statins and the elderly: recent evidence and current indications
All rights reserved. The study design evaluated this model over a "short term period" follow up (approximately 4 years) compared to the traditional "10-year" risk prediction window which may be a time frame inapt for individuals with <10 years of life expectancy. Virani reports research support from American Diabetes Association/American Heart Association/Veterans Affairs; honorarium from American College of Cardiology as the Associate Editor for Innovations, ACC.org, and the National Lipid Association; none of these are related to the topic of this work. Current statin use and symptoms among older adults in routine community practice have not been well characterized since the release of the 2013 American College of Cardiology/American Heart Association guideline. Navar reports research support from Regeneron/Sanofi and Amgen Pharmaceuticals; consultant for Sanofi and Amgen; and funded by National Institutes of Health K01HL133416‐01. Data are presented as number (percentage), with the percentage generated as a percentage of the number of patients in that particular age (≤75 vs >75 years old) and statin treatment status subgroup (currently receiving a statin, currently receiving a high‐intensity statin, previously receiving a statin, or never receiving a statin). Although some cite adverse effect risk as a potential cause for statin underuse in older populations, we observed similar rates of reported statin symptoms in older versus younger patients. For this analysis, patients ≤75 years were included if they would have met a recommendation for high‐ or moderate‐intensity statin therapy under the most recent ACC/AHA cholesterol guideline, and patients >75 years old were included if they would have met an indication for statin therapy independent of their chronologic age.1 Patients qualified for high‐intensity statin therapy for purposes of secondary prevention if they had a history of clinical ASCVD. Fisher's exact tests were used when the cell number was <5. Future clinical trials are needed to more definitively identify the proper statin treatment approach in older patients. Differences in type of ASCVD between older and younger populations may also contribute to differences in statin treatment patterns, with younger populations more frequently having a history of myocardial infarction or percutaneous coronary intervention, which may be more likely to prompt high‐intensity statin use than other forms of ASCVD. In our large, contemporary, practice‐based study, we found that many patients >75 years in primary prevention are receiving a statin. An important consideration in the treatment of older adults is, perhaps, the identification of the highest risk individuals in the older adult primary prevention cohort. Among adults currently receiving a statin, older patients were actually less likely to report experiencing any adverse symptoms (41.3% versus 46.6%; P=0.003) or myalgias specifically (27.3% versus 33.3%; P<0.001). “Your physiology doesn't suddenly change when you turn 75 … Individuals over 75 years of age may often have multiple comorbidities and take many medications. Compared with younger adults, older patients had a higher prevalence of heart failure and chronic kidney disease, but a lower prevalence of diabetes mellitus and a lower body mass index. Overall and by subgroups, we described patient characteristics of the study population by age group (>75 versus ≤75 years) using frequencies with percentages for categorical variables and medians with interquartile range for continuous variables. All analyses were performed using SAS, version 9.4 (SAS Institute, Inc, Cary, NC). These trends were similar among older versus younger patients who were taking a high‐intensity statin. Recently in a compelling retrospective cohort study, Orkaby et al. Ms Campbell did not receive compensation for her contributions, apart from her employment at the institution where this study was conducted. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication: The U.S. Preventive Services Task Force Recommendation This clinical recommendation summarizes the use of statins as a preventive measure for adults aged 40 to 75 years with no history of cardiovascular disease (CVD) and for those who have one or more CVD risk factors with a calculated 10-year CVD event risk of 7.5 percent or greater. 