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http://www.nytimes.com/2002/12/26/health/26CELE.html

Study Questions Drug as Shield Against Ulcers

By THE ASSOCIATED PRESS

he widely used arthritis drug Celebrex does not protect the stomach from dangerous bleeding ulcers as well as thought, a study suggests.

Celebrex and two similar new anti-inflammatory drugs are heavily advertised as being safer for arthritis patients based on earlier research that found they caused fewer ulcers and other gastrointestinal complications than older anti-inflammatory medicines. Together, the three new drugs have annual sales exceeding $6 billion.

Their safety has been called into question by a study, reported in today's New England Journal of Medicine, that focused on arthritis patients at high risk of recurrent ulcers. It showed that nearly 10 percent each year would develop another bleeding ulcer.

The study found the same for an older anti-inflammatory drug, diclofenac, combined with the ulcer medicine Prilosec, which doctors often give arthritis patients to protect their stomachs. Neither treatment protected as many patients from dangerous kidney complications as past studies had showed, the researchers, in Hong Kong, said.

The Asian researchers and some other experts said the results, while showing that the treatments work the same, indicated that more study was needed on preventing bleeding stomach ulcers in vulnerable older people who for years ease joint pain with nonsteroidal anti-inflammatory drugs.

"I think patients and doctors need to be aware" of a risk of gastrointestinal bleeding and renal toxicity, so high-risk patients should be monitored closely by their doctor, said Dr. John H. Klippel, medical director of the Arthritis Foundation.

A spokesman for the Pharmacia Corporation, which makes Celebrex, said the company interpreted the findings as showing that Celebrex reduced the risk of gastrointestinal complications in high-risk patients.

"It is our feeling that these findings should guide future research in the area," the spokesman, Paul Fitzhenry, said yesterday.

Representatives of AstraZeneca Pharmaceuticals LP, which sells Prilosec, did not return calls.

The study included 287 patients who had a previous bleeding ulcer and so were at high risk of developing another, potentially life-threatening ulcer.

Half took the anti-inflammatory diclofenac together with Prilosec; half received Celebrex. It is one of three brand-name drugs in a newer class called cox-2 inhibitors because they block the cox-2 enzyme. It produces chemicals called prostaglandins that cause pain and inflammation in the stomach as part of the body's repair process.

These drugs, which include Vioxx and Bextra, do not block action of the cox-1 enzyme, which protects the stomach lining. Older anti-inflammatory drugs like diclofenac block both cox enzymes, and so can cause stomach irritation and worsen ulcers.

Complications from taking the older drugs hospitalize about 107,000 Americans, and ulcer complications kill an estimated 16,500 each year.

Of the study patients receiving Celebrex, about 5 percent had recurrent bleeding during the six months of research, compared with about 6.5 percent for those getting diclofenac and Prilosec.

However, that equates to annual rates of about 9 percent and 11 percent, respectively, Dr. David Y. Graham of the Veterans Affairs Medical Center in Houston wrote in an accompanying editorial.

"The results were unexpected: Neither regimen provided a good or even acceptable level of protection from recurrent bleeding," Dr. Graham wrote.

Both treatments did a good job in reducing pain and enabling patients to perform daily activities over the six-month experiment.

But about 25 percent of those in the Celebrex group and 31 percent in the diclofenac/Prilosec group suffered kidney complications, including high blood pressure and swollen ankles; about 6 percent in each group suffered life-threatening kidney failure.

Dr. Klippel said the findings showed that doctors must monitor high-risk patients on these anti-inflammatory drugs for increased pain and bloody stools indicating an ulcer flareup. They should also watch for swelling in the extremities and elevated blood pressure, signs that the kidneys cannot excrete enough fluid.

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