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Circulation. 2019;139:e1082–e1143. DOI: 10.1161/CIR.0000000000000625 June 18/25, 2019 e1107 CLINICAL STATEMENTS AND GUIDELINES

(Table 3, Section 3.2.). The addition of ezetimibe or bile acid sequestrants to statin therapy typically provides an additional 15% to 25% reduction in LDL-C. Much greater additive reductions occur by adding a PCSK9 inhibitor to statin plus ezetimibe. In clinical practice, lifestyle and statin therapy are commonly introduced together. The maximum percentage change will occur by 4 to 12 weeks after starting a statin or combined therapy. At this time, drug efficacy or initial adherence to therapy can be evaluated. Periodic remeasurements will make it possible to confirm adherence to therapy. Because recommended intensities of drug therapies will vary in adolescents, young adults, adults 40 to 75 years of age, those with severe hypercholesterolemia, and those receiving therapy for secondary prevention, the recommended LDL-C levels to achieve will also vary.

4.4.4 Primary Prevention in Other Age Groups

4.4.4.1. Older Adults Additional recommendations for adults >75 years of age are included in Section 4.1. (Secondary ASCVD Prevention) and Section 4.3. (Diabetes Mellitus in Adults). Recommendations for Older Adults Referenced studies that support recommendations are summarized in Online Data Supplements 18 and 19.

COR LOE Recommendations

IIb B-R 1.  In adults older than 75 years of age with an LDL-C level of 70 to 189 mg/dL (1.7 to 4.8 mmol/L), initiating a moderate-intensity statin may be reasonableS4.4.4.1-1–S4.4.4.1-8

IIb B-R 2.  In adults older than 75 years of age, it may be reasonable to stop statin therapy when functional decline (physical or cognitive), multimorbidity, frailty, or reduced lifeexpectancy limits the potential benefits of statin therapy.S4.4.4.1-9

IIb B-R 3.  In adults 76 to 80 years of age with an LDL-C level of 70 to 189 mg/dL (1.7 to 4.8 mmol/L), it may be reasonable to measure CAC to reclassify those with a CAC score of zero to avoid statin therapy.S4.4.4.1-10,S4.4.4.1-11

Synopsis

Mounting risk factors and subclinical disease are endemic in the rapidly growing population of older adults. Data from RCTS4.4.4.1-1–S4.4.4.1-4 and a related meta-analysisS4.4.4.1-5 support primary prevention with statin therapy in older adults up to age 79 years, but some studies do not.S4.4.4.1-12 Nonetheless, data in older subsets (≥80 years of age) remain sparse.S4.4.4.1-6–S4.4.4.1-8 Furthermore, as adults grow older they are more susceptible to statinrelated risks,S4.4.4.1-13–S4.4.4.1-15 including those that arise from altered pharmacokinetics and pharmacodynamics, as well as the impact of side effects on health issues such as multimorbidity, polypharmacy, frailty, and cognitive decline. In some patients, the aggregate risks associated with statins may exceed their likely benefits. Limited life spans may also undercut the minimum time for likely statin benefits, especially the 4 to 5 years associated with statins’ stroke-reducing benefits.S4.4.4.1-15 Decisions to not initiate statins, or even to deprescribe them, are reasonable in older adults when aggregate risks outweigh potential for meaningful benefit.S4.4.4.1-9,S4.4.4.1-16–S4.4.4.1-18 A shared decision-making process between clinicians and patients that targets individualized decisions is warranted, with regular reassessments over time. CAC determinationS4.4.4.1-10,S4.4.4.1-11 focuses statin therapy on those who benefit most. For older adults with CAC scores of zero, the likelihood of benefits from statin therapy does not outweigh the risks.

Recommendation-Specific Supportive Text

1.	 An RCT enrolling 5 084 men and women 70 to 82 years of age showed no benefit from pravastatin 40 mg/d versus placebo in the primaryprevention subgroup.S4.4.4.1-12 Another RCT using pravastatin 40 mg per day versus usual care in older adults showed no statin benefitS4.4.4.1-19 but there were important concerns about both adherence in those assigned to pravastatin and drop-in statin therapy in those assigned to usual care.S4.4.4.1-1,S4.4.4.1-2,S4.4.4.1-4 A recent metaanalysisS4.4.4.1-3 combining data from JUPITER and HOPE-3 in those ≥70 years of age showed a statistically significant 26% RRR for nonfatal MI, nonfatal stroke, or cardiovascular death. A prospective cohort studyS4.4.4.1-5 comparing healthy older patients (age ≥70 years) who used statins with those who did not showed significantly lower risk of death but nonsignificant cardiovascular event reduction in the statin group. Other recent meta-analysesS4.4.4.1-6–S4.4.4.1-8 support primary prevention for adults in their 70s. Thus, clinician–patient discussion of risk versus benefit remains particularly important with inconsistent support and few data for adults >80 years of age. Even a small increase in geriatric-specific adverse effects with statins could offset any cardiovascular benefit.S4.4.4.1-20 Statins may be indicated if, after a clinician–patient discussion, the potential for benefit is thought to outweigh the risks of adverse effects, drug–drug interactions, and cost. 2.	 A counterpoint to the rationale for statin therapy in primary prevention for adults of older ages is the compelling rationale to discontinue therapy in older adults with severe age-related management complexities. Customary risks associated with statins may be intensified by age (eg,

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