NICE issues final draft guidance on PCSK9 inhibitors
Alirocumab (Praluent) and evolocumab (Repatha) have been recommended by NICE for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia to help reduce the risk of cardiovascular disease.
Despite the widespread use of statins and other lipid-lowering therapies to reduce raised cholesterol levels, some people in the UK remain at significant risk of having a cardiovascular event and are unable to lower their cholesterol to levels indicated within national guidelines. Both alirocumab and evolocumab reduce levels of LDL-cholesterol by up to 62% compared with placebo, and up to 40% compared with ezetimibe, another commonly used drug to lower cholesterol.
Both drugs belong to the most recent cholesterol-lowering class of treatments called PCSK9 inhibitors. PCSK9 is a protein that plays an important role in managing ‘bad’ cholesterol by regulating the number of receptors for ‘bad’ cholesterol on the liver’s surface. By reducing PCSK9, the treatment increases the availability of receptors for ‘bad’ cholesterol and therefore lowers the levels of ‘bad’ cholesterol in the blood.
The new draft guidance recommends evolocumab or alirocumab for patients whose LDL-C persists above levels specified by NICE despite maximal tolerated lipid-lowering therapy. NICE specifies an LDL-C level >3.5 mmol/l where the patient has existing cardiovascular disease alongside heterozygous familial hypercholesterolaemia (HeFH) or a very high risk of further cardiovascular events without HeFH. It specifies an LDL-C level >4.0 mmol/l for treatment of patients with cardiovascular disease who have a high risk (without HeFH); and an LDL-C level >5.0 mmol/l for patients with HeFH who do not have cardiovascular disease.