lemborexant

TOKYO and STAMFORD, Conn. – January 15, 2019 – Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, “Purdue Pharma”) today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.

This application was based on the results of two pivotal Phase 3 clinical studies in patients with insomnia, SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303), enrolling approximately 2,000 patients, as well as important safety studies, including assessment of postural stability after middle-of-the-night awakening and a next-morning driving study. SUNRISE 1, a one-month, double-blind, placebo-controlled study, included the first ever Phase 3 head-to-head comparison versus zolpidem ER and objectively assessed sleep parameters (time to sleep onset, sleep efficiency, and wake after sleep onset) resulting in the largest (objective) polysomnography dataset collected to date in patients with insomnia. SUNRISE 2 was a 12-month study and subjectively assessed for ability to fall asleep and stay asleep based on patient self reports (sleep diaries).

Lemborexant, which acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli, is being jointly developed by Eisai and Purdue Pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.

Eisai and Purdue Pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

 About Lemborexant

Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling which regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep.

About SUNRISE 1 (Study 304)

SUNRISE 11 was a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study evaluating the efficacy and safety of lemborexant in 1,006 male or female adult patients 55 years and older (45 percent of patients were 65 years and older) with insomnia disorder conducted in North America and Europe. SUNRISE 1 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a 30-day treatment period and a minimum two-week period without treatment prior to the end-of-study visit. In this study, patients were randomized to receive placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg). The primary objective for SUNRISE 1 was to demonstrate using polysomnography that lemborexant at either the 5 mg or 10 mg dose is superior to placebo on objective sleep onset, as measured by latency to persistent sleep after the last two nights of one month of treatment. Key secondary objectives included change from baseline in sleep efficiency and wake after sleep onset (WASO) for both lemborexant doses compared to placebo, and WASO in the second half of the night (WASO2H) for both lemborexant doses compared to zolpidem ER, each after the last two nights of one month of treatment.

About SUNRISE 2 (Study 303)

SUNRISE 22 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 male or female adult participants 18 to 88 years of age with insomnia disorder. SUNRISE 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment and a two-week period without treatment prior to the end-of-study-visit. In this study, during the placebo-controlled treatment period, patients were randomized to receive placebo or one of two treatment regimens (lemborexant 5 mg or 10 mg). During the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg. Patients who received active treatment during the first period continued on the treatment to which they were originally randomized. The primary objective was to determine the efficacy of lemborexant 5 mg and 10 mg compared to placebo on patient-reported (subjective) sleep onset latency after six months of treatment. Key secondary endpoints were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset (sWASO) for lemborexant 5 mg and 10 mg compared to placebo after six months of treatment.

About Sleep Disorders

Population studies show that sleep disorders affect many more people worldwide than previously thought.3 Insomnia disorder is the most common sleep disorder affecting approximately 30 percent of the adult population worldwide.3,4 Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.5,6

Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.5,7

Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.8 Studies suggest an optimal sleep duration between seven and eight hours.9

Women are 1.4 times more likely than men to suffer from insomnia.10 Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.11

About Eisai Co., Ltd

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

About Purdue Pharma L.P.

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue Pharma is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.

References

Source: Eisai Co., Ltd.

Posted: January 2019

lemborexant FDA Approval History

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FDA Approves First Generic Version of Sabril to Help Treat Seizures in Adults and Pediatric Patients with Epilepsy

January 16, 2019 — The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

“Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year,” said FDA Commissioner Scott Gottlieb, M.D. “We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Today’s action demonstrates that there is an open pathway to approving products like this one. We’re especially focused on new policies aimed at making the generic review process more predictable, efficient and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals. We know it’s not enough just to approve a record number of generic medicines. We also want to see firms launch these products so that patients can benefit from their availability, and we intend to take steps to advance these goals.”

Complex partial seizures, a common type of seizures, start in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds, and are often followed by a period of disorientation, confusion and/or fatigue.

The FDA requires appropriate data and information to demonstrate that generic drugs meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts. As with brand-name drugs, the FDA also inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. Teva’s generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure safe use of the product. Brand and generic drug makers are required to develop a single shared-system REMS program (unless FDA waives the single shared system requirement) when a generic drug seeks approval and the brand drug has a REMS associated with it.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness (somnolence), involuntary eye movement (nystagmus), tremor, blurred vision, memory impairment, weight gain, joint pain (arthralgia), upper respiratory tract infection, aggression, double vision (diplopia), abnormal coordination and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.

