OVERSTATINIZATION?

I don't have to tell you that statins, medications used to lower blood cholesterol levels are amongst the most commonly prescribed drugs in the United States and Europe. Lipitor sales alone exceeded 120 billion dollars between 1996 and 2011. There is no question that statins lower LDL cholesterol, the "lousy' cholesterol that is known to cause plaque in our arteries leading to heart attacks, strokes and peripheral artery disease. In recent years they have been shown to have an anti-inflammatory effect which may, in actuality be a chief reason for its ultimate usefulness in preventing both fatal and non fatal cardiac events. But with the recently published guidelines announced at the American Heart Association (AHA) meeting this past November, have we gone a bit too far in recommending this class of meds?

      This past November the AHA, in collaboration with the American College of Cardiology (ACC), urged a shift in how statins are prescribed. Until now, the drugs had primarily been used to treat high cholesterol in high risk individuals. Now the guidelines say they should be used as preventative tools to lower one's risk of heart attack and stroke. It seems as if everyone is on some form of statin today. Children as young as the age of six have been prescribed these drugs without knowing the long term side effects in the pediatric age group. I sometimes wonder will we one day find statins in our drinking water, LOL!

      Now, as a traditionally trained cardiologist practicing for 28 years, I am in full agreement in using whatever is necessary to control LDL cholesterol levels in high risk groups. These include those who have previously sustained a cardiac event such as a heart attack or stroke regardless of whether or not they go on to require coronary bypass graft surgery , balloon angioplasty or stents. The aim in such patients is to avoid at all costs subsequent cardiac events, and we have a plethora of data to support the usage of statins in this high risk group. This is referred to as secondary prevention. Another high risk group for which there seems to be little argument for treatment is in the diabetic population. Because roughly 70 % of diabetics will go on to experience a heart attack or stroke in their lifetime, data supports treating this high risk group as if they actually had coronary heart disease.

      But what about the masses of people out there who have elevated LDL cholesterol levels but who are not diabetic and who have never experienced a cardiac event? Treating these patients with the aim of avoiding a future event would be considered primary prevention, and the data to support the widespread usage of statins in this large group is less supported by the medical literature.

      This was precisely the topic with the announcement of the new guidelines. Usually cardiologists tend to adhere to the recommendations of these two prestigious organizations, but this time there was intense criticism. Main concerns from the cardiology community focused on flawed methods used in arriving at these recommendations (problems with risk calculation), ethics (conflicts of interest), and inferences (too many people offered treatment). Adherence to these guidelines would eventually lead to massive use of statins at the population level, or overstatinization. The new guidelines mean there would be more than a billion people taking statins worldwide. Furthermore, it should be pointed out that 8 of the 15 panelists writing these recommendations had industry ties, which certainly brings into consideration conflicts of interest.

      Such a major change may also have unintended consequences that threaten to move our society even further from prevention toward an increasing reliance on drugs. Those of you who are familiar with my philosophy of being your own "medical advocate" or taking control of your health will realize that the new guidelines do little to help motivate patients to adopt a healthier lifestyle with diet and exercise. Instead of focusing on the traditional medical model of disease.

      The ACC/AHA guidelines demonstrate that even in a topic where there are extensive amounts of data and published clinical trials, crucial evidence is still missing.

      In conclusion I agree with previously published data on the use of statins or whatever is necessary to treat elevated LDL cholesterol levels in those high risk patients (i.e. those with a documented history of clinical heart disease and/or in the diabetic population). This constitutes secondary prevention. I believe that the new ACC/AHA guidelines that would statinize over a billion people worldwide (primary prevention) is an oversimplification of calculated risk. We certainly need well-founded randomized, placebo-controlled studies before subjecting an entirely new population of patients to statin therapy given the potential attendant side effects and expense of using a lifelong class of medications. 

We at HeartWise Fitness and Longevity center are pleased to announce this useful service to our patients here at HeartWise.

Dr. Elkin is a board-certified internist, cardiologist and anti-aging medical specialist.

VERY IMPORTANT NOTE / DISCLAIMER: I am offering—always—only general information and my own opinion on this blog. Always contact your physician or a health professional before starting any treatments, exercise programs or using supplements. ©Howard Elkin MD FACC, 2013

*Originally Published Monday, February 3, 2014