Statin Therapy for the Prevention and Treatment of Cardiovascular Disease

– All patients who were previously diagnosed with or currently have a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including an ASCVD procedure; OR

– Patients aged 20 to 75 years who have ever had a low-density lipoprotein cholesterol (LDL-C) level >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia; OR

– Patients aged 40-75 years with a diagnosis of diabetes; OR

– Patients aged 40 to 75 with a 10-year ASCVD risk score of >= 20 percent.

Data collected between 2011 and 2014 indicates that more than 94.6 million U.S. adults, 20 years or older, had total cholesterol levels equal to 200 mg/dL or more, while almost 28.5 million had levels 240 mg/dL or more (Benjamin et al., 2018). Elevated blood cholesterol is a major risk factor for CVD and statin therapy has been associated with a reduced risk of CVD. Numerous randomized trials have demonstrated that treatment with a statin reduces LDL-C and reduces the risk of major cardiovascular events by approximately 20 percent (Ference, 2015).

In 2018, updated guidelines on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults were published (Grundy et al., 2019). This guideline was published by an Expert Panel, which synthesized evidence from randomized controlled trials to identify people most likely to benefit from cholesterol-lowering therapy. The American College of Cardiology (ACC)/American Heart Association (AHA)/Multi-society (MS) Guideline recommendations are intended to provide a strong evidence-based foundation for the treatment of blood cholesterol for the primary and secondary prevention and treatment of ASCVD in patients of all ages. The document concludes that the addition of statin therapy reduces the risk of ASCVD among high-risk individuals, defined as follows: individuals with clinical ASCVD, with LDL-C >= 190 mg/dL, with diabetes, or individuals with >= 20 percent risk of ASCVD as determined via use of an ASCVD risk estimator derived from the Pooled Cohort Equations (Grundy et al., 2019).

One study surveying U.S. cardiology, primary care, and endocrinology practices found that 1 in 4 guideline-eligible patients were not on a statin and less than half were on the recommended statin intensity. Untreated and undertreated patients had significantly higher LDL-C levels than those receiving guideline-directed statin treatment (Navar et al., 2017). In a follow-up study authored by Nanna et al., the same clinics were divided into tertiles based on the percentage of patients with guideline-recommended statin use. The researchers found that patients in the high-tertile clinics were more likely to achieve target LDL-C levels than patients at the low- or mid-tertile clinics, and this held true when patients were stratified by primary and secondary prevention (Nanna et al., 2019a).

Research also indicates that certain populations are far less likely to receive guideline-recommended statin therapy than others. A retrospective study of the National Health and Nutrition Examination Survey found that Black and Hispanic race or ethnicity, low income, lack of health insurance coverage, poor health care access, young age, and female gender are predictors of lower statin utilization (Gu et al., 2018). In particular, there is extensive evidence that women are far less likely than men to be prescribed guideline-recommended statin therapy (Nanna et al., 2019b), despite research showing that female patients with cardiovascular disease derive the same or greater benefit from statin therapy as male patients with cardiovascular disease (Puri et al., 2014).

The Statin Safety Expert Panel that participated in a National Lipid Association (NLA) Statin Safety Task Force meeting in October 2013 reaffirms the general safety of statin therapy. The panel members concluded that for most patients requiring statin therapy, the potential benefits of statin therapy outweigh the potential risks. In general terms, the benefits of statins to prevent non-fatal myocardial infarction, revascularization, stroke, and CVD mortality, far outweigh any potential harm related to the drug (Jacobson, 2014).

Recommendations for Management of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults – Statin Treatment:

Secondary Prevention:

1. In patients who are 75 years of age or younger with clinical ASCVD, high-intensity statin therapy should be initiated or continued with the aim of achieving a 50 percent or greater reduction in LDL-C levels (Class I Recommendation), (Grundy et al., 2019).

2. In patients with clinical ASCVD in whom high-intensity statin therapy is contraindicated or who experience statin-associated side effects, moderate-intensity statin therapy should be initiated or continued with the aim of achieving a 30 to 49 percent reduction in LDL-C levels (Class I Recommendation), (Grundy et al., 2019).