Last year, the FDA began to publish a list of inquiries from generic drug developers seeking the FDA’s assistance in obtaining samples from brand companies, which included Sabril, noting these brand companies were potentially blocking access to the samples of their brand products when the brand products are subject to limited distribution programs, including REMS. The FDA has continued to emphasize that even in the case of limited distribution programs, there should be a path forward for generic drug development. Additionally, the FDA’s list of off-patent, off-exclusivity branded drugs without approved generics is an effort the FDA began in 2017 and will continue to refine and update periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.

Today’s approval of generic vigabatrin tablets was granted to Teva Pharmaceuticals USA.

Source: FDA

Posted: January 2019

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A new way by which the human brain marks time: Novel findings may further understanding of age-related dementia

With a little help from HBO’s “Curb Your Enthusiasm,” University of California, Irvine neurobiologists have uncovered a key component of how the human brain marks time.

Using high-powered functional MRI on college students watching the popular TV show, they were able to capture the processes by which the brain stores information related to when events happen, or what is known as temporal memory. The study appears in Nature Neuroscience.

The researchers identified a new network of brain regions involved in these processes, confirming in humans the results of mouse studies reported last summer by Nobel laureate Edvard Moser and colleagues, who pinpointed the nerve cells in the same areas that give each moment a distinctive signature. A News & Views article in Nature Neuroscience highlights how these findings fit together.

Michael Yassa, director of UCI’s Center for the Neurobiology of Learning & Memory and senior author on the study, said the research may further understanding of dementia, as these temporal memory regions are the first to experience age-related deficits and also show some of the first pathological hallmarks of Alzheimer’s disease, most notably tangles.

“Whether these alterations have consequences for time-related memory remains to be seen; it’s something that we are currently testing,” he added.

Real-time brain imaging

In the UCI study, participants sat with their heads inside a high-resolution fMRI scanner while watching the TV show and then viewing still frames from the episode, one at a time.

The researchers found that when subjects had more precise answers to questions about what time certain events occurred, they activated a brain network involving the lateral entorhinal cortex and the perirhinal cortex. The team had previously shown that these regions, which surround the hippocampus, are associated with memories of objects or items but not their spatial location. Until now, little had been known about how this network might process and store information about time.

“The field of neuroscience has focused extensively on understanding how we encode and store information about space, but time has always been a mystery,” said Yassa, a professor of neurobiology & behavior. “This study and the Moser team’s study represent the first cross-species evidence for a potential role of the lateral entorhinal cortex in storing and retrieving information about when experiences happen.”

“Space and time have always been intricately linked, and the common wisdom in our field was that the mechanisms involved in one probably supported the other as well,” added Maria Montchal, a graduate student in Yassa’s lab who led the research. “But our results suggest otherwise.”

Testing time-related memory

Yassa said it’s worth noting that his group published another report last year in Neuron showing that the lateral entorhinal cortex is dysfunctional in older adults with lower-than-average memory performance. That study did not test memory for time but rather discrimination memory for similar objects.

Most studies examining time in the laboratory employ static objects on a computer screen, Yassa said, but they tell very little about how the brain processes information in the real world. This is why the UCI study used “Curb Your Enthusiasm,” a situational comedy that mirrors real life, as it involves people, scenes, dialogue, humor and narrative.

“We chose this show in particular because we thought it contained events that were relatable, engaging and interesting,” he said. “We also wanted one without a laugh track. Interestingly, while the show is hilarious for some of us, it did not seem to instigate a lot of laughter among the college undergraduates we tested — which was excellent for us, as we needed to keep their heads inside the scanner.”

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Digestion: This green onion plant promotes intestinal activity positive

Leeks: onion plant can contribute to good intestinal health

Leek belongs to due to its low calorie content to the “lean” varieties of vegetables. The healthy onion plant contains essential vitamins and minerals. Regular consumption of Leeks can contribute to good intestinal health.

