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Introduction:

Recently, the American Heart Association (AHA) and American College of Cardiology (ACC) released new guidelines that increased the focus on prescribing statins to lower LDL cholesterol levels. With the new guidelines, it is estimated that in the United States, 44 percent of men and 22 percent of women would meet the criteria for taking a statin.

The answer to the question “Do the New Guidelines for Statins Make Sense” is yes only if the criteria is providing further big profits to the drug industry. There is no question that elevated cholesterol and triglyceride levels greatly increase the risk of death due to cardiovascular disease (CVD). Yet while the drug companies (the AHA and the ACC) would like us all to believe that it’s as simple as taking a statin drug to reduce your risk of a heart attack or stroke, it’s just not that simple. Cholesterol-lowering statin drugs are sold primarily under the premise that they will save lives by lowering cholesterol levels, but in reality they have not demonstrated an ability to extend life in over 75% of the patients these drugs are currently prescribed for.

A recent letter to the editor of the Journal of the American College of Cardiology offers a very interesting perspective. The title of the letter pretty much states the issue: Is Myopathy the Achilles’ Heel of Statins? Differences Between the New Cholesterol Treatment Guidelines and Everyday Clinical Practice. This letter questions the safety of widespread promotion of statin use, and calls to attention the discrepancy in side effect rates reported by drug companies compared to what physicians in practice actually observe.

Background Data:

The debate on the use of any treatment should be one of risk versus benefit. With statins, it seems that the benefits have been grossly overstated, while side effects are minimized.

First, let’s take a look at the benefit. Research does show that in people with a history of a heart attack, stroke, or current signs and symptoms of existing CVD, statins do produce some benefits in reducing deaths due to a heart attack. However, large evaluations of studies in people without a history of heart attack or stroke, who took statin drugs and lowered their LDL cholesterol, have shown they did not live any longer than the people in the placebo group. Even in patients at a high risk for a heart attack results have shown that the use of statin therapy did help these patients live longer.

In terms of risk, it has long been known that statin medications have many side effects including:
• Liver problems and elevated liver function tests.
• Interference with the manufacture of Coenzyme Q10 (CoQ10) – a key substance responsible for energy production within our body.
• Muscle damage including rhabdomyolysis, the breaking down of muscle tissue that can prove fatal.
• Nerve damage is 26 times higher in statin users, compared to the normal population.
• Impaired mental functions can occur in some patients with prolonged use.
• Possible increased risk of cancer and heart failure with long-term use.
• Increased muscle damage caused by exercise and reduced exercise capacity.
• Diabetes and obesity – A 2012 study by the Mayo Clinic found that the use of statins in postmenopausal women increased the risk for type 2 diabetes by 71%.

New Data:

The muscle damage that statins can cause is referred to as “statin-induced myopathy.” It can range in severity to general stiffness, fatigue, and weakness (myopathy); to pain (myalgia); severe inflammation (myositis); and major destruction of the muscle (rhabdomyolysis). The standard line from the drug companies is that statin-induced myopathy occurs in just 1 in 10,000 patients prescribed statins. However, that number does not reflect “real world” occurrence.

Drug companies arrive at the low occurrence rate by preselecting the patients in the studies excluding those with a higher risk for statin-induced myopathy and then they use very strict criteria on what is myopathy. For example, there is an enzyme in muscle cells called creatine kinase (CK) that will leak into the blood if the muscle cell is severely damaged. Most clinical trials of statins used an elevation of 10 times the upper limit normal as signifying myopathy. The problem is that this sort of elevation is a very rare manifestation of myopathy.

More common are symptoms such as stiffness and weakness, and/or muscle pain. In many of the trials the patients were not interviewed for these sort muscle complaints. Was the failure to ask the patient if they were experiencing these side effects an oversight or a cover-up?

How common are symptoms of myopathy in statin users based upon observational studies? It looks like nearly 10%. In other words, about 1,000 times more common than what the drug companies are claiming. That is a big difference.

Commentary:

If you did not get a chance to attend my free webcast and chat on An Honest Appraisal of Statins and Their Alternatives – you can access a recording of the webinar by clicking here: An Honest Appraisal of Statins and Their Alternatives.

Also, you can download a free PDF of my book on Cholesterol and Heart Health – What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know. Feel free to forward it to any friend or family member that can benefit from it.

The bottom line is that there are safer and more effective strategies in the primary prevention of CVD than taking a statin.

References:

Rallidis LS, MD; Anastasiou-Nana M. Is Myopathy the Achilles’ Heel of Statins? Differences Between the New Cholesterol Treatment Guidelines and Everyday Clinical Practice. J Am Coll Cardiol. 2014;63(21):2300-2301

See also:
Rallidis LS, Fountoulaki K, Anastasiou-Nana M. Managing the underestimated risk of statin-associated myopathy. Int J Cardiol. 2012 Sep 6;159(3):169-76.

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