What are the indications for HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitor, also known as Statin (e.g. Atorvastatin), therapy?

From the Guidelines

Statins are recommended for patients with elevated cardiovascular risk, including established atherosclerotic cardiovascular disease (ASCVD), LDL cholesterol ≥190 mg/dL, diabetes mellitus in adults aged 40-75 years, and 10-year ASCVD risk ≥7.5% in adults aged 40-75 years. The indications for HMG-CoA reductase inhibitor, also known as Statin, therapy are based on the patient's cardiovascular risk profile. According to the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol 1, statin therapy is recommended for patients with elevated cardiovascular risk.

The following are the indications for statin therapy:

• Established atherosclerotic cardiovascular disease (ASCVD)
• LDL cholesterol ≥190 mg/dL
• Diabetes mellitus in adults aged 40-75 years
• 10-year ASCVD risk ≥7.5% in adults aged 40-75 years

Common statin medications include atorvastatin, rosuvastatin, and simvastatin. Dosing depends on the specific medication and patient factors, but typically starts at a moderate intensity and may be increased if needed. The 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol recommends the following dosing strategy:

• High-intensity statin therapy: atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily
• Moderate-intensity statin therapy: atorvastatin 10-20 mg daily or rosuvastatin 5-10 mg daily
• Low-intensity statin therapy: simvastatin 10-20 mg daily or pravastatin 10-20 mg daily

To implement statin therapy, the following steps should be taken:

1. Assess patient's cardiovascular risk using risk calculators
2. Check baseline lipid panel and liver function tests
3. Start with moderate-intensity statin (e.g., atorvastatin 10-20 mg daily)
4. Follow up in 4-12 weeks to assess efficacy and tolerability
5. Adjust dose as needed based on LDL response and side effects

Statins work by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, which leads to increased LDL receptor expression and enhanced clearance of LDL from the bloodstream, effectively lowering cardiovascular risk 1. The benefits of statin therapy have been consistently demonstrated in numerous studies, including a recent meta-analysis of 28 trials that showed a 21% reduction in major vascular events for every 1 mM drop in LDL-cholesterol 1.

From the FDA Drug Label

Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

The indications for HMG-CoA reductase inhibitor, also known as Statin (e.g. Atorvastatin), therapy are:

• Primary prevention: to reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
• Secondary prevention: to reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
• Lipid lowering: as an adjunct to diet to reduce low-density lipoprotein (LDL-C) in adults with primary hyperlipidemia, adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH), and adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia
• Treatment of other lipid disorders: as an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia and hypertriglyceridemia 2 2

From the Research

Indications for HMG-CoA Reductase Inhibitor Therapy

The indications for HMG-CoA reductase inhibitor, also known as statin, therapy are as follows:

• Primary prevention of cardiovascular disease (CVD) in adults aged 40 to 75 years with one or more CVD risk factors (e.g., dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD risk of 10% or greater 3
• Secondary prevention of CVD in patients with a history of CVD, as statins have been shown to reduce the risk of CVD events and mortality in these patients 4
• Patients at high risk of CVD, including those with elevated low-density lipoprotein (LDL) cholesterol levels, as statins have been shown to effectively reduce serum LDL cholesterol concentrations and prevent CVD events 4, 5

Patient Selection

When selecting patients for statin therapy, the following factors should be considered:

• 10-year CVD risk, as calculated using a risk assessment tool such as the European Systematic COronary Risk Evaluation 6
• Presence of CVD risk factors, such as dyslipidemia, diabetes, hypertension, or smoking 3
• LDL cholesterol level, as statins are most effective in reducing CVD risk in patients with elevated LDL cholesterol levels 4, 5
• Patient tolerance to potential adverse effects of statin therapy, as the potency and dose of statin should be tailored to the individual's cardiovascular risk and tolerance to adverse effects 4

Special Considerations

In certain patient populations, the use of statins may need to be individualized, such as:

• Patients aged 76 years or older, as the evidence is insufficient to determine the balance of benefits and harms of statin use in this population 3
• Patients with diabetes, as statins have been shown to increase the risk of developing diabetes in some patients, particularly those at low or intermediate CVD risk 6