Tresiba® Demonstrated Significantly Improved Blood Sugar Control and Lower Rates of Hypoglycaemia Versus Insulin Glargine U300 in Real-World Evidence Study

Findings from CONFIRM - a large real-world evidence (RWE) study comparing the effectiveness of Tresiba^® (insulin degludec injection) versus insulin glargine U300 - will be presented on Monday, 25 June 2018 at the American Diabetes Association's 78^th Scientific Sessions (ADA) in Orlando, US. The retrospective, non-interventional comparative effectiveness study, which included more than 4,000 adults with type 2 diabetes who were starting basal insulin for the first time, showed that after six months those treated with Tresiba^® had significantly lower HbA_1c compared to those treated with insulin glargine U300 (-1.5% vs. -1.2% respectively; p=0.029).^[1]
As a secondary endpoint, there was a 30% lower rate of hypoglycaemic episodes with Tresiba^® compared to insulin glargine U300 (p=0.045).^[1] In this study, hypoglycaemic events, ranging from mild to severe, were registered using the International Classification of Diseases (ICD) codes 9/10 following diagnosis from a physician.^[2]
This real-world study also showed in another secondary endpoint that people treated with Tresiba^® were more likely to stay on their treatment. Those treated with insulin glargine U300 had a 37% higher rate of discontinuing treatment after two years (p<0 .001="" sup="">[1]
"Real-world studies are important to understanding how clinical trials may translate into real value for patients in everyday clinical practice," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "The CONFIRM results add to the body of evidence on Tresiba^® for adults with type 2 diabetes."

Message from Commissioner Andriukaitis for World Blood Donor Day 2017

Since 2015, Europe has been left reeling by terror attacks in France, Belgium, Germany, Sweden and the United Kingdom. We have been shocked and saddened by these attacks and we mourn the victims. But we will not allow these atrocities to undermine our resilience, our compassion or our spirit of solidarity. Each of these terrible events also had something positive in common: the willingness of citizens to donate blood.

Today, on World Blood Donor Day, I call on EU citizens to demonstrate this continued compassion and solidarity in a tangible way and to become blood donors. Fittingly, the World Health Organization has chosen to focus on blood donation in emergencies as this year's theme, and I fully endorse the campaign message:

Don't wait until disaster strikes
GIVE BLOOD
GIVE NOW
GIVE OFTEN

It is vital that hospitals have a sufficient supply of all blood types at all times, so that in the unpredictable event of a crisis or emergency, doctors and surgeons are in the best position to save lives. As blood can only be stored for a limited period of time before use, there is a constant need for donations.

Let me point out that donated blood is not only needed in the event of a terrorist attack, it is also necessary for everyday medical emergencies such as car crashes, childbirth complications, and complex surgical procedures, amongst many others.

Every year, following donations by EU citizens, some 26 million units of blood are supplied and used in hospitals. My job as the European Health Commissioner is to help ensure that 1400 EU blood establishments apply the highest standards of quality and safety at every step - from collection to distribution. Patients' lives depend on it, and blood donors deserve the assurance that their donation will be put to good use.

The Commission is currently evaluating the 2002 blood Directive to ensure that it remains fit for purpose. As part of the evaluation, there is an ongoing public consultation of citizens and stakeholders, which runs until the end of August. Everyone who participates will have their voice heard, so I invite you to do so.

Blood is the most precious gift that anyone can give to another person, so allow me to repeat: Give blood. Give now. Give often.

Commission publishes guides on patient blood management

The Commission has today published two guides on Patient Blood Management (PBM).  The guides, one addressed to authorities and the other addressed to hospitals, have been developed via a Public Health Programme service contract (nº 20136106).

