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Thinking Through the FDA’s Statin Warning

Does Lowering Your Cholesterol with Medication Affect Your Brain?

You may have heard about the recent Food and Drug Administration (FDA) warning added to the label of statins (cholesterol-lowering medications) concerning possible cognitive side effects.

For those with heart disease, however, cholesterol medication (Lipitor, Crestor, Zocor) can mean the difference between a heart attack and successful disease management. If this news has you on edge- don't panic. Chances are that the benefits of statins outweigh the risks.

Basis for the FDA's Concerns

Some researchers are convinced that taking statin drugs can be a slippery slope to issues like memory loss, cloudy thinking and learning challenges.

Here's why: Your cells rely on cholesterol - a fat, waxy steroid - to provide the structure for cell membranes in every part of the body. This includes the brain, where cholesterol assists in the functioning of neurons tied to memory and quick thinking. Some scientists believe this link is a possible explanation for the cognitive trouble experienced by some statin drug takers.

A study by the American Journal of Medicine somewhat substantiates this viewpoint. In this study, 209 participants were separated into two groups and given either a placebo or lovastatins (a cholesterol medication to lower "bad" LDL cholesterol) to take over the course of six months. Cognitive function for psychological performance, depression, hostility and quality of life was tested at the beginning and end of the study.

Results found that those on the placebo experienced a slight improvement in all areas at the completion of the study. Those taking the lovastatin, however, improved only on memory recall. In all other areas, there was a decrease in previous function - particularly in a test gauging attention and psychomotor speed.

Reassurance About the Risk

Peter Oettgen, MD, Director of Preventive Cardiology at BIDMC

To help clarify this issue, Heartmail spoke with Peter Oettgen, MD, Director of Preventive Cardiology at Beth Israel Deaconess Medical Center's Cardiovascular Health and Lipid Center.

"Statin drugs target the synthesis of cholesterol, which is mainly made in the liver," says Oettgen. "Changes in cognitive function affect a very small number of patients, which suggests that in most patients the cholesterol in the brain is not significantly affected by statin medications."

Those taking statin medications who do show changes to cognitive function almost always experience a cessation of those symptoms after discontinuing use of the drug.

"Because side effects are rare and easy to treat, the FDA warning serves to inform patients of the risk so they can watch for symptoms, not as a reason to discontinue use of statin drugs or to seek out an alternative therapy," Oettgen adds.

Some Studies Show Cognitive Improvements

A study conducted in 2008 found that the use of statins actually decreases the likelihood of dementia and cognitive impairment. The study focused on 1,674 dementia-free participants of Mexican-American heritage. Of these, 452 (27 percent) were taking statin medications. During five years of monitoring, 130 patients developed dementia or cognitive impairments, and researchers discovered that those on statin drugs were about half as likely to report an incident of dementia or cognitive impairment.

Oettgen explains the apparent dichotomy: "Some types of dementia are vascular-related. In those cases, statin drugs may improve vascular function and in turn actually improve cognitive function in patients whose dementia is related to vascular disease."

Statins are Still Vital to Lowering Heart Risks

Though cognitive health and function is certainly important, if you're living with heart disease, the importance of taking a cholesterol-lowering medication cannot be disputed.

Statins do more than just lower your cholesterol. They also stabilize the lining of blood vessels, making plaques less likely to rupture, which reduces your chance for heart attack.

In a study published in the Journal of the American College of Cardiology, researchers pooled database evidence from clinical trial outcomes where statins were compared to placebos, standard therapy, or no treatment. The information they gathered indicated that statins had a clear effect on reducing mortality attributed to cardiovascular disease and cardiovascular events.

"If you're at risk for heart disease, statin drugs remain the most therapeutic drugs for lowering cholesterol. The vast majority of studies have shown significant risk reduction with statin use," says Oettgen.

If you take statins and experience cognitive changes such as memory loss or confusion, discuss your symptoms with your doctor. Don't stop taking your statin medication without speaking to your physician first.

"Most changes in cognitive function are reversible with discontinuation of the drug, so closely monitoring a patient's progress and reaction is the best way to address the FDA warning," says Oettgen.

If the side effects occur, an alternative lipid-lowering medication may be the solution.

The final verdict: the risk of cognitive lapses from statins appears to be minimal, reversible and rare. For those who have high cholesterol and are at risk for or have heart disease, statin drugs can be a lifesaver. So live a healthy lifestyle and follow your physician's advice if you are given a statin drug prescription. Your heart will thank you.

Above content provided by the CardioVascular Institute at Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.

Posted June 2012

Contact Information

CardioVascular Institute at
Beth Israel Deaconess Medical Center
330 Brookline Avenue
Boston, MA 02215