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Take a look at a selection of our recent media coverage:

New scientific statement on blood pressure measurement published

4th March 2019

The accurate measurement of blood pressure is essential for the diagnosis and management of hypertension, a major risk factor for heart disease and stroke, according to an updated American Heart Association scientific statement on blood pressure measurement in humans, published in the American Heart Association journal Hypertension.
 
The statement, which updates a previous statement on the topic published in 2005, provides an overview of what is currently known about blood pressure measurement. and supports recommendations in the 2017 American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure
 
The auscultatory method – where a healthcare provider uses a blood pressure cuff, a stethoscope and a mercury sphygmomanometer (device that measures blood pressure) – has been the gold standard for office blood pressure measurement for several decades. The mercury sphygmomanometer has a simple design and is not subject to substantial variation across models made by different manufacturers. However, mercury devices are no longer being used due to environmental concerns about mercury.
 
“Many oscillometric devices, which use an electronic pressure sensor within the blood pressure cuff, have been validated (checked for accuracy) which allow for accurate blood pressure measurement in the healthcare office settings while reducing human errors associated with the auscultatory approach,” said Paul Muntner, PhD, chair of the writing group for the scientific statement.
 
“Additionally, newer automated oscillometric devices can obtain multiple measurements with the single push of a button, which can be averaged to better estimate blood pressure,” said Muntner, who is also a professor at the University of Alabama at Birmingham.
 
The statement also summarises current knowledge about ambulatory blood pressure monitoring, which is done when a patient wears a device which measures their blood pressure throughout the day to identify white coat hypertension and masked hypertension.
 
Substantial data have been published since the last scientific statement in 2005 showing the importance of measuring blood pressure outside of the clinic setting. 
 
As detailed in the scientific statement, patients with white coat hypertension may not have an increased risk for cardiovascular disease and may not benefit from initiating antihypertensive medication. In contrast, patients with masked hypertension have a substantial increased risk for cardiovascular disease.
 
The 2017 hypertension guideline also recommends conducting ambulatory blood pressure monitoring to screen for white coat hypertension and masked hypertension in clinical practice.
 
The American Heart Association continues to recommend patients measure their blood pressure at home using a blood pressure device with an upper arm cuff that has been checked for accuracy by a healthcare provider.

Trial shows home monitoring significantly reduces staff workload and hospital visits

Two-year data from the RM-ALONE Trial1 evaluating the safety and workflow efficiency of remote cardiac monitoring with remote interrogations were recently published in the European Heart Journal.
 
The authors analysed the efficacy of Biotronik Home Monitoring® as a follow-up method after the implantation of cardiac implantable electronic devices (CIEDs) without regular in-person evaluations with a physician. 
 
The randomised clinical trial was conducted with 445 Spanish pacemaker and implantable cardioverter defibrillator (ICD) patients across 16 major Spanish hospitals. After a 12-week post-implant face-to-face visit with their implanting physician, participants were assigned to one of two groups and monitored for 24 months. Patients in the first group only received remote cardiac monitoring and remote interrogations (HMo) as follow-up routine, while the control group received remote monitoring in combination with in-person evaluations every six months (HM + IO). 
 
The trial results underline that Biotronik Home Monitoring is an effective and safe system to timely detect major adverse cardiovascular events (MACEs). The authors found no significant difference in safety between remote monitoring only and remote monitoring and scheduled in-office visits. MACEs experienced per patient were statistically comparable between the two study groups, with 20% of patients experiencing ≥1 MACE in the Home Monitoring only (HMo) group versus 19.5% in the Home Monitoring plus in-office follow-ups (HM + IO) group (P = 0.006 for non-inferiority). 
 
Furthermore, the authors showed that Home Monitoring is a cost-efficient method that can significantly reduce the workload of medical staff in hospitals. In the HMo group, the time physicians spent per patient was significantly shorter in comparison to the HM + IO group: 4 min versus 10 min in HM + IO (P < 0.0001). Moreover, the data showed a 79.2% reduction of in-office visits with no significant differences in unscheduled visits between the groups.2
 
“The two-year results from RM-ALONE demonstrate that remote monitoring with remote interrogations may be a safe substitute for conventional in-person follow-ups of patients with cardiac implants,” said RM-ALONE’s principal investigator Dr Francisco Javier García-Fernández, Hospital Universitario de Burgos, Burgos, Spain. “Our results now raise the question of whether the current guidelines for CIEDs should be adjusted according to our latest research findings.”
 