Patient blood management (PBM) is a patient-focused, evidence-based and systematic approach to improve patient outcomes through the safe and rational use of blood and blood products and avoiding unnecessary transfusions. Essential elements of PBM include: the prevention of conditions that might otherwise result in the need for transfusion (through health promotion and screening for early detection of anemia), appropriate diagnosis and optimal treatment, including the use of alternatives to transfusion, good surgical and anaesthetic techniques, the use of alternatives to blood transfusion and blood conservation. The high prevalence of untreated pre-operative anaemia, the unmet need for improved bleeding management and a liberal transfusion practice, point towards huge potential to improve outcome through rationalisation of transfusion. The PBM approach has been endorsed and promoted by the World Health Organization and is widely accepted as current best practice.

The publication is timely as, just last month, the journal Transfusion published impressive results from a comprehensive 5-year PBM programme in Western Australia, the world’s largest programme to date on PBM. It included 605,046 patients admitted to Western Australia’s four major adult tertiary-care hospitals, with results showing a 28% reduction in hospital mortality, a 15% reduction in average hospital length of stay, a 21% decrease in hospital-acquired infections (transfused patients are more susceptible to infection) and a 31% decrease in the incidence of heart attack or stroke. The use of blood products was reduced by 41% during the study period, achieving not only these significant patient outcome benefits but also representing a very substantial cost saving to the health service.

The Commission hopes that the EU Public Health Programme investment in the development of these guides will enhance the efforts of health authorities and professionals across the EU to achieve similar results for EU patients.

THRIVA MAKES HEALTH PERSONAL WITH BLOOD TEST AND TRACK SERVICE

 Statistics about health problems and the incidence of preventable diseases are all too familiar. Yet we still ignore the advice we’re given and struggle to make healthy lifestyle choices. It’s only when something goes wrong that we give our bodies the time and energy they deserve. Step up Thriva, the proactive health startup whose finger-prick blood tests are empowering people to make better lifestyle choices by making health personal.

With health problems often going undetected until its too late, Thriva is kick-starting a revolution in healthcare by making it easy and affordable for people to gain access to the data that really matters - helping them detect issues early and take action before it’s too late. Its finger-prick blood tests can be done at home and results are delivered to your personal online health dashboard. By providing deep insights into what’s actually going on inside your body, with personalized advice from a qualified GP, Thriva’s finger-prick blood tests are a powerful motivator that you can’t easily ignore.

Following rapid growth and investment from Seedcamp, a leading London venture capital firm, Thriva is now launching Baseline – a test that can uncover a variety of important red flags before they become serious illnesses or diseases. These include high cholesterol levels (linked to cardiovascular disease), Vitamin-D deficiency (linked to fatigue and bone health, cardiovascular disease and cancer), iron deficiency (linked to chronic fatigue and pregnancy complications) and poor liver function (linked to liver disease as well as cardiovascular disease, heart disease and cancer).

“While personal fitness trackers and wearables are a popular way of measuring performance, they provide very limited insight into the state of your body or the impact of poor lifestyle choices,” comments Hamish Grierson, co-founder and CEO at Thriva. “Our blood test insights make health issues very personal and very real. If you discover you have high levels of cholesterol or abnormal liver function, you become very connected to what your body is trying to tell you and are far more likely to take corrective action.”

Thriva’s blood-testing kits are quick and easy to use. They contain everything you need for a finger-prick test including lancets, wipes, a small collection tube and a pre-paid mailer. It doesn’t involve any big needles and takes just a few minutes.  The blood tests are carried out by an accredited lab and are available in a matter of days - less time that it takes to get an appointment with a doctor.

The results come with bespoke recommendations from a GP, all of which can be viewed on your personal online health dashboard via the Thriva online dashboard. They’re also very affordable - the LifeTracker test costs £49 for a one-off check or £39 per quarterly test on subscription. So for the same price as a subscription to Spotify, you can now track important body state data, make your health a priority and take back control of your body.

“We know health is hard but by making it personal, convenient and affordable, Thriva is helping people find the motivation to make better, more proactive lifestyle choices,” continues Hamish Grierson.

Quick facts:

·      The top five killers (cancer, heart disease, stroke, lung disease and stroke) are responsible for over 150,000 deaths a year in England alone – with the Department of Health estimating that two-thirds of them are entirely avoidable.

