Management protocols for Lipid Management In Diabetes in United States

Elevated triglyceride levels (≥ 150 mg/dL [≥ 1.7 mmol/L]) and/or low HDL cholesterol (< 40 mg/dL for men, < 50 mg/dL for women)

Identify as indication for lifestyle therapy intensification.

Adults with prediabetes or diabetes at time of diagnosis or initial medical evaluation

Obtain a lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).

Adults with prediabetes or diabetes annually or more frequently if indicated

Obtain a lipid profile.

Individuals < 40 years with prediabetes or diabetes

Obtain a lipid profile at least every 5 years after initial evaluation (more frequent for youth-onset Type 1 diabetes).

At initiation of statins or other lipid-lowering therapy

Obtain a lipid profile.

4–12 weeks after initiation or a change in dose of statin or other lipid-lowering therapy

Obtain a lipid profile to monitor response to therapy.

Annually after initiation of statin or other lipid-lowering therapy

Obtain a lipid profile.

If LDL cholesterol levels are not responding despite medication adherence

Use clinical judgment to adjust therapy.

Lifestyle Management

Implement weight loss (if indicated) to improve lipid profile and insulin sensitivity.

Lifestyle Management

Adopt a Mediterranean or DASH eating pattern, prioritizing whole foods and healthy fats.

Lifestyle Management

Reduce saturated fat and trans fat intake to lower LDL cholesterol.

Lifestyle Management

Increase intake of dietary n-3 fatty acids, viscous fiber, and plant stanol/sterol.

Lifestyle Management

Increase physical activity to optimize lipid levels and glycemic management.

Elevated triglyceride levels (≥ 150 mg/dL [≥ 1.7 mmol/L]) and/or low HDL cholesterol (< 40 mg/dL for men, < 50 mg/dL for women)

Intensify lifestyle therapy and optimize glycemic management.

Adults with diabetes aged 40–75 years without ASCVD

Use moderate-intensity statin therapy in addition to lifestyle therapy.

Adults with diabetes aged 20–39 years with additional ASCVD risk factors

It may be reasonable to initiate statin therapy in addition to lifestyle therapy.

Adults with diabetes aged 40–75 years at higher cardiovascular risk (one or more additional ASCVD risk factors)

Use high-intensity statin therapy. Goal: reduce LDL cholesterol by ≥ 50% of baseline and obtain LDL cholesterol < 70 mg/dL (< 1.8 mmol/L).

Adults with diabetes aged 40–75 years with multiple additional ASCVD risk factors and 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.

Adults > 75 years with diabetes already on statin

It is reasonable to continue statin treatment.

Adults > 75 years with diabetes initiating statin

It may be reasonable to initiate moderate-intensity statin therapy after discussion of potential benefits and risks.

All ages with diabetes and ASCVD

High-intensity statin therapy should be added to lifestyle therapy.

Diabetes and ASCVD: goals not achieved on maximum tolerated statin therapy

Add ezetimibe or a PCSK9 inhibitor with proven benefit. Goals: LDL cholesterol reduction ≥ 50% from baseline and LDL cholesterol < 55 mg/dL (< 1.4 mmol/L).

Statin intolerance: intended statin intensity not tolerated

Use the maximum tolerated statin dose.

Diabetes and ASCVD intolerant to statin therapy

Consider alternative cholesterol-lowering therapies: PCSK9 inhibitor (monoclonal antibody), bempedoic acid, or PCSK9 inhibitor (inclisiran siRNA).

Fasting triglycerides ≥ 500 mg/dL (≥ 5.7 mmol/L)

Evaluate for secondary causes of hypertriglyceridemia and consider medical therapy (e.g., fibric acid derivatives, fish oil) to reduce pancreatitis risk.

Hypertriglyceridemia > 150 mg/dL (> 1.7 mmol/L) or nonfasting > 175 mg/dL (> 2.0 mmol/L)

Address and treat lifestyle factors (obesity, metabolic syndrome), secondary factors (diabetes, chronic liver/kidney disease, hypothyroidism), and medications that raise triglycerides.

Individuals with ASCVD or other cardiovascular risk factors on a statin with managed LDL cholesterol but elevated triglycerides (150–499 mg/dL [1.7–5.6 mmol/L])

Addition of icosapent ethyl can be considered to reduce cardiovascular risk.

Statin plus fibrate combination therapy

Generally not recommended.

Statin plus niacin combination therapy

Generally not recommended.

Statin intolerance: initial steps

Switch statin type, lower dose, use non-daily dosing.

Statin intolerance: if above steps insufficient

Consider non-statin agents (PCSK9 inhibitors, bempedoic acid) as alternatives or adjuncts.

Individuals of childbearing potential: generally

Lipid-lowering agents should be stopped prior to conception and avoided if not using reliable contraception.

Individuals of childbearing potential with familial hypercholesterolemia or prior ASCVD event

Benefits may outweigh risks; preconception counseling is essential.