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 (celecoxib capsules), had two- to threefold 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 diclofenac.
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 six 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 twofold 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 Dr. Goldstein.
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 inflammation. Celebrex targets only COX-2, thus reducing inflammation and the pain associated with it, without blocking the beneficial effects of COX-1.
"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 previous symptoms."
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 indigestion, 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 symptoms.
Celebrex is co-promoted by Searle, now part of Pharmacia Corporation, and Pfizer Inc.
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JAMA