Timothy P. Hofer, MD, MSc; Jeremy B. Sussman, MD, MSc; Rodney A. Hayward, MD
This article was published at www.annals.org on 9 February 2016.
Financial Support: Drs. Hofer and Hayward are supported by the Michigan Center for Diabetes Translational Research (National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health [P60 DK-20572]). Dr. Sussman is supported by a Veterans Affairs Health Services Research and Development Service Career Development Award.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2428.
Requests for Single Reprints: Timothy P. Hofer, MD, MS, Veterans Affairs Center for Clinical Management Research, Institute for Health Policy and Innovation, North Campus Research Complex, Building 16-328W, 2800 Plymouth Road, SPC 2800, Ann Arbor, MI 48109-2800; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Hofer and Sussman: Veterans Affairs Center for Clinical Management Research, Institute for Health Policy and Innovation, North Campus Research Complex, Building 16-328W, 2800 Plymouth Road, SPC 2800, Ann Arbor, MI 48109-2800.
Dr. Hayward: Director, National Clinician Scholars Program, Institute for Health Policy and Innovation, North Campus Research Complex, Building 10, Room G016, 2800 Plymouth Road, SPC 2800, Ann Arbor, MI 48109-2800.
Author Contributions: Conception and design: T.P. Hofer, J.B. Sussman, R.A. Hayward.
Analysis and interpretation of the data: R.A. Hayward.
Drafting of the article: T.P. Hofer.
Critical revision of the article for important intellectual content: T.P. Hofer, J.B. Sussman, R.A. Hayward.
Final approval of the article: T.P. Hofer, J.B. Sussman, R.A. Hayward.
Statistical expertise: R.A. Hayward.
Hofer T., Sussman J., Hayward R.; New Studies Do Not Challenge the American College of Cardiology/American Heart Association Lipid Guidelines. Ann Intern Med. 2016;164:683-684. doi: 10.7326/M15-2428
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Published: Ann Intern Med. 2016;164(10):683-684.
Published at www.annals.org on 9 February 2016
The 2013 lipid guidelines from the American College of Cardiology and the American Heart Association broke from earlier guidelines by focusing on cardiovascular risk rather than low-density lipoprotein (LDL) cholesterol levels or targets to guide lipid treatment. However, many have called for a return to LDL cholesterol targets, citing recent evidence that nonstatin lipid-lowering medications can also reduce cardiovascular outcomes (1, 2). This evidence includes IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial), which found that adding ezetimibe to statin therapy decreased cardiovascular events by 6% to 7% in patients with acute coronary syndrome (3). In addition, clinical trials examining a new class of lipid-lowering agents (proprotein convertase subtilisin/kexin type 9 antibodies [PCSK9-abs]) found a relative reduction of up to 50% in cardiovascular events (4). Should this new evidence lead us to abandon risk-based approaches and return to the LDL-based, treat-to-target approach?
Thomas F. Whayne, Jr, MD, PhD, FACP
Gill Heart Institute; University of Kentucky
June 14, 2016
Contintued controversy regarding a tailored or targeted approach to LDL-C
In their Ideas and Opinions commentary, Hofer et al. offer up more controversy and potential confusion regarding a targeted or tailored reduction of low-density lipoprotein cholesterol (LDL-C) as they firmly state that the available new clinical evidence reinforces the importance of cardiovascular (CV) risk and the secondary importance of LDL-C levels (1). Elimination of LDL-C targets was first proposed by Hayward and Krumholz (2). Nevertheless, CV risk benefit from the reduction of LDL-C has been well-established for many years by multiple studies such as ileal bypass, long before consideration of additional pleiotropic effects of statins (3). In a private academic CV consulting practice, it remains quite frequent to see referred high-risk CV patients with no attention paid to LDL-C or the use of a statin. The 2013 American College of Cardiology/American Heart Association Guideline advocates a high-dose statin for the high risk CV patient and assessment of risk by cohort equations on a computer (4). This computer assessment is not going to happen when a busy primary care practitioner is facing a full waiting room of patients he or she is late seeing. The secret is to keep it simple. A strategy of LDL-C reduction to a specific target does not interfere with awareness of the complexities of atherosclerosis and our need for increased understanding of these many unknowns (5). An experienced clinician recognizes that each patient requires individualized management. Why not put the issue of an LDL-C target to rest by an acknowledgement that each patient needs a tailored approach based on a clinical assessment of CV risk that includes baseline lipid levels as well as multiple other CV risk factors? From this tailored approach, a target for LDL-C could then be set based on the starting level and the appropriate intensity of statin and other management. Therefore, each patient should have a plan tailored to their individual clinical status with a different LDL-C target for each patient. Too much has been made of what should be a simple plan that is tailored to each patient situation, guided by a target for LDL-C. There is ample evidenced-based medicine to support this proposal to simplify controversy, put the issue to rest, and avoid confusion that some major new approach is indicated. Unfortunately, the lipid hypothesis is still not adequately accepted and followed by many practitioners. A direct simple approach is more likely to improve this unfortunate reality.
