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Applying the New Statin Guidelines to the Long-Term Care Population
A joint expert panel of the American College of Cardiology (ACC) and the American Heart Association (AHA) recently updated its evidence-based clinical practice recommendations for primary care physicians and specialists concerned with managing atherosclerotic cardiovascular disease, including coronary artery disease (CAD), stroke, and peripheral arterial disease (PAD). The guidelines have identified four major groups of patients who are most likely to benefit from cholesterol-lowering statin therapy: those who have cardiovascular disease; those with an LDL cholesterol level of 190 mg/dL or higher; those with type 2 diabetes and aged between 40 and 75 years; and those with an estimated 10-year risk of cardiovascular disease of 7.5% or higher and aged between 40 and 75 years.
These guidelines have caused a stir in the healthcare community. Many praise the guidelines for broadening the reach of statin therapy to those who will likely benefit from it, while others are concerned that the 10-year risk algorithm may be oversimplifying the complex needs of patients and overestimating the need for statins. For prescribers providing care to older persons in long-term care (LTC) settings, what do these guidelines mean? Will more LTC residents be advised to start statin therapy? What about residents who meet the aforementioned criteria but have a poor prognosis? To answer these questions, Annals of Long-Term Care® (ALTC) spoke with editorial advisory board member Wilbert S. Aronow, MD, AGSF, cardiology and geriatrics divisions, Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.
ALTC: What is the prevalence of atherosclerotic cardiovascular disease in the elderly LTC population?
Aronow: In 1160 men, mean age 80 years, in an LTC health facility, the prevalence of CAD was 43%, the prevalence of stroke was 32%, and the prevalence of peripheral arterial disease was 32%.1 At 46-month mean follow-up, the incidence of new coronary events was 46% and of new stroke was 23%.1 In 2464 women, mean age of 81 years, in an LTC health facility, the prevalence of CAD was 41%, the prevalence of stroke was 31%, and the prevalence of peripheral arterial disease was 26%.1 At 46-month mean follow-up, the incidence of new coronary events was 44% and of new stroke was 21%.1 Of 2737 older persons (865 men and 1872 women; mean age, 81 years) in an LTC health facility, 690 (25%) had diabetes mellitus.2
Does statin therapy reduce cardiovascular events in older persons residing in LTC settings and in the community?
In elderly nursing home residents with cardiovascular disease, 1313 statin users were matched with 1313 nonusers of statins.3 At 1-year follow-up, statin users had a 31% reduction in all-cause mortality (95% confidence interval [CI], 19%-42%). The reduction in all-cause mortality in statin users was 31% in men (95% CI, 6%-49%), 31% in women (95% CI, 14%-44%), 33% in persons aged 65 to 74 years (95% CI, -1%-55%), 33% in persons aged 75 to 84 years (95% CI, 13%-48%), and 28% in persons aged 85 years and older (95% CI, 2%-47%).3
In an observational prospective study including 1410 persons (65% women; mean age, 81 years) with prior myocardial infarction in an LTC health facility, 679 persons (48%) were treated with statins.4-6 At 36-month mean follow-up, stepwise Cox regression analysis showed that the individuals treated with statins had a 50% reduction in new coronary events (P<.0001),4 a 60% reduction in stroke (P<.0001),5 and a 48% reduction in heart failure (P<.0001).6
In an observational prospective study that included 660 LTC residents (60% women; mean age, 80 years) with symptomatic PAD, 318 (48%) received treatment with statins.7 At 39-month mean follow-up, stepwise Cox regression analysis showed that the residents receiving statins had a 56% reduction in coronary events (P<.0001).7
In an observational prospective study including 529 persons (68% women; mean age, 79 years) with diabetes mellitus and prior myocardial infarction in an LTC health facility, 279 (53%) were treated with statins.8 At 29-month mean follow-up, stepwise Cox regression analysis showed that persons treated with statins had a 37% reduction in coronary events (P <.0001) and a 47% reduction in stroke.8 In 54 persons (50% women; mean age, 76 years) with CAD in a university-affiliated LTC health facility, 47 (87%) were treated with statins.9
