Study Questions Effectiveness of Celebrex, 2 Other Arthritis Drugs

The blockbuster arthritis drug Celebrex doesn’t protect the stomach from dangerous bleeding ulcers as well as thought, a study published today 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% each year would develop another bleeding ulcer.

The study, reported in today’s issue of the New England Journal of Medicine, included 287 patients who had a previous bleeding ulcer and so were at very high risk of developing another, potentially life-threatening 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 researchers 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. John 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 Paul Fitzhenry said.

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 stomach lining . 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.