Ulcers Less Common with Celecoxib and Rofecoxib Than with Other NSAIDs
The COX-2 inhibitors celecoxib (Celebrex) and rofecoxib (Vioxx) were designed specifically to reduce pain and inflammation without causing the stomach discomfort or ulcers associated with taking other NSAIDs (nonsteroidal anti-inflammatory drugs). But recently, some scientists have criticized claims of reduced ulcer risk. Now, two new studies in the September 21, 2002 BMJ (formerly the British Medical Journal ) report that people taking COX-2 inhibitors do appear to have a lower risk of ulcers than people taking other prescription NSAIDs.
Examples of other prescription NSAIDS include prescription-strength ibuprofen, naproxen (Naprosyn), and diclofenac with misoprostol (Arthrotec).
About the Study
One study was a meta-analysis conducted by researchers from the Institute of Health Sciences in Oxford, England and a researcher from Pfizer (a division of Pharmacia, the company that manufactures celecoxib). These researchers pooled and analyzed data from nine studies comparing celecoxib to placebo (inactive pill) or other NSAIDs for treating osteoarthritis and rheumatoid arthritis. All studies reported safety and effectiveness data and all were felt to be well designed. Using the data from all nine studies, the researchers compared the following results among celecoxib users, other NSAIDs users, and people taking placebo:
- Effectiveness of medication at relieving pain and stiffness and improving physical function
- Number of ulcers, bleeds, and obstructions in the stomach or intestines in each group
- Number of people in each group who dropped out of the studies due to adverse reactions
In the second study, Canadian researchers studied the medical records of over 40,000 adults aged 65 and older taking prescription NSAIDS (including celecoxib and rofecoxib) and 100,000 not taking prescription NSAIDs. The NSAIDs users were people who filled their first NSAID prescription between April 17, 2000 and March 31, 2001. The researchers tracked the participants’ medical records through March 31, 2001. They compared the number of hospitalizations for bleeding ulcers among participants taking celecoxib or rofecoxib, those taking conventional NSAIDs, and those not taking any NSAIDs.
The meta-analysis of nine celecoxib studies found that celecoxib was as effective as other NSAIDS, but significantly more effective than placebo. In addition, people taking celecoxib were 71% less likely to develop an ulcer and 39% less likely to have a bleed or obstruction than those taking other NSAIDs.
The Canadian study reported similar findings. Celecoxib users were no more likely to be hospitalized for a bleeding ulcer than people taking placebo. But users of other NSAIDs were 3 to 4 times more likely to be hospitalized for a bleeding ulcer than celecoxib users. Surprisingly, rofecoxib users were nearly 2 times more likely to be hospitalized for a bleeding ulcer than celecoxib users. However, rofecoxib did not carry as high a risk of ulcer as the other NSAIDS did.
Although these results suggest that celecoxib is the safer pain reliever for arthritis pain, these studies have their limitations. First, because studies are designed differently, meta-analyses lack a certain degree of precision, though they are helpful for drawing general conclusions about overall risk and benefit. Second, neither of these studies involved direct patient interviews to obtain detailed information about other factors that could affect ulcer risk, such as smoking, alcohol use, diet, and proper use of the medication. Third, the Canadian study only assessed hospitalization for bleeding ulcers but not treatment for less serious ulcers and digestive problems, which can also result from taking COX-2 inhibitors.
How Does This Affect You?
Taken together, these two studies suggest that celecoxib and rofecoxib do in fact carry less risk of developing ulcers and their complications than other NSAIDs, and celecoxib carries a lower risk than rofecoxib. The findings also indicate that celecoxib, rofecoxib, and other NSAIDs are all effective at relieving arthritis pain and stiffness.
Does this mean you won’t get an ulcer or other stomach problem if you take celecoxib? Not necessarily. This research simply provides more information about the safety of rofecoxib and celecoxib. It is important to note that since COX-2 inhibitors are considerably more expensive than conventional NSAIDs, it is not feasible to have every arthritis sufferer switch to celecoxib or rofecoxib. The best approach is to determine which patients are most likely to suffer stomach complications from conventional NSAIDs and recommend that they take COX-2 inhibitors.
In an editorial, Dr. Roger Jones of the King’s and Thomas’s School of Medicine in London poses some cautions. First, more research is needed to fully understand the risks and benefits of taking these medications for people who have other medical conditions besides their arthritis. And second, researchers need to follow up on studies suggesting that rofecoxib may increase the risk of cardiovascular problems.
U.S. Food and Drug Administration
National Institute on Aging
Deeks JJ, Smith LA, Bradley MD. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. BMJ. 2002;325:619-623.
Mamdani M, Rochon PA, Juurlink DN, et al. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs. BMJ. 2002;325:624-627.
Jones R. Efficacy and safety of COX 2 inhibitors. BMJ. 2002;325:607-608.
Last reviewed Sep 26, 2002 by ]]>Richard Glickman-Simon, MD]]>
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