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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Researchers used records from 526 GP practices across regional and metropolitan Victoria, representing almost half of that state’s residents, to analyse opioid prescribing rates between 2017 and 2022.

Two newly published peer-reviewed papers based on that data provide a comprehensive view of where the most opioids are being prescribed and give insight into the impact of recent PBS measures designed to reduce rising opioid-related harms, including overdose.

One study, published in the International Journal of Clinical Pharmacy, found a general decrease in opioid prescribing by general practitioners, but identified a 69% increase in new opioid prescription rates for Victorians aged between 15 and 24.

The research also found that while prescription rates decreased for most opioids, the number of prescriptions for tapentadol surged by 263%.

Another recent paper, published in Pain Medicine, found a decline in the number of people being prescribed opioids for extended periods of time.

The paper found most people were prescribed opioids in the short term, with the proportion still being prescribed opioids three months after their initial prescription falling from 5.4% in 2018 to 3.6% in 2022.

Researchers also compared how gender, socio-economic status and geographical region impacted opioid prescribing rates, finding disparities between male and female patients, disadvantaged patients, as well as those in regional and remote areas.

The study found that while women are getting more opioid prescriptions overall (53%), men are more likely to start new prescriptions. It also revealed that the most disadvantaged groups saw a decrease (12%) in opioid prescriptions, while the least disadvantaged saw an increase (6%).

Regional and remote areas had the highest rates of opioid prescribing and new prescription rates, although these rates decreased significantly over the study period.

Deputy Director of Monash Addiction Research Centre, Professor Suzanne Nielsen, says there is a need for targeted interventions to ensure opioids are available when clinically needed, and equitably across all groups and geographical regions, while minimising the risk of harm.

“We know some regions have access to pain management services, which can drive increased opioid use,” she says. “Although overall reductions are positive, we want to see equitable access for pain management, and access to opioids where they are clinically appropriate.”

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The harm reduction measure will be offered at the upcoming Hardmission Festival, Pitch Music and Arts Festival, March Ultra Music Festival and The Warehouse Project.

This follows the pill-testing trial at the recent Beyond the Valley Festival. Pill testing was introduced following the spike in drug-related harm last year with nine people critically unwell at Hardmission Festival all experiencing hyperthermia after using high-potency MDMA in a hot and humid environment and one death related to a suspected overdose at Pitch Music and Arts Festival.

Victorian Minister for Mental Health Ingrid Stitt said, “Following a spike in drug harm last festival season, this service is more important than ever. It offers a sensible health-led approach that will save the lives of young Victorian festivalgoers.”

“The results from Beyond the Valley speak for themselves: pill testing does not encourage people to use drugs. It allows people to see what’s really in their substances and make informed health decisions.”

Associate Professor Arunogiri Associate Professor at Monash Addiction Research Centre and Acting Executive Clinical Director of Turning Point said, “It is fantastic to see the further expansion of the drug checking trial in Victoria. This evidence-based health measure will help keep more people safe and reduce illicit drug harms.

“The first festival trial at Beyond the Valley provided very encouraging data, consistent with research that shows drug checking often results in people discarding their drugs.

“With the increasing detection of dangerous substances such as nitazenes in the illicit drug supply, drug checking services can be a critical part of an early warning system. Making these measures more widely available is absolutely vital.”

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The project involved researchers from Australia, China and Singapore and was led by the Hypertension Research Laboratory at Monash University’s School of Biological Sciences, headed by Professor Francine Marques.

The findings are highly significant for the estimated one in three Australians who have hypertension, which is a leading cause of stroke, heart disease and kidney disease.

“We had evidence that dietary fibre, via the production of gut microbial substances called short-chain fatty acids, reduces blood pressure,” said Professor Marques. “But we didn’t understand how this gut-to-host communication took place.”

The key is in two protein receptors in intestinal cells which can be switched on by short-chain fatty acids. These receptors are called GPR41 and GPR43.

“They are what we call ‘G-protein coupled receptors’, part of the largest group of receptors on cell membranes that activate signalling from the surface to the inside of cells,” Professor Marques said.

“They are highly present in immune cells and cells of the lining of the intestinal wall. Once they are activated, they are known to trigger anti-inflammatory mechanisms.

“What is exciting about them is that the molecules that bind to and activate them are produced by the gut when we ingest fibre in our diet.”

