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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Published in Clinical Endocrinology, the review was led by UK consultant endocrinologist Professor Annice Mukherjee and Monash University clinician researcher Professor Susan Davis AO.

“This review recommends tailored use of MHT for well-defined indications, recognising its value for menopause symptom relief and skeletal benefits for many midlife women,” state the authors.

“MHT may be used as long as benefits outweigh the risks, through shared decision-making.

“There is insufficient clinical evidence to support the long-term use of MHT in some contemporary cohorts of women accessing MHT in clinical practice.”

Professor Davis, Director of the Women’s Health Research Program at Monash University, emphasises the review’s focus on evidence-based recommendations for prescribing.

“This paper reviews the evidence-based recommendations for menopausal hormone therapy and recommended prescribing,” she says.

“It also highlights that prescribing estrogen in doses higher than approved may increase the likelihood of vaginal bleeding, and that no studies have shown higher than regulator-approved doses of menopausal hormone therapy to be safe with regards to breast cancer and other disease risks.”

These findings contribute to the ongoing discussions around best practices for menopause management, particularly for healthcare professionals navigating treatment options for midlife women.

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Researchers from the University of Sydney’s Centre for Rural Health have uncovered a possible solution.

Their study, published in JAMA Network Open, found integrating lifestyle support into back pain care could reduce disability and enhance quality of life.

The randomised controlled trial included 346 participants from across Australia, all of whom had chronic low back pain and at least one lifestyle risk factor, such as obesity, poor diet, sedentary habits, or smoking.

Participants were randomly assigned to one of two groups: the “Healthy Lifestyle Program (HeLP)” or standard guideline-based physiotherapy care for managing their low back pain.

The HeLP participants received support from physiotherapists, dietitians and telephone health coaches who helped them work out which lifestyle habits might be influencing their back pain, such as weight, inactivity, poor diet, poor sleep, smoking or excessive alcohol use.

They were then provided evidence-based advice over a six-month period to help address the lifestyle challenge.

The approach showed several benefits compared to standard care including reduced disability, with participants scoring an average of 1.3 points lower on the Roland Morris Disability Questionnaire (higher scores indicate greater disability).

HeLP participants also lost an average of 1.6kg more than the control group.

Chief Investigator Associate Professor Chris Williams explained that the findings challenge traditional views of back pain management:

“Resolving back pain needs to focus on more than the back. Our bodies are not like machines, we are more like ecosystems where lots of factors interact and determine how we work and feel.

“Back pain is no different. So, when someone has back pain that doesn’t get better, they should expect to get comprehensive care about a range of health factors, not just a focus on what’s happening in their spine. We should shout this message from roof tops.

“Increasing numbers of studies have shown that pathologies like bulging discs and joint degeneration are rarely the cause of long-term back pain.

“The problem is, few people are told this, and even fewer are given support to focus on the things that influence long-term pain and disability. Too many people are referred for surgery or prescribed medications that don’t help—and may even lead to more harm.”

The study underscores the need for a shift in the treatment of back pain care, away from pills and procedures, and towards addressing the lifestyle factors that can make all the difference.

Lead author and University of Sydney Senior Research Officer Dr Emma Mudd emphasised the real world impact the program could have.

“Many people with long-term back pain tell us they feel abandoned, often being referred for high cost and ineffective treatments without being offered recommended treatments that promote self-management,” Dr Mudd said.

“By shifting the focus to include lifestyle changes and providing simple, supportive interventions, patients feel empowered to take control of their pain. This approach not only improves their symptoms but also enhances their overall quality of life.”

The researchers believe that lifestyle-integrated care, like the HeLP program, could benefit patients beyond pain management, potentially reducing risks for other chronic diseases. However, Dr Mudd noted that global guidelines have yet to fully embrace this approach:

“Our research could influence future updates to back pain guidelines. Patients valued the holistic support, and the outcomes speak for themselves.”

“Clinicians treating back pain should consider how they integrate lifestyle support into their day-to-day care. There doesn’t appear to be a right or a wrong way to do this, as long as the patient feels they are being heard, and they are part of the decision making,” said Associate Professor Williams.

For more information, visit: Healthy Lifestyle Care vs Guideline-Based Care for Low Back Pain.

Text by: The University of Sydney. 

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A vascular ‘fingerprint’ on the light sensitive tissue layer at the back of the eye — the retina — can predict a person’s risk of stroke as accurately as traditional risk factors alone, but without the need for multiple invasive lab tests, finds research published online in the journal Heart.

