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Thursday 23rd December, 2004
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Intake of naproxen was found to increase cardiovascular and
cerebrovascular events when compared with those
on placebo.
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The National Institutes of Health (NIH) announced today
that research investigators suspended, until further notice,
the use of two drugs, naproxen (220 mg twice a day) and
celecoxib (200 mg twice a day), in a large, three-arm,
national Alzheimer?s disease prevention trial sponsored by
the National Institute on Aging (NIA), a part of the NIH.
The trial, called the Alzheimer?s Disease Anti-Inflammatory
Prevention Trial (or ADAPT) was designed to assess the potential
benefit of long-term use of non-steroidal anti-inflammatory drugs (NSAIDs)
? naproxen (Aleve?) and the COX-2 inhibitor celecoxib (Celebrex? )
in decreasing the risk of developing Alzheimer?s Disease in people
70 years of age or older who were considered to be at increased risk
because of family history, but did not have symptoms of the disease.
Approximately 2400 volunteer participants were randomly assigned
to receive naproxen, celecoxib, or placebo for periods of time up to
three years. Although no significant increase in risk for celecoxib
was found in this trial, the use of these drugs in the study was
suspended in part because of findings reported last week from a
National Cancer Institute (NCI) trial to test the effectiveness of
celecoxib in preventing colon cancer. In addition, however, data
from the ADAPT trial indicated an apparent increase in
cardiovascular and cerebrovascular events among the participants
taking naproxen when compared with those on placebo.
?This step is being taken as a precautionary measure to ensure
the safety of the study?s participants,? said NIH Director, Elias A.
Zerhouni, M.D. ?The investigators made their decision based on the
risk/benefit analysis specific to this trial,? added Dr. Zerhouni.
The ADAPT trial began in 2001 and was conducted at six sites
across the U.S. ? Tampa, FL; Rochester, NY; Baltimore, MD; Sun City,
AZ; Seattle, WA; and, Boston, MA. The principal investigator for the
study is John Breitner, M.D., of the Veterans Affairs Medical Center
Puget Sound and the University of Washington.
Investigators and NIH scientists will continue to review this and
other NSAIDs studies sponsored by NIH in the light of these
findings. It should be pointed that the cancer prevention trials and
the ADAPT study are among the first long-term, clinical trials to
test these classes of drugs. These studies are examining these
compounds for uses very different from the uses for which these
medications are currently approved. NIH and FDA will work together
to provide the public with information they need to make informed
health decisions.
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