7.6 Lipid-Lowering Agents

Lipid-lowering drugs reduce cardiovascular risk by decreasing LDL cholesterol and other atherogenic lipoproteins. Statins are first-line therapy with extensive evidence for reducing MI, stroke, and cardiovascular mortality.

Lipoproteins Overview

Atherogenic Lipoproteins

LDL-C: Primary target—direct correlation with CV risk

VLDL: Triglyceride-rich, precursor to LDL

Lp(a): LDL-like + apo(a), independent risk factor

Protective Lipoproteins

HDL-C: Reverse cholesterol transport, anti-inflammatory

Higher HDL → lower CV risk (but raising HDL hasn't shown benefit)

Statins (HMG-CoA Reductase Inhibitors)

Mechanism

Inhibit HMG-CoA reductase—rate-limiting enzyme in cholesterol synthesis

↓ Hepatic cholesterol → ↑ LDL receptor expression → ↑ LDL uptake from blood

Result: ↓ LDL-C (20-60%), modest ↓ TG (10-30%), modest ↑ HDL (5-15%)

Pleiotropic Effects

Plaque stabilization, ↓ inflammation (↓ CRP), improved endothelial function

↓ Thrombogenicity, antioxidant effects

Benefits beyond LDL lowering—contribute to CV risk reduction

Common Statins

High-intensity: Atorvastatin 40-80mg, rosuvastatin 20-40mg (↓ LDL ≥50%)

Moderate-intensity: Atorvastatin 10-20mg, rosuvastatin 5-10mg, simvastatin 20-40mg, pravastatin 40-80mg (↓ LDL 30-50%)

Low-intensity: Simvastatin 10mg, pravastatin 10-20mg, lovastatin 20mg (↓ LDL <30%)

Naming: "-statin" suffix

Clinical Evidence & Indications

↓ CV events, MI, stroke, all-cause mortality (~25-40% relative risk reduction)

Primary prevention: High CV risk (diabetes, LDL >190, 10-yr ASCVD risk >7.5%)

Secondary prevention: Established ASCVD (CAD, prior MI, stroke, PAD)—high-intensity statin

Consider moderate-intensity if age >75 or not tolerating high-intensity

Adverse Effects

Myopathy: Muscle pain, weakness (5-10%), ↑ CK

Rhabdomyolysis (rare but serious): Severe myopathy, myoglobinuria, acute renal failure

Risk factors: High dose, drug interactions (CYP3A4 inhibitors—esp. with simvastatin), renal/hepatic impairment

Hepatotoxicity: ↑ transaminases (~1%), usually mild—monitor LFTs at baseline

New-onset diabetes: Modest ↑ risk (9% over 4 years)—benefits outweigh risks

Cognitive effects controversial—large trials show no clear harm

Drug Interactions

Most statins metabolized by CYP3A4 (atorvastatin, simvastatin, lovastatin)

Avoid with simvastatin: Gemfibrozil, azole antifungals, macrolides, CCBs (diltiazem, verapamil), grapefruit juice

Safer options: Pravastatin, rosuvastatin (not CYP3A4), pitavastatin

Ezetimibe

Mechanism

Inhibits NPC1L1 transporter in small intestine brush border

Blocks cholesterol absorption (dietary + biliary cholesterol)

↓ LDL-C ~15-20% as monotherapy

Clinical Use

Add-on to statin when LDL goal not achieved (synergistic effect)

Alternative for statin-intolerant patients (less effective alone)

IMPROVE-IT trial: ezetimibe + statin ↓ CV events vs. statin alone

Safety

Well-tolerated, few side effects (GI upset, fatigue)

No significant drug interactions

Safe to combine with statins—no ↑ myopathy risk

PCSK9 Inhibitors

Mechanism

Monoclonal antibodies against PCSK9 (proprotein convertase subtilisin/kexin type 9)

PCSK9 normally binds LDL receptors → lysosomal degradation

Inhibition → ↑ LDL receptor recycling → ↑ LDL clearance

↓ LDL-C 50-60% (most potent LDL-lowering agents)

