Continue Pravastatin in This 58-Year-Old Patient
Continue pravastatin 40 mg daily without interruption. Your patient has well-controlled LDL (82 mg/dL), only mild ALT elevation (42 U/L, which is <3× upper limit of normal), and no symptoms of liver injury or myopathy—none of these findings warrant statin discontinuation. 1, 2
Why the Statin Should Be Continued
The ALT Elevation Is Not Clinically Significant
Mild ALT elevations (<3× ULN) during statin therapy do not predict significant liver toxicity and do not require drug discontinuation. 3 Your patient's ALT of 42 U/L represents a minimal elevation that occurs commonly with both statins and fibrates and does not indicate hepatic injury. 2
The ACC/AHA guidelines specify that statins should be discontinued only if severe hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs—none of which are present in your patient. 1, 2
Persistent increases to >3× ULN occur in only approximately 1% of pravastatin-treated patients, and your patient is well below this threshold. 2
Your Patient Requires Ongoing Statin Therapy for Cardiovascular Protection
At age 58 with hypertension, hypertriglyceridemia, and likely metabolic syndrome features, this patient remains at elevated cardiovascular risk and requires continued statin therapy for secondary prevention. 1, 4
Pravastatin 40 mg daily reduces major coronary events by approximately 27% and produces consistent 24% reduction in cardiovascular death in secondary prevention populations. 1, 5, 6
The cardiovascular benefit of statins persists throughout treatment duration, with 23–28% relative risk reduction per 39 mg/dL LDL-C decrease maintained for >5 years. 4
The Combination of Pravastatin Plus Fenofibrate Is Appropriate
While combination statin-fibrate therapy increases myopathy risk, pravastatin specifically shows no tendency to increase muscle enzyme levels even when combined with other lipid-lowering agents. 7 Your patient has no muscle symptoms and the combination is addressing both elevated LDL and triglycerides appropriately.
The FDA label notes that fibrates may increase myopathy risk when used with statins, but this risk is managed through monitoring—which you are already doing. 2
Monitoring Strategy Going Forward
Liver Enzyme Surveillance
Recheck CMP (including ALT) in 3 months as you planned. 1, 2 The ACC/AHA recommends liver enzyme testing before statin initiation and when clinically indicated thereafter—your mild elevation warrants follow-up but not discontinuation. 1
If ALT rises to ≥3× ULN on repeat testing, then consider dose reduction or alternative strategies. 2, 3 If clinical symptoms of hepatic injury develop (jaundice, right upper quadrant pain, dark urine), discontinue immediately. 2
Muscle Symptom Monitoring
Continue to assess for unexplained muscle pain, tenderness, or weakness at each visit. 1, 2 The combination of statin plus fibrate requires vigilance for myopathy, though pravastatin has an excellent safety profile with myopathy occurring in <0.1% of patients. 2
If muscle symptoms develop, check creatine kinase (CK) and discontinue both agents if CK is >10× ULN or if rhabdomyolysis is suspected. 1, 2
Lipid Goals and Therapy Optimization
Your patient's current LDL of 82 mg/dL is above the optimal target of <70 mg/dL for high-risk patients. 1, 4 If triglycerides improve to <200 mg/dL with continued fenofibrate and lifestyle measures, consider intensifying statin therapy (increasing pravastatin to 80 mg or switching to high-intensity statin) or adding ezetimibe to achieve LDL <70 mg/dL. 1, 4
The 2013 ACC/AHA guidelines recommend high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) for secondary prevention to achieve ≥50% LDL reduction. 4 Pravastatin 40 mg is moderate-intensity and may be suboptimal for this patient's risk profile.
Common Pitfalls to Avoid
Do not discontinue statins for mild, asymptomatic ALT elevations <3× ULN. This is the most common error and deprives patients of proven cardiovascular benefit. 1, 3
Do not assume the ALT elevation is solely from statin therapy. Your patient is on fenofibrate (which also elevates transaminases), has mild hypercalcemia possibly from HCTZ, and may have fatty liver from metabolic syndrome. 2
Do not ignore the microscopic hematuria and calcium oxalate crystals. While unrelated to statin therapy, persistent hematuria requires urologic evaluation as you planned, and HCTZ may be contributing to both hypercalcemia and calcium oxalate stone formation. 1
Do not use moderate-intensity statins as definitive therapy in high-risk patients. If this patient has established ASCVD (which is not explicitly stated but suggested by the comprehensive prevention regimen), high-intensity statin therapy is indicated. 4