Statin Guidelines: The Past, The Present, and The Future
Abstract
In June of 2013 the American College of Cardiology and American Heart Association released a revised version of guidelines regarding the recommendations of HMG CoA reductase inhibitors (statins). Following this, the United States Preventive Services Task Force released its own set of guidelines regarding the use of statins in 2016. Both sets of guidelines included recommendations that differed significantly from previously established statin recommendations. However, the guidelines included several differences between the two sets. This article discusses both sets of guidelines and reviews the published literature analyzing the adoption of the new recommendations.References
Stone NJ, Robinson JG, Lichtenstein AH, et al. 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. Circulation. 2014;129
Downs J, Clearfield M, Weis S et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels. Results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998; 279:1615–1622.
Nakamura H, Arakawa K, Itakura H et al. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Lancet 2006; 368:1155–1163.
Ridker PM, Danielson E, Fonseca FAH et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359:2195–207.
Pedersen TR, Faergeman O, Kastelein JJP et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005; 294:2437–45.
Rana JS, Tabada GH, Solomon MD, et al. Accuracy of the atherosclerotic cardiovascular risk equation in a large contemporary, multiethnic population. J Am Coll Cardiol. 2016;67(18):2118–2130.
Cook NR, Ridker PM. Further insight into the cardiovascular risk calculator controversy: the roles of statins, revascularizations, and under-ascertainment in the Women's Health Study. JAMA Intern Med. 2014;174(12):1964–1971.
DeFilippis AP, Young R, Carrubba CJ, et al. An analysis of calibration and discrimination among multiple cardiovascular risk scores in a modern multiethnic cohort. Ann Intern Med. 2015;162(4):266–275.
Bibbins-Domingo K, Grossman DC, Curry SJ, et al; US Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(19)1997-2007.
Pagidipati NJ, Navar A, Mulder H, Sniderman AD, Peterson ED, Pencina MJ.
Comparison of recommended eligibility for primary prevention statin therapy based on the US Preventive Services Task Force recommendations vs the ACC/AHA guidelines. JAMA. doi:10.1001/jama.2017.3416
Tran JN, Kao TC, Caglar T, et al. Impact of the 2013 cholesterol guideline on patterns of lipid-lowering treatment in patients with atherosclerotic cardiovascular disease or diabetes after 1 year. J Manag Care Spec Pharm. 2016;22(8):
Rodriguez F, Lin S, Maron DJ, Knowles JW, Virani SS, Heidenreich PA. Use of high-intensity statins for patients with ASCVD in the VA Health System. Am Heart J. 2016; 182:97-102.
Rosenson RS, Kent ST, Brown TM, et al. Underutilization of high-intensity statin therapy after hospitalization for coronary heart disease. J Am Coll Cardiol. 2015;65(3):270-277.
Colantonio LD, Huang L, Monda KL, Bittner V, Serban M-C, Taylor B, Brown TM, Glasser SP, Muntner P, Rosenson RS. Adherence to High-Intensity Statins Following A Myocardial Infarction Hospitalization Among Medicare Beneficiaries JAMA Cardiology April 19, 2017.
Okerson T, Patel J, DiMario S, Burton T, Seare J, Harrison DJ. Effect of 2013 ACC/AHA Blood Cholesterol Guidelines on Statin Treatment Patterns and Lowâ€Density Lipoprotein Cholesterol in Atherosclerotic Cardiovascular Disease Patients. JAMA March 2017, Volume 6, Issue 3
Cabana MD, Rand CS, Powe NR, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282(15):1458-1465.
Virani SS, Pokharel Y, Steinberg L, Chan W, Akeroyd JM, Gowani SA, Kalra A, Polsani V, Miedema MD,Jones PH, Nambi V, Petersen LA, Ballantyne CM. Provider understanding of the 2013 ACC/AHA cholesterol guideline. J Clin Lipidol. 2016; 10:497–504.e494.
Bellows BK, Olsen CJ, Voelker J, Wander C. Antihyperlipidemic medication treatment patterns and statin adherence among patients with ASCVD in a managed care plan after release of the 2013 ACC/AHA guideline on the treatment of blood cholesterol. J Manag Care Spec Pharm.2016;22:892–900
Committee on Quality of Health Care in America, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001.
Kochanek KD, Murphy SL, Xu J, Tejada-Vera B, Division of Vital Statistics National Vital Statistics Reports, Vol. 65 No. 4, June 30, 2016
World Health Organization, Fact Sheet: Top 10 Causes of Death. January 2017.
Writing Group M, Mozaffarian D, Benjamin EJ, et al. Heart disease and stroke statistics-2016 update: a report from the American Heart Association. Circulation 2016;133:e38-360.
Cholesterol Treatment Trialists C, Mihaylova B, Emberson J, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomized trials. Lancet 2012;380:581-90.
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