Alzheimer's Club

By Michelle Fay Cortez and Elizabeth Lopatto

Pfizer Inc.'s best-selling cholesterol drug Lipitor failed to slow mental and physical worsening in patients with Alzheimer's disease, a study found.

The results clash with previous research that showed high cholesterol raises the risk of Alzheimer's disease, an inexorable loss of memory and function that affects 4.5 million Americans. The study of 640 patients, the largest ever on cholesterol-lowering statin drugs for the condition, found patients fared the same whether they got Lipitor or placebo.

Pfizer, which funded the study presented at the American Academy of Neurology's annual meeting in Chicago, is looking for ways to expand Lipitor's use as competing medications lost patent protection. Lipitor accounts for about 40 percent of Pfizer's profits and its sales slid 7 percent to $3.1 billion in the first quarter, the company said.

The study ``did not demonstrate significant benefits on the symptoms of mild to moderate Alzheimer's disease,'' said Howard Feldman, who helped guide the study and is head of neurology at the University of British Columbia Hospital in Canada. ``There are some noteworthy findings that require further analysis and should inform further research to determine the potential for statin use in this population.''

Patients in the 18 month study received Aricept, New York- based Pfizer's Alzheimer's drug, in addition to either Lipitor or a matching placebo. There were no differences between the groups in the ability to think and reason by the end of the trial. Mental, behavioral and physical abilities were all similar, the researchers said.

Analysis in Men

After the study was completed, an unplanned analysis suggested men getting Lipitor may have had a slower rate of decline, the researchers said. Those results must be confirmed with additional trials. In addition, imaging scans of the brain suggested less shrinking in the hippocampus, previously considered an indicator of worsening disease.

Pfizer said it is not planning additional studies of Lipitor in patients with Alzheimer's disease.

The first symptom of Alzheimer's may be mild forgetfulness. As it progresses, patients forget how to brush their teeth, change their clothes, or recognize once-familiar people. They become confused and agitated and eventually require constant care, according to the Bethesda, Maryland-based National Institute on Aging.

The number of patients with Alzheimer's disease is expected to soar in the coming years as the baby boomers age. Someone is currently diagnosed with the disease every 71 seconds, and 10 million baby boomers will develop it eventually, according to the Alzheimer's Association.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.netElizabeth Lopatto in New York at elopatto@bloomberg.net.

Source: Bloomberg (17 April 2008) [FullText]