The Wall Street Journal-20080212-Can a Drug That Helps Hearts Be Harmful to the Brain-

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Can a Drug That Helps Hearts Be Harmful to the Brain?

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Cognitive side effects like memory loss and fuzzy thinking aren't listed on the patient information sheet for Lipitor, the popular cholesterol-lowering drug. But some doctors are voicing concerns that in a small portion of patients, statins like Lipitor may be helping hearts but hurting minds.

"This drug makes women stupid," Orli Etingin, vice chairman of medicine at New York Presbyterian Hospital, declared at a recent luncheon discussion on women and the brain. Dr. Etingin told of a typical patient in her 40s, unable to concentrate or recall words. Tests found nothing amiss, but when the woman stopped taking Lipitor, the symptoms vanished. When she resumed taking Lipitor, they returned.

"I've seen this in maybe two-dozen patients," Dr. Etingin said later, adding that they did better on other statins. "This is just observational, of course. We really need more studies, particularly about cognitive effects and women."

Pfizer Inc.'s Lipitor is the world's best-selling medicine, with revenue of $12.6 billion in 2007. The company says the drug's safety and efficacy have been demonstrated in more than 400 clinical trials and 145 million patient years of experience, and that the extensive data "do not establish a casual link between Lipitor and memory loss."

On balance, many cardiologists see little cause for concern. Statins are widely credited with reducing heart attacks and strokes in people at high risk. And just 15% of patients complain of side effects; muscle aches and liver toxicity are the most common.

"The benefits far outweigh the risks," says Antonio Gotto, dean of the Weill-Cornell Medical School and past president of the American Heart Association. Dr. Gotto, who has consulted for most of the statin makers and been involved in many of the trials, says, "I would hate to see people frightened off taking statins because they think it's going to cause memory loss."

Thinking and memory problems are difficult to quantify, and many people who take statins are elderly and have other conditions and medications that could have cognitive side effects. There's even some evidence that statins may ward off Alzheimer's by reducing plaque and inflammation in the brain.

Still, anecdotes linking statins to memory problems have been rampant for years. The chronology can be very telling, says Gayatri Devi, an associate professor of neurology and psychiatry at New York University School of Medicine, who says she's seen at least six patients whose memory problems were traceable to statins in 12 years of practice. "The changes started to occur within six weeks of starting the statin, and the cognitive abilities returned very quickly when they went off," says Dr. Devi. "It's just a handful of patients, but for them, it made a huge difference."

Cognitive effects are the second most common problem, after muscle aches, reported by patients to the Statin Effect Study at the University of California, San Diego. "We have some compelling cases," says Beatrice Golomb, the study's lead researcher.

In one, a San Diego woman was so forgetful that her daughter explored getting her Alzheimer's care and refused to let her babysit her 9-year-old child. Then the mother stopped taking a statin. "Literally, within eight days, I was back to normal -- it was that dramatic," says Jane Brunzie, age 69.

The brain is largely cholesterol, much of it in the myelin sheaths that insulate nerve cells and in the synapses that transmit nerve impulses. Some doctors theorize that lowering cholesterol could slow the connections that facilitate thought and memory. Statins may also lead to the formation of abnormal proteins seen in the brains of Alzheimer's patients.

It pays to think hard about whether you could accomplish your goals with diet and exercise instead. Pay close attention to any side effects and talk with your doctor. A different dose or statin might be better.

As Ms. Brunzie says, "You have to use your own brain, as well as your doctor's brain, when it comes to your health."

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Drug Research

Learn more at these sites:

www.statineffects.com

The University of California-San Diego Statin Effects Study

www.fda.gov/medwatch

The FDA's Adverse Event reporting program

www.nlm.nih.gov/medlineplus/druginformation.html

Drug information from health-care organizations.