By James C. Cotter, MD, MPH, Regional Medical Director

The 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines recommended treatment with statins for 4 categories of individuals:

1. Secondary prevention for those with established ASCVD
2. Primary prevention of ASCVD for those with LDL-C ≥190 mg/dL
3. Primary prevention of ASCVD for individuals with diabetes mellitus and LDL-C of 70 to 189 mg/dL
4. Primary prevention of ASCVD for those without diabetes mellitus, with LDL of 70 to 189 mg/dL, but with an estimated 10-year absolute risk of ≥7.5% as assessed by the Pooled Cohort equations.

I don’t think any of us disagree with the first three recommendations since they are clearly associated with known or increased risk of ASCVD in our patients. The last recommendation, however, has troubled me, especially since, as an older man, I should be taking a statin.

As noted above, the ACC/AHA guidelines recommend treatment if the 10-year risk of ASCVD is greater or equal to 7.5% in people without ASCVD or diabetes. The ACC ASCVD risk estimator shows that a non-smoking man without diabetes or hypertension at age 61 has a current 10-year ASCVD risk of 7.6% (Variables entered in the calculator: BP 130/80, total cholesterol 140, HDL 45, LDL 90, no DM, never smoked). A woman would reach the 7.5% risk between 68 and 69 years of age.

I know that statins are well tolerated in many individuals. The risk of unfavorable side effects is much less than the beneficial effects in reducing heart disease morbidity and mortality. Nonetheless, statins may have adverse effects and have been associated with myopathy, rhabdomyolysis, hepatotoxicity, peripheral neuropathy and many more side effects in some patients. Should hundreds of millions of people take statins with sales well over $22 billion per annum based on the ACS risk calculator?

A recent article in the Journal of the American Medical Association (JAMA 2018;319(15):1566-1579) showed some interesting findings. This meta-analysis of 136,299 patients showed that all-cause mortality was clearly reduced in patients with higher baseline LDL-C levels who were treated with statins. The association was not present when the baseline LDL-C level was less than 100 mg/dL.

It makes sense to me that lowering a high LDL is a good idea for patients with increased ASCVD risk, but it is not clear to me that taking a statin is the right thing to do for a low risk man who just happens to be over 61 years of age or a low risk woman who reaches age 68, but who have a baseline LDL-C level below 100. We should prescribe medications only when the evidence shows the benefits outweigh the risks, even if those risks are small.

Disclosure: this is just the opinion of an older man who doesn’t like taking medication.

James Cotter, MD MPH

References:

Circulation. 2016;133:1795-1806

JAMA. 2018;319(15):1566-1579

ACC ASCVD Risk Estimator Plus: http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/