To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ACR: Celecoxib Safer Than Traditional Analgesics For Chronic Conditions URL: http://www.pslgroup.com/dg/147E26.htm Doctor's Guide November 17, 1999
STANFORD, CA -- November 17, 1999 -- Arthritis sufferers can breathe a sigh of relief now that a comprehensive study has shown that a new, heavily prescribed, anti-inflammatory drug has a low risk of dangerous side effects, say researchers at Stanford University Medical Center. Until recently, patients who were taking standard medications -- such as aspirin, ibuprofen or naproxen -- to control the pain and swelling that accompany arthritis had to endure the possibility that their treatment could make them sicker or in rare cases even kill them. But the new drug reduces the possibility of serious gastrointestinal bleeding that can accompany long-term use of the old standbys. "We've been talking about the risks," said Dr. Gurkirpal Singh. "But now we can tell people about the solution. This is one of the solutions." Singh's research indicates that taking the new drug celecoxib is significantly safer than the traditional treatments for the pain and inflammation that accompany chronic conditions like rheumatoid arthritis and osteoarthritis. The Stanford researchers analyzed the rate of reported side effects in people who received samples or prescriptions for celecoxib from January until June 1999. They analyzed over 280 million patient days -- the equivalent of 280 million people taking the drug for one day. The researchers expressed their findings in "patient days" or "patient years" because the data they used are based on prescriptions, not on individual patients. They concluded that the rate of gastrointestinal bleeding in celecoxib users was no higher than in people taking no drugs at all. Additionally, the Stanford researchers found that patients taking traditional NSAIDs for their pain and inflammation are nearly three times more likely than celecoxib users to suffer a serious bout of stomach bleeding. Singh, a senior research scholar and clinical assistant professor of medicine (immunology and rheumatology) at Stanford, presented the findings in a poster session at the Annual Meeting of the American College of Rheumatology in Boston. The data Singh and his colleagues analyzed showed a complication rate of 0.01 percent per 100 patient years, but they expect the data to reflect a reporting of only 10 to 15 percent of complications, Singh explained. "Our findings are based on a far more conservative assumption of 95 percent underreporting," he said. While the risk associated with occasional use is slight, drugs such as aspirin and other non-steroidal anti-inflammatory drugs (or NSAIDs) can induce ulcers and severe bleeding in the stomach lining when taken over long periods of time. People with chronic conditions such as rheumatoid arthritis increase their cumulative risk with every dose they take. (Acetaminophen, which is not an NSAID, does not have this side effect.) Sometimes these bleeding episodes can be fatal. About 13 of every 1000 rheumatoid arthritis patients who take NSAIDs for one year will have a serious medical complication from the drugs, and about 16,500 NSAID-related deaths occur each year in this country, according to a recent review in the New England Journal of Medicine, co-authored by Singh. The bleeding occurs because the NSAIDs interfere with the synthesis of prostaglandins, chemicals that are responsible for the pain and inflammation that plague arthritis sufferers. Wholesale inhibition of prostaglandin production is a double-edged sword, though, because they are also responsible for maintaining the integrity of the lining of the stomach and intestinal tract. In their absence, the production of the mucous that protects the stomach lining from acidic gastric juices and other harsh chemicals in the digestive system is inhibited, and the tissue is left defenseless. Prostaglandins are made by two enzymes, cyclooxygenase (or cox) 1 and 2. Cox-1 synthesizes prostaglandins in many types of cells, but cox-2 seems to confine its activity primarily to cells that are responding to inflammatory signals -- the type of response that causes arthritis sufferers such pain. Until now, some NSAIDs blocked both cox proteins from doing their jobs, knocking out the troublesome prostaglandins in the joints as well as the ones protecting the lining of the stomach. "There was no joint pain or fever," explained Singh of the traditional treatment "but there were holes in the stomach." Scientists responded by creating a new generation of NSAIDs, including celecoxib, which inhibit only one part of the prostaglandin synthetic pathway the one controlled by cox-2. The researchers anticipated that by leaving the cox-1 pathway intact they could prevent the dangerous bleeding episodes without compromising the drug's effectiveness against arthritis pain. Singh noted that brisk sales of celecoxib illustrate the strong desire for a safe alternative to the older NSAIDs. Prescriptions for the drug recently exceeded 12 million, surpassing sildenafil citrate (Viagra) in first year sales, he said. Other studies have indicated that celecoxib is just as good as traditional NSAIDs in controlling pain and inflammation, Singh added. "It's as effective, but no more effective," said Singh. This distinction is important because the new drugs can cost substantially more than many other NSAIDs. Therefore they may not be a practical choice for every patient. "High risk patients should definitely be taking these drugs," said Singh. "If cost was no consideration, then everyone should be taking them; but these are not inexpensive drugs." --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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