Controversy Over Cholesterol-lowering Statin Use

Heart disease risk calculator center of dispute

Doctor drawing heart symbol

There’s a controversy in the world of heart disease prevention that may affect millions of people: the one-third of all American adults who have increased risk of heart attack and stroke.

In early November important new guidelines on cholesterol-lowering statin use were released. I responded favorably about this development in this previous post.

The key aspect of the guidelines developed by the American Heart Association and American College of Cardiology was the identification of patients who were still healthy, but who had an increased risk of developing heart disease.

Calculator becomes center of controversy

These guidelines provided a new online risk calculator to determine which otherwise healthy patients should be treated with statins to prevent heart attack and stroke. The number of patients identified using this calculator could effectively add millions more people who could be prescribed statins — a huge shift from the prior guidelines.

After the online heart risk calculator became accessible, I and other doctors raised an alarm that the calculator may overestimate risk. Some authorities, including me, now suggest that the calculator needs to be reassessed before the guidelines are implemented.

This has set off lively discussion over how to proceed with the guidelines on how patients should be treated with statins. Overtreatment is never a good idea. So we stressed that more time needs to be taken to evaluate these guidelines.

Target numbers also controversial

Another area of controversy involves the abandonment of target values for LDL (bad) cholesterol for patients requiring treatment. The previous target levels were never based on solid scientific evidence, but were effective in helping doctors and patients achieve goals.

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The new guidelines suggest that patients not be concerned about target levels and simply take either a high or moderate dose of statin medication. So patients either take a statin or don’t, based on the level of risk determined using the calculator.

The elimination of goals may be confusing to patients and physicians.

Guidelines still sound overall

For the most part, however, the new guidelines make good sense.

The guidelines still identify at-risk patients who would benefit from statins, including those with:

  • Cardiovascular disease, including angina, previous heart attack or stroke or other related condition
  • Very high level of LDL (bad) cholesterol (above 190 mg/dL)
  • Diabetes, who are between the ages of 40 and 75

There’s no argument that these patients should use statins. The question concerns those who have no history of cardiovascular disease — and in which the new calculator comes into play.

So how do you know if you should take statins?

Guidelines are just that: guidelines. While the medical community sorts this all out, patients should talk with their doctors about their particular heart risks. It’s not all about numbers. Medicine is also an art, and talking is one of the best tools we have.

The most important factors to discuss with your doctor remain the same:

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  • Cholesterol level
  • Blood pressure
  • Weight
  • Lifestyle (if you’re a smoker, diet and exercise factors, etc.)

You may need statins and that’s a lifelong commitment. You should know that these medications are safe and very affordable now.

Don’t forget that a heart-healthy lifestyle is important for everyone. For those on the borderline of risk, eating a Mediterranean diet and regular exercise can help keep you healthy. For those who have heart disease or need to take a statin, a heart-healthy diet will help keep you at the lowest dose possible.

Right approach to preventing disease

The guidelines will be revised and improved. Meanwhile, your doctor and you can use information from both the old and new guidelines to figure out your course of treatment.

As far as controversy goes: It’s all about getting it right to prevent heart disease. That’s what we care about.

More information

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Steven Nissen, MD

Steven Nissen, MD, is Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic. In 2007, TIME Magazine named him “one of the 100 most influential people in the world.”
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  • lunchlady

    I also follow the news but as a patient, I still have the option of saying “no thank you”
    Statins can be debilitating for some people and can cause terrible muscle pain…I have seen it first hand….and it still has not been proven to prevent heart disease…but it might be a good time to buy stock in the companies that make it…

    • JB Sellars1

      The reason we use statins in this country is that they work.

      • alanib

        What is the definition of they work? Do they lower lipid levels? Yes they do. Is that beneficial for cardiovascular health and/or overall health? Have meta studies proven an overall benefit as measured by a significant reduction in cardiovascular morbidity and mortality rates in the general population after so many years of widespread use? I have heard about increases in all cause mortality among statin users where that mortality increased with increased dose age. Doctors get their treatment protocols from industry sponsored research performed by researchers with financial interests in the outcomes. How can we trust the fox to watch the chicken coop?

        • JB Sellars1

          they lower the lipids which im not sure that is a good thing.

  • GeorgeBMac

    Dr Nissen described the controversies surrounding the new guidelines well.

    However, there are two more that he did not mention :
    1). The new guidelines ignore important risk factors that have been identified in recent years – things like inflammation, carotid intimedial thickness, coronary calcium and so on …. These newer risk factors may explain why 50% of people who die of a heart attack have ” normal” cholesterol.
    2) the guidelines failed to justify why they recommend cholesterol lowering medication simply because the patient has other risk factors unrelated to cholesterol (such as high blood pressure ). They MIGHT be helpful in those situations – but the evidence is limited and circumstantial.

  • chicky 1141

    I’m very confused , this past Sept my family Dr. told me when my blood was tested(the test described as somewhat like an MRI of my blood showing I was very high in Choleastral(Genetic) LDL-P the count was 2608. I should be at 1000 count. I was put on Simivistatin ,which I could not tolerate, now on Crestor 5mg. Triglycerides at 332. this analysis compiled by Diagnostic labs(
    Don’t drink or smoke need to get back to walking, my weight is 181, Im 5ft 5in.and 72 yrs old, I do have high BP,which maybe due to Sciatic pain. Am I know in the high risk category. I don’t want to be on stattins!

    • The_Beating_Edge_Team

      Chicky1141 – I spoke to Dr. Hazen, Co-Section Head of Preventive Cardiology and he stated: An LDL-P of 2608 is substantially elevated, and indicates you have a very high level of LDL (bad) cholesterol TG level of 332 is also substantially above the goal of <150.

