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FRIDAY, Aug. 20 (HealthDayNews) -- A new painkiller, one of the family of COX-2 inhibitors, appears to be as safe as certain other drugs when it comes to cardiac effects.

And it's safer than other drugs that can cause gastrointestinal complications, new research contends.

The drug, lumiracoxib (Prexige), is not yet approved by the U.S. Food and Drug Administration. The new research, which was financed by the drug's maker, Novartis, will form the basis of the claim for approval, said Dr. Michael Farkouh, chairman of the cardiovascular committee of the trial and assistant professor of medicine at New York University School of Medicine.

The report on the trial results appears in the Aug. 21 issue of the journal The Lancet.

Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are widely used to relieve pain but they can have serious side effects, including ulcers. COX-2 inhibitors are a newer class of drugs that seem to relieve pain just as well and seemingly without the side effects. Lumiracoxib is the most selective COX-2 inhibitor, meaning it works on a very specific pathway in the body, limiting ancillary effects. There have been concerns, however, about whether COX-2 inhibitors may increase the incidence of heart attacks.

The new trial, called Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), involved 18,325 patients aged 50 or older, all of whom had osteoarthritis. The participants were randomly chosen to receive either 400 milligrams of lumiracoxib once a day; 500 mg of naproxen (an NSAID with some anti-clotting properties) twice a day; or 800 mg of ibuprofen (an NSAID that is relatively inert) three times a day.

The participants were a "real world sample," Farkouh said, meaning that some had coronary disease.

"If you had a history of heart attack and stroke, you were in the trial as long as they [heart attack or stroke] had not happened within six months," he said. "Fifty percent of the people had hypertension, 20 percent had high cholesterol, 10 percent of people had had an event in the past. We didn't go out and try to find people who had heart disease but we did not exclude them." Some participants were taking low doses of aspirin for its heart-protecting effects.

In the study, the incidence of non-fatal heart attacks, stroke or death related to a cardiovascular incident was not significantly different in the three groups. "The final conclusion is that it's not a significant health problem. The risk of myocardial infarction [heart attack] is not something that would stop us using these drugs," Farkouh said.

There was an 80 percent reduction in the risk of gastrointestinal complications -- such as bleeding, perforation or obstruction -- in the lumiracoxib group versus the other groups. The benefit was canceled out when those patients were also taking aspirin, however.

Farkouh feels the heart-related results will be borne out with other COX-2 inhibitors as well, but that lumiracoxib will have an advantage. "Ours is a newer generation compound and may have unique properties. It has higher selective binding," he said. "I think it will have an edge because it was studied in more patients. This is a landmark trial because of its size. It was a $140 million study but it could lead to a billion dollar drug."

However, Dr. Gary W. Falk, author of an accompanying commentary in the journal, does not think the new drug will offer that much of an advantage.

"The bottom line here is it really doesn't change much," said Falk, who is with the department of gastroenterology and hepatology at the Cleveland Clinic. "It's a very well done study and it basically confirms two things that have been shown by smaller studies -- that compared to regular NSAIDs, this [lumiracoxib] has less adverse GI [gastrointestinal] effects but if you throw aspirin in, the drug loses its benefit."

There are several remaining questions, including whether the drug can be used safely in patients who have had a heart attack or stroke or those who are at high risk for GI troubles. There are also some lingering concerns about liver toxicity, Falk said.

"It's a big, big study. It shows in a much larger sample some of what we've already seen," he said. "But there are still a lot of questions out there."

More information

For more on osteoarthritis, visit the Arthritis Foundation.

(SOURCES: Michael E. Farkouh, M.D., assistant professor of medicine, New York University School of Medicine, New York City; Gary W. Falk, M.D., department of gastroenterology and hepatology, Cleveland Clinic, Ohio; Aug. 21, 2004, The Lancet)

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