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.”

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The CVD Impact Report launched on 29 February 2024 in federal parliament provides how the Federal Government’s investment of $364 million over five years could save more than 4,000 lives and return $3 billion in healthcare savings to the economy through the establishment of the novel test, treat, track model.

The new CVD Impact Report has been designed to optimise cholesterol and CVD management in Australia through better and more timely CVD testing and screening (and therefore diagnosis), earlier access to CVD treatments, as well as improved access to digital tools, such as text message prompts, supporting the management and follow-up care of CVD.

At the heart of this model is a push to empower Australians to learn more about their individual risk of CVD, and in doing so, take proactive steps to reducing their risk factors. Uniquely, the new model proposes harnessing the existing skillsets of pharmacists and nurse practitioners to deliver heart health testing in community settings. Such a multidisciplinary approach to care is expected to relieve the latent and growing pressure on GPs, who are vastly outnumbered and under-resourced in regional and rural areas.

According to Dr Karam Kostner, Associate Professor of Medicine at the University of Queensland and Director of Cardiology at Mater Hospital, Brisbane, the need for a new approach to CVD prevention, treatment and management has never been more urgent.

“I have seen first-hand the impact of cardiovascular disease. Traditional CVD models of care have focused heavily on reducing CVD risk factors, including blood pressure and better management of cholesterol levels. And whilst these remain critical, we also urgently need a new way of tackling the disease, with an emphasis on earlier diagnosis and therefore intervention. The model of care – test, treat, track- launched in Canberra today, is a step in the right direction,” said Dr Kostner.

“The impact of CVD in Australia is devastating, claiming one life every 12 minutes with the impact felt the greatest in regional and rural Australia. Novartis is committed to improving the lives of those impacted by CVD and working with all stakeholders across the ecosystem, including the federal and state level government partners, hospitals, patients and other public and private parties to help make the biggest impact for Australian CVD patients and their families.”

The report was commissioned by Nocartis and developed by Australian health economists from HTAnalysts. The benefit of the new model of care, according to Matt Zeller, Country President of Novartis Australia and New Zealand, is that it is entirely scalable and adaptable.

“At the heart of the CVD Impact Report is diagnosing CVD earlier in community by utilising the existing expertise of community pharmacists, who are well-placed to lead CVD testing, particularly in regional and rural Australia where access to primary care is more of a challenge. Increased community-based CVD testing alone will result in $17.4 million savings for those impacted by CVD. Such savings would truly make a positive impact on many Australian families.” said Mr Zeller.

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Associate Professor Nathan Palpand and Professor Glenn King from the University of Queensland’s Institute for Molecular Bioscience have previously shown that the drug candidate Hi1a protects cells from the damage caused by heart attack and stroke.

Dr Palpant said a subsequent study has put the drug through a series of preclinical tests designed to mimic real-life treatment scenarios.

“These tests are a major step towards helping us understand how Hi1a would work as a therapeutic – at what stage of a heart attack it could be used and what the doses should be,” Dr Palpant said.

“We established that Hi1a is as effective at protecting the heart as the only cardioprotective drug to reach Phase 3 clinical trials, a drug that was ultimately shelved due to side effects.

“Importantly, we found that Hi1a only interacts with cells in the injured zone of the heart during an attack and doesn’t bind to healthy regions of the heart – reducing the chance of side effects.”

Professor King, who recently won the Prime Minister’s Prize for Innovation for developing the world’s first insecticides from spider venom, discovered Hi1a in the venom of the K’gari funnel web spider.

“Hi1a could reduce damage to the heart and brain during heart attacks and strokes by preventing cell death caused by lack of oxygen,” Professor King said.

“Our testing and safety studies from independent contract research organisations has provided evidence that Hi1a could be an effective and safe therapeutic.”

Infensa Bioscience, a company co-founded by the researchers, raised $23 million in 2022 to develop Hi1a for commercial purposes.

Infensa CEO and UQ researcher, Associate Professor Mark Smythe, said cardiovascular disease is the leading cause of death globally.

“Most deaths from cardiovascular disease are caused by heart attacks and strokes, yet there are no drugs on the market that prevent the damage they cause,” Dr Smythe said.

“An effective drug to treat heart attacks would have worldwide impact, providing a breakthrough to improve the lives of millions of individuals living with heart disease.”

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This year’s awarded projects will investigate some of the toughest and most insidious unsolved mysteries of cardiovascular disease (CVD), championing the cause for more advanced prevention, treatment and management of heart disease, stroke and blood vessel disease, with the end goal of improving the lives of people of all ages and backgrounds.

