Changing the Statins Quo

The controversy around the new cholesterol treatment guidelines

Published on March 19, 2014by Chris Tait

Considering that one in three Americans will die of cardiovascular disease, and that 60 percent will have either a heart attack or a stroke at some point in their lives, preventive measures have become increasingly valued among patients and doctors.

But how to go about preventing cardiovascular disease has been a controversial issue.

That controversy ramped up in November, with the American College of Cardiology (ACC) and the American Heart Association (AHA)’s  new cholesterol guidelines, which were developed to help clinicians determine when they should prescribe a particular cholesterol-lowering medication, known as a statin, to treat high cholesterol.

At the center of the debate has been one of the major changes in recommendations, a reformulation of how a patient’s risk for cardiovascular disease is calculated. This change, informed by the latest scientific research, is meant to identify people whose overall health will improve from statin use while reducing the number of those who are less likely to benefit, according to the ACC/AHA committee.

But months after the release, the new guidelines remain strongly contested by members of the medical community who worry that the recommendations may result in over-prescription of statins and may be more of a boon for drug companies than patients.

Statins like Lipitor and Crestor are a group of drugs that reduce the amount of cholesterol produced by the liver. They are commonly prescribed for patients at risk of heart attack and stroke as well as a number of other adverse cardiovascular conditions.

While the prevalence of heart disease has remained relatively steady throughout the past decade, the use of statin medication to prevent it has escalated dramatically—about ten-fold over the past 20 years.

After the last time the ACC/AHA guidelines were updated, in 2001, there was a three-fold increase in the number of Americans for whom statin therapy was recommended which has prompted concern that statins are being over-prescribed.

Those criticizing the 2013 recommendations worry the number of Americans taking statins will double from 36 million to 72 million patients—one-third of adults over the age of 40. However, studies find that statins reduce cholesterol in many patients who have not had success with a heart healthy diet and exercise, and are credited with saving thousands of lives from premature cardiovascular death, according to a meta-analysis published in the Journal of the American Medical Association.

Since 2001, the body of evidence surrounding the effectiveness of statin therapy has greatly expanded, largely through randomized clinical trials, which are the gold standard in medical research.

According to the ACC/AHA panel, the research suggests that four groups of individuals, distinguished by age and clinical risk factors, would benefit from statin-therapy and that statins safely reduce incidence of cardiovascular disease events, like heart attacks and strokes.

Drawing on this research, the ACC and AHA made available an online risk calculator to help physicians estimate their patients’ 10-year risk for cardiovascular disease based on traditional clinical and lifestyle risk factors.

Supporting clinicians say the tool is user-friendly and will help foster important conversations between patients and doctors who are deciding on an appropriate medication regimen.

Opponents, however, challenge the calculator, on the grounds that it greatly overestimates one’s cardiovascular disease risk, potentially resulting in millions being unnecessarily prescribed to statin therapy.

Some experts, like Dr. Peter Alagona, Pennsylvania State University’s program director for diagnostic cardiology, express concerns about the impact of the new guidelines on payments for medical treatment.

He wonders whether patients who fall outside of the new guidelines but whose doctors recommend they stay on statin therapy would be denied reimbursement from their insurance companies.

And in a New York Times op-ed published immediately after the release of the guidelines, Dr. John Abramson, professor of primary care at Harvard Medical School, criticized the ACC/AHA panel for their alleged ties to the pharmaceutical industry, which he said would stand to benefit more than anyone should statin prescriptions increase according to projections.

Dr. Abramson argues that drug treatment in general provides false reassurances that discourage patients from making lifestyle changes to treat and prevent against cardiovascular disease.

But Dr. Neil Stone, who chaired the panel that developed the 2013 guidelines and who is a professor of cardiology at Northwestern University’s Feinberg School of Medicine, attributes the contentious debate to one particular component of the new guidelines.

Previously, patients were recommended to take a statin if their level of LDL cholesterol was above a certain threshold. Subsequently, they were recommended to get their LDL level down to 70 milligrams per deciliter, sometimes meaning taking statins in conjunction with other medications which has never been proven to prevent against cardiovascular disease.

Because evidence from recent randomized clinical trials does not provide enough support for treatment based on these targets, the new guidelines identified four groups of patients on whom physicians should focus their efforts to reduce cardiovascular disease events:

  1. Anyone with a history of cardiovascular disease
  2. Those with elevated LDL cholesterol
  3. Anyone with diabetes between ages 40-75
  4. Those without diabetes, with elevated cholesterol, aged 40-75, with a ≥ 7.5 percent 10-year risk of cardiovascular disease according to the risk calculator

The controversy is centered on those in the fourth group. Critics worry that the risk calculator will cause physicians to prescribe statins to patients who previously weren’t on the medication.

Dr. Stone says most critics of the new guidelines did not appreciate additional recommended steps put out by the panel, which address how to proceed in treating patients in this particular group.

The new recommendations are more comprehensive in using the latest evidence to ensure that the decision to begin statin therapy will prove to be beneficial., he says. In fact, some patients who were previously on statins according to the old guidelines, may be encouraged to adopt lifestyle changes before seeking medication, pending a discussion with their physician, according to Dr. Stone.

Dr. Stone also says that the guidelines do not unquestionably prescribe statin therapy to patients in this group, but rather call for a collaborative decision-making process between the physician and patients that provides an opportunity for a pragmatic discussion that balances scientific evidence with individual values, context, and ultimately the preferences of the patient.

This component of the guidelines should quell critics’ fears that the risk calculator will be used in an overly simplistic fashion.

“The decision to prescribe statins is not automatic. Risk discussion with a physician needs to take place for those in this group,” says Dr. Stone

And while a “heart healthy lifestyle” is always the primary recommendation for those susceptible to cardiovascular disease, which includes a balanced diet and regular exercise, lifestyle changes may not always be enough for those at highest risk, especially in the short term.

Dr. Stone believes that some of the media reporting has obscured his committee’s  recommendations: “Translating to physicians means getting the word out on what we actually said. It’s unfair for them to have to hear misconceptions about what wasn’t said.”

Edited by Kathleen Bachynski, Josh Brooks, and Elaine Meyer