The National Institute for Health and Care Excellence has changed its position on the use of MSD’s Ezetrol on the National Health Service, reverting back to original guidelines published in 2007.

Following a review of its 2007 guidelines, the cost regulator was recommending Ezetrol (ezetimibe) for adults with primary (heterozygous-familial and non-familial) hypercholesterolaemia when a statin can’t be taken, but only if patients need lipid modification therapy for the primary prevention of cardiovascular disease and have both type II diabetes and a 20% or greater 10-year risk of developing cardiovascular disease, or they need lipid-modification therapy for secondary prevention of CVD. 

However, after taking into account comments received during the consultation process, NICE says it now feels that the clinical effectiveness of the drug is consistent with that in its original 2007 guidance after all. 

Therefore, it is now re-recommending Ezetrol on its own as an option for treating primary hypercholesterolaemia in adults in whom initial statin therapy is contraindicated or not tolerated, and in combination with initial statin therapy as an option when cholesterol concentration is not appropriately controlled, or where a person is unable to have higher doses of the statin because it is likely to cause side effects, and a change to an alternative statin is being considered. 

Primary heterozygous-familial hypercholesterolaemia is an inherited condition caused by a faulty gene that affects around 120,000 people in the UK. Non-familial hypercholesterolaemia develops from a mix of genetic traits and other factors such as diet, smoking and lack of exercise, and is thought to affect around 2,000,000 people. In both cases, raised levels of cholesterol put patients at higher risk of developing CVD, the leading cause of death in the country.

Ezetrol is a cholesterol-absorption inhibitor that blocks intestinal absorption of dietary and biliary cholesterol and related plant sterols, but without affecting uptake of triglycerides or fat-soluble vitamins. This means that the drug can be combined with a statin to provide either a complementary or an alternative mode of cholesterol reduction.