What is the maximum dose of atorvastatin (Lipitor)?

Maximum Dose of Atorvastatin

The maximum dose of atorvastatin is 80 mg once daily. 1

FDA-Approved Dosing Range

• The FDA-approved dosage range for atorvastatin is 10 mg to 80 mg once daily in adults 1
• For pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), the dosage range is also 10 mg to 80 mg once daily 1
• For pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH), the maximum dose is lower at 20 mg once daily 1

High-Intensity Statin Therapy Context

• Atorvastatin 40-80 mg daily is classified as high-intensity statin therapy, which achieves ≥50% reduction in LDL cholesterol 2, 3
• Multiple guidelines from the American College of Cardiology, American Heart Association, and American Diabetes Association consistently define atorvastatin 40-80 mg as the high-intensity dosing range 2

Clinical Evidence Supporting Maximum Dose

• Atorvastatin 80 mg daily has been extensively studied and proven effective in major cardiovascular outcomes trials 2, 3
• In the PROVE-IT TIMI 22 trial, atorvastatin 80 mg achieved a median LDL-C of 62 mg/dL and reduced cardiovascular events by 16% compared to moderate-intensity statin therapy 2, 3
• In the SPARCL trial, atorvastatin 80 mg daily reduced stroke recurrence in patients with recent stroke or TIA 2, 3

Important Dose Modifications

Drug interactions may require limiting atorvastatin to lower maximum doses: 1

• Do not exceed 20 mg daily when taking: saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir (with or without ritonavir), elbasvir plus grazoprevir, letermovir, clarithromycin, or itraconazole 1
• Do not exceed 40 mg daily when taking nelfinavir 1

Safety Considerations at Maximum Dose

• Atorvastatin 80 mg is generally well tolerated, though it carries a slightly higher rate of liver enzyme elevations (3.3%) compared to lower-intensity statins 2, 3, 4
• Unlike simvastatin 80 mg (which the FDA no longer recommends initiating due to myopathy risk), atorvastatin 80 mg has a low incidence of muscular toxicity and can be safely initiated 3, 4
• No dosage adjustment is needed for renal dysfunction, making atorvastatin suitable across a wide range of patients 2, 4

Practical Dosing Approach

• Patients requiring LDL-C reduction greater than 45% may be started at 40 mg once daily 1
• The dose can be titrated up to the maximum of 80 mg daily if needed to achieve lipid goals 1
• Atorvastatin can be taken at any time of day, with or without food 1