Study Questions Celebrex Use For Ulcers

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Study Questions Celebrex Use For Ulcers

December 26, 2002

BOSTON (AP) -- The blockbuster arthritis drug Celebrex doesn't 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.

But their safety has been called into question recently. The new study,

which focused on arthritis patients at high risk of recurrent ulcers,

escalates the controversy involving Celebrex, showing nearly 10 percent each

year would develop another bleeding ulcer.

The study found the same thing for an older anti-inflammatory drug combined

with ulcer medicine Prilosec, which doctors often give arthritis patients to

protect their stomachs. In addition, neither treatment protected as many

patients from dangerous kidney complications as past studies showed, the

researchers said.

The Hong Kong researchers and some other experts said the results, while

showing the treatments work the same, indicate more study is needed on

preventing bleeding stomach ulcers in vulnerable older people who for years

ease joint pain with nonsteroidal anti-inflammatory drugs, or NSAIDs.

" I think patients and doctors need to be aware ... there is a risk of

gastrointestinal bleeding and there is a risk of renal toxicity, " so

high-risk patients should be monitored closely by their doctor, said Dr.

H. Klippel, medical director of the Arthritis Foundation.

A spokesman for Pharmacia Corp., which makes Celebrex, said the company

interprets the findings as showing Celebrex as reducing the risk of

gastrointestinal complications in high-risk patients.

" It is our feeling that these findings should guide future research in the

area, " spokesman Fitzhenry said Wednesday.

Representatives of AstraZeneca Pharmceuticals LP, which sells Prilosec, did

not return calls seeking comment Wednesday.

The study, reported in Thursday's New England Journal of Medicine (news -

web sites), included 287 patients who had a previous bleeding ulcer and so

were at very 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 NSAIDs 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 also include Vioxx and Bextra, do not block action of the

cox-1 enzyme, which protects the lining of the stomach. Older NSAIDs such as

diclofenac block both cox enzymes, and so can cause stomach irritation and

exacerbate ulcers.

Complications from taking older anti-inflammatory 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. 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, " 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.

Klippel said that shows doctors must monitor high-risk patients on these

anti-inflammatory drugs for increased pain and bloody stools indicating an

ulcer flareup. They also should watch for swelling in the extremities and

elevated blood pressure —, signs the kidneys can't excrete enough fluid.

" Physicians should avoid prescribing these drugs to patients with known

kidney diseases, poorly controlled hypertension and heart failure, " said the

lead researcher, Dr. Francis K.L. Chan. " Previous studies reported a very

low incidence of kidney side effects because they excluded patients with

major medical illnesses. "

Still, the study backs up the American College of Rheumatology's current

guidelines for treating arthritis and gives doctors options, said Dr. Todd

Stitik, associate professor of physical medicine and rehabilitation at

University of Medicine and Dentistry of New Jersey in Newark.

For patients whose prescription plan covers the pricey cox-2 inhibitors, one

less pill is more convenient and reduces chances of interactions with their

other medicines, he said. For others, numerous generic anti-inflammatory and

ulcer drugs are available.

Some arthritis patients can limit or avoid pain medications, Stitik noted,

through treatments ranging from stretching and other exercise to weight

loss, hot or cold packs and braces or splints.

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