The team’s findings are now published in Circulation Research with a strong focus on gut permeability, or how much it leaks, based on pre-clinical lab work.

“Our study shows that the lack of activation of the receptors, copying a situation when we don’t have enough fibre in our diet, leads to increased gut permeability, allowing microbial components into the circulation,” said lead author Dr Rikeish R Muralitharan, a research fellow in the School of Biological Sciences.

“This activates inflammation in key organs such as the kidney, which regulate blood pressure, and which leads to hypertension. What is exciting here is that this systemic increased inflammation we observe in diseases such as hypertension may start in the gut, and we demonstrate that GPR41 and 43 are, at least partially, responsible for the blood pressure-lowering and cardio-protective effects of a high fibre diet.”

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Led by experts at the University of Adelaide, UNSW Sydney and Monash University, the evidence-based Australian Guidelines have been published in the Medical Journal of Australia alongside the launch of consumer resources including a new Monash Ask Fertility App.

The Guideline has been developed in engagement with consumers, including Indigenous and women from culturally and linguistically diverse (CALD) backgrounds.

CRE WHiRL is led by Monash University’s Professor Helena Teede, who joined University of Adelaide Professor Robert Norman and UNSW Sydney’s Dr Michael Costello as the experts leading the Guideline.

Professor Teede said the Guideline was developed using the most robust processes, involved all stakeholders including those with lived experience of infertility, and was approved by the NHMRC, so the community could be reassured it was trustworthy.

“Unexplained infertility greatly impacts quality of life, and it is important to ensure those affected receive the best advice and care for optimal outcomes, whilst avoiding rapidly rising use of often unproven treatments, increasing costs and inequity seen in Australia for those with unexplained infertility,” Professor Teede said.

“This new guideline will help to streamline and simplify treatments, potentially reducing cost and increasing equity, by avoiding complex testing and treatments that were not necessarily evidence-based. The Guideline’s evidence-based advice will play an important role in improving health outcomes for those with unexplained infertility and is adapted for the Australian health system and context,” Professor Norman added.

Dr Costello said that a lack of evidence-based guidelines and limited independent consumer information and empowerment strategies have compounded this. “The ESHRE and Australian Guideline uses the best available scientific evidence to guide health professionals in diagnosing and treating those with unexplained infertility,” he said.

The Guideline outlines the definition of unexplained infertility, diagnostic tests, treatments and differences between explained and unexplained infertility.

It is aimed at but not limited to general practitioners, gynaecologists, andrologists, infertility specialists, reproductive surgeons and those with unexplained infertility.

“The Guideline aims to assist healthcare professionals and couples in appropriate and effective management of the condition, acknowledging that each medical decision must consider individual characteristics, preferences, socioeconomic status, beliefs and values,” Dr Costello said.

“It should also be acknowledged that couples with unexplained infertility may experience considerable impact on their quality of life and they can be offered support and therapeutic counselling.”

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Professor Susan Davis, who heads the Monash University Women’s Health Research Program in the School of Public Health and Preventive medicine, is leading the four studies.

“The testosterone changes across midlife and the menopause have never been documented with accuracy or precision,” Professor Davis said. “Despite menopause affecting 51 per cent of the population, these hormone changes at menopause remain uncertain.”

Professor Davis, who developed the Practitioner’s Toolkit for Managing the Menopause, said the world-first Menopause Matters: The Australian Women’s Midlife Years (AMY) Study will provide critical information for healthcare providers and policy makers.

The project surveyed more that 8000 women aged 40-69 about menopause, their mood and wellbeing, sexual function, and paid and unpaid work.

“The findings will have a major socioeconomic impact beyond women’s health,” Professor Davis said. “It will enable workplace policies or amendments pertaining to female workers to be formulated based on sound information, such that outdated perceptions and/or negative social attitudes about menopausal women are not reinforced.

“Ultimately, this study will improve the health and well-being of women before, during the menopause transition and beyond, and ensure that they are able to continue to contribute to the community with equity and confidence.”

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“Despite numerous guidelines recommending lifestyle modifications as first-line treatment for hypertension, specific recommendations regarding fibre intake have been notably absent,” said lead study author Associate Professor Francine Marques from the Monash University School of Biological Sciences.

“Dietary fibre has emerged as a crucial yet underappreciated part of hypertension management,” she said.