A “slim” vegetable

Leeks not only contains a lot of fiber and plenty of folate, but it is also a supplier for the vitamins E, B1, B6, C and K. in Addition, are included in the Leek of important minerals such as potassium, calcium, Magnesium and iron. How the consumer writes Central Bremen, in a communication, belongs to the bulbous plant of the “lean” varieties of vegetables. 100 grams of contain only 30 calories.

Leek nourishes the beneficial intestinal bacteria

Similar to the onion and leek are attributed to antibiotic effects, this is a result of the contained sulphur-containing essential Oils.

According to the consumer regular consumption of leeks can contribute to good intestinal health.

The vegetable stimulates the bowels and nourishes the beneficial intestinal bacteria.

Versatile

Leek has a spicy-tart, slightly onion-like Aroma. It is ideal as an ingredient for a vegetable broth. However, more than a healthy Soup is leeks.

The vegetables can serve as a spice, but also raw, boiled, or sautéed to be eaten. Most of the vitamins of leeks contains, if it was only briefly heated.

The green and white rods to taste in casseroles, pies, Quiches, Pasta sauces, salads or simply as a side dish to meat or fish.

Not together with aroma-sensitive food store

When buying the vegetables is contaminated often with Sand and earth. You should cut fresh chives to Clean the longitudinal, fan-like bend apart and rinse under running water.

The consumer, according to Leek in the fridge up to five days.

Due to its intense smell, it should not be stored together with flavor-sensitive foods, such as milk,.

The reason for the intense smell and Aroma of the leeks, the so-called Allicin, which also contributes in the case of garlic for the health benefits.

This sulfur compound acts according to health experts, anti-bacterial and anti-oxidant, protects the body cells from free Radicals. (ad)

3 Ways to Make Grapefruit Taste Freakin' Amazing

Grapefruit is great fruit. One cup of grapefruit sections have about 3 grams of fiber for around 70 calories and, because grapefruit has such high water content, it’s also good for hydration.

Yet, how do you typically eat grapefruit? Halved and half-heartedly dug out with a spoon? If you’re being honest, you probably don’t even really like eating the stuff. But that’s only because you haven’t enjoyed it the right way.

If you think of grapefruit as an ingredient that you can combine with others, instead of the main focus, you’ll begin to appreciate the sweet-sour citrus fruit more.

And what better time than right now, when citrus is at its peak season?

Try these three great grapefruit recipes.

Blend It: Grapefruit Smoothie

Hearst Test Kitchen

In a blender, puree, ½ ruby red grapefruit (peeled), ¾ cup fresh orange juice, 2 cups frozen mango chunks and ¼ cup Greek yogurt* (*optional; if omitting, add ¼ cup more orange juice) until smooth. Feeds 1

Broil It: Caramelized Rosemary Grapefruit

Hearst Test Kitchen

Preheat your broiler. Halve a grapefruit and place both halves on a rimmed baking sheet. Sprinkle each half with ½ tsp chopped fresh rosemary and 1 tsp sugar. Broil just until the sugar starts to caramelize, 1 to 2 minutes. Feeds 2

Marinate With It: Grapefruit Marinated Steak

Hearst Test Kitchen

1. In a blender, puree ¼ cup fresh grapefruit juice, 4 scallions(thinly sliced), zest of 1 lime, 1 clove garlic (pressed), 2 Tbsp fish sauce and 2 tsp honey until smooth. Transfer to a bowl, add 1½ skirt steak (cut into 4-in pieces), turn to coat and refrigerate for at least 30 minutes.

2. Heat a grill pan or grill over medium-high. Remove from marinade and grill to desired doneness, 2 to 4 minutes per side for medium-rare; let rest 10 minutes before slicing.

3. In a bowl, whisk together 2 Tbsp each olive oil, fresh grapefruit juice and fresh lime juice and ½ tsp each salt and pepper. Remove the peel and pith from 1 grapefruit and sliced. Add to the vinaigrette along with 1 small English cucumber (sliced) and 2 scallions (sliced) and toss to combine. Fold in 5 cups arugula or baby kale and sliced steak. Feeds 4 to 6

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Advances in the study of drugs to combat cognitive impairment in schizophrenia

A study by the UPV/EHU has assessed whether drugs used to delay cognitive deterioration in patients with Alzheimer’s are effective in improving cognitive impairments in patients with schizophrenia. Through an analysis of nine clinical trials carried out worldwide, the researchers specified a series of methodological improvements in the study of drugs that ensure the functional recovery of these patients.

