Author + information
- Neil J. Stone, MD, MACP∗ (, )
- C. Noel Bairey Merz, MD,
- Karol E. Watson, MD, PhD and
- Sidney C. Smith Jr., MD
- ↵∗Northwestern Medicine, 676 North St. Clair; Suit 600 (Cardiology), Chicago, Illinois 60611
As part of the writing group for the 2013 American College of Cardiology/American Heart Association Cholesterol Guidelines for adults, we wish to point out that the recent paper by Maddox et al. (1) contains some important inaccuracies about the cholesterol guidelines that should be corrected.
First, they incorrectly state what the cholesterol guideline wrote about the use of nonstatins (2). While it is true that the cholesterol guidelines do not make a Class I recommendation of nonstatin therapies for routine risk reduction of atherosclerotic cardiovascular disease (ASCVD), there is an entire section on nonstatins, including the following paragraph on page 2913 in Section 6.3.2 of the guideline.
Clinicians treating high-risk patients who have a less-than-anticipated response to statins, who are unable to tolerate a less-than-recommended intensity of a statin, or who are completely statin intolerant, may consider the addition of a nonstatin cholesterol-lowering therapy. High-risk individuals include those with ASCVD, those with LDL-C ≥190 mg/dl, and those with diabetes 40–75 years of age. In this situation, this guideline recommends clinicians preferentially prescribe drugs that have been shown in RCTs to provide ASCVD risk-reduction benefits that outweigh the potential for adverse effects and drug-drug interactions and consider patient preferences (2).
This not an inconsequential point. In recent randomized controlled trials (RCTs), niacin and ezetemibe, when added to intensive statin therapy, both lowered low-density lipoprotein cholesterol (LDL-C), but the addition of niacin did not result in improved outcomes and was associated with safety issues (3,4). This is contrasted with a recently reported RCT in a high-risk acute coronary syndrome population with 1 high-risk feature, where addition of ezetemibe to a moderate-intensity statin was shown to be both safe and incrementally effective (5).
Second, they incorrectly state what the guidelines say about follow-up therapy. Although the guidelines no longer endorse arbitrary LDL-C goals, we are uncertain how the authors could infer that the guidelines require little or no follow-up therapy.
Figure 5, entitled “Monitoring Therapeutic Response and Adherence,” and associated text on pages 2912 to 2913 indicate that the guidelines endorse follow-up lipids, especially LDL-C. Follow-up lipids are needed to not only determine attainment of the therapeutic response to the appropriate intensity of statin, but also to monitor adherence to statin and lifestyle therapy.
Both of these errors are serious threats to the appropriate use of this evidence-based guideline. We respectfully request that Maddox et al. submit an erratum to the journal to correct these inaccurate statements regarding the 2013 American College of Cardiology/American Heart Association guideline on the treatment of blood cholesterol to reduce the risk of atherosclerotic cardiovascular risk in adults.
Please note: Dr. Bairey-Merz is a consultant to Gilead (grant study section), Pfizer, and Amgen; and has received research grants from the National Heart, Lung, and Blood Institute (NHBLI), Gilead, and the Flight Attendants Medical Research Institute (FAMRI). Dr. Watson is a consultant with Merck and Daiichi Sankyo, and has received grants from NHLBI, NIDDK, BD2K consortium (all NIH). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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