Nov. 23, 1999 (Seattle) -- Two newly approved arthritis drugs are as effective as traditional medicines but are less likely to cause ulcers, according to a pair of studies in the Nov. 24 issue of the Journal of the American Medical Association. But an accompanying editorial suggests that for many people, the new drugs may not be worth the cost.
"These are good drugs, but they're not necessary for everyone," says Walter Peterson, MD. Peterson is a researcher at the Dallas VA Medical Center, a faculty member at the University of Texas Southwestern Medical Center at Dallas, and one of the authors of the editorial. Peterson tells WebMD, "If you are young and healthy, you're going to pay a lot more without getting much benefit."
He estimates that a typical arthritis patient would spend more than $70 a month for one of the new drugs, compared with less than $10 a month for a generic substitute.
The studies look at the prescription drugs Celebrex (celecoxib) and Vioxx (rofecoxib), both of which have reached the market in the past few months. The drugs were designed to prevent pain and inflammation the same way products such as ibuprofen or aspirin do. Unlike ibuprofen, aspirin, and other nonsteroidal anti-inflammatory drugs (NSAIDs), Celebrex and Vioxx are designed so that they do not cause changes in the lining of the stomach and intestine that can lead to ulcers.
The new studies confirm that the drugs are safe and effective. "They do exactly what they are supposed to do," says Lee Simon, MD, the lead researcher of one of the studies and a faculty member at Harvard Medical School. He tells WebMD, "Every patient who is taking medication for arthritis pain needs to know about these new drugs."
Simon led a team that studied Celebrex, which has become a best-selling product in the U.S. The researchers found that for 1,149 people with rheumatoid arthritis, the drug was as effective as a traditional NSAID at reducing pain and inflammation. But examination of the patients' stomach and upper gastrointestinal tract showed that less than 6% of people taking these newer anti-inflammatory agents had ulcers, compared with 26% of people taking the older NSAIDs. Most of the ulcers were so small, however, that patients were unaware they had them.
The second study, led by a researcher from Birmingham, England, looked at the risk of serious ulcers among people who took Vioxx. To increase accuracy, researchers combined the results of eight studies that included a total of more than 5,000 patients who took Vioxx for arthritis.
The researchers found that people taking Vioxx were about half as likely as those taking a traditional NSAID to have ulcers that perforated the stomach wall, which caused bleeding or pain.
Such a reduction is important, but it appears more dramatic than it really is, says Peterson. He says that's because even among people who take large doses of aspirin or similar NSAIDs every day, dangerous or painful ulcers are very rare.
So Peterson says the new drugs should be reserved for older people or people who have already had an ulcer. "For low-risk patients," he says, "the cost of preventing serious ulcers by using these drugs is very high -- about $400,000 for each complication avoided."
The study involving Celebrex was funded by G.D. Searle & Co., maker of the drug. The research involving Vioxx received funding from its maker, Merck & Co. Inc.
- Two new prescription drugs for treating arthritis, Celebrex and Vioxx, work just as well as older medications but are less likely to cause ulcers.
- The occurrence of dangerous or painful ulcers as a side effect is rare, even among people who take large, daily doses of aspirin or other similar drugs.
- The new arthritis drugs are much more expensive and, according to an editorialist, should be reserved for people at high risk of getting an ulcer.