What are the guidelines for initiating statin (HMG-CoA reductase inhibitor) therapy?

From the Guidelines

Statins should be initiated in individuals with established atherosclerotic cardiovascular disease (ASCVD), LDL cholesterol ≥190 mg/dL, diabetes mellitus (age 40-75 with LDL 70-189 mg/dL), or those with a 10-year ASCVD risk ≥7.5% (age 40-75 with LDL 70-189 mg/dL) as recommended by the most recent guidelines 1.

Key Considerations for Statin Initiation

• The decision to start statin therapy should be based on a comprehensive assessment of the patient's risk factors, including age, coexisting conditions, and risk factors 1.
• For patients with diabetes aged 40-75 years without ASCVD, moderate-intensity statin therapy is recommended in addition to lifestyle therapy 1.
• High-intensity statin therapy is recommended for patients with diabetes aged 40-75 years at higher cardiovascular risk, including those with one or more additional ASCVD risk factors 1.

Statin Therapy Recommendations

• High-intensity statins like atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily are recommended for patients with ASCVD or very high LDL levels.
• Moderate-intensity statins such as atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin 20-40 mg, or pravastatin 40-80 mg daily are appropriate for most primary prevention cases.

Monitoring and Follow-up

• Before starting treatment, baseline liver function tests and creatine kinase should be measured.
• Patients should be counseled about potential side effects including muscle pain, which occurs in 5-10% of users.
• Treatment efficacy should be assessed with lipid panels 4-12 weeks after initiation, with an LDL reduction of 30-50% expected for moderate-intensity and >50% for high-intensity statins.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. ( 2.1) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1) Adults:Recommended dosage range is 5 mg to 40 mg once daily. ( 2. 1) The guideline for starting statin is to initiate with a dose of 5 mg to 40 mg once daily for adults, and the dosage may be adjusted based on LDL-C levels assessed as early as 4 weeks after initiation 2.

• The recommended dosage range varies for different patient populations, including:
  • Pediatric Patients with HeFH: 5 mg to 10 mg once daily for patients aged 8 to less than 10 years, and 5 mg to 20 mg once daily for patients aged 10 years and older.
  • Pediatric Patients with HoFH: 20 mg once daily for patients aged 7 years and older.
  • Asian Patients: initiate at 5 mg once daily.
  • Patients with Severe Renal Impairment: initiate at 5 mg once daily; do not exceed 10 mg once daily.

From the Research

Guideline for Starting Statin

The decision to initiate statin therapy is based on individual consideration and shared decision-making, taking into account the patient's cardiovascular risk and comorbidities 3. The guidelines recommend the following:

• Statins are the first-line therapy for primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) 4, 3, 5, 6
• High-intensity statins are recommended for patients with ASCVD (secondary prevention) and high-risk patients without clinical ASCVD 6
• The goal of statin therapy is to reduce low-density lipoprotein (LDL) cholesterol levels by 50% or greater in patients with ASCVD 6
• In patients who cannot tolerate high-intensity statins, a moderate-intensity statin can be combined with ezetimibe 6
• Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can be used in very high-risk patients to lower LDL cholesterol levels substantially and reduce risk 5, 6

Patient Selection

The selection of patients for statin therapy depends on their cardiovascular risk and comorbidities. The guidelines recommend the following:

• Patients with severe hypercholesterolemia, diabetes with associated risk factors, and patients aged 40 to 75 years with a 10-year risk for ASCVD of 20% or greater are considered high-risk primary prevention patients 6
• Patients with a 10-year risk of 7.5% to less than 20% can be considered for coronary artery calcium scoring to determine their risk level 6
• Very high-risk patients can benefit from the addition of non-statin drugs, such as ezetimibe, PCSK9 inhibitors, or bempedoic acid, to their statin therapy 5, 6

Safety and Efficacy

The safety and efficacy of statin therapy have been extensively studied. The guidelines recommend the following:

• Statins have been proven to effectively reduce the risk of ASCVD and are recommended as a first-line therapy for primary and secondary prevention of ASCVD 4, 3, 5, 6
• PCSK9 inhibitors have been shown to significantly decrease serum LDL cholesterol levels and reduce ASCVD risk when added to maximally tolerated statin therapy 4, 5
• Ezetimibe has been shown to lead to additional LDL cholesterol reduction and decreased ASCVD risk when added to statin therapy, without raising significant safety concerns 4, 7