A meta-analysis was performed that included 19,569 persons aged 65 to 82 years in nine double-blinded, randomized, placebo-controlled secondary prevention trials investigating the effects of statins on mortality and cardiovascular events.10 Mean follow-up was 4.9 years. Compared with placebo, statins reduced all-cause mortality by 22% (95% CI, 11%-0.35%), CAD mortality by 30% (95% CI, 17%-47%), nonfatal myocardial infarction by 26% (95% CI, 11%-40%), need for revascularization by 30% (95% CI, 17%-47%), and stroke by 28% (95% CI, 6%-44%).10
A meta-analysis was performed that included 51,351 older persons (28% women) enrolled in 18 double-blinded, randomized, placebo-controlled secondary prevention and primary prevention trials investigating the effect of statins on mortality and cardiovascular events.11 Compared with placebo, statins reduced all-cause mortality by 15% (95% CI, 7%-22%), CAD death by 23% (95% CI, 15%-29%), fatal or nonfatal myocardial infarction by 26% (95% CI, 22%-30%), and fatal or nonfatal stroke by 24% (95% CI, 10%-35%).11
A double-blinded, randomized, placebo-controlled trial including 60 patients (47% women; mean age, 75 years) with intermittent claudication due to PAD showed that patients receiving simvastatin had a 24% and 42% increase in treadmill exercise time until the onset of intermittent claudication at 6 months and 1 year after treatment, respectively (both P <.0001).12 A double-blinded, randomized, placebo-controlled study including 354 patients (32% women; mean age, 68 years) with intermittent claudication due to PAD showed that patients receiving atorvastatin 80 mg daily had an increase in pain-free treadmill walking distance by 40% at 1 year (P =.025).13 Another double-blinded, randomized, placebo-controlled study including 86 patients (mean age, 67 years) with intermittent claudication due to PAD showed that patients receiving simvastatin had an increase in total walking distance by 126 meters at 6 months (P <.001).14
A meta-analysis was performed of eight randomized, double-blinded, placebo-controlled trials that enrolled 24,674 elderly persons (43% women; mean age, 73 years) and investigated the effect of statins on all-cause mortality, cardiovascular mortality, myocardial infarction, and stroke in persons without cardiovascular disease.15 Mean follow-up was 3.5 years. Compared with placebo, statins reduced myocardial infarction by 39% (95% CI, 15%- 57%) and stroke by 24% (95% CI, 7%-37%), but insignificantly reduced all-cause mortality by 6% and cardiovascular mortality by 9%.15
With the delineation of the four target patient groups described in the guidelines, does this mean that more LTC patients will become candidates for statin therapy?
No. LTC patients with atherosclerotic cardiovascular disease, diabetes mellitus, a serum low-density lipoprotein (LDL) cholesterol level ≥190 mg/dL, or those aged 40 to 75 years with a serum LDL cholesterol level between 70 and 189 mg/dL and an estimated 10-year risk of atherosclerotic cardiovascular disease of ≥7.5% should be treated with statins.
How should LTC providers go about putting these guidelines into practice in the care of their elderly patients?
Medical directors of LTC medical facilities should speak to the physicians taking care of patients in their facility about these guidelines and perform quality assurance audits on the use of statins in patients for whom they are indicated.
With regard to the formula that calculates 10-year risk, there have been concerns expressed in the media that the calculator may be overestimating risk and therefore overestimating the need for statins. What is your opinion?
For the primary prevention of atherosclerotic vascular disease, the new pooled Cohort Risk Assessment Equations provide a more comprehensive assessment of the estimated 10-year risk for an atherosclerotic cardiovascular event, as they consider both CAD and stroke, rather than CAD alone ( https://static.heart.org/ahamah/risk/Omnibus_Risk_Estimator.xls).
I am a member of the Board of Directors of the American Society of Preventive Cardiology, which endorsed these 2013 ACC/AHA guidelines. We did so because they are based on the highest quality evidence available. I support these guidelines and find them to be the best ones available for treating blood cholesterol levels to reduce cardiovascular risk.
Would these guidelines apply to elderly persons who are in hospice care with a poor prognosis or end-stage dementia?
