Use of NSAIDs suspended in large Alzheimer's prevention trial
The National Institutes of Health (NIH) announced 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 national Alzheimer’s disease prevention trial sponsored by the
National Institute on Aging (NIA), a part of the NIH. The principal
investigator for the study is John Breitner, MD, of the Veterans Affairs
Medical Center Puget Sound and the University of Washington.
The Alzheimer’s Disease Anti-Inflammatory Prevention Trial
(or ADAPT) began in 2001 and was conducted at six sites: Tampa, FL;
Rochester, NY; Sun City, AZ; Baltimore; Seattle; and Boston. It was designed
to assess 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 in
people 70 years of age or older who, while not exhibiting symptoms of the
disease, were considered to be at increased risk because of family history.
Approximately 2,400 volunteers 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 from a National Cancer Institute trial to
test the effectiveness of celecoxib in preventing colon cancer.
Additionally, 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.
The NIH noted that the cancer prevention trials and the ADAPT study were
among the first long-term, clinical trials to test these classes of drugs,
with the compounds being examined for uses very different from those for
which the medications are currently approved.
“This step is being taken as a precautionary measure to
ensure the safety of the study’s participants,” said NIH Director Elias A.
Zerhouni, MD. “The investigators made their decision based on the
risk/benefit analysis specific to this trial,” he added.
In light of the findings, investigators and NIH scientists
have stated they will continue to review this and other NIH-sponsored NSAIDs
studies and that the NIH and the FDA will work together to provide the
public with the information required to make informed health decisions.
SOURCE: NIH, National
Institute on Aging, Media Advisory, Dec. 20, 2004.
