From the Guidelines
The most recent US guidelines on statin indications, as per the 2025 standards of care in diabetes, recommend statin therapy for people with diabetes aged 40–75 years without ASCVD, using moderate-intensity statin therapy in addition to lifestyle therapy 1.
Statin Indications
The guidelines recommend statin therapy for several specific patient groups, including:
- Patients with clinical atherosclerotic cardiovascular disease (ASCVD)
- Those with LDL cholesterol ≥190 mg/dL
- Diabetic patients aged 40-75 with LDL 70-189 mg/dL
- Non-diabetic adults aged 40-75 with LDL 70-189 mg/dL who have a 10-year ASCVD risk ≥7.5%
Statin Intensity
High-intensity statins (atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily) are recommended for patients with ASCVD, those with LDL ≥190 mg/dL, and higher-risk diabetic patients 1. Moderate-intensity statins (atorvastatin 10-20 mg, rosuvastatin 5-10 mg, simvastatin 20-40 mg, pravastatin 40-80 mg, or lovastatin 40 mg daily) are appropriate for lower-risk individuals.
Monitoring and Follow-up
Before starting statins, clinicians should assess baseline liver function and creatine kinase levels, screen for potential drug interactions, and discuss lifestyle modifications 1. Patients should be monitored for muscle symptoms, with follow-up lipid panels recommended 4-12 weeks after initiation to assess response and adherence.
Mechanism of Action
Statins work by inhibiting HMG-CoA reductase, reducing cholesterol synthesis in the liver, increasing LDL receptor expression, and enhancing clearance of LDL from circulation, which ultimately reduces cardiovascular event risk 1.
Special Considerations
For people with diabetes aged 40–75 years at higher cardiovascular risk, including those with one or more additional ASCVD risk factors, high-intensity statin therapy is recommended to reduce LDL cholesterol by ≥50% of baseline and to obtain an LDL cholesterol goal of <70 mg/dL (<1.8 mmol/L) 1. For people with diabetes aged 40–75 years at higher cardiovascular risk, especially those with multiple additional ASCVD risk factors and an LDL cholesterol ≥70 mg/dL (≥1.8 mmol/L), it may be reasonable to add ezetimibe or a PCSK9 inhibitor to maximum tolerated statin therapy 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 most recent US guidelines on statin indications, as per the rosuvastatin label 2, include:
- Primary prevention: to reduce the risk of major adverse cardiovascular events in adults without established coronary heart disease who are at increased risk of CV disease.
- Secondary prevention: to reduce LDL-C in adults with primary hyperlipidemia, slow the progression of atherosclerosis, and reduce LDL-C in adults and pediatric patients with heterozygous or homozygous familial hypercholesterolemia.
- Treatment of other lipid disorders: as an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia.
From the Research
Statin Indications
The most recent US guidelines on statin indications are as follows:
- The US Preventive Services Task Force (USPSTF) recommends that clinicians prescribe a statin for the primary prevention of cardiovascular disease (CVD) for adults aged 40 to 75 years who have one or more CVD risk factors (such as dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD risk of 10% or greater 3.
- The USPSTF also recommends that clinicians selectively offer a statin for the primary prevention of CVD for adults aged 40 to 75 years who have one or more of these CVD risk factors and an estimated 10-year CVD risk of 7.5% to less than 10% 3.
- For adults 76 years or older with no history of CVD, the evidence is insufficient to determine the balance of benefits and harms of statin use for the primary prevention of CVD events and mortality 3.
Benefits and Risks of Statin Use
The benefits of statin use include:
- A mean reduction in low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage 4.
- A reduction in the risk of myocardial infarction, ischemic stroke, and other complications of atherosclerotic disease 4, 3.
- A reduction in the risk of CVD events and all-cause mortality in adults aged 40 to 75 years with no history of CVD and who have one or more CVD risk factors 3.
The risks of statin use include:
- A risk of statin-induced serious muscle injury, including rhabdomyolysis, of less than 0.1% 4.
- A risk of serious hepatotoxicity of approximately 0.001% 4.
- A risk of statin-induced newly diagnosed diabetes mellitus of approximately 0.2% per year of treatment 4.
Special Populations
For patients with diabetes, delaying statin therapy is associated with a higher cardiovascular risk, which is mediated by higher low-density lipoprotein cholesterol levels 5. For patients with heart failure, statins do not reduce the risk of cardiovascular death, but may reduce the rate of heart failure hospitalization and atherosclerotic events 6.