Key principles
- Primary therapeutic target is LDL-cholesterol (LDL-C).
- Treatment decisions are based on overall CVD risk, not LDL level alone.
- Statins are first-line therapy for most patients requiring pharmacologic treatment.
- Treatment goals are defined according to risk category.
Lipid profile reference values
| Parameter | Optimal | Borderline | High |
|---|
| LDL-C | <2.6 mmol/L (<100 mg/dL) | 2.6–4.1 (100–159) | ≥4.1 (≥160) |
| Total cholesterol | <5.2 mmol/L (<200 mg/dL) | 5.2–6.2 (200–239) | ≥6.2 (≥240) |
| HDL-C | >1.0 mmol/L (>40 mg/dL men) · >1.3 mmol/L (>50 mg/dL women) | Low if below these values |
Cardiovascular risk categories and LDL targets
| Risk category | Examples | LDL target |
|---|
| Low risk | No major risk factors | <3.0 mmol/L (<116 mg/dL) |
| Moderate risk | Multiple risk factors | <2.6 mmol/L (<100 mg/dL) |
| High risk | Diabetes, CKD, markedly elevated risk score | <1.8 mmol/L (<70 mg/dL) |
| Very high risk | Established ASCVD (MI, stroke, PAD) | <1.4 mmol/L (<55 mg/dL) |
Indications for statin therapy
1) Secondary prevention (established ASCVD)
- Initiate high-intensity statin.
- Target: LDL-C <1.4 mmol/L (<55 mg/dL).
2) LDL-C ≥4.9 mmol/L (≥190 mg/dL)
- Suggestive of familial hypercholesterolemia.
- Start high-intensity statin regardless of age or calculated risk.
3) Diabetes mellitus (age ≥40 years)
- At least moderate-intensity statin.
- If any of the following → use high-intensity statin: diabetes ≥10 years, age ≥50, albuminuria, eGFR <60 (CKD), hypertension, smoking, family history of premature ASCVD.
- Target: LDL-C <1.8 mmol/L (<70 mg/dL).
4) Primary prevention (age 40–75, LDL-C 1.8–4.9 mmol/L)
Step 1: Calculate 10-year ASCVD risk.
| ASCVD risk | Decision |
|---|
| <5% | Lifestyle only |
| 5–7.4% | Consider moderate-intensity statin if risk enhancers present |
| 7.5–19.9% | Start moderate-intensity statin |
| ≥20% | Start high-intensity statin |
Risk enhancers (used when ASCVD risk 5–7.4%)
- Family history of premature ASCVD.
- LDL ≥4.1 mmol/L (≥160 mg/dL).
- Metabolic syndrome.
- CKD.
- Chronic inflammatory disease.
- South Asian ancestry.
- Persistent elevated lipids.
Statin intensity classification
| Intensity | Medication | Expected LDL reduction |
|---|
| High | Atorvastatin 40–80 mg · Rosuvastatin 20–40 mg | ≥50% |
| Moderate | Atorvastatin 10–20 mg · Rosuvastatin 5–10 mg · Simvastatin 20–40 mg | 30–49% |
| Low | Simvastatin 10 mg · Pravastatin 10–20 mg | <30% |
Stepwise treatment approach
- Step 1: Initiate statin per indication and risk category.
- Step 2: Reassess lipid profile after 4–12 weeks.
- Step 3: If LDL target not achieved → add Ezetimibe 10 mg once daily.
- Step 4: If still above target (very high risk) → refer to specialist as appropriate.
Follow-up and safety monitoring
Baseline tests (before statin)
Mandatory: lipid profile, ALT.
CK: not routine; check only if history of muscle disease, previous intolerance, unexplained muscle symptoms, hypothyroidism, CKD, high-risk or frail patients.
Routine follow-up
| Test | Timing |
|---|
| Lipid profile | 4–12 weeks after starting or dose change |
| Lipid profile (stable) | Every 6–12 months |
| ALT or CK | Only if symptoms develop |
Routine CK or LFT monitoring is not required in asymptomatic patients.
Muscle symptoms (statin myalgia)
Mild pain, CK normal or <3× ULN
- Continue statin. Reassure. Reassess in 2–4 weeks.
Persistent symptoms or CK 3–10× ULN
- Hold statin temporarily (2–4 weeks or until resolution).
- Check CK, TSH, renal function.
- Restart: lower dose or different statin once symptoms resolve.
Severe symptoms or CK >10× ULN
- Stop statin immediately.
- Evaluate for rhabdomyolysis.
- Refer if indicated.
Liver enzyme elevation
ALT <3× ULN
- Continue statin. Repeat in 4–6 weeks.
ALT ≥3× ULN (confirmed)
- Stop statin.
- Investigate possible causes.
- Restart lower dose or different statin after normalization.
Stop statin immediately if
- CK >10× ULN.
- ALT ≥3× ULN with symptoms.
- Suspected rhabdomyolysis.
- Severe unexplained muscle pain.
