NIH Suspends Study of Celebrex, Naproxen

WASHINGTON - An Alzheimer's disease prevention trial was suspended after researchers said there were more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve.

The study, involving some 2,500 patients, was to test whether naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease among healthy elderly patients who were at an increased risk of the disease.

Officials at the National Institutes of Health said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of cardiovascular events - heart attack or stroke - than patients taking placebo.

Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug were associated with an increase in heart attack risk. Preliminary data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke for Celebrex, officials said.

Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class - COX2 enzyme inhibitors - as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke.

Officials acknowledged that the implications for the continued use of naproxen is not clear and will require further study.

Dr. Sandra Kweder of the Food and Drug Administration said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke and that the findings are "confusing." No immediate action, however, is expected toward naproxen, she said.

"We are not contemplating any specific regulatory action over the next few days," said Kweder. "We will be working with the NIH to try to understand the data better and determine what will be appropriate from there."

She said patients who routinely take naproxen should follow the drug package instructions carefully, including the directions to not take it for more than 10 days, and to consult a doctor if pain persists.

Efforts to obtain reaction Monday night produced no answers at phone numbers for Bayer Healthcare, the maker of Aleve.

In the earlier studies of the COX2 drugs, an increase in cardiovascular events was noted only after a long-term use of the medications.

The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or a placebo.

The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking, or if they were taking a placebo.

The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's or cognitive decline, but will not be given the test drugs.

Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study.

He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex.

John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said.

This is an extrememly new release by NIH. My Medscape site did not even have any results for this, I was searching for its "white paper" Here is what I found, I hope it reassures you. Moderator, please let me know if I cannot post from a government site. Just wanted to reassure those person's who are taking it. Thanks!

Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) This study is currently recruiting patients. Sponsored by: National Institute on Aging (NIA) Department of Veterans Affairs University of Washington Johns Hopkins University Information provided by: National Institute on Aging (NIA)

Purpose The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline. Condition Treatment or Intervention Phase Alzheimer Disease Drug: Naproxen Sodium (Aleve) Drug: Celecoxib (Celebrex) Phase III

Study Type: Interventional Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study Further Study Details: Expected Total Enrollment: 2625 Study start: January 2001 Considerable evidence suggests that inflammation may play a role in the neurodegenerative process of Alzheimer's disease (AD), and the use of non-steroidal anti-inflammatory drugs may be associated with reduced occurrence of AD. ADAPT is a randomized trial that will test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline. This long-term trial will run for 5 to 7 years.

The study is sponsored by the National Institute on Aging and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System with the University of Washington, in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY. At each of these six sites, the goal is the enroll approximately 700 men and women, totalling 2,625 participants. Participants must be 70 years of age or older, have a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease. Participants will be asked to take an anti-inflammatory medication or placebo (inactive pill) twice daily. Before enrolling in the trial, participants will be asked to go to a study site for two medical evaluations. Once enrolled, they will need to go to a study site for a medical evaluation every six months and to participate in a telephone interview twice a year for an average of up to seven years of follow-up. Eligibility Ages Eligible for Study: 70 Years and above, Genders Eligible for Study: Both Accepts Healthy Volunteers Criteria

Inclusion Criteria: * Aged 70 years or older. * Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease. * Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed. * Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing. * Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts * Ability and intention to participate in regular study visits, in the opinion of the study physician. * Provision of informed consent. Exclusion Criteria: * History of peptic ulcer disease with bleeding or obstruction. * Clinically significant liver or kidney disease. * History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs. * Use of anti-coagulant medication. * Cognitive impairment or dementia. * Current alcohol abuse or dependence Location and Contact Information Janette Negele 206-277-6548 jnegele@u.washington.edu Arizona

He probably wasn't the first but Shakespeare is often credited with the remark that "One man's meat is another man's poison."

In the '60s, biochemist Roger Williams was one of the most notable to note that human variability varied so greatly as to make gross generalizations about the study of human beings almost meaningless. The difference, he observed, between one person's miracle elixir and another's fatal dose typically was a factor of a thousand. Our most common awareness of this in normal contemporary life is that for some, milk is the "perfect food" while others will literally starve faster and die of dehydration from that consumption. Most of the latter don't because far before reaching those lethal levels, they figure out that something is drastically wrong. But those listening to the advertising instead of their actual experience may end up in the emergency rooms to learn the devastating news that they may be lactose intolerant.

That same kind of reaction is encountered with just about everything in this world. For some, apparently many, the NSAIDs are a dream come true in relieving their chronic tormenting pains -- while unsurprisingly, a few will have unfavorable reactions and outcomes.

To pronounce as safe only that which is safe to absolutely and unconditionally everyone without exception is an impossibility perpetrated by the priests and scribes of junk science, often as not, mainstream media.

While these bozos like to protest that one should not shoot the messenger but rather the message, the fact is, one can not have a greater understanding of a phenomenon than the understanding of the messenger. The charlatans of junk science exploit this fact and prey upon the gullibilities of ambitious journalists trying to make a name for themselves by distorting their misunderstanding to sensationalistic proportions, not understanding the fuller picture.

On a cycle of once a year when we've forgotten the last, we're offered the story that radio waves or microwaves destroys our DNA, causing cancers among other things -- while overlooking all the great advances in the quality of life incalculable. These purists believe we should abandon every vestige of technology and human understanding, and revert to the safety of burying our heads in the ground at every whiff of danger.

The researcher offering these proclamation of inevitable doom, are quick to add, "Nothing is conclusive yet; we'll just have to spend billions of dollars studying this more closely though. Quite conveniently, my facilities are ready to go." The newspaper editing usually omits those last provisos.

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