BHF response to results of cholesterol-lowering drug clinical trial

17 March 2017        

Category: BHF Comment


Long-awaited clinical trial results have today shown a new cholesterol lowering drug could further reduce the risk of a heart attack or stroke for those already taking statins.

The results of the FOURIER study of evolocumab, published in the New England Journal of Medicine, could take us a step closer to these types of drugs becoming part of our armoury to treat heart disease.

The study of 27,564 patients living with heart disease and taking statins, found the drug lowered cholesterol by an average of 59% and reduced the risk of a heart attack or stroke in two years of follow-up.

‘A significant advance’

Our Medical Director, Professor Sir Nilesh Samani, said:

“This trial is a significant advance as it found that giving patients evolocumab, a PCSK9 inhibitor, on top of statins not only helped to further reduce LDL-cholesterol but also reduced the risk of cardiovascular events in people already affected by heart disease, without causing major side effects.

“However, the trial was stopped early, after only 2.2 years of average follow-up, and therefore it is difficult to be certain about the 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.”

Biggest killer worldwide

Coronary heart disease is the single biggest killer in the UK and worldwide and ‘bad’ LDL-cholesterol is a major cause.

While statins have had a significant impact in reducing the risk of heart disease for millions of people, they are not tolerated by everyone and only reduce cholesterol by a certain amount.

This promising new approach blocks the action of PCSK9, a molecule which reduces the breakdown of LDL-cholesterol in the liver. Evolocumab (Repatha) was recommended by NICE in 2016, but only for adults with dangerously high cholesterol levels despite treatment with statins.

Creating new treatments which use this approach could save the lives of more patients with high cholesterol and those who can’t tolerate statins, if found to be effective and affordable.