Nearly 2,600 people in the United States die each day as a result of cardiovascular disease—that’s one death every 33 seconds. High LDL cholesterol , high blood pressure , high levels of homocysteine in the blood , and platelet aggregation (tendency to stick to each other and the walls of blood vessels) are all major risk factors for cardiovascular disease and can all be treated with drugs or vitamins.

A study in the June 28, 2003 issue of the British Medical Journal suggested that a theoretical pill, called the Polypill, could potentially reduce coronary artery disease by 88% and stroke by 80%. This Polypill would be comprised of a statin (the most effective cholesterol-lowering medication), three blood pressure-lowering drugs, folic acid, and aspirin .

About the Study

The researchers first identified a combination of drugs and vitamins that have been tested for their safety and efficacy in reducing LDL cholesterol, blood pressure, serum homocysteine, and platelet aggregation. The formulation they came up with was as follows:

  • A statin (for example, 10 milligrams atorvastatin or 40 milligrams simvastatin) for lowering LDL cholesterol
  • Three blood pressure-lowering drugs (half the standard dose of three of the following: thiazides, beta-blockers , angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, and calcium channel blockers )
  • Folic acid (0.8 milligrams) for reducing serum homocysteine
  • Aspirin (75 milligrams) as an antiplatelet agent

To estimate the effects of the Polypill, the researchers looked at the data from over 750 studies, which included a total of about 400,000 participants. Then they used the data to calculate the effect of changing the four risk factors with a daily dose of the Polypill. They used this information to estimate the years of life gained for people who start using the Polypill at age 55. They also looked at the adverse effects that would be associated with the Polypill.

The Findings

According to this study, if all people began taking the Polypill at age 55, one in three would benefit. In fact, it was estimated that each of these people would gain an average of 11–12 years of life free from a heart attack or stroke.

The researchers estimated that 8–15% of people taking the Polypill would experience symptoms caused by one or more of the drug components. Since aspirin has been associated with hemorrhagic stroke (bleeding into the brain, the most serious of the adverse effects that would be associated with the Polypill), the researchers closely examined the risks of taking low dose aspirin. They found that aspirin prevents more strokes than it causes, reducing the risk of stroke by 16%.

The following limitations of the Polypill were identified:

  • Beta-blockers are unsuitable for people with asthma.
  • Some people are intolerant of aspirin.
  • Statins may rarely cause rhabdomyolysis (a severe muscle condition leading to kidney failure ) and hepatitis.
  • ACE inhibitors and angiotensin II receptor antagonists may cause kidney failure.

How Does This Affect You?

The researchers proposed that all people age 55 and older, and younger people with known cardiovascular risk factors should take the Polypill. The analysis of existing studies indicated that the benefits associated with taking the Polypill would outweigh the risks. This would be true even in individuals with “normal” blood pressure, cholesterol, homocysteine levels, and platelet function.

The researchers in this study hope that the Polypill will soon be available to the public. They have filed a patent application for the formulation of the pill they describe in their study, as well as a trademark application for the name “Polypill.”

But critics of Polypill raise a number of concerns about recommending multiple medications to the general public. First, while it is true that a large collection of randomized trials shows that statins, blood pressure-lowering drugs, and aspirin are reasonably safe and effective in reducing cardiovascular disease risk, the combination of medications will almost certainly prove to be more dangerous and less effective in real life situations. Folic acid, furthermore, has only been shown to reduce serum homocysteine in observational studies; it has never been shown to actually lower the risk of cardiovascular disease directly in more reliable randomized trials. Second, Polypill users may feel so invulnerable to cardiovascular disease that they reject health-promoting behaviors like exercise all together. If for no other reason, critics argue, this is why the idea that a simple pill can save you in the end should be vigorously discouraged.

Despite these reservations, interest in the Polypill is likely to remain high. Before asking your doctor for a prescription, however, it is probably best to at least wait for the results of randomized trials that compare the safety and effectiveness of the Polypill to a placebo.