Celebrex found no riskier than rival drugs

The drugs seemed miraculous when they were introduced in 1999, and they soon became blockbusters, with billion-dollar sales.

Vioxx, made by Merck, and Celebrex, made by Pfizer, could quell pain and inflammation just as well as drugs such as ibuprofen and naproxen, but they did not cause ulcers and gastrointestinal bleeding.

But then, the shocker. A Merck clinical trial asking if Vioxx could also prevent colon cancer revealed that the drug increased the risk of heart attacks, and the company pulled it off the market in 2004.

Ever since, a question has hung over Celebrex. Did it cause heart attacks, too?

A decade ago, the Food and Drug Administration asked Pfizer to find out.

An estimated 2 million people in the United States take Celebrex or generic celecoxib, said Dr. Milton Pressler, a cardiologist in charge of clinical affairs for Pfizer Essential Health.

The drug is available only by prescription; as the trial dragged on, its patent expired, so now generic companies also sell it.

The study involved 24,000 people with arthritis who were at high risk for heart disease or already had it.

A third of them were randomly assigned to take Celebrex, a third to take naproxen and a third to take ibuprofen.

The doses were equivalent and neither the participants nor the investigators knew who was taking what.

The results were published Sunday online in the New England Journal of Medicine.

The researchers emphasized that the findings only apply to people taking the drugs every day for months or years and who are at high risk for heart disease or already have it.

They do not apply to someone who pops an occasional ibuprofen such as Advil for a pulled muscle or takes a naproxen such as Aleve for a headache.

The study found that, during the trial, 188 of the celecoxib patients (2.3 percent) died of heart disease or hemorrhage, or had a heart attack or a stroke, compared with 201 patients taking naproxen (2.5 percent) and 218 patients (2.7 percent) taking ibuprofen.

The study did have some real weaknesses, said Dr. Elliott M. Antman, a professor of medicine at Harvard Medical School. Only a minority of the patients actually had documented heart disease, and it is those patients who are most worrisome.

Many dropped out, making it hard to interpret the data.