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Dupilumab Safe, Effective in Kids With Moderate-to-Severe Asthma

Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.

A fully human monoclonal antibody, dupilumab also improved lung function vs placebo by week 12, an improvement that lasted the length of the 52-week trial.

Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.

Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.

Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.

Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.

Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥ 150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) and 259 patients with baseline blood eosinophils ≥ 300 cells/µl.

“The primary endpoint was the annualized rate of severe asthma exacerbations,” Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”

At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥ 300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.

Results also indicate a favorable safety profile for dupilumab.

Table. Safety Profile of Dupilumab vs Placebo
Event Placebo (No. of Patients [%]) Dupilumab (No. of Patients [%])
Any Treatment-Emergent Adverse Event (TEAE) 107 (79.9) 225 (83)
Any Treatment-Emergent Severe Adverse Event  6 (4.5)  13 (4.8)
Any TEAE leading to death  0 (0)  0 (0)
Any TEAE leading to permanent treatment discontinuation  2 (1.5)  5 (1.8)

James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told Medscape Medical News that adding the dupilumab option for children in the 6-11 age group is “huge.”

Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.

“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Tracy said.

More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.

Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”

Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.

“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.

Bacharier reported speaker fees and research support from Sanofi/Regeneron. Tracy has disclosed no relevant financial relationships.

European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021: Poster #938. Presented July 10, 2021.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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Topical Ruxolitinib Found Safe, Effective in 52-Week AD Study

After treatment with ruxolitinib cream for 52 weeks, between 60% and 80% of atopic dermatitis patients maintained clear or almost clear skin, with no safety signals, results from a long-term analysis of clinical trial data showed.

“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.

Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).

According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.

In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.

A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).

Long-term data

During the symposium, Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.

Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.

The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.

In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.

“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”

Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

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High blood pressure: One of the ‘most effective’ ways to lower your BP right now

A healthy blood pressure range falls between 90/60mmHg and 120/80mmHg, but many people – around a third of Britons – exceed those guidelines. What can be done about it right now? Lowering your blood pressure will be in your best interest to minimise the risk of:

  • Heart attack
  • Stroke
  • Kidney disease
  • Eye disease
  • Cognitive decline.

“You don’t have to embark on a major life overhaul to make a difference in your blood pressure,” noted Harvard Health Medical School.

“If you have a medical condition, you should consult a GP before starting,” the NHS cautioned.

To get a glimpse into what the NHS 12-week weight loss plan involves, week one details simple dietary swaps you can make for breakfast, lunch and dinner.

For example, “swap white bread for wholemeal or wholegrain varieties” for when you’re having a slice of toast.

When it comes to lunch, it’s advisable to swap white rice and pasta for wholemeal versions to increase your fibre content.

The plan also tells you the best type of protein to eat to feel fuller for longer. These are:

  • Beans, peas and lentils
  • Fish
  • Lean cuts of meat
  • Skinless white-meat poultry
  • Lower-fat dairy products (milk, cheese, yoghurt)
  • Eggs
  • Tofu
  • Quorn.

“No matter how healthily you eat, you can still put on weight if you’re eating too much,” the NHS warned.

So this is where portion control really comes in handy, which is why it’s helpful to:

  • Eat with smaller plates and bowels
  • To eat slowly
  • Not to eat in front of the TV
  • Aim for two portions of vegetables on your plate.

The NHS plan also gives advice for when you’re eating out, such as:

  • Avoid appetisers including bread, nuts or olives
  • Stay clear of ‘supersize’ or ‘go large’ options
  • If you’re having dessert, share it and go for fruit-based options
  • Stop eating before you feel full.

Did you know it can take around 20 minutes for your stomach to tell your brain that you’re full?

This is why it can be so easy to mindlessly keep eating, not realising that you’re stuffing in calories for the sake of it.

If you’d like to begin your weight loss journey right now the best thing you can do is download the NHS Weight Loss Plan.

The next step requires commitment and persistence, which is down to you.

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This post originally appeared on Daily Express :: Health Feed
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Lower Steroid Dose Proves Effective for New-Onset ANCA Vasculitis

A reduced dose of prednisolone plus rituximab was as effective as a conventionally high dose in treating patients with newly diagnosed antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis, according to a new Japanese study, along with significantly fewer adverse events as well.

“To our knowledge, this is the first trial in ANCA-associated vasculitis showing that a lower glucocorticoid dose may reduce serious adverse events,” wrote Shunsuke Furuta, MD, PhD, of the department of allergy and clinical immunology at Chiba (Japan) University Hospital, and colleagues. The study was published June 1, 2021, in JAMA.

