Authors: GOLDSTEIN, J. L.¹; LOWRY, S. C.²; LANZA, F. L.³; SCHWARTZ, H. I.⁴; DODGE, W. E.²

Source: Alimentary Pharmacology & Therapeutics, Volume 23, Number 10, May 2006 , pp. 1489-1498(10)

Publisher: Wiley-Blackwell

Abstract:

Summary Background

The effect of low-dose aspirin on endoscopic ulcer incidence in cyclo-oxygenase-2-selective inhibitor or non-selective non-steroidal anti-inflammatory drug users remains controversial. Aim

To compare prospectively the incidence of endoscopic ulcers in healthy subjects receiving low-dose aspirin plus celecoxib or naproxen. Methods

In this double-blind, placebo-controlled, 1-week study, subjects (50–75 years) were randomized to receive aspirin 325 mg o.d. plus either celecoxib 200 mg o.d., naproxen 500 mg b.d., or placebo. Baseline and end of study endoscopies were performed. The primary end point was incidence of one or more gastric and duodenal ulcers. Results

A lower incidence of gastric and duodenal ulcers was seen in celecoxib/aspirin-treated subjects (19%) vs. naproxen/aspirin (27%; RR: 0.63, 95% CI: 0.44–0.92). Both naproxen/aspirin and celecoxib/aspirin groups demonstrated a higher incidence of gastric and duodenal ulcers vs. placebo/aspirin (8%; RR: 3.7, 95% CI: 1.8–7.6 and RR: 2.6, 95% CI: 1.2–5.8, respectively). Conclusions

Fewer endoscopic ulcers were observed in patients treated with celecoxib/aspirin vs. naproxen/aspirin. However, celecoxib/aspirin was associated with a significantly higher incidence of gastric and duodenal ulcers than aspirin alone. Further studies are required to determine the generalizability of these findings in the aspirin users and to determine the appropriate strategy to minimize risk in susceptible patients.

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2036.2006.02912.x

Affiliations: 1: College of Medicine, University of Illinois at Chicago, Chicago, IL, USA 2: Pfizer Inc., New York, NY, USA 3: Section of Gastroenterology, Baylor College of Medicine, Houston, TX, USA 4: Miami Research Associates, Miami, FL, USA

Publication date: 2006-05-01

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• By this author: GOLDSTEIN, J. L. ;  LOWRY, S. C. ;  LANZA, F. L. ;  SCHWARTZ, H. I. ;  DODGE, W. E.

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