FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 347:2104-2110 December 26, 2002 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Graham, D. Y. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Current guidelines recommend that patients at risk for ulcer disease who require treatment for arthritis receive nonsteroidal antiinflammatory drugs (NSAIDs) that are selective for cyclooxygenase-2 or the combination of a nonselective NSAID with a proton-pump inhibitor. We assessed whether celecoxib would be similar to diclofenac plus omeprazole in reducing the risk of recurrent ulcer bleeding in patients at high risk for bleeding.

Methods We studied patients who used NSAIDs for arthritis and who presented with ulcer bleeding. After their ulcers had healed, we randomly assigned patients who were negative for Helicobacter pylori to receive either 200 mg of celecoxib twice daily plus daily placebo or 75 mg of diclofenac twice daily plus 20 mg of omeprazole daily for six months. The end point was recurrent ulcer bleeding.

Results In the intention-to-treat analysis, which included 287 patients (144 receiving celecoxib and 143 receiving diclofenac plus omeprazole), recurrent ulcer bleeding occurred in 7 patients receiving celecoxib and 9 receiving diclofenac plus omeprazole. The probability of recurrent bleeding during the six-month period was 4.9 percent (95 percent confidence interval, 3.1 to 6.7) for patients who received celecoxib and 6.4 percent (95 percent confidence interval, 4.3 to 8.4) for patients who received diclofenac plus omeprazole (difference, –1.5 percentage points; 95 percent confidence interval for the difference, –6.8 to 3.8). Renal adverse events, including hypertension, peripheral edema, and renal failure, occurred in 24.3 percent of the patients receiving celecoxib and 30.8 percent of those receiving diclofenac plus omeprazole.

Conclusions Among patients with a recent history of ulcer bleeding, treatment with celecoxib was as effective as treatment with diclofenac plus omeprazole, with respect to the prevention of recurrent bleeding. Renal toxic effects are common in high-risk patients receiving celecoxib or diclofenac plus omeprazole.

Source Information

From the Department of Medicine and Therapeutics (F.K.L.C., L.C.T.H., J.C.Y.W., A.J.H., W.K.L., V.W.S.W., J.J.Y.S.), the Department of Surgery (B.Y.S., S.C.S.C.), the Department of Pharmacy (K.C.L.), and the Department of Anatomical and Cellular Pathology (K.F.T.), Prince of Wales Hospital, Chinese University of Hong Kong; and the Medical Unit, United Christian Hospital (V.K.S.L.) — all in Hong Kong, China.

Address reprint requests to Dr. Chan at the Department of Medicine and Therapeutics, Prince of Wales Hospital, 30-32 Ngan Shing St., Shatin, Hong Kong, China, or at fklchan{at}cuhk.edu.hk.

Full Text of this Article

Related Letters:

Celecoxib versus Diclofenac and Omeprazole to Prevent Recurrent Ulcer Bleeding
Nurmohamed M. T., Lems W. F., Lanas A., McKeogh D. F., Chan F. K.L., Graham D. Y.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:2464-2466, Jun 12, 2003. Correspondence

This article has been cited by other articles:

