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Ed. Note: The following
is a press release from the National Institutes of Health. December
20, 2004
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.
Information for the public and health professionals will be posted at
http://www.nih.gov/ as soon as
additional data become available.
The NIH comprises the Office of the Director and 27 Institutes and
Centers. The Office of the Director is the central office at NIH, and is
responsible for setting policy for NIH and for planning, managing, and
coordinating the programs and activities of all the NIH components. The
NIH, the Nation's medical research agency, is a component of the U.S.
Department of Health and Human Services.
The NIA is one of 27 Institutes and Centers at the NIH. It leads the
Federal Government effort conducting and supporting research on the
biomedical and social and behavioral aspects of aging and the problems of
older people. For more information on aging-related research and the NIA,
please visit the NIA website at
http://www.nia.nih.gov/. The public may also call for publications
describing these efforts and offering health information for older people
and their families at 1-800-222-2225, the toll free number for the
National Institute on Aging Information Center
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