The National Institute for Health and Care Excellence has begun the proces of updating its guidance on the use of ezetimibe (Ezetrol) for primary hypercholesterolaemia by the NHS.
NICE has today published draft guidance recommending the drug as an option for some adults with primary – both heterozygous-familial and non-familial – hypercholesterolaemia.
“This draft guidance is good news some people who are aren’t able to take a statin to reduce their cholesterol”
NICE has provisionally recommended ezetimibe for use on its own for adults with primary hypercholesterolaemia, when a statin is considered inappropriate or is not tolerated.
However, it is only recommended if the patient needs lipid modification therapy for the primary prevention of cardiovascular disease and has both type 2 diabetes and a 20% or greater 10 year risk of developing CVD based on the QRISK2 risk assessment tool.
Either that or the patient needs lipid-modification therapy for the secondary prevention of CVD.
Professor Carole Longson, director of NICE’s Health Technology Evaluation Centre, said: “Primary hypercholesterolaemia is an important risk factor for developing CVD, the most common cause of death in the UK, as well as being a major cause of morbidity and reduced quality of life.
“This draft guidance is therefore good news some people with this condition who are aren’t able to take a statin to reduce their cholesterol,” she said.
The draft guidance updates NICE’s previous guidance on the drug from 2007. The new version reflected that current clinical practice had a greater emphasis on managing CVD risk rather than meeting target cholesterol levels, said the institute.
Consultees, including the company, healthcare professionals and members of the public have until 10 November to comment on the preliminary guidance.
Comments received during the consultation will be fully considered at a meeting on 18 November, after which the next version of the next draft guidance will be issued.
Ezetimibe is a cholesterol-absorption inhibitor that blocks the intestinal absorption of dietary and biliary cholesterol and related plant sterols, without affecting the uptake of triglycerides or fat-soluble vitamins.
Because of this mechanism of action, ezetimibe can be combined with a statin to provide either a complementary or an alternative mode of cholesterol reduction.
Ezetimibe, which is manufactured by Merck Sharp and Dohme, is taken orally at a dose of 10mg once a day. It is available in a 10mg dose at a net price per 28-tablet pack of £26.31 (excluding VAT).
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A fixed-dose combination tablet containing ezetimibe and simvastatin, in various strengths, is also available.
Primary heterozygous-familial hypercholesterolaemia is an inherited condition caused by a genetic fault and affects about 120,000 people in the UK. Patients have raised cholesterol levels from birth.
Primary non-familial hypercholesterolaemia is more common and is caused by a number of genetic factors interacting with dietary and other lifestyle factors to cause high cholesterol levels.
Current NICE guidance, published in 2007, states:
- Ezetimibe can be taken on its own by a person who would normally be given a statin to treat their condition but can’t because the person has a condition or takes another medicine that interferes with how the statin works, or because the statin is likely to cause side effects.
- Ezetimibe can be taken at the same time as a person’s usual statin rather than changing to a new statin when cholesterol levels are not low enough despite increasing the dose of the statin, or if a person is unable to try higher doses of the statin because it is likely to cause side effects.