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Data Confirm Gastrointestinal Safety Profile of COX-2 Specific Inhibitor BEXTRA(R) versus Non-Specific Comparator NSAIDs in Arthritis Patients

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Analyses of pooled study results for the COX-2 specific inhibitor BEXTRA(R) (valdecoxib tablets), presented at this year’s annual scientific meeting of the American College of Rheumatology (ACR), underscored its improved upper gastrointestinal (GI) safety as well as its cardiovascular safety profile.

Data were retrospectively analyzed from 10 clinical trials lasting 6 to 26 weeks to determine the frequency with which GI events occurred in osteoarthritis (OA) and rheumatoid arthritis (RA) patients who were treated with BEXTRA and selected non-specific NSAIDs (naproxen, ibuprofen or diclofenac) or placebo. Researchers measured how frequently patients experienced adverse effects on the gastrointestinal system, including stomach ulcer, upset stomach and abdominal pain. The incidence of GI events that occurred with daily dosages of valdecoxib ranging from the recommended dose of 10 mg to 80 mg was compared with the NSAIDs at recommended dosages or with placebo. Researchers classified patients by age group: under 55 years and 55 years or over.

“Among patients in both age groups, we found that GI events occurred at a similar rate in those patients treated with valdecoxib as those treated with placebo, but at a significantly lower rate than that of patients treated with these non-specific NSAIDs,” said researcher Glenn Eisen, M.D., Associate Professor, Gastroenterology Division, Vanderbilt University Medical Center, Nashville, Tennessee. “We concluded that valdecoxib has a superior upper GI safety profile, even among patients under 55 years.”

Comparable Incidence of Thrombotic Events vs. Naproxen and Placebo

Results from a second retrospective analysis were also presented on the incidence of serious thrombotic adverse events among 3,218 RA patients collected from four randomized controlled trials lasting from six weeks to three months, in which recommended and higher than recommended doses of BEXTRA were compared with naproxen 500 mg twice daily and placebo. “Serious thrombotic events” were defined as heart attack, stroke and other blood clotting events.

“Our analysis suggests that valdecoxib shows no greater incidence of cardiovascular events than either naproxen or placebo,” said lead author Andrew Whelton, MD, Adjunct Professor of Medicine, Johns Hopkins University, Baltimore, Maryland. “While more data are necessary to confirm this conclusion, our findings suggest that valdecoxib demonstrates a cardiovascular safety profile similar to that of placebo or naproxen.”

According to Dr. Whelton, “Whether patients were or were not taking aspirin did not significantly impact the incidence of serious adverse events.”

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