Which patients are eligible for statin therapy?

From the Guidelines

Patients eligible for statin therapy include those with established atherosclerotic cardiovascular disease (ASCVD), LDL cholesterol levels ≥190 mg/dL, diabetes mellitus (age 40-75), and individuals with elevated cardiovascular risk (typically 10-year risk ≥7.5%). According to the most recent guidelines, statins are recommended for secondary prevention in patients with prior heart attack, stroke, or peripheral artery disease 1. The following categories of patients are eligible for statin therapy:

• Those with established clinical ASCVD (secondary prevention)
• Primary elevation of LDL-C levels ≥190 mg/dl
• Diabetes, age 40 to 75 years, who have LDL-C levels 70 to 189 mg/dl
• Primary prevention without diabetes, age 40 to 75 years, with an estimated 10-year risk ≥7.5% 1 Common statins include atorvastatin (10-80 mg daily), rosuvastatin (5-40 mg daily), simvastatin (10-40 mg daily), and pravastatin (10-80 mg daily) 1. Treatment is typically lifelong, with regular monitoring of lipid levels and liver function tests. Intensity of therapy should match the patient's risk level, with high-intensity statins (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for those at highest risk. Statins work by inhibiting HMG-CoA reductase, reducing cholesterol synthesis in the liver, which leads to increased LDL receptor expression and enhanced clearance of LDL from the bloodstream, effectively lowering LDL cholesterol levels by 20-60% depending on the specific statin and dosage, significantly reducing cardiovascular event risk 1.

From the FDA Drug Label

Inclusion in the trial required 1) a baseline LDL-C level ≥190 mg/dL or 2) a baseline LDL-C level ≥160 mg/dL and positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative. The mean baseline LDL-C value was 219 mg/dL (range: 139 to 385 mg/dL) in the atorvastatin calcium group compared to 230 mg/dL (range: 160 to 325 mg/dL) in the placebo group Atorvastatin calcium significantly decreased plasma levels of total-C, LDL-C, TG, and apolipoprotein B during the 26-week double-blind phase

The patients who are eligible for statin therapy are those with:

• High LDL-C levels: ≥190 mg/dL
• High LDL-C levels with family history or premature cardiovascular disease: ≥160 mg/dL with positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative
• Heterozygous familial hypercholesterolemia (HeFH) or severe hypercholesterolemia: as seen in the clinical trials, patients with HeFH or severe hypercholesterolemia were included in the trials and showed significant reduction in LDL-C levels with atorvastatin therapy 2

From the Research

Eligibility for Statin Therapy

The following categories of patients are eligible for statin therapy:

• Patients with diabetes, as statin therapy has been shown to be highly efficacious in reducing cardiovascular disease (CVD) risk in this group 3, 4
• Patients with established CVD, as statin therapy can help reduce the risk of future CVD events 3, 5
• Patients at high risk of developing CVD, regardless of their cholesterol level 5
• Patients with hypercholesterolemia, as statin therapy can help lower low-density lipoprotein cholesterol (LDL-C) levels 5
• Patients with a history of acute coronary syndrome, as statin therapy can help reduce the risk of future ischemic events 5

Specific Guidelines for Statin Therapy

• For patients with diabetes, the goal is to lower LDL-C to at least 2.6 mmol/L (100 mg/dL) and, if possible, to 1.8 mmol/L (70 mg/dL) 3
• For patients with established CVD, the goal is to lower LDL-C to at least 1.8 mmol/L (70 mg/dL) 3
• For patients without established CVD, the decision to initiate statin therapy should be based on a risk-based approach, taking into account factors such as age, sex, and presence of other CVD risk factors 4
• Coronary artery calcium (CAC) scoring can be used to help risk-stratify patients with diabetes and guide decision-making about statin therapy 4

Benefits and Risks of Statin Therapy

• Statin therapy has been shown to reduce the risk of major cardiovascular events, including myocardial infarction, stroke, and coronary revascularization 6
• However, statin therapy is also associated with potential risks, including muscle injury, hepatotoxicity, and increased risk of newly diagnosed diabetes mellitus 7
• The benefits of statin therapy generally outweigh the risks for patients at high risk of CVD events, but the decision to initiate statin therapy should be individualized and based on a careful consideration of the potential benefits and risks 7