“Our comprehensive analysis emphasises the evidence supporting the effectiveness of dietary fibre in lowering blood pressure and reducing the risk of cardiovascular events.”

The findings of the review have significant implications for public health initiatives and future hypertension guidelines.

By recognising the vital role of dietary fibre, healthcare professionals can take proactive steps to address hypertension and promote cardiovascular health.

The study found that a higher intake of dietary fibre is associated with a significant reduction is systolic acid and diastolic blood pressure, independent of pharmacological interventions. Each additional 5 grams of fibre per day is estimated to reduce systolic blood pressure by 2.8 mmHg and diastolic blood pressure by 2.1 mmHg.

The review also provides resources for medical teams and patients of what foods to prioritise to increase fibre intake and reach their recommendations.

“Our study highlights the urgent need for healthcare providers to prioritise dietary fibre as vital for hypertension management,” Associate Professor Marques said.

“By incorporating dietary fibre into treatment plans and empowering patients to increase their intake, we can significantly reduce the burden of hypertension and improve cardiovascular outcomes.”

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In Alzheimer’s disease, protein clusters known as ‘amyloids’ accumulate to abnormally high levels in the brain. Distinct amyloids have been associated with the onset of various neurodegenerative diseases, including Alzheimer’s and Parkinson’s disease.

As such, the swift detection and recognition of different amyloids in the brain is crucial for early diagnosis of amyloid-related neurodegenerative diseases.

In this study, completed by a team led by Dr Amandeep Kaur, ARC DECRA Fellow at the Monash Institute of Pharmaceutical Sciences (MIPS) and Professor Elizabeth New and Professor Margaret Sunde from The University of Sydney, the team reports the development of an array of fluorescent sensors with the ability to correctly differentiate between different amyloids associated with neurodegenerative diseases and, therefore, monitor disease progression.

The team also tested the sensors’ performance on samples taken from the brains of mouse models of Alzheimer’s disease and observed that the fluorescence patterns differed between early (at age 6 months) and later (at age 12 months) stages of the disease.

Dr Kaur said although there are several methods for detection of amyloids, they are far from perfect and there is a lot of work to be done to develop methods for earlier and accurate diagnosis of Alzheimer’s disease and other types of dementia.

“Alzheimer’s is an irreversible neurodegenerative disorder; however, there are many advantages to early detection including enhanced medical attention, management of symptoms and, hopefully, future treatments that will be able to target the disease in its earliest stages, before irreversible brain damage or cognitive decline has occurred,” said Dr Kaur.

Dr Kaur, Professor New and Professor Sunde collaborated to develop a solution to this pressing need, bringing together their expertise in chemistry, fluorescent sensors and amyloid biology.

“Our team focused on developing a versatile fluorescent sensor array for amyloids to monitor Alzheimer’s and other disease progression and to distinguish these disease-associated amyloids from similar, naturally occurring amyloids that play functional roles,” said Dr Kaur.

“It is our hope this method, using an array of sensors that can light up amyloids, could be used as a tool for researchers to help distinguish between many different types of amyloids and could inform new strategies for early and decisive diagnosis of amyloid-related diseases.”

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This level of sleep deprivation increases the risk of serious injury or fatality in safety critical situations.

Published in Science Advances, the biomarker used a combination of markers found in the blood of healthy volunteers. Together, these markers accurately predicted when the study volunteers had been awake for more than 24 hours under controlled laboratory conditions.

The biomarker detected whether individuals had been awake for 24 hours with a 99.2 percent probability of being correct, when compared to their own well-rested sample. When a single sample was considered without the well-rested comparison (similar to a diagnostic blood test), it dropped to 89.1 per cent, which was still very high.

With about 20 per cent of Australia’s road accidents caused by sleep deprivation, researchers hope the discovery may inform future tests to quickly and simply identify sleep deprived drivers. The biomarker could also be developed for other situations where sleep deprivation may lead to catastrophic consequences, such as in safety-critical workplaces.

Senior author Professor Clare Anderson led the research while she was with the Monash University School of Psychological Sciences and Turner Institute for Brain and Mental Health. She is now Professor of Sleep and Circadian Science at the University of Birmingham in the UK.

“This is a really exciting discovery for sleep scientists, and could be transformative to the future management of health and safety relating to insufficient sleep,” Professor Anderson said. “While more work is required, this is a promising first step.