2,3 Given the paucity of adults >70 years in clinical trials, the evidence for the efficacy of statins for primary prevention in older adults is limited. The patients were treated at 138 US practices in the Patient and Provider Assessment of Lipid Management (PALM) registry in 2015. The benefit of … We reported the estimated odds ratios (ORs) and 95% confidence intervals (CIs). used age-stratified data from two primary prevention statin trials (JUPITER [Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin] and HOPE-3 [Heart Outcomes Prevention Evaluation 3]) and derived that the use of rosuvastatin significantly lowered the risk for a composite outcome of nonfatal MI, nonfatal stroke, or cardiovascular death by 26%, compared with placebo, in subjects >70 years of age initially free of ASCVD.5. For secondary prevention, older patients were slightly less likely to receive any statin (80.1% versus 84.2% [P=0.003]; adjusted odds ratio, 0.81; 95% confidence interval, 0.66–1.01 [P=0.06]), but were much less likely to receive a high‐intensity statin (23.5% versus 36.2% [P<0.0001]; adjusted odds ratio, 0.54; 95% confidence interval, 0.45–0.65 [P=0.0001]). Indeed, in the 2018 ACC/AHA guidelines, a CACs of zero is highlighted as a potential gate keeper to discontinue long term statin therapy in those older adults without ASCVD events. Furthermore, older patients were slightly less likely to report myalgias (27.3% vs. 33.3%; P<0.001) or any symptoms (41.3% vs. 46.6%; P=0.003). As such, these trials are bound to answer important questions of whether there are meaningful outcomes associated with use of statins in older adults and if yes, are the 'benefits' worth the overall risk? Our study was designed to evaluate patterns of statin use and symptoms in older adults in contemporary community practice. The PREVENTABLE trial is aiming to enroll 20,000 community-dwelling primary prevention patients age ≥75 and randomize individuals to atorvastatin 40 mg daily, or placebo. In the adjusted (multivariable) model, independent variables included age and covariates (sex, race, ASCVD, including myocardial infarction, coronary artery disease, coronary artery bypass grafting, percutaneous coronary intervention, stroke/transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, carotid artery stenosis, noncoronary arterial revascularization, diabetes mellitus, heart failure, chronic kidney disease, smoking, body mass index, insurance status by type, annual income, and whether the patient saw a cardiologist). Fourth, it was impossible to determine whether symptoms described by patients were directly attributable to statin therapy, and it is unlikely that reported symptoms were all directly attributed to statin use. Statins appear to be similarly tolerated in older and younger adults. For primary prevention, the models did not include history of ASCVD. Healthy lifestyle is still key for preventing heart disease. Patients qualified for at least moderate‐intensity statin therapy if they had no indication for high‐intensity statin and one of the following: (1) diabetes mellitus with a 10‐year ASCVD risk <7.5% or (2) 10‐year ASCVD risk ≥7.5% on the basis of the pooled cohort risk equation and no diabetes mellitus. Statins were similarly tolerated between older and younger patients. Using the Patient and Provider Assessment of Lipid Management (PALM) registry, we determined whether adults aged >75 were (1) less likely to be treated with a statin, (2) less likely to be treated with a high‐intensity statin, or (3) more likely to have patient‐reported symptoms than their younger counterparts. The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure. In contrast, statins would be indicated in elderly individuals with optimal risk factors since they exceed the ACC/AHA 7.5% risk threshold by age 65 (men) or 71 (women) and the NICE-UK 10% QRISK2 risk threshold by age 65 (men) or 68 (women) years. Lifestyle changes are key for reducing your … The U.S. Preventive Services Task Force guideline states that current evidence is insufficient to assess the balance of benefits and harms of statins in people older than 75 years who have no history of stroke or heart attack.2 For people 65 to 75 years of age with one or more risk factors, the U.S. Preventive Services Task Force recommends that clinicians selectively presc… Figure: Practical Barriers in Statin Utilization Amongst Older Adults, Clinical Topics: Dyslipidemia, Geriatric Cardiology, Prevention, Atherosclerotic Disease (CAD/PAD), Lipid Metabolism, Nonstatins, Novel Agents, Statins, Keywords: Primary Prevention, Secondary Prevention, Cholesterol, LDL, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Propensity Score, Prevalence, American Heart Association, Risk Factors, Life Expectancy, Coronary Artery Disease, Aged, 80 and over, Veterans, Goals, Atherosclerosis, Follow-Up Studies, Independent Living, Cost-Benefit Analysis, Aspirin, Calcium, Cardiovascular Diseases, Blood Pressure, Confidence Intervals, Myalgia, Odds Ratio, Pravastatin. The American Diabetes Association (ADA) standards of care for diabetes state that statin therapy should be initiated in individuals with diabetes and other cardiovascular risk factors with a target LDL cholesterol of <100 mg/dl. And there's some evidence that this age group may be more prone to statin side effects, such as muscle pain, an increased risk of diabetes, and liver problems. Although the absolute risk of cardiovascular disease increases with advancing age, prior studies have demonstrated that older adults were less likely to be treated with