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The Unintended Consequences Of The New Statin Guidelines

December 24th, 2013

The American Heart Association (AHA), in collaboration with the American College of Cardiology (ACC), recently released guidelines that urge a shift in how statins are prescribed. Until now, the drugs had primarily been used to treat high cholesterol; now, the guidelines say they should be used as preventive tools to lower an individual’s overall risk of heart attack and stroke. This change will pave the way for tens of millions of Americans who were previously not candidates for statin therapy to be placed on statins.

Advocates say this new approach will make a big difference in the fight against heart attack and stroke. But in practice such a major change may also have unintended consequences that threaten to move our society even further from prevention toward an increasing reliance on drugs.

Newly Defined Benefit Groups

The new guidelines were the first to be released in nine years and they represent a radical departure from the common practice of focusing on LDL cholesterol and initiating statin therapy to achieve certain targets. Previously, patients were encouraged to keep their LDL cholesterol below 100, and for certain high-risk patients, below 70. Under the new guidelines, treatment should be driven by an individual’s overall risk for heart attack and stroke. Treatment to target goals has been abandoned in the guidelines.

In a departure from previous practice, the guidelines now encourage physicians to prescribe statins to everyone who meets at least one of four newly defined benefit groups:

  1. Anyone whose LDL cholesterol is 190 or above
  2. Anyone who has a history of heart disease
  3. All diabetics between the ages of 40-75
  4. Anyone who has a 10 year risk of having a heart attack or stroke of 7.5 percent or higher.

The new guidelines also make it far less likely that those outside of the four newly identified benefit groups will be placed on a statin. Those under 40, and those who have LDL cholesterol levels above 100, which was previously described as optimal, but below 190, will likely no longer be prescribed a statin, unless their risk is 7.5 percent over 10 years. Those under 40, regardless of their risk factors, rarely if ever have a 10-year heart attack risk of 7.5 percent or higher.

Statins and the Risk Formula

The new guidelines also focus exclusively on statins, which will likely decrease the market share of other cholesterol-lowering agents like Zetia and Vytorin, which have been popular in recent years, as physicians previously sought to combine multiple medications to reach target goals. Since the guidelines have been released, controversy has ensued: Many are questioning whether the calculator physicians were encouraged to use to calculate their patients’ risk may, in fact, overestimate their true risk. If that is the case, the new risk formula would place millions of Americans on a statin, including many who won’t actually benefit. The AHA and ACC stand by the risk formula and guidelines.

The previous guidelines, which drive current practice, were abandoned because clinical trials over the past three years did not show a consistent benefit to treating LDL cholesterol to treatment goals of 70 or 100. The treatment most consistently shown to decrease heart attack risk was statin therapy instituted regardless of the LDL cholesterol level achieved. The guidelines also suggest that statins should be prescribed in the maximum dose tolerable, and encourage the prescription of high-intensity, high-dose statins for many benefit groups.

The policy implications of these guidelines are staggering. Estimates show that if these recommendations are fully implemented, close to a third of all Americans will be placed on a statin. But these developments beg the question: Is this the right policy? Is taking a statin the most effective way for the millions of Americans who are at risk of heart disease to reduce their risk?

When appropriately prescribed, evidence substantiates that statins do reduce heart attack risk, but how do they compare to other interventions? We know that lower cholesterol is better, and we know that statins help to reduce heart disease risk, but we also know that the most effective way to reduce heart disease is not necessarily by taking more pills in ever-increasing doses – it’s to engage in lifestyle change. The best way to reduce risk is by losing weight if overweight, quitting smoking if a smoker, exercising if sedentary, and eating a Mediterranean style diet. Over the past few decades, we have gotten less active, we weigh more, and we eat too much unhealthy food. The new guidelines may have the unintended consequence of de-emphasizing the things that we know reduce risk the most in favor of treatments that are less effective.

