What are the considerations for discontinuing statin therapy?

From the Guidelines

Discontinuing statin therapy should be considered in patients with severe side effects, such as significant myopathy, rhabdomyolysis, or liver dysfunction, as well as in those with terminal illness or limited life expectancy, significant drug interactions, or during pregnancy or planning conception. When considering statin discontinuation, it is essential to weigh the risks of continued therapy against the benefits of cardiovascular protection. The decision to discontinue statin therapy should be made on a case-by-case basis, taking into account the individual patient's circumstances and medical history. Some key considerations for discontinuing statin therapy include:

• Severe side effects, such as myopathy, rhabdomyolysis, or liver dysfunction, which require immediate discontinuation of statin therapy 1.
• Terminal illness or limited life expectancy, where the benefits of continued therapy may not justify the burden 1.
• Significant drug interactions, such as with cyclosporine, macrolide antibiotics, or certain antifungals, which may necessitate temporary discontinuation 1.
• Pregnancy or planning conception, where statins should be stopped due to potential fetal risks 1.
• Mild to moderate muscle symptoms, where a trial of statin discontinuation for 2-4 weeks may determine if symptoms are truly statin-related 1. It is crucial to monitor lipid levels and cardiovascular risk when stopping statins, as discontinuation can lead to rapid increases in LDL cholesterol and potentially increased cardiovascular event risk 1. The most recent guidelines recommend a patient-centered approach to statin therapy, considering the individual's preferences, values, and medical history when making decisions about discontinuation 1. Ultimately, the decision to discontinue statin therapy should be made through shared decision-making between the patient and provider, taking into account the latest evidence and guidelines 1.

From the FDA Drug Label

Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Discontinue atorvastatin calcium tablets if IMNM is suspected. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium tablets. Discontinue simvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Discontinue simvastatin if IMNM is suspected. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue simvastatin.

The considerations for discontinuing statin therapy include:

• Myopathy or rhabdomyolysis: Discontinue statin therapy if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.
• Immune-mediated necrotizing myopathy (IMNM): Discontinue statin therapy if IMNM is suspected.
• Hepatic injury: Discontinue statin therapy if serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs.
• Other conditions: Temporarily discontinue statin therapy in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. 2 3

From the Research

Considerations for Discontinuing Statin Therapy

• The decision to discontinue statin therapy should be made with caution, as it may lead to adverse outcomes, including increased risk of cardiovascular events and mortality 4, 5, 6.
• Studies have shown that discontinuing statin therapy, particularly after acute events such as acute myocardial infarction or stroke, can have harmful effects on cardiovascular outcomes and all-cause mortality 4, 7.
• A systematic review of the evidence found that non-adherence or discontinuation of statin therapy was associated with detrimental effects on cardiovascular and cerebrovascular outcomes, including disease severity and mortality 5.
• Even a brief discontinuation of statins might be harmful, and statin treatment should not be interrupted except if there is a very good reason 6.
• Patients should be instructed on the importance of adhering to their medication, and adherence should be monitored regularly 6.

Special Considerations

• In patients with acute ischemic stroke, discontinuation of statin therapy may confer a significantly higher likelihood of early neurological deterioration and poor outcome, and treatment should be continued 7.
• In stable cardiac patients, short-term discontinuation of statin therapy may not lead to a clinically important increased risk of acute coronary syndromes 8.
• However, in high-risk patients, discontinuation of statin therapy can significantly increase the incidence of cardiovascular and cerebrovascular events as well as all-cause mortality 5.