For the first time in more than a decade, the National Heart, Lung and Blood Institute (NHLBI) is poised to release cholesterol guidelines that may reshape the treatment of millions of Americans.
Currently under institute review, the guidelines – known as ATP IV because they are the fourth revision to original recommendations made in the late ’80s – will set the tone for future clinical practice.
“The new guidelines are meant to provide physicians with a feeling of certainty when they prescribe medications for patients with high-risk conditions, as well as to understand those areas where the best science and the patient’s preference affect a decision,” said Neil Stone, MD ’68, Robert Bonow MD Professor and chair of the panel that developed the cholesterol recommendations.
Science, Not Opinion
When the group of 15 physicians and scientists began the revision process in 2008, they were, for the first time, challenged with emphasizing evidence-based fact while minimizing professional opinion.
“The NHLBI convened a series of panels on cholesterol, hypertension, and obesity, but the guidelines were to be strictly evidence based and instead of wide in scope, they would focus on the answers to several pivotal questions,” said Stone, professor of medicine-cardiology, and a member of the Feinberg Cardiovascular Institute and Center for Behavior and Health.
The cholesterol panel focused on low-density lipoprotein (LDL) and non-high-density lipoprotein cholesterol cut points, as well as the evidence behind the use of lipid-lowering drugs.
“At the end of the day, the answers to our questions and the results from the risk-assessment work group will allow the panel to offer guidance on who should get treated, how intensively, and under what circumstance,” Stone said.
LDL, or “bad,” cholesterol levels were a major component of the institute’s last guidelines released in 2002. Those recommendations called on doctors to push LDL levels below set targets as the concept of low cholesterol became synonymous with heart health.
Because LDL cholesterol can aggregate on the inside of artery walls, causing blockages that can lead to heart attacks, higher LDL cholesterol levels mean higher risk.
For most people, the LDL number to aim for became 130 milligrams per deciliter, while individuals with intermediate-risk factors were told to be below 100 and high-risk patients at 70 or lower. Prevailing opinion helped establish the marks, with an agreed upon notion that the lower the LDL level, the better.
Involved from the Start
Chosen to be part of the NHLBI panel that issued its report in 1988, Stone has played a role in cholesterol guidelines since their inception.
“At that time, most Americans did not know their cholesterol levels and most doctors did not see the value in measuring them. These guidelines changed everything greatly,” Stone said. “The results of that panel were based on a landmark lipid trial that showed that treating cholesterol could reduce the chance of heart attack in those patients who had previously experienced one.”
In the late ’90s, he was again tapped, this time to be a member of the third cholesterol panel. That group recognized statins as a first-line drug for cholesterol based on several landmark trials.
Prescribed mainly to lower LDL cholesterol, a 2010 report from the Centers for Disease Control and Prevention showed that one in four Americans older than 45 were taking statins.
Role as Chair
This time around, Stone is clear to point out the panel’s commitment to science, with a focus on data from randomized clinical trials.
“After framing our questions, an independent group searched the literature and then rated these studies based on quality metrics so we did not look at any study that we felt to be poor in quality,” said Stone, a cardiologist at Northwestern Memorial Hospital. “I like to think of this evidence-based process as providing clinicians with an idea of how much certainty they have toward the decisions that need to be made when dealing with a patient’s cholesterol.”
Making sure the recommendations would reflect the best data available, the panel next developed evidence statements, and finally a series of recommendations.
“It’s been a challenging experience as we have tried to avoid an emphasis on expert opinion to be sure that clinicians get the benefit of what the evidence really shows,” Stone said. “What makes this so difficult is synthesizing all of it into a brief and practical set of guidelines.”
Although the evidence-based protocol marks a new approach to clinical recommendations, after the guideline process began in 2008, the Institute of Medicine indicated that an unbiased, evidence-based approach will be the standard moving forward.
Joining Stone on the ATP IV panel is Donald Lloyd-Jones, MD, ScM, senior associate dean for clinical and translational research. Lloyd-Jones was co-chair of the risk assessment group, whose results were used in developing the guidelines.