When do you initiate statin therapy for primary prevention of cardiovascular disease?

From the Guidelines

Statin therapy for primary prevention of cardiovascular disease should be initiated in adults aged 40-75 years with LDL cholesterol ≥70 mg/dL and a 10-year atherosclerotic cardiovascular disease (ASCVD) risk score ≥7.5%. This recommendation is based on the most recent and highest quality study, which suggests that statin therapy can reduce the risk of ASCVD events in individuals with elevated LDL cholesterol and high ASCVD risk 1. The guidelines recommend moderate-intensity statin therapy for most patients, reserving high-intensity therapy for those at highest risk, such as individuals with diabetes or LDL ≥190 mg/dL.

Some key points to consider when initiating statin therapy for primary prevention include:

• Adults aged 40-75 years with LDL cholesterol ≥70 mg/dL and a 10-year ASCVD risk score ≥7.5% should be considered for statin therapy 1
• Individuals with diabetes, LDL ≥190 mg/dL, or moderate risk (5-7.5% 10-year risk) with risk-enhancing factors should also be considered for statin therapy 1
• Common statins include atorvastatin (10-80 mg daily), rosuvastatin (5-40 mg daily), and simvastatin (20-40 mg daily) 1
• Lipid levels and liver function tests should be checked at baseline, 4-12 weeks after initiation, and then annually 1

It's worth noting that the US Preventive Services Task Force recommends offering a low- to moderate-dose statin to certain adults without a history of CVD when they have a calculated 10-year risk of a cardiovascular event of 7.5% to 10% 1. However, the most recent guidelines from the American Heart Association and American College of Cardiology recommend statin therapy for individuals with a 10-year ASCVD risk score ≥7.5% 1.

Overall, the decision to initiate statin therapy for primary prevention should be based on individual risk assessment and consideration of the potential benefits and harms of therapy. The most recent and highest quality evidence supports the use of statin therapy in adults aged 40-75 years with LDL cholesterol ≥70 mg/dL and a 10-year ASCVD risk score ≥7.5% 1.

From the FDA Drug Label

The JUPITER study, the effect of Rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 males (≥50 years) and females (≥60 years) who had no clinically evident CV disease, LDL-C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Rosuvastatin significantly reduced the risk of major CV events (252 events in the placebo group vs. 142 events in the rosuvastatin group) with a statistically significant (p<0.001) relative risk reduction of 44% and absolute risk reduction of 1.2%.

Statin therapy for primary prevention of cardiovascular disease is initiated in patients with:

• No clinically evident CV disease
• LDL-C levels <130 mg/dL
• hsCRP levels ≥2 mg/L
• Estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria
• Additional risk factors such as hypertension, low HDL-C levels, cigarette smoking, or a family history of premature CHD 2

From the Research

Initiating Statin Therapy for Primary Prevention

Statin therapy is initiated for primary prevention of cardiovascular disease in individuals with specific risk factors and LDL-C levels. The decision to start statin therapy is based on the estimated 10-year cardiovascular disease risk and the presence of certain risk factors.

• Individuals with an estimated 10-year cardiovascular disease risk of 10% or greater and one or more risk factors (such as dyslipidemia, diabetes, hypertension, or smoking) are recommended to start statin therapy 3.
• For individuals with an estimated 10-year cardiovascular disease risk of 7.5% to less than 10% and one or more risk factors, statin therapy may be considered, but the likelihood of benefit is smaller 3.
• A long-term benefit approach to statin eligibility identifies nearly 1 in 6 individuals as having a high degree of expected long-term benefit of statins, with a number needed to treat of less than 7 4.
• Individuals with primary elevations of LDL-C ≥190 mg/dL are at a higher risk of atherosclerotic cardiovascular disease and may benefit from statin therapy 5.

Risk Factors and LDL-C Levels

The presence of certain risk factors and LDL-C levels plays a crucial role in determining the need for statin therapy.

• Individuals with LDL-C levels ≥190 mg/dL are at a higher risk of atherosclerotic cardiovascular disease and may benefit from statin therapy 5.
• A 10-year benefit-based approach to statin therapy includes younger individuals with higher LDL-C levels who would not be currently recommended for treatment 4.
• Healthy lifestyle factors, such as non-obese waist circumference, physical activity, non-smoking, and a healthy diet, can reduce the risk of cardiovascular disease and may be considered before initiating statin therapy 6.

Guidelines and Recommendations

Various guidelines and recommendations are available for initiating statin therapy for primary prevention of cardiovascular disease.

• The US Preventive Services Task Force recommends statin therapy for adults aged 40 to 75 years with one or more cardiovascular disease risk factors and an estimated 10-year cardiovascular disease risk of 10% or greater 3.
• The National Cholesterol Education Program Adult Treatment Panel III guidelines recommend an LDL-C goal of less than 100 mg/dL for individuals at moderately high risk of developing cardiovascular disease 7.