To determine the most effective and safe dose of glucocorticoids for treating this specific subset of patients with vasculitis, the researchers launched an open-label noninferiority clinical trial at 21 hospitals in Japan. A group of 140 patients with new-onset ANCA-associated vasculitis (AAV) without severe glomerulonephritis or alveolar hemorrhage were enrolled and split evenly into two treatment subgroups: reduced-dose prednisolone (0.5 mg/kg per day) plus four doses of rituximab (375 mg/m2 per week) or high-dose prednisolone (1 mg/kg per day) plus rituximab. The median age for all enrolled patients was 73, and approximately 58% were women.

Of the 140 original patients, 134 (95.7%) completed the trial. After 6 months, 49 participants in the reduced-dose group (71%) and 45 in the high-dose group (69.2%) achieved remission, as assessed via the Birmingham Vasculitis Activity Score. The difference between the two groups – 1.8 percentage points (one-sided 97.5% confidence interval, –13.7 to infinity) – met the prespecified margin of –20 percentage points for noninferiority (P = .003 for noninferiority). Relapse within 6 months occurred in three participants in the reduced-dose group and zero in the high-dose group, frequencies that the researchers identified as not statistically different (difference, 4.3%; 95% CI, –0.5% to 9.3%; P = .24).

Serious adverse events occurred less frequently in the reduced-dose group (21 events in 13 patients, 18.8%), compared with the high-dose group (41 events in 24 patients, 36.9%), as did serious infections in the reduced-dose group (7 events in 5 patients, 7.2%) versus the high-dose group (20 events in 13 patients, 20%). Two patients died in the reduced-dose group and three died in the high-dose group; those frequencies were noted as not statistically different (difference, –1.7%; 95% CI, –4.7% to 8.2%; P = .67). Causes of death included subarachnoid hemorrhage in a 58-year-old in the reduced-dose group, along with a case of sepsis in an 80-year-old and two gastrointestinal bleedings in a 75-year-old and an 85-year-old in the high-dose group.

End-stage kidney disease (ESKD) occurred in one patient in the high-dose group and none in the reduced-dose group. Cumulative survival rates at 6 months were not significantly different between the reduced-dose (97.1%) and the high-dose (95.3%) groups (95% CI, –4.7% to 8.2%; P = .58).

Less Glucocorticoids Makes Sense for Subset of Patients With Milder Vasculitis

“We always worry about how much steroids we’re giving our patients,” said Anisha B. Dua, MD, an associate professor of rheumatology at Northwestern University, Chicago. “And it’s not a shock to find out that we can use less. That’s been the theme of many studies across vasculitities that have been coming out: ‘Maybe we are using too much steroids.’ It’s really important to have actual data supporting that, though, so clinicians can feel more confident and figure out what population it applies to.”

She added that, because the study focused on patients with milder disease, it’s no surprise that remission was achieved with a lesser dose.

“I see a lot of vasculitis patients, and this gives me more confidence in a subset of them – new ANCA vasculitis, MPO positive, not very severe disease – to get away with using less steroids up front,” she said.

To apply these findings more broadly across vasculitis patients, Dr. Dua stressed the need for a follow-up study, preferably a randomized, controlled trial, with an expanded population and a longer duration.

“There were 3 relapses in the low-dose group and zero in the high-dose group in the first 6 months,” she said. “I’d be interested to know when those happened and also, over time, whether the low-dose regiment up front impacts the rate of relapse in the long term.”

The authors acknowledged the study’s limitations, including the necessity of an open-label trial because of the inevitable visible effects of high-dose glucocorticoid on patients. They also addressed the potential subjectivity of the Birmingham Vasculitis Activity Score, though they added that “other endpoints, including death, ESKD, and serious adverse events, were objective.” Finally, they acknowledged that their study was nationwide but not international, with disease phenotypes that were typical of Japanese patients with AAV. That said, “previous studies have shown that treatment responses are similar between Japan and other countries,” they wrote.

The study was funded by an intramural competitive grant from Chiba University Hospital. The authors reported numerous potential conflicts of interest, including receiving grant support, lecture fees, and personal fees from various pharmaceutical companies.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

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Transradial Complex PCI Effective With Slim, Large-Bore Sheath

Transradial vascular access is often preferred over the transfemoral route in percutaneous coronary intervention (PCI) for its lower associated risks of bleeding and vascular complications. But transfemoral access is overall better at accommodating the larger catheters and sheaths frequently needed for PCI of complex lesions.