The fingerprint, comprising 29 indicators of vascular health, is a practical and readily implementable approach that is particularly well suited for primary healthcare and low-resource settings, conclude the researchers.

Stroke affects around 100 million people around the globe and kills 6.7 million of them every year, point out the researchers.

Most cases are caused by modifiable risk factors, such as high blood pressure, high cholesterol, poor diet, and smoking.

The retina’s intricate vascular network is known to share common anatomical and physiological features with the vasculature of the brain, making it an ideal candidate for assessing damage from systemic ill health, such as diabetes, explain the researchers.

Its potential for stroke risk prediction hasn’t been fully explored, due to variable study findings and inconsistent use of the specialised imaging technique for the back of the eye — fundus photography — they add.

But machine learning (AI), such as the Retina-based Microvascular Health Assessment System (RMHAS), has opened up the possibilities for the identification of biological markers that can accurately predict stroke risk without the need for invasive lab tests, say the researchers.

To explore this further, they measured 30 indicators across 5 categories of retinal vascular architecture in fundus images from 68,753 UK Biobank study participants.

The 5 categories included calibre (length, diameter, ratio) density, twistedness, branching angle and complexity of the veins and arteries.

And they accounted for potentially influential risk factors: background demographic and socioeconomic factors; lifestyle; and health parameters, including blood pressure, cholesterol, HbA1c (blood glucose indicator), and weight (BMI).

The final analysis included 45,161 participants (average age 55). During an average monitoring period of 12.5 years, 749 participants had a stroke.

These people tended to be significantly older, male, current smokers, and to have diabetes. They also weighed more, had higher blood pressure, and lower levels of ‘good’ cholesterol, all of which are known risk factors for stroke.

In all, 118 retinal vascular measurable indicators were included, of which 29 were significantly associated with first time stroke risk after adjusting for traditional risk factors. Over half (17) were density indicators; 8 fell into the complexity category; 3 were calibre indicators; and 1 came under the twistedness category.

Each change in density indicators was associated with an increased stroke risk of 10-19%, while similar changes in calibre indicators was associated with an increased risk of 10-14%.

Each decrease in the complexity and twistedness indicators was associated with an increased risk of 10.5-19.5%.

This retinal ‘vascular fingerprint’, even when combined with just age and sex, was as good as the use of traditional risk factors alone for predicting future stroke risk, the findings showed.

This is an observational study, and therefore no firm conclusions can be drawn about cause and effect.

The researchers acknowledge that the findings may not apply to diverse ethnicities as most of the UK Biobank’s participants are White. Nor were they able to assess the risk associated with different types of stroke.

Nevertheless, they conclude: “Given that age and sex are readily available, and retinal parameters can be obtained through routine fundus photography, this model presents a practical and easily implementable approach for incident stroke risk assessment, particularly for primary healthcare and low-resource settings.”

For more information, visit: Retinal vascular fingerprints predict incident stroke: findings from the UK Biobank cohort study.

Text by: BMJ Group. 

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The study, conducted by researchers from the National Drug & Alcohol Research Centre (NDARC) and the Medicines Intelligence Centre of Research Excellence at UNSW Sydney, revealed a 33% reduction in Pharmaceutical Benefits Scheme (PBS) opioid dispensing claims, primarily for long-acting formulations.

This decline follows the implementation of government measures aimed at curbing opioid use.

However, despite these efforts, private prescriptions for opioids rose by 55%, offsetting around a quarter of the PBS reductions.

“While Australia has reduced its overall consumption of opioid analgesics, our findings indicate a significant rise in private prescriptions, which come with higher out-of-pocket costs for people in pain,” lead author and pharmacoepidemiologist Kendal Chidwick said.

“Reasons for the increase in private market use may include accessing opioids not subsidised under the PBS, or efforts to avoid the PBS restrictions altogether.”

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Developed by the Centre for Research Excellence in Women’s Health in Reproductive Life (CRE-WHiRL) at Monash University in collaboration with key international health organisations, the guidelines involve both global health experts and women with lived experience.

Simultaneously published in Climacteric and two other leading journals, the guidelines aim to address critical gaps in POI care, including delayed diagnosis, inconsistent management and patient dissatisfaction.

Key updates in the 2024 guidelines 

The updated guidelines, developed in partnership with the European Society of Human Reproduction and Embryology (ESHRE), the International Menopause Society and the American Society for Reproductive Medicine, include 145 evidence-based recommendations.