statins than their younger counterparts.15, 16 Older adults in the PALM registry represent a high‐risk population, with higher rates of ASCVD than younger patients, and had a higher prevalence of being treated with statins, particularly moderate‐intensity statins. For primary prevention, use of any statin or high‐dose statin did not vary by age group: any statin, 62.6% in those >75 years old versus 63.1% in those ≤75 years old (P=0.83); high‐dose statin, 10.2% versus 12.3% in the same groups (P=0.14). The treatment difference in high‐intensity statin use among patients with known ASCVD was particularly striking, and older patients more frequently received moderate‐intensity statin therapy, which suggests that clinicians have been applying the most recent ACC/AHA guideline recommendation for moderate‐intensity statins to older patients with an ASCVD history.1 Other factors affecting access to statins may also affect statin use, such as lower income, varying insurance coverage, competing illnesses and comorbidities, and higher likelihood of being homebound, although differences in high‐intensity statin use persisted even after correction for heart failure, income, and insurance status. CI indicates confidence interval. Conversely, higher‐risk older adults with a history of ASCVD were less likely than their younger counterparts to be treated with statins overall or with high‐intensity statin therapy. Peterson contributed to the conception and design of the study, the supervision, data acquisition, and interpretation, the article drafting, and the critical revision of the article. Patient surveys were administered via an iPad before being seen in the clinic. Statin drugs have been shown to reduce the risk of cardiovascular disease (CVD) in young and middle-aged adults. Missing/do not know/prefer not to answer responses for the income variable were imputed to the 2014 median census household income on the basis of the patient residence zip code or the enrolling site zip code if the patient zip code was missing. Table S1. Overall, older patients had higher rates of established ASCVD compared with younger adults (60.9% versus 47.6%; P<0.0001). Patients >75 years have been poorly represented in large primary and secondary ASCVD prevention statin trials. Income is based on self‐report; when missing, we used zip code–based median income for modeling. Older adults in the lower‐risk primary prevention cohort were equally likely to be treated with any statin or a high‐intensity statin for primary prevention. Statins continue to provide the most effective lipid-lowering treatment in most cases. In brief, they inhibit 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase, which is a key enzyme in the initial chain of the steroid synthesis of cholesterol. For primary prevention, model adjusted for sex, race, diabetes mellitus, heart failure, CKD, smoking, BMI, insurance, income, and whether the patient saw a cardiologist. The PALM registry is composed of 7736 patients with ASCVD or at high risk for ASCVD from 138 cardiology, primary care, and endocrinology practices nationwide.14 As described previously,14 data were collected cross‐sectionally at enrollment and included patient demographic and socioeconomic characteristics, comorbidities, medical history, core laboratory lipid panels, patient experiences, and beliefs about lipid‐lowering therapy from patient surveys and provider characteristics. bInsurance: “other” includes all answers that are not “no,” “private,” “Medicare,” or “Medicaid.”. With respect to the prevalence of statin use in older adults, another analysis from the Patient and Provider Assessment of Lipid Management (PALM) registry7 compared statin use and dosing between adults >75 and ≤75 years old in the setting of either primary or secondary prevention. This study found that higher cholesterol (total, HDL, or LDL) in people aged 50+ was associated with a lower all-cause mortality. Published on behalf of the American Heart Association, Inc., by Wiley. It is well established that statins reduce adverse cardiovascular outcomes but it remains unclear whether this reduction applies to older adults. In fact, side effects of statins are rare, according to a new American Heart Association scientific statement published Monday in Arteriosclerosis, Thrombosis and Vascular Biology . Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, CardioSource Plus for Institutions and Practices, Nuclear Cardiology and Cardiac CT Meeting on Demand, Annual Scientific Session and Related Events, ACC Quality Improvement for Institutions Program, National Cardiovascular Data Registry (NCDR), Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism. However, very few statin trials have included elderly patients alone. However, the use of statins at baseline did significantly lower risk for physical disability over a period of approximately 6 years follow up. Despite their high risk of ASCVD, the evidence for primary prevention statin therapy and high‐intensity statin therapy in secondary prevention in older adults is incomplete. Missing data were infrequent, except for the income variable. Statins are a common treatment for high cholesterol. In the setting of primary prevention, older and younger patients had a similar likelihood of receiving statin therapy, including high‐intensity statin therapy. Patients were classified as having ASCVD if they had prior myocardial infarction, coronary artery disease, coronary artery bypass grafting, percutaneous coronary intervention, stroke/transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, carotid artery stenosis, or noncoronary arterial revascularization. Multivariable logistic regression models examined the association between older age and statin use and dosing. Total cholesterol 2. But the picture is becoming clearer. Approximately 25% (1,704) of the 6,717 individuals enrolled were >75 years old. Despite their high risk of ASCVD, the evidence for primary prevention statin therapy and high‐intensity statin therapy in secondary prevention in older adults is incomplete.4, 5, 17, 18 Clinical trial data suggest a clinical benefit of moderate‐intensity statins in those aged ≥75 years when used for secondary prevention, and prior observational studies have demonstrated a significant risk reduction gleaned from statin therapy in this population.11, 15, 16, 19 Similarly, a recent observational study suggests a significant survival advantage exists among older adults with ASCVD treated with high‐ versus moderate‐intensity statins, amplified at maximal doses of high‐intensity statins.20 On the other hand, a recent post hoc analysis from the ALLHAT‐LLT (Antihypertensive and Lipid‐Lowering Treatment to Prevent Heart Attack Trial) found a signal (P=0.07) for possible increased all‐cause mortality among older adults treated with statins.7 These findings highlight the necessity for clinical trials to evaluate the efficacy and safety of statin therapy, including high‐intensity therapy, for both primary and secondary prevention of cardiovascular disease, specifically in older adults. Covariates included patient demographics and socioeconomic characteristics, medical history, laboratory results, patient beliefs about statins, adverse effects, and willingness for change. © 2021 American College of Cardiology Foundation. Statins have proved beneficial for the prevention of cardiovascular disease in adults,1, 2, 3 but patients >75 years have been underrepresented in randomized controlled trials.4, 5 In addition, concerns have been raised about the adverse effects of statins and polypharmacy as a reason not to treat older patients as aggressively as younger patients.1, 6 Although data are mixed for primary prevention after the age of 75 years,7 studies in older patients with atherosclerotic cardiovascular disease (ASCVD) suggest no attenuation of benefit. In multivariable analyses, there was no difference in statin use or high‐intensity statin use between older and younger adults eligible for statins for purposes of primary prevention (statin OR, 1.07 [95% CI, 0.88–1.30]; high‐intensity statin OR, 0.92 [95% CI, 0.68–1.24]) (Figure 2). Finally, relative to younger patients, we found that older individuals treated with any or high‐intensity statins specifically had similar likelihoods of having adverse symptoms as their similarly treated younger peers. We used a 2‐tailed α=0.05 to establish statistical significance of all tests. © American Heart Association, Inc. All rights reserved. Nevertheless, in secondary prevention settings, older individuals were less likely to be treated with any statin overall (80.1% versus 84.2%; P=0.003) and much less likely to receive high‐intensity statins (23.5% versus 36.2%; P<0.0001). For overall and secondary prevention, model adjusted for sex, race, atherosclerotic cardiovascular disease (including myocardial infarction, coronary artery disease, coronary artery bypass grafting, percutaneous coronary intervention, stroke, abdominal aortic aneurysm, peripheral arterial disease, carotid artery stenosis, noncoronary arterial revascularization, and prior transient ischemic attack), diabetes mellitus, heart failure, chronic kidney disease (CKD), smoking, body mass index (BMI), insurance, income, and whether the patient saw a cardiologist. The future outlook overall is hopeful. Because the 10‐year risk calculator is meant to be used for those 40 to 79 years old, we calculated risk for those ≥80 years as if they were 79 years, which represents the minimum risk for these adults given increased risk with age. Further research is warranted, but in the interim, judicious application of statin therapy to higher-risk elderly patients is appropriate. Statins, common cholesterol-lowering medications, may protect women's hearts from damage caused during chemotherapy for early-stage breast cancer, according to … This is an open access article under the terms of the. 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