March 13, 2019

expert reaction to two papers looking at a new class of cholesterol-lowering drug, bempedoic acid

Reactions to research published in NEJM that demonstrate that use of bempedoic acid led to significantly lower LDL cholesterol levels.

Prof Jane Armitage, Professor of Clinical Trials and Epidemiology, Medical Research Council Population Health Research Unit, University of Oxford, said:

“This is an interesting report of a 12-month trial of a new cholesterol lowering drug which works by a different mechanism than statins or other current treatments.  The trial randomized 2200 people at increased risk of cardiovascular disease who were taking statins and showed modest but potentially valuable reductions in LDL (bad) cholesterol similar to those seen with ezetimibe.

“The results are promising but longer and larger studies (which are on-going) will be needed to provide reassurance about the overall safety and efficacy of bempedoic acid.

“The 3% (13.1% vs 10.1%:  bempedoic acid vs placebo) excess risk of muscle adverse effects is possibly just a chance finding, larger studies are needed to confirm or refute this.  However, this is a much greater excess than observed in randomized statin studies.

“The accompanying genetic study suggests that, as expected, the reduction is cholesterol would be associated with less heart disease but such genetic studies cannot tell us whether the drug will be safe for a wide range of people.”

Prof Sir Nilesh Samani, Medical Director at the British Heart Foundation, said:

“Research has shown a clear link between cholesterol and heart disease.  People with high cholesterol levels may need to combine medication along with a healthy lifestyle to bring these levels down.

“On the whole statins do a great job of lowering cholesterol.  However, this new drug could provide real benefit for the few people who can’t take them or require additional treatments to get it to the right level.  The research suggests that it has the potential to reduce risk of heart attacks and strokes without major side effects.”

‘Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol’ by Kausik K. Ray et al. was published in the New England Journal of Medicine at 21:00 UK time on Wednesday 13 March 2019.

‘Mendelian Randomization Study of ACLY and Cardiovascular Disease’ by Brian A. Ference et al. was published in the New England Journal of Medicine at 21:00 UK time on Wednesday 13 March 2019

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Declared interests

Prof Jane Armitage: “My important conflicts for this are that I am an investigator in a study (ORION 4) of a new injectable drug to lower cholesterol and in the past I have been a lead investigator in studies of statins and other cholesterol lowering drugs.”

None others received.

None received.