Cleveland Clinic heart and vascular specialists are responding with mixed reactions to new cholesterol guidelines for preventing heart disease recently published by The American Heart Association (AHA) and American College of Cardiology (ACC).
They applaud the recommendation to use statins to lower blood cholesterol levels in a wider group of patients, but favor a measured, individual approach.
Contrary to the new recommendation by the AHA/ACC, they favor sustaining the use of LDL-C target goals.
They say advice to stop using LDL-C target goals is based on limited information — only major randomized control trials (RTCs) and meta analyses of RCTs — while Cleveland Clinic Preventive Cardiology guidelines are based on major RCTs as well as pathophysiology, a large number of clinical trials, epidemiologic data and clinical experience with patients.
Cleveland Clinic experts also recommend caution in using a new risk calculator proposed by the new guidelines until further validation.
Expanding statin use, caveats
Based on recent research based solely on rigorous randomized controlled trials, the guidelines advise physicians to prescribe statins for patients with heart disease, as well as those found to be “at risk” for heart disease in the next 10 years.
The guidelines widen the pool of those “at risk” to include patients:
- With diabetes
- At risk for a stroke
Cleveland Clinic specialists say that emphasizing moderate- to high-intensity statin therapy in these newly defined “at risk” patients (including those at moderate to high risk) should have substantial long-term public health benefits.
However, they caution that basing guidelines exclusively on outcomes from randomized controlled trials offers limited information and can’t paint the entire picture of a patient’s risk factors and overall cardiovascular risks.
They note that applying the new guidelines results in overtreatment in some patients, particularly the elderly.
Even worse, they say that the new guidelines will lead to undertreatment of others who are at increased lifetime risk, but are younger than middle age, and thus represent a sector of the population not easily tested in randomized control trials.
This is because the new guidelines do not make recommendations for patients less than age 40 as they are rarely studied in randomized controlled trials in which outcomes like heart attack, stroke, and death are the primary end points.
Overall, the experts say the guidelines need to be crafted by looking at the totality of evidence. They need to take into account the pathophysiology of the disease process – not just data from randomized controlled trials.
The doctors emphasize that cardiovascular disease takes decades to develop, and preventative efforts need to begin early in life – and not delay prescriptive preventive efforts (i.e. statins in those with moderately high LDL-c) until middle age, which is what the guidelines effectively foster.
Why retain LDL cholesterol target goals
The recommendation to eliminate target goals for lowering bad cholesterol is a major concern of the Cleveland Clinic experts.
For certain patients, they say this could cause confusion – not just for patients but also for doctors. Some patients could fall into a “treatment limbo,” with no clear direction about what they should do.
Benefits of retaining target goals to lower LDL-C (bad cholesterol) include:
- Tracking method for patients making lifestyle and dietary changes
- Guidance for healthcare providers making treatment decisions (with a focus on treating a single patient, and not a population)
The target goals allow doctors to gauge heart disease risk in patients who are taking intermediate- or high-potency statins, but for whom inadequate LDL-C lowering has occurred. Moreover, Cleveland Clinic experts say if a patient has difficulty taking standard doses of statins because of side effects, the absence of LDL-C goals makes decision-making nearly impossible.
Risk calculator yields uneven results
Another new guideline recommendation is the use of a newly released “risk calculator,” which will be used to determine who receives medication and who doesn’t.
However, in testing it, Cleveland Clinic experts have found that its calculations yield uneven results. For this reason, they have lingering concerns and advise that the calculator needs further testing and reporting in peer-reviewed publications, allowing vetting in multiple independent patient populations to evaluate its accuracy.
What patients can do
If you’re a patient and wondering how to respond to the new guidelines, Cleveland Clinic experts advise you to have a frank discussion with your doctor. Ask questions and work closely with your doctor for an individualized, studied approach to preventing heart disease, as well as other conditions.
Health policy changes
On a broader scale, Cleveland Clinic experts say caution and great scrutiny are in order when making widespread health policy changes. There are more long-term benefits to such an approach, including more public acceptance, they say.
*A note of thanks to Cleveland Clinic experts who weighed in on this post, including: Steven Nissen, MD, Chairman, Department of Cardiovascular Medicine; Stanley Hazen, MD, PhD, Head, Preventive Cardiology; Leslie Cho, MD, Section Head of Preventative Cardiology and Rehabilitation; Michael Rocco, MD, Medical Director of Cardiac Rehabilitation and Stress Testing, Section of Preventive Cardiology; and Chad Raymond, DO, Section of Preventative Cardiology. More detailed commentary can be found at CCJM