Should a 73-year-old female with fatty liver disease, hypertransaminasemia (elevated aspartate transaminase (AST) and alanine transaminase (ALT)), and low albumin levels restart statins (HMG-CoA reductase inhibitors) after discontinuation due to abnormal liver function tests?

From the Guidelines

I would not recommend restarting statins at this time without further evaluation. The elevated liver enzymes (AST-96, ALT-106), low albumin (3.2), and abnormal albumin/globulin ratio (0.80), along with the ultrasound showing fatty liver, suggest liver dysfunction that could be exacerbated by statins. Statins are known to cause liver enzyme elevations in some patients, and your current liver function tests indicate ongoing liver stress, as noted in the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol 1.

Key Considerations

• The presence of fatty liver, as indicated by the ultrasound, is a significant concern, and statins are not contraindicated in patients with increased ASCVD risk with chronic, stable liver disease, but limited data suggest potential benefit, as mentioned in the guideline 1.
• The guideline also states that an asymptomatic increase in transaminases (>3 times upper limit of normal) is an infrequent statin-associated side effect that often resolves with dose reduction or rechallenge with alternative statins 1.
• Severe statin-associated hepatotoxicity is rare, and the incidence is not impacted by routine monitoring of transaminases, according to the guideline 1.

Recommendations

• I recommend consulting with your healthcare provider for a comprehensive evaluation of your liver condition and cardiovascular risk.
• They may suggest addressing the fatty liver through lifestyle modifications (weight loss if appropriate, limiting alcohol, managing diabetes if present) and monitoring your liver enzymes for 2-3 months before reconsidering statin therapy.
• If statins are deemed necessary for cardiovascular protection, your doctor might consider alternative lipid-lowering medications or a different statin at a lower dose with careful monitoring, as suggested in the 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults 1.
• The decision to restart statins should balance cardiovascular benefit against the risk of worsening liver function in your specific situation.

From the FDA Drug Label

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Discontinue pravastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12. 1)].

The patient in question is a 73-year-old female, and the information provided does not indicate pregnancy. However, the drug label does discuss the potential for fatty liver indirectly by mentioning the mechanism of action of pravastatin and its effects on cholesterol synthesis.

• The patient's lab results show elevated AST and ALT levels, which may indicate liver damage or disease.
• The ultrasound of the abdomen showed fatty liver, which may be a contraindication for restarting statins.
• There is no direct information in the drug label that addresses the specific situation of a patient with fatty liver and elevated liver enzymes. The FDA drug label does not answer the question.

From the Research

Statin Use in Patients with Fatty Liver Disease

• The patient's blood work showed elevated liver enzymes (AST-96, ALT-106) and a low albumin level (3.2), which may indicate liver damage or disease 2.
• The ultrasound of the abdomen confirmed the presence of fatty liver disease, a condition closely related to metabolic syndrome and cardiovascular disease 3, 4.
• Studies have shown that statins can be safely used in patients with elevated liver enzymes and may even have a beneficial effect on liver function and cardiovascular risk 2, 4, 5, 6.

Benefits of Statin Use in Fatty Liver Disease

• Statins have been shown to improve liver function tests, including ALT and AST levels, in patients with non-alcoholic fatty liver disease (NAFLD) 5, 6.
• Statins may also have a beneficial effect on liver histology, reducing steatosis grade and NAFLD activity score (NAS) 5.
• The use of statins in patients with NAFLD may reduce the risk of cardiovascular events and liver-related mortality 3, 4.

Safety of Statin Use in Fatty Liver Disease

• The risk of hepatic injury caused by statins is estimated to be about 1%, similar to that of patients taking a placebo 2.
• Patients with transaminase levels no more than three times the upper limit of normal can continue taking statins, and often the elevations will resolve spontaneously 2.
• Statin liver safety in NAFLD patients has been demonstrated in several studies, with reduced ALT, AST, and GGT levels after statin treatment 6.

Considerations for Restarting Statins

• Given the patient's fatty liver disease and elevated liver enzymes, it may be beneficial to restart statins under close monitoring of liver function tests 2, 4, 5, 6.
• The decision to restart statins should be made on a case-by-case basis, taking into account the patient's individual risk factors and medical history 2, 3, 4.