Available Agents

Evolocumab (Repatha), Alirocumab (Praluent)

SC injection every 2 weeks or monthly

FOURIER & ODYSSEY trials: ↓ CV events (15-20% relative risk reduction)

Indications

High CV risk with LDL >70 despite maximally tolerated statin + ezetimibe

Familial hypercholesterolemia (FH)

Statin intolerance with high CV risk

Expensive—cost-effectiveness considerations

Side Effects

Generally well-tolerated

Injection site reactions, flu-like symptoms (uncommon)

No safety concerns with very low LDL levels (<25 mg/dL)

Fibrates

Mechanism

PPAR-α (peroxisome proliferator-activated receptor alpha) agonists

↑ Lipoprotein lipase (LPL) → ↑ TG clearance, ↓ VLDL production

↓ TG (30-50%), ↑ HDL (10-20%), variable LDL effect

Common Fibrates

Fenofibrate, gemfibrozil

Naming: "-fibrate" or "-fibrozil" suffix

Clinical Use

Primary indication: Severe hypertriglyceridemia (>500 mg/dL) to prevent pancreatitis

Mixed dyslipidemia (low HDL + high TG) in metabolic syndrome

CV benefit unclear—trials show modest/no benefit over statins

NOT first-line for ASCVD prevention (statins superior)

Adverse Effects & Interactions

Myopathy (especially with statins—avoid gemfibrozil + statin)

Fenofibrate safer than gemfibrozil for combination (if needed)

Cholelithiasis (gallstones)—↑ cholesterol in bile

GI upset, ↑ LFTs, potentiates warfarin

Omega-3 Fatty Acids

Mechanism & Effects

EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)

↓ VLDL synthesis, ↑ TG clearance → ↓ TG (20-50% at high doses)

Anti-inflammatory, antiplatelet, membrane stabilizing effects

Clinical Use

Severe hypertriglyceridemia (>500 mg/dL)—adjunct to fibrates/lifestyle

Prescription formulations (4g EPA): icosapent ethyl (Vascepa), omega-3-acid ethyl esters

REDUCE-IT trial (icosapent ethyl): ↓ CV events in high TG patients on statins

Side Effects

Fishy aftertaste, GI upset, ↑ bleeding (high dose)

May ↑ LDL in some patients

Bile Acid Sequestrants (Resins)

Mechanism

Bind bile acids in intestine → ↓ reabsorption (interrupt enterohepatic circulation)

Liver converts cholesterol to bile acids → ↑ LDL receptor expression

↓ LDL-C 15-30%, may ↑ TG

Agents & Use

Cholestyramine, colestipol, colesevelam

Add-on to statin (rarely used—poor tolerability)

Safe in pregnancy (not absorbed systemically)

Side Effects

GI: constipation, bloating, nausea (major limitation—poor adherence)

Interfere with absorption of fat-soluble vitamins (A, D, E, K) and many drugs

Give other meds 1h before or 4h after resin

Contraindicated if high TG (>300 mg/dL)

Bempedoic Acid

Newer Oral Agent

Inhibits ATP citrate lyase—enzyme upstream of HMG-CoA reductase

Prodrug activated only in liver (not muscle)—↓ myopathy risk

↓ LDL-C ~15-25%

Clinical Use

Add-on to statins or for statin-intolerant patients

CLEAR Outcomes trial: ↓ CV events

Combination product with ezetimibe available

Treatment Approach Summary

ASCVD Risk Reduction (High LDL)

1. Statin (first-line)—intensity based on risk/indication

2. Add ezetimibe if LDL goal not met (typically LDL <70 for secondary prevention)

3. Add PCSK9 inhibitor if still above goal with high/very high risk

Alternative: Bempedoic acid if statin-intolerant or additional LDL lowering needed

Hypertriglyceridemia

Moderate (150-499 mg/dL): Lifestyle, statin (if CV risk), consider fibrate if severe

Severe (≥500 mg/dL): Fibrate + omega-3 fatty acids (prevent pancreatitis)

Address secondary causes: diabetes control, alcohol, medications (thiazides, beta-blockers, estrogen)