The impact of low-dose aspirin on endoscopic gastric and duodenal ulcer rates in users of a non-selective non-steroidal anti-inflammatory drug or a cyclo-oxygenase-2-selective inhibitor.

Abstract

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.

• Authors: J L Goldstein, S C Lowry, F L Lanza, H I Schwartz, W E Dodge
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 23 Issue 10 Pg. 1489-98 (May 15 2006) ISSN: 0269-2813 [Print] England
• PMID: 16669964 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase 2 Inhibitors
• Pyrazoles
• Sulfonamides
• Naproxen
• Celecoxib
• Aspirin

Topics

• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Aspirin (administration & dosage, adverse effects)
• Celecoxib
• Cyclooxygenase 2 Inhibitors (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Administration Schedule
• Duodenal Ulcer (chemically induced)
• Endoscopy, Gastrointestinal (methods)
• Female
• Humans
• Male
• Middle Aged
• Naproxen (administration & dosage, adverse effects)
• Prospective Studies
• Pyrazoles (administration & dosage, adverse effects)
• Stomach Ulcer (chemically induced)
• Sulfonamides (administration & dosage, adverse effects)
• Treatment Outcome