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NHS rolls out wearable for advanced Parkinson’s



Hundreds of NHS patients with advanced Parkinson’s disease are set to benefit from a wearable drug infusion to help better control their symptoms.

The treatment, called foslevodopa–foscarbidopa, is gradually released around-the-clock, and will now offer an additional option for certain patients experiencing movement-related symptoms and whose condition is no longer responding to their oral medicines.

The easy-to-use infusion is delivered through a cannula under the skin and controlled by a small automatic pump worn 24 hours a day to help steadily manage patients’ symptoms with fewer side effects.

It works by releasing a combination of medications into the body, with the drug foslevodopa being turned into the chemical dopamine, which can better transmit messages between the parts of the brain and nerves that control movement.

The new treatment option is being rolled out on the NHS in England over the coming weeks (from 27 February) and it is expected that nearly 1,000 patients will be eligible across the country.

Many Parkinson’s patients currently take large numbers of tablets to control their symptoms – sometimes more than 20 a day – which can be difficult to maintain.

People taking medicine this way often report that the peak of their whole day is in the morning and despite taking more tablets they go ‘downhill’ throughout the day.

It can also be a challenge for patients taking these pills to balance symptom control with side-effects, with some patients including impulse control disorders and excessive movement.

Tablets can also lose their effects in the middle of the night, meaning patients can wake up with symptoms and may not be able to get out of bed to go the toilet without risking a fall.

However, by infusing this new drug formula throughout the day and overnight, symptoms can be more steadily managed – with patients also having the option to manually give themselves a boost in dose at any point during the day if needed.

James Palmer, NHS England’s Medical Director for Specialised Services and a Consultant Neurosurgeon, said: “This is great news for hundreds of patients who are living with an often difficult and debilitating condition.

“This important therapy will now offer a vital new option on the NHS for those who aren’t suitable for other treatments such as deep brain stimulation, and we hope it will help nearly a thousand patients to manage their symptoms more effectively and go about their day with a better quality of life.”

Parkinson’s is a condition in which parts of the brain become progressively damaged over many years and it affects around 128,000 people in England.

Foslevodopa-foscarbidopa will now offer an additional treatment option to patients living with advanced Parkinson’s disease who have developed severe motor fluctuations and who are no longer benefitting from other oral treatments but whose condition has been found to respond to the drug levodopa.

Since 2015, NHS England has offered a similar but more invasive treatment where the drugs needed to be delivered into the gut by a permanently placed feeding tube. The new device being rolled-out across the country is small and completely portable, with the infusions taking place under the skin. The easy to fit and remove drug vial normally needs to be changed once a day and the cannula is changed every three days, which can be done at home by patients or their carers.

John Whipps, 70, from Looe, Cornwall, was among those who took part in clinical trials which found that the treatment was safe and effective.

John said: “It’s absolutely wonderful that more people can get this drug now. Compared to the previous treatments it really is like chalk and cheese.

“Before this, I was on nearly 20 tablets a day just for my Parkinson’s symptom control, and then all the other tablets on top of that. And I would frequently wake in the middle of the night with internal tremors and take more tablets, but this pump just keeps running through the night.

“I couldn’t plan to do anything, as you don’t know if you’re going to have an off day and need to stay at home.

“So this pump has made life much more plan-able. It’s just one pump change a day you need to factor in, compared to the constant regime of tablets at different times a day.”

Health Minister Maria Caulfield, commented: “This is fantastic news for the hundreds of people in this country who live with advanced Parkinson’s. The symptoms of this disease can be incredibly debilitating, and this therapy will enable people to manage their condition more evenly throughout the day and reduce the side effects of medication.

“This rollout also reinforces the NHS’s collective ability to tackle the big medical challenges of our time and is evidence of the government’s commitment to using technology to deliver faster, simpler and fairer health outcomes for all.”

Laura Cockram, head of Campaigns at Parkinson’s UK, added: “Parkinson’s disease is the fastest growing neurological condition in the world, and it affects everyone differently. Foslevodopa-foscarbidopa (Produodopa) could be a life-changing option for those whose symptoms are not well controlled by oral medication.

“There are very few advanced treatments for the condition, so we are delighted another one is available. The infusion means people will be able to better manage their symptoms and could potentially have a big impact on families’ lives.

