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Research Letter |

Eligibility for Statin Therapy According to New Cholesterol Guidelines and Prevalent Use of Medication to Lower Lipid Levels in an Older US Cohort The Atherosclerosis Risk in Communities Study Cohort FREE

Michael D. Miedema, MD, MPH1; Faye L. Lopez, MS, MPH2; Michael J. Blaha, MD, MPH3; Salim S. Virani, MD, PhD4; Josef Coresh, MD, PhD5; Christie M. Ballantyne, MD6,7; Aaron R. Folsom, MD, MPH2
[+] Author Affiliations
1Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
2Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis
3Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins School of Medicine, Baltimore, Maryland
4Center for Innovations, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
5Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
6Section of Cardiovascular Research, Department of Medicine, Baylor College of Medicine, Houston, Texas
7Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
JAMA Intern Med. 2015;175(1):138-140. doi:10.1001/jamainternmed.2014.6288.
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Published online

The 2013 guidelines of the American College of Cardiology and American Heart Association (ACC/AHA) for treatment of cholesterol levels recommend statin therapy for individuals at an elevated absolute risk for cardiovascular disease (CVD).1 This risk-based approach is a paradigm shift from prior Adult Treatment Panel (ATP) III guidelines2 that were influenced heavily by thresholds for low-density lipoprotein cholesterol levels. A recent analysis estimated that the ACC/AHA guidelines will lead to a significant increase in statin use in the United States, largely owing to an increase in the eligibility of adults older than 60 years without CVD or diabetes mellitus.3 The effect of the new guidelines on older individuals is important because they are at high risk for CVD but also may be prone to the adverse effects of statin use.4 The aim of this study was to analyze the potential effect of the new guidelines and contemporary use of statins in older black and white individuals in the Atherosclerosis Risk in Communities (ARIC) cohort using recent data.

The study was approved by the institutional review boards of the participating universities, and all participants provided written informed consent. We performed a cross-sectional analysis of black and white participants in the ARIC Study who participated in study visit 5 (2011-2013). The ARIC Study is a longitudinal study of CVD sponsored by the National Heart, Lung, and Blood Institute.5 Of the 10 036 ARIC participants who were alive through August 31, 2013, a total of 6538 participants took part in visit 5 (response rate, 65.1%). Of these, 6088 (mean age, 75.6 years [range, 66-90 years]; 58.4% female) had sufficient data to be included in the study.

Medication use was verified by reviewing medications that participants brought to the visit. We analyzed the prevalence of indications for statin therapy according to ACC/AHA guidelines and ATP III guidelines (which were the most relevant guidelines at the time of ARIC visit 5) and the use of statins and other medications to lower lipid levels.

A considerable portion of the ARIC cohort used medication to lower lipid levels at visit 5, but uncontrolled hyperlipidemia was still common according to the ATP III guidelines then in place (Table 1). Individuals with a high absolute risk for coronary heart disease (>20% for 10 years) were the least likely to be at their goal for low-density lipoprotein cholesterol levels (49.2% not at goal), whereas participants with not more than 1 risk factor for coronary heart disease were most likely to be at goal (18.6% not at goal). Full implementation of the prior ATP III guidelines should have resulted in treatment of 72.8% of our sample.

Table Graphic Jump LocationTable 1.  Prevalence of Hyperlipidemia and Rates of Control According to ATP III Cholesterol Guidelines in 6088 Participants From Visit 5 of the ARIC Study, 2011-2013

In contrast, according to ACC/AHA guidelines, 97.1% of ARIC participants 75 years or younger met 1 of the 4 major indications for statin therapy (clinical CVD, diabetes, low-density lipoprotein cholesterol level >190 mg/dL [to convert to millimoles per liter, multiply by 0.0259], or absolute 10-year CVD risk ≥7.5%) (Table 2). Of these individuals 75 years or younger, 49.8% were taking a statin but only 9.0% were taking a high-intensity statin (Table 2). Half the cohort studied was older than 75 years and 53.2% of these individuals were taking a statin. Individuals older than 75 years are not included in the ACC/AHA guidelines owing to lack of evidence in this age group. These findings confirm that implementation of the new guidelines should increase statin use significantly in individuals aged 65 to 75 years.

Table Graphic Jump LocationTable 2.  Frequency of Eligibility for Statin Therapy and Prevalence of Medication Use to Lower Lipid Levels According to ACC/AHA Guidelines in 6088 Participants From Visit 5 of the ARIC Study, 2011-2013a

The increase in statin eligibility according to the new guidelines is largely a consequence of the 7.5% CVD risk threshold in primary prevention. Although substantial evidence supports a risk-based approach for statin allocation,1 the 7.5% CVD risk threshold is aggressive, creating a nearly universal recommendation for statin use in individuals aged 65 to 75 years. The recently updated lipid guidelines in the United Kingdom6 have chosen a 10% risk threshold for CVD to allocate statin use. The ideal risk threshold for CVD, the optimal role for statin therapy in the elderly, and the overall utility of statin therapy in primary prevention remain highly controversial topics that require further research.