Key highlights include:

• Faster diagnosis: A single elevated follicle-stimulating hormone (FSH) level combined with irregular or absent periods for four months is now sufficient for diagnosis. Repeated FSH tests are now only needed when the diagnosis remains unclear.
• Comprehensive care: Healthcare professionals are encouraged to evaluate patient sexual wellbeing, fertility needs, psychological health and risk of osteoporosis and cardiovascular disease.
• Personalised hormone therapy: Hormone therapy remains the cornerstone for symptom relief and chronic disease prevention should be initiated promptly and continued until the typical age of menopause unless contraindicated.
• New insights: The updated guidelines introduce new evidence on genetic causes, muscle health impacts, non-hormonal therapies, lifestyle interventions and complementary therapies.

“The new guidelines mean faster diagnosis of POI, conveyed in a sensitive manner and involving shared decision-making between healthcare professionals and women experiencing POI,” Associate Professor Amanda Vincent, Co-Chair of the guideline development group said.

“This provides healthcare professionals with the clear advice on best practice in POI care, based on the best evidence currently available.”

Additional tools and resources

The guidelines come with updated consumer resources, including the Ask Early Menopause App, which provides evidenced-based tools, a personal dashboard and a discussion forum.

Used by more than 9000 women worldwide, the app empowers women to better manage early menopause and engage in informed discussions with healthcare providers.

For healthcare professionals, a comprehensive toolkit is available that offers practical support to deliver best-practice care based on the latest evidence.

What is POI?

Affecting approximately 4% of women globally, POI is characterised by the loss of ovarian function before the age of 40 — occurring at an average age of 48-51 years in women globally.

POI can lead to infertility, psychological distress and increased risks of chronic conditions such as osteoporosis, cardiovascular disease, dementia and cognitive decline.

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Group CEO Justine Cain said Diabetes Australia, as the national peak body, was steadfast in its resolve to provide leadership around research funding.

“Research is the key to changing the future of diabetes in Australia. It creates hope for a cure, and for better day-to-day management, which is vital for people living with diabetes,” Ms Cain said.

“This significant commitment, by Diabetes Australia, will provide greater certainty for our diabetes research community and grow its life changing impact in discovering better treatments, and ultimately a cure for all types of diabetes. We are unwavering in our commitment to support the community,” she said.

Australian Diabetes Society CEO Professor Sof Andrikopoulos said the research community welcomed the announcement.

“Understanding the condition’s process and its complications is the only way we can ensure people living with diabetes can live well. This can only happen with significant investment in research,” Associate Professor Andrikopoulos said.

Diabetes Australia says it will engage with the research community and people living with diabetes in early 2025 to design an approach that ensures that the $40 million investment achieves maximum impact over the next ten years.

Australian Diabetes Society CEO Professor Sof Andrikopoulos said the research community welcomed the announcement.

“Understanding the condition’s process and its complications is the only way we can ensure people living with diabetes can live well. This can only happen with significant investment in research,” Associate Professor Andrikopoulos said.

research, diabetes, funding, Diabetes Australia, diabetes management, Australian Diabetes Society

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Expanding on existing evidence, two new studies from Flinders University highlight the protective effects of a diet rich in fibre — abundant in fruits, vegetables, whole grains, legumes — fish, and dairy against deadly digestive cancers.

“We’ve identified many direct links between poor diet choices and digestive cancers,” Dr Yohannes Melaku from Flinders Health and Medical Research Institute (FHMRI) said.

“A diet high in healthy fats and vegetables, while limiting the consumption of sugars and alcohol, could potentially reduce the risk of bowel and other cancers.”

Dr Melaku adds that high-fibre foods like fruits and vegetables promote healthy gut bacteria that can reduce inflammation.

“The emphasis on fibre and healthy fats should be an integral part of everyone’s diet,” he said.

Conversely, a high consumption of red and processed meats, fast foods, refined grains, sugary drinks, and alcohol are associated with a higher risk of GI cancers, which account for 1 in 4 cancer cases and 1 in 3 cancer deaths worldwide.

“As awareness around bowel cancer grows, our research serves as a timely reminder of the power of nutrition in disease prevention,” Dr Melaku said.

“With the growing number of digestive cancers, such as bowel cancer, being diagnosed worldwide, and increasingly in people under 50 years old, it’s time for action to protect people’s digestive health.”

While there is growing evidence that dietary interventions can be effective at preventing or delaying some diseases, the researchers say that further trials are needed to investigate the full impact that diet has on cancers.

They also stress the need for greater education on healthy eating and incorporating nutrition interventions in clinical settings.

