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Provisional green light for new cholesterol drugs

Options for those who don’t respond to statins, but who are at very high risk of CVD

Caroline White

Friday, 06 May 2016

The National Institute for Health and Care Excellence has given the provisional green light to two new drugs for treating high cholesterol in people at extremely high risk of heart attacks or strokes who have not responded to statins.

Cardiovascular disease was the cause of approximately 150,000 deaths in England in 2012.

In draft guidance, published today, NICE recommends alirocumab (Praluent, Sanofi) and evolocumab (Repatha, Amgen) for adults with primary hypercholesterolaemia or mixed dyslipidaemia to help curb their risk of cardiovascular disease.

The drugs are recommended only for people with these conditions whose cholesterol levels are not adequately controlled with other drugs such as statins, or who can’t tolerate statins because of their side effects or who have another condition which means they can’t take them.

People with primary hypercholesterolaemia or mixed dyslipidaemia have an increased risk of cardiovascular disease because long term raised cholesterol levels accelerate the build-up of fatty deposits in the arteries.

People with the inherited form of the disease (familial hypercholesterolaemia) have raised cholesterol levels from birth, so their risk of cardiovascular disease increases from an early age to as high as 50% by the age of 50 in men and at least 30% in women by the age of 60.

The draft guidance recommends use of the drugs only if they are provided at the discounted price agreed with the companies.

The evidence informing the decision, shows that alirocumab cut levels of LDL-cholesterol by up to 62% compared with placebo, and up to 40% compared with ezetimibe, another drug commonly used to lower cholesterol. Similar reductions were seen with evolocumab.

Both alirocumab and evolocumab are given by self-administered injection once a fortnight or once a month for the 420 mg dose of evolocumab.

Unlike statins, which work by slowing down the production of cholesterol by the liver, alirocumab and evolocumab work by blocking a protein called PCSK9, allowing the liver to remove cholesterol from the blood.

The PCSK9 protein appears to control the number of low-density lipoprotein receptors, which bind to low-density lipoproteins (LDLs), the primary carriers of cholesterol in the blood.

“People with hypercholesterolaemia or mixed dyslipidaemia who have a high risk of a heart attack or stroke despite taking the highest tolerated dose of other cholesterol-lowering drugs, have very few treatment options,” commented Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation.

But she added: “However, both drugs are relatively expensive, costing over £4,000 per patient per year compared with about £350 for ezetemibe. Therefore, the draft guidance recommends alirocumab and evolocumab as a cost effective use of NHS resources only with the discounts agreed with the companies and only for people with hypercholesterolaemia or mixed dyslipidaemia whose cholesterol is still not under control despite making changes to their lifestyle and taking other cholesterol-lowering drugs.”

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