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    New Drug Treats Arthritis, Easy on Stomach

    But Huge Trial Raises Questions Over Value of Prexige

    Pain, Ulcers, and Heart Disease continued...

    But NSAIDs also increase a person's risk of ulcers. Coxibs are specifically designed to have a much lower ulcer risk. How well they do this is a matter of debate -- especially in patients taking low-dose aspirin to prevent heart disease.

    Further complicating the issue is evidence from other coxib trials that the new pain relievers might increase a person's risk of heart disease.

    Study co-leader Michael Doherty, MD, professor of rheumatology at the University of Nottingham in England, says the study turned up interesting data about this. He points out that patients taking naproxen had a lower risk of heart disease than those taking either Prexige or ibuprofen. This, he says, suggests that naproxen has an unsuspected heart benefit, not that Prexige is toxic to the heart.

    He admits more study is needed. Falk argues that the study included too few heart patients to prove that Prexige is safe for the heart. He also says the study offers little new information about patients at high risk of heart disease and/or digestive system complications.

    "We all had great hopes for this coxib class of drugs to eliminate our problems, but they don't," Falk says. "There is a group of people for whom coxib treatment makes sense. ... The million-dollar question is what to do about patients at high risk. These studies don't answer that. We worry about people whose age is over 65. We worry about people with prior ulcers or gastrointestinal complaints. We worry about people on steroids. We worry about people on high doses of NSAIDs or aspirin. All those questions need to be asked."

    Thomas J. Schnitzer, MD, PhD, professor of medicine and assistant dean for clinical research at Northwestern University, is the lead researcher of the paper reporting the study's main findings. He says Falk asks excellent questions but that no single study could answer them all.

    "I believe this study shows that coxibs can prevent meaningful, serious, gastrointestinal events," Schnitzer tells WebMD. "Even to the extent seen here, it has major clinical meaning in high-risk patients. But this study is not directed to answer every question about these patients. If I have a patient on aspirin at relatively high risk of gastrointestinal complications who requires an analgesic agent, I think the choice of a coxib is arguably a better choice based on these data." But he adds that these patients at high risk of developing an ulcer should consider taking a medication to protect their stomach along with their coxib.

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