NEW YORK (Reuters Health) Aug 20 - When patients who routinely
take low-dose aspirin are also treated with a COX-2 selective inhibitor,
the incidence of ulcers increases to a rate comparable to that seen
with nonsteroidal anti-inflammatory drugs, according to a report
in the August issue of Gastroenterology.
Low-dose aspirin alone is generally associated with a significant
risk of serious gastrointestinal side effects, the study found,
and enteric coating does not carry a lower risk for bleeding compared
with plain aspirin.
COX-2 selective inhibitors significantly decrease the risk of gastrointestinal
side effects compared to nonsteroidal anti-inflammatory drugs, according
to a multicenter team led by Dr. Loren Laine of the University of
Southern California School of Medicine in Los Angeles. But until
now, there have been no randomized trials to study the interaction
of low-dose aspirin with COX-2 inhibitors, the team writes.
In the trial the researchers describe this month, 1,615 patients
with osteoarthritis who were at least 50 years old were randomized
to receive either placebo, enteric-coated aspirin in a dose of 81mg/day,
ibuprofen in a dose of 800mg 3 times daily, or a combination of
the low-dose enteric-coated aspirin and rofecoxib, 25mg/day.
After 12 weeks of treatment, the cumulative incidence of ulcers
was 5.8% in the placebo group, 7.3% in the aspirin-alone group,
17.1% in the ibuprofen group, and 16.1% in the combination aspirin/COX-2
group.
In this study, the investigators point out, low-dose aspirin alone
did not significantly increase the risk of ulcers.
Addition of a COX-2 selective inhibitor, however, brought the incidence
of ulcers up "to a rate not significantly less than a nonsteroidal
anti-inflammatory drug alone," the authors said.
None of the patients in the study were taking aspirin for cardiovascular
prophylaxis. Identification of the relative impact of these agents
"on gastrointestinal mucosal injury in patients taking low-dose
aspirin for vascular prophylaxis will require further study,"
the authors conclude.
Gastroenterology 2004;127:395-402.
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