Thomas F. Whayne, Jr, MD, PhD, FACP
Professor of Medicine (Cardiology)
Gill Heart Institute
University of Kentucky
Lexington, KY 40536-1200
Timothy P. Hofer, MD, MSc, Rodney A. Hayward, MD
University of Michigan
July 22, 2016
Dr. Whayne reiterates some common concerns about the new ACC/AHA guidelines, namely that they somehow undermine the low-density lipoprotein (LDL) hypothesis, will cause practitioners to undertreat high risk patients and will take too much time relative to a treat-to-target approach for primary care practitioners (PCPs). Although interestingly, he goes on to suggest what sounds like a potentially even more complex approach whereby PCPs should have a “plan tailored to [each patient’s] individual clinical status with a different LDL-C target for each patient”.We clearly stated that the evidence we cited supporting the benefit based treatment approach (BTT) was based on assuming that LDL is the sole mechanism of statin’s cardiovascular disease (CVD) reduction. The ACC/AHA guidelines do not undermine or ignore the LDL hypothesis but reflect accumulating evidence that, even accepting the LDL hypothesis, overall CVD risk remains the most important factor in estimating a patient’s absolute risk reduction from LDL reduction and a BTT approach will save more lives than a treat to target approach.(1)As two primary care providers with over 50 combined years in practice, we can say that far from making life more complicated for PCPs, dropping LDL targets provides substantial simplification of work for PCPs in terms of monitoring LDL and adjusting statin doses. Calculating CVD risk has been recommended by all lipid guidelines since ATP III so hardly can be said to be new additional work imposed by the ACC/AHA guidelines. PCPs also need to assess CVD risk to follow Aspirin primary prevention guidelines. Cardiovascular risk assessment is also equally important for making optimal decision regarding blood pressure treatment (2). Furthermore, given that cardivovascular risk was an entry criteria for the recent SPRINT trial(3), it is almost certain to be in any subsequent updates of hypertension treatment guidelines. Primary care practitioners have more than enough reasons to calculate the cardiovascular risk of their patients and it can then be used across multiple decision tasks in primary care, simplifying their work rather than complicating it and improving their patients outcomes.Finally, based once again on the specific arguments and evidence we presented in our article, we respectfully disagree with Dr. Whayne’s statement without reference that “[t]here is ample evidenced-based medicine to support” a treat to target approach.Timothy P. Hofer, MD and Rodney A. Hayward, MD1. Hayward RA, Krumholz HM, Zulman DM, Timbie JW, Vijan S. Optimizing statin treatment for primary prevention of coronary artery disease. Ann Intern Med. 2010;152:69-77. [PMID: 20083825]2. Sussman J, Vijan S, Hayward R. Using benefit-based tailored treatment to improve the use of antihypertensive medications. Circulation 2013 Nov;128(21):2309–2317. PMID: 24190955 PMCID: PMC40262013. SPRINT Research Group, Wright JT, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N. Engl. J. Med. 2015 Nov;373(22):2103–2116. PMID: 26551272 PMCID: PMC4689591
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