Research highlights include:

• A project to improve our understanding of how the heart adapts to high level exercise (“athlete’s heart”), thereby helping to identify the genetic risks that can predispose the athlete to dangerous rhythm problems, heart failure and sudden cardiac death.
• An investigation to improve the diagnosis and treatment of heart disease specifically in women, to close the current gender gap in cardiovascular care.

• A cutting-edge project to explore novel treatments for ischaemic stroke, which occurs when blood supply to part of the brain is interrupted or reduced, often leading to debilitating brain damage and bacterial stroke-associated pneumonia (SAP).
• Research to develop a tool for assessing heart health knowledge in First Nations women to develop more culturally aligned diagnosis and treatment.

• A study to identify barriers to genomic testing for familial hypercholesterolaemia (FH), the most common genetic cause of early coronary heart disease, which affects one-in-250 Australians.

• An mRNA-based therapy using tiny, injectable materials that serve as “nano delivery vehicles” for targeted, trackable, treatment of heart disease.

• A comprehensive study of the causes of coronary atherosclerosis (fatty deposits that block the coronary arteries), using samples from healthy donors and coronary atherosclerosis patients.

• A research project to identify novel genetic causes of congenital heart disease (CHD), the leading cause world-wide of birth defect-associated infant illness and death.

A full list of research projects is available online here.

Heart Foundation CEO David Lloyd said that the generosity of donors during the past 12 months had ensured the organisation could continue to help support vital cardiovascular research.

“These 73 innovative projects build on the Heart Foundation’s strong legacy of supporting cardiovascular research since 1959,” he said.

“The Heart Foundation supports research right across the spectrum: from work in fundamental biology that aims to discover the basic mechanisms of disease, to clinical research, to work in health services and public health – and it’s pleasing to see that spread continues with this year’s funding outcomes.

“Our support is only possible with thanks to the generosity of everyday Australians who want to live in a world where cardiovascular disease is no longer a threat to them or their loved ones. It’s a cause championed by the Heart Foundation too, as we strive to realise our long-term vision of making the generation that turns 50 in 2050 the nation’s healthiest ever.”

More than four million Australians are living with a cardiovascular disease and nearly 44,000 deaths are attributed to one, with coronary heart disease continuing to be the leading single cause of disease and death in Australia — accounting for more than 17,300 deaths each year.

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Pulling together 20 previous clinical trials the researchers found benefits from switching to a vegetarian diet for 6 months. However, the study authors say more high-quality trials will help clarify the effects of healthy plant-based diets in people with cardiovascular disease.

The results of this study suggest that consuming a vegetarian diet may modestly but significantly improve cardiometabolic outcomes beyond standard pharmacological therapy in individuals at high risk of cardiovascular diseases (CVDs), highlighting the potential protective and synergistic effects of vegetarian diets for the primary prevention of CVD.

For more information, visit: jamanetwork.com/journals/jamanetworkopen/fullarticle/2807597

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In fact, cardiologists at the Victor Chang Cardiac Research Centre want more people aware of what’s referred to as metabolic syndrome, or syndrome X, which includes a cluster of conditions that increase cardiovascular disease risk.

Syndrome X (which is also known as insulin-resistance syndrome) is said to affect approximately 30% of Australians and is known to increase the risk of heart disease, stroke, and type 2 diabetes.

So, how is Syndrome X diagnosed?

The syndrome can be diagnosed if 3 any of the following risk factors are met:

• Large waist circumference (equal to or greater than 80 cm for women and 94 cm for men – though this varies for certain ethnic groups);
• High blood pressure (equal to or greater than 130 systolic or 85 diastolic);
• Reduced levels of HDL ‘good’ cholesterol (lower than 1.0 mmol/L in men and 1.3 mmol/L in women);
• High levels of blood triglycerides (equal to or greater than 1.7 mmol/L);
• High fasting blood sugar (greater than 5.5 mmol/L).

“As a cardiologist, I’ve lost count of the number of patients I have seen and treated with cardiovascular issues like heart attack that have arisen as a direct result of metabolic syndrome – it is such a pervasive and growing issue in our society,” says Cardiologist and Victor Chang Cardiac Research Institute’s Executive Director Professor Jason Kovacic.

“Most of us have heard about how carrying extra weight, particularly around the abdomen, can affect our health, but people are still largely unaware of metabolic syndrome and how damaging it can be for our hearts and blood vessels.

“With more than half of Australians already having at least one of the risk factors for metabolic syndrome, people need to be made aware of the steps they can take to avoid it.

