An astounding paper was published in the mainstream JAMA Internal Medicine. Researchers analyzed 21 randomized clinical trials examining the effect of cholesterol-lowering statin drugs and efficacy in reducing total mortality (death) and cardiovascular outcomes. The absolute risk for reducing all-cause mortality was 0.8%, heart attack was 1.3%, and stroke was 0.4% compared to control groups. In other words, there was a weak association between reducing LDL-cholesterol with statin drugs and preventing cardiovascular problems and death.
The paper I am citing was investigating relative risk reduction and absolute relative risk reduction. In practical terms, if treatment with statins reduces the risk of an event such as a heart attack from 1 percent to 0.5 percent, the relative risk reduction is 50 percent. However, the absolute risk reduction would be 0.5 percent. This means that 200 people would need statin treatment to avoid one heart attack event.
You can see how a headline of a treatment that just gives the relative risk reduction can be misleading without understanding the absolute risk reduction. This is why the honest authors of the JAMA Internal Medicine state that reporting relative risk reduction without absolute risk reduction has “the potential to inflate the clinical importance” of a treatment. This is particularly important for people who do not have existing cardiovascular disease or a strong family history of cardiovascular disease. An article in The Pharmaceutical Journal questions the use of statin therapy for “preventative purposes” and recommends patients without known risk be assessed differently.
The JAMA Internal Medicine authors stated that when considering absolute benefit, doctors and patients need to discuss the potential harm from statin therapy. One of the possible adverse effects of statin drugs is myopathy. Myopathy refers to muscle disease. Statin-related myopathy can include muscle fatigue, pain, tenderness, weakness, cramping, and tendon pain. Different studies provide vastly different risk for statin myopathy risk. The authors note that the frequency reported in studies can be much lower if the criteria for having myopathy are much higher. If a definition used by a study is any muscle symptom since starting the statin therapy, then the frequency is much higher. For example, one review study found that statin myopathy was between 9% to 20%. One Canadian study found that 25 out of 44 people who took statins had statin-induced muscle injury based on muscle biopsy testing. In addition, Mayo Clinic reports other potential side effects of statins include memory loss or confusion, increased blood sugar or type 2 diabetes, and liver damage.
If your doctor has recommended a statin drug due to high cholesterol, but you do not have cardiovascular disease or a strong family history of cardiovascular disease, consider the absolute risk reduction and potential side effects before deciding to take a statin. Furthermore, ask about imaging such as a coronary calcium score and bilateral carotid ultrasound to determine if you have any plaque buildup that is of concern. If there is no evidence of atherosclerosis (plaque buildup) then you should consider diet, lifestyle, and targeted nutritional supplements for cardiovascular disease prevention.
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Dr. Mark Stengler NMD, MS, is a bestselling author in private practice in Encinitas, California, at the Stengler Center for Integrative Medicine. His newsletter, Dr. Stengler’s Health Breakthroughs, is available at www.markstengler.com and his product line at www.drstengler.com
Mayo Foundation for Medical Education and Research. (2022, September 2). Statin side effects: Weigh the benefits and risks. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013
Mohaupt M, Karas R, Babiychuk E, Sanchez-Freire V, Monastyrskaya K, Iyer L, Hoppeler H, Breil F, Draeger A. 2009. Association between statin-associated myopathy and skeletal muscle damage. Canadian Medical Association Journal 181:E11-E18.
Portney, Leslie G. Foundations of Clinical Research Applications to Evidence-Based Practice . F.A. Davis Company. Kindle Edition.Sathasivam, S., & Lecky, B. (2008). Statin induced myopathy. BMJ, 337(https://doi.org/10.1136/bmj.a2286
Byrne, P., Demasi, M., Jones, M., Smith, S. M., O'Brien, K. K., & DuBroff, R. (2022). Evaluating the Association Between Low-Density Lipoprotein Cholesterol Reduction and Relative and Absolute Effects of Statin Treatment: A Systematic Review and Meta-analysis. JAMA internal medicine, 182(5), 474–481. https://doi.org/10.1001/jamainternmed.2022.0134
