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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Developed by researchers at Flinders University with support from Breast Cancer Network Australia and Cancer Council SA, Finding My Way – Advanced is designed to support people through stage 4, also known as advanced metastatic breast cancer, which is a treatable but currently incurable form of the disease.

Program developer and clinical psychologist Associate Professor Lisa Beatty from Flinders University’s College of Education, Psychology and Social Work says that while metastatic breast cancer can’t be cured, improvements in medicine can help keep the cancer under control and have thankfully led to many people living longer, in some cases more than 10 years.

“This gives rise to a unique situation where someone can live for a reasonably long time following their diagnosis but alongside this, they also have to live with the uncertainty that the cancer may progress at any point,” says Associate Professor Beatty.

“Our program is designed to help them through this journey, from navigating the healthcare system and their treatment, through to providing coping strategies for the physical, emotional and social changes that an individual may experience.

“Our ultimate goal is to help people come to terms with living with advanced or metastatic breast cancer as a chronic condition, but more important to be able to live well with it.”

Initially developed over ten years ago, a different version of the program, Finding My Way, was designed to support those with a diagnosis of all forms of early-stage cancer, with that program now freely available in Australia, and also adapted by health services in England, Europe and the US.

“While that initial program has had a positive impact, we realised the materials weren’t suited for those with an advanced stage diagnosis and we were missing the opportunity to support an important part of the cancer community,” says Associate Professor Beatty.

“People with metastatic cancer are often overlooked when it comes to support services, so we wanted to create something that was targeted to their unique circumstances.

“We’re starting with advanced breast cancer for this trial, but our hopes are to also tailor the program to other advanced cancers in the future.”

Thanks to funding from Cancer Australia, Associate Professor Beatty and her team are now undertaking a large study to test the effectiveness of Finding my Way – Advanced, in hopes it too can be made freely available.

Currently the support service is only available to those enrolled in the study, but recruitment is still underway, with the researchers inviting those interested in using the program to get in touch (further details below) or enrol directly via the website: www.findingmywayadvanced.org.au.

Delivered online, with people able to access it in the privacy of their own home and at their own pace, the program contains cognitive behavioural therapy, alongside relaxation and mindfulness techniques and writing exercises.

There are six modules available;

1. Navigating healthcare
2. The unique challenges: (particularly living with fear of progression and uncertainty)
3. Physical symptoms
4. Emotional distress
5. How you see yourself
6. Your family and friends: How to build a support network and also support your loved ones and children

“Finding my Way – Advanced provides a wealth of information to the individual following their diagnosis but beyond that it includes evidence-based strategies to help them through this difficult time in their life,” says Associate Professor Beatty.

“Initial feedback from users has included finding the program helpful and relatable, easy to use, and of high quality. The online aspect has been particularly valued as it is convenient, accessible at any time, and enables women to self-pace their progress; ‘If I didn’t want to finish that module, I didn’t have to so I could go out and then come back in later ‘.”

“As medicine continues to advance and more people live with these incurable cancers for longer, this population will only continue to grow, and we need to ensure they are well supported with evidence-backed services that are easily accessible.”

BCNA Director of Policy, Advocacy and Support Services Vicki Durston said this online program is a much-needed tool for those who have been diagnosed with metastatic breast cancer, and provides support on diagnosis, treatment and living well.

“I’d really like to acknowledge the two BCNA Consumer Representatives, who are living with metastatic breast cancer, who were advisers on the design of the resource,” Ms Durston said.

“BCNA has been proud to be part of this long-standing research partnership with Flinders University on a project that will have a significant impact for people living with metastatic breast cancer.”

Cancer Council SA’s General Manager, Support and Research Dr Peter Diamond says, “Cancer Council SA is proud to have supported development of Finding My Way and now Finding My Way – Advanced. This tailored and unique program is so important to support people to live well, understand treatments and cope with the challenges of an advanced metastatic breast cancer diagnosis.”

For more information or to join the trial go to www.findingmywayadvanced.org.au or contact the Study Coordinator Ms Morgan Leske on morgan.leske@flinders.edu.au or findingmyway@flinders.edu.au. Criteria includes that participants must be aged over 18, have a diagnosis of stage 4 or metastatic breast cancer, the ability to access a computer and a reasonable understanding of English.

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The announced prescribing trial for the treatment of UTIs is set to begin on 1 April 2023, with a trial for the renewal of oral contraceptive pill prescriptions to begin on 1 July 2023 and allow pharmacists to extend an original script issued by a GP or nurse practitioner in the past 2 years.