Schizophrenia is a serious, chronic mental disorder, and one of the leading causes of disability worldwide. Various symptoms of this disorder, such as delusions and hallucinations, are treatable by means of antipsychotics, improving symptomatology. Yet patients experience many difficulties on a social and functional level. In other words, “they have severe problems in carrying out everyday life activities ranging from personal hygiene or managing their finances to maintaining a stable social network, having a partner or holding down a job. And there is no treatment for this,” said neuropsychologist Arantzazu Zabala, one of the authors of the work.

Since 2000, explained Zabala, “it has emerged that it is the cognitive impairments that correlate most with functional deficits, and since then, to combat these deficits, the scientific community has been developing a broad range of interventions, including cognitive enhancers. These are drugs which, when added to the routine, antipsychotic treatment, could reverse, or to a certain extent, reduce the cognitive impairments displayed by patients.”

Nine clinical trials from around the world were analysed in a study conducted by researchers from the UPV/EHU, the University of La Rioja, the BioCruces Health Research Institute and Cibersam (Centre for Biomedical Research into Mental Health). The trials involved patients with schizophrenia and used three acetylcholinesterase inhibitors (deonepezil, galantamine and rivastignine), which are effective in improving the cognitive impairments of patients with Alzheimer’s.

Zabala said, “Right now, there is insufficient evidence to be able to recommend acetylcholinesterase inhibitors as a cognitive enhancer for patients with schizophrenia.” In fact, numerous limitations in the nine trials studied have emerged in this meta-analysis, and various improvements that need to be applied to studies of this type have been proposed.

Dr. Zabala is nevertheless optimistic: “Much work remains to be done, but it’s heading in the right direction.” The researcher insists that the trials “are original pieces of work, are among the first ones, but right now, the therapeutic targets have expanded greatly. Our work draws attention to the need for studies that will offer sufficient methodological quality to be able to guarantee the effectiveness of the compounds.”

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‘Amazing’ toddler survived sepsis and FOUR bouts of meningitis

Toddler who survived sepsis and FOUR bouts of meningitis may never walk or talk because of brain damage – but his parents say he is the ‘happiest boy you will ever meet’

  • Luca Johnson – who has a twin called Lola – was born 12 weeks premature 
  • He survived sepsis and four bouts of meningitis before he was nine months
  • Doctors have now warned the brain damage could stop him from ever walking 
  • But his mother, Jodie, 30, says she has faith her son will defy the odds again 
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Luca Johnson may have already had five close shaves with death but his parents say he is the ‘happiest boy you’ll ever meet’.

The toddler, who was born 12 weeks premature, has been left with extensive brain damage after surviving sepsis and four bouts of meningitis. 

Doctors have warned the now 18-month-old may never walk, talk or even sit up on his own because of the lasting damage.

But Luca’s mother, Jodie, 30, says she has every faith her ‘amazing’ son – who has a twin sister called Lola  – will defy the odds once again because ‘anything is possible’. 


The toddler, who was born 12 weeks premature, has been left with extensive brain damage after surviving sepsis and four bouts of meningitis (pictured with twin sister Lola)

Speaking about her son’s uncertain future, the full-time carer said: ‘We just don’t know what or how his future will play out.

‘I still get emotional now, but it’s Luca who keeps us all going with his big smile. He’s the happiest boy you will ever meet.

‘He has physio every week to build his strength, so he may never sit up, walk or talk.

‘But with plenty of physio and dedication I believe anything is possible. I have every faith in him.

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Mrs Johnson, from Leigh, Greater Manchester, added: ‘He has a very long road ahead of him, but I think 2019 is Luca’s year.

‘I want to show the world what an amazing little boy he is and what an inspiration he will be to others. 

‘Even though he has brain damage, it doesn’t stop him and it’s not the end of the world.’ 

Mrs Johnson and her husband Matthew, 28, found out they were expecting twins in May 2017 – a year after she gave birth to their son Nova.


