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Statin Use for the Primary Prevention of Cardiovascular Disease in AdultsUS Preventive Services Task Force Recommendation Statement
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US Preventive Services Task Force
US Preventive Services Task Force
Recommendation Statement
November 15, 2016
Abstract
Importance Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States, accounting for 1 of every 3 deaths among adults.
Objective To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in adults.
Evidence Review The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of dyslipidemia in adults 21 years and older; the benefits and harms of statin use in reducing CVD events and mortality in adults without a history of CVD events; whether the benefits of statin use vary by subgroup, clinical characteristics, or dosage; and the benefits of various treatment strategies in adults 40 years and older without a history of CVD events.
Conclusions and Recommendations The USPSTF recommends initiating use of low- to moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater (B recommendation). The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5% to 10% (C recommendation). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults 76 years and older (I statement).
The USPSTF concludes that adults who smoke or have dyslipidemia, diabetes, or hypertension and a 10% or greater 10-year CVD event risk should be offered a low- to moderate-dose statin. Adults with diabetes or dyslipidemia and a 20% or greater 10-year CVD event risk are most likely to benefit from statin use.
Potential Harms of Statin Use
The USPSTF found adequate evidence that the harms of low- to moderate-dose statin use in adults aged 40 to 75 years are small. Randomized clinical trials (RCTs) of statin use for the primary prevention of CVD events have largely used low and moderate doses; under these conditions, statin use was not associated with serious adverse events such as cancer, severely elevated liver enzyme levels, or severe muscle-related harms. However, evidence concerning the association between statin use and diabetes mellitus is mixed, with 1 prevention trial suggesting that there may be a small increased risk of developing diabetes with use of high-dose statins. Myalgia is a commonly reported adverse effect of statins, but placebo-controlled trial data do not support the conclusion that statin use has a major causative role in its occurrence. Evidence for cognitive harms is relatively sparse; further research would be needed to more definitively establish the relationship between statin use and cognitive function. The USPSTF found no clear evidence of decreased cognitive function associated with statin use. These findings are consistent with those from a recent systematic review of RCTs and observational studies assessing the effect of statins on cognition that found no effect on incidence of Alzheimer disease or dementia.7 The recently published HOPE-3 (Heart Outcomes Prevention Evaluation 3) trial found that statin use increased risk of cataract surgery, which was unanticipated and not a predetermined outcome of the trial.8 None of the other primary prevention trials reported this outcome.9
The USPSTF found inadequate evidence on the harms of statin use for the prevention of CVD events in adults 76 years and older without a history of heart attack or stroke.
Clinicians may selectively offer adults who smoke or have dyslipidemia, diabetes, or hypertension and a 7.5% to 10% 10-year CVD event risk a low- to moderate-dose statin. Fewer persons in this population will benefit from the intervention, so the decision to initiate use of low- to moderate-dose statins should reflect shared decision making that weighs the potential benefits and harms, the uncertainty about risk prediction, and individual patient preferences, including the acceptability of long-term use of daily medication.
More research is needed to address the efficacy and safety of long-term statin use in this population and to determine effects of earlier vs delayed initiation of statin use, particularly in persons with highly elevated lipid levels (eg, persons with familial hypercholesterolemia).
Recommendations of Others
The ACC and AHA recommend statin use in asymptomatic adults aged 40 to 75 years without a history of CVD who have an LDL-C level of 70 to 189 mg/dL if they also have diabetes (use of moderate- to high-dose statins is recommended, depending on the patient's 10-year CVD event risk) or an estimated 10-year CVD event risk of 7.5% or greater, as calculated with the Pooled Cohort Equations risk calculator (shared decision making is recommended before initiating use of moderate- to high-dose statins). Instead of treating to a specific LDL-C target, the ACC and AHA recommend fixed-dose statin therapy using either a high-intensity regimen (daily dose reduces LDL-C level by approximately ≥50%) or a moderate-intensity regimen (daily dose reduces LDL-C level by approximately 30% to <50%).24 In response, the Mayo Clinic established a task force, which generally provides consistent recommendations, although it emphasizes lifestyle modifications rather than statin therapy in adults 40 years and older who have an LDL-C level less than 100 mg/dL or are sufficiently motivated to reduce their CVD event risk to less than 7.5%.43
The Canadian Cardiovascular Society recommends statin therapy combined with health behavior modification in men 40 years and older and women 50 years and older without CVD risk factors and in adults of any age with CVD risk factors who also have a 20% or greater 10-year CVD event risk or an LDL-C level of 135 to 190 mg/dL and a 10% to 20% CVD event risk (based on the Framingham risk score). Statin therapy in adults with a Framingham risk score of less than 10% is reserved for those with genetic hypercholesterolemia or an LDL-C level of 193 mg/dL or greater. The treatment strategy is treatment-to-target rather than by therapy dose (eg, ≥50% reduction in LDL-C level).44
The UK National Institute for Health and Care Excellence recommends that statin therapy (specifically, atorvastatin [20 mg]) for the primary prevention of CVD events be offered to adults 40 years and older with a 10% or greater 10-year CVD event risk, as estimated by the QRISK2 assessment tool. Before offering statin therapy, clinicians should discuss the benefits of lifestyle modification and optimize the management of all other modifiable CVD risk factors.45
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