PSA NSW President Chelsea Felkai said that the pilot will significantly improve access to timely care for NSW patients, and reaffirmed PSA’s support for the program.

“Pharmacists are well-positioned to deliver quality, timely care to NSW patients experiencing uncomplicated Urinary Tract Infections,” Ms Felkai said.

“Congratulations to PSA NSW Vice-President Dr Sarah Dineen-Griffin and the University of Newcastle for her work in getting the UTI clinical trial up and running.

“Pharmacists participating in the pilot program will undergo additional training, including identifying signs of complex health conditions that require a referral to a GP or hospital.

“Trained Queensland pharmacists have been successfully prescribing for uncomplicated UTIs since 2020, giving patients timely access to medicines in an environment where it could otherwise take up to six weeks to get a GP appointment.

“The GP crisis shows no signs of easing, so we need every healthcare professional to be working to their top of scope and contributing to their full capacity.

“We have a health system that is approaching breaking point. The health profession needs to work together to support patients as their health needs become more complex. This includes reducing duplication and empowering patients with self-care.

“The entire pharmacist profession remains committed to working collaboratively with the entire health sector to deliver best outcomes for patients.”

PSA National President, Dr Fei Sim, also commended the NSW Government on this announcement, and called on other jurisdictions to follow suit.

“PSA has been calling on governments around Australia to allow pharmacists to play a greater role in community health.

“Pharmacists have the skills and medicine expertise to renew prescriptions for stable, chronic conditions. With ongoing GP shortages across the country, it is time for other jurisdictions to follow NSW’s lead.

“We are already working with pharmacists in NSW and around the country to provide clinical support and treatment guidelines for pharmacists to treat Urinary Tract Infections, and will continue to support patients getting timely access to healthcare.”

Text By: The Pharmaceutical Society of Australia

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The team at Neuroscience Research Australia (NeuRA) will conduct the trial with aim to support people living with mild to moderate dementia and manage their diagnosis, as well as educating loved ones.

There are more than 500,000 people in Australia with dementia, and 250 new diagnoses each day, with that number expected to rise to over 300 per day within the next five years.

“Our aim with SHAPE is to provide individuals with early dementia, and their families, with access to knowledge and support, so they are better able to manage their own health and wellbeing, and the changes that occur,” says Senior Principal Scientist at NeuRA and Director of UNSW Ageing Futures Institute, Professor Kaarin Anstey.

Results from previous research show self-management groups are beneficial for people with early-stage dementia. However, this intervention has never been conducted online.

What the trial involves

Participants in the trial will either receive a ‘SHAPE intervention’ or a control.

The intervention involves an online group session once a week for 10 weeks, where each participant will be given an easy-to-use iPad to join these sessions. Additionally, family members and friends will access to an e-learning programme.

People in the control group will receive a placebo programme but will have access to the official e-learning programme, containing the study materials, after the trial is complete.

For more information on the trial and for those who fit the criteria, visit neura.edu.au/project/shape.

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This comes from an EU funded study presented at the 6^th World Congress of Paediatric Gastroenterology, Hepatology and Nutrition.

It’s the first study to examine the long-term effect of maternal supplementation with fish oil and/or 5-MTHF (folic acid) on resting state functioning – when a person is not engaged in a cognitive or active task – in school-age children.

“The results demonstrate that the quality of maternal nutrient supply during the period of rapid early brain development in pregnancy, has a lasting impact on later brain function at school age,” Professor Dr Berthold Koletzko, Head of Metabolic and Nutritional Medicine at Dr von Hauner Children’s Hospital says.

“Women before and during pregnancy should therefore be supported in achieving a good quality diet and be counselled on potential fish oil supplement use.”

Coordinator of the study and Director of the EURISTIKOS Excellence Centre for Paediatric Research at the University of Granada, Spain, Professor Christina Campoy adds: “Our research provides evidence that children born to mothers who had taken fish oil during the second half of pregnancy had improved memory.”

The study  

The study followed up on 57 children of mothers from a previous research programme who had been given 500mg of docosahexaenoic acid (DHA) and 150mg of eicosapentaenoic acid (EPA) fish oils per day.

This was either with or without 400 micrograms of 5-MTHF (folic acid), folic acid alone, or placebo during the second half of their pregnancies.

“The results from this study indicated that early nutrition during pregnancy can have a significant impact on brain development in children, with the potential to enhance cognitive performance,” Professor Magnus Domellof, Chair of ESPGHAN Nutrition Committee says.

“We look forward to the outcomes of the study being tested in further trials.”