Now, a randomized trial adds to observational evidence that transradial complex PCI can be safely performed using thin-walled introducer sheaths that preserve the large-bore internal diameters of introducers used for femoral access but are slim enough for the radial artery.

Use of such a thin-walled 7F introducer sheath allowed complex-lesion procedures to reap the benefits of radial access without safety issues or sacrificing procedural success, the researchers report. The risk of clinically important bleeding or vascular complications needing intervention, the primary endpoint, in radial procedures was less than one-fifth of transfemoral-access procedures using standard 7F introducers.

Radial-access procedures in the 388-patient trial, called COLOR (Complex Large-Bore Radial PCI), exclusively used the Glidesheath Slender (Terumo) 7F thin-walled radial introducer sheath. Femoral procedures used standard 7F sheaths designed for femoral access.

“In the majority of complex PCI, we tend to use the 7F Glidesheath. It gives us the ability to use regular guiding catheters but is virtually one size [1F] smaller in outer diameter, so it will cause less radial-artery occlusion,” principal investigator Maarten A.H. van Leeuwen, MD, PhD, Isala Heart Center, Zwolle, the Netherlands, told theheart.org | Medscape Cardiology.

With that device, he said, “performing a complex PCI through the radial artery is similar to and as easy as in the femoral artery. I was convinced about that, but now also our study shows that it will lead to a similar procedural success rate as the in femoral artery.”

Other companies market such thin-walled introducers for radial access, including the RAIN Sheath (Cordis) and the Prelude IDeal (Merit Medical). The COLOR results may apply as well to them, “but that would require confirmation in studies because they are not completely similar,” said van Leeuven.

He is senior author on the trial’s publication May 18 in JACC: Cardiovascular Interventions. The results were also presented the same day by lead author Thomas A. Meijers, MD, Isala Heart Center, during the virtual Congress of European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021).

The multicenter randomized trial “confirms that radial access is safe even in complex PCI requiring large-bore guiding catheters, with fewer bleeding events and vascular complications compared with femoral access,” agrees an accompanying editorial. The reduced bleeding risk with radial access was driven by bleeding that met Bleeding Academic Research Consortium (BARC) 2 criteria, the editorialists observe.

Moreover, “procedural success and clinical outcomes are comparable between the two access sites in complex coronary lesions,” and the 3.6% rate of crossover from radial to femoral access was low, write Marco Valgimigli, MD, PhD, and Antonio Landi, MD, both from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.

The trial randomly assigned patients undergoing planned PCI for complex lesions — of which more than half were chronic total occlusions (CTO); the others included heavily calcified, left-main, and complex bifurcation coronary lesions — to the transradial or transfemoral procedures, 194 in each group. They received similar periprocedural medications and their activated clotting time levels were comparable, the group reports.

The procedural success rate was 89.2% for transfemoral and 86.0% for transradial cases (P = .29). The groups did not differ significantly in procedure duration, volume of contrast agent used, or radiation dose.

Rates of the primary endpoint reflecting bleeding and vascular complications at discharge were 19.1% for transfemoral and 3.6% for transradial procedures (< .001).

The discharge rate of major adverse cardiac events (MACE), which included death, myocardial infarction (MI), or repeat target-vessel revascularization, was not significantly different, at 2.6% and 3.1% for transfemoral and transradial cases, respectively.

Discharge MACE events in COLOR consisted entirely of periprocedural MI. Of note, the Ultimaster Tansei (Terumo) sirolimus-eluting stent had been “highly recommended” for all procedures but, ultimately, hardware choices, with the exception of the Glidesheath introducer, were left to operator discretion.

MACE rates at 30 days were 2.6% in the transfemoral-access group and more than twice as high, 6.7%, in the transradial-access group (P = .06).

“Importantly, one would expect that the mitigation of bleeding and vascular complications with radial access would favorably (or at least neutrally) affect the 30-day MACE rate,” the editorialists write.

But given that the numerically higher rate with transradial access was of “borderline statistical significance,” they continue, “in this regard, as properly acknowledged by the investigators, the trial is inconclusive, given the small sample size and the low number of events. Therefore, this finding should not be overemphasized.”

van Leeuwen agreed that the trial was grossly underpowered for MACE and, besides, there seemed to be no biologically plausible explanation for a higher MACE rate with transradial access. “So, it can only be hypothesis-generating.”

COLOR was supported by Terumo EMEA. van Leeuwen is a consultant for Terumo. Meijers reports no relevant relationships. Disclosures for the other authors are in the report. Valgimigli discloses receiving grants from Abbott, Terumo, Medicure, and AstraZeneca; and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia. Landi reports no relevant relationships.