No. These persons should not be treated with statins. Statins are also not indicated for persons with New York Heart Association class II to IV heart failure or for those undergoing maintenance hemodialysis. Until cardiovascular outcome data from randomized clinical trials investigating the efficacy of statins in the primary prevention of atherosclerotic vascular disease in adults older than 75 years become available, clinical judgment must be used in addition to lifestyle measures in deciding for each person whether statins should be used.
1. Aronow WS, Ahn C, Gutstein H. Prevalence and incidence of cardiovascular disease in 1160 older men and 2464 older women in a long-term health care facility. J Gerontol A Biol Sci Med Sci. 2002;57(1):M45-M46.
2. Aronow WS, Ahn C. Incidence of heart failure in 2,737 older persons with and without diabetes mellitus. Chest. 1999;115(3):867-868.
3. Eaton CB, Lapane KL, Murphy JB, Hume AL. Effect of statin (HMG-CoA reductase inhibitor) use on 1-year mortality and hospitalization rates in older patients with cardiovascular disease living in nursing homes. J Am Geriatr Soc. 2002;50(8):1389-1395.
4. Aronow WS, Ahn C. Incidence of new coronary events in older persons with prior myocardial infarction and serum low-density lipoprotein cholesterol ‚â•125 mg/dL treated with statins versus no lipid-lowering drug. Am J Cardiol. 2002;89(1):67-69.
5. Aronow WS, Ahn C, Gutstein H. Incidence of new atherothrombotic brain infarction in older persons with prior myocardial infarction and serum low-density lipoprotein cholesterol ‚â•125 mg/dL treated with statins versus no lipid-lowering drug. J Gerontol Med Sci. 2002;57(5):M333-M335.
6. Aronow WS, Ahn C. Frequency of congestive heart failure in older persons with prior myocardial infarction and serum low-density lipoprotein cholesterol ‚â•125 mg/dL treated with statins versus no lipid-lowering drug. Am J Cardiol. 2002;90(2):147-149.
7. Aronow WS, Ahn C. Frequency of new coronary events in older persons with peripheral arterial disease and serum low-density lipoprotein cholesterol ‚â•125 mg/dl treated with statins versus no lipid-lowering drug. Am J Cardiol.2002;90(7):789-791.
8. Aronow WS, Ahn C, Gutstein H. Reduction of new coronary events and of new atherothrombotic brain infarction in older persons with diabetes mellitus, prior myocardial infarction, and serum low-density lipoprotein cholesterol ‚â•125 mg/dL treated with statins. J Gerontol A Biol Sci Med Sci. 2002;57(11):M747-M750.
9. Joseph J, Koka M, Aronow WS. Prevalence of use of antiplatelet drugs, beta blockers, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers in older patients with coronary artery disease in an academic nursing home. J Am Med Dir Assoc. 2008;9(2):124-127.
10. Afilalo J, Duque G, Steele R, Jukema JW, de Craen AJ, Eisenberg MJ. Statins for secondary prevention in elderly patients: a hierarchical bayesian meta-analysis. J Am Coll Cardiol. 2008;51(1):37-45.
11. Roberts CGP, Guallar E, Rodriguez A. Efficacy and safety of statin monotherapy in older adults: a meta-analysis. J Gerontol A Biol Sci Med Sci. 2007;62(8):M879-M887.
12. Aronow WS, Nayak D, Woodworth S, Ahn C. Effect of simvastatin versus placebo on treadmill exercise time until the onset of intermittent claudication in older patients with peripheral arterial disease at six months and at one year after treatment. Am J Cardiol. 2003;92(6):711-712.
13. Mohler ER III, Hiatt WR, Creager MA. Cholesterol reduction with atorvastatin improves walking distance in patients with peripheral arterial disease. Circulation. 2003;108(12):1481-1486.
14. Mondillo S, Ballo P, Barbati R, et al. Effects of simvastatin on walking performance and symptoms of intermittent claudication in hypercholesterolemic patients with peripheral vascular disease. Am J Med. 2003;114(5):359-364.
15. Savarese G, Gotto AM Jr, Paolillo S, et al. Benefits of statins in elderly subjects without established cardiovascular disease: a meta-analysis. J Am Coll Cardiol. 2013;62(22):2090-2092.
