COX-2 Inhibitors Safer Than NSAIDs
SAN DIEGO, CA -- June 2000 --
The COX-2 inhibitor celecoxib causes significantly fewer
gastrointestinal (GI) events than non-steroidal
anti-inflammatory drugs (NSAIDs) in patients treated for
arthritic pain and inflammation, according to a study
presented at a symposium during
Jay Goldstein, MD, associate professor of medicine at the
University of Illinois at Chicago, said COX-2
have been shown to be as effective -- or more so --
than NSAIDs in managing symptoms of
In a direct comparison that was part of the Celecoxib
Long-term Arthritis Safety Study (CLASS),
patients treated with celecoxib at four times the
highest recommended OA dose over a 13-month study
period were generally free of the side effects that have
long been associated with NSAIDs, Dr.
The study was designed to mirror real-world conditions.
A broad spectrum of patients were enrolled,
including adult patients
of all ages (mean age 60 years; 70 percent were women)
and disease severity,
and patients taking low-dose
aspirin for cardioprotection (21 percent).
The double-blind, parallel, intent-to-treat study followed
8,000 patients -- 5,800 with osteoarthritis (OA)
with rheumatoid arthritis (RA) -- and compared celecoxib
(800 mg daily) to typical daily
doses of ibuprofen (2400 mg daily)
and diclofenac (150 mg daily).
The study demonstrated distinct clinical advantages in using
the COX-2 inhibitor for this patient
Ulcer complications, blood loss and GI symptoms all occurred
less often with celecoxib, he
"The findings are strong and convincing," he added.
In these patients, typically, the incidence of upper GI problems,
such as bleeding and obstruction, after
use of NSAIDs is between one and two percent, he said.
However, with celecoxib, it
was far less than one percent,
resulting in a two-fold reduction compared with standard
"Many physicians feel that patients requiring short-term
administration of traditional NSAIDs are not at
for a serious gastrointestinal event," Dr. Goldstein said.
"These results tell a different story,
many of the events caused by traditional NSAIDs occurred
within the first few
GI bleeding was significantly higher in the groups taking
NSAIDs, although some of the incidence was
due to occult injury,
he noted. In fact, 16 percent of patients on NSAIDs
required diagnostic evaluation
and 3.7 percent needed
a GI work-up. Conversely, 12.6 percent of the
celecoxib users required
diagnostic evaluation and only 2.8 percent
needed a GI work-up. This difference resulted
in a 25
percent decrease in office visits
and associated medical costs.
Additionally, despite the recent controversy regarding COX-2
cardiovascular safety, celecoxib patients
with or without aspirin
showed no increase in cardiovascular events (stroke, MI)
conventional NSAIDs, he added.
At these high doses, celecoxib caused no dose-dependent renal
A separate study that evaluated ulcer formation found that as
many as one in five NSAID users
In contrast, celecoxib can be used at four times the maximum
OA dose -- 400 mg
bid -- without causing observable or perceived
side effects, he said.
The risk for developing ulcer complications for H. pylori
infection also was compared in the CLASS
study. In the celecoxib
group, H. pylori was not a risk, but it was for
the NSAID group.
An assessment of hemoglobin levels among the groups
showed the same kind of trend. A drop in
was associated with NSAID use, but there was
no such association with celecoxib.
The two NSAIDs were linked to changes that, in turn, appeared
to culminate in withdrawal from the
Patients on diclofenac reported substantially more dyspepsia
and lower abdominal pain. Ibuprofen
more commonly associated with treatment failure or
withdrawal due to lack of efficacy.
A literature review of recent studies and anecdotal reports on
concomitant aspirin use and COX-2
show that COX-2 inhibitors are showing the same pattern
among different groups. It is
they may be used in a complementary way as well, Dr. Goldstein said.
This would include
patients who are taking aspirin for cardiac risk,
but who also need the painkilling effects of COX-2
Dr. Goldstein is medical director of clinical resource management
of the University of Illinois Hospital
Clinics in Chicago.
He is a member of the American College of Gastroenterologists
and the American
Society for Gastrointestinal Endoscopy.
Related Link: celecoxib.