New Drug Treats Arthritis, Easy on Stomach
But Huge Trial Raises Questions Over Value of Prexige
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
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."
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
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.
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
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."
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
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
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
complicating the issue is evidence from other coxib trials that the new pain
relievers might increase a person's risk of heart disease.
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