3. In patients older than 75 years of age with clinical ASCVD, it is reasonable to initiate moderate- or high-intensity statin therapy after evaluation of the potential for ASCVD risk reduction, adverse effects, and drug–drug interactions, as well as patient frailty and patient preferences (Class IIa Recommendation), (Grundy et al., 2019).

Primary Prevention

1. In patients 20 to 75 years of age with an LDL-C level of 190 mg/dL or higher (>= 4.9 mmol/L), maximally tolerated statin therapy is recommended. (Class I Recommendation), (Grundy et al., 2019).

2. In adults 40 to 75 years of age with diabetes mellitus, regardless of estimated 10-year ASCVD risk, moderate-intensity statin therapy is indicated (Class I Recommendation), (Grundy et al., 2019).

3. To facilitate decisions about preventive interventions, it is recommended to screen for traditional ASCVD risk factors and apply the race- and sex-specific Pooled Cohort Equations (PCE) to estimate 10-year ASCVD risk for asymptomatic adults 40 to 75 years of age. The higher the estimated risk, the more likely the patient is to benefit from statin treatment (Grundy et al., 2019).

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 of these CVD risk factors and an estimated 10-year CVD event risk of 7.5 percent to less than 10 percent has at least a small net benefit (USPSTF 2022).

Statin Safety and Statin-Associated Side Effects

A clinician–patient risk discussion is recommended before initiation of statin therapy to review net clinical benefit, weighing the potential for ASCVD risk reduction against the potential for statin-associated side effects, statin–drug interactions, and safety, while emphasizing that side effects can be addressed successfully (Class I Recommendation), (Grundy et al., 2019).

– Acute coronary syndromes

– History of myocardial infarction

– Stable or unstable angina

– Coronary or other arterial revascularization

– Stroke or transient ischemic attack (TIA)

– Peripheral arterial disease of atherosclerotic origin

Lipoprotein density cholesterol (LDL-C) result:

– A fasting or non-fasting LDL-C laboratory test performed and direct or calculated test result documented in the medical record. When both direct and calculated test results are available on the same day, the direct LDL-C test result should be used.

Statin therapy:

– Administration of one or more of a group of medications that are used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia.

Statin Medication Therapy List (NOTE: List does NOT include dosage):

[Generic name] (Brand or trade name) and (-) Medication type, if applicable:

[Atorvastatin] (Lipitor) – Statin

[Fluvastatin] (Lescol XL or Lescol) – Statin

[Lovastatin (Mevinolin)](Mevacor or Altoprev) – Statin

[Pitavastatin] (Livalo or Zypitamag or Nikita) – Statin

[Pravastatin Sodium] (Pravachol) – Statin

[Rosuvastatin Calcium] (Crestor) – Statin

[Simvastatin] (Zocor) – Statin

[Amlodipine Besylate/Atorvastatin Calcium] (Caduet) – Fixed Dose Combination

[Ezetimibe / Rosuvastatin] (Roszet) – Fixed Dose Combination [Ezetimibe/Simvastatin] (Vytorin) – Fixed Dose Combination

Statin-Associated Muscle Symptoms (SAMS) – The 2018 ACC/AHA/MS Guideline (Grundy et al., 2019) includes the following SAMS: myalgias, myositis, myopathy, or statin-associated autoimmune myopathy. Patients who experience significant or repeated statin-associated muscle symptoms may prefer not to take or continue statin therapy and therefore may be removed from the denominator.

The initial population covers four distinct populations. Use the following process to prevent counting patients more than once.

Initial Population 1:

All patients who were previously diagnosed with or currently have a diagnosis of clinical ASCVD, including an ASCVD procedure before the end of the measurement period.

– If YES, meets Initial Population 1 risk category.

– If NO, screen for next risk category.

Initial Population 2:

Patients aged 20 to 75 years at the beginning of the measurement period who have ever had a laboratory test result of LDL-C >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia.

– If YES, meets Initial Population 2 risk category.

– If NO, screen for next risk category.

Initial Population 3:

Patients aged 40 to 75 years at the beginning of the measurement period with an active diagnosis of Type 1 or Type 2 diabetes at any time during the measurement period.

– If YES, meets Initial Population 3 risk category.

– If NO, screen for next risk category.

