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New controversy over guidelines to reduce cardiac risk

November 27, 2013

Update: Last week The New York Times reported that the nation’s leading heart organizations released a sweeping new set of guidelines for lowering cholesterol, along with an online calculator meant to help doctors assess risks and treatment options. But, experts in the field have identified concerns as the calculator appears to greatly overestimate risk, so much so that it could mistakenly suggest that millions more people are candidates for statin drugs.
One of the worries is that with many patients already leery of taking statins, the public might see the flawed calculator as another reason to question the recommendations to take the heart-helping, cholesterol-lowering medication. Dr. Gregory Giugliano, director, Cardiac Cath Lab and Research in the Heart & Vascular Program at Baystate Medical Center, adds his thoughts on the controversy.

“The concept behind the guidelines is well-intentioned--with the idea to identify varying levels of patient risk for heart disease and to target high-risk patients for aggressive treatment. Researchers attempted to combine multiple risk models into one, and, in doing so may have oversimplified the new model such that it may overestimate risks among certain groups of patients. Clearly, the current calculator needs to be validated in different populations across the country. But, the key thing to remember is that we are talking about ‘guidelines’ to assist physicians and patients in making treatment decisions, not absolute rules. The best thing for patients to do is to discuss their risks with their doctor, maintain a healthy diet and exercise regularly,” says Dr. Giugliano.

Last week’s story
A major shift in cardiovascular disease prevention is on the horizon as doctors are now being urged to look beyond cholesterol numbers in prescribing cholesterol-lowering statin drugs, and to assess a patient’s heart attack risk on a broader scale by prescribing statins to patients falling under one or more risk categories.

As a result, it is expected that twice as many Americans will be eligible for cholesterol-lowering statins – some 30 million – based on these controversial new guidelines from two of the country’s leading cardiovascular associations – the American College of Cardiology and the American Heart Association in collaboration with the National Heart, Lung and Blood Institute.

“The takeaway message in this newly announced strategy to cut heart risk is something that is not new to most cardiologists, but that is now in writing for all physicians. Historically, some doctors have started their patients on low-dose statin therapies, then upped that dose a little after rechecking their levels 6-12 months later. We’ve known for quite a while that the goal for high-risk patients should be an initial, aggressive statin dose to achieve at least a 30-50% reduction of LDL in some cases, and a greater than 50% LDL reduction in others, as emphasized in these new guidelines,” said Dr. Gregory Giugliano, director, Cardiac Catheterization Laboratory and Cardiovascular Research in the Heart and Vascular Program at Baystate Medical Center.

He added the initial statin dose should be chosen based on how much LDL percent reduction is desired and that these percent reductions are quite predictable among the statins. As for the controversy, some doctors are concerned about exposing more patients to the dangerous side effects of statin drugs, including muscle pain, liver damage, and the increased risk of developing type 2 diabetes. “I don’t see this as a real controversy. Some people have raised a concern that lowering a patient’s LDL cholesterol too much may lead to other problems, but this theory has not been proven by the wealth of data we have. When it comes right down to it, the benefits of statins in reducing one’s risk for a heart attack or stroke in these defined populations far outweigh the risks. Side effects with statin therapy do exist, but the overall tolerability of this class of drugs is very good and the incidence of life-threatening side effects is exceedingly small,” said Dr. Giugliano.

He added that the new guidelines again emphasize the protocol for physicians to evaluate patients clinically and collect routine blood work to monitor the effects of the statins.
As for those who will benefit the most from being prescribed statins, the new guidelines list:
• Those with pre-existing heart disease
• People with diabetes (ages 40 to 75)
• Patients with very high LDL cholesterol of 190 or more, often thought to be genetic
• And, anyone with a 7.5% risk of developing cardiovascular disease over a 10 year period.