Comments on New Guidelines for Cholesterol-Lowering Drugs

new cholesterol drug guidelines

Do the latest guidelines on cholesterol-lowering drugs reflect the latest research?

New guidelines were recently released by the American Heart Association and the American College of Cardiology for cholesterol-lowering drugs known as statins.

Part of the release included a controversial online cardiovascular risk calculator. Critics of the calculator propose that the algorithm greatly overestimates risk by 75-150% – turning millions more people into candidates for statin drug therapy.

Individuals taking statin drugs could double.

[See Risk Calculator For Cholesterol Appears Flawed (NY Times).]

There are numerous problems with the new recommendations:

  • Individuals with type 2 diabetes will effectively take more statin drugs despite a study suggesting that statins themselves have been correlated with an increase incidence of type 2 diabetes.

  • Statin drugs are not necessarily benign drugs. Studies suggest that the only population that sees benefit from the drugs in terms of mortality are middle aged men (<70-75 years old) who have already experienced a true cardiac event such as a heart attack. A very slight mortality benefit might also be seen in men who have not had a true cardiac event, but who have elevated hs-CRP who then take statins. No other groups have seen a statistically significant benefit in reduced cardiovascular and all-cause mortality including women, elderly, middle-aged men without cardiovascular disease or high hs-CRP. In fact, all-cause mortality may increase in some of these groups.

  • Statin drugs are “pleuripotent” which means they have simultaneously positive and negative effects on the body – creating somewhat of a wash of risk-benefit. For example, statins have been shown to have antioxidant and prooxidant effects in different people and have different effects on risk for cancer and renal disease among other findings.

  • Most common side effects include muscle pain, cognitive impairment, and fatigue. Many other side effects occur at lesser degrees. When patients ask their doctors if these are connected to their statin medication, 47-51% of doctors dismiss the possibility of a link, and few doctors (14%) bring up the possibility of side effects when first recommending the drug.

  • Cholesterol is actually necessary for the body. It is involved in most tissues of the body and supports cell energy, cell membrane function, nervous system health, sex hormone health, protection against harmful free radicals, and healthy gene expression.

  • LDL has been recently questioned as a useful marker for risk of heart disease mortality – with LDL particle number, other markers such as lipoprotein(a) and hs-CRP, as well as risk ratios such as Total Cholesterol:HDL, and Triglyercide:HDL gaining more attention.

  • Few still know that statins block production of an important cell component known as CoenzymeQ10 (CoQ10/ubiquinol) which you may have read about when it comes to health of the heart, muscle and nervous system. CoQ10 is a natural fat-soluble anti-oxidant and a component of our cells’ mitochondria which are involved in creating energy – especially in cardiac and nervous tissue where the concentration of mitochondria is highest.

  • Publication bias has been previously demonstrated in industry-funded research. The FDA looked at a selective publication of a series of 74 industry-funded trials on anti-depressants. Of 38 positive trials reviewed by the FDA,  37 had been published. Of 36 negative trials, only 14 were published (22 went unpublished). Of the 14 published negative articles, 3 demonstrated inconclusive results, and 11 were actually written in a way that appeared positive. Overall, published positive trials outweighed negative trials by >3:1, keeping in mind that bias was still slanted to a positive viewpoint in the 11 negative articles published. In general, 94% of industry-funded studies published showed a positive outcome.

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