Acute or active liver disease

Statins are not recommended in patients with:

• unexplained active liver disease or,
• unexplained elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that are greater than 3 x the upper limit of normal (ULN).

For acute or active liver disease, such as viral hepatitis A or B or alcoholic liver disease, statins may be considered once the patient’s liver disease is fully controlled and levels of ALT, AST, total bilirubin, and alkaline phosphatase have returned to normal.

For additional guidance on assessing liver function or when to refer see our series of articles on Assessing liver function and interpreting liver blood tests.

Stable or chronic liver disease

The use of statins is cautioned in patients with a history of liver disease such as elevated liver enzyme levels, metabolic dysfunction–associated fatty liver disease, hepatitis C, cirrhosis, liver transplant, and hepatocellular carcinoma.

Although robust prospective clinical trial data on the safety and efficacy in liver disease are limited, available data suggest that statins can be used with caution after assessing individual risks and benefits. For example, weigh up the risk of hepatotoxicity against long-term cardiovascular benefits.

Additional risks factors include, but are not limited to:

• positive smoking status
• excessive use of alcohol
• risk of hepatotoxicity from other medication (such as prescribed medication, over the counter medicines, herbal and complementary medicines)
• abnormal liver blood tests

For further practical information on starting statins, see NICE CKS lipid modification guidance and our articles on Assessing liver function and interpreting liver blood tests.

When starting statins in patients with liver impairment, consider a lower dose of a high-intensity statin, such as atorvastatin 20 mg daily or rosuvastatin 10 mg daily, with gradual dose escalation to achieve target lipid levels.

Adjust to a lower dose or lower intensity statin if the patient experiences adverse effects or if the clinical situation warrants more caution. NICE guidance advises that any statin at any dose reduces cardiovascular disease risk.

For risk factors associated with statin intolerance, alternative causes for suspected adverse effects, or for the management of patients unable to tolerate statins, see the Statin Intolerance Pathway.

Monitoring

In clinical practice, no additional monitoring of statins is required for patients with chronic liver disease. However, additional monitoring may be required in certain cases, such as if symptoms or signs of hepatotoxicity appear or if the patient is at an elevated risk of adverse effects due to polypharmacy and multiple health conditions. If in doubt, consider consulting a cardiology or liver specialist.

For general advice on monitoring statin therapy, see our statin monitoring tool.

For further practical advice on managing mildly elevated and raised liver transaminase levels see NICE CKS lipid modification guidance.

Counselling

Advise patients to report any symptoms of liver disease, such as itching (pruritis) or jaundice. For further details on red flag symptoms and when to refer, see our series of articles on Assessing liver function and interpreting liver blood tests.

Further advice

In primary care, seek further advice from a cardiology or liver specialist, or contact the SPS Medicines Advice service if:

• the patient is on other hepatotoxic medicines
• the clinical scenario is complex
• you have uncertainties regarding cardiovascular risk

Further resources

The SPS series on Assessing liver function and interpreting liver blood tests explains how to assess liver function including the purpose of liver blood tests, how to interpret them and what to do if they are abnormal.

The Accelerated Access Collaborative (AAC) Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD and Statin Intolerance Pathway underpin lipid therapy decisions for adults with lipid disorders.

The Lifespan Pathway for Lipid Management 2024 discusses lipid therapies in children, prenatal counselling, use of statins during childbearing age and deprescribing of lipid therapies during end-of-life care.

With thanks to the British Hepatology Pharmacy Group (BHPG) for their contributions to this article.