Two popular drugs used primarily to treat arthritis pain 'might increase the risk of a heart attack according to a study published today in the Journal of  the American Medical Associaton.

But experts caution that more studies are needed to determine whether there is indeed a link between cardiovascular problems and Celebrex and Vioxx, two heavily promoted drugs taken by millions of Americans each year.

Researchers at the Cleveland Clinic Foundation analyzed results from previous drug trials to determine whether patients who took the so-called "super aspirins" suffered more heart attacks and other cardiovascular problems than anticipated.

Co-author Dr. Steven E. Nissen, the Cleveland Clinic's vice chairman of the Department of Cardiovascular Medicine' acknowledged the studies are not controlled for such things as age and previous heart attacks.

The trials he and the other researchers retrospectively examined were intended to compare gastro-intestinal risks and not specifically designed to look at heart problems associated with the drugs known as cox-2 inhibitors.

Still, the new findings published in JAMA are suspicious enough to warrant more research. Nissen said.

He and the other authors are calling for a trial into the potential cardiovascular risk associated with Celebrex and Vioxx..

"We've urged both companies to perform such a trial and do it as soon as possible." Nissen said. "Even a modest increase in cardiovascular risk really has major public health implicaiions.

In the meantime. Nissen said doctors should use caution prescribing the drugs for patients with a history of heart problems.

But officials from Pharmacia Corp. and Merck & Co. disputed the validity of the Cleveland Clinic findings. Pharmacia manufactures Celebrex and Merck makes Vioxx.

Dr. Steve Geis, Pharmacia's group director of clinical research. called the JAMA article "grossly inaccurate."

Both companies maintain that extensive studies have not found any link between their drugs and an increased risk of heart attacks.

"We have not seen any signal at all suggesting there could be cardiovascular risk with Celebrex," Geis said.

Since their introduction about two years ago, Celebrex and Vioxx have become among the most popular drugs worldwide for their ability to relieve pain without causing many gastrointestinal problems as aspirin and other medications.

But the Cleveland Clinic researchers found that patients who took Celebrex had a 60 percent higher rate of heart attacks and related problems than a placebo group in an aspirin trial. Likewise, patients who took Vioxx had a 50 percent higher rate than the placebo group.

The analysis also determined that the risk of a heart attack or other serious cardiac event was more than two times greater for patients who took Vioxx than for those who took a traditional non-steroidal anti-inflammatory drug (NSAID) called naproxen.

No significant difference was found in the rate of cardiovascular problems between those who took Celebrex and NSAIDs.

An advisory panel of the U.S. Food and Drug Administration suggested earlier this year that Vioxx carry a warning about potential cardiovascular risks. The FDA has not ruled on the recommendation.

However, it's unclear whether the difference in heart attack rates reflects naproxen's potential ability to decrease blood clots rather than any negative effects from Vioxx, said Dr. Laura Demopoulous, Merck's senior director of cardiovascular clinical research.

Additionally. the Vioxx-NSAID study involved patients with rheumatoid arthritis, an inflammatory disease that can increase the risk for heart problems, she said

"The differences they saw could have been related to differences in risk." she said.

The Cleveland Clinic's Nissen said researchers suspect that cox-2 inhibitors might increase the risk of heart problems by decreasing the body's supply of prostacl yin, a naturally occurring substance that dilates blood vessels and prevents clotting.

More research is needed 10 determine whether combining cox-2 drugs with a daily aspirin. which is known to promote blood vessel dilation and prevent clotting, could reduce the potential risk, he said.

Until more studies are completed, patients should work with their doctors to weigh the benefits and risks of all the available drugs said Tim Brown. a pharmacologist with Akron General Medical Center and West Side Family Practice.

In fact, the older anti-inflammatory drugs are just as effective for many patients, particularly those without a history of gastro-intestinal problems, Brown said.

Regardless, he warned, "People should never just stop either one of these medications without talking to their physicians or pharmacists first."

reprint from Akron Beacon Journal, Wednesday, August 22, 2001

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