“While our results are promising, more work needs to be done with a greater focus on nutrition in clinical settings using nutritional biomarkers to better understand the relationship between diet and GI cancer,” Associate Professor Amy Reynolds said.

“We need to understand how different dietary patterns may influence the risk of developing digestive cancers.

“We also want to see an increase in education around healthy eating, which could lead to better health outcomes for those at risk for GI cancers.”

The studies, published in the European Journal of Nutrition and Nutrition Reviews, highlight the importance of prioritising nutrition as a preventative measure for improving digestive health and long-term well-being.

How community pharmacy can help

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New Zealand researchers have discovered that sarmentosin, a novel bioactive compound found in blackcurrant powder and juice, acts as a Monoamine oxidase-B (MAO-B) inhibitor — a function that helps preserve dopamine levels in the brain, which are vital for mood regulation and cognitive health.

The study, published in The Journal of Agricultural Chemistry, was conducted by researchers from Plant & Food Research and Callaghan Innovation, and revealed that sarmentosin directly inhibits MAO-B enzymes, providing a natural alternative to synthetic inhibitors, which are said to be often associated with adverse side effects.

“While previous studies suggested that MAO-B inhibition was linked to bioactives other than anthocyanins in blackcurrants, it wasn’t until this study that we identified sarmentosin as the primary bioactive behind this function,” Dr Dominic Lomiwes, Science Team Leader for Immune Health & Physical Performance at Plant & Food Research, said.

As part of the randomised, placebo-controlled, crossover clinical study blood samples from healthy individuals were analysed to further examine the effect of sarmentosin on MAO-B activity.

Blood sample analysis results showed further the potent effects of sarmentosin on MAO-B — sarmentosin significantly reduces MAO-B activity, supporting the maintenance of dopamine levels and, in turn, mood and cognitive performance.

“We observed MAO-B inhibition in every participant who consumed the blackcurrant products containing sarmentosin. What’s remarkable is that the effect we saw in the lab translated directly to human subjects, which is extremely exciting,” Dr Lomiwes said.

‘Mind-blowing commercial possibilities’

This groundbreaking discovery has already sparked commercial innovation.

New Zealand-based functional food company Ārepa — the study’s partner — has patented the new molecule sarmentosin for use in its brain health products, which are available through Coles and Woolworths.

Ārepa co-founder Angus Brown says the potential application of this discovery for the functional food and beverage industry is very exciting.

“The commercial possibilities of the discovery of sarmentosin and its positive effects on brain health are pretty mind-blowing,” Mr Brown said.

“We can now extract the sarmentosin molecule from our Neuroberry blackcurrants and use it in other food and beverage products, and know it will have the same effect.”

Plant & Food Research Chief Scientist Professor Richard Newcomb highlights the importance of this discovery for both the scientific and commercial sectors in New Zealand.

“The results from this clinical trial are incredibly encouraging and lay the foundation for new innovations that benefit both consumers and businesses,” he said.

What the study means for Australians 

The discovery is of global importance and suggests a natural alternative that could be used to support mood, mental health and overall cognitive function.

It could play a key role in the prevention of age-related mental decline, supporting healthy ageing and longevity.

This is particularly important given Australia’s ageing population – which is expected to nearly double to 8.8 million by 2057 – and Dementia is set to become the leading cause of death in the country.

Melbourne-based Professor of Human Psychopharmacology and Chief Scientific Officer at Ārepa, Professor Andrew Scholey, expects to see new innovations in food and medicine arise over the years to improve mental health and help promote healthy brain function.

His goal is to find natural-based solutions to delay the onset of neurological decline through science-backed brain foods that can be scaled and made accessible and convenient for everyone worldwide.

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The clinical-stage company, which focuses on anti-inflammatory drugs for chronic degenerative diseases associated with ageing, has developed ALPHA-003, a drug designed to minimise brain damage before it occurs.

This is unlike existing dementia treatments that focus on mitigating the consequences of brain cell damage.

“The underlying problem with most forms of dementia is the destruction of a key structural component of brain cells known as micro-tubules,” Associate Professor Kieran Scott, Professor of Oncology at Western Sydney University, and co-discoverer of ALPHA-003, said.

“These long, hollow tubes are vital to healthy brain function. In dementia, these microtubules degrade, resulting in the death of brain cells.

“To date, no-one has found a way of preventing microtubular destruction.

“We believe ALPHA-003 has the potential to be that first drug by stabilising the two main brain cell components whose job is to protect microtubules from damage – tau and neurofilaments.”

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