The Therapeutic Goods Administration (TGA) has granted approval for semaglutide 2.4mg (Wegovy) as an adjunct therapy to reduce major adverse CVD events, including cardiovascular death, non-fatal heart attacks, and non-fatal strokes.

The approval follows findings from the SELECT trial, a global study involving more than 17,000 participants across 41 countries, including Australia.

Results published in late 2023 showed that Wegovy reduced cardiovascular events by 20% in people with pre-existing heart disease who were overweight or obese but did not have diabetes.

Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial and Director of the Victorian Heart Institute at Monash University, emphasises the significance of the approval.

“This approval highlights the critical role of overweight and obesity as major drivers of heart disease — on par with cholesterol, blood pressure, diabetes and smoking,” he says.

“It reinforces that these risks can be actively reduced with targeted therapies.

“The SELECT trial demonstrated that the cardiovascular benefits of semaglutide extend beyond weight loss.

“This drug also positively impacts inflammation, blood lipids and blood pressure, which are all crucial in preventing heart attacks and strokes.

“What this tells us is that if you have heart disease and are overweight or obese, not only are you at a higher risk of another cardiovascular event, but that risk can now be significantly reduced.

“This is a groundbreaking result for patients.”

The post ‘Groundbreaking’: TGA approves weight loss drug for CVD appeared first on Retail Pharmacy.

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

Through the trial, published in the New England Journal of Medicine (NEJM) the new cholesterol-lowering drug, bempedoic acid, demonstrated the following benefits:

• 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, renowned cardiologist and Director of the new Victorian Heart Hospital at Monash Health and Monash University’s Victorian Heart Institute, co-led the landmark worldwide trial.

Currently, 2.5 million Australians take statins to lower their cholesterol. Prof. 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 your blood. That cholesterol can make arteries narrow making it hard for blood to circulate, 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 your livers or high blood sugar.

The new bempedoic acid drug – currently called Nexletol – is being developed by US-based Esperion Therapeutics and will go to the Therapeutics Goods Administration for approval for use in Australia.

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

The new world-class Victorian Heart Hospital operated by Monash Health at Monash University’s Clayton Campus is Australia’s first specialist cardiac hospital. It will offer a full range of cardiovascular services, including critical and emergency care, outpatient clinics, imaging services, and a full cardiac surgical team.

Text by: Monash University

The post Revolutionary new cholesterol drug to save lives appeared first on Retail Pharmacy.

Published in the Journal of the American College of Cardiology: Cardiovascular Imaging, the HUYGENS study treated high-risk patients over a 12 month period and was successful in a number of ways by combining commonly used statins together with a cholesterol-lowering drug called Evolocumab, which is already available to patients.

Using a new imaging method, researchers were able to view a change in the biology or composition of the harmful plaque in the arteries following treatment,  not only reducing its size but changing it from hot to cold, rendering it effectively scar tissue and stable.

The degree to which this was successful was also directly related to how much the patient’s bad cholesterol was lowered.

Lowering cholesterol is an important strategy in helping mitigate risk factors, but the new therapy was highly effective in reducing cholesterol ratios down to 0.7mmol/L, which is lower than the current clinical guidelines of less than or equal to 1.8 mmol/L suggested in the first instance.

Plaque consists of cholesterol, fatty substances, waste products, calcium and the clot-making substance fibrin. It typically builds up on artery walls over many years and can clog or damage your arteries, which limits or stops blood flow to your heart muscle.

Professor Stephen Nicholls, Director of Monash University’s VHI and HUYGENS trial lead, says the trial tells clinicians that they need to work as hard as they can to keep cholesterol down as low as they can and maintain it.

“It is important after a heart attack to lower cholesterol as much as possible and with this new therapy, we can reduce it to an extent we haven’t seen before while also stabilising plaque, making it less likely to burst. This is a new frontier in therapy,” says Professor Nicholls.

He adds: “If you’ve had a heart attack, you are twice as likely to die prematurely compared to the general population.

“These findings show that plaque reduction and stabilisation was doubled for high-risk patients who had already experienced a heart attack, making it effective for those who need it most.”

The post Game-changing therapy in heart health appeared first on Retail Pharmacy.