Experts offer insights into new CV risk guidelines

Issue: January 2014

Cardiology Today asked its Editorial Board members and other experts in the field to provide perspective on the new American College of Cardiology/American Heart Association/The Obesity Society 2013 Guidelines on Lifestyle Management to Reduce Cardiovascular Risk; Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults; Assessment of Cardiovascular Risk; and Management of Overweight and Obesity in Adults. The guidelines were published online in Circulation and the Journal of the American College of Cardiology.

We welcome you to share your impressions of the guidelines by leaving a comment below.

Rita F. Redberg, MD; Cardiology Today Editorial Board member:

Rita F. Redberg

I think the focus in primary prevention should be on promoting a healthy lifestyle — Mediterranean-style diet, regular physical activity and no smoking. To the extent the guidelines addressed promoting a healthy lifestyle, I thought they were helpful. I also thought the emphasis on risk was excellent. However, I did not understand the reason to switch to a new risk score that includes stroke and transient ischemic attack endpoints and means that healthy Americans all now will be scored at a higher risk, while at the same time the guidelines lowered the threshold for prescribing statins to 7.5% 10-year atherosclerotic CVD (ASCVD) risk, which is a very low-risk group. There was no evidence to support these changes. The result will be that millions more Americans will be recommended to take statins, especially as the requirement of a baseline high LDL level was also removed. The benefits of statins in healthy Americans are slight, a 1% to 2% MI reduction for 5-year use and no reduction in mortality, and the adverse events are plentiful, including diabetes, memory loss, weakness, fatigue, and joint and muscle pains.

Steven E. Nissen, MD; Cardiology Today Editorial Board member:

Steven E. Nissen

The really big change is leaving the idea behind of treating to target levels. That is a very radical tectonic shift in the approach to management of patients with risk for CVD. It will take some time for people to adjust. Another important change is the vast expansion of the number of people for whom statin therapy is recommended. There will be substantial controversy about these new recommendations. One of the biggest ones is that the risk calculator that has now been proposed is brand new and has never been published or validated. Some people think that the risk calculator is not very accurate, and it tends to overestimate risk. If that’s true, then these guidelines will need to be revised very soon.

Alan J. Garber, MD, PhD; Cardiology Today Editorial Board member:

Alan J. Garber

The American Association of Clinical Endocrinologists (AACE) will not endorse the recent CV risk reduction guidelines of the ACC and AHA. The first and most broadly applicable reason is that the new guidelines from ACC and AHA are not consistent with the AACE guidelines for lipid management and CV risk reduction. There is a difference [in] the organizational view of evidence bases for these guidelines: ACC uses a narrow, tightly defined set of relatively few clinical trials, and excluded other forms of clinical evidence from their consideration. While that may appear to be superficially reasonable, there are large populations of patients at risk for CVD in America for whom large-scale randomized controlled trials have never been done, and in whom evidence is otherwise available only through lesser levels of evidence, such as epidemiologic or database analyses.

We believe that patients dying of CVD should benefit from the totality of medical knowledge and medical information, as well as the medical experience of skilled health care professionals. For that reason, we think there should be multiple levels of consideration in the recommendations for CV risk reductions, and that the current guidelines are insufficiently narrow for the broad population in the United States.

Jeffrey I. Mechanick; president, AACE:

Jeffrey I.
Mechanick

The guidelines had been reviewed by AACE; we were unable to endorse these guidelines, although they add quite a bit to the momentum in managing obesity and the obesity epidemic in this country. Firstly, these guidelines fail to view obesity in the full form of a disease, which is what AACE, The Obesity Society and other societies had espoused over the last few years. In fact, at the recent meeting of the American Medical Association in June, using Resolution 420, which was authored by AACE, the AMA adopted a position that obesity is a disease.

These particular guidelines advance the field of obesity by urging all physicians to risk-stratify their patients for risk of obesity and risks as a result of obesity based on the BMI. However, they may fall short in introducing the use of pharmacotherapy, and also using the complications-centric model for risk stratification that AACE has developed. We view all efforts to improve care for the obese patient as movements forward in providing and optimizing health care in this country. But, within the obesity space, we strongly support a position where obesity is genuinely regarded as a disease, and that management is based on a complications-centric approach.

Udho Thadani, MD, MRCP, FRCPC, FACC, FAHA; Cardiology Today Editorial Board member:

Udho Thadani

I have often questioned the previously published treatment guidelines to manage elevated LDL, as many of the recommendations were made on expert opinion rather on solid outcome data from randomized clinical trials. I was pleasantly surprised to note, that in at least one of the four published online guidelines on Nov. 12, 2013, many of the recommendations made are based on the results of randomized clinical outcome trials. In my opinion, this should simplify treatment for secondary prevention in the majority of men and women with ASCVD, by using the high-intensity statin treatment with potent agents such as atorvastatin or rosuvastatin (Crestor, AstraZeneca) — provided the high doses of these drugs are tolerated. From the evidence provided, I do not believe there is any need for routine monitoring of fasting lipids in this group of patients.

However, I have a major concern for the lifetime routine use of the moderate-intensity statin treatment for the primary prevention for patients without diabetes or with LDL <190 mg/dL. The guidelines unfortunately are based on the expert opinion to calculate the Pooled Cohort Equations to estimate ASCVD risk, which to my knowledge has not been prospectively tested. Many middle-aged asymptomatic women and men will qualify according to the guidelines and will be required to take lifelong statin treatment, which may be of only a marginal benefit, with a possible potential for adverse effects during lifelong therapy.

C. Noel Bairey Merz, MD, FACC, FAHA; Cardiology Today Editorial Board member:

C. Noel Bairey
Merz

The new guidelines more precisely identify subjects where clinical trial evidence indicates more benefit than harm compared to the prior guidelines. The guidelines also simplify treatment to use moderate-to-high doses of potent statins in at-risk subjects, optimizing treatment feasibility and limiting cost related to repeated testing and ineffective secondary medications.

Nanette K. Wenger, MD; Cardiology Today Editorial Board Member:

Nanette K. Wenger

The writing committee for the 2013 Guideline on the Assessment of Cardiovascular Risk has done a commendable job. One of the most important changes concerns the global risk score. For years, many have been unhappy with the Framingham risk score because there were a number of important variables that were not captured. The Pooled Cohort Equations are very important. The panel members included Framingham and Framingham offspring data, but they also included recent studies such as ARIC, MESA and other NHLBI databases in these race- and sex-specific pooled cohort equations. This format is online for clinicians to use, and we must aggressively add this to the major electronic medical record formats. The organizations that endorsed this have signed on to that concept. It must be formulated as the best and simplest tool for the clinician to use and for patients to understand. As there’s current excitement about it and as people are talking about it, having it immediately available is important.

Disclosure: Garber reports serving on the AACE board of directors; on advisory boards for Halozyme, Janssen, Merck, Novo Nordisk and Vivus; on speakers’ bureaus for Janssen, Merck, Novo Nordisk, Santarus and Vivus; and consulting for Janssen, Lexicon, Merck, Novo Nordisk, Santarus and Vivus. Mechanick reports receiving honoraria from Abbott Nutrition International for lectures and program development. Wenger reports financial ties with Arbor Pharmaceuticals. Bairey Merz, Nissen, Redberg and Thadani report no relevant financial disclosures.