Luca’s mother, Jodie, 30, says she has every faith her ‘amazing’ son – who has a twin sister called Lola – will defy the odds once again because ‘anything is possible’

They hoped the pregnancy would go as smoothly as their first – but things took a turn for the worse when her labour started at just 26 weeks.

Mrs Johnson was then whisked away to Bolton Hospital in an ambulance but the twins’ heart rate were beginning to slow down.

Doctors knew an emergency caesarean was required, and they were delivered by ‘amazing’ medical staff on September 24, weighing just 2lbs each.

Lola exceeded all expectations during her stint in intensive care. Though, Luca was not as fortunate, spending three months needing round-the-clock care.  

Luca contracted sepsis – a violent, and often fatal, immune response to an infection – when he was just six weeks old. He was given morphine to control the pain.

After overcoming the odds to beat sepsis, he then contracted bacterial meningitis a month later, aged just 11 weeks.

Luca’s parents were finally allowed to take their son home from intensive care on Christmas Day, weighing just 4lb 10oz.


Mrs Johnson added: ‘He has a very long road ahead of him, but I think 2019 is Luca’s year’ (pictured with her husband Matthew, Luca, Lola and their other son Nova)

He went on to endure meningitis three more times – in March, May and June 2018 – before he was nine months old, leaving him with permanent brain damage. 

Luca has since been diagnosed with periventricular leukomalacia (PVL) – a type of brain injury common in premature babies.

And he is also known to have a form of cerebral palsy, another form of brain injury that severely affects his development.  

Mrs Johnson spent months questioning why someone was so badly trying to take her son away from her, after nearly losing him on countless occasions. 

She said: ‘Luca has had to fight since the day he was born because he had life threatening infections and he was ventilated for two weeks.

‘At just six weeks old he got sepsis. He should have still been in my belly at that time, but we were very close to losing him.


Mrs Johnson said they first noticed something was wrong with Luca during his third bout of meningitis (pictured with her husband Matthew, Luca, Lola and their other son Nova)

‘Then at 11 weeks old he caught bacterial meningitis before being on antibiotics for three weeks.

‘We thought we were over the worst but little did we know that in March 2018 he would be back in hospital for his second bout of bacterial meningitis.

‘Only a few weeks later, in May things took another turn for the worst and we found ourselves back in hospital to hear the news that he had meningitis again.’

Mrs Johnson said they first noticed something was wrong with Luca during his third bout of meningitis.   

She added: ‘By June of that year my boy got ill again. I thought that it couldn’t surely have been the same cause again. 

‘We took him to the hospital to be seen to once again only to be told the bad news yet again that he had meningitis for a fourth time, and he was only nine months old.’

Mrs Johnson added: ‘It was the scariest thing I have ever gone through and it wasn’t just once we went through it.

‘It felt like a nightmare that never ended, but all I could do was hope that some sort of miracle would happen.’

An MRI and CT scan then showed he had extensive brain damage.  

Mrs Johnson said: ‘We needed a bit of time to process things because nothing will ever prepare you for being told your boy has brain damage.’

WHAT IS MENINGITIS?

Meningitis is inflammation of the membranes that surround and protect the brain and spinal cord.

Anyone can be affected but at-risk people include those aged under five, 15-to-24 and over 45.

People exposed to passive smoking or with suppressed immune systems, such as patients undergoing chemotherapy, are also more at risk.

The most common forms of meningitis are bacterial and viral.

Symptoms for both include:

  • Pale, blotchy skin with a rash that does not fade when compressed with a glass
  • Stiff neck
  • Dislike of bright lights  
  • Fever, and cold hands and feet
  • Vomiting
  • Drowsiness 
  • Severe headache 


Headache is one of the main symptoms

Bacterial meningitis 

Bacterial meningitis requires urgent treatment at hospital with antibiotics.  

Some 10 per cent of bacterial cases are fatal.

Of those who survive, one in three suffer complications, including brain damage and hearing loss. 

Limb amputation is a potential side effect if septicaemia (blood poisoning) occurs.

Vaccines are available against certain strains of bacteria that cause meningitis, such as tuberculosis.