“It won’t be suitable for everybody though, and people with Parkinson’s should speak to their consultant or Parkinson’s nurse to see whether it’s an option for them.”



Increased mortality in countryside compared to city



Increased mortality in countryside compared to city

A new study of nearly a million emergency admissions in Norway has found increased mortality in the elderly who live in the countryside compared to those that live in the city.

Research shows that elderly people living in rural areas have higher mortality rates if they are discharged to a municipality under pressure. Additionally, the research found that elderly people over the age of 70 who live in a municipality with fewer than 10,000 inhabitants are particularly vulnerable.

The research has been carried out in light of the growing population in Norway which is set to see 250,000 more Norwegians over the age of 80.

The study

Gudrun Maria Waaler Bjørnelv, associate professor of Health Economics at NTNU, is concerned that municipal authorities in Norway may not be prepared for an ageing population.

Working with a research team from NTNU, St. Olavs Hospital, Trondheim Municipal Authority and SINTEF, Bjørnelv has studied all Norwegians over the age of 70 who were admitted to emergency departments from 2012 to 2016, which amounted to just over 350,000 people.

This group of elderly people had almost 900,000 emergency hospital admissions during this period. The researchers followed them for 30 days after the day they were admitted.

Nursing and care services that were under pressure led to increased mortality in elderly who were under their care, and that elderly people in small municipalities had the highest mortality rate.

A small municipality was defined as having fewer than 10,000 inhabitants. According to Statistics Norway, 70% of Norwegian municipalities in 2016 had fewer than 10,000 inhabitants. In total, 17% of the population lives in a small municipality.

Bjørnelv stated: “Previously, it was thought that small municipalities do better than large municipalities, because they have fewer patients in hospitals waiting to be discharged to the municipal services.

“Our findings, however, indicate that small municipalities are more vulnerable during periods when the demand for nursing and care services is higher than the municipality can supply.”

“We need to take a closer look at the municipal services, and it needs to happen now.”

Bjørnelv points out that small municipalities may experience more pressure regarding demand for available nursing home places and health professionals.

“This may make them more vulnerable to fluctuations and pressure on health services,” Bjørnelv said.

To investigate how mortality rates among patients changed, the researchers relied on information regarding the amount of pressure individual municipalities were under.

“If there is a build-up of patients who are ready to be discharged from hospital to one municipality, this suggests that the municipal services such as home care and nursing homes are under pressure. It shows that they do not have the capacity to receive these patients,” stated Bjørnelv.

The study investigated how mortality rates changed if people were admitted to emergency departments during periods of increased pressure in the municipality. That would be during periods where many people from the same municipality as the acutely admitted patient were waiting to be discharged from hospital.

“Is there a greater tendency to move some people home after hospitalisation rather than to a municipal short-term care facility if the municipality is under pressure? Is it better for elderly people from a pressured municipality to longer in the hospital – without the municipality having to pay a ‘fine’ to the hospital? What is best for the patient?” Bjørnelv said.

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Reducing biological ageing through diet



A new USC study shows how cycles of a fasting-mimicking diet reduce insulin resistance, liver fat, immune system aging, and biological age in clinical trial patients.

The study, published in Nature Communications, adds to the body of evidence supporting the beneficial effects of the fasting-mimicking diet (FMD).

The FMD is a five-day diet high in unsaturated fats and low in overall calories, protein, and carbohydrates and is designed to mimic the effects of a water-only fast while still providing necessary nutrients and making it much easier for people to complete the fast. 

The diet was developed by the laboratory of USC Leonard Davis School Professor Valter Longo, the senior author of the new study.

Longo stated: “This is the first study to show that a food-based intervention that does not require chronic dietary or other lifestyle changes can make people biologically younger, based on both changes in risk factors for aging and disease and on a validated method developed by the Levine group to assess biological age.”

Previous research led by Longo has indicated that brief, periodic FMD cycles are associated with a range of beneficial effects including promoting stem cell regeneration, lessening chemotherapy side effects and reducing the signs of dementia in mice.

In addition, the FMD cycles can lower the risk factors for cancer, diabetes, heart disease and other age-related diseases in humans.

The Longo lab also had previously shown that one or two cycles of the FMD for five days a month increased the healthspan and lifespan of mice on either a normal or Western diet, but the effects of the FMD on aging and biological age, liver fat, and immune system aging in humans were unknown until now.