Lifestyle change is also emphasized in the guidelines, but it can be very difficult to change deeply embedded behaviors, no matter how unhealthy they may be. When people are unable or unwilling to make those changes, frustrated clinicians looking for another solution often turn to medication as the easy answer for their patients. But a blanket prescription that everyone who has heart disease, or who is at risk for it, take a statin may encourage those most at risk to be lulled into a false sense of security. As cholesterol numbers go down, patients may no longer feel at risk, but the truth is a lot more complicated. For individuals who fall into the four benefit groups, then, yes, the drugs will likely lower their risk of a heart attack; but they will still likely have a heart attack at some point in their life. Medications cannot effectively insulate us from the results of our unhealthy choices.

Statins Offer Benefits But Not For Everyone

Diabetics ages 40 to 75 are among the groups for whom the guidelines recommend regular statin use, and the evidence substantiates that this is good advice. But many diabetics would be able to normalize their blood sugar by losing weight and eating a heart-healthy diet. At the same time, those who are at risk for diabetes may actually increase their diabetes risk even further by taking a statin. On the other hand, according to the National Diabetes Prevention Program, modest behavior change including exercise and healthy diet can help people with pre-diabetes lose 5-7 percent of their total weight and decrease their risk of a diabetes diagnosis by 58 percent. Most people with Type II diabetes can reduce or eliminate their need for medications by making healthy choices. Since two thirds of diabetics die of heart disease or stroke, and many diabetics and heart disease patients already take a statin, they have the most to benefit from sustained lifestyle change.

Statins do offer benefits, but not for everyone. In a 2012 article for the Saturday Evening Post, reporter Sharon Begley cites Dr. Eric Topol, a cardiologist and chief academic officer of Scripps Health. He explains that only one or two out of 100 patients, who don’t have pre-existing heart disease but who do have risk factors will benefit from taking a statin. Other research shows that 68 people would have to take a statin for five years for one to avoid a heart attack while 268 people would have to take a statin for five years for one to avoid a stroke.

Guidelines like those released last month reinforce how far society and our health care system have swung away from prevention and towards the medical model, which treats disease, but often does an inadequate job of promoting public health. Lifestyle change won’t help everyone. Some may still need to take a statin, even after they change their lifestyle. But for many, making healthier choices is enough. As medical science advances, we will continue to have better drugs, and the tendency of providers might be to expand their use. But the solutions to many of the ills that plague large numbers of Americans—high blood pressure, high cholesterol, diabetes, and the heart disease that they cause—do not lie in taking more and more pills to treat more of our preventable chronic conditions. They lie in motivating the millions of Americans who are currently living an unhealthy lifestyle to make better choices.

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3 Responses to “The Unintended Consequences Of The New Statin Guidelines”

  1. Jay Heinecke Says:

    This article makes many statements that are patently false. For example, the author says “The policy implications of these guidelines are staggering. Estimates show that if these recommendations are fully implemented, close to a third of all Americans will be placed on a statin.”

    Really? One third of Americans?

    And I know of no data from randomized, controlled clinical trials showing that “The best way to reduce risk is by losing weight if overweight” or “exercising if sedentary”.

  2. Jim E Says:

    No problem here whatsoever….sort of proves my point in a discussion I had in Iceland recently with regards to the comparison and contrast of various health systems. From an economic and financial standpoint, there continues to be waaaay more money to be made to treat illness versus preventing/mitigating a specific illness in the US. Yes…I know that we as practitioners do make some headway and do try to have our patients do the “right thing’..but…in the grand cosmos of design….realistically…..if everyone did stop smoking, did drink only in moderation, did wear seat belts, did respect each other and decrease crime in general, yadda yadda yadda…then what is the ripple effect on the 30% of the US population that is employed in health care and then therefore MAY no longer be needed to be employed due to said changes and what about the potential increase in medicare outlays that would be needed to keep the non-working, elderly population in metrically appropriate, evidence based health??? At the risk of sounding “conspiracy-driven” (which I am not), what would happen to the US economy if everyone did do the “right thing”?

  3. Erik Says:

    I think these were intended consequences.

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