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New drug appears to cut cholesterol significantly

Evolocumab use cut cholesterol levels by 60% in patients

Adrian O'Dowd

Monday, 20 March 2017

A new class of cholesterol-lowering drug being trialed in the USA appears to have a significant effect on cholesterol levels when taken with statins, according to a study,* published at the weekend in the New England Journal of Medicine.

An international team of researchers, which included researchers from Imperial College London, have been studying the drug called evolocumab (brand name Repatha) and appeared to find it helped patients cut their risk of cardiovascular disease (CVD), stroke and heart attack.

Researchers looked at the protective effect of evolocumab on patients in 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol.

A total of 27,564 patients, of average age 63 who continued to take statins, were randomised between February 2013 and June 2015 so that 13,784 patients received injections of evolocumab – 140 mg twice a month or 420 mg once a month – while 13,780 received a placebo injection.

The drug was given over a 12-month period and the main endpoint of the study was measured as a composite of a number of related conditions such as heart attack or stroke, or death from CVD.

At the end of the treatment period, researchers found that on average, patients taking evolocumab plus statins were able to reduce their LDL cholesterol levels by an average of 59%, from 92 mg/dL to 30 mg/dL, compared to those taking placebo plus statins.

The group which had received evolocumab experienced fewer events such as heart attack or stroke, compared to the placebo arm of the study, with 1,344 (9.8%) compared to 1,563 (11.3%) respectively.

Overall, this equated to a 15% reduction in the risk of serious cardiovascular events for patients taking the drug with statins. The benefits were seen across all subtypes of patients, even in those who started with low levels of cholesterol.

In addition, there appeared to be no significant difference in the occurrence of side effects between the treatment and placebo groups in the study.

Professor Peter Sever, from the National Heart and Lung institute at Imperial College London, who led the UK arm of the trial involving 1,500 patients across 75 centres, said: “This is one of the most important trials of cholesterol-lowering since the first statin trial, published 20 years ago.

“Our results suggest this new, extremely potent class of drug can cut cholesterol dramatically, which could provide great benefit for a lot of people at risk of heart disease and stroke.”

Evolocumab is a human monoclonal antibody that works by blocking a protein that reduces the liver’s ability to remove LDL cholesterol from the blood, called PCSK9.

The treatment was approved for use in the USA last year as an addition to statin therapy and lifestyle changes aimed at lowering LDL cholesterol in some adults with cardiovascular disease.

In the UK, NICE has considered the drug for select cases only, such as patients with familial hypercholesterolaemia.

Professor Sir Nilesh Samani, medical director at the British Heart Foundation, said the trial was a significant advance, but added: “The trial was stopped early after only 2.2 years of average follow-up and therefore it is difficult to be certain about the actual extent of the longer-term benefit, including the impact on dying from heart disease, as well as longer term safety. These are important considerations when these drugs are approved for clinical use.”

* Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. New England Journal of Medicine, 17 March 2017. DOI: 10.1056/NEJMoa1615664

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