“Unfortunately, once you have one of these risk factors, you’re more likely to develop the other risk factors. So, it can be a bit of a snowball effect,” says Professor Kovacic.

Positive lifestyle changes can help to both prevent and treat metabolic syndrome.

“We know this syndrome is largely caused by poor diet, sedentary lifestyle, smoking and the like,” says Professor Kovacic.

“This is good news because it means we also know how to reduce the risk of metabolic syndrome – this includes making healthy changes to the way we eat and the amount of physical activity we do.”

Tips to lessen your risk

Professor Kovacic advises Australians to focus on making simple lifestyle changes including:

• Maintaining a healthy diet by reducing portions, and eating more vegetables, healthy unsaturated fats from foods like olive oils, fish, and nuts, and fibre from whole grains and other plant foods.
• Upping your exercise to 30 minutes or more of moderate activity per day, five or more days per week.
• Quitting smoking.
• Reducing your alcohol intake to no more than seven standard drinks a week – though the lower the better.

“We know that changing our behaviour isn’t always easy, but whether it’s taking the kids for a bike ride on the weekend or finding ways to add more plant foods to your favourite recipes, every little bit helps reduce the risk of heart issues in the future,” says Professor Kovacic.

Undergoing regular Heart Health Checks to keep an eye on your cholesterol, triglycerides, blood pressure, and blood sugar levels are also recommended.

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The new guidelines –  2023 Australian Guideline for assessing and managing cardiovascular disease risk – which were last updated in 2012, identify the importance of kidney disease as a major risk factor for heart disease, reinforcing the need for GPs to do a Kidney Health Check before completing their cardiovascular assessment.

Kidney disease remains severely underdiagnosed due to its symptomless nature.

Now, those being assessed for cardiovascular disease (CVD) will have their kidney health assessed earlier, giving them more time to treat and manage the interlinking conditions.

Chris Forbes, Kidney Health Australia CEO and Chair of the Australian Chronic Diseases Prevention Alliance (ACDPA) says the new calculator is a powerful tool that will enable earlier detection and treatment of chronic kidney disease, ultimately reducing the number of associated cardiovascular deaths.

“Kidney disease and the resultant potential for cardiovascular death is a ticking time bomb for the 1.8 million Aussies currently living with undiagnosed kidney disease,” says Mr Forbes.

“The guidelines and calculator are another critical step in detecting and managing both diseases earlier to save thousands of lives.”

According to Kidney Health Australia’s recently released Deloitte Economics Access Report, earlier detection of kidney disease could result in 38,200 fewer deaths due to kidney failure and CVD-related events, 237,234 fewer CVD hospitalisations and save the economy $3.3 billion in reduced occurrence of kidney-related cardiovascular disease hospitalisations over the next 20 years.

Endorsed by the Royal Australian College of General Practitioners (RACGP), the guidelines offer clinicians practical advice and tools to facilitate shared decision-making with their patients.

The guidelines also provide greater support for First Nations Australians. Among First Nations Australian adults with cardiovascular disease, 32% have comorbid CKD (compared to 21% of non-Indigenous Australians).

Dr Karen Dwyer, Clinical Director at Kidney Health Australia, who was part of the guidelines’ development team says: “It is critical to make the link – think kidney disease, think heart disease. Think heart disease, think kidney disease.”

Mr Forbes adds: “Diagnosing and managing kidney disease earlier prevents heart deaths and hospitalisations, reduces economic impacts and keeps Aussies out of hospital, working and enjoying life longer.”

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Published in the prestigious journal Circulation Research, the study investigated the movement of neutrophils, a type of white blood cell that is an essential part of the immune system.

Neutrophils, the first responders when there’s an injury or infection, move from blood vessels to the site of injury and initiate inflammation and healing. However, prolonged retention of neutrophils, such as at the site of vascular injury, can result in chronic inflammation and a build-up of atherosclerotic plaques that can lead to strokes and heart attacks.

Dr Joyce Chiu, the lead author of the study from the ACRF Centenary Cancer Research Centre, said that the team had uncovered the method by which neutrophils unstick from blood vessels as they move towards the site of injury. This mechanism, she said, could be potentially harnessed to reduce chronic inflammation by preventing the movement of neutrophils to certain areas of the body.

“Molecules known as integrins help neutrophils stick to the walls of blood vessels to prevent the cells from being carried away by blood flow. To move to the site of injury, neutrophils must stick and unstick from blood vessel walls. While we knew how integrins helped neutrophils stick, we did not know how they unstick,” said Dr Chiu.

