Clinical research studyCelecoxib Versus Naproxen and Diclofenac in Osteoarthritis Patients: SUCCESS-I Study
Section snippets
Patients
The SUCCESS-1 study was specifically designed with inclusion and exclusion criteria that would yield a study population representative of osteoarthritis patients in community-based, outpatient, clinical practices in each of the participating countries. Eligible patients were aged 18 years or older; had osteoarthritis of the hip, knee, or hand (meeting American College of Rheumatology classification criteria) of at least 6 months duration before randomization; required daily anti-inflammatory
Results
A total of 13 274 patients from 1142 study centers in 39 countries were randomized. Of these patients, 13 194 received at least 1 dose of study medication (intention-to-treat cohort): 4393 celecoxib 100 mg twice daily, 4407 celecoxib 200 mg twice daily, 905 naproxen 500 mg twice daily, and 3489 diclofenac 50 mg twice daily. Geographically, 6511 patients were from Europe and South Africa, 2873 from Latin America, 2736 from the U.S. and Canada, 681 from Asia, and 393 from Australia and New Zealand.
Discussion
We found that celecoxib 100 mg twice daily was comparable to naproxen and diclofenac for relief of the signs and symptoms of osteoarthritis of the knee, hip, or hand. Additionally, celecoxib 100 mg twice daily and 200 mg twice daily were similar in efficacy. We found a significant reduction in serious upper gastrointestinal events in celecoxib-treated patients compared with patients on naproxen or diclofenac.
These results are important considering that differing conclusions with regard to
Acknowledgments
We are indebted to the SUCCESS-1 investigators for their participation in the study, Suzanne P. Boots for her dedication and invaluable assistance in managing the study, and Lorraine R. Baer, PharmD for editorial contributions and assistance in the preparation of the manuscript.
References (40)
- et al.
Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery paina randomized, controlled trial
Clin Ther
(1999) - et al.
Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor
Am J Gastroenterol
(2000) - et al.
Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complicationsrandomised controlled trial
Lancet
(2004) - et al.
Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery
J Thorac Cardiovasc Surg
(2003) - et al.
Comparison of thromboembolic events in patients treated with celecoxib, a cyclooxygenase-2 specific inhibitor, versus ibuprofen or diclofenac
Am J Cardiol
(2002) - et al.
Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib
Am J Cardiol
(2003) - et al.
COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease
Lancet
(2002) - et al.
Sulfone COX-2 inhibitors increase susceptibility of human LDL and plasma to oxidative modificationcomparison to sulfonamide COX-2 inhibitors and NSAIDs
Atherosclerosis
(2004) - et al.
Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs
N Engl J Med
(1999) - et al.
Epidemiology of NSAID-induced GI complications
J Rheumatol
(1999)
Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritissystematic review of randomised controlled trials
BMJ
Efficacy of celecoxib versus ibuprofen in the treatment of acute paina multicenter, double-blind, randomized controlled trial in acute ankle sprain
Am J Orthop
Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugsa 6-week and a 1-year trial in patients with osteoarthritis
Arch Fam Med
A placebo and active comparator-controlled trial of rofecoxib for the treatment of rheumatoid arthritis
Scand J Rheumatol
Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs
JAMA
Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study
JAMA
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis
N Engl J Med
The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis
Arthritis Rheum
Osteoarthritis clinical trialscandidate variables and clinimetric properties
J Rheumatol
Validation study of WOMACa health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee
J Rheumatol
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This study was supported by a grant from Pharmacia Corporation and Pfizer, Inc. The study design as well as data analysis and interpretation were performed by the study design committee, of which the sponsor was a member. The study sponsors were responsible for data collection and management, in collaboration with the authors. Two independent Gastrointestinal Events adjudication committees performed the data analysis and interpretation of gastrointestinal events. The authors had full access to all the data and had final responsibility for data analysis, interpretation, manuscript preparation and the decision to submit for publication.
Conflict of Interest Statement: Gurkirpal Singh received research support from Searle, Pharmacia, Pfizer, Merck, Boehringer Ingelheim, TAP Pharmaceuticals, Wyeth, Altana, Glaxo Smith Kline, Novartis, and Centocor; consultancies, travel grants, speakers bureau from Searle, Pharmacia, Pfizer, Merck and Boehringer Ingelheim. John G. Fort and Carl Wallmark were employees of Pharmacia/Pfizer and own stock in Pfizer, Inc. Jay L. Goldstein: consultancies, honoraria, travel grants, travel expenses, speakers bureau, and research grants from Searle, Pharmacia, Pfizer, TAP Pharmaceuticals, and Astra-Zeneca. Roger A. Levy: Investigator and Speakers bureau (Pfizer, Aventis, Wyeth and Schering-Plough); Advisory board (Pfizer and Novartis). Patrick S. Hanrahan: travel grants from Pfizer. Alfonso E. Bello: former employee of Pharmacia/Pfizer. Lilia Andrade-Ortega: Advisory board (Pfizer); travel grants (Schering Plough). Naurang M. Agrawal: honoraria (Pharmacia and Pfizer); advisory board (Pfizer). Glenn M. Eisen: consultancies and honoraria (Pfizer). William F. Stenson: consultancies (Pharmacia and Pfizer). George Triadafilopoulos: research support from Pfizer, Astra-Zeneca and TAP Pharmaceuticals; consultant to Pfizer, Merck, Boerhinger-Ingelheim, Astra-Zeneca, TAP Pharmaceuticals, Janssen and Wyeth; honoraria and travel support for lectures and meetings from Pfizer, Merck, Boerhinger-Ingelheim, Astra-Zeneca, TAP Pharmaceuticals, Janssen and Wyeth.