Final Recommendation Statement

Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication

August 23, 2022

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Cardiovascular disease (CVD) is the leading cause of morbidity and death in the US, resulting in more than 1 of every 4 deaths.1 Coronary heart disease is the single leading cause of death and accounts for 43% of deaths attributable to CVD in the US.2,3 In 2019, an estimated 558,000 deaths were caused by coronary heart disease and 109,000 deaths were caused by ischemic stroke. Men have a higher overall prevalence of and mortality from CVD, although women experience higher mortality from certain cardiovascular events, such as stroke. On average, men experience CVD events earlier in life compared with women. The prevalence of CVD also differs by race and ethnicity. Among both sexes, Black adults have the highest prevalence of CVD.4

Return to Table of Contents

The US Preventive Services Task Force (USPSTF) concludes with moderate certainty that statin use for the prevention of CVD events and all-cause mortality in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 10% or greater has at least a moderate net benefit.

The USPSTF concludes with moderate certainty that statin use for the prevention of CVD events and all-cause mortality in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 7.5% to less than 10% has at least a small net benefit. The decision to initiate therapy should depend on individual patient preference for a potential small benefit relative to the potential harms and inconvenience of taking a daily medication.

The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of statin use for the primary prevention of CVD events and mortality in adults 76 years or older with no history of CVD.

See the Table for more information on the USPSTF recommendation rationale and assessment. For more details on the methods the USPSTF uses to determine the net benefit, see the USPSTF Procedure Manual.5

Return to Table of Contents

Patient Population Under Consideration

These recommendations apply to adults 40 years or older without a history of known CVD and who do not have signs and symptoms of CVD. These recommendations do not apply to adults with a low-density lipoprotein cholesterol (LDL-C) level greater than 190 mg/dL (4.92 mmol/L) or known familial hypercholesterolemia. These populations are at very high risk for CVD, and considerations on the use of statins in these populations can be found in other organizations’ guidelines.

Assessment of Risk

The American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations may be used to estimate 10-year risk of CVD. The ACC/AHA risk estimator is, to date, the only US-based CVD risk prediction tool that has published external validation studies in other US-based populations.6 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 level, antihypertension treatment, presence of diabetes, and smoking status, and focuses on hard clinical outcomes (myocardial infarction and death from coronary heart disease; ischemic stroke and stroke-related death) as the outcomes of interest. Age is one of the strongest risk factors for CVD, and the 10-year CVD event risk estimated by the ACC/AHA risk estimator is heavily influenced by increasing age. The risk prediction equations generally show higher risk for Black persons than White persons.6 The USPSTF recognizes that race is a social construct, and it is an imperfect proxy for social determinants of health and the effects of structural racism. Concerns about calibration of the Pooled Cohort Equations exist, with many external validation studies showing overprediction in broad populations (men and women across racial and ethnic groups).7-9 Limited evidence also suggests underprediction in disadvantaged communities10,11 that could lead to underutilization of preventive therapies. Clinicians should recognize that predictions of 10-year CVD events using the Pooled Cohort Equations are estimates.

The likelihood that a patient will benefit from statin use depends on their absolute risk of having a future CVD event, a risk estimation that, as noted above, is imprecise based on the currently available risk estimation tools. The higher a person’s 10-year risk of a CVD event, the greater the chance of benefit from statin use. Thus, the expected benefit of statin therapy for persons with a 10-year CVD risk of 10% or greater exceeds the expected benefit for persons with a 10-year CVD risk of 7.5% to less than 10%. Clinicians should discuss with patients the potential risk of having a CVD event and the expected benefits and harms of statin use. For patients with an estimated 10-year CVD risk of 10% or greater and who smoke or have dyslipidemia, diabetes, or hypertension, the USPSTF recommends that clinicians prescribe a statin once the rationale has been explained and the patient agrees to take a statin.12 For patients with an estimated 10-year CVD risk of 7.5% to less than 10% (and who have ≥1 of the risk factors noted above), clinicians may selectively offer a statin, taking patient values and preferences into account. Patients in this estimated risk range who place a higher value on the potential benefits than on the potential harms and inconvenience of taking a daily medication may choose to initiate a statin.

