To Be Or Not To Be... On Statins?

BIDMC Cardiologist Urges Common Sense amid Controversy

Newly released guidelines for the use of cholesterol-lowering statin drugs recently erupted into an unusual headline-grabbing dispute among heart care experts, leaving patients in a state of bewilderment.

The new recommendations were released Nov. 12 by two leading heart organizations, the American Heart Association and the American College of Cardiology. Under the new guidelines the number of Americans taking statin drugs, could double, to an estimated 72 million people, or about 30 percent of adults. The guidelines take the sole focus off LDH ("bad") cholesterol levels and advise doctors to look at the presence of diabetes, existing cardiovascular disease and lifestyle.

Researchers raise questions

Only a few days after the release of the new guidelines, two prominent Brigham and Women's Hospital researchers raised serious questions about the risk calculator doctors are supposed to use to identify those at risk for heart attack or stroke and thus be deemed in need of the drugs. The calculator crunches a number of factors, including age, race, gender and heart risks like blood pressure and cholesterol.

The researchers said the calculator appears to greatly overestimate risk, and would put millions on the drugs who might not need them. They said they were surprised that the risk calculator remained a key part of the plan because they had expressed concerns prior to release of the new guidelines. Their comments made headlines across the nation and created a buzz in the cardiovascular community.

The controversy did not, however, ruffle experienced cardiologists like Dr. J. Peter Oettgen of the CardioVascular Institute at BIDMC, who is director of the CVI's Preventive Cardiology Program. (Dr. Oettgen was not involved in drawing up the new guidelines or devising the calculator.)

What is a doctor to do?

"This kind of disagreement in academic medicine can happen, particularly after new guidelines are released," he says. "In time, after further discussion and review, it will all be straightened out. In the meantime, physicians treating patients will continue to use their best clinical judgment in recommending statins."

Dr. Oettgen will continue to assess a variety of factors in determining who should get statins and who should not. "I have always considered other risk factors besides LDL cholesterol, including smoking, blood pressure and diabetes," he says. "This is what most physicians do."

The new guidelines essentially lower the threshold for those said to be at risk for heart attack or stroke. They encourage doctors to treat these patients with statins even if they don't have elevated levels of LDL or "bad" cholesterol and they urge doctors to use more potent statins as a first-line treatment. In particular, the guidelines recommend that physicians prescribe statins for people between ages 40 and 75 for whom the calculator predicts a 10-year heart attack or stroke risk of 7.5 percent or higher.

A shift in thinking – or not?

In responding to the initial release of the new guidelines, Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and a past president of the American College of Cardiology, called the change "a tectonic shift in thinking about how to select people for treatment," according to news reports.

But after the Brigham physicians raised their concerns at a meeting of the AHA in Dallas a few days after release of the guidelines, Dr. Nissen quickly called for a halt to implementation of the guidelines. Those responsible for drawing up the new guidelines said they would review the data presented by the Brigham doctors and will determine if changes are needed.

Dr. Oettgen, too, is concerned that the calculator could result in many people going on statins who don't need them. In addition, he thinks the guidelines should give more guidance on how physicians should treat patients with high LDL cholesterol who nonetheless fall under the 7.5 percent 10-year risk threshold. Also, he notes, it may be important to consider a patient's lifetime risk of heart attack or stroke in addition to the 10-year risk.

Still, Dr. Oettgen says the goals of the new guidelines are good, and he will discuss the issue with his patients. He plans to use the calculator on a trial basis, but not as a substitute for his own clinical judgment. However, he predicts that most doctors will hold off on using the calculator for a few months to see what happens in terms of any adjustments that might be made.

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

Posted January 2014