NIH stops study due to increased heart attacks, strokes in patients taking naproxen

By Paul Recer
5:16 p.m. December 20, 2004

WASHINGTON - A study testing whether Celebrex or naproxen would
reduce the risk of Alzheimer's disease was halted Monday after
researchers noted an increase in heart attack and stroke among
participants who were taking naproxen, an over-the-counter pain
reliever on the market for nearly 30 years.

Officials at the National Institutes of Health said the study was
stopped after three years when it was noticed that patients taking
naproxen, sold under the brand name Aleve, 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 was associated with an increase in heart
attack risk. Data from the Alzheimer's study, however, did not
indicate an increased risk for heart attack or stroke.

Celebrex and naproxen are both pain relievers commonly used to treat
arthritis. Naproxen has been approved for sale, first as a
prescription and then as an over-the-counter drug, since 1976.

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.

"We agree that this is confusing," she said. The FDA will closely
evaluate the findings from the NIH study, said Kweder, but that no
new regulatory action with naproxen is expected within the next few

She said patients who routinely take naproxen should follow the drug
directions carefully, including the instruction not to take it for
more than 10 days, and to consult a doctor if there continues to be

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 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.

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,
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

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 about 70
patients of the 2,500 suffered stroke or heart attack, including 23
deaths, and that there were about 50 percent more such events in the
naproxen arm of the study than in the placebo division.
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