Aleve Suspended in Clinical Trial of Elderly Due to Increased Heart Risk

Celebrex also suspended, although no problems seen in this trial

Dec. 21, 2004 – The use of Aleve and Celebrex was suspended yesterday by the National Institutes of Health in a national Alzheimer’s disease prevention trial, which involved senior citizens 70 and older who were considered at increased risk of AD. The researchers say use of Aleve (naproxen) at 220 mg twice a day indicated an “apparent increase in cardiovascular and cerebrovascular events” in the elderly participants. There was no problem found with Celebrex (celecoxib) at 200 mg twice a day, but this drug was suspended due to problems noted in other trials.

The trial, called the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (or ADAPT) is sponsored by the National Institute on Aging and 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 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 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.