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More inWhite Papers  

pills bottleMay 11 2016

NICE has recommended the use of alirocumab (Praluent) and evolocumab (Repatha) for use in patients with primary hypercholesterolaemia or mixed dyslipidaemia. However, the drugs will have to be available to the NHS at discounted prices agreed with the manufacturers, Sanofi and Amgen.

The final draft guideline on the two drugs supports their use for people whose high cholesterol levels have not been controlled adequately by other drugs such as statins, or for people who cannot tolerate the side effects of other lipid-lowering drugs.

The drugs are selective PCSK9 inhibitors, which prevent the PCSK (proprotein convertase subtilisin/kexin type 9) enzyme from binding to low density lipoprotein (LDL) receptors on liver cell surface, blocking breakdown of LDL. PCKS9 will break down LDL-receptors, so by blocking the PCKS9 enzyme, the increased availability of liver LDL-receptor level helps reduce serum LDL-cholesterol.

NICE said: “The committees heard that alirocumab reduced levels of LDL-cholesterol (so-called ‘bad cholesterol’) by up to 62% compared with placebo, and up to 40% compared with ezetimibe, another commonly used drug to lower cholesterol. Similar reductions were seen with evolocumab.”

Patients administer the drugs by injecting themselves, with alirocumab (75mg and 150mg) or evolocumab 140mg taken fortnightly, and evolocumab 420mg once a month.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “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.

“The committee concluded that both drugs are effective in reducing levels of ‘bad cholesterol’ when compared with placebo, ezetimibe or statins in people with hypercholesterolaemia or mixed dyslipidaemia.

“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 Therefore the draft guidance recommends alirocumab and evolocumab as a cost effective use of NHS resources only with the discounts agreed with the companies and only for people with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.”

NICE has pointed out that “until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.”

In a separate announcement, the British Heart Foundation has flagged up research saying that a short-term daily dose of statins before and after heart surgery does not prevent heart complications.

The study involved 1,922 patients in sinus rhythm who were scheduled to have elective heart surgery. Patients received either rosuvastatin 20mg or placebo for the period around surgery. Primary outcomes were postoperative atrial fibrillation or myocardial injury within five days after surgery. Other outcomes included major in-hospital adverse events, duration of stay in the hospital and intensive care unit, left ventricular and renal function, and blood biomarkers.

Although the drug did decrease LDL-cholesterol and C-reactive protein after surgery, “the rate of postoperative atrial fibrillation did not differ significantly between the rosuvastatin group and the placebo group (21.1% and 20.5%, respectively).” Rosuvastatin had no beneficial secondary outcomes, but there was an increase in the rate of postoperative acute kidney injury with rosuvastatin.

BHF Professor Barbara Casadei, who led the research at the University of Oxford, said: “Although guidelines currently recommend statins at the time of heart surgery to reduce complications, the evidence was not very strong.

“The results of our large randomised placebo-controlled trial conclusively prove that there are no benefits to taking statins shortly before and after heart surgery to reduce postoperative complications but there is an adverse effect on kidney function.”

Links:

NICE announcement

BHF announcement

Z Zheng at al. ‘Perioperative Rosuvastatin in Cardiac Surgery’. New England Journal of Medicine. May 5 2016. 374: 1744-1753

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