June 28, 2010


Dr. Eric Van De Graaff, Cardiologist at CHI Health Clinic Heart and Vascular Specialists, wrote a very poignant article in defense of statins. His timing was perfect. It’s almost as if he knew the Archives of Internal Medicine’s June 28th article was going to be published.

You will be hearing a lot about this article: Statins and All-Cause Mortality in High-Risk Primary Prevention. The argument the study makes is that there may be little benefit in primary prevention patients to justify using statin medicines to lower your cholesterol level. (Primary prevention is defined as avoiding the development of a disease. Most population-based health promotion activities are primary preventive measures.) Before you stop your Lipitor, please consider Professor Van De Graaff’s article in addition to mine where I “ditto” his argument.

Although diet and exercise are paramount, one can argue that protection through medication should be considered in patients at risk for dying from heart disease — if medication is indeed effective.

It takes time for atherosclerosis (plaque build-up) in the coronary arteries to become clinically evident heart disease. Trials that are stopped after only 4 years may not show a benefit because it may take many more years for the plaque build-up to result in a cardiac event (a heart attack). This is the definition of a false negative study: failure to detect a difference when a difference does in fact exist.

Let’s use a simple country nephrology analogy. Take 2 cars in good condition. Drive up to Northern Minnesota. Rust-proof one car but leave the other alone. Drive the 2 cars during the winter, allowing the salty roads to attempt to rust the cars. After the first few years, we may be unable to detect a difference. However, after 5-10 years, the rust proofing shows a benefit whereas the other did not. People are not cars; however, a high salt, fatty diet resulting in obesity can lead to heart disease over time. Perhaps we didn’t perform due diligence and give enough time to allow a difference to happen because it takes many years for fatty material to deposit in a vessel wall:

The problem with primary prevention trials is that they require too much time and are extremely expensive. Pharmaceutical companies don’t want to pay because of drug patent-life issues and decreased return on investment. Therefore, the National Institute of Health needs to fund this study. The problem however, is who wants to wait a generation to find out the results when you could be benefiting right now?

Fortunately we have many good 4 dollar a month medicines. For now, in a high risk population, I would opine that we should consider using cost effective statin drugs. This may be a leap of faith, but until proven otherwise, the mechanism of action makes sense. Given the billions of dollars Americans waste on vitamins, it could be argued they would be willing to pay for the proposed benefit. Moreover, if a generic statin is not powerful enough, you might want to consider a more powerful statin, like Lipitor. That choice is between you and your clinician.

Finally, there is no question that patients who already have established heart disease should be on a statin because these cholesterol lowering medications prevent death from heart disease and complications related to heart disease. This is called secondary prevention.

So let’s say that you are a purest and want to wait until you have absolute evidence of cardiovascular disease. The question now becomes when to intervene. When does a stable heart plaque become unstable? Are our current markers adequate to know when to start statins? Do you want to wait until you have a heart attack prior to starting the medication? Determining whether you have heart disease or not is a challenge, one I will defer to CHI Health Clinic Heart and Vascular Specialists and the primary care docs. However, in my opinion, once there is evidence of plaque, I think a statin (or other risk factor modifier such as blood pressure pills) should be started.

Ask your doctor if you are on a statin for primary prevention or secondary prevention. This will help you determine whether or not you should consider continuing, or starting, a cholesterol lowering statin or not. The decision should be an individual choice, free from algorithms, so that you are comfortable with your doctor, your care, and are taking control of your health.

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