Hundreds of thousands of Australians with life-threatening high cholesterol could benefit from a new pill in the pipeline, following the successful research and trial by Prof Stephen Nicholls, Director of the Victorian Heart Hospital and Victorian Heart Institute, based at the Monash University Clayton campus.
More than 300 Australian patients with high cholesterol took part in the four-year clinical trial involving 14,000 people in 32 countries. Through the trial, published in the New England Journal of Medicine, the new cholesterol-lowering drug, bempedoic acid, demonstrated the following benefits:
• Lowered low-density lipoprotein cholesterol, commonly referred to as ‘bad cholesterol’, by 20-25%;
• Reduced cardiovascular complications by 13%;
• Reduced heart attacks by 23%; and
• Reduced coronary revascularizations (a procedure to open blocked arteries) by 19%.
Nicholls, a well-known cardiologist and Director of the new Victorian Heart Hospital at Monash Health and Monash University’s Victorian Heart Institute, co-led the worldwide trial.
Currently, 2.5m Australians take statins to lower their cholesterol. Nicholls said about 20% of patients on statins had tolerance issues and about 50% 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,’’ Nicholls said. “It has the potential to help between 100,000 and 500,000 people in Australia.’’ The new bempedoic acid drug - currently called Nexletol - is being developed by US-based Esperion Therapeutics and will go to the TGA for approval for use in Australia. The drug is expected to be available for Australian patients in the next two years.
Bempedoic Acid is currently licensed in Europe and UK and not available in Australia. The supply of unlicensed medicines is available in Australia under the Special Access Scheme. HL Pharma is a specialist supplier of Unlicensed Products including products through the Special Access Scheme. Please contact us for further information.