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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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

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Community pharmacists are in a prime position to raise awareness around the risk factors for heart disease, along with promoting healthy lifestyle strategies that support a healthy heart.

Heart disease is the leading cause of death in Australia.

“One person dies in this country every 12 minutes due to heart disease,” said Professor Stephen Nicholls, Program Director at Victorian Heart Hospital, Monash Heart and Intensive Care, Director at the Victorian Heart Institute, and President of the Cardiac Society of Australia and New Zealand. “More than 50,000 Australians have a heart attack each year [and] the risk will increase with age.”

With statistics such as these, it’s well understood that for community pharmacists, promoting heart health measures should be a priority.

So, what can be suggested to customers looking for advice about heart health?

“A lot of heart disease is preventable, even if you have a strong family history,” Professor Nicholls said, adding that “lifestyle is key” and the advice should be: “watch what you eat, exercise regularly, and no smoking”.

He also points to the importance of regular blood tests and heart checks.

“Know your numbers,” he said, referring to cholesterol, blood pressure, and blood sugar levels. “We can’t treat them if we don’t know them.”

Diet and heart health 

Associate Professor Lisa Moran, Head of the Lifestyle Research Program at Monash University, says the “main nutrition recommendation to prevent heart disease is to follow a heart-healthy eating pattern”.

“This means choosing foods that are naturally low in saturated and trans fats, rich in unsaturated fats, and rich in wholegrains, fibre, and antioxidants, such as vegetables, fruits, wholegrains, nuts and seeds, fish and seafood, and smaller amounts of healthy protein,” she said, adding that it’s also important to limit salt and processed sugar intake.

Heart Foundation recommendations for a healthy diet to prevent heart disease also include limiting processed meats, limiting lean red meat [intake] to one to three times per week, and choosing regular or reduced-fat milk, cheese, and yoghurt, Professor Moran says.

“Replace saturated fats with unsaturated fats, limit trans fats, and aim to increase omega-3 intake by two to three serves of fish per week,” she said.

Associate Professor Moran points to coconut oil as being high in saturated fat – “although it’s a slightly different type of saturated fat from that found in animal foods”.

“There’s no evidence to support the consumption of coconut oil for heart health,” she said. “Coconut oil has been shown in clinical trials to result in higher total cholesterol and LDL, or bad cholesterol.”

What’s the best diet for heart health? 

Customers seeking advice from a community pharmacy on improving heart health may ask about different types of diets. Given the recent popularity of different diets purported to offer various health benefits, community pharmacists need to be across these diets to give sound advice.

Diets often recommended for improving heart health include the Mediterranean, DASH (‘Dietary approaches to stop hypertension’), and MIND (Mediterranean-DASH intervention for neurodegenerative delay’) diets. Intermittent fasting is also often recommended.

Associate Professor Moran says these diets are “generally consistent with the Australian Dietary Guidelines and provide the recommended amounts of core food groups – fruit, vegetables, breads and cereals, protein-rich foods and dairy foods or alternatives – while reducing the amounts of discretionary foods, or processed foods high in added fat, salt, and sugar”.

“These are all healthy alternatives that people could follow to improve their heart or blood vessel health,” she said.

“The Mediterranean diet contains lots of plant-based foods, such as wholegrains, vegetables, legumes, fruit, nuts, seeds, herbs and spices, and olive oil, which are the foundation of the diet. Fish, seafood, dairy, and poultry are included in moderation. Olive oil, nuts, and seeds provide unsaturated fat, and fish provides polyunsaturated fat.”

Associate Professor Moran says the DASH diet “reduces your dietary intake of sodium, which reduces blood pressure and improves heart health, and increases your dietary intake of potassium, calcium, and magnesium, which helps to control blood pressure”.

“The MIND diet is a combination of both [Mediterranean and DASH], which emphasises healthy foods from both these approaches to slow cognitive decline and dementia,” she said.

Regarding intermittent fasting and its heart health benefits, Associate Professor Moran says the research here is more limited compared with the other dietary approaches.

“Currently, the research indicates that intermittent fasting is one option for achieving weight loss, but that it generally isn’t more effective than non-fasting approaches to lose weight – that is, continuous energy restriction or reducing your energy intake by a smaller amount each day,” she said. “Some people may find it a useful structure to achieve a reduced energy intake and help them lose weight, but others may equally prefer other more traditional strategies.”

Combining diet and exercise 

Exercise is another important lifestyle factor for those thinking about heart health. According to the Department of Health and Aged Care, adults aged 18-64 years should aim for “2.5 to 5 hours of moderate-intensity physical activity each week [or] 1.25 to 2.5 hours of vigorous-intensity physical activity each week [or] an equivalent combination of moderate and vigorous activities”.

We know eating healthily and exercising are beneficial for heart health, but with so much information presented about various dietary approaches, such as intermittent fasting and time-restricted eating (TRE), and exercise regimes such as high-intensity interval training (HIIT), what’s the best combination?

Looking specifically at TRE and HIIT, a new randomised controlled trial published in the journal Cell Metabolism has found that combining the two approaches improves long-term glycaemic control and has a greater effect on fat reduction – both in fat mass and visceral fat.

“Isolated TRE and HIIT have received increasing attention for being effective and feasible strategies for at-risk populations,” said senior author Trine Moholdt, Head of the Exercise, Cardiometabolic Health and Reproduction Research Group at Norwegian University of Science and Technology.

“We wanted to compare the effects of the combination of TRE and HIIT with their isolated effects and to determine whether TRE and HIIT would act synergistically in improving health in individuals with risk for cardiometabolic disease. This finding highlights the importance of changing both dietary and physical activity habits for individuals who wish to rapidly improve their health and lower their disease risk.”

Within the study, the interventions lasted seven weeks. Several measures were taken, both before and after the study, including the participants’ blood pressure, body mass index, blood fat, and cholesterol levels, and several measures of blood glucose and insulin levels.

The researchers found that the participants who combined TRE and HIIT were able to improve their average long-term glycaemic control. They were also able to effectively reduce fat mass and visceral fat and increase their cardiorespiratory fitness. However, there were no statistically significant differences in blood lipids, appetite hormones, or vital signs after any of the interventions, compared with the control group.

“High adherence rates are important,” said another of the study’s authors, Kamilla La Haganes, a PhD student at NTNU. “Adherence rates to general lifestyle recommendations are low, and our diet-exercise strategies may serve as an alternative.”

After the study was completed, 18 participants from the control group also chose to try one of the study’s interventions.

“We recommend this kind of program for people who wish to have a relatively simple way of changing diet and exercise habits and improving their health,” Ms Moholdt said. “TRE is a less tedious and time-efficient method to lose weight compared with daily calorie counting, and HIIT is tolerable and safe for previously sedentary individuals and can be completed within 30 to 40 minutes.”

According to the study authors, a limitation of the study was that the intervention period was only seven weeks. They say longer-term investigations are needed to determine effects and feasibility for longer periods of time. The study also took place during Covid-19 lockdowns, which affected the participants’ lifestyles and could have influenced the results.

The researchers are inviting the participants back for follow-up testing two years after they completed the study, to check whether they have continued with the interventions. The researchers also plan to determine whether the combination of TRE and HIT will induce the same health benefits and have equally good adherence rates in a completely home-based setting. That study will include both men and women.

“Together, these two new studies will tell us more about the long-term feasibility and also the possibility for implementation in a real-world setting,” Ms La Haganes said. “Additionally, we can investigate if there are any sex differences in response to these interventions.”

 This feature was originally published in the November issue of Retail Pharmacy magazine.

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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.”

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