·      The UK has one of the worst death rates from liver disease in Europe and medical experts have warned early detection is ‘virtually non-existent’. The NHS recently revealed a deficit of £2.45bn and could be facing a £20bn deficit by 2020 according to Incisive Health.

·      NHS Vale of York Clinical Commissioning Group recently proposed delaying non-life threatening procedures by a year for those with a body mass index exceeding 30.

·      The global market for “connected healthcare” will expand by a third every year to reach £37bn by 2020, according to PwC, the consultancy, and the U

Additional hormone measurement reveals pregnant women at high risk of preeclampsia

An additional blood test for pregnant women accurately predicts which women with high thyroid function are at risk of developing preeclampsia, according to a study presented today at the European Congress of Endocrinology. The findings may help identify high-risk pregnant women and potentially avoid unnecessary treatment that carries the risk of foetal abnormalities.

Preeclampsia is a condition that occurs during the second half of pregnancy, where women have high blood pressure and pass protein in their urine. It occurs in 2-8% pregnancies and in some cases leads to serious complications for both mother and child, including seizures, kidney failure, haemorrhage and preterm birth.

One of the risk factors for preeclampsia is hyperthyroidism, which can be caused by medical conditions such as Graves’ Disease or toxic thyroid nodules. However, high levels of hCG, a hormone that rises naturally during pregnancy, also leads to high thyroid function but this type of pregnancy-related hyperthyroidism does not have an increased risk of preeclampsia.

As taking drugs to treat high thyroid function during pregnancy carries the risk of causing foetal abnormalities, it is important to distinguish between an overactive thyroid caused by pregnancy-related hCG or one caused by a conventional underlying thyroid condition.

In this study, researchers measured the hormones of 5153 women during early pregnancy (before the 18^thweek) and found that women with high levels of thyroid hormone but low levels of hCG were between three and eleven times more likely to develop preeclampsia. Women with high levels of thyroid hormone and high levels of hCG were not at increased risk of preeclampsia. The researchers accounted for other factors including the age, smoking, education and ethnicity of the expectant mothers as well as the gender of the baby.

“Most pregnant women will have high thyroid hormone levels because of a natural rise in hCG, rather than an underlying thyroid condition like Grave’s Disease or toxic nodules”, said lead author of the study Dr Tim Korevaar from the Erasmus University Medical Center in Rotterdam.

“Doctors do not currently screen for preeclampsia, although many do measure thyroid hormone during pregnancy,” continued Dr Korevaar. “Measuring hCG as well may help doctors to more accurately interpret thyroid function tests in pregnant women.”

“Our work will potentially reassure the vast majority of patients who do not actually have an underlying thyroid condition by helping them avoid unnecessary treatment”.

Diabetes associated with increased risk of serious bacterial blood infection

Patients with diabetes are almost three times more susceptible to life-threatening blood infections byStaphylococcus aureus bacteria, according to a study published today in the European Journal of Endocrinology. These findings could indicate a need for greater infection surveillance among long-term diabetes patients.

S. aureus is a bacterium that normally lives harmlessly on the skin. Occasionally it causes infections, which can be fatal if the bacteria enter the bloodstream. The incidence of S. aureus infection has increased in the past 20 years driven by both known and unknown factors. The presence of this bacterium within the blood stream is a serious medical condition, with a 30-day mortality rate of 20-30%. This study found that, diabetes patients have a 2.8 times increased risk of S. aureus blood infection acquired outside of a hospital.

Researchers from Aalborg University Hospital and Aarhus University Hospital in Denmark analysed records of 30,000 people from four different medical registries in Denmark over a twelve year period. The team compared the risk of infection when taking into account different types of diabetes, how long patients had been diagnosed with the condition and other associated complications of living with diabetes.