Previous studies have highlighted the fact that Home Monitoring further improves patient safety due to the early detection of device- and patient-related events.3,4,5 All-cause mortality risk in severe heart failure patients has been shown to have been reduced by more than 60%5 and by 38% in broader populations of heart failure patients.6 Additionally, studies have observed a significant reduction in inappropriate ICD shocks and hospitalisation rates when using BIOTRONIK Home Monitoring.7,8
 
“These extremely promising results from the RM-ALONE study show how Biotronik Home Monitoring contributes to patient safety significantly while reducing the need for in-office evaluations as well the workload on clinical staff,” said Albert Panzeri, Vice President at Biotronik. “Automatic daily data transmission, a user-friendly handling as well as a specific workflow, enabling fast patient contact after an event are all key features that make our system unique on the market.”
 
References
  1. The results of the RM-ALONE study were first presented at ESC Congress 2018.
  2. García-Fernández FJ et al. Eur Heart J. 2019, Feb 21. doi: 10.1093/eurheartj/ehz067.
  3. Varma N et al. Circulation. 2010, 122(4).
  4. Mabo P et al. Eur Heart J. 2012, 33(9).
  5. Hindricks G et al. Lancet. 2014, 384(9943).
  6. Hindricks G et al. European Heart Journal. 2017, May 10.
  7. Guedon-Moreau L et al. J Cardiovasc Electrophysiol. 2014, 25(7).
  8. Burri H et al. Europace. 2013, 15(11).

Inhibiting cancer-causing protein could prevent scleroderma fibrosis

1st March 2019

In a recent study, published in Proceedings of the National Academy of Sciences, Amr Sawalha MD, a professor in the Division of Rheumatology at the University of Michigan and his team examined scleroderma at the molecular level to better understand the fibrosis process.1
 
“We examined the molecule EZH2, which has been known to play a role in several types of cancer,” Sawalha says. “This protein regulates gene expression, by affecting modifications that happen to DNA and other proteins attached to DNA, through a process called epigenetic regulation.”
 
Sawalha and fellow researchers had previously identified a role for EZH2 in lupus flares.
 
“EZH2 is overexpressed in lupus T cells, which makes these white blood cells active in lupus patients,” he says. “We then expanded our studies to scleroderma and specifically looked at the role of EZH2 in fibroblasts and endothelial cells in this disease.”
 
The research team first isolated cells from scleroderma patients in collaboration with the Michigan Medicine Scleroderma Program. The programme provides care for a large number of scleroderma patients at the University of Michigan. They then expanded their studies to animal models to further test findings identified in the human cells.
 
“Both increased fibrosis and abnormal blood vessel function, or defective angiogenesis, are major aspects of pathology in this autoimmune disease,” says Eliza Tsou, PhD, a research assistant professor at U-M and first author of the study. “We dissected the cells and found that increased levels of EZH2 were contributing to this disease process in scleroderma patients.”
 
After identifying the molecule, the research team examined what happened in the cells when EZH2 was inhibited.
 
“When we suppressed EZH2, we found we could correct increased fibrosis and abnormal blood vessel function in scleroderma,” Sawalha says.
 
Because EZH2 is a molecule known to play a role in cancer patients, Sawalha says the ability to translate their laboratory work to patients may be easier.
 
“What is nice is that EZH2 inhibitors are already developed and in clinical trials in certain cancers,” he says. “Therefore, our findings can be more readily translated to the bedside by repurposing already existing inhibitors for EZH2 to treat scleroderma.”
 
As there are currently no effective treatment options for scleroderma, Sawalha notes that this type of research is important for future studies and trials.
 
“We will continue to research this disease at the molecular level and try to identify additional therapeutic targets for this patient population,” he says.
 
Reference
  1. Tsou P-S et al. Inhibition of EZH2 prevents fibrosis and restores normal angiogenesis in scleroderma. PNAS 2019;201813006 DOI: 10.1073/pnas.1813006116
Source: University of Michigan

Oral immunotherapy for egg allergy study results are encouraging

28th February 2019

New research regarding egg oral immunotherapy (eOIT) has been presented at the annual American Academy of Allergy, Asthma and Immunology conference in San Francisco.
 