“There is strong evidence that less than five hours’ sleep is associated with unsafe driving, but driving after 24 hours awake, which is what we detected here, would be at least comparable to more than double the Australian legal limit of alcohol performance wise.”

The test may also be ideal for future forensic use but further validation is required.

First author Dr Katy Jeppe, from the Monash Proteomics and Metabolomics Platform, previously from the School of Psychological Sciences, said it was difficult to say how soon the test could be developed for post-accident use.

“Next steps would be to test it in a less controlled environment and maybe under forensic conditions, particularly if it was to be used as evidence for crashes involving drivers falling asleep,” Dr Jeppe said.

“Given it’s blood, the test is more limited in a roadside context, but future work could examine whether our metabolites, and therefore the biomarker, are evident in saliva or breath.”

This sleep deprivation biomarker is based on 24 hours or more awake, but can detect down to 18 hours awake. A biomarker for limited sleep over the previous night could be developed but more research is required to combine the time since sleep with the amount of sleep in the predictions.

“Much further work would be needed if laws were to change and a sleep deprivation test introduced on the road or in workplaces,” Dr Jeppe said. “This would include further validation of biomarkers, as well as establishing safe levels of sleep to prevent and recover from impairment, not to mention the extensive legal process.”

“A biomarker for limited sleep over the previous night could be developed, and others have made progress in this respect (Depner et al.).”

Sleep deprivation can have fatal consequences for other safety-critical occupations. Major catastrophes including the Chernobyl nuclear reactor meltdown and the Challenger space shuttle Disaster* are thought to be caused, in part, by human error associated with fatigue.

“Objective tests that identify individuals who present as a risk to themselves or others are urgently needed in situations where the cost of a mistake is fatal,” Professor Anderson said.

“Alcohol testing was a game changer for reducing road crashes and associated serious injuries and fatalities, and it is possible that we can achieve the same with fatigue. But much work is still required to meet this goal.”

This research was conducted in association with the Cooperative Research Centre for Alertness, Safety and Productivity.

 *Report of the Presidential Commission on the Space Shuttle Challenger Accident. II. Washington, DC: U.S. Government Printing Office; 1986. Appendix G Chernobyl: International Nuclear Safety Advisory Group. Summary report on the post accident review meeting on the Chernobyl accident (25–29 August, 1986; Vienna, Austria). International Atomic Energy Agency, November 1986. ISBN #92-0-123186-5

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 SoundSmiles app project lead, health technology researcher and proud Wadjak/Ballardong Noongar man Associate Dean (Indigenous) Professor Christopher Lawrence from Monash University’s Faculty of Information Technology (IT) said Aboriginal children experience ear disease and hearing loss at rates at least ten times higher than non-Aboriginal children.

“The impacts of ear disease can drastically change the trajectory of a child’s life. Young people who have hearing loss are more likely to experience social and emotional problems,” Professor Lawrence said.

Researchers and clinicians from Monash University, the Ear Science Institute Australia and Curtin University co-designed the culturally sensitive SoundSmiles app along with Western Australia-based Aboriginal medical services organisations Puntukurnu Aboriginal Medical Service (PAMS) and South West Aboriginal Medical Service (SWAMS).

As detailed in the SoundSmiles report released this year, primary school-aged children can be guided by their teachers to answer daily questions about their hearing and mental health, through the app.

The app also aims to provide information and engage the students in activities related to their ears and wellbeing in order to raise their awareness regarding these important aspects of their health.

Professor Lawrence said SoundSmiles capitalises on the increasing use of mobile technologies by children in Aboriginal communities.

“The kids enjoy using tablets and, through the SoundSmiles app, they’ll learn skills and develop better connections with expert services which impact their ear and mental health positively,” Professor Lawrence said.

 Ear Science Institute Australia CEO Adjunct Associate Professor Sandra Bellekom said it is vital that Western Australia takes practical steps given the influence ear health has on mental health in Aboriginal communities.

“We are proud at Ear Science to bring together our strong links with the Pilbara and Southwest community and our links across academia to co-create inventive solutions that will improve quality of life for Indigenous children. Research that has real-life impact is our mission,” Associate Professor Bellekom said.

“This unique, cross-disciplinary collaboration of researchers and remote health, education and community workers can make a real difference. We thank the Chief Executive Officers of PAMS and SWAMS, Robby Chibawe and Lesley Nelson, respectively, for their support and contribution.”

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