Cleveland Clinic has been ranked #1 in Heart Care since 1995 and continues to do so. In response to the new ACC/AHA cholesterol guideline in an issue of the Cleveland Clinic Journal of Medicine, physician leaders in the Section of Preventive Cardiology presented a review of the recent ACC/AHA guideline on the treatment of blood cholesterol. Although the authors respectfully address advantages to the different approach the 2013 ACC/AHA guideline used to addressing high cholesterol (resulting in the recommendation to use higher intensity statins and dosing), they also address the fact that this guideline, based only on randomized controlled trials (RCTs), is “idealistic” and ends up with “significant limitations.” 1
“An entire generation of patients who have not reached the age of inclusion (40 years) in most randomized controlled trials with hard outcomes is excluded (unless the LDL-C level is very high), potentially setting back decades of progress in the field of prevention. Prevention only works if started.” 1 Limitations of the cholesterol guideline listed in the article include: lack of information from RCTs with non-statin therapies such has niacin, avoidance of research findings that have led to our current understanding of the pathophysiology of atherosclerotic disease, no information from genetic studies that link exposure of atherogenic particles over lifetime with cardiovascular risk, and failure to address volumes of information addressing the relationship between low-density lipoprotein cholesterol (LDL-C) levels with risk of clinical events, regardless of how LDL-C was lowered (e.g., benefit of lowering LDL via ileal bypass). They remind us that lack of information from controlled trials is not equal to lack of benefit from various therapies and that RCTs often don’t address the types of patients we see in clinical practice settings.
The authors present case studies using the new ACC/AHA guideline and show reasons for concern for both potential over and under-treatment of patients with statins. For example, in patients with lipoprotein “little a” [Lp(a)] excess, elevated inflammatory markers and/or rheumatoid arthritis, the authors suggest treatment based on other types of research data (not RCTs). They express concerns related to the idea that therapy for patients is not “tailored to the individual” and lack of guidance in how to treat patients who have recurrent cardiovascular events when already on recommended statin therapy.1
Concerns addressed in the commentary also include the fact that the panel of experts who developed the ACC/AHA guideline did not try to harmonize their approach with previous lipid/lipoprotein guidelines or current international recommendations. The Cleveland Clinic authors “suggest caution in strict adherence to the new guidelines and urge physicians to consider a hybrid of the old guidelines and the new ones”.1 They recommend using LDL-C and non-HDL-C goals and targets and lowering Apolipoprotein B (Apo B) and LDL-particle number as recommended by other recently published expert guidelines but also using the new guideline to “emphasize global risk assessment and high-intensity statin treatment.” 1*
The commentary goes on to state that “removing LDL-C goals is a fundamental flaw of the new guidelines.” 1
Reference: Raymond C, Cho L, Rocco M, and Hazen S. New cholesterol guidelines: Worth the wait? Cleveland Clinic J of Med. 2014; 81: 11-19.
*Refer to the Cleveland HeartLab web site video re: the Latest Recommendations on Standard and Advanced Lipids from our 2012 Cleveland HeartLab Symposium for recent recommendations from other expert groups including the American Diabetes Association, American Association of Clinical Endocrinologists, the International Atherosclerosis Society, and the National Lipid Association.