UNC School of Medicine was one of five centres to participate in the study, led by the Consortium of Food Allergy Research (COFAR) and funded by the National Institutes of Health (NIH). The trial began with either eOIT or a placebo for 55 patients aged 5-11 who were allergic to egg. The treatments were randomised, with 40 subjects receiving treatment and 15 receiving placebo. 
 
The treatments lasted up to four years, during which patients were tested for their sensitivity to egg. Those who were considered desensitised – requiring a higher quantity of egg to cause an allergic reaction – could eat 10g, or about two teaspoons, of pure egg without reaction. Desensitised patients then stopped eOIT and were tested for sensitivity again. Those who did not have a reaction were considered sustained unresponsiveness (SU). After completing eOIT, concentrated egg (scrambled, fried or boiled egg) and/or baked egg (eggs incorporated into something like a cake) were recommended to be added into the patients’ diet. For five years following the allergy treatment, patients were asked to report how much egg they ate, in what form they ate it, how often they ate it and how they felt afterward.
 
At the end of eOIT, 50% of patients were classified with SU, 28% of patients were classified as desensitised (without SU) and 22% as not desensitised. Of SU-classified patients, 100% were able to eat both baked and concentrated egg.
 
“Egg allergy is one of the most common food allergies and usually appears in early childhood. It has significant risk for severe allergic reactions and negatively affects quality of life for children with the allergy,” said Edwin Kim MD, study lead author and assistant professor of medicine and paediatrics at the UNC School of Medicine and director of the UNC Food Allergy Initiative. “While the allergy does seem to go away with age, it can last into the second decade of life for most people. Any treatment that can allow the introduction of egg into the diet of someone with egg allergy provides nutritional benefits and peace of mind for the patient and their family.”
 
Source: University of North Carolina Health Care

NHS prescription charge to rise to £9 per item in England

NHS prescriptions are set to rise by 20p per item from 1 April 2019, the Government announced on Thursday (21 February).

The raise from £8.80 to £9 will apply to each medicine or appliance dispensed, while the cost of prescription pre-payment certificates (PPC) has been frozen for a year at £29.10 for a three-month PPC and £104 for a 12-month PPC.

PPCs are available for patients who require four or more items in three months or more than 12 in a year.

The Department of Health and Social Care (DHSC) said that “taken together, this means prescription charge income is expected to rise broadly in line with inflation.”

Last year’s prescription charge increase of 20p – from £8.60 to £8.80 – was described by campaigner Prescription Charges Coalition as “catastrophic“.

It is hoped that the rise in charges will contribute towards the £22 billion in ‘efficiency savings’ the Government required of the NHS as part of the Five Year Forward View, adopted in the 2015 spending review.

The Five Year Forward View detailed that £22 billion of the predicted £30 billion NHS funding gap would be made up through efficiency and reform.

These savings are to come alongside the Government’s 2015 commitment to a £10 billion investment by 2020 to 2021 to fund “frontline NHS services”.

The DHSC said the savings would “secure the best value from NHS resources and primary care must play its part”.

Chair of the Royal Pharmaceutical Society (RPS) English Board Sandra Gidley said: “The consequences of the relentless rise in prescription charges are well-known. If you can’t afford your medicines, you become more ill, which leads to poor health and expensive and unnecessary hospital admissions.

“Every day, pharmacists are asked by patients who are unable to afford all the items in their prescription which ones they could ‘do without’.  Patients shouldn’t have to make choices that involve rationing their medicines. No-one should be faced with a financial barrier to getting the medicines they need.”

She added that prescriptions should be free in England as they are in Scotland, Wales and Northern Ireland so that “no-one would have to worry about payment decisions affecting their health”.

How does the immune system maintain a healthy gut microbiota?

An international research group from the Cluster of Excellence “Precision Medicine in Chronic Inflammation” in Kiel and Charité – Universitätsmedizin Berlin has uncovered a critical mechanism that controls immune reactions against microorganisms in the intestine. The results have been published in Nature Immunology.1
 
Led by Prof Dr Alexander Scheffold, the group as has uncovered a critical mechanism that establishes the balance between immune system and microbiota.
 
