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Previous Volume 352:238-244 January 20, 2005 Number 3 Next

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

ABSTRACT

Background Concurrent therapy with a proton-pump inhibitor is a standard treatment for patients receiving aspirin who are at risk for ulcer. Current U.S. guidelines also recommend clopidrogel for patients who have major gastrointestinal intolerance of aspirin. We compared clopidogrel with aspirin plus esomeprazole for the prevention of recurrent bleeding from ulcers in high-risk patients.

Methods We studied patients who took aspirin to prevent vascular diseases and who presented with ulcer bleeding. After the ulcers had healed, we randomly assigned patients who were negative for Helicobacter pylori to receive either 75 mg of clopidogrel daily plus esomeprazole placebo twice daily or 80 mg of aspirin daily plus 20 mg of esomeprazole twice daily for 12 months. The end point was recurrent ulcer bleeding.

Results We enrolled 320 patients (161 patients assigned to receive clopidogrel and 159 to receive aspirin plus esomeprazole). Recurrent ulcer bleeding occurred in 13 patients receiving clopidogrel and 1 receiving aspirin plus esomeprazole. The cumulative incidence of recurrent bleeding during the 12-month period was 8.6 percent (95 percent confidence interval, 4.1 to 13.1 percent) among patients who received clopidogrel and 0.7 percent (95 percent confidence interval, 0 to 2.0 percent) among those who received aspirin plus esomeprazole (difference, 7.9 percentage points; 95 percent confidence interval for the difference, 3.4 to 12.4; P=0.001).

Conclusions Among patients with a history of aspirin-induced ulcer bleeding whose ulcers had healed before they received the study treatment, aspirin plus esomeprazole was superior to clopidogrel in the prevention of recurrent ulcer bleeding. Our finding does not support the current recommendation that patients with major gastrointestinal intolerance of aspirin be given clopidogrel.

Source Information

From the Departments of Medicine and Therapeutics (F.K.L.C., J.Y.L.C., L.C.T.H., V.W.S.W., A.J.H., J.C.Y.W., W.K.L., Y.T.L., H.L.Y.C., J.J.Y.S.), the School of Pharmacy (V.W.Y.L., K.K.C.L.), and the Departments of Surgery (J.Y.W.L., S.C.S.C.) and 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., N.N.S.K.) — all in Hong Kong.

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

Full Text of this Article

Related Letters:

Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Bleeding
Wolk M. J., Jacobs A. K., Wargo K. A., Baty S. R., Knowles G., Barski P. R. Jr., Chan F. K.L., the Gastrointestinal Research Group
Extract | Full Text | PDF  
N Engl J Med 2005; 352:1716-1718, Apr 21, 2005. Correspondence

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