October 27, 2000

Researchers participate in Celebrex study

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Albert Reynolds, Ph.D., left, and Panos Anastasiadis’, Ph.D., research is featured on the cover of September’s issue of Nature Cell Biology. (photo by Dana Johnson)

Researchers participate in Celebrex study

Two Vanderbilt University Medical Center faculty played instrumental roles in a recent study that found the arthritis drug Celebrex causes significantly fewer ulcers than non-steroidal, anti-inflammatory drugs, including aspirin.

Dr. Theodore Pincus, professor of medicine in rheumatology, and Dr. Glenn Eisen, associate professor of medicine in gastroenterology, served as co-authors of a recent Journal of the American Medical Association article about the Celecoxib Long-term Arthritis Safety Study (CLASS), a double-blind, randomized, placebo controlled trial conducted from September 1998 to March 2000. It enrolled more than 8,000 participants for treatment over six months at 386 clinical sites in the United States and Canada.

Pincus was a member of the study’s safety board, which monitored data for trends that might have suggested the trial may have been harmful to participants. Eisen served on the trial’s GI events board, helping to determine the causes and severity of gastrointestinal symptoms experienced by participants.

Study participants who took Celebrex, a COX-2 inhibitor, experienced fewer symptomatic ulcers and ulcer complications as well as liver and kidney toxicity, even though the drug was given at much higher doses than those clinically indicated.

That’s an important finding, Pincus said. “Most people who are at risk for GI events probably should be treated with a COX-2 inhibitor, either Celebrex or Vioxx (a similar drug).”

COX-2 selective inhibitors block the enzyme involved in inflammation in the joint without blocking the related COX-1 enzyme, which helps protect the lining of the stomach.

Patients who typically are not considered at-risk might also do better on a COX-2 inhibitor, because, Pincus says, although GI events are more likely to occur in people at risk – those older than 75 or who are taking corticosteroids – most of the events occurred in people who didn’t have any risk factors.

Participants who took aspirin with Celebrex did not do as well as those on Celebrex alone, Pincus said. There are no data to show that Celebrex can protect against cardiovascular disease, as does aspirin.

“Overall, Celebrex is just as effective as traditional NSAIDS, but in some people it may not be as effective,” Pincus said. “We’re not all the same and traditional NSAIDS might work best for some. It’s like saying the best thing to have for supper tonight is a T-bone steak. For some people that’d be great. But there are some people who really wouldn’t like that.”

The next step is to see what happens in the large numbers of people who take the drug in clinical practices, Pincus said.