What is the maximum dose of pravastatin (Pravachol)?

From the Guidelines

The maximum dose of pravastatin is 80 mg once daily, as supported by the PROVE-IT TIMI 22 study 1, which demonstrated the efficacy and safety of high-dose pravastatin in patients with acute coronary syndrome.

Key Considerations

• Pravastatin therapy typically starts at 10-40 mg once daily, with dosage adjustments made after 4 weeks based on lipid response and tolerability 1.
• The 80 mg dose is usually reserved for patients who require intensive cholesterol lowering or those who haven't achieved their target lipid levels with lower doses.
• For elderly patients or those with renal impairment, it's recommended to start with 10 mg daily and titrate up as needed.

Administration and Monitoring

• Pravastatin should be taken at the same time each day, preferably in the evening, as cholesterol synthesis peaks overnight.
• Unlike some other statins, pravastatin can be taken with or without food.
• Patients on the 80 mg dose should be monitored closely for potential side effects, such as muscle pain, liver enzyme elevations, and rarely rhabdomyolysis 1.

Mechanism of Action

• Pravastatin works by inhibiting HMG-CoA reductase, the enzyme responsible for cholesterol production in the liver.

Clinical Evidence

• The PROVE-IT TIMI 22 study 1 compared 40 mg of pravastatin with 80 mg of atorvastatin daily and found a 16% reduction in the hazard ratio for the primary composite endpoint of all-cause death, MI, UA requiring rehospitalization, revascularization, and stroke in favor of the high-dose regimen.

From the FDA Drug Label

2.2 Recommended Dosage in Adult Patients The recommended starting dosage is pravastatin sodium tablets 40 mg to 80 mg once daily. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment

The maximum dose of pravastatin is 80 mg once daily in adult patients 2.

• In patients with severe renal impairment, the maximum recommended dosage is 40 mg once daily.
• In patients taking cyclosporine, the maximum recommended dosage is 20 mg once daily.
• In patients taking clarithromycin and erythromycin, the maximum recommended dosage is 40 mg once daily.

From the Research

Maximum Dose of Pravastatin

The maximum dose of pravastatin is discussed in several studies:

• According to the study 3, the maximum dose of pravastatin used in the trial was 80 mg/day, which was administered to hypercholesterolemic subjects with chronic liver disease.
• The study 4 mentions that 40 mg of pravastatin daily can reduce total cholesterol by 25-34% with a consistent risk reduction of 24% of death from cardiovascular diseases.
• Other studies, such as 5, 6, and 7, used doses of pravastatin ranging from 10 mg/day to 40 mg/day, with some studies allowing for dose escalation to 20 mg bid or 40 mg/day.

Key Findings

Some key findings related to the maximum dose of pravastatin include:

• The study 3 found that high-dose pravastatin (80 mg/day) was safe and well-tolerated in hypercholesterolemic subjects with chronic liver disease.
• The study 4 suggests that pravastatin can be used at a dose of 40 mg/day to achieve significant reductions in total cholesterol and LDL cholesterol.
• The studies 5, 6, and 7 demonstrate the efficacy and safety of pravastatin at doses ranging from 10 mg/day to 40 mg/day in various patient populations.