Given that participants in clinical trials of statin therapy were enrolled based on the presence of 1 or more CVD risk factors, and that the magnitude of benefit of statin use is proportional to a person’s estimated 10-year CVD risk, the USPSTF recommends that clinicians evaluate both the presence of CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) as well as estimated 10-year risk of CVD in determining which persons should initiate use of statins.

Treatment and Statin Intensity

There are limited data directly comparing the effects of different statin intensities on health outcomes. A majority of the trials reviewed by the USPSTF used moderate-intensity statin therapy.13 Based on available evidence, use of moderate-intensity statin therapy seems reasonable for the primary prevention of CVD in most persons.

Implementation

Several studies have reported inequities in statin use based on demographic and socioeconomic factors such as race and ethnicity, sex, area poverty level, and income level. Some studies found that Black adults have a decreased likelihood of being prescribed a statin14 and statin use15 compared with White adults. Having no health insurance was also associated with decreased likelihood of statin use, as was having multiple vulnerabilities (defined as age 65 years or older, being a woman, being Black, area poverty level of 10% or greater, or no health insurance).15 Older age, having health insurance, and higher income were associated with an increased likelihood of statin use.16,17 Data from the 2013-2014 National Health and Nutrition Examination Survey found that among persons eligible for statin use, statin use was higher among non-Hispanic White (58.3%) persons compared with non-Hispanic Asian (49.2%), non-Hispanic Black (44.3%), or Hispanic (33.7%) persons.18 It is essential to equitably improve statin use in both women and men of all races and ethnicities, regardless of socioeconomic level or health insurance status, to achieve the full benefits of statin use, and especially among Black adults and Hispanic adults, who have the highest prevalence of CVD4 and the lowest use of statins, respectively.

Additional Tools and Resources

The Centers for Disease Control and Prevention provides information about cholesterol-lowering medications, including statins (https://www.cdc.gov/cholesterol/treating_cholesterol.htm), and resources for clinicians (https://www.cdc.gov/cholesterol/educational_materials.htm).

Million Hearts, a national initiative from the US Department of Health and Human Services to prevent myocardial infarctions and strokes, provides information on statins (https://millionhearts.hhs.gov/learn-prevent/scoop-on-statins.html).

Suggestions for Practice Regarding the I Statement 

Potential Preventable Burden

According to the National Center for Health Statistics, heart disease and cerebrovascular disease were respectively the first and fourth leading causes of death in adults 65 years or older in 2018, although data were not reported separately for adults older than 75 years.19 However, trial data on the benefits of statin use in persons older than 75 years are limited,13 and the available evidence is insufficient to recommend for or against initiating statin use for the primary prevention of CVD in this age group.

Potential Harms

Evidence on the potential harms of statin use for the primary prevention of CVD events specifically in adults 76 years or older is limited. Evidence from trials in the general adult population shows that statins are not associated with an increased risk of myalgia, elevated alanine aminotransferase level, or cognitive harms compared with placebo.13 Almost all trials did not find an association between statin use and incidence of diabetes; 1 trial, JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), found that high-intensity statin therapy was associated with increased risk of diabetes,20 although a subsequent analysis found that this increased risk was limited to participants with diabetes risk factors at baseline (metabolic syndrome, impaired fasting glucose, body mass index ≥30 [calculated as weight in kilograms divided by square of height in meters], or hemoglobin A1c level >6%).21

Current Practice

Data on statin use for the primary prevention of CVD in persons 76 years or older are limited. One study estimated that 10.7 million adults 75 years or older were taking a statin in 2013 to 2014, although it did not distinguish between statin use for primary vs secondary prevention.18 A second study reported that among adults 75 years or older without a history of CVD, those with diabetes had rates of statin use more than 2 times higher than among those without diabetes (76.1 and 34.5 initiators per 1000 person-years, respectively). This study did not report the prevalence of statin use.22