The researchers Dr Christian Neumann (Charité), Dr Sascha Rutz (Genentech, San Francisco), Prof Dr Axel Kallies (University of Melbourne and Walter and Eliza Hall Institute of Medical Research, Melbourne), and Prof Scheffold and colleagues studied molecular regulators of immune-microbiome interactions in mice. The team focused on regulatory T cells. 
 
“We have identified a molecule, c-Maf, which is critical for the development and function of specific regulatory T cells in the gut,” explained Scheffold. C-Maf prevents the immune system from attacking the microbiota. “If this molecule is missing, the gut’s immune system overreacts and the microbiota composition changes considerably,” added first author Dr. Neumann of Charité’s Institute of Microbiology, Infectious Diseases and Immunology. This change in composition proved remarkably stable: When the researchers transferred the altered microbiota to mice with intact c-Maf-dependent regulatory T cells, they also developed an overreaction of the intestinal immune system.
 
“These results show that both the immune system and the microbiota mutually contribute to establishing and maintaining the balance in the gut,” emphasises Prof Scheffold. “This could explain how a microbial imbalance can contribute to chronic inflammatory bowel disease and why the treatment often fails“. 
 
These findings could lead to new therapeutic approaches that, for example in the case of inflammatory bowel disease, aim to influence and harmonise both immune response and microbiota. In the future, the team would like to study how an established pathological interaction between intestinal bacteria and the immune system can be destabilised in patients and restored to its original state.
 
Reference
  1. Neumann C et al. c-Maf-dependent Treg cell control of intestinal TH17 cells and IgA establishes host-microbiota homeostasis. Nat Immunol 2019;Feb 18. doi: 10.1038/s41590-019-0316-2

UK Government to spend £11m preventing medicine shortages in preparation for no-deal Brexit

The Department of Health and Social Care (DHSC) will spend around £11m on warehouse contracts to store medicines as a contingency measure for a no-deal Brexit, Hospital Healthcare Europeunderstands.

In October last year, health and social care secretary Matt Hancock told the Health and Social Care Committee that the Government had issued an invitation to tender for additional storage space to stockpile medicines.

The measure was implemented to ensure access to medicines in the event of a no-deal Brexit.

The DHSC told our sister publication Healthcare Leader that it “expects to spend around £11m on warehouse contracts to store medicines in preparation for a no-deal Brexit”.

In October, Mr Hancock said he was expecting the value of the contracts to be “in the low tens of millions of pounds”.

He was, however, unable to share a more precise figure and said the Government was buying the space ‘from the market’ and would in some cases have to build new facilities.

Last month, health minister Stephen Hammond said the Government had signed a contract worth around £1m to accommodate 5,000 pallets of cold medicines across the UK.

Questioned in Parliament last week, Mr Hancock was asked how much the DHSC has already spent on preparing for a no-deal Brexit ‘after activating NHS no-deal contingency plans’. He was also asked “what the overall bill for this will be”.

Diverging from what the DHSC told Healthcare Leader, Mr Hancock specified in Parliament that “around £11m has been spent already”, whereas the DHSC said it is money the department is expecting to spend.

The DHSC was unable to clarify the difference between the two statements at this point.

Mr Hancock said last week: “The NHS is not generally buying the extra medicines that are going into the elongated stockpiles but the pharmaceutical industry is because of course we’ll eventually buy most of those medicines for the NHS.

“So there have been costs in the pharmaceutical industry as well but the cost so far to the taxpayers is £11m and I expect it to remain around that level if not a little higher.”

Last year, Mr Hancock asked pharmaceutical companies to stockpile six weeks’ worth of medicines to prepare for the eventuality of a no-deal Brexit.

The UK is expected to leave the European Union on 29 March and at a press conference in Sharm-el-Sheikh yesterday (25 February) Prime Minister Theresa May said everybody should be focused on leaving with a deal by the set date. Her comments follows calls from MPs to delay Brexit day.

