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 The alternative COX-2 inhibitors may reduce these adverse events, but some have been withdrawn from the market due to cardiovascular complications and other adverse effects.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.
# # #
Full text of the article mentioned above is available upon request. Contact firstname.lastname@example.org to obtain copies or to schedule an interview.
© 2006 The American Journal of Medicine. All rights reserved. Unauthorized use prohibited.
ABOUT THE AMERICAN JOURNAL OF MEDICINE
The American Journal of Medicine, known as the “Green Journal,” is one of the oldest and most prestigious general internal medicine journals published in the United States. AJM, the official journal of The Association of Professors of Medicine, a group comprised of chairs of departments of internal medicine at 125-plus U.S. medical schools, publishes peer-reviewed, original scientific studies that have direct clinical significance. The information contained in this article in The American Journal of Medicine is not a substitute for medical advice or treatment, and the Journal recommends consultation with your physician or healthcare professional. AJM is published by Elsevier, a leading global publisher of scientific, technical, and medical journals, books, and reference works. It is a member of the Reed Elsevier plc group.
Elsevier is a global information analytics business that helps institutions and professionals advance healthcare, open science, and improve performance for the benefit of humanity. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, more than 35,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a global provider of information and analytics for professionals and business customers across industries. www.elsevier.com
Phone: (212) 633-3944