Other Related USPSTF Recommendations

The USPSTF has made several recommendations related to the prevention of CVD in adults, including aspirin use to prevent CVD,23 screening for high blood pressure,24 screening for prediabetes and type 2 diabetes,25 interventions for tobacco smoking cessation,26 behavioral counseling to promote a healthy diet and physical activity for CVD prevention in adults (with and without cardiovascular risk factors),27,28 and behavioral interventions to prevent obesity-related morbidity and mortality in adults.29

Return to Table of Contents

This recommendation replaces the 2016 USPSTF recommendation on statin use for the primary prevention of CVD and is generally consistent with that recommendation.30 In 2016, the USPSTF recommended that adults without a history of CVD (ie, symptomatic coronary artery disease or ischemic stroke) use a low- to moderate-dose statin for the prevention of CVD events and mortality when all of the following criteria are met: (1) they are aged 40 to 75 years; (2) they have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking); and (3) they have a calculated 10-year risk of a cardiovascular event of 10% or greater. The USPSTF also recommended that clinicians may choose to offer a low- to moderate-dose statin to adults without a history of CVD who meet criteria 1 and 2 above and have a calculated 10-year risk of a cardiovascular event of 7.5% to less than 10%. The USPSTF concluded that the evidence was insufficient to assess the balance of benefits and harms of initiating statin use for the primary prevention of CVD events and mortality in adults 76 years or older.30

Return to Table of Contents

Scope of Review

To update its 2016 recommendation statement, the USPSTF commissioned a systematic review13,31 of the evidence on the benefits and harms of statins in reducing CVD-related morbidity or mortality or all-cause mortality. The evidence review also investigated whether the benefits or harms of statin treatment vary in populations of interest defined by demographic, clinical, or socioeconomic characteristics, by statin intensity, or by titration of statin therapy to a target LDL-C level vs use of a fixed statin dose.

Benefits of Preventive Medication

The USPSTF reviewed 22 trials that reported on the benefits of statin use for primary prevention. Mean duration of follow-up was 3.3 years. Mean age of study participants ranged from 52 to 66 years in all trials except for 1, PROSPER (Prospective Study of Pravastatin in the Elderly at Risk), which enrolled persons aged 70 to 82 years (mean age, 75 years).32 Among the trials that used a fixed statin dose, most (12/16) used a moderate-intensity statin, as defined by ACC/AHA criteria. Fifteen trials reported race and ethnicity; White persons were the most common group in 14 of those trials, representing 41% to 99% of the study population. The proportion of Black participants, reported in 5 trials, ranged from less than 1% to 37%. Data for other races and ethnicities were limited. All trials enrolled persons with at least 1 cardiovascular risk factor, and a few required the presence of multiple cardiovascular risk factors at baseline. The most common risk factors were dyslipidemia (which was variably defined), diabetes, and hypertension.13,31

In pooled analyses, statin therapy was associated with decreased risk of all-cause mortality (18 trials; n = 85,816; relative risk [RR], 0.92 [95% CI, 0.87 to 0.98]; absolute risk difference [ARD], −0.35%), fatal or nonfatal stroke (15 trials; n = 76,610; RR, 0.78 [95% CI, 0.68 to 0.90]; ARD, −0.39%), and fatal or nonfatal myocardial infarction (12 trials; n = 76,498; RR, 0.67 [95% CI, 0.60 to 0.75]; ARD, −0.89%). In several trials, primary outcome was reported as a composite of CVD events, with the exact components of this end point varying across trials. In a pooled analysis of 15 trials, statin therapy was also associated with a decreased risk of composite cardiovascular outcomes (n = 74,390; RR, 0.72 [95% CI, 0.64 to 0.81]; ARD, −1.28%).13,31

Twelve trials (n = 75,138) reported on cardiovascular mortality. Only 1 trial, WOSCOPS (West of Scotland Coronary Prevention Study; n = 6595), reported a statistically significant difference between statin and placebo in risk of cardiovascular mortality (RR, 0.68 at 6 years [95% CI, 0.48 to 0.98]; ARD, −0.70% [95% CI, −1.36% to −0.05%]).33 In pooled analyses of all 12 trials, statin therapy was associated with a slight reduction in cardiovascular mortality risk at 2 to 6 years that was not statistically significant (RR, 0.91 [95% CI, 0.81 to 1.02]; ARD, −0.13%; [95% CI, −0.25% to −0.02%]).13,31

