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New Drug Treats Arthritis, Easy on Stomach

But Huge Trial Raises Questions Over Value of Prexige
WebMD Health News

Aug. 19, 2004 -- Prexige, like its sister drugs Bextra, Celebrex, and Vioxx, fights arthritis pain as well as ibuprofen and naproxen, but with less risk of causing stomach ulcers.

That's the news from an 18,000-patient clinical trial comparing Prexige to ibuprofen and naproxen in patients with osteoarthritis. It likely will pave the way for U.S. approval of the newest member of the prescription drug family known as Cox-2 inhibitors. The drugs are also called "coxibs," because their generic names end with "coxib."

Yet the trial results are by no means a total victory either for coxibs in general or for Prexige in particular. As earlier trials show for other coxibs, patients who took Prexige got about the same pain relief as those taking naproxen or ibuprofen, which are sold over-the-counter. Patients on Prexige did have four times fewer ulcer complications than those on naproxen or ibuprofen.

But serious stomach ulcer risk in patients on naproxen or ibuprofen was only 1% over a one-year period. And study participants who took aspirin for heart-disease prevention, as many arthritis patients do, got no significant ulcer protection from Prexige.

"It is not a slam dunk," Michael E. Farkouh, MD, tells WebMD. "[Prexige] is not dropping the risk of ulcers from 20% to 1%, but from 1% to less than that."

"It shows that if you combine a coxib with a low dose of aspirin, the coxib loses its benefit," Gary W. Falk, MD, tells WebMD. "From a clinical point of view, that is a real problem."

The complex study findings appear in two papers and a sharply worded editorial in the Aug. 21 issue of The Lancet. Farkouh, associate director of the cardiovascular clinical research center at New York University, is lead author of a report on the heart disease implications of the study. Falk, director of The Cleveland Clinic's center for swallowing and esophageal disorders, is co-author of the editorial.

Pain, Ulcers, and Heart Disease

Coxibs are pain relievers. They reduce inflammation, the painful reddening and swelling of tissues in response to injury or infection. In this way they act like aspirin, ibuprofen, naproxen, and other nonsteroidal anti-inflammatory drugs, or NSAIDs.

But NSAIDs also increase a person's risk of ulcers. Coxibs are specifically designed to have a much lower ulcer risk. How well they do this is a matter of debate -- especially in patients taking low-dose aspirin to prevent heart disease.

Further complicating the issue is evidence from other coxib trials that the new pain relievers might increase a person's risk of heart disease.

Study co-leader Michael Doherty, MD, professor of rheumatology at the University of Nottingham in England, says the study turned up interesting data about this. He points out that patients taking naproxen had a lower risk of heart disease than those taking either Prexige or ibuprofen. This, he says, suggests that naproxen has an unsuspected heart benefit, not that Prexige is toxic to the heart.

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