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The Frailty, Ageing and Inflammation Trial for Health (FAITH) is being led by the School of Population Health at UNSW Sydney, Neuroscience Research Australia (NeuRA), and the Microbiome Research Centre (MRC), St George & Sutherland Clinical School.

Meeting dietary guidelines can become more challenging with ageing and in particular lower fruit, vegetable and fibre intakes are observed, which leads to a reduction in the production of beneficial short chain fatty acids.

Short chain fatty acids are important in influencing the microbiome. In the absence of these fatty acids, the body is unable to dampen down inflammation, which may promote the onset of age-related illnesses.

“Diet plays a fundamental role in shaping the gut microbiome, and diet and nutritional status are among the most important, modifiable determinants of human health.

“It is exciting that we are starting to understand the links between brain, body and gut health,” says lead investigator Dr Adrienne Withall.

The FAITH study will provide valuable information about whether key nutrients can improve low grade inflammation and affect the microbiome in older Australian adults.

The hypothesis underlying this research has come from over 18 years of clinical experience from dietitian, Milena Katz.

This research is the focus of Milena’s PhD and she approached a major Australian supplement provider to see if they would donate the products to enable her to test her theory.

“They liked our proposed trial and agreed to donate their supplements. Now we need people to get involved,” says Ms Katz.

“Importantly, this information will help to inform medical dietary therapy to help older people to age well.”

The call for participation comes at a time when good nutrition has become a focus for older Australians as the The Royal Commission into Aged Care Quality and Safety’s final report is publicly released.

Participation in the FAITH trial involves a biological sample collection at the start and end of the trial, completing surveys and taking nutritional supplements for four months.

All participants enrolled in the study receive a four months’ supply of dietary supplements, regular monitoring and dietary advice.

The participants allocated into the control group will receive the intervention supplements after the trial is completed.

To find out more about the trial, contact study coordinator Milena Katz at m.katz@unsw.edu.au. 

For more information about MRC’s work, visit: microbiome.org.au/

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The REMAP-CAP trial looked at the effect of treatments on a combination of survival and length of time patients need support in an ICU.

The results show that treatment with the immune modulator, tocilizumab met an efficacy endpoint among critically ill patients with severe Covid-19, compared to patients who did not receive any immune modulation treatment.

Though the relative contribution of survival and reduced length of time needing organ support in ICU has not yet been analysed, the trial showed that patients receiving tocilizumab were more likely to improve compared to patients who received no immune modulator.

However, it is not yet known what the relative benefits of this medication are compared to other immune modulators. Data on this is expected in the coming weeks and months.

While the findings are yet to be peer-reviewed and published, due to the clinical implications for patients, the researchers have released findings and are now working to analyse and publish the full results as soon as possible.

“These early findings show that treatment with this immune-modulating drug [tocilizumab] is effective for critically ill Covid-19 patients in intensive care units,” says Professor Steve Webb, an intensive care specialist and Professor of Critical Care Research at Monash University – the global coordinating centre for the trial, which has been supported by the Minderoo Foundation and the National Health and Medical Research Council (NHMRC).

“When we have the results available from all participants, we hope our findings will offer clear guidance to clinicians for improving the outcomes of the sickest Covid-19 patients.”

Dr Lennie Derde, a consultant in Intensive Care Medicine at the University Medical Centre in Utrecht, the sponsor of the study in Europe, and the Immune Modulation Domain Specific Working Group Chair says that “this is an absolutely amazing result”.

“To have a second effective therapy for critically ill patients within months of the start of the pandemic is unprecedented,” continues Dr Derde.

“Specific targeting of the immune response is theoretically attractive, and now we have shown it works.”

With Minderoo a proud support of the REMAP-CAP trial, Dr Steve Burnell who leads Minderoo Foundation’s Covid-19 response says that “these latest findings … represent the second effective therapy for patients with serious Covid-19”.

“REMAP-CAP’s agility and flexibility are what makes it so innovative – its design enables researchers to collaborate, test and share data quickly.

“Australia is fortunate to currently have so few Covid-19 cases, but the pandemic continues to have a devastating impact in many countries.

“These latest results will ensure more critically ill patients around the world receive the life-saving treatments they need and, importantly, avoid treatments that do not help.”

About the trial

The REMAP-CAP trial began investigating treatments for Covid-19 in March 2020, enrolling hospitalised patients with either moderate or severe (requiring ICU care) Covid-19 disease.

The study design randomises patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for Covid-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body’s response to the virus.

In total, more than 2,000 patients in 15 countries have been enrolled at more than 260 hospitals worldwide and randomised to multiple treatment combinations.