According to Dr Chiu, the study discovered that a molecule called protein disulfide isomerase (PDI), secreted by neutrophils, plays a crucial role in helping the cells unstick from blood vessels as they move towards the site of injury.

Dr Chiu believes that this finding suggests that PDI could be a target for new drugs to treat chronic inflammation in diseases, including cardiovascular diseases.

“New drugs can be designed to inhibit PDI, to keep neutrophils from ‘unsticking’ and migrating from blood vessel walls. Preventing neutrophils from moving around can help prevent chronic inflammation by reducing their ability to accumulate at sites of injury or infection,” Dr Chiu said.

“Our research could pave the way for new treatments and management strategies that are able to limit the extent of inflammation and potentially improve outcomes for individuals with chronic inflammatory and cardiovascular conditions.”

Text: Centenary Institute. 

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The findings have been published in the world-leading academic journal, Bioprinting.

The new technology creates personalised ‘bio-inks’ made of a patient’s own stem cells. The ‘bio-inks’ are then used to 3D-print cardiac tissues to repair areas of dead tissue caused by heart attacks.

“Thanks to our study we have a better understanding of how bioengineered heart tissues work in the body after their transplantation,” said Dr Carmine Gentile, head of the Cardiovascular Regeneration Group at UTS.

“Our study demonstrated that bio-engineered patches were the best and most robust treatment of heart failure – patches generated with other approaches either did not induce any improvement or the improvement was inconsistent.

“Our bio-engineered patches promise to be safer, more consistent and cost-effective for the patient.”

Cardiovascular disease is the leading cause of death worldwide. In Australia, it accounts for about one in four deaths – claiming a life every 12 minutes.

Heart failure is a frequent complication of heart disease, with inadequate blood supply resulting in the death of heart tissue in an affected area. Life-long drug therapy may be required as a result, and end-stage heart failure means some patients join the waiting list for a heart transplant.

“Because this technology will enable patients to use their own stem cells to create the heart ‘patches’, not only can they potentially dramatically reduce the trauma and cost of a heart transplant, but also avoid hurdles such as a body rejecting donor tissues,” said Dr Gentile.

Further testing for long term effects of this technology are underway before starting clinical trials.

Heart Research Australia, a key funding partner of the research, commended the advances made by Dr Gentile and his research team in striving to improve the devastating statistics surrounding heart disease.

“It’s wonderful to hear that this research partnership has proven to be successful and is now able to progress to the next stage. We are excited about the potential of this technology to help the hundreds of thousands of people affected by heart failure each year,” said Nicci Dent, CEO Heart Research Australia.

Text by: UTS

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The study compared SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA). Both classes reduce major adverse cardiovascular events in people with type two diabetes.

Women with type two diabetes have a greater risk of developing cardiovascular disease and heart failure than men. Despite this, the treatment approaches for diabetes-induced cardiovascular disease are the same.

The study, published in The Lancet Regional Health – Western Pacific, included 8026 men and women under 30, discharged from a Victorian hospital between 1st July 2013 and 1st July 2017, and dispensed an SGLT2i or GLP-1RA within 60 days of discharge.

The study found that men dispensed SGLT2i had a 22 per cent reduction rate in major adverse cardiovascular events compared to men who supplied a GLP-1RA. In women, there was no significant difference between SGLT2i and GLP-1RAs for their effects on major adverse cardiovascular events.

The study’s first author and MIPS PhD candidate, Abhipree Sharma, said the apparent disparity between the relative benefits of SGLT2i versus GLP-1RAs in type two diabetes men and women warrants further investigation.

“Treatment recommendations for type two diabetes-associated cardiovascular disease and heart failure remain the same in men and women despite known sex differences in the development and presentation of these diseases.”

“Our analyses suggest that these newer classes of glucose-lowering therapies can, in fact, exert more favourable effects depending on age and sex, which is something we believe needs to be explored further,” said Ms Sharma.

Leader of Heart Failure Pharmacology at MIPS and corresponding senior author, Professor Rebecca Ritchie, said there may be a number of reasons women with type two diabetes are more at risk of developing cardiovascular disease and heart failure than men with type two diabetes.

“Typically, women with type two diabetes present with greater insulin resistance, endothelial dysfunction, inflammation, abdominal adiposity, body mass index, and blood glucose and cholesterol levels than men with type two diabetes. Additionally, increases in cardiovascular disease and heart failure risk in postmenopausal women suggests an integral role for estrogen in cardioprotection in women.”

“Our hope is that the findings from this large population-based study will lead to a deeper dive into the most effective pharmacological treatment recommendations based on factors including sex, age and heart failure history,” Professor Ritchie concluded.

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