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COX-2 Inhibitors Safer Than NSAIDs

SAN DIEGO, CA -- June 2000 -- The COX-2 inhibitor celecoxib causes significantly fewer adverse gastrointestinal (GI) events than non-steroidal anti-inflammatory drugs (NSAIDs) in patients treated for arthritic pain and inflammation, according to a study presented at a symposium during Digestive Disease Week.

Jay Goldstein, MD, associate professor of medicine at the University of Illinois at Chicago, said COX-2 inhibitors have been shown to be as effective -- or more so -- than NSAIDs in managing symptoms of arthritis.

In a direct comparison that was part of the Celecoxib Long-term Arthritis Safety Study (CLASS), patients treated with celecoxib at four times the highest recommended OA dose over a 13-month study period were generally free of the side effects that have long been associated with NSAIDs, Dr. Goldstein said.

The study was designed to mirror real-world conditions. A broad spectrum of patients were enrolled, including adult patients of all ages (mean age 60 years; 70 percent were women) and disease severity, and patients taking low-dose aspirin for cardioprotection (21 percent).

The double-blind, parallel, intent-to-treat study followed 8,000 patients -- 5,800 with osteoarthritis (OA) and 2,200 with rheumatoid arthritis (RA) -- and compared celecoxib (800 mg daily) to typical daily doses of ibuprofen (2400 mg daily) and diclofenac (150 mg daily).

The study demonstrated distinct clinical advantages in using the COX-2 inhibitor for this patient population. Ulcer complications, blood loss and GI symptoms all occurred less often with celecoxib, he said. "The findings are strong and convincing," he added. In these patients, typically, the incidence of upper GI problems, such as bleeding and obstruction, after such chronic use of NSAIDs is between one and two percent, he said. However, with celecoxib, it was far less than one percent, resulting in a two-fold reduction compared with standard NSAID users.

"Many physicians feel that patients requiring short-term administration of traditional NSAIDs are not at risk for a serious gastrointestinal event," Dr. Goldstein said. "These results tell a different story, highlighting that many of the events caused by traditional NSAIDs occurred within the first few weeks."

GI bleeding was significantly higher in the groups taking NSAIDs, although some of the incidence was due to occult injury, he noted. In fact, 16 percent of patients on NSAIDs required diagnostic evaluation and 3.7 percent needed a GI work-up. Conversely, 12.6 percent of the celecoxib users required diagnostic evaluation and only 2.8 percent needed a GI work-up. This difference resulted in a 25 percent decrease in office visits and associated medical costs.

Additionally, despite the recent controversy regarding COX-2 cardiovascular safety, celecoxib patients with or without aspirin showed no increase in cardiovascular events (stroke, MI) compared with conventional NSAIDs, he added. At these high doses, celecoxib caused no dose-dependent renal or hepatic toxicity.

A separate study that evaluated ulcer formation found that as many as one in five NSAID users developed ulcers. In contrast, celecoxib can be used at four times the maximum OA dose -- 400 mg bid -- without causing observable or perceived side effects, he said.

The risk for developing ulcer complications for H. pylori infection also was compared in the CLASS study. In the celecoxib group, H. pylori was not a risk, but it was for the NSAID group.

An assessment of hemoglobin levels among the groups showed the same kind of trend. A drop in hemoglobin was associated with NSAID use, but there was no such association with celecoxib.

The two NSAIDs were linked to changes that, in turn, appeared to culminate in withdrawal from the trial. Patients on diclofenac reported substantially more dyspepsia and lower abdominal pain. Ibuprofen was more commonly associated with treatment failure or withdrawal due to lack of efficacy.

A literature review of recent studies and anecdotal reports on concomitant aspirin use and COX-2 inhibitors show that COX-2 inhibitors are showing the same pattern among different groups. It is possible that they may be used in a complementary way as well, Dr. Goldstein said. This would include patients who are taking aspirin for cardiac risk, but who also need the painkilling effects of COX-2 inhibitors.

Dr. Goldstein is medical director of clinical resource management of the University of Illinois Hospital Clinics in Chicago. He is a member of the American College of Gastroenterologists and the American Society for Gastrointestinal Endoscopy. Related Link: celecoxib.

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