The effects of interventions are assessed separately for moderate and severely ill patients.

For more about the REMAP-CAP trial, visit: remapcap.org.

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Common treatments, which include non-steroidal, anti-inflammatory medications, have only mild to moderate effects and are associated with adverse events.

As such, there is a need for safer and more effective options to treat this debilitating condition.

In response to this, a new Australian-led study has shown that turmeric extract may help to combat pain in people with osteoarthritis.

The small trial of 70 patients compared the extract to placebo and found it modestly but statistically significantly reduced knee pain over 12 weeks.

After 12 weeks, they found that patients taking the turmeric supplements reported less pain than those in the placebo group with no adverse events.

The randomised, double-blind, placebo-controlled trial, published in the Annals of Internal Medicine, also found that those in the turmeric group also took fewer pain killers than those in the placebo group.

However, the researchers note that due to the modest effect of the turmeric extracts on knee pain, small sample size of the study, short duration of follow-up and the single research centre, multi-centre trials with larger sample sizes and long duration of follow-up are needed to assess the clinical significance of their findings.

While more research is needed, turmeric may be a safe, viable option to ease the pain of those with osteoarthritis.

To read the research, visit: acpjournals.org/doi/10.7326/M20-0990

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This is a win for the Pharmacy Guild as it has been lobbying for broader pharmacist scope of practice.

The Urinary Tract Infection Pharmacy Pilot – Queensland (UTIPP-Q) trial’s drug therapy protocol allows a pharmacist, in the interests of participating in the trial, to dispense certain restricted drugs without the requirement for a script or purchase order, subject to the restrictions listed for it and in accordance with the treatment protocol established under the UTIPP-Q.

The trial has been implemented as part of the state government’s response to the inquiry into the establishment of a pharmacy council and transfer of pharmacy ownership in Queensland.

Participating pharmacists will be able to sell and supply Trimethoprim; or Nitrofurantoin if Trimethoprim is not appropriate for the patient; or Cefalexin if Trimethoprim and Nitrofurantoin are not appropriate for the patient where they feel the restricted drug is essential to a woman’s wellbeing.

“Before selling and supplying a restricted drug under this drug therapy protocol, the pharmacist must advise the client of the contra-indications and known side effects of the drug,” according to the protocol.

“If the supply of one of the restricted drugs specified in this drug therapy protocol is not an appropriate treatment option (for example, due to contraindications), then the pharmacist has the option to supply one of the other two drugs.

“However, the pharmacist must refer the client to a medical practitioner if the referral criteria is met or all three drugs are inappropriate.”

Pharmacists may not sell and supply a restricted drug specified in this protocol in quantities that are more than a single manufacturer’s pack of the restricted drug, and drugs must be correctly labelled and appropriate records kept.

Participating pharmacists are expected to have completed training to participate in the trial, to record data in the GuildCare NG UTIPP-Q recording module, and to maintain their eligibility to participate.

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These recommendations are based on evidence that aerobic exercise improves fitness in general, and in Type 2 Diabetes, leads to better blood glucose control, which can be very beneficial.

However, the ‘one-size-fits-all’ approach is not appropriate for these recommendations due to the variability in weight loss and glucose benefit in response to exercise in adults with Type 2 Diabetes.

What the trial involves

The first step involves, one group initially being asked to perform 150 minutes per week of aerobic exercise for 8 weeks, based on participants preferences (either jogging, cycling, walking or swimming).

Depending on health responses (specifically, change in body weight and change in glucose control), the participant may be asked to undertake step two.

Step two is 8 more weeks of exercise at a higher level, and again, depending on step two, the participant may be asked to progress onto step three.

Where: these assessments will be conducted at the School of Human Movements and Nutritional Sciences at UQ’s St Lucia campus.

Participant benefits

Participants will receive the following free benefits:

• Personalised training program
• Expert advice from Allied Health Professionals
• Body composition assessment
• FITBIT Charge 3 smartwatch (valued at $189)
• Fitness test
• Heart health
• Blood vessel assessment
• Parking at The University of Queensland for the days of the assessments.

Eligibility:

Males or female aged 25-69, confirmed type 2 diabetes (HbA1c ≥ 6.5%), waist circumference ≥ 80cm for women and ≥ 94cm for men, own a smartphone and to be willing to wear a Fitbit activity monitor for the duration of the study.

Register interest:

Klaus Jungbluth at k.jungbluthrodriguez@uq.net.au

Shelley Keating at s.keating@uq.edu.au

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