Heart Risk Seen In Aleve Study
Study Dropped After Three Years
Dec 21, 2004 6:24 pm US/Eastern
WASHINGTON (CBS) Now there are questions about the over-the-counter pain reliever naproxen, commonly known under the brand name Aleve and in use for 28 years.
They were raised by a large Alzheimer's study, which has since been suspended.
Researchers found there were more heart attacks and strokes among patients taking naproxen.
The study, involving some 2,500 patients, was to test whether naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease among healthy elderly patients who were at an increased risk of the disease.
Officials at the said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of cardiovascular events — heart attack or stroke — than patients taking placebo.
Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug were associated with an increase in heart attack risk. Preliminary data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke for Celebrex, officials said.
Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class — COX2 enzyme inhibitors — as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke.
The FDA plans a meeting in February to get to bottom of the COX2 problem, reports CBS News Medical Correspondent Dr. Elizabeth Kaledin. The hope is the public will soon have an answer whether these drugs do more harm than good.
"What this kind of information does is kind of raise a flag that says be careful with drugs," Stuart Schweitzer, a professor of health services at UCLA and a specialist in pharmaceutical policy, told CBS Radio News. "There aren't any completely innocuous drugs.
"It appears to be getting more and more difficult to find really safe drugs for common diseases," Schweitzer said.
Dr. Sandra Kweder of the Food and Drug Administration said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke and that the findings are "confusing." No immediate action, however, is expected toward naproxen, she said.
"We are not contemplating any specific regulatory action over the next few days," said Kweder. "We will be working with the NIH to try to understand the data better and determine what will be appropriate from there."
She said patients who routinely take naproxen should follow the drug package instructions carefully, including the directions to not take it for more than 10 days, and to consult a doctor if pain persists.
"If a patient needs a drug and derives a lot of benefit from it, and if the absolute risk of this side effect is still small, then the advice probably should be to continue using that drug," said Schweitzer.
Otherwise, "I guess we go back to aspirin, and there the problem is that some patients do have a gastric, a stomach reaction," he added.
In the earlier studies of the COX2 drugs, an increase in cardiovascular events was noted only after a long-term use of the medications.
The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or a placebo.
The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking, or if they were taking a placebo.
The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's or cognitive decline, but will not be given the test drugs.
Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study.
He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex.
Suspending the study, Zerhouni said, "is the prudent thing to do."
John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said.
"With Naproxen, we've been doing very large clinical trials, and large clinical trials tend to uncover side effects that were there all along, but we didn't notice them," said Schweitzer. |