This story was first published by our sister title Healthcare Leader

Crohn’s disease study reveals potential for personalised treatment

27th February 2019

A UK-wide collaboration led by the University of Exeter and the Royal Devon & Exeter NHS Foundation Trust, part-funded by Crohn’s & Colitis UK and Guts UK, and supported by the NIHR has concluded that trials are needed to investigate whether early personalised dosing, guided by blood level monitoring, might help reduce the rate of treatment failure.

Published in The Lancet Gastroenterology & Hepatology, the Personalised anti-TNF therapy in Crohn’s disease study (PANTS) followed 1610 patients with Crohn’s disease starting anti-TNF treatment at 120 UK hospitals – the largest cohort of its kind.1

The anti-tumour necrosis factor (TNF) drugs, infliximab and adalimumab are used to treat patients with moderate to severe Crohn’s disease and ulcerative colitis when other treatments have not worked.

Although anti-TNF drugs have given new hope for people with Crohn’s and Colitis, and provided an important treatment option, they do not work in some patients. The research looked at the factors involved in why treatment fails many people with Crohn’s disease. The PANTS study showed that about a quarter of patients had no response to the drugs and in one third of initial responders, the drug stopped working within the first year of treatment. Nearly 10% of people experienced harmful side effects that resulted in the treatment being stopped. Overall 37% of patients starting anti-TNF drugs were well and still on treatment at the end of the first year.

Anti-TNF drugs are large, complex molecules and repeated administration causes the immune system to recognise the drug as a potential threat rather than a medicine. This leads to the production of antibodies. These anti-drug antibodies block the action of anti-TNF drugs and increase the rate at which the drugs are removed from the body, reducing drug levels and the effectiveness of treatment.  Findings from the PANTS study suggests that the risk of forming antibodies to anti-TNF therapy might be reduced by using personalised dosing particularly at the start of treatment, together with the use of a thiopurine or methotrexate drug alongside infliximab and adalimumab.

Introduced in the 1990s, anti-TNF drugs now rank in the top 5 NHS drug spend. However, in 2015 the introduction of a biologically similar version of infliximab, called CT-P13, was launched in the UK offering significant costs savings for the NHS. In the PANTS study, CT-P13 was shown to be as safe and effective as the original infliximab (Remicade).

Dr Tariq Ahmad, of the University of Exeter Medical School, who led the research, said: “The results from the PANTS study suggest there are opportunities to optimise the use of anti-TNF therapies to increase treatment effectiveness. In particular, our data suggests that early personalised dosing, guided by blood level monitoring, together with the use of thiopurine or methotrexate therapy, may help achieve optimal drug levels and minimise the risk of anti-drug antibody formation. We now have cheaper versions of infliximab and adalimumab which means that personalised dose intensification is now more affordable.”

Helen Terry, Director of Research, Crohn’s and Colitis UK said: “Anti-TNF drugs have been life-changing for many patients with Crohn’s, but we need to understand why this treatment doesn’t always work. Sometimes patients can go on a long journey to find the best medication for them, but this study means that personalised treatment could be implemented earlier. As well as improving patient outcomes, personalised dosing could also lead to cost-savings for the NHS.”

Julie Harrington, Chief Executive Officer  of Guts UK, a charity committed to fighting digestive disorders, said: “These findings show the importance of personalising the treatment for patients with Crohn’s disease. Guts UK are delighted to have supported the early stages of this study.”

Reference

  1. Kennedy NA et al. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol 2019;February 26. 

Genetic test improves safety of IBD treatments

26th February 2019

A ground-breaking and large-scale NHS research collaboration, led by the University of Exeter and the Royal Devon & Exeter NHS Foundation Trust, has discovered a gene mutation that allows the identification of patients at risk of a drug side effect, allowing clinicians to tailor alternative treatments to these individuals.

The research, funded by the charities Crohn’s and Colitis UK, for Crohns, and the International Serious Adverse Event Consortium (iSAEC) and supported by the NIHR, has been published in JAMA.1 This finding will reduce the risk of drug side effects caused by treatment with thiopurines (consisting of azathioprine and mercaptopurine). This group of drugs is commonly used for the treatment of autoimmune and inflammatory diseases.