JACC Cardiovasc Interv. Presented May 18, 2021. Abstract, Editorial

Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2021. Presented May 18, 2021.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

Author: Steve Stiles
This post originally appeared on Medscape Medical News Headlines

Two COVID shots effective against India variant: English health body

2/2 Two COVID shots effective against India variant: English health body© Reuters. FILE PHOTO: A phial of the Pfizer/BioNTech COVID-19 vaccine concentrate is diluted with 1.8ml sodium chloride ready for use at Guy’s Hospital. Victoria Jones/Pool via REUTERS/File Photo 2/2

LONDON (Reuters) – A double dose of COVID-19 vaccines is almost as effective against the fast-spreading variant of the coronavirus first identified in India as it is against Britain’s dominant strain, English health officials said on Saturday.

Britain’s health minister said the data was groundbreaking and he was increasingly hopeful that the government would be able to lift more COVID restrictions next month.

A study by Public Health England found the Pfizer-BioNTech vaccine was 88% effective against symptomatic disease from the B.1.617.2 variant two weeks after the second dose.

That compared with 93% effectiveness against the B.1.1.7 “Kent” strain which is Britain’s dominant COVID variant.

Two doses of the AstraZeneca (NASDAQ:) vaccine were 60% effective against symptomatic disease from the Indian variant compared with 66% effectiveness against the Kent variant, PHE said.

“I’m increasingly confident that we’re on track for the roadmap, because this data shows that the vaccine, after two doses, works just as effectively (against the Indian variant),” Health Secretary Matt Hancock told broadcasters.

Under the government’s plans, a lifting of remaining coronavirus restrictions is due to take place from June 21.

Britain has rushed out Europe’s fastest vaccination programme so far but it has faced a new challenge from the spread of the variant first found in India.

Data published on Saturday showed new COVID cases reported in Britain rose by 10.5% in the seven days to May 22 although it remained a fraction of levels seen earlier this year.

Prime Minister Boris Johnson this month ordered an acceleration of remaining second doses to the over 50s and people who are clinically vulnerable.

PHE said a first dose of both vaccines was 33% effective against symptomatic disease from B.1.617.2 after three weeks, lower than its 50% effectiveness against B.1.1.7.

Hancock said that showed that getting both doses of the vaccine was “absolutely vital.”

Concern about rising cases in Britain of the variant first found in India prompted Germany to say on Friday that anyone entering the country from the United Kingdom would have to quarantine for two weeks on arrival.

Also on Friday, the head of Germany’s public health institute said existing COVID-19 vaccines might be less effective against the B.1.617.2 variant.

X: Therefore doesn`t .

Author: Reuters
This post originally appeared on Stock Market News

AstraZeneca vaccine 97 percent effective against Indian Covid variant says new study

Health secretary Matt Hancock has said the Indian variant can “spread even faster” than the Kent variant and is “becoming the dominant strain in some parts of the country” such as Bolton and Blackburn.

But in Bolton, where a number of people have ended up in hospitals with the Indian variant, the “vast majority” of those patients have been eligible for a Covid vaccine but had not yet had one, Mr Hancock added.

Sir Mark Walport, a member of Sage, said while vaccines still seemed to be protecting people from severe Covid cases they appeared less effective at stopping transmission of the Indian variant.

The deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI), Professor Anthony Harnden, told BBC Radio 4’s Today programme: “The vaccines may be less effective against mild disease but we don’t think they’re less effective against severe disease.

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How to lose visceral fat: 'Short-term' keto diet is a ‘rapid and effective’ intervention s

Visceral fat is distinct from subcutaneous fat – the fat gathers around your belly area. It lurks near the liver and intestines, hiking the risk of metabolic complications, such as insulin resistance. Fortunately, you can reverse the harmful belly fat by making healthy dietary modifications.
Twenty young females consumed four weeks of a normal diet as a baseline and then switched to a low-carbohydrate, high-fat, and adequate protein keto diet for another four weeks.

The results showed that, without impairing the cardiorespiratory fitness level, the four-week keto diet intervention significantly reduced body weight and body mass index (BMI).

BMI is a measure that uses your height and weight to work out if your weight is healthy.

What’s more, waist circumference, hip circumference, and body fat percentage was reduced following the keto diet intervention.

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“These findings suggest that keto diet can be used as a rapid and effective approach to lose weight and reduce abdominal adiposity in overweight/obese Chinese females without exacerbating their cardiorespiratory fitness,” the researchers concluded.

Keto diet – what it involves

Harvard Health explains: “The diet aims to force your body into using a different type of fuel.