Evidence on the benefits of statins in persons 75 years or older is limited. As noted, most trials had a mean participant age in the 50s and 60s; only 1 trial, PROSPER (n = 3239 for primary prevention), had a study population with a mean age of 75 years.32 One additional trial, ALLHAT-LLT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial–Lipid Lowering Trial), reported stratified results for the age group 75 years or older (in addition to other age groups).34,35 The primary prevention data from PROSPER found no decrease in all-cause mortality (RR, 1.07 [95% CI, 0.86 to 1.35]), risk of stroke (RR, 1.03 [95% CI, 0.73 to 1.45]), or in a composite cardiovascular outcome (RR, 0.94 [95% CI, 0.78 to 1.14]) among persons taking a statin compared with placebo.32 In the ALLHAT-LLT primary prevention population, statin therapy was associated with higher risk of all-cause and cardiovascular mortality in persons 75 years or older than in those aged 65 to 74 years (hazard ratio, 1.36 [95% CI, 0.98 to 1.89] vs 1.05 [95% CI, 0.82 to 1.33], respectively, for all-cause mortality; RR, 1.39 [95% CI, 0.85 to 2.25] vs 0.99 [95% CI, 0.71 to 1.39], respectively, for cardiovascular mortality), but estimates for the age group 75 years or older were imprecise and the difference was not statistically significant.34,35 However, ALLHAT-LLT had several limitations, including its open-label design, high loss to follow-up, and high crossover from the usual care treatment group. This trial reported a small differential in LDL-C–lowering effect between the statin therapy group and usual care group and showed no benefit of statin use overall.

In stratified analyses, the relative benefits of statin therapy did not appear to differ across a variety of demographic and clinical variables, including age (with the caveat that data are limited for persons older than 75 years), sex, and race and ethnicity, or the presence or absence of specific risk factors such as hypertension or diabetes. No trials reported how benefits of statin therapy vary according to socioeconomic characteristics.13,31

No study directly compared treatment with statins titrated to attain a target cholesterol level vs fixed-dose treatment strategies. There were also limited data directly comparing the effects of different statin intensities on health outcomes. Across-study comparisons did not indicate differences in outcomes based on dose titration vs fixed-dose statin therapy or based on statin intensity. As noted, most trials used a moderate-intensity statin.13,31

Harms of Preventive Medication

The USPSTF reviewed 19 trials (n = 75,005) and 3 observational studies (n = 417,523) that reported on the harms of statin therapy in adults without a history of a CVD event. In pooled analyses of trial data, statin therapy was not associated with increased risk of study withdrawal due to adverse events or serious adverse events.13,31 Although observational studies have reported an association between statin use and muscle pain,36 a pooled analysis of 9 trials (n = 46,388) found no increased risk of myalgia with statin therapy compared with placebo.13,31 Trials also did not find an association between statin therapy and myopathy or rhabdomyolysis, although these events were uncommon, so the estimates of relative risk are imprecise.13,31

Twelve trials (n = 55,358) reported no difference between statin therapy and placebo in risk of elevation in aminotransferase levels, and pooled analyses of 13 trials (n = 71,733) found no difference between statin therapy and placebo or no statin in risk of any cancer.13,31

Six trials (n = 59,083) and 3 observational studies (n = 417,523) reported on risk of new-onset diabetes with statin therapy. Based on a pooled analysis of 6 trials, there was no difference between statins and placebo or no statin in risk of diabetes (RR, 1.04 [95% CI, 0.92 to 1.19]; I2 = 52%; ARD, 0.00% [95% CI, −0.00% to 0.01%]).12 One trial of high-intensity statin therapy (JUPITER) reported an increased risk of diabetes with statin use (3.0% vs 2.4%; RR, 1.25 [95% CI, 1.05 to 1.49])20 that was subsequently found to be limited to study participants with 1 or more diabetes risk factors (metabolic syndrome, impaired fasting glucose, body mass index ≥30, or hemoglobin A1c level >6%) at baseline.21 Cohort studies reported mixed findings. One case-control study found no association between statin use and risk of diabetes,37 an analysis from the Women’s Health Initiative found an increased risk (adjusted hazard ratio, 1.48 [95% CI, 1.38 to 1.59]),38 and a third cohort reported mixed findings that varied by 10-year cardiovascular mortality risk (based on the SCORE instrument) and adherence to statin therapy.39