Viral meningitis 

Viral is rarely life-threatening but can cause long-lasting effects, such as headaches, fatigue and memory problems. 

Thousands of people suffer from viral meningitis every year in the UK. 

Treatment focuses on hydration, painkillers and rest.

Although ineffective, antibiotics may be given when patients arrive at hospital just in case they are suffering from the bacterial form of the disease. 

Source: Meningitis Now 

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Eat to live, not to shrink

There are almost eight billion people on Earth and possibly 9 billion ideas of the perfect diet but there is no scientific proof the latest fad diet will work.

Food has evolved from a means of survival and metabolising energy into an undefined entity. It comes from all over the globe, in fashionable phases, and innumerable forms and culinary permutations. Our ancestors would be scratching their heads if they came across a multi-coloured quinoa Buddha bowl – although that wouldn’t be a bad lunch option.

Food as the key to being healthy, slim, satiated and to achieve longevity is even more of a conundrum, but Wits University experts agree – fad diets are not the answer. Intermittent fasting, prehistoric diets, nano-level blood diets, Banting and ketone counting are not only ineffective for long-term health, they may do more harm than good.

There is evidence that fad diets may be harmful, and eliminating foods (such as carbs) from a balanced diet can possibly cause apoptosis or cell death. Professor Gavin Norton, Co-Director of the Cardiovascular Pathophysiology and Genomic Research Unit at Wits, says, “I believe very little in fad diets as by their very nature there is no evidence that they save lives. Even more established diets, such as low-salt diets, have never been shown to save lives and more evidence shows that they may in fact kill us. The only diet ever to show benefit is a Mediterranean diet. The safest thing to do is eat a balanced diet with all the nutrients recommended by professional nutritionists who, if trained properly, would never recommend a fad diet to begin with.”

Dr. Sandra Pretorius, who deals with non-communicable diseases at the Centre for Exercise Science and Sports Medicine at Wits, says human beings should avoid any diet that eliminates or severely restricts entire food groups, such as carbohydrates. “Even if you take a multivitamin, you’ll still miss out on some of the crucial macro- and micronutrients or vitamins and minerals,” she says. “Also, avoid diets that allow unlimited quantities of any food, such as grapefruit and cabbage soup. It’s boring to eat the same thing over and over and hard to stick with monotonous plans.”

Pretorius adds any diet that excludes exercise is unlikely to work for weight loss.

What about the weight?

“Given our individual uniqueness there is no universal diet which fits all,” says Associate Professor Kennedy Erlwanger from the School of Physiology in the Faculty of Health Sciences at Wits, whose research explores food and nutrition and its impacts on metabolic health.

“Generally, one considers diets as a means to accomplishing weight loss, with the target nutrient culprits being fat and sugar or carbohydrates. It is important to note that these are normal dietary requirements, which have specific important roles in our well-being. The various iterations of diets revolve around the source, type, quantity and frequency of intake as well as the quality of these nutrients,” he says.

Instead, says Erlwanger, focus on the point of nutrition, which is “to produce healthy outcomes which include appropriate growth, disease-free states, physical and emotional well-being”. Remembering that some people need specific diets for unique situations, such as post-surgical recovery or muscle building for athletes, Erlwanger says there is a type of diet that should work for most of us to live long, healthy (and hopefully moderately sized) lives. In simple terms, it is the Mediterranean diet – and for no other reason than the science has shown results.

Food, flora and family

“Studies on populations where a larger proportion than that of the rest of the world’s population is characterised by longevity, low incidence of metabolic diseases, hypertension and cancers, show that the food consumed is unrefined, plant-based, relatively meat free, high in seeds and nuts – Mediterranean,” says Erlwanger.

But it isn’t just about the food. It is how you consume it and what goes along with the lifestyle. “Familial closeness and physical activity are key components of lifestyle in these healthy populations,” he says.

And don’t forget your gut. Increasingly, the microflora and fauna in the gut has been proven to affect everything from our digestion to mental health.

The next step to healthier diets is personalised nutrition says Erlwanger. This is a tailor-made approach “based on physical, biochemical and genetic profiles, amongst other biological factors” and another reason you can’t turn to a fad diet, because what may work for a friend, might not work for you.

