Soy Nutrition Institute

Primary Prevention of Heart Disease: Diet or Drugs?

By Mark Messina, PhD, Executive Director, Soy Nutrition Institute



Should statins be added to drinking water like fluoride?  Given the prevalence of heart disease, some experts have noted – mostly tongue in cheek – that Americans might benefit from a regular source of these cholesterol-lowering drugs. A more serious idea is that of a “polypill” that combines statins with aspirin, the B-vitamin folate and blood pressure-lowering medications. Such a drug might reduce heart disease by as much as 80%.1

Pharmaceuticals targeting high cholesterol rose to the forefront of medical treatment in the mid-1990s with the publication of the Scandinavian Simvastatin Survival Study (or the “4S study”).2 This trial involved 4,444 patients with angina pectoris or a previous heart attack and who also had elevated cholesterol. They were randomly assigned to receive either a placebo or the cholesterol-lowering drug simvastatin. Over an average of 5 ½ years, simvastatin dramatically lower LDL-cholesterol by 35% and markedly reduced mortality by 12% compared to 8% in the placebo group.   

Currently, nearly 40 million Americans take statin drugs, and they represent only about half the number of people who might benefit from them.3  

According to the guidelines of the American College of Cardiology and the American Heart Association, there are four groups of people who should be taking cholesterol-lowering medications:


Group 1     Those with a self-reported history of coronary heart disease, heart attack, angina or stroke

Group 2     Those with an LDL-cholesterol level ≥190 mg

Group 3     People between the ages of 40 and 75 who have diabetes and an LDL- cholesterol level between 70 and 189, but no history of heart attack or stroke.

Group 4     People between the ages of 40 and 75 with an with LDL-cholesterol level between 70 and 189 and an estimated 10-year ASCVD (Atherosclerotic Cardiovascular Disease) risk from Pooled Cohort Equation greater than 7.5%.  (This is an assessment of heart disease risk based on a number of factors including age, total and HDL cholesterol level, blood pressure and smoking status.)

The benefits of statins for those in the first three groups are clear. However, there is continued debate about the wisdom of using statins to treat the fourth group. Although the use of statins for this population group is recommended by the U.S. Preventive Services Task Force, other experts disagree.4,5  Rita F. Redberg, MD, and Mitchell H. Katz, MD, who are the editor and deputy editor of the JAMA Internal Medicine, respectively, recently argued in an editorial that the proposed benefit of statins for those at relatively low risk of heart disease is outweighed by the risks of these drugs.6  They wrote: “It is incumbent on clinicians to be sure that before recommending that a patient take a daily pill that has multiple adverse effects, there is evidence that the medication will lead to a better quality of life, longer life, or both. Such evidence is lacking for statins in primary prevention.” Side effects of statins include muscle pain, liver inflammation and possibly, an increased blood sugar level.

They also pointed out that people taking statins are more likely to become obese and more sedentary over time compared to non-statin users. This may be the result of a mistaken belief that drug therapy negates the need for an overall heart-healthy lifestyle.7 

In contrast, there is no debate about the benefits of a heart healthy diet. Canadian researcher Dr. David Jenkins and colleagues have shown that a portfolio diet, which combines a number of heart healthy elements—a sort of poly-diet answer to the polypill—can reduce LDL-cholesterol levels by as much as 30%.8 In addition to healthy fats and fiber, this diet featured soyfoods as a prominent component. More specifically, the portfolio diet was low in saturated fat, high in mixed nuts and fruits and vegetables and contained 1 g phytosterols, 9 g viscous fiber and 23 g soy protein per 1,000 kcal.

An added benefit of these comprehensive dietary approaches is that they may also reduce risk for cancer and other chronic diseases, something that statins won’t do. Drug therapy has a place in treating people at very high risk for heart disease, but it can never take the place of a healthy diet.


  1. Wald, N.J. and Law, M.R. A strategy to reduce cardiovascular disease by more than 80%. BMJ. 2003, 326, 1419.
  2. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994, 344, 1383-9.
  3. Mercado, C., DeSimone, A.K., Odom, E., Gillespie, C., Ayala, C., and Loustalot, F. Prevalence of cholesterol treatment eligibility and medication use among adults--United States, 2005-2012. MMWR Morb Mortal Wkly Rep. 2015, 64, 1305-11.
  4. Bibbins-Domingo, K., Grossman, D.C., Curry, S.J., Davidson, K.W., Epling, J.W., Jr., Garcia, F.A., Gillman, M.W., Kemper, A.R., Krist, A.H., Kurth, A.E., et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016, 316, 1997-2007.
  5. Chou, R., Dana, T., Blazina, I., Daeges, M., and Jeanne, T.L. Statins for Prevention of Cardiovascular Disease in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016, 316, 2008-2024.
  6. Redberg, R.F. and Katz, M.H. Statins for primary prevention: The debate is intense, but the data are weak. JAMA. 2016, 316, 1979-1981.
  7. Sugiyama, T., Tsugawa, Y., Tseng, C.H., Kobayashi, Y., and Shapiro, M.F. Different time trends of caloric and fat intake between statin users and nonusers among US adults: gluttony in the time of statins? JAMA Intern Med. 2014, 174, 1038-45.
  8. Jenkins, D.J., Kendall, C.W., Faulkner, D., Vidgen, E., Trautwein, E.A., Parker, T.L., Marchie, A., Koumbridis, G., Lapsley, K.G., Josse, R.G., et al. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002, 51, 1596-604.

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