Draft Recommendation Statement
Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication
February 22, 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.
- Update in Progress for Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication
|Adults ages 40 to 75 years who have one or more cardiovascular risk factors and have an estimated 10-year cardiovascular disease (CVD) risk of 10% or greater||The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults who are ages 40 to 75 years, have one or more of the following CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking), and have an estimated 10-year risk of a cardiovascular event of 10% or greater.||B|
|Adults ages 40 to 75 years who have one or more cardiovascular risk factors and have an estimated 10-year CVD risk of 7.5% to 10%||The USPSTF recommends that clinicians selectively offer a statin for the primary prevention of CVD for adults who are ages 40 to 75 years, have one or more of the following CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking), and have an estimated 10-year risk of a cardiovascular event of 7.5% to 10%. The likelihood of benefit is smaller in this group than in persons with a 10-year risk of 10% or greater.||C|
|Adults age 76 years or older||The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality in adults age 76 years or older.||I|
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 United States, resulting in one out of every four deaths.1 Coronary heart disease is the single leading cause of death and accounts for 43% of deaths attributable to CVD in the United States.2,3 In 2019, there were an estimated 558,000 deaths caused by coronary heart disease and 109,000 deaths caused by ischemic stroke. Males carry a higher overall burden of CVD, although females experience higher mortality from certain cardiovascular events, such as stroke. Males tend to experience CVD events earlier in life compared with females. The burden of CVD also differs by race and ethnicity. Among both sexes, Black Americans have the highest prevalence of CVD.4
The U.S. Preventive Services Task Force (USPSTF) concludes with moderate certainty that statin use for the prevention of CVD events and all-cause mortality in adults ages 40 to 75 years with no history of CVD and who have one or more of the following CVD risk factors (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 ages 40 to 75 years with no history of CVD and who have one or more of the following CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD event risk of 7.5% to 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 age 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
Patient Population Under Consideration
These recommendations apply to adults age 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 (LDL) cholesterol level greater than 190 mg/dL or known familial hypercholesterolemia.
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 U.S.-based CVD risk prediction tool that has published external validation studies in other U.S.-based populations.6 The estimator has separate equations based on sex and for Black 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 (heart attack 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 it is important to note that 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. Thus, the expected benefit for persons with a 10-year CVD risk of 10% or greater is greater than the expected benefit for persons with a 10-year CVD risk of 7.5% to 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 prescribing a statin. For patients with an estimated 10-year CVD risk of 7.5% to 10% (and who have one or more 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.
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.12 Based on available evidence, use of moderate-intensity statin therapy seems reasonable for the primary prevention of CVD in most persons.
Several studies have reported inequities in statin utilization 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 statin use compared with White adults.13,14 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).14 Older age, having health insurance, and higher income were associated with an increased likelihood of statin use.15,16 Data from the 2013–2014 National Health and Nutrition Examination Survey found that among persons eligible for statin use, statin use was higher among White non-Hispanic (58.3%) persons compared with Black non-Hispanic (44.3%), Asian non-Hispanic (49.2%), or Hispanic (33.7%) persons.17 It is crucial to equitably improve statin use in both women and men of all races and ethnicities, regardless of socioeconomic or health insurance status, to achieve the full benefits of statin use, and especially among Black 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 has information about cholesterol-lowering medications, including statins, at https://www.cdc.gov/cholesterol/treating_cholesterol.htm, and resources for clinicians at https://www.cdc.gov/cholesterol/educational_materials.htm. Million Hearts, a national initiative to prevent heart attacks and strokes, has information on statins at 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 the first and fourth leading causes of death in adults age 65 years or older in 2018, although data were not reported separately for adults older than age 75 years.18 However, trial data on the benefits of statin use in persons older than age 75 years are limited,12 and the available evidence is insufficient to recommend for or against initiating statin use for the primary prevention of CVD in this age group.
