Highest Dose of Pravastatin
The highest dose of pravastatin is 80 mg daily, though the FDA-approved maximum dose is 40 mg for most patients. 1
Pravastatin Dosing Information
- The FDA-approved pravastatin formulation is available in 10 mg, 20 mg, and 40 mg tablets 1
- The recommended starting dose for adults is 40 mg once daily, with a maximum FDA-approved dose of 80 mg daily 1
- For patients requiring high-intensity statin therapy who cannot achieve their LDL-C goal with pravastatin 80 mg daily, alternative LDL-C-lowering treatments should be prescribed 1
- In clinical trials, pravastatin 40 mg daily has been the most commonly studied dose for cardiovascular risk reduction 2
Special Population Considerations
- For pediatric patients aged 8-13 years with heterozygous familial hypercholesterolemia, the recommended dose is 20 mg once daily 1
- For pediatric patients aged 14-18 years, the recommended starting dose is 40 mg once daily 1
- In patients with severe renal impairment, the recommended starting dose is 10 mg once daily with a maximum of 40 mg daily 1
- For patients taking cyclosporine, the maximum recommended dose is 20 mg once daily 1
- For patients taking clarithromycin or erythromycin, the maximum recommended dose is 40 mg once daily 1
Efficacy and Safety Considerations
- In the PROVE-IT trial, pravastatin 40 mg was compared to atorvastatin 80 mg, with pravastatin 40 mg achieving a median LDL-C of 95 mg/dL (compared to 62 mg/dL with high-dose atorvastatin) 2, 3
- High-dose pravastatin (80 mg/day) has been studied in patients with chronic liver disease and was found to be safe and well-tolerated while significantly lowering LDL-C, total cholesterol, and triglycerides 4
- Standard-dose pravastatin (10-20 mg/day) was more effective than low-dose pravastatin (5 mg/day) in reducing cardiovascular events in elderly patients 5
- Pravastatin 40 mg daily typically reduces LDL-C by 30-40%, while higher doses may provide additional modest benefits 6
Risk Considerations
- High-intensity statins, including high-dose pravastatin, may modestly increase the risk of new-onset diabetes, particularly in patients with two or more components of metabolic syndrome 2
- The risk of myopathy increases with higher pravastatin doses, particularly in patients over 65 years, those with hypothyroidism, renal impairment, or when used with certain other medications 1
- In the PROVE-IT trial, no cases of severe myopathy (rhabdomyolysis) were observed with pravastatin 40 mg daily 2
Clinical Decision-Making
- When selecting pravastatin dose, consider:
- Patient's cardiovascular risk profile 2
- Baseline LDL-C level and target goal 2
- Potential drug interactions (particularly with cyclosporine, clarithromycin, or erythromycin) 1
- Renal function (dose adjustment needed for severe impairment) 1
- Age (special considerations for elderly and pediatric patients) 1, 7
While pravastatin 80 mg daily has been studied and can be used in selected patients, the FDA-approved maximum dose is 40 mg for most patients, and alternative statins should be considered for those requiring high-intensity therapy 1, 2.