“Instead of relying on sugar (glucose) that comes from carbohydrates (such as grains, legumes, vegetables, and fruits), the keto diet relies on ketone bodies, a type of fuel that the liver produces from stored fat.”

According to the health body, because the keto diet has such a high fat requirement, followers must eat fat at each meal.

You should opt for unsaturated fats, such as nuts (almonds, walnuts), seeds, avocados, tofu, and olive oil, it advises.

“But saturated fats from oils (palm, coconut), lard, butter, and cocoa butter are encouraged in high amounts.”

Protein, which is a key part of the keto diet, has been shown to promote weight loss.

Bupa explains: “Protein can be a helpful way to lose weight because it makes you feel fuller than carbs and fat do.”

If you include a lean source of protein, such as skinless white chicken, in your meals you may find that you’re not as hungry, and so eat less, notes the health body.

Good sources include chicken breast, tuna, mackerel, salmon, eggs, milk, red lentils, chickpeas, brown bread, nuts and soya.

“And remember that a portion of protein is about as big as the palm of your hand,” notes Bupa.

It adds: “Alternatively, there are lots of protein products on the market, such as supplements and powders, but if you decide to use these make sure you have a trained sports dietitian or nutritionist supervising your diet.”

This article originally appeared on Daily Express :: Health Feed
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Pfizer vaccine: How effective is the Pfizer vaccine?

Pfizer is one of three vaccines being rolled out in the UK, alongside Moderna and Oxford/AstraZeneca. The AstraZeneca vaccine has been the focus of much analysis in the last few weeks following emerging reports of some patients experiencing blood clots after a dose of the vaccine. As a result, the UK has now stopped rolling it out to those under 30 years old, leaving many to look at vaccination alternatives. Pfizer/BioNTech’s vaccine was approved for use in the UK in December 2020, following extensive tests and clinical trials into its efficacy and safety.

How effective is the Pfizer vaccine?

The Pfizer vaccine is very effective at preventing a person becoming infected with COVID-19.

Latest data from Pfizer’s Phase III study, of their COVID-19 vaccine, BNT162b2, showed the vaccine is more than 90 percent effective in stopping the virus.

The updated analysis is from a data pool of 927 confirmed symptomatic Covid cases observed in a trial through until March 13.

The trial was carried out in line with guidance from the US’s Drug and Food Administration (FDA) for all firms assessing vaccines to review safety and efficacy.

READ MORE: Is the AstraZeneca vaccine safe for over 60s?

The Pfizer vaccine showed to be 95.3 percent effective against severe cases of COVID-19, as defined by the FDA.

The vaccine also appears to be effective for up to six months, as demonstrated in the trial.

Safety data from more than 12,000 vaccinated participants who were followed up for six months after their second dose showed increased safety and tolerance of the virus.

Vaccine efficacy of 100 percent in preventing Covid cases was seen in South Africa, where the new variant has been running rampant.

CEO and chairman of Pfizer, Albert Bourla, said: “These data confirm the favourable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA.

“The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”

Studies have also been conducted in the UK recently, which saw the effectiveness of the Pfizer vaccine come back high once more.

A study of 237 healthcare workers who were tested for antibody and T-cell responses was carried out as part of the largest and most analytical study not he immune system’s response following a Covid jab.

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Preliminary findings from the Department of Health and Social Care’s (DHSC) PITCH study, published on March 26, 2021, shows just one dose of Pfizer’s vaccine generates antibody responses in 99 percent of recipients. 

The PITCH data also shows that people who have previously had the virus generate stronger T-cell and antibody responses following one dose of the Pfizer vaccine.

The study shows that after two doses, the levels of protection with the Pfizer vaccine were even greater, which underlines the importance of not missing your second dose.

Researchers discovered among people who’d contracted the virus in the past, the T-cell response widened after vaccination, and recognised more areas of the Covid spike protein – the part of the virus which attacks the immune system and causes severe disease.

This means that, even if you’ve already been infected, one dose of Pfizer’s vaccine will provide you with better protection and enhanced immune responses to the virus than through natural infection.

One dose of Pfizer’s jab provides a good level of protection, but to be fully shielded from Covid, you should get both doses as soon as you’re invited to do so.

Health Minister Lord Bethell said: “These findings from the PITCH study are crucial to increasing our understanding of the immune response to COVID-19 and how the Pfizer vaccine is working to protect people across the UK already.

“I urge everyone to come forward to be vaccinated when invited and to take up both doses of the vaccine as both are vital to ensuring long-term protection from COVID-19.”

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