Crohn’s disease and ulcerative colitis (collectively as inflammatory bowel disease (IBD)) are incurable lifelong conditions that affect approximately 1 in 150 people in the UK. The main symptoms are urgent diarrhoea, often with rectal bleeding, abdominal pain, profound fatigue and weight loss. The condition disrupts people’s education, working, social and family life. Drugs to suppress the immune system are the mainstay of treatment; however, more than half of patients with Crohn’s disease and about 20% of patients with ulcerative colitis will require surgery at some point. The lifetime medical costs associated with the care of a person with IBD are similar to the costs of treating diabetes or cancer.

About a third of patients with IBD are treated with a thiopurine drug; however, approximately 7% of patients develop the adverse reaction of bone marrow suppression. This means that the body’s immune system is less able to fight infection and patients are at risk of sepsis.
Previous studies have identified mutations in a gene known as TPMT, which predisposes patients to thiopurine-induced bone marrow suppression. Clinicians either adjust the dose or avoid thiopurines altogether if routine tests show that patients are likely to carry faulty versions of the TPMT gene. However, only a quarter of patients who suffer from bone-marrow suppression have abnormalities in TPMT, suggesting that other genes may be involved.

Through the National Institute of Health Research Clinical Research Network, 82 NHS hospitals in the UK recruited patients to the study. In addition patients were recruited from international collaborators in the Netherlands, USA, Australia, France, New Zealand, South Africa, Malta, Denmark, Sweden, Italy and Canada. The Exeter IBD Research Group also recruited UK patients via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme, which collects reports of patients who have experienced complications of treatment.
DNA from approximately 500 patients with IBD that suffered thiopurine-induced bone marrow suppression and 680 controls (IBD patients who had received thiopurines and had no history of bone marrow suppression), were analysed to identify  genes possibly associated with this adverse drug reaction.

The researchers found an association between mutations in a gene called NUDT15 and bone marrow suppression. This gene mutation had previously only been thought important in patients of East Asian descent.

Chief Investigator of the study, Dr Tariq Ahmad, of the University of Exeter Medical School, said: “In the largest genetic analysis into the side effects of thiopurine drugs we’ve discovered variation in a gene that can help us identify who is susceptible to thiopurine-induced bone marrow suppression.  In line with the NHS 10 year plan to increase personalised medicine, testing for this genetic abnormality prior to prescribing thiopurine drugs will reduce the risks to patients, and costs to the NHS, associated with this potentially serious drug side effect.

“Working with patients and clinicians from across the UK, we have shown the power of the NHS to deliver clinically meaningful genetic research outcomes.”

The team found three different variants in NUDT15 that were associated with bone marrow suppression in European patients. Lead author Dr Gareth Walker added: “Personalising medicine according to a person’s genetics will hopefully allow doctors to treat their patients in a safer, more effective manner.”

“We hope that once a predictive test is developed, patients will be able to have a simple blood test before starting these drugs. This will allow doctors to modify treatments, either by reducing the dose or opting for different treatment altogether.”

Dr Matt Nelson, head of Genetics at GlaxoSmithKline and chair of the International Serious Adverse Event Consortium scientific committee, said: “We established the iSAEC as a non-profit biomedical research consortium, working with leading academic investigators to better understand the genetic risk underlying drug-induced serious adverse events. We are so pleased the discoveries from our collaborative research with Dr Ahmad and the IBD research network will make IBD treatment safer for patients.”

Reference

  1. Walker G et al. Association of Genetic Variants in NUDT15 With Thiopurine-Induced Myelosuppression in Patients With Inflammatory Bowel Disease. JAMA 2019;321(8):773-785.

Deleting gene could help alleviate rheumatoid arthritis, study finds

25th February 2019

Deleting a specific gene in mice alleviates arthritis symptoms and could be used to formulate a cure in humans, researchers have found.

Researchers at the University of Virginia School of Medicine found that deleting a gene called ELMO1 in mice reduced inflammation in acute and chronic arthritis models.1

This was particularly surprising because the researchers had hypothesised that deleting the gene would worsen inflammatory arthritis because it promotes cytoskeletal reorganisation during engulfment.

Studies revealed that ELMO1 works with receptors that are linked to neutrophil function in arthritis.

Reference

  1. Arandjelovic S et al. A noncanonical role for the engulfment gene ELMO1 in neutrophils that promotes inflammatory arthritis. Nat Immunol2019;20(2):141 DOI: 10.1038/s41590-018-0293-x

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