New Painkiller Causes Fewer GI Problems

But it's a cox-2 drug, which have been linked to heart problems, experts note

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HealthDay Reporter

FRIDAY, Feb. 9, 2007 (HealthDay News) -- A new cox-2 painkiller called etoricoxib causes fewer upper gastrointestinal problems than the traditional pain medicine diclofenac, researchers report.

"In the trial, there was a difference in the overall events between the two drugs," said lead researcher Dr. Loren Laine, a professor of medicine at the University of Southern California Keck School of Medicine. "There was not a significant difference seen in the more serious and less common events, like major bleeding. The difference was largely seen in the uncomplicated ulcers, which are symptomatic but not generally life-threatening."

The study is published in the Feb. 10 issue of The Lancet.

Etoricoxib (brand name Arcoxia) is a cox-2 inhibitor that has not been approved for use in the United States yet, although it is being used in Europe. Cox-2 drugs, such as Celebrex, Vioxx and Bextra, were developed to be less damaging to the stomach and intestinal tract. But, several of the cox-2 drugs have been linked to an increased risk of heart attack and stroke. As a result, Vioxx and Bextra were pulled from the market in 2004 and 2005, respectively. Celebrex is the only cox-2 inhibitor available to consumers. Etoricoxib is made by Merck & Co., the maker of Vioxx.

Diclofenac is a nonsteroidal anti-inflammatory (NSAID). NSAIDs such as diclofenac and aspirin are associated with gastrointestinal side effects, such as bleeding ulcers, when taken for an extended period.

In the new study, Laine and his colleagues analyzed data from three clinical trials, in which 34,701 arthritis patients were treated with etoricoxib or diclofenac. The patients were allowed to take additional medications called proton pump inhibitors, like Prilosec, to protect against gastrointestinal problems. In addition, patients with risk factors for heart attacks were allowed to take aspirin, which protects the heart.

The researchers found that upper gastrointestinal problems were significantly less common with etoricoxib than with diclofenac. But, more serious gastrointestinal events, such as major bleeding, were the same in both groups. The effects of etoricoxib or diclofenac did not differ significantly in people using proton pump inhibitors or aspirin.

Laine said all cox-2 inhibitors carry a risk of heart attack and stroke. "One wouldn't expect this one (etoricoxib) to be different," he said. "But it could provide another option for patients."

The new trial was done as part of the U.S. Food and Drug Administration's approval process, Laine noted.

Dr. Joost Drenth, of Radboud University Nijmegen Medical Center, the Netherlands, and author of an accompanying editorial in the journal, said there wasn't enough difference between the drugs in terms of gastrointestinal toxicity to show that etoricoxib was better.

"My advice would be to fall back to the good, old, classic NSAIDs with the addition of a proton pump inhibitor. Because we know adding a proton pump inhibitor to NSAIDs will decrease the incidence of dyspepsia," he said.

Another expert thinks etoricoxib and diclofenac are really two similar drugs, because diclofenac acts very much like a cox-2 inhibitor.

"It's not surprising that you don't see much of a difference when you compare Coke and Pepsi," said Dr. James M. Scheiman, a professor of medicine at the University of Michigan Medical Center.

Scheiman thinks the main concern with cox-2 inhibitors is weighing the cardiac risks with the gastrointestinal risks. "Which drug a patient should take is entirely driven by their underlying cardiac and gastrointestinal risk," he said. "Cox-2 inhibitors have a clear advantage on the gastrointestinal side when compared to drugs that aren't cox-2 inhibitors."

Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine, agreed. "If you have cardiovascular concerns and no gastrointestinal risk, I would avoid the cox-2 inhibitors like the plague," he said.

"If you had a prior ulcer and can't tolerate Tylenol, and are lucky enough not to have any cardiovascular risk, then I would lean toward a cox-2 inhibitor or a traditional NSAID and a proton pump inhibitor," Fendrick said. "If you have both risks, then I would use acetaminophen or low-dose narcotics or a more cardiac safe NSAID, like Naproxen, and a proton pump inhibitor."

More information

For more information on cox-2 inhibitors, visit the U.S. Food and Drug Administration.

SOURCES: Loren Laine, M.D., professor of medicine, University of Southern California Keck School of Medicine, Los Angeles; Joost Drenth, M.D., Radboud University Nijmegen Medical Center, the Netherlands; Mark Fendrick, M.D., professor of internal medicine, University of Michigan School of Medicine, and professor of health management and policy, University of Michigan School of Public Health, Ann Arbor; James M. Scheiman, M.D., professor of medicine, University of Michigan Medical Center, Ann Arbor; Feb. 10, 2007, The Lancet

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