Initial Population 4:

Patients aged 40 to 75 at the beginning of the measurement period with a 10-year ASCVD risk score of >= 20 percent during the measurement period.

– If YES, meets Initial Population 4 risk category.

– If NO, patient does NOT meet Initial Population criteria and is NOT eligible for measure inclusion.

Initial Population Guidance for Encounter:

In order for the patient to be included in the Initial Population, the patient must have ONE initial population-eligible visit, defined as follows: outpatient visit, initial or established office visit, face-to-face interaction, preventive care services, or annual wellness visit.

LDL-C Laboratory test result options:

The measure can be reported for all patients with a documented LDL-C level recorded as follows:

To meet Initial Population 1:

There is no LDL-C result required.

To meet Initial Population 2:

If a patient has ANY previous laboratory result of LDL-C >= 190 mg/dL, report the highest value >= 190 mg/dL.

To meet Initial Population 3:

There is no LDL-C result required.

To meet Initial Population 4:

There is no LDL-C result required.

The 10-year ASCVD risk assessment options:

The 10-year ASCVD risk score is calculated using the Pooled Cohort Equations: 1) the 2013 ACC/AHA ASCVD Risk Estimator (maps to LOINC Code 79423-0) OR 2) the ACC Risk Estimator Plus (maps to LOINC Code 99055-6). If your EHR does not have either of these risk calculators, we recommend that you use the on-line versions. The 10-year ASCVD risk score (quantitative result, i.e., result.value, “%”) must be documented in a structured field. The 10-year ASCVD risk assessment must be performed during the measurement period. Any documentation of a 10-year ASCVD risk score >=20 will qualify patient for the denominator population, even if risk score changes later in the measurement period.

Numerator instructions and guidance:

– Current statin therapy use must be documented in the patient’s current medication list or ordered during the measurement period.

– ONLY statin therapy meets the measure Numerator criteria (NOT other cholesterol lowering medications).

– Prescription or order does NOT need to be linked to an encounter or visit; it may be called to the pharmacy.

– Statin medication “samples” provided to patients can be documented as “current statin therapy” if documented in the medication list in health/medical record.

– Patients who meet the denominator criteria for inclusion, but are not prescribed or using statin therapy, will NOT meet performance for this measure unless they have an allowable denominator exception. Patients with an allowable denominator exception should be removed from the denominator of the measure and reported as a valid exception.

– There is only one performance rate calculated for this measure: the weighted average of the four populations.

– Adherence to statin therapy is not calculated in this measure.

– It may not be appropriate to prescribe statin therapy for some patients (see exceptions and exclusions for the complete list).

Intensity of statin therapy in primary and secondary prevention:

The expert panel of the 2018 ACC/AHA/MS Guidelines (Grundy et al., 2019) defines recommended intensity of statin therapy on the basis of the average expected LDL-C response to specific statin and dose. Although intensity of statin therapy is important in managing cholesterol, this measure assesses prescription of ANY statin therapy, irrespective of intensity. Assessment of appropriate intensity and dosage documentation added too much complexity to allow inclusion of statin therapy intensity in the measure at this time.

Lifestyle modification coaching:

A healthy lifestyle is important for the prevention of cardiovascular disease. However, lifestyle modification monitoring and documentation added too much complexity to allow its inclusion in the measure at this time.

Millimoles per liter (mmol/L) must be converted to milligrams per deciliter (mg/dL) for reporting this measure.

This eCQM is a patient-based measure. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM.

Population 2: Patients aged 20 to 75 years at the beginning of the measurement period who have ever had a laboratory result of LDL-C >=190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia.

Population 3: Patients aged 40 to 75 years at the beginning of the measurement period with Type 1 or Type 2 diabetes

Population 4: Patients aged 40 to 75 at the beginning of the measurement period with a 10-year ASCVD risk score (i.e., 2013 ACC/AHA ASCVD Risk Estimator or the ACC Risk Estimator Plus) of >= 20 percent during the measurement period.

Patients who have a diagnosis of rhabdomyolysis at any time during the measurement period.

Patients who are receiving palliative or hospice care.

Patients with active liver disease or hepatic disease or insufficiency.

Patients with end-stage renal disease (ESRD).

Patients with documentation of a medical reason for not being prescribed statin therapy.