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Statin Use for the Primary Prevention of Cardiovascular Disease in Adults, Preventive Medication, 2016

* Indicates an old grade definition


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

  • Statin Use for the Primary Prevention of CVD: Preventive Medicine -- Adults age 40 to 75 years with no history of CVD, 1 or more CVD risk factors, and a calculated 10-year CVD event risk of 10% or greater.
    Grade: B
    Specific Recommendations:

    The USPSTF recommends that adults without a history of cardiovascular disease (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.

    Identification of dyslipidemia and calculation of 10-year CVD event risk requires universal lipids screening in adults aged 40 to 75 years.

    Considerations for Implementation

    To determine whether a patient is a candidate for statin therapy, clinicians must first determine the patient’s risk of having a future CVD event. However, clinicians’ ability to accurately identify a patient’s true risk is imperfect, because the best currently available risk estimation tool, which uses the Pooled Cohort Equations from the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the assessment of cardiovascular risk,1 has been shown to overestimate actual risk in multiple external validation cohorts.2-4 The reasons for this possible overestimation are still unclear. The Pooled Cohort Equations were derived from prospective cohorts of volunteers from studies conducted in the 1990s and may not be generalizable to a more contemporary and diverse patient population seen in current clinical practice. Furthermore, no statin clinical trials enrolled patients based on a specific risk threshold calculated using a CVD risk prediction tool; rather, patients had 1 or more CVD risk factors other than age and sex as a requirement for trial enrollment.

    Because the Pooled Cohort Equations lack precision, the risk estimation tool should be used as a starting point to discuss with patients their desire for lifelong statin therapy. The likelihood that a patient will benefit from statin use depends on his or her absolute baseline risk of having a future CVD event, a risk estimation that is imprecise based on the currently available risk estimation tool. Thus, clinicians should discuss with patients the potential risk of having a CVD event and the expected benefits and harms of statin use. Patients 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 statin use for reduction of CVD risk. The USPSTF has made several other recommendations relevant to the prevention of CVD in adults (see the “Other Approaches to Prevention” section).

    Patient Population Under Consideration

    These recommendations apply to adults 40 years and older without a history of CVD who do not have current signs and symptoms of CVD (ie, symptomatic coronary artery disease or ischemic stroke). Some individuals in this group may have undetected, asymptomatic atherosclerotic changes; for the purposes of this recommendation statement, the USPSTF considers these persons to be candidates for primary prevention interventions. These recommendations do not apply to adults with a low-density lipoprotein cholesterol (LDL-C) level greater than 190 mg/dL (to convert LDL-C values to mmol/L, multiply by 0.0259) or known familial hypercholesterolemia; these persons are considered to have very high cholesterol levels and may require statin use.

    Frequency of Service:

    No Frequency of Service information currently available.

    Risk Factor Information:

    Adults meeting the following criteria are at increased risk: 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.

    Risk Factors for CVD

    For the purposes of this recommendation, dyslipidemia is defined as an LDL-C level greater than 130 mg/dL or a high-density lipoprotein cholesterol (HDL-C) level less than 40 mg/dL (to convert HDL-C values to mmol/L, multiply by 0.0259). Most participants enrolled in trials of statin use for the prevention of CVD had an LDL-C level of 130 to 190 mg/dL or a diabetes diagnosis; hypertension and smoking were also common among trial participants.6 Persons with an LDL-C level greater than 190 mg/dL were usually excluded from trial participation, as it was not considered appropriate to randomly assign them to placebo. Thus, these recommendations do not pertain to persons with very high cholesterol levels (ie, LDL-C >190 mg/dL) or familial hypercholesterolemia, as they were excluded from most prevention trials.

  • Statin Use for the Primary Prevention of CVD: Preventive Medication--Adults aged 40 to 75 years with no history of CVD, 1 or more CVD risk factors, and a calculated 10-year CVD event risk of 7.5% to 10%
    Grade: C
    Specific Recommendations:

    Although statin use may be beneficial for the primary prevention of CVD events in some adults with a 10-year CVD event risk of less than 10%, the likelihood of benefit is smaller, because of a lower probability of disease and uncertainty in individual risk prediction. Clinicians may choose to offer a low- to moderate-dose statin to certain adults without a history of CVD 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 7.5% to 10%.

    Considerations for Implementation

    To determine whether a patient is a candidate for statin therapy, clinicians must first determine the patient’s risk of having a future CVD event. However, clinicians’ ability to accurately identify a patient’s true risk is imperfect, because the best currently available risk estimation tool, which uses the Pooled Cohort Equations from the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the assessment of cardiovascular risk,1 has been shown to overestimate actual risk in multiple external validation cohorts.2-4 The reasons for this possible overestimation are still unclear. The Pooled Cohort Equations were derived from prospective cohorts of volunteers from studies conducted in the 1990s and may not be generalizable to a more contemporary and diverse patient population seen in current clinical practice. Furthermore, no statin clinical trials enrolled patients based on a specific risk threshold calculated using a CVD risk prediction tool; rather, patients had 1 or more CVD risk factors other than age and sex as a requirement for trial enrollment.

