Healthy Skepticism Library item: 1266

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Publication type: news

Duenwald M.
Study Says Drug Group Can't Help Alzheimer's
The New York Times 2003 Jun 4
http://www.nytimes.com/2003/06/04/us/study-says-drug-group-can-t-help-alzheimer-s.html

Full text:

Anti-inflammatory drugs do not live up to their promise as a treatment for Alzheimer’s disease, a study being published today finds.

Patients with mild-to-moderate Alzheimer’s who took the over-the-counter drug naproxen, whose brand name is Aleve, or the prescription drug rofecoxib, under the Vioxx brand, for one year saw their symptoms continue to progress at the same rate as patients who took placebo pills.

“I was disappointed,” said Dr. Paul S. Aisen of the Georgetown University Medical Center in Washington, leader of the study, in The Journal of the American Medical Association. “I had been optimistic, based on the laboratory evidence, that suppression of inflammation would be useful in Alzheimer’s patients. But we saw no evidence of benefit.”

An open question is whether similar drugs might prevent Alzheimer’s in people who do not have symptoms.

In all, 351 people, with an average age of 73 to 74, were studied. One-third were given naproxen, one-third rofecoxib and one-third a placebo. After a year, tests of memory and use of language showed that the Alzheimer’s progressed unabated in each group. Researchers also rated subjects’ moods; their functioning like shopping or using telephones; and their enjoyment of life. The scores were essentially the same.

A year and a half ago, Dutch researchers who observed middle-age and elderly people for more than six years found that people who regularly took drugs like naproxen and ibuprofen for at least two years were one-sixth as likely to develop Alzheimer’s dementia as people who did not take the drugs.

Dr. Lenore J. Launer, an epidemiologist with the National Institute on Aging who commented on the new study, said she remained optimistic that anti-inflammatories might be useful in preventing the disease.

“Alzheimer’s disease is a long process that may start in middle age or younger,” Dr. Launer said in an interview. “Perhaps once people are so far along in the disease process, anti-inflammatory drugs won’t work.”

A seven-year study financed by the National Institutes of Health to find out whether anti-inflammatory drugs can help prevent Alzheimer’s is under way. Researchers are testing naproxen and celecoxib, under the Celebrex brand, a so-called cox-2 inhibitor similar to rofecoxib.

More than four million Americans have Alzheimer’s, according to the National Institute on Aging. Nearly 54,000 Americans died of the disease in 2001, making it the eighth leading cause of death, according to the National Center for Health Statistics.

Inflammation does play a role, some research has demonstrated. Autopsies of patients’ brains have shown anti-inflammatory proteins in and around plaques and tangles that are characteristic of the illness. Also, scientists have suppressed the production of plaque-producing proteins in laboratory mice by dampening their inflammatory response.

Researchers have long warned against treating Alzheimer’s with anti-inflammatories until evidence from a controlled trial like Dr. Aisen’s was available.

The drugs can cause nausea, stomachache or, in some cases, severe gastrointestinal bleeding. About 3 percent of the subjects in Dr. Aisen’s study experienced such serious problems. One person developed a perforated intestine. Nevertheless, Dr. Aisen said, the preliminary evidence had been so compelling that it led some doctors to recommend anti-inflammatory drugs like naproxen, ibuprofen and the cox-2 inhibitors.

“Treatment of Alzheimer’s disease patients with these drugs is not justified,” Dr. Aisen said.

Nor should anyone take anti-inflammatories in the hope of preventing Alzheimer’s, he said, adding:

“People who are looking to reduce their risk of Alzheimer’s disease should not take these drugs until the results of prevention trials are in and we can weigh the risks and against the benefits.”

He said it was possible, but not likely, that the drugs in the study might have shown a benefit if they had been given for a longer time.

“Because the results at one year were so clearly negative,” Dr. Aisen said, “I’m not planning to do a longer treatment trial.”

Rather, he is looking into other possible treatments, including B vitamins, which might lower levels of homocysteine, an amino acid thought to play a role in heart disease and Alzheimer’s. Another promising possibility, Dr. Aisen said, is to identify drugs that would inhibit an enzyme, beta secretase, which appears to lead to the release of plaque-making proteins in the brain.

“Alzheimer’s disease is a terrible fatal illness, and the numbers are going up as the elderly population increases,” he said. “We should do everything we possibly can to investigate all promising strategies.”