The following are key points to remember about this US Preventive Services Task Force (USPSTF) recommendation statement on statin use for the primary prevention of cardiovascular disease (CVD):

1. To update its 2016 recommendation, the USPSTF commissioned a review of the evidence on the benefits and harms of statins for reducing CVD-related morbidity or mortality or all-cause mortality. This recommendation is consistent with the 2016 USPSTF recommendation.
2. The target population included adults aged ≥40 years without a history of known CVD and who do not have signs and symptoms of CVD.
3. The American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations may be used to estimate 10-year risk of CVD. To date, it is the only US-based CVD risk prediction tool that has published external validation studies in other US-based populations. The estimator has separate equations based on sex and for Black persons and non-Black persons, which include the risk factors of age, cholesterol levels, systolic blood pressure, antihypertension treatment, presence of diabetes, and smoking status, and focuses on hard clinical outcomes (myocardial infarction [MI] and death from coronary heart disease; ischemic stroke and stroke-related death) as the outcomes of interest. The 10-year CVD event risk estimated by the ACC/AHA risk estimator is heavily influenced by increasing age, and risk prediction equations generally show higher risk for Black persons than White persons. Clinicians should recognize that predictions of 10-year CVD events using the Pooled Cohort Equations are estimates and often overestimate.
4. Benefits of statin use based upon moderate-intensity statins:
   • Convincing evidence that statin use reduces the probability of CVD events (MI or ischemic stroke) and all-cause mortality by at least a moderate amount in adults aged 40-75 years with no history of CVD and who have ≥1 CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of ≥10%. Grade B: recommended.
   • Convincing evidence that statin use reduces the probability of CVD events (MI or ischemic stroke) and all-cause mortality by at least a small amount in adults aged 40-75 years with no history of CVD and who have ≥1 CVD risk factors (i.e., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 7.5% to <10%. Grade C: no recommendation.
   • Inadequate evidence to conclude whether initiating statin use in adults aged ≥76 years with no history of CVD and who are not already taking a statin is beneficial in reducing the incidence of CVD events and mortality. Grade I: insufficient evidence to make recommendation. The balance of benefits and harms cannot be determined.
5. Harms of statin use: Convincing evidence that the harms of statin use in adults aged 40-75 years are at most small. There is inadequate evidence on the harms of statin use for the primary prevention of CVD events in adults aged ≥76 years.
6. More studies are needed to address the following:
   • Improving the accuracy of CVD risk prediction in all racial and ethnic and socioeconomic groups.
   • The balance of benefits and harms of initiating statin use for the primary prevention of CV events in adults aged ≥76 years.
   • The efficacy and safety of long-term statin use in adults aged <40 years, and to determine the effects of earlier versus delayed initiation of statin use, particularly in persons with an estimated high long-term (longer than 10 years [e.g., lifetime]) risk of CVD.
   • The causes of disparities in statin use and effective methods to reduce disparities.
   • Trials that directly compare statin therapy titrated to target lipid levels versus fixed-dose therapy to inform optimal dosing strategies.
   • Trials that directly compare higher- versus lower-intensity statin therapy and are powered to assess clinical outcomes are also needed.
   • Definitively determining whether statin therapy is associated with increased risk of diabetes in primary prevention populations.
   • The role of patient preferences in decisions to prescribe statins for persons across the spectrum of CVD risk.

Perspective: While none of the suggestions for future studies are inappropriate, particularly improving CV risk prediction, limiting CVD to fatal and nonfatal MI, and stroke and fatal stroke to decide statin therapy at any age reduces the potential of more lipid-lowering therapy, particularly in high-risk groups without atherosclerotic CVD. National guidelines from the great majority of countries who publish them, including those with socialized medicine and conservative governments such as Canada and Great Britain, are much more likely to use statins for primary prevention.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Geriatric Cardiology, Prevention, Vascular Medicine, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Hypertension, Smoking

Keywords: Atherosclerosis, Blood Pressure, Cardiovascular Diseases, Cholesterol, Coronary Disease, Diabetes Mellitus, Dyslipidemias, Geriatrics, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypertension, Ischemic Stroke, Lipids, Myocardial Infarction, Primary Prevention, Risk Factors, Smoking, Socioeconomic Factors

< Back to Listings