    Because the Pooled Cohort Equations lack precision, the risk estimation tool should be used as a starting point to discuss with patients their desire for lifelong statin therapy. The likelihood that a patient will benefit from statin use depends on his or her absolute baseline risk of having a future CVD event, a risk estimation that is imprecise based on the currently available risk estimation tool. Thus, clinicians should discuss with patients the potential risk of having a CVD event and the expected benefits and harms of statin use. Patients 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 statin use for reduction of CVD risk. The USPSTF has made several other recommendations relevant to the prevention of CVD in adults (see the “Other Approaches to Prevention” section).

    Patient Population Under Consideration

    These recommendations apply to adults 40 years and older without a history of CVD who do not have current signs and symptoms of CVD (ie, symptomatic coronary artery disease or ischemic stroke). Some individuals in this group may have undetected, asymptomatic atherosclerotic changes; for the purposes of this recommendation statement, the USPSTF considers these persons to be candidates for primary prevention interventions. These recommendations do not apply to adults with a low-density lipoprotein cholesterol (LDL-C) level greater than 190 mg/dL (to convert LDL-C values to mmol/L, multiply by 0.0259) or known familial hypercholesterolemia; these persons are considered to have very high cholesterol levels and may require statin use.

    Frequency of Service:

    No Frequency of Service information currently available.

    Risk Factor Information:

    Adults meeting the following criteria are at increased risk: 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 7.5% to 10%.

    Risk Factors for CVD

    For the purposes of this recommendation, dyslipidemia is defined as an LDL-C level greater than 130 mg/dL or a high-density lipoprotein cholesterol (HDL-C) level less than 40 mg/dL (to convert HDL-C values to mmol/L, multiply by 0.0259). Most participants enrolled in trials of statin use for the prevention of CVD had an LDL-C level of 130 to 190 mg/dL or a diabetes diagnosis; hypertension and smoking were also common among trial participants.6 Persons with an LDL-C level greater than 190 mg/dL were usually excluded from trial participation, as it was not considered appropriate to randomly assign them to placebo. Thus, these recommendations do not pertain to persons with very high cholesterol levels (ie, LDL-C >190 mg/dL) or familial hypercholesterolemia, as they were excluded from most prevention trials.

  • Statin Use for the Primary Prevention of CVD: Preventive Medication -- Adults 76 years and older with no history of CVD
    Grade: I
    Specific Recommendations:

    The USPSTF concludes that the current evidence is 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 and older without a history of heart attack or stroke.

    Considerations for Implementation

    To determine whether a patient is a candidate for statin therapy, clinicians must first determine the patient’s risk of having a future CVD event. However, clinicians’ ability to accurately identify a patient’s true risk is imperfect, because the best currently available risk estimation tool, which uses the Pooled Cohort Equations from the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the assessment of cardiovascular risk,1 has been shown to overestimate actual risk in multiple external validation cohorts.2-4 The reasons for this possible overestimation are still unclear. The Pooled Cohort Equations were derived from prospective cohorts of volunteers from studies conducted in the 1990s and may not be generalizable to a more contemporary and diverse patient population seen in current clinical practice. Furthermore, no statin clinical trials enrolled patients based on a specific risk threshold calculated using a CVD risk prediction tool; rather, patients had 1 or more CVD risk factors other than age and sex as a requirement for trial enrollment.

    Because the Pooled Cohort Equations lack precision, the risk estimation tool should be used as a starting point to discuss with patients their desire for lifelong statin therapy. The likelihood that a patient will benefit from statin use depends on his or her absolute baseline risk of having a future CVD event, a risk estimation that is imprecise based on the currently available risk estimation tool. Thus, clinicians should discuss with patients the potential risk of having a CVD event and the expected benefits and harms of statin use. Patients 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 statin use for reduction of CVD risk. The USPSTF has made several other recommendations relevant to the prevention of CVD in adults (see the “Other Approaches to Prevention” section).

    Patient Population Under Consideration

    These recommendations apply to adults 40 years and older without a history of CVD who do not have current signs and symptoms of CVD (ie, symptomatic coronary artery disease or ischemic stroke). Some individuals in this group may have undetected, asymptomatic atherosclerotic changes; for the purposes of this recommendation statement, the USPSTF considers these persons to be candidates for primary prevention interventions. These recommendations do not apply to adults with a low-density lipoprotein cholesterol (LDL-C) level greater than 190 mg/dL (to convert LDL-C values to mmol/L, multiply by 0.0259) or known familial hypercholesterolemia; these persons are considered to have very high cholesterol levels and may require statin use.

    Frequency of Service:

    No Frequency of Service information currently available.

    Risk Factor Information:

    Risk Factors for CVD

    For the purposes of this recommendation, dyslipidemia is defined as an LDL-C level greater than 130 mg/dL or a high-density lipoprotein cholesterol (HDL-C) level less than 40 mg/dL (to convert HDL-C values to mmol/L, multiply by 0.0259). Most participants enrolled in trials of statin use for the prevention of CVD had an LDL-C level of 130 to 190 mg/dL or a diabetes diagnosis; hypertension and smoking were also common among trial participants.6 Persons with an LDL-C level greater than 190 mg/dL were usually excluded from trial participation, as it was not considered appropriate to randomly assign them to placebo. Thus, these recommendations do not pertain to persons with very high cholesterol levels (ie, LDL-C >190 mg/dL) or familial hypercholesterolemia, as they were excluded from most prevention trials.

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