Food fights

While we may see evidence of weight-loss in those who follow fad diets, and that menus cater more frequently for those who want to leave the buns off a burger, Professor Demitri Constantinou, Director of the Centre for Exercise Science and Sports Medicine says the evidence should be more reliable than “popularity”.

“People are all different and have different pathology, which may mean they may in fact react differently to similar diets. Very often, fads are driven by popularity and certain industries,” says Constantinou.

“What we know about good nutrition and diet is that even within the scientific sphere there is a lot of controversy. The American Heart Association removed saturated fats and replaced them with polyunsaturated fats, for instance, but if you look at the evidence, this may not reduce your risk of heart disease. Lots of the advice we see is not evidence-based. In the absence of very obvious choices, like too much sugar being unhealthy, the average person has a problem making decisions because even scientists are not convinced one way or another!”

However, Constantinou says that what evidence has showed does lean toward the Mediterranean diet, because it is supported by research. This means moderation, and portions of fruit, vegetables and legumes.

“It is largely plant-based meals with a moderate intake of meat, using things like herbs instead of salt. Obviously in the Mediterranean, butter and margarine don’t feature, and olive oil is preferred.”

We eat what we think

But at the heart of the matter is that old human conditioning towards the ‘quick fix’.

Constantinou says he has seen extreme dieting in patients, one who ate only grapes for a week or two. “It’s a component of the Mediterranean diet but that is not sensible. It is about desperation. People seek to have something that is going to give them the most benefit the quickest – ‘if you do this, this is what is going to happen’ – that isn’t how it works,” he said.

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Claims that bilingualism keeps brains young could be ‘wishful thinking’

Speaking two languages is a highly valuable skill but is an unlikely defence against age-related cognitive decline as previously thought, according to new research on ageing and bilingualism.

Scientists from the Donders Institute for Brain, Cognition and Behaviour at Radboud University in the Netherlands have been studying how bilingualism might protect against a deterioration in mental processing as people age. Older bilingual people were asked to perform attention and memory tasks while the research group scanned their brains to study interactions between different types of brainwaves.

“We wanted to know what is going on in the brain when people are starting to experience attention problems,” explained Professor Ole Jensen, who supervised the project and now heads the Neuronal Oscillations research group at the Centre for Human Brain Health at the University of Birmingham, UK.

The study, which was carried out as part of a project called NeWMaBIL, confirms that older people are less able than younger subjects to modulate their brainwaves when their attention shifts, however no link has been found between bilingualism and age-related attention deficits.

“The initial idea was that if you were bilingual, you were better at executive functioning,” said Prof. Jensen, referring to processes including memory, attention and problem solving. “The study’s results are still being analysed, but it would seem that the data is not there to demonstrate this bilingual advantage.”

He added, “It’s good to learn two languages for a lot of reasons – including social interactions and travel – but I suspect executive control is secondary.”

Decline

It is widely known that cognitive abilities generally decline as people grow old. What researchers are yet to conclude is what constitutes normal ageing. By developing a better understanding of the changes experienced in the interior – or subcortical – regions of both healthy and unhealthy brains, targeted healthcare strategies can be created to help individuals who are experiencing attention problems as they age.

“Different problems could have different sources and therefore require different interventions,” said Prof. Jensen.

As the length of life and the incidence of dementia increase worldwide, scientists are under growing pressure to identify factors that will attenuate the negative effects of ageing on cognitive control. Until the 1960s, it was commonly believed that bilingualism had a negative impact on the brain, creating confusion and ultimately damaging cognition.

Not only has this argument since been laid to rest but several studies from the early 2000s concluded bilingualism had a positive impact on ageing, delaying the onset of age-related neurological decline. It was suggested that people who regularly spoke multiple languages outperformed monolinguals in important cognitive tasks.

What was thought to trigger this bilingual advantage? The constant management of two competing languages. This skillful mental dance – where attention was both maintained and shifted as the speaker moved from one language to the next – was believed to confer an element of protection against age-related cognitive decline.

In 2013, a ground-breaking study published in the American Academy of Neurology concluded that bilingual patients developed dementia a staggering 4.5 years later than monolingual ones.