Evidence on the association between statins and renal or cognitive harms is very limited but does not indicate increased risk.13,31 In 1 trial, statin therapy was associated with increased risk of cataract surgery, which was unanticipated and not a predetermined outcome of the trial (3.8% vs 3.1%; RR, 1.24 [95% CI, 1.03 to 1.49]; ARD, 0.73%).40 Other trials did not note or report on this outcome.

Response to Public Comment

A draft version of this recommendation statement was posted for public comment on the USPSTF website from February 22 to March 21, 2022. Some comments sought clarification on why the USPSTF is recommending that both presence of a CVD risk factor and estimated 10-year CVD risk be used when considering initiation of a statin. As noted in the Practice Considerations section, statin trial inclusion criteria required the presence of 1 or more CVD risk factors. Additionally, the magnitude of the benefits of statin use is proportional to a person’s CVD risk level; thus, the USPSTF concluded that a 10-year CVD risk of 7.5% to less than 10% provides at least a small net benefit and a 10-year CVD risk of 10% or greater provides at least a moderate net benefit. Some comments sought clarification on whether coronary artery calcium score could be used as a criterion for statin use. The USPSTF addressed the use of coronary artery calcium score for CVD risk assessment in a separate recommendation.41 Some comments sought clarification on whether persons 76 years or older who are already taking a statin should continue its use. The USPSTF reiterates that this recommendation is about initiating a statin for the primary prevention of CVD events and mortality; in adults 76 years or older, the evidence is insufficient to assess the balance of benefits and harms of initiating statins. Some comments expressed concerns about the accuracy of the Pooled Cohort Equations across populations. The USPSTF understands these concerns and calls for more research on improving the accuracy of CVD risk prediction in all racial and ethnic and socioeconomic groups in the Research Needs and Gaps section. In addition, the USPSTF wants to clarify that these recommendations do not pertain to adults with familial hypercholesterolemia or an LDL-C level greater than 190 mg/dL (4.92 mmol/L). Considerations for statin use in these populations can be found in other organizations’ guidelines and resources on management of these conditions.

Return to Table of Contents

More studies are needed that 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 cardiovascular events in adults 76 years or older.
  • The efficacy and safety of long-term statin use in adults younger than 40 years, and to determine the effects of earlier vs delayed initiation of statin use, particularly in persons with an estimated high long-term (longer than 10 years [eg, 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 vs fixed-dose therapy to inform optimal dosing strategies. Trials that directly compare higher- vs 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.
Return to Table of Contents

The 2018 and 2019 ACC/AHA guidelines define cardiovascular risk categories as high (10-year risk of cardiovascular events ≥20%), intermediate (10-year risk of cardiovascular events ≥7.5% to <20%), and borderline (10-year risk of cardiovascular events 5% to <7.5%).42,43 The guidelines recommend initiation of statin therapy in persons at intermediate or high risk and a risk discussion for persons at borderline risk, and recommend consideration of risk enhancers to refine risk assessments based on the Pooled Cohort Equations and inform decision-making for persons at intermediate and borderline risk.42,43 These risk enhancers include family history of early coronary heart disease, presence of chronic kidney disease, metabolic syndrome, preeclampsia, premature menopause, inflammatory diseases, HIV, and South Asian ancestry.42,43

The 2014 US Department of Veterans Affairs/US Department of Defense Clinical Practice Guideline recommends initiation of a moderate-dose statin in persons with an estimated 10-year cardiovascular risk of 12% or greater and shared decision-making for persons with an estimated 10-year cardiovascular risk of 6% to 12%.44

