A new treatment has been approved for NHS use for treating hypercholesterolaemia, meaning access should be made available to treat eligible patients.
The National Institute for Health and Care Excellence has this week published final updated guidance on ezetimibe (Ezetrol) for primary heterozygous-familial and non-familial hypercholesterolaemia.
It has recommended ezetimibe on its own as an option for treating primary hypercholesterolaemia in adults in whom initial statin therapy is contraindicated or not tolerated.
It also recommended ezetimibe in combination with initial statin therapy as an option when cholesterol concentration is not appropriately controlled after the dose of the statin has been increased, 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.
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 its mechanism of action, ezetimibe can be combined with a statin to provide either a complementary or an alternative mode of cholesterol reduction.
The NICE technology appraisal guidance for ezetimibe is unchanged from final recommendations in the previous final appraisal determination phase of its assessment process, but followed a change in decision from earlier draft versions.
- NICE changes mind on drug for hypercholesterolaemia
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In a separate move, the Medicines and Healthcare products Regulatory Agency has approved a new indication for ezetimibe, which is manufactured by Merck Sharp & Dohme.
statins cholesterol drug
As a result, ezetimibe is now indicated to reduce the risk of cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome when added to ongoing statin therapy or initiated concomitantly with a statin.
Both the updated licence indication and the NICE guidance were based on outcomes from the landmark IMPROVE-IT trial involving more than 18,000 patients.
It demonstrated that ezetimibe was the first non-statin cholesterol-lowering medication to show additional benefit in decreasing the risk of CVD events when added to a statin.
Ezetimibe is taken orally at a dose of 10mg once daily. It is available in a pack of 28 costing £26.31 (excluding VAT) and also in a fixed‑dose combination tablet with simvastatin 20mg, 40mg or 80mg.