For the study, the research team analysed the diet’s effects in two clinical trial populations, each with men and women between the ages of 18 and 70. Patients who were randomised to the fasting-mimicking diet underwent three to four monthly cycles, adhering to the FMD for five days, then ate a normal diet for 25 days.

The FMD is comprised of plant-based soups, energy bars, energy drinks, chip snacks, and tea portioned out for 5 days as well as a supplement providing high levels of minerals, vitamins, and essential fatty acids. Patients in the control groups were instructed to eat either a normal or Mediterranean-style diet.

An analysis of blood samples from trial participants showed that patients in the FMD group had lower diabetes risk factors, including less insulin resistance and lower HbA1c results. Magnetic resonance imaging also revealed a decrease in abdominal fat as well as fat within the liver, improvements associated with a reduced risk of metabolic syndrome. 

The FMD cycles also appeared to increase the lymphoid-to-myeloid ratio – an indicator of a more youthful immune system.

Further statistical analysis of the results from both clinical studies showed that FMD participants had reduced their biological age – a measure of how well one’s cells and tissues are functioning, as opposed to chronological age – by two and a half years on average.

“This study shows for the first time evidence for biological age reduction from two different clinical trials, accompanied by evidence of rejuvenation of metabolic and immune function,” Longo said.

The study lends more support to the FMD’s potential as a short-term periodic, achievable dietary intervention that can help people lessen their disease risk and improve their health without extensive lifestyle changes, Longo said.

“Although many doctors are already recommending the FMD in the United States and Europe, these findings should encourage many more healthcare professionals to recommend FMD cycles to patients with higher than desired levels of disease risk factors as well as to the general population that may be interested in increased function and younger age,” Longo said.

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Lung cancer survival boosted with immunotherapy treatment



A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved lung cancer survival rates, according to a new study.

This was compared to the use of chemotherapy alone for patients with operable non-small cell lung cancer.

The findings of the Phase III trial by researchers at The University of Texas MD Anderson Cancer Center were published in the New England Journal of Medicine.

The AEGEAN trial evaluated durvalumab given peri-operatively, meaning therapy is given both before and after surgery.

Participants received pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab.

Others received a pre-surgical placebo and chemotherapy followed by a post-surgical placebo.

AEGEAN was the first Phase III trial investigating peri-operative immunotherapy in patients with resectable non-small cell lung cancer to report positive outcomes.

“Our goal is to increase cures for lung cancer,” said principal investigator Dr John Heymach, chair of thoracic/head and neck medical oncology at MD Anderson Cancer Center.

“Throughout decades of research with post-surgical and pre-surgical chemotherapy, we only succeeded in increasing cures by around 5%.

“This one study alone has the potential to increase that percentage significantly, and we look forward to many more improvements going forward.”

Success rates

Of the patients receiving peri-operative durvalumab, 17.2% had a pathologic complete response compared to just 4.3% of those receiving chemotherapy alone.

At the first interim analysis of event-free survival, with a median follow-up of 11.7 months, the median event-free survival was 25.9 months in the placebo arm, but had not been reached in the durvalumab arm.

These data correspond to a 32% lower chance of patients experiencing disease recurrence, progression events or death with the immunotherapy-based treatment when compared to chemotherapy alone.

About four times as many patients treated with peri-operative durvalumab plus chemotherapy achieved a pathologic complete response when compared to those treated with chemotherapy alone.

Durvalumab, an immune checkpoint inhibitor targeting PD-L1, has previously been approved for treating patients with biliary tract cancer, liver cancer, small cell lung cancer and non-small cell lung cancer.

Currently, durvalumab is used for treating patients with locally advanced, un-resectable non-small cell lung cancer following definitive chemoradiotherapy, and for patients with metastatic non-small cell lung cancer in combination with tremelimumab and platinum-based chemotherapy.

For resectable non-small cell lung cancer, previous studies have shown some benefit from using post-surgical or pre-surgical immunotherapy, but Heymach explained the benefits have been modest so far.

MD Anderson is engaged in longstanding multidisciplinary efforts to use pre-surgical treatments to improve outcomes for patients.

Numerous clinical studies, such as the NEOSTAR and NeoCOAST trials, are evaluating pre-surgical immunotherapy and novel combinations to eliminate viable tumours before surgery and to reduce recurrence rates.

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