Celebrex is safer than Vioxx, research shows

Study doesn't rule out risk of heart attack with drug

December 07, 2004|By David Kohn | David Kohn,SUN STAFF

Since Vioxx was withdrawn from the market nine weeks ago, patients and doctors have worried that the popular drug Celebrex, a similar anti-inflammatory, might also increase the risk of heart attack. A study released yesterday eased these fears, but researchers said the jury is still out.

In the online Annals of Internal Medicine, scientists reported that patients taking Vioxx were three times as likely to have heart attacks as those on Celebrex.

"There was a difference in risk between Celebrex and Vioxx," said the study's lead author, Dr. Stephen Kimmel, a cardiologist and epidemiologist at the University of Pennsylvania School of Medicine.

The study focused on 1,718 people who had had heart attacks and 6,800 who did not. The researchers asked subjects which drugs they were taking at the time of the attack, and then analyzed this information in the context of their overall health.

Pfizer, which makes Celebrex, praised the study. "The data appears to be consistent with the data amassing demonstrating that Celebrex is safe," said Pfizer spokeswoman Susan Bro.

But Kimmel and others emphasized that Celebrex is not off the hook. The study didn't show whether Celebrex was safe, only that it was safer than Vioxx.

Merck & Co., the maker of Vioxx, withdrew the drug Sept. 30 after studies showed it significantly raised heart attack risk.

Some researchers say the drug may have caused as many as 55,000 unnecessary heart attack deaths during its five years on the market. Critics say the Vioxx case shows that the Food and Drug Administration is not adequately monitoring the safety of the country's prescription drugs.

Both Vioxx and Celebrex are Cox-2 inhibitors, a class of drug that reduces pain and inflammation by blocking cyclooxygenase-2 (Cox-2). When introduced in the late 1990s, the drugs were regarded as a breakthrough, particularly for those with rheumatoid arthritis, because they caused fewer stomach problems than existing anti-inflammatories. But some researchers now worry that all Cox-2 inhibitors may increase heart attack hazards.

Yesterday's report supports a study that appeared last spring, as well as the results from an unpublished article written by an FDA scientist. Both found that Celebrex had a significantly lower heart attack risk than Vioxx.

Even so, Mark Aronson, a general internist at Beth Israel Deaconess Medical Center in Boston, recommended that patients avoid Celebrex until the question of heart attack risk has been settled.

At this point, he said, he prescribes Celebrex only for patients with a high risk of gastrointestinal problems and a low risk of heart attack. For the rest, he uses other anti-inflammatories, including aspirin, Tylenol and naproxen.

He said that more research is needed to nail down the relationship between heart attack and Cox-2 inhibitors. Scientists don't yet have a clear sense of how these drugs affect the heart.

Vioxx - and perhaps some other Cox-2 inhibitors - may cause damage by triggering a complex process that leads to an increase in clots and a hardening of the arteries.

But this theory hasn't been proved yet, Aronson said: "Nobody knows the exact mechanism."

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