• de Carlos, F., Cobo, J., Perillan, C., Garcia, M. A., Arguelles, J., Vijande, M., Costales, M. (2007). Orthodontic tooth movement after different coxib therapies. Eur J Orthod 29: 596-599 [Abstract] [Full Text]  
• Ong, C.K.S., Lirk, P., Tan, C.H., Seymour, R.A. (2007). An Evidence-Based Update on Nonsteroidal Anti-Inflammatory Drugs. Clin Med Res 5: 19-34 [Abstract] [Full Text]  
• Zarraga, I. G. E., Schwarz, E. R. (2007). Coxibs and Heart Disease: What We Have Learned and What Else We Need to Know. J Am Coll Cardiol 49: 1-14 [Abstract] [Full Text]  
• Yazici, Y, Yazici, H (2007). A survey of inclusion of the time element when reporting adverse effects in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor {alpha} inhibitors. Ann Rheum Dis 66: 124-127 [Abstract] [Full Text]  
• Zhang, J., Ding, E. L., Song, Y. (2006). Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials. JAMA 296: 1619-1632 [Abstract] [Full Text]  
• Chaiamnuay, S., Allison, J. J., Curtis, J. R. (2006). Risks versus benefits of cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs.. Am J Health Syst Pharm 63: 1837-1851 [Abstract] [Full Text]  
• Hur, C., Chan, A. T, Tramontano, A. C, Gazelle, G S. (2006). Coxibs Versus Combination NSAID and PPI Therapy for Chronic Pain: An Exploration of the Risks, Benefits, and Costs. The Annals of Pharmacotherapy 40: 1052-1063 [Abstract] [Full Text]  
• Avorn, J. (2006). Evaluating Drug Effects in the Post-Vioxx World: There Must Be a Better Way. Circulation 113: 2173-2176 [Full Text]  
• Adebayo, D, Bjarnason, I (2006). Is non-steroidal anti-inflammaory drug (NSAID) enteropathy clinically more important than NSAID gastropathy?. Postgrad. Med. J. 82: 186-191 [Abstract] [Full Text]  
• Yoong, J. K C (2004). Coxibs and serious adverse cardiovascular events: a class-effect?. JRSM 97: 609-609 [Full Text]  
• Shah, S., Thomas, B. (2004). Nonsteroidal anti-inflammatory analgesics and gastrointestinal protection in palliative care patients. Palliat Med 18: 739-740  
• Greenberger, N. J., Sharma, P. (2004). Update in Gastroenterology and Hepatology. ANN INTERN MED 141: 374-380 [Full Text]  
• Jacobsen, R. B, Phillips, B. B. (2004). Reducing Clinically Significant Gastrointestinal Toxicity Associated with Nonsteroidal Antiinflammatory Drugs. The Annals of Pharmacotherapy 38: 1469-1481 [Abstract] [Full Text]  
• O'Dell, J. R. (2004). Therapeutic Strategies for Rheumatoid Arthritis. NEJM 350: 2591-2602 [Full Text]  
• Dickman, A., Ellershaw, J. (2004). For Discussion NSAIDs: gastroprotection or selective COX-2 inhibitor?. Palliat Med 18: 275-286 [Abstract]  
• Spiegel, B. M.R., Gralnek, I. M. (2004). Cost-Effectiveness of Cyclooxygenase-2 Inhibitors in Chronic Arthritis. ANN INTERN MED 140: 761-762 [Full Text]  
• WARNER, T. D., MITCHELL, J. A. (2004). Cyclooxygenases: new forms, new inhibitors, and lessons from the clinic. FASEB J. 18: 790-804 [Abstract] [Full Text]  
• Mulshine, J. L., Atkinson, J. C., Greer, R. O., Papadimitrakopoulou, V. A., Van Waes, C., Rudy, S., Martin, J. W., Steinberg, S. M., Liewehr, D. J., Avis, I., Linnoila, R. I., Hewitt, S., Lippman, S. M., Frye, R., Cavanaugh, P. F. Jr. (2004). Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia. Clin. Cancer Res. 10: 1565-1573 [Abstract] [Full Text]  
• Stollberger, C., Finsterer, J. (2004). Both Thrombotic and Nonthrombotic Cardiovascular and Cerebrovascular Side Effects of Nonsteroidal Anti-Inflammatory Drugs Should Be Considered. Stroke 35 : e26-e26 [Full Text]  
• (2003). ADDITIONAL ARTICLES ABSTRACTED IN ACP JOURNAL CLUB. Evid. Based Med. 8: 99-99 [Full Text]  
• Nurmohamed, M. T., Lems, W. F., Lanas, A., McKeogh, D. F., Chan, F. K.L., Graham, D. Y. (2003). Celecoxib versus Diclofenac and Omeprazole to Prevent Recurrent Ulcer Bleeding. NEJM 348: 2464-2466 [Full Text]  
• Spiegel, B. M.R., Targownik, L., Dulai, G. S., Gralnek, I. M. (2003). The Cost-Effectiveness of Cyclooxygenase-2 Selective Inhibitors in the Management of Chronic Arthritis. ANN INTERN MED 138: 795-806 [Abstract] [Full Text]  
• (2003). NSAID-Associated Recurrent Ulcer Bleeding: COX-2 Inhibitors vs. Acid Reduction. JWatch Gastroenterology 2003: 5-5 [Full Text]  
• (2003). NSAID or COX-2 Therapy for Patients with Previous Bleeding Ulcers?. JWatch General 2003: 5-5 [Full Text]  
• Graham, D. Y. (2002). NSAIDs, Helicobacter pylori, and Pandora's Box. NEJM 347: 2162-2164 [Full Text]