Corresponding Author: Michael D. Miedema, MD, MPH, Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, 800 E 28th St, Minneapolis, MN 55414 (mdm307@mail.harvard.edu).

Published Online: November 17, 2014. doi:10.1001/jamainternmed.2014.6288.

Author Contributions: Dr Miedema and Ms Lopez had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: Miedema, Lopez, Blaha, Virani, Folsom.

Drafting of the manuscript: Miedema.

Critical revision of the manuscript for important intellectual content: Lopez, Blaha, Virani, Coresh, Ballantyne, Folsom.

Statistical analysis: Miedema, Lopez.

Obtained funding: Coresh, Folsom.

Administrative, technical, or material support: Virani.

Study supervision: Folsom.

Conflict of Interest Disclosures: Dr Ballantyne has received institutional grant support from Abbott Diagnostics, Amarin, Amgen, Eli Lilly, Esperion, GlaxoSmithKline, Genentech, Merck, Novartis, Pfizer, Regeneron, Roche, Roche Diagnostic, Sanofi-Synthelabo, the National Institutes of Health, and the American Heart Association and has served as a consultant to Abbott Diagnostics, Aegerion, Amarin, Amgen, Arena, Cerenis, Esperion, Genentech, Genzyme, Kowa, Merck, Novartis, Pfizer, Resverlogix, Regeneron, Roche, and Sanofi-Synthelabo. No other disclosures were reported.

Stone  NJ, Robinson  J, Lichtenstein  AH,  et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines.  2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;6(25, part B):2889-2934.
PubMed   |  Link to Article
National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).  Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421.
PubMed
Pencina  MJ, Navar-Boggan  AM, D’Agostino  RB  Sr,  et al.  Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431.
PubMed   |  Link to Article
Pasternak  RC, Smith  SC  Jr, Bairey-Merz  CN, Grundy  SM, Cleeman  JI, Lenfant  C; American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute.  ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Circulation. 2002;106(8):1024-1028.
PubMed   |  Link to Article
ARIC Investigators.  The Atherosclerosis Risk in Communities (ARIC) Study: design and objectives. Am J Epidemiol. 1989;129(4):687-702.
PubMed
National Collaborating Centre for Primary Care (UK). Lipid modification: cardiovascular risk assessment of blood lipids for the primary and secondary prevention of cardiovascular disease [Internet]. London, England: Royal College of General Practiioners (UK): July 2014. http://www.nice.org.uk/guidance/cg181/resources/guidance-lipid-modification-cardiovascular-risk-assessment-and-the-modification-of-blood-lipids-for-the-primary-and-secondary-prevention-of-cardiovascular-disease-pdf. Accessed May 15, 2014.

Figures

Tables

Table Graphic Jump LocationTable 1.  Prevalence of Hyperlipidemia and Rates of Control According to ATP III Cholesterol Guidelines in 6088 Participants From Visit 5 of the ARIC Study, 2011-2013
Table Graphic Jump LocationTable 2.  Frequency of Eligibility for Statin Therapy and Prevalence of Medication Use to Lower Lipid Levels According to ACC/AHA Guidelines in 6088 Participants From Visit 5 of the ARIC Study, 2011-2013a

References

Stone  NJ, Robinson  J, Lichtenstein  AH,  et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines.  2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;6(25, part B):2889-2934.
PubMed   |  Link to Article
National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).  Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421.
PubMed
Pencina  MJ, Navar-Boggan  AM, D’Agostino  RB  Sr,  et al.  Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431.
PubMed   |  Link to Article
Pasternak  RC, Smith  SC  Jr, Bairey-Merz  CN, Grundy  SM, Cleeman  JI, Lenfant  C; American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute.  ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Circulation. 2002;106(8):1024-1028.
PubMed   |  Link to Article
ARIC Investigators.  The Atherosclerosis Risk in Communities (ARIC) Study: design and objectives. Am J Epidemiol. 1989;129(4):687-702.
PubMed
National Collaborating Centre for Primary Care (UK). Lipid modification: cardiovascular risk assessment of blood lipids for the primary and secondary prevention of cardiovascular disease [Internet]. London, England: Royal College of General Practiioners (UK): July 2014. http://www.nice.org.uk/guidance/cg181/resources/guidance-lipid-modification-cardiovascular-risk-assessment-and-the-modification-of-blood-lipids-for-the-primary-and-secondary-prevention-of-cardiovascular-disease-pdf. Accessed May 15, 2014.

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