New cholesterol lowering drug could be approved for Australian patients in two years

More than 300 Australian patients with high cholesterol took part in a breakthrough four-year clinical trial involving 14,000 people in 32 countries.

The trial was testing the effectiveness of cholesterol-lowering drug, bempedoic acid, which was shown to significantly reduce bad cholesterol, reduce heart attacks and reduce the need for procedures to open blocked arteries.

Bempedoic acid (currently called Nexletol) is being developed by US-based Esperion Therapeutics and an application will go to the Therapeutics Goods Administration for approval for use in Australia.

The successful research and trial co-led by cardiologist Professor Stephen Nicholls, Director of the Victorian Heart Hospital and Victorian Heart Institute, could be a game changer for people with high cholesterol many of whom cannot tolerate statins traditionally given to reduce choesterol. Currently, 2.5 million Australians take statins to lower their cholesterol.

Professor Nicholls said about 20 per cent of patients on statins had tolerance issues and about 50 per cent of high-risk patients didn't get their cholesterol down to target levels so they need other options.

"This new drug provides another option for lowering cholesterol and is particularly important for patients that cannot tolerate statins. That's a real problem in clinical practice which limits our ability to effectively lower cholesterol in many patients,'' Professor Nicholls said.

"It has the potential to help between 100,000 and 500,000 people in Australia.''

Statins decrease the risk of having a stroke or heart attack because they cut down the amount of bad cholesterol in the blood which can narrow arteries, making it hard for blood to circulate and creating the risk of heart attack or stroke.

Statins may cause mild side effects, including headache, nausea, dizziness, diarrhea, constipation or achy muscles or joints. Rarely, statins may cause bad side effects, including confusion, memory loss, damage to the livers or high blood sugar.

The trial, published in the New England Journal of Medicine showed bempedoic acid lowered low-density lipoprotein (LDL) cholesterol, commonly referred to as 'bad cholesterol', by 20-25 per cent; reduced cardiovascular complications by 13 per cent; reduced heart attacks by 23 per cent; and reduced coronary revascularisations (a procedure to open blocked arteries) by 19 per cent.

Professor Nicholls said he expected the drug to be available for Australian patients in the next two years.