Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind...

Area of Science:

• Gastroenterology
• Pharmacology

Background:

• Low-dose aspirin is widely used for cardiovascular prevention.
• Gastrointestinal ulcers are a known complication of NSAID use.

Purpose of the Study:

• To assess the ulcer risk associated with low-dose aspirin.
• To evaluate the interaction between low-dose aspirin and a COX-2 selective inhibitor regarding ulcer risk.

Main Methods:

• A double-blind trial compared placebo, low-dose aspirin, rofecoxib + low-dose aspirin, and ibuprofen in osteoarthritis patients.
• Patients were aged 50+ and free of ulcers/erosive esophagitis at baseline.
• Endoscopies were repeated at 6 and 12 weeks.

Main Results:

• The 12-week cumulative ulcer incidence was 5.8% (placebo), 7.3% (aspirin), 16.1% (rofecoxib + aspirin), and 17.1% (ibuprofen).
• The combination of rofecoxib and aspirin, and ibuprofen alone, showed significantly higher ulcer rates than placebo and aspirin alone (P < 0.001).
• Mean increases in erosion numbers were significantly higher with aspirin, rofecoxib + aspirin, and ibuprofen compared to placebo.

Conclusions:

• Low-dose aspirin alone did not significantly increase ulcer incidence.
• Adding a COX-2 selective inhibitor to low-dose aspirin increased ulcer incidence to a rate comparable to nonselective NSAIDs.
• Further research is required to fully understand the gastrointestinal mucosal injury risks of COX-2 inhibitors and NSAIDs in low-dose aspirin users.