What is the best tool to determine if a patient requires a statin (HMG-CoA reductase inhibitor)?

From the Guidelines

The best tool to decide if a patient needs a statin is the ASCVD (Atherosclerotic Cardiovascular Disease) Risk Calculator, which estimates a patient's 10-year risk of heart attack or stroke, and can be further informed by coronary artery calcium scoring (CACS) for intermediate-risk patients. Patients with a 10-year ASCVD risk score ≥7.5% are generally candidates for statin therapy, as are those with LDL cholesterol ≥190 mg/dL, diabetes with LDL ≥70 mg/dL, or established cardiovascular disease 1. When initiating statins, moderate-intensity options include atorvastatin 10-20 mg daily or rosuvastatin 5-10 mg daily, while high-intensity regimens include atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily. The choice between moderate and high-intensity therapy depends on the patient's risk level, with higher-risk patients requiring more aggressive treatment. Some key points to consider when deciding on statin therapy include:

• The presence of clinical ASCVD, diabetes, LDL-C ≥ 190 mg/dL, or level of estimated 10-year ASCVD risk 1
• The use of CACS to reclassify ASCVD risk and personalize individual therapy, particularly for intermediate-risk patients 1
• The importance of counseling patients about potential side effects like muscle pain and the importance of reporting symptoms promptly 1
• The need for baseline liver function tests and lipid panels before starting treatment, with follow-up testing 4-12 weeks after initiation to assess response and adherence. Overall, the decision to initiate statin therapy should be based on a comprehensive assessment of the patient's risk factors, medical history, and individual characteristics, with the goal of reducing the risk of ASCVD events and improving overall health outcomes.

From the FDA Drug Label

To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor.

The best tool to decide if a patient needs a statin is not explicitly stated in the provided drug labels. However, the labels do mention the importance of assessing CV risk factors and LDL-C levels in determining the need for statin therapy.

• Key factors to consider include:
  • Age
  • High-sensitivity C-reactive protein (hsCRP) levels
  • Additional CV risk factors
  • LDL-C levels
  • Presence of established coronary heart disease or other cardiovascular conditions 2, 3.

From the Research

Decision Tools for Statin Therapy

To determine if a patient needs a statin, several factors and tools can be considered:

• The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines identify four patient groups who benefit from moderate- or high-intensity statin treatment 4
• Assessment of atherosclerotic cardiovascular disease (ASCVD) risk is the cornerstone of primary ASCVD prevention, enabling targeted use of the most aggressive therapies in those most likely to benefit 5
• The Predicting Risk of Cardiovascular Disease Events (PREVENT) equations can be used to estimate 10-year risk of ASCVD, as an update to the 2013 pooled cohort equations (PCEs) 6

Statin Benefit Groups

The four statin benefit groups identified by the 2013 ACC/AHA guidelines are:

• Patients with atherosclerotic cardiovascular disease (ASCVD)
• Patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dl
• Patients with diabetes
• Patients with a 10-year ASCVD risk ≥7.5%

Risk Assessment and Calculation

The 10-year ASCVD risk can be calculated using the PREVENT equations or the PCEs:

• The PREVENT equations were derived from contemporary cohorts and removed race and added variables for kidney function and statin use 6
• The PCEs can also be used to estimate 10-year ASCVD risk, but may overestimate risk compared to the PREVENT equations 6

Considerations for Statin Therapy

When considering statin therapy, the following factors should be taken into account:

• The choice and dose of statin can impact the percentage LDL-C reduction and achievement of ≥50% reduction in LDL-C 4
• Non-statin medications, such as ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, can provide enhanced low-density lipoprotein cholesterol reduction and cardiovascular benefits in high-risk patients inadequately managed with statins alone 7, 8