Source: DGNews  |  Posted 9 years ago

By Ed Susman

ORLANDO, FL -- May 23, 2003 -- The cyclooxygenase-2 (COX-2) inhibitor valdecoxib was associated with a 41% reduced risk of causing upper gastrointestinal pain than nonsteroidal anti-inflammatory drugs (NSAIDs) in people with rheumatoid arthritis or osteoarthritis.

Jay Goldstein, MD, professor of medicine at the University of Illinois at Chicago presented results of a retrospective analysis here May 20th at Digestive Disease Week 2003.

"Valdecoxib was significantly better tolerated than the most widely used NSAIDs and was associated with a similar risk of developing upper gastrointestinal symptoms as placebo," said Dr. Goldstein. "We determined that risk factors for developing upper gastrointestinal adverse events include younger age, female gender, osteoarthritis diagnosis, history of gastroduodenal ulcer, and history of NSAID-related intolerance."

Dr. Goldstein reported that 4,715 patients were included in the analysis of five 12-week, prospective, randomised, double-blind, parallel-group, placebo-controlled clinical trials which recorded adverse events in studies of the use of valdecoxib in arthritis patients.

In the intent-to-treat population, 973 patients were randomised to placebo; 2,236 were randomised to valdecoxib (10, 20, or 40 mg/day); and 1,185 patients were randomised to an NSAID: naproxen 1,000 mg/day, ibuprofen 2,400 mg/day, or diclofenac sodium 150 mg/day.

"The cumulative incidence of moderate-to-severe upper gastrointestinal adverse events within 12 weeks was 15% among the patients on NSAIDs; 10.5% for patients on placebo, and 9% for patients prescribed valdecoxib," he said.

For the incidence of moderate to severe upper GIevents, that translated into a relative risk reduction of 41% for valdecoxib and 37% for placebo when compared with NSAIDs. Upper GIevents included abdominal pain, dyspepsia and nausea. "Moderate to severe" was defined as limiting the patient