Love 'Em or Leave 'Em: Experts on Both Sides Debate the New Lipid Guidelines

Michael O'Riordan
January 20, 2014
DALLAS, TX and WASHINGTON, DC It has been two months since the new clinical guidelines
for the treatment of cholesterolwere published[1], and feedback is starting to slowly emerge as
clinicians begin incorporating the recommendations into clinicalpractice.

The American College of Cardiology (ACC) and American Heart Association (AHA)
guidelines, which were developed in conjunction with the National Heart, Lung, and Blood
Institute (NHLBI), were a radical departure from previous iterations, most notably in their
abandonment of LDL-cholesterol targets. In the past, clinicians were advised to treat patients
with cardiovascular disease to less than 100 mg/dL or the optional goal of less than 70 mg/dL.
As reported by heartwire at the time, the expert panel stated there was simply no evidence
from randomized, controlled clinical trials to support treatment to a specific target. As a result,
the new guidelines make no recommendations for specific LDL-cholesterol or non-HDL
targets for the primary and secondary prevention of atherosclerotic cardiovascular disease.
For one clinician, Dr Stanley Hazen (Cleveland Clinic, OH), the strict adherence to only
clinical-trial data is a limitation and not a strength of the new guidelines.
"First, it ignores a wealth of information on the pathophysiology of the disease process.
Second, it presumes that the reason trials are designed is to answer guideline questions," he
told heartwire . "They aren't. Trials are designed by pharmaceutical companies trying to get
claims issued on their drugs. More important, the absence of randomized clinical-trial data
"First, it ignores a wealth of information on the pathophysiology of the disease process.
Second, it presumes that the reason trials are designed is to answer guideline questions," he
told heartwire . "They aren't. Trials are designed by pharmaceutical companies trying to get
claims issued on their drugs. More important, the absence of randomized clinical-trial data
does not justify inaction if LDL cholesterol remains elevated."
Second, it presumes that the reason trials are designed is to answer guideline questions," he
told heartwire . "They aren't. Trials are designed by pharmaceutical companies trying to get
claims issued on their drugs. More important, the absence of randomized clinical-trial data
does not justify inaction if LDL cholesterol remains elevated."
Accelerating Vascular Age
In his commentary published January 8, 2014 in the Cleveland Clinic Journal of Medicine,
Hazen, along with first author Dr Chad Raymond (Cleveland Clinic, OH), lay out their
concerns with the clinical guidelines and highlight some of the shortcoming with the new
recommendations[2].
For Hazen, there are multiple reasons that physicians should continue to treat to specific LDLcholesterol targets, the first and foremost being that patients are different and no single treatment fits

such a large and heterogeneous patient population at risk for cardiovascular disease and stroke. The
guidelines simply call for a moderate- or high-dose statin in high-risk patients depending on the clinical
scenario and no subsequent assessment of LDL cholesterol.
"In the very highest-risk patients, the ones with extraordinarily high levels of cholesterol, those who get
maximally tolerated statins, if there is still a substantial LDL-cholesterol burden, they are going to have
substantial residual risk," he said. "The preponderance of data in aggregate shows that there is higher
residual risk proportionate to the LDL level that's remaining. The new guidelines completely ignore the
pathophysiology of the disease processa disease that takes decades to develop."
The clinical guidelines are unique among documents past in that the emphasis is strictly on statin
therapy rather than LDL-cholesterol-lowering medications more generally. In individuals with
atherosclerotic cardiovascular disease, high-intensity statin therapysuch as rosuvastatin (Crestor,
AstraZeneca) 20 to 40 mg or atorvastatin 40 to 80 mgshould be used to achieve at least a 50%
reduction in LDL cholesterol unless otherwise contraindicated or when statin-associated adverse events
are present. In that case, doctors should use a moderate-intensity statin. Similarly, for those with LDLcholesterol levels >190 mg/dL, a high-intensity statin should be used with the goal of achieving at least
a 50% reduction in LDL-cholesterol levels.
For Hazen, the new clinical guidelines "turn back the clock on cardiovascular disease prevention" and
have the potential to both overtreat older low-risk patients and undertreat those who are young yet are
at higher lifetime risk.
For example, he cites a 25-year-old man who presents because his 45-year-old father just died from a
heart attack. He has a fasting total cholesterol level of 310 mg/dL, HDL cholesterol of 50 mg/dL, triglyceride
level of 400 mg/dL, and LDL cholesterol of 180 mg/dL. Even with the strong family history of premature
coronary disease, because of his young age, the current guidelines do not suggest treatment because they
do not apply to those less than 40 years old. However, even if his age were 40, his calculated 10-year risk
would be <7.5% based on a new and controversial risk calculator published alongside the guidelines.

References
1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the
treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A
report of the American College of Cardiology/American Heart Association. J Am Coll
Cardiol 2013. Article. Circulation 2013. Article.
2. Raymond C, Cho L, Rocco M, Hazen SL. New cholesterol guidelines: Worth the
wait? Cleve Clin J Med 2014; DOI: 10.3949/ccjm.81a.13161. Article