Compared to patients without diabetes, people with type-1 diabetes were 7.2 times more at risk of S. aureus infection whereas people with type-2 were 2.7 times more at risk. Also more at risk were those suffering from other complications – such as heart and circulation problems, and diabetic ulcers. Kidney problems associated with diabetes were one of the highest risk factors, with a 4.2 times increased risk.

The risk of infection also increased with the number of years a patient had had diabetes; those who had suffered for 10 years or more were 3.8 times more at risk. The extent to which patients had control over their diabetes was also considered, with those with poor management of their diabetes showing a greater risk.

“It has long been a common clinical belief that diabetes increases the risk of S. aureus infection, but until now this has been supported by scant evidence,” says lead author Jesper Smit. “Poor management of diabetes can lead to an impaired immune response. This may be the reason why diabetes patients are at higher risk of infection. Similarly, diabetic patients often suffer associated illnesses –the burden of multiple healthcare problems can also increase susceptibility to infection.”

Following this study, the next steps will be to investigate how diabetes may affect the prognosis of blood infections of S. aureus, and determine how the increased risk factor of diabetes may correspond to disease outcome.

It is important to note the limitations of the study; the medical data available did not allow the researchers to adjust for smoking or body mass index in their sample – two factors which may affect the immune response and subsequent possible infection. It must also be noticed that methicillin-resistant S. aureus(MRSA) is rare in Denmark, and the epidemiology of S. aureus may be different in countries where MRSA prevails.

Detecting breast cancer's fingerprint in a droplet of blood

One in eight women will be diagnosed with breast cancer during her lifetime. The earlier cancer is detected, the better the chance of successful treatment and long-term survival. However, early cancer diagnosis is still challenging as testing by mammography remains cumbersome, costly, and in many cases, cancer can only be detected at an advanced stage. A team based in the Dept. of Biomedical Engineering at McGill University's Faculty of Medicine has developed a new microfluidics-based microarray that could one day radically change how and when cancer is diagnosed. Their findings are published in the April issue of the journal Molecular & Cellular Proteomics. For years, scientists have worked to develop blood tests for cancer based on the presence of the Carcinoembryonic Antigen (CEA), a protein biomarker for cancer identified over 40 years ago by McGill's Dr. Phil Gold. This biomarker, however, is also found in healthy people and its concentration varies from person to person depending on genetic background and lifestyle. As such, it has not been possible to establish a precise cut-off between healthy individuals and those with cancer.
"Attempts have been made to overcome this problem of person-to-person variability by seeking to establish a molecular 'portrait' of a person by measuring both the concentration of multiple proteins in the blood and identifying the signature molecules that, taken together, constitute a characteristic 'fingerprint' of cancer," explains Dr. David Juncker, the team's principal investigator. "However, no reliable set of biomarkers has been found, and no such test is available today. Our goal is to find a way around this."
Dr. Mateu Pla-Roca, the study's first author, along with members of Juncker's team, began by analyzing the most commonly used existing technologies that measure multiple proteins in the blood and developing a model describing their vulnerabilities and limitations. Specifically, they discovered why the number of protein targets that can be measured simultaneously has been limited and why the accuracy and reproducibility of these tests have been so challenging to improve. Armed with a better understanding of these limitations, the team then developed a novel microfluidics-based microarray technology that circumvents these restrictions. Using this new approach, it then became possible to measure as many protein biomarkers as desired while minimizing the possibility of obtaining false results.
Juncker's biomedical engineering group, together with oncology and bioinformatics teams from McGill's Goodman Cancer Research Centre, then measured the profile of 32 proteins in the blood of 11 healthy controls and 17 individuals who had a particular subtype of breast cancer (estrogen receptor-positive). The researchers found that a subset of six of these 32 proteins could be used to establish a fingerprint for this cancer and classify each of the patients and healthy controls as having or not having breast cancer.
"While this study needs to be repeated with additional markers and a greater diversity of patients and cancer subsets before such a test can be applied to clinical diagnosis, these results nonetheless underscore the exciting potential of this new technology," said Juncker.
Looking ahead, Juncker and his collaborators have set as their goal the development of a simple test that can be carried out in a physician's office using a droplet of blood, thereby reducing dependence on mammography and minimizing attendant exposure to X-rays, discomfort and cost. His lab is currently developing a hand-held version of the test and is working on improving its sensitivity so as to be able to accurately detect breast cancer and ultimately, many other diseases, at the earliest possible stage.