Return to Table of Contents

The US Preventive Services Task Force members include the following individuals: Carol M. Mangione, MD, MSPH (University of California, Los Angeles); Michael J. Barry, MD (Harvard Medical School, Boston, Massachusetts); Wanda K. Nicholson, MD, MPH, MBA (University of North Carolina at Chapel Hill); Michael Cabana, MD, MA, MPH (Albert Einstein College of Medicine, New York, New York); David Chelmow, MD (Virginia Commonwealth University, Richmond); Tumaini Rucker Coker, MD, MBA (University of Washington, Seattle); Esa M. Davis, MD, MPH (University of Pittsburgh, Pittsburgh, Pennsylvania); Katrina E. Donahue, MD, MPH (University of North Carolina at Chapel Hill); Carlos Roberto Jaén, MD, PhD, MS (University of Texas Health Science Center, San Antonio); Martha Kubik, PhD, RN (George Mason University, Fairfax, Virginia); Li Li, MD, PhD, MPH (University of Virginia, Charlottesville); Gbenga Ogedegbe, MD, MPH (New York University, New York, New York); Lori Pbert, PhD (University of Massachusetts Medical School, Worcester); John M. Ruiz, PhD (University of Arizona, Tucson); James Stevermer, MD, MSPH (University of Missouri, Columbia); John B. Wong, MD (Tufts University School of Medicine, Boston, Massachusetts).

Return to Table of Contents

Conflict of Interest Disclosures: Authors followed the policy regarding conflicts of interest described at https://uspreventiveservicestaskforce.org/uspstf/about-uspstf/conflict-interest-disclosures. All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. 

Funding/Support: The USPSTF is an independent, voluntary body. The US Congress mandates that the Agency for Healthcare Research and Quality (AHRQ) support the operations of the USPSTF. 

Role of the Funder/Sponsor: AHRQ staff assisted in the following: development and review of the research plan, commission of the systematic evidence review from an Evidence-based Practice Center, coordination of expert review and public comment of the draft evidence report and draft recommendation statement, and the writing and preparation of the final recommendation statement and its submission for publication. AHRQ staff had no role in the approval of the final recommendation statement or the decision to submit for publication. 

Disclaimer: Recommendations made by the USPSTF are independent of the US government. They should not be construed as an official position of AHRQ or the US Department of Health and Human Services. 

Additional Information: The US Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific preventive care services for patients without obvious related signs or symptoms. It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment. The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision-making to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms. Published by JAMA®—Journal of the American Medical Association under arrangement with the Agency for Healthcare Research and Quality (AHRQ). ©2022 AMA and United States Government, as represented by the Secretary of the Department of Health and Human Services (HHS), by assignment from the members of the United States Preventive Services Task Force (USPSTF). All rights reserved.

Copyright Notice: USPSTF recommendations are based on a rigorous review of existing peer-reviewed evidence and are intended to help primary care clinicians and patients decide together whether a preventive service is right for a patient's needs. To encourage widespread discussion, consideration, adoption, and implementation of USPSTF recommendations, AHRQ permits members of the public to reproduce, redistribute, publicly display, and incorporate USPSTF work into other materials provided that it is reproduced without any changes to the work of portions thereof, except as permitted as fair use under the US Copyright Act.

AHRQ and the US Department of Health and Human Services cannot endorse, or appear to endorse, derivative or excerpted materials, and they cannot be held liable for the content or use of adapted products that are incorporated on other Web sites. Any adaptations of these electronic documents and resources must include a disclaimer to this effect. Advertising or implied endorsement for any commercial products or services is strictly prohibited.

This work may not be reproduced, reprinted, or redistributed for a fee, nor may the work be sold for profit or incorporated into a profit-making venture without the express written permission of AHRQ. This work is subject to the restrictions of Section 1140 of the Social Security Act, 42 U.S.C. §320b-10. When parts of a recommendation statement are used or quoted, the USPSTF Web page should be cited as the source.

