A newer medication used to treat
arthritis appeared to have fewer deleterious side effects than the traditional
therapies studied, according to a study published in the Sept. 13 issue of the
Journal of the American Medical Association (JAMA).
Arthritis -- a chronic, often crippling disease -- is commonly treated
with nonsteroidal anti-inflammatory drugs like ibuprofen. But these
medications are also associated with a multitude of gastrointestinal problems,
from upset stomach to life-threatening bleeding ulcers.
In the study, patients who took the medication Celebrex(R) (celecoxib
capsules), had two- to three-fold fewer serious gastrointestinal
complications-including bleeding ulcers, perforated ulcers and obstructions,
or blockages of the upper gastrointestinal tract-than those who received
ibuprofen or another widely prescribed anti-inflammatory drug called
With Celebrex, the study also found a lower incidence of symptoms like
stomach upset, abdominal pain and nausea.
"This is good news for arthritis patients seeking a safe and effective
option for treating this chronic condition, which requires them to take
medication indefinitely," said Dr. Jay Goldstein, professor of medicine at the
University of Illinois at Chicago, a study author and chair of the
Gastrointestinal Events Committee. "The news is especially significant because
many arthritis patients are unable to use and often have to discontinue
traditional therapies because of gastrointestinal or other side effects."
In this long-term safety study, 8,000 patients received a minimum of
6 months of study medication, comparing four times the recommended dose of
Celebrex for treating osteoarthritis (800 mg daily) to typical daily doses of
ibuprofen (2400 mg) and diclofenac (150 mg).
In addition to the lower incidence of serious gastrointestinal
complications in patients taking Celebrex versus the two other drugs, the
study also reported positive findings in a variety of other safety measures,
including less gastrointestinal blood loss and less renal and liver toxicity.
No difference was noted in the incidence of cardiovascular events between
Celebrex and the traditional anti-inflammatory drugs.
Clinically significant blood loss was reduced by more than two-fold with Celebrex versus the other two therapies. "This finding is important because
chronic gastrointestinal blood loss to this degree often goes undetected and
can result in anemia and may force patients to discontinue treatment," said
Nonsteroidal anti-inflammatory drugs work by blocking an enzyme called cyclo-oxygenase, which exists in the body in two forms, COX-1 and COX-2. COX-1
helps protect the stomach; COX-2 is associated with pain and inflammation.
Celebrex targets only COX-2, thus eliminating inflammation and the pain
associated with it, without blocking the beneficial effects of COX-1 on the
"Compared with traditional nonsteroidal anti-inflammatory agents, Celebrex
has been shown to effectively manage the pain and inflammation of arthritis,
while reducing the potential for ulcer complications and other serious side
effects that can lead to hospitalization and even death," said Dr. Goldstein.
"This is particularly important because 60 to 80 percent of gastrointestinal
complications from nonsteroidal anti-inflammatory drug use occur without
Nonsteroidal anti-inflammatory medications are one of the greatest sources
of serious adverse drug reactions reported to the U.S. Food and Drug
Administration. Gastrointestinal complications from these drugs are estimated
to cause 107,000 hospitalizations and nearly 16,500 deaths each year in the
United States. Up to 30 percent of patients taking traditional nonsteroidal
anti-inflammatory drugs develop persistent gastrointestinal symptoms and more
than 1 in 10 patients discontinue treatment with these drugs because of
undesirable side effects.
According to the Arthritis Foundation, an estimated 43 million Americans
have arthritis. The most common form is osteoarthritis, which affects more
than 21 million people in the United States.
In previous clinical trials, the most common side effects of Celebrex were
dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.
In the present study, patients taking Celebrex had a higher incidence of skin
rash, although none was serious. As with all nonsteroidal anti-inflammatory
drugs, serious gastrointestinal tract ulcerations can occur without warning
Celebrex is co-promoted by Searle, now part of Pharmacia Corporation, and