      With LDL as high as this, even with extra care in diet, one would not expect to be able to reduce it into a more reasonable range without the use of medications (statins).

      Why the great concern with taking these medications? They have helped to reduce more heart attacks, strokes and prolong life more than any other medication class ever invented.

      While there are some side effects in some with statins (like with any medication), statistically, they are remarkably well tolerated by most. Further, for the rare (percent wise) individuals that do have side effects, they are almost always completely reversible.

      Sounds like you are on a good start with keeping at it with the alternative low dose statin (Crestor). But in truth, I think that may not be enough based on what is indicated – so an appointment with a specialist in preventive cardiology is appropriate, to deal with global efforts to help reduce cardiac risks – including aggressive diet, exercise, blood pressure control, getting the lipids to goal (LDLc, TG) and examination of things like risks of diabetes, thyroid function, and other risk assessments to help gauge overall cardiac risks and appropriate preventive measures.

      Good luck – let us know if we can help you further – betsyRN

  • Emilee

    I have tried all the statins, each one has caused major pain and weakness of my muscles. I take niacin and omega-3 and my cholesterol just goes up and down .

    • The_Beating_Edge_Team

      See response to Donna below – this can be very tricky – but an experienced Preventive Cardiology team can help you reach your goals through a combination of medical and lifestyle interventions. betsyRN

  • Donna

    Every statin I take gives me muscle and joint pain. My cholesterol remains high. My doctor recommended red yeast rice, but I read it has the same side effects as statins.

  • GeorgeBMac

    Thank you Dr Nissen for that clarification….

    I respect most highly a physician who is willing and able to take an unbiased view of the whole picture.

  • Hezi Green

    There is no such term as ” bad cholesterol ” (LDL)! Cholesterol is needed for every cell in our body (LDL & HDL). The compound found in the clogged arteries is oxidized cholesterol , that predominantly accrues as a result of high carbohydrate diets, and not enough saturated fats.

  • Jody

    My dad was on Zocor generic version Simvastatin for 2 years and the neurologist just took him off it due to severe muscle weakness that is worsening. Trying several rounds of physical therapy but he continues to have troubles standing, walking, and is falling more- it is sad to see

    • angelwings581

      try taking COQ10 for cramps from statins. no medicine is 100% safe to take over a long time period.

  • John

    I was on Pravastain for several months. Over time, I became very tired by late afternoon every day. Also, experienced aching joints, weakness in muscles and connective tissue. I finally got off of the statin and feel much better. Substituted CoQ10 and Omega 3 Fish Oil (understand you need to watch that you use the correct
    version). My wife and several friends have had the same experience. Statins are definitely not for everyone.

    • The_Beating_Edge_Team

      Thanks John – it is true the same medicines and the same doses do not work with everyone. You need to work with your doctor to find the right medicines to reach your goals. Please note that not everyone can take or should take supplements such as CoQ10 and Fish Oil as well. People often think of supplements and vitamins as safe because they are not traditional medicines. Discussion with your doctor and monitoring of your LDL and cholesterol goals, your other risk factors and symptoms – and – lifestyle changes (diet and exercise) are key. Glad you are doing well! betsyRN

  • MR

    What about alternatives such as Nattokinase, Serrepeptase, Bergamet, Kyolic Garlic. Lipator gave me horrible side effects. Never taking a statin again

  • Marty Walker

    I started Testosterone therapy over a year ago. Since then I’ve had two heart attacksn staing that now I believe that the tESTOSTERONE CAUSED THIS. aLSO THE cHOLESTERAL meds caused me to have the most hurting legs. Felt like my muscles were tearing away from my bones. This pain was in the 8 or 9 range. I think you Docs are right.

  • Bobby Olson

    “The previous target levels were never based on solid scientific evidence, but were effective in helping doctors and patients achieve goals.”

    Oh just wonderful. In the first half of this statement I’m being told we have been taking statins to achieve low target levels in vain as there never was any solid scientific evidence for it.

    But in the second half of the statement, “were effective in helping doctors and patients achieve goals”

    So whats the point of achieving these goals if there was no solid scientific evidence to support them?

  • Patience Merriman

    Stains will eventually be banned as some of the most damaging drugs ever created. Here is a fact that the drug companies (and their paid allies in the medical; profession) conveniently ignore: more than 50% of people who suffer fatal heart attacks have NORMAL cholesterol levels. Yes– normal. It is obvious that cholesterol plays almost no role at all in heart attacks. To learn more, I recommend reading “The Cholesterol Myth” — it’s a scientific analysis of all the deeply flawed studies implicating cholesterol in heart disease. Two real causes of heart disease are the excessive sugar and refined grain products that form the core of our terrible American diet.

    Smoking and lack of exercise are also key factors. Please, before you start taking a POWERFUL DRUG every day of your life, try a less drastic approach. Eliminate sugar and flour products, stop smoking, start exercising. Give it 3-4 months, then get your lab work done. Your doctor will be amazed.

    • Dr Stephen Arvay

      The fact is that there is no study which shows a direct causal path between cholesterol and heart disease.
      Furthermore, there are no studies involving statins and the adverse effects of sugar, flour, and smoking!
      So, if the real causes are sugar, flour, smoking, etc., what does this tell you
      about physicians who continue to prescribe statins?

  • Linda Tieman

    Thank you for this article. I think the new guidelines are ridiculous! The side effects are frightening in many ways. I’m taking Krill Oil and CoQ10 has been recommended also.