What are the indications for initiating HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, commonly referred to as statins, for the management of hypercholesterolemia?

From the Guidelines

The indications for initiating HMG-CoA reductase inhibitors, commonly referred to as statins, for the management of hypercholesterolemia include individuals with a history of cardiovascular disease, those with high levels of low-density lipoprotein (LDL) cholesterol (greater than 190 mg/dL), and people with diabetes, as stated in the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol 1.

Specific Patient Groups

The following patient groups should be considered for statin therapy:

• Patients with clinical cardiovascular disease, such as those with a history of heart attack, stroke, or peripheral artery disease, who should be started on a high-intensity statin (e.g., atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily) 1.
• Patients with LDL cholesterol levels of 190 mg/dL or higher, who should be started on a high-intensity statin.
• Patients with diabetes who are 40-75 years old, who should be started on a moderate-intensity statin (e.g., atorvastatin 10-20 mg daily or rosuvastatin 5-10 mg daily) 1.
• Patients without clinical cardiovascular disease or diabetes, but with an LDL cholesterol level of 70-189 mg/dL and a 10-year risk of cardiovascular disease of 7.5% or higher, who should be started on a moderate-intensity statin.

Goal of Statin Therapy

The goal of statin therapy is to reduce LDL cholesterol levels by 50% or more for high-intensity statins, and by 30-49% for moderate-intensity statins, as recommended by the 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults 1.

Additional Considerations

The 2017 AHA/ACC clinical performance and quality measures for adults with ST-elevation and non-ST-elevation myocardial infarction recommend treating patients with clinical atherosclerotic cardiovascular disease, including those with myocardial infarction, with high-intensity statin therapy 1. The USPSTF also recommends starting low- to moderate-dose statins in adults aged 40 to 75 years who have one or more cardiovascular disease risk factors and a calculated 10-year cardiovascular disease event risk of 10% or greater 1.

From the FDA Drug Label

Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: 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. As an adjunct to diet to: reduce LDL-C in adults with primary hyperlipidemia. reduce LDL-C and slow the progression of atherosclerosis in adults reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH) As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

The indications for initiating HMG-CoA reductase inhibitors (statins) for the management of hypercholesterolemia are:

• Primary prevention of major adverse cardiovascular events in adults without established coronary heart disease who are at increased risk of CV disease
• Adjunct to diet to reduce LDL-C in adults with:
  • Primary hyperlipidemia
  • Heterozygous familial hypercholesterolemia (HeFH)
  • Homozygous familial hypercholesterolemia (HoFH)
• Treatment of:
  • Primary dysbetalipoproteinemia
  • Hypertriglyceridemia 2

From the Research

Indications for Initiating Statin Therapy

The indications for initiating HMG-CoA reductase inhibitors, commonly referred to as statins, for the management of hypercholesterolemia are as follows:

• Patients with atherosclerotic cardiovascular disease (ASCVD) 3, 4
• Patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dl 3
• Patients with diabetes 3, 4
• Patients with a 10-year ASCVD risk ≥7.5% 3, 4
• Patients with severe hypercholesterolemia 4
• Patients aged 40 to 75 years with a 10-year risk for ASCVD of 20% or greater 4

Patient Groups that Benefit from Statin Therapy

The 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines identify four patient groups who benefit from moderate- or high-intensity statin treatment:

• Those with ASCVD
• Those with LDL-C ≥190 mg/dl
• Those with diabetes
• Those with a 10-year ASCVD risk ≥7.5% 3

High-Intensity Statin Therapy

High-intensity statins are recommended for patients at high risk for ASCVD, with a goal for LDL-C reduction of 50% or greater 4

• High-intensity statins include rosuvastatin 20-40 mg and atorvastatin 40-80 mg 3
• The choice and dose of statin have an impact on the percentage LDL-C reduction and achievement of ≥50% reduction in LDL-C, overall and within each of the four statin benefit groups 3