The American Journal of Medicine
Volume 119, Issue 3 , Pages 255-266, March 2006

Celecoxib Versus Naproxen and Diclofenac in Osteoarthritis Patients: SUCCESS-I Study

  • Gurkirpal Singh, MD

      Affiliations

    • Department of Medicine, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, Calif
    • Corresponding Author InformationRequests for reprints should be addressed to Gurkirpal Singh, MD, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Institute of Clinical Outcomes Research and Education (ICORE), 100 Hamilton Avenue, Suite 225 #22, Palo Alto, CA 94301
    • ,
  • John G. Fort, MD

      Affiliations

    • Pfizer, Inc., Peapack, NJ
    • ,
  • Jay L. Goldstein, MD

      Affiliations

    • Department of Medicine, University of Illinois at Chicago
    • ,
  • Roger A. Levy, MD

      Affiliations

    • Universidade do Estado do Rio de Janeiro, Brazil
    • ,
  • Patrick S. Hanrahan, MD

      Affiliations

    • Sir Charles Gairdner Hospital, Hornsby, Western Australia
    • ,
  • Alfonso E. Bello, MD

      Affiliations

    • Department of Medicine, University of Illinois at Chicago
    • ,
  • Lilia Andrade-Ortega, MD

      Affiliations

    • Rheumatology Department, Centro Medico Nacional 20 de Noviembre ISSSTE, Mexico, Mexico
    • ,
  • Carl Wallemark

      Affiliations

    • Pfizer, Inc., Peapack, NJ
    • ,
  • Naurang M. Agrawal, MD

      Affiliations

    • Department of Medicine, Duke University Medical Center, Durham, NC
    • ,
  • Glenn M. Eisen, MD

      Affiliations

    • Department of Medicine, Oregon Health and Sciences University, Portland
    • ,
  • William F. Stenson, MD

      Affiliations

    • Department of Medicine, Washington University Medical School, St. Louis, Mo
    • ,
  • George Triadafilopoulos, MD

      Affiliations

    • Department of Medicine, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, Calif
    • ,
  • SUCCESS-I Investigators

Abstract 

Purpose

To evaluate the efficacy and upper gastrointestinal (UGI) safety of celecoxib, compared with nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs), among patients with osteoarthritis.

Methods

A total of 13274 osteoarthritis patients from 39 countries were randomly assigned to double-blind 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. Standard validated measures were used to assess osteoarthritis efficacy. Serious UGI events were evaluated by 2 blinded, independent, gastrointestinal events committees.

Results

Results from all primary efficacy assessments showed that both dosages of celecoxib were as effective as NSAIDs in treating osteoarthritis. Significantly more ulcer complications occurred within the nonselective NSAID group (0.8/100 patient-years) compared with the celecoxib group (0.1/100 patient-years) (odds ratio = 7.02; 95% confidence interval [CI], 1.46 to 33.80; P =.008). There were fewer ulcer complications in the celecoxib group compared with the NSAID group, both in patients taking concomitant aspirin and those not taking aspirin, but the difference reached statistical significance only in the latter comparison. The number of cardiovascular thromboembolic events was low and not statistically different between the groups (eg, myocardial infarction rates: celecoxib 10 events [0.55/100 patient-years] vs NSAIDs 1 event [0.11/100 patient-years], (P =.11), but the study was not powered to detect such differences.

Conclusions

In the treatment of osteoarthritis, celecoxib is as effective as the nonspecific NSAIDs naproxen and diclofenac, but has significantly fewer serious upper gastrointestinal events.

Keywords:  Celecoxib , Nonsteroidal anti-inflammatory agents , Osteoarthritis , Gastrointestinal events , Cardiovascular events , Rofecoxib , Naproxen , Diclofenac , NSAID gastropathy

 

 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.

PII: S0002-9343(05)00913-7

doi:10.1016/j.amjmed.2005.09.054

The American Journal of Medicine
Volume 119, Issue 3 , Pages 255-266, March 2006

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