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New Arthritis Drugs No Magic Bullet Against Bleeding Ulcers

Study finds Celebrex works as well as two-drug treatment, though

THURSDAY, Dec. 26, 2002 (HealthDayNews) -- A one-drug treatment using a newer arthritis medication is as effective as a two-drug combination in preventing the most serious side effect of arthritis treatment. But neither totally eliminates the problem, a study finds.

The specter haunting the millions of Americans who are treated for arthritis with nonsteroidal anti-inflammatory drugs (NSAIDs) is a bleeding ulcer that can be life-threatening. In the United States, an estimated 107,000 patients are hospitalized and 16,500 die each year because of NSAID-related ulcer complications. Gastroenterologists have tried a number of tactics against the problem, but it won't go away.

Now researchers in Hong Kong report that a newer kind of NSAID, called a cox-2 inhibitor, works as well in high-risk arthritis patients -- those who have already experienced bleeding -- as a combination of a conventional NSAID and a different kind of drug, a proton pump inhibitor.

As their name implies, NSAIDs fight arthritis by reducing inflammation. A cox-2 inhibitor does the same thing, but it also prevents formation of a molecule that attacks the lining of the stomach. A proton pump inhibitor reduces the production of stomach acid.

In the new study, a group at the Prince of Wales Hospital in Hong Kong tested the cox-2 inhibitor celecoxib, marketed as Celebrex, and a combination of the NSAID diclofenac (Cataflam or Voltaren) and the proton pump inhibitor omeprazole (Prilosec) on 287 patients who already had experienced ulcer bleeding.

Both treatments reduced, but did not eliminate, recurrent bleeding, says a report in today's issue of the New England Journal of Medicine. The cox-2 inhibitor had a slight advantage that was not statistically significant, with 4.9 percent of patients taking the drug having bleeding, compared to 6.4 percent of those getting combination therapy.

The incidence of kidney problems caused by drug treatment was also lower in those getting Celebrex (24.3 percent) compared to those getting combination therapy (30.8 percent).

"Other trials have shown that the newer drugs are clearly safer than the older drugs," says Dr. David Y. Graham, chief of gastroenterology at the Veterans Administration Medical Center in Houston, and the author of an accompanying editorial in the journal. "The hypothesis was that they were completely safe. They are safer, but not squeaky clean."

While this was "a relatively limited study in high-risk patients," it does show that "one drug can be narrowly better than a combination of these two drugs," says Dr. John G. Fort, vice president of medical affairs at Pharmacia, the company that markets Celebrex.

One-drug treatment does offer practical advantages, Fort says. "You have better patient compliance and a better side effect profile, particularly in a patient population that has accompanying medical conditions," he notes.

Fort and Graham agree that more must be done to solve the problem.

"Reducing the serious side effects associated with NSAIDs is a very important unmet medical need," Fort says.

"What we have been doing is better than nothing, but not much," says Graham. One possible regimen that deserves a trial is the combination of a cox-2 inhibitor with a proton pump inhibitor, he adds.

What To Do

You can learn about the benefits and problems of NSAID treatment of arthritis from the National Institute of Diabetes and Digestive and Kidney Diseases. Also, the Arthritis Foundation has more on the joint disorder.

SOURCES: David Y. Graham, M.D., chief of gastroenterology, Veterans Administration Medical Center, Houston; John G. Fort, M.D., vice president of medical affairs, Pharmacia, Peapack, N.J.; Dec. 26, 2002, New England Journal of Medicine

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