**Source: McGill University

Snacking on raisins may offer a heart-healthy way to lower blood pressure

If you have slightly higher than normal blood pressure -- known as prehypertension -- consider eating a handful of raisins. New data suggest that, among individuals with mild increases in blood pressure, the routine consumption of raisins (three times a day) may significantly lower blood pressure, especially when compared to eating other common snacks, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field. Even though raisins are popularly cited to lower blood pressure on various websites and are known to have intrinsic properties that could benefit heart and vascular health, researchers believe this is the first controlled study to scientifically support raisins' blood pressure-lowering effects compared to alternative snacks.
"It is often stated as a known fact that raisins lower blood pressure. But we could not find much objective evidence in the medical literature to support such a claim," said Harold Bays, MD, medical director and president of Louisville Metabolic and Atherosclerosis Research Center (L-MARC) and the study's lead investigator. "However, our study suggests if you have a choice between eating raisins or other snacks like crackers and chocolate chip cookies, you may be better off snacking on raisins at least with respect to blood pressure."
In this investigation, Dr. Bays and his team conducted a randomized controlled clinical trial to compare the blood pressure effect of eating raisins versus other snacks in 46 men and women with prehypertension. Participants were randomly assigned to snack on raisins or prepackaged commercial snacks that did not contain raisins, other fruits or vegetables but had the same number of calories per serving three times a day for 12 weeks. The study controlled for individual differences in nutrition and physical activity.
Data analyses found that compared to other snacks, raisins significantly reduced systolic blood pressure at weeks 4, 8, and 12, ranging from -4.8 to -7.2% or -6.0 to -10.2 mmHg (p values <0.05). Within group analysis demonstrated that raisins significantly reduced mean diastolic blood pressure at all study visits, with changes ranging from -2.4 to -- 5.2 mmHg (p values < 0.05). Pre-packaged snacks (including crackers and cookies) did not significantly reduce systolic or diastolic blood pressure at any study visit.
"Overall, these findings support what many people intrinsically believe: that natural foods often have greater health benefits than processed foods," Dr. Bays said.
The study did not identify how raisins lower blood pressure. However, raisins are high in potassium, and have fiber, polyphenols, phenolic acid, tannins and antioxidants.
"Raisins are packed with potassium, which is known to lower blood pressure," Dr. Bays said. "They are also a good source of antioxidant dietary fiber that may favorably alter the biochemistry of blood vessels, causing them to be less stiff, which in turn, may reduce blood pressure."
Although this study was not designed or powered to evaluate for outcomes benefits, other studies support that in patients with prehypertension, mild lowering of blood pressure with medications may have clinical benefits in reducing cardiovascular events.
According to the Centers for Disease Control and Prevention, nearly one in three (28 percent) American adults have prehypertension -- defined as a systolic pressure from 120 to 139 millimeters of mercury (mm Hg) or a diastolic pressure from 80 to 89 mm Hg. This study's findings help validate some current nutritional recommendations. For example, 60 raisins -- about a handful -- contain 1 gram of fiber and 212 milligrams of potassium, which are both recommended in the Dietary Approaches to Stop Hypertension (DASH) diet.
Dr. Bays cautions that this was a single site study; larger trials are needed to confirm the blood pressure-regulating effect of raisins. Nonetheless, he says work in this area is particularly exciting because applying similar scientific methods to natural products, as required for drug development, provides consumers with objective data about which foods may or may not benefit heart health.
This study was funded by the California Raisin Marketing Board through a grant to L-MARC Research Center.

**Source: American College of Cardiology