Evidence on the potential harms of statin use for the primary prevention of CVD events specifically in adults age 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 transaminase level, or cognitive harms compared with placebo.12 Almost all trials did not find an association between statin use and incidence of diabetes; one 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,19 with a subsequent analysis finding that this increased risk was limited to participants with diabetes risk factors at baseline (metabolic syndrome, impaired fasting glucose, body mass index of 30 kg/m2 or greater, or hemoglobin A1c level greater than 6%).20
Data on statin use for the primary prevention of CVD in persons age 76 years or older are limited. One study estimated that 10.7 million adults age 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.17 A second study reported that among adults age 75 years or older without a history of CVD, those with diabetes had rates of statin use that were more than 2 times higher than among persons without diabetes (76.1 and 34.5 initiators per 1,000 person-years, respectively). This study did not report the prevalence of statin use.21
Other Related USPSTF Recommendations
The USPSTF has made several recommendations related to the prevention of CVD in adults, including aspirin use for the prevention of CVD, which is currently being updated,22 screening for high blood pressure,23 screening for prediabetes and type 2 diabetes,24 interventions for tobacco smoking cessation,25 behavioral counseling to promote a healthful diet and physical activity for CVD prevention in adults (with and without cardiovascular risk factors),26,27 and behavioral interventions to prevent obesity-related morbidity and mortality in adults.28
When final, this recommendation will replace the 2016 USPSTF recommendation on statin use for the primary prevention of CVD. The current draft recommendation is consistent with the 2016 USPSTF recommendation. In 2016, the USPSTF recommended that adults without a history of CVD (i.e., 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 ages 40 to 75 years; 2) they have one or more CVD risk factors (i.e., 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 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 age 76 years or older.29
Scope of Review
To update its 2016 recommendation statement, the USPSTF commissioned a systematic review12 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 cholesterol 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 followup was 3 years. Mean age ranged from 52 to 66 years in all trials except for one, PROSPER (PROspective Study of Pravastatin in the Elderly at Risk), which enrolled persons ages 70 to 82 years and had a mean age of 75 years.30 Among the trials that used a fixed statin dose, most (12/16) utilized 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 five trials, ranged from less than 1% to 37%. Data for other races and ethnicities were limited. All trials enrolled persons with at least one 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.12
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]; I2=0%; 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]; I2=22%; ARD, −0.39%), and fatal or nonfatal myocardial infarction (12 trials; N=76,498; RR, 0.67 [95% CI, 0.60 to 0.75]; I2=11%; ARD, −0.89%). Several trials reported on a composite outcome of CVD events as a primary outcome; the exact composition of this composite end point varied 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]; I2=51%; ARD, −1.28%).12
Twelve trials (N=75,138) reported on cardiovascular mortality. Only one trial, WOSCOPS (West of Scotland Coronary Prevention Study; n=6,595), 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%]).31 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]; I2=0%; ARD, −0.13% [95% CI, −0.25% to −0.02%]).12
Evidence on the benefits of statins in persons age 75 years or older is limited. As noted, most trials had a mean participant age in the 50s and 60s; only one trial, PROSPER (n=3,239 for primary prevention), had a study population with a mean age of 75 years.30 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 of 75 years or older (in addition to other age groups).32,33 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.30 In the ALLHAT-LLT primary prevention population, statin therapy was associated with higher risk of all-cause and cardiovascular mortality in persons age 75 years or older than in those ages 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] for all-cause mortality; RR, 1.39 [95% CI, 0.85 to 2.25] vs. 0.99 [95% CI, 0.71 to 1.39], for cardiovascular mortality, respectively), but estimates for the age 75 years or older group were imprecise and the difference was not statistically significant.32,33 It should also be noted that ALLHAT-LLT had several limitations, including its open label design, high loss to followup, and high crossover from the usual care arm. It reported a small differential in LDL cholesterol lowering effect between the statin therapy and usual care arms, 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 age 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.12
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.12
Harms of Preventive Medication
The USPSTF reviewed 19 trials (N=75,005) and three observational studies (N=417,523) that reported on the harms of statin therapy in adults without a history of a prior 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.12 Although observational studies have reported an association between statin use and muscle pain,34 a pooled analysis of nine trials (N=46,388) found no increased risk of myalgia with statin therapy compared with placebo.12 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.12
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.12
Six trials (N=59,083) and three observational studies (N=417,523) reported on risk of new-onset diabetes with statin therapy. Based on a pooled analysis of six 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]).19 A subsequent analysis of this trial found that the increased risk of diabetes was limited to study participants with one or more diabetes risk factors (metabolic syndrome, impaired fasting glucose, body mass index of 30 kg/m2 or greater, or hemoglobin A1c level greater than 6%) at baseline.20 Cohort studies reported mixed findings. One case-control study found no association between statin use and risk of diabetes,35 an analysis from the Women’s Health Initiative found an increased risk (adjusted hazard ratio, 1.48 [95% CI, 1.38 to 1.59]),36 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.37
Evidence on the association between statins and renal or cognitive harms is very limited but does not indicate increased risk.12 In one 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%).38 Other trials did not note or report on this outcome.
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 age 76 years and or older.
- The efficacy and safety of long-term statin use in adults younger than age 40 years, and to determine the effects of earlier vs. delayed initiation of statin use, particularly in persons at high estimated long-term (longer than 10 years [e.g., lifetime]) risk of CVD.
- The causes of disparities in statin utilization 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.
The ACC/AHA defines 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%). It recommends initiation of statin therapy in persons at “intermediate” or “high” risk, and a risk discussion for persons at “borderline” risk. It recommends 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. These risk enhancers include family history of early coronary heart disease, presence of chronic kidney disease, metabolic syndrome, pre-eclampsia, premature menopause, inflammatory diseases, HIV, and South Asian ancestry.39
The U.S. Department of Veterans Affairs/U.S. Department of Defense recommends initiation of a moderate-dose statin in persons with an estimated 10-year cardiovascular risk of 12% or greater, and shared decision making in persons with an estimated 10-year cardiovascular risk of 6% to 12%.40
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15. Gamboa CM, Colantonio LD, Brown TM, et al. 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.
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38. Yusuf S, Bosch J, Dagenais G, et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374(21):2021-31.
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40. Department of Veterans Affairs. Department of Defense. VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia for Cardiovascular Risk Reduction. 2014. https://www.healthquality.va.gov/guidelines/CD/lipids/VADoDDyslipidemiaCPG2014.pdf. Accessed February 3, 2022.
|Benefits of statin use||
|Harms of statin use||
Abbreviations: CVD=cardiovascular disease; USPSTF=U.S. Preventive Services Task Force.