Return to Table of Contents

1. Heron M. Deaths: leading causes for 2017. Natl Vital Stat Rep. 2019;68(6):1-77.
2. Xu J, Murphy S, Kochanek K, Arias E. Mortality in the United States, 2018. NCHS Data Brief. 2020;(355):1-8.
3. Virani SS, Alonso A, Benjamin EJ, et al; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-e596.
4. Virani SS, Alonso A, Aparicio HJ, et al; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2021 update: a report from the American Heart Association. Circulation. 2021;143(8):e254-e743.
5. U.S. Preventive Services Task Force. Procedure Manual. Updated May 2021. Accessed February 3, 2022. https://uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual
6. Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S49-73.
7. DeFilippis AP, Young R, Carrubba CJ, et al. An analysis of calibration and discrimination among multiple cardiovascular risk scores in a modern multiethnic cohort. Ann Intern Med. 2015;162(4):266-275.
8. Cook NR, Ridker PM. Calibration of the pooled cohort equations for atherosclerotic cardiovascular disease: an update. Ann Intern Med. 2016;165(11):786-794.
9. Rana JS, Tabada GH, Solomon MD, et al. Accuracy of the atherosclerotic cardiovascular risk equation in a large contemporary, multiethnic population. J Am Coll Cardiol. 2016;67(18):2118-2130.
10. Dalton JE, Perzynski AT, Zidar DA, et al. Accuracy of cardiovascular risk prediction varies by neighborhood socioeconomic position: a retrospective cohort study. Ann Intern Med. 2017;167(7):456-464.
11. Colantonio LD, Richman JS, Carson AP, et al. Performance of the atherosclerotic cardiovascular disease pooled cohort risk equations by social deprivation status. J Am Heart Assoc. 2017;6(3):e005676.
12. US Preventive Services Task Force. Collaboration and shared decision-making between patients and clinicians in preventive health care decisions and US Preventive Services Task Force recommendations. JAMA. 2022;327(12):1171-1176.
13. Chou R, Cantor A, Dana T, et al. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: A Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 219. Agency for Healthcare Research and Quality; 2022. AHRQ publication No. 22-05291-EF-1.
14. Dorsch MP, Lester CA, Ding Y, Joseph M, Brook RD. Effects of race on statin prescribing for primary prevention with high atherosclerotic cardiovascular disease risk in a large healthcare system. J Am Heart Assoc. 2019;8(22):e014709.
15. Schroff P, Gamboa CM, Durant RW, Oikeh A, Richman JS, Safford MM. Vulnerabilities to health disparities and statin use in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study. J Am Heart Assoc. 2017;6(9):e005449.
16. Gamboa CM, Colantonio LD, Brown TM, Carson AP, Safford MM. Race-sex differences in statin use and low-density lipoprotein cholesterol control among people with diabetes mellitus in the Reasons for Geographic and Racial Differences in Stroke study. J Am Heart Assoc. 2017;6(5):e004264.
17. Gu A, Kamat S, Argulian E. Trends and disparities in statin use and low-density lipoprotein cholesterol levels among US patients with diabetes, 1999-2014. Diabetes Res Clin Pract. 2018;139:1-10.
18. Wall HK, Ritchey MD, Gillespie C, Omura JD, Jamal A, George MG. Vital Signs: prevalence of key cardiovascular disease risk factors for Million Hearts 2022 - United States, 2011-2016. MMWR Morb Mortal Wkly Rep. 2018;67(35):983-991.
19. National Center for Health Statistics. Health, United States, 2019: Table 7: Leading Causes of Death and Numbers of Deaths, by Age: United States, 1980 and 2018. Accessed February 3, 2022. https://www.cdc.gov/nchs/data/hus/2019/007-508.pdf
20. Ridker PM, Danielson E, Fonseca FA, et al; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-2207.
21. Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012;380(9841):565-571.
22. Panozzo CA, Curtis LH, Marshall J, et al. Incidence of statin use in older adults with and without cardiovascular disease and diabetes mellitus, January 2008–March 2018. PLoS One. 2019;14(12):e0223515.
23. US Preventive Services Task Force. Aspirin use to prevent cardiovascular disease: US Preventive Services Task Force recommendation statement. JAMA. 2022;327(16):1577-1584.
24. US Preventive Services Task Force. Screening for hypertension in adults: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2021;325(16):1650-1656.
25. US Preventive Services Task Force. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. JAMA. 2021;326(8):736-743.
26. US Preventive Services Task Force. Interventions for tobacco smoking cessation in adults, including pregnant persons: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(3):265-279.
27. US Preventive Services Task Force. Behavioral counseling interventions to promote a healthy diet and physical activity for cardiovascular disease prevention in adults with cardiovascular risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2020;324(20):2069-2075.
28. US Preventive Services Task Force. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults without cardiovascular risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(2):167-174.
29. US Preventive Services Task Force. Behavioral weight loss interventions to prevent obesity-related morbidity and mortality in adults: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(11):1163-1171.
30. US Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(19):1997-2007.
31. Chou R, Cantor A, Dana T, et al. Statin use for the primary prevention of cardiovascular disease in adults: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. Published August 23, 2022.
32. Shepherd J, Blauw GJ, Murphy MB; PROSPER Study Group. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002;360(9346):1623-1630.
33. Shepherd J, Cobbe SM, Ford I, et al; West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333(20):1301-1307.
34. Han BH, Sutin D, Williamson JD, et al; ALLHAT Collaborative Research Group. Effect of statin treatment vs usual care on primary cardiovascular prevention among older adults: the ALLHAT-LLT randomized clinical trial. JAMA Intern Med. 2017;177(7):955-965.
35. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002;288(23):2998-3007.
36. Macedo AF, Taylor F, Casas JP, Adler A, Prieto-Merino D, Ebrahim S. Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis. BMC Med. 2014;12(51).
37. Jick SS, Bradbury BD. Statins and newly diagnosed diabetes. Br J Clin Pharmacol. 2004;58(3):303-309.
38. Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s Health Initiative. Arch Intern Med. 2012;172(2):144-152.
39. Porath A, Arbelle JE, Fund N, Cohen A, Mosseri M. Statin therapy: diabetes mellitus risk and cardiovascular benefit in primary prevention. Isr Med Assoc J. 2018;20(8):480-485.
40. Yusuf S, Bosch J, Dagenais G, et al; HOPE-3 Investigators. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374(21):2021-2031.
41. US Preventive Services Task Force. Risk assessment for cardiovascular disease with nontraditional risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(3):272-280.
42. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139:e1082–1143.
43. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the primary prevention of cardiovascular disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646.
44. Department of Veterans Affairs. Department of Defense. VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia for Cardiovascular Risk Reduction. 2014. Accessed February 3, 2022. https://www.healthquality.va.gov/guidelines/CD/lipids/VADoDDyslipidemiaCPG2014.pdf

