Large-Scale Study Demonstrates Celecoxib Safe and Effective Osteoarthritis Treatment with Minimal Gastrointestinal Complications

February 22, 2006 – Arthritis can be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) but the incidence of gastrointestinal problems is significant, resulting in approximately 103,000 hospitalizations and 16,500 deaths per year in the United States. The alternative COX-2 inhibitors may reduce these adverse events, but some have been withdrawn from the market due to cardiovascular complications and other adverse effects. Several questions remain about the safety advantage of COX-2 inhibitors compared with nonspecific NSAIDs.

In a report in the March 2006 issue of The American Journal of Medicine, researchers from eight university and hospital health centers and Pfizer Inc present the results of a large, multinational, “real-world,” controlled clinical trial in patients with osteoarthritis. Over 13,000 patients from 39 countries in six continents were randomly assigned for treatment with either celecoxib 100 mg twice daily (BID), celecoxib 200 mg BID, or nonselective NSAID therapy (diclofenac 50 mg BID or naproxen 500 mg BID) for 12 weeks.

Each patient was seen three times during the study and the efficacy of their treatment was assessed by three separate means. Any possible serious upper gastrointestinal adverse event had to be investigated by two independent committees (both blinded to patient randomization), using two different methodologies and definitions.

Results from all primary efficacy assessments showed that both dosages of celecoxib were as effective as NSAIDs in treating the signs and symptoms of osteoarthritis. The most commonly reported adverse events were abdominal pain and dyspepsia, both of which were experienced by significantly more NSAID patients than celecoxib patients. In addition, serious upper gastrointestinal events, such as gastric or duodenal perforations, gastric outlet obstruction, or upper gastrointestinal bleeding, occurred significantly less often with the celecoxib group than with NSAIDs.

There was no significant difference between celecoxib and the NSAID group in any cardiovascular adverse event rate, with the exception of investigator-reported cardiac failure. The rate of cardiac failure was 0.22/100 patient-years with celecoxib and 1.00/100 patient-years with the NSAID group. The incidence of cerebrovascular disorders was low and statistically similar between the groups. The risk of myocardial infarction (MI) was also low and statistically similar among the treatment groups.

Writing in the article, Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine at Stanford University, concludes, “Our study shows that the COX-2-specific inhibitor celecoxib is as effective as the nonspecific NSAIDs naproxen and diclofenac, but has significantly fewer serious upper gastrointestinal events. The number of cardiovascular thromboembolic events in our study was low and, although numerical differences were noted, these did not reach statistical significance. Because current clinical osteoarthritis treatment guidelines vary in their recommendations regarding the appropriate therapeutic role of COX-2-specific inhibitors, clinicians should consider a number of factors, including the risk for upper gastrointestinal events, duration of therapy, as well as costs, before deciding upon individual patient treatment.”

The article, “Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I study” by Gurkirpal Singh, MD, John G. Fort, MD, Jay L. Goldstein, MD, Roger A. Levy, MD, Patrick S. Hanrahan, MD, Alfonso E. Bello, MD, Lilia Andrade-Ortega, MD, Carl Wallemark, Naurang M. Agrawal, MD, Glenn M. Eisen, MD, William F. Stenson, MD, and George Triadafilopoulos, MD, appears in The American Journal of Medicine, Volume 119, Issue 3 (March 2006), published by Elsevier.

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© 2006 The American Journal of Medicine. All rights reserved. Unauthorized use prohibited.

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