blockbuster cox-2 drug Vioxx off the market after a study it sponsored found heightened cardiovascular risk in volunteers taking the drug. Since then, federal officials have been formally reviewing the risks of using Celebrex in more than 40 federally sponsored studies into other potential uses of the drug. Both Celebrex and Bextra remain on the market, but in increasingly limited use.

cox-2 inhibitors, which are promoted as being less likely to cause gastrointestinal bleeding than other widely used painkillers, were aggressively advertised after they came on the market in the late 1990s.

Source: Tulsa World

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