What do NICE say?
NICE guidance relates only primary (heterozygous-familial or non-familial) hypercholesterolaemia, and not to primary or secondary prevention of cardiovascular disease. It advises that ezetimibe▼ monotherapy is an option for the treatment of adults with who would otherwise be initiated on statin therapy (as in NICE guidance TA 94) but who are unable to do so because statins are contraindicated or they were unable to tolerate them.
Ezetimibe▼ may also be used in combination with a statin in some limited circumstances in adults with primary hypercholesterolaemia. This option should be considered only where statin therapy has not appropriately controlled serum total or LDL cholesterol despite appropriate statin dose titration (or in people who cannot tolerate higher doses of a statin) and consideration is being given to changing from the initial statin used to an alternative statin.
What do they mean by ‘intolerance’?
“Intolerance” was defined by NICE as the presence of clinically significant adverse effects from statin therapy that are considered to represent an unacceptable risk to the patient or that may result in compliance with therapy being compromised. Adverse effects include new-onset muscle pain (often associated with levels of muscle enzymes in the blood indicative of muscle damage), significant gastrointestinal disturbance or alterations of liver function tests.
What does appropriate control of cholesterol mean?
NICE guidance does not state what “appropriate control of cholesterol concentrations” should be, but says this should be based on “individualised risk assessment”. More information on lipid management, including the arguments for and against fixed cholesterol targets or aiming for a “meaningful drop” in cholesterol concentrations, can be found on the lipids section of NPC. The great majority of patients will achieve a good reduction in their total cholesterol, and meet the Quality and Outcomes Framework (QOF) standard of 5 mmol/L total cholesterol or less, on simvastatin 40 mg a day alone. This is widely tolerated and has a low acquisition cost to the NHS.
When the decision has been made to treat with ezetimibe▼ plus a statin, ezetimibe should be prescribed on the basis of lowest acquisition cost.
It is worth noting that ezetimibe▼ is not licenced for primary or secondary prevention of cardiovascular events, as there are no published outcome studies which examine this.
Clinicians who treat adults with primary hypercholesterolaemia should take this technology appraisal fully into account when deciding on treatment. Ezetimibe▼ is a “black triangle” drug under intensive surveillance by the MHRA. Health care professionals (and patients) are therefore requested to report all suspected adverse reactions from it to the MHRA.