Return to Table of Contents

Rationale Assessment
Benefits of statin use
  • Convincing evidence that statin use reduces the probability of CVD events (myocardial infarction or ischemic stroke) and all-cause mortality by at least a moderate amount in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 10% or greater.
  • Convincing evidence that statin use reduces the probability of CVD events (myocardial infarction or ischemic stroke) and all-cause mortality by at least a small amount in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 7.5% to less than 10%.
  • Inadequate evidence to conclude whether initiating statin use in adults 76 years or older with no history of CVD and who are not already taking a statin is beneficial in reducing the incidence of CVD events and mortality
Harms of statin use
  • Convincing evidence that the harms of statin use in adults aged 40 to 75 years are at most small.
  • Inadequate evidence on the harms of statin use for the primary prevention of CVD events in adults 76 years or older.
USPSTF assessment
  • The USPSTF concludes with moderate certainty that statin use for the prevention of CVD events and all-cause mortality in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 10% or greater has at least a moderate net benefit.
  • The USPSTF concludes with moderate certainty that statin use for the prevention of CVD events and mortality in adults aged 40 to 75 years with no history of CVD and who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 7.5% to less than 10% has at least a small net benefit. The decision to initiate therapy should depend on individual patient preference for a potential small benefit relative to the potential harms and inconvenience of taking a daily medication.
  • The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of statin use for the primary prevention of CVD events and mortality in adults 76 years or older with no history of CVD.

Abbreviations: CVD, cardiovascular disease; USPSTF, US Preventive Services Task Force.

Return to Table of Contents