Replicate

But attempts to replicate the findings of these studies have largely failed, and a growing number of laboratory studies and meta-analyses of existing studies have struggled to confirm the link between speaking multiple languages and better cognition.

“The debate hasn’t been settled yet but I suspect the claims (of bilingual advantage) are partially driven by wishful thinking,” said Prof Jensen. “It sounds very nice that learning multiple languages will improve your executive function, but so far the data is not there to make a strong conclusion.”

Much of the research on the cognitive effects of bilingualism is based on the theory that bilingual language control is effortful, says Angela de Bruin, a postdoctoral researcher from the Basque Center on Cognition, Brain and Language, in Spain. However, she argues that using two languages does not always have to require a lot of effort. More research is needed to refine our understanding of how much effort correlates with healthy ageing, she says.

Usually, studies are lab-based and require bilinguals to alternate languages in response to cues indicating which language to use and when to switch. For instance, a picture of a horse may appear on screen, and the study participants must name it in a given language. When the image changes, the language in which the picture needs to be named changes too. Switching requires effort and the bilingual brain is in constant conflict.

“These studies measure how fast a person can name a picture,” said de Bruin. “Ageing … comes with decline, which means naming slows down. But that’s not necessarily a problem or even the full story.”

In Dr. de Bruin’s work on a project called CAB, Basque/Spanish speakers in the Basque Country were asked to name pictures in their language of choice. Dr. de Bruin found that bilinguals switched frequently between Spanish and Basque when they were allowed to naturally switch between languages.

When she measured how much time they needed to name pictures, she discovered that bilinguals – even the elderly – produced words significantly faster when they were free to pick their language than when they were following language instructions.

“Where older people really have to control their language, maybe it’s more effortful to switch,” she said. “But when they are with other bilinguals it doesn’t need to be that effortful.”

She also said there may be factors that offset problems with speed. “Older adults may be slower to name a picture but they have a wider vocabulary. We over emphasise what goes wrong with age.”

Dr. de Bruin continues to investigate the language switching habits of bilinguals in both young and ageing brains. She believes it is not the link between bilingualism and cognitive decline that needs further investigation but rather the relationship between language deterioration in bilinguals and disease.

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Healthy digestion: This bulbous plant influences the bowel activity positive

Leeks: onion plant can contribute to good intestinal health

Leek belongs to due to its low calorie content to the “lean” varieties of vegetables. The healthy onion plant contains essential vitamins and minerals. Regular consumption of Leeks can contribute to good intestinal health.

A “slim” vegetable

Leeks not only contains a lot of fiber and plenty of folate, but it is also a supplier for the vitamins E, B1, B6, C and K. in Addition, are included in the Leek of important minerals such as potassium, calcium, Magnesium and iron. How the consumer writes Central Bremen, in a communication, belongs to the bulbous plant of the “lean” varieties of vegetables. 100 grams of contain only 30 calories.

Leek nourishes the beneficial intestinal bacteria

Similar to the onion and leek are attributed to antibiotic effects, this is a result of the contained sulphur-containing essential Oils.

According to the consumer regular consumption of leeks can contribute to good intestinal health.

The vegetable stimulates the bowels and nourishes the beneficial intestinal bacteria.

Versatile

Leek has a spicy-tart, slightly onion-like Aroma. It is ideal as an ingredient for a vegetable broth. However, more than a healthy Soup is leeks.

The vegetables can serve as a spice, but also raw, boiled, or sautéed to be eaten. Most of the vitamins of leeks contains, if it was only briefly heated.

The green and white rods to taste in casseroles, pies, Quiches, Pasta sauces, salads or simply as a side dish to meat or fish.

Not together with aroma-sensitive food store

When buying the vegetables is contaminated often with Sand and earth. You should cut fresh chives to Clean the longitudinal, fan-like bend apart and rinse under running water.

The consumer, according to Leek in the fridge up to five days.

Due to its intense smell, it should not be stored together with flavor-sensitive foods, such as milk,.

The reason for the intense smell and Aroma of the leeks, the so-called Allicin, which also contributes in the case of garlic for the health benefits.

This sulfur compound acts according to health experts, anti-bacterial and anti-oxidant, protects the body cells from free Radicals. (ad)

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