"In the past, physicians have considered ulcerative colitis and Crohn's disease as contraindications for prescribing NSAIDs. These studies represent an important advance for patients with inflammatory bowel disease and their gastroenterologists searching for safe medications to help with pain relief," said Joshua R. Korzenik, MD, author of an accompanying editorial from Massachusetts General Hospital in Boston. "Patients with ulcerative colitis and Crohn's disease can now use COX-2 inhibitors for brief periods of time to relieve pain with the assurance that they are not risking a flare-up of their disease symptoms."
COX-2 Inhibitors Effective in Providing Pain Relief and Avoiding Relapse of IBD
(Prevalence and Mechanism of NSAID-Induced Clinical Relapse in Patients with IBD, Takeuchi et al.)
Patients with IBD often need anti-inflammatory painkillers for peripheral arthritis, back pain, fractures and osteoarthritis. However, some researchers have argued that these painkillers have negative effects on IBD patients in remission. According to a study in this month's issue of Clinical Gastroenterology and Hepatology, patients with IBD who use NSAIDs tolerate the drugs well and less than one in three patients experiences a flare-up in symptoms. Furthermore, the study shows COX-2 inhibitors, previously thought to cause symptom recurrence in IBD patients, significantly reduce the likelihood of disease relapse.
To date, this is the most comprehensive study to address the effects of NSAIDs on disease activity in patients with IBD.
"Our findings suggest that patients with 'silent' inflammatory bowel disease requiring anti-inflammatory drugs tolerate NSAIDs very well, despite the minimal risk for disease relapse," said Ingvar Bjarnason, MD, study author. "If a patient with IBD requires an NSAID for pain relief then these drugs should not be withheld on the belief that they will cause worsening of disease symptoms."
Researchers from Guy's, Kings and St. Thomas' Medical School in London conducted a study that involved 209 patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease) between the ages of 20 and 70 years old who were in full clinical remission for six weeks prior to the start of the study. Patients were given several painkillers, including acetaminophen, naproxen and a COX-2 inhibitor nimesulide for four weeks to determine rate of relapse. This study shows that NSAIDs cause clinical relapse within a few days of ingestion in only 17 to 28 percent of asymptomatic patients with IBD while drugs that were selective for COX-1 and COX-2 were not associated with relapse.
Celecoxib Provides Short-Term Pain Relief to Patients with Ulcerative Colitis in Remission
(Safety of Celecoxib in Patients with Ulcerative Colitis in Remission: A Randomized, Placebo-Controlled Pilot Study, Sandborn et al.)
Another study published in this month's Clinical Gastroenterology and Hepatology addresses the gastrointestinal safety of COX-2 inhibitors in providing pain relief without relapse in IBD patients in remission. Therapy with celecoxib (Celebrex), a COX-2 inhibitor, for up to 14 days did not have a greater relapse rate than placebo in patients with ulcerative colitis in remission with a history of arthritis, arthralgia or other conditions causing them to need pain relievers.
"Previous uncontrolled pilot studies have shown a potential association between COX-2 inhibitors and clinical relapse in patients with ulcerative colitis," said William J. Sandborn, MD, lead study author. "However, the findings of our placebo-controlled study represent the first concrete evidence that short-term therapy with celecoxib does not lead to increased disease relapse in these patients. Additional studies should be conducted in other inflammatory bowel disease patient populations to determine if this class of drugs would be equally as beneficial to the patients."
This multi-center, randomized, double-blind, placebo-controlled pilot trial was conducted by researchers from the Mayo Clinic at 34 centers in the United States, Argentina, Canada, Croatia, Denmark, Russia, Turkey and Sweden between August 2001 and March 2004. The study included 222 patients with ulcerative colitis in remission who were randomized to receive celecoxib (200 mg) or placebo twice daily for 14 days. While these researchers are optimistic about the benefit provided to these patients, they advise physicians to heed the recent findings that COX-2 inhibitors can increase the risk of cardiovascular toxicity.
"While these findings show promise for short-term pain relief in IBD patients in remission, further studies need to be conducted to determine the efficacy for longer durations, in patients with active disease or those already being treated with steroids," said Dr. Korzenik.
Inflammatory bowel disease (IBD) is a term that refers to both ulcerative colitis and Crohn's disease. According to the most recent data from the National Health Interview Survey, there are more than two million prevalent cases of Crohn's disease and more than one million cases of ulcerative colitis in the U.S. Ulcerative colitis, a condition in which the lining of the large intestine becomes inflamed and ulcerated, most commonly affects people between 15 and 40 years of age. Common symptoms include abdominal cramps, bloody diarrhea, fever, weight loss and rectal bleeding. People with chronic, severe ulcerative colitis are at an increased risk of developing colorectal cancer. Crohn's disease causes chronic inflammation of the intestinal wall. While the cause of Crohn's is relatively unknown, it usually starts during the teenage years or early adulthood and is characterized by pain in the abdomen, diarrhea and weight loss.
More information on inflammatory bowel disease is available at www.gastro.org.
About the AGA
The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is the oldest medical-specialty society in the United States. Comprised of two non-profit organizations--the AGA and the AGA Institute--our more than 14,500 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. The AGA, a 501(c6) organization, administers all membership and public policy activities, while the AGA Institute, a 501(c3) organization, runs the organization's practice, research and educational programs. On a monthly basis, the AGA Institute publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The organization's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
About Clinical Gastroenterology and Hepatology
The mission of Clinical Gastroenterology and Hepatology is to provide readers with a broad spectrum of themes in clinical gastroenterology and hepatology. This monthly peer-reviewed journal includes original articles as well as scholarly reviews, with the goal that all articles published will be immediately relevant to the practice of gastroenterology and hepatology. For more information, visit www.cghjournal.org.
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