Benefit

health

Don’t Give up on COVID-19 Plasma, Experts Say, After Study Finds No Benefit | Top News

LONDON (Reuters) – Researchers called on Friday for more research into using blood from recovered COVID-19 patients – or so-called convalescent plasma – as a potential treatment, after a small trial of hospitalised patients in India found it was of no benefit

The Indian results, published in the BMJ British Medical Journal, found that the plasma, which delivers antibodies from COVID-19 survivors to infected people, did not help hospitalised patients fight off the infection, and failed to reduce death rates or halt progression to severe disease.

The findings are a setback for a potential therapy that U.S. President Donald Trump touted in August as a “historic breakthrough”, and one experts say has been used in some 100,000 patients in the United States already, despite limited evidence on its efficacy.

Scientists not directly involved in the India study, which involved around 460 patients, said its results were disappointing but should not mean doctors give up hope altogether on convalescent plasma.

They said further and larger trials are needed, including in COVID-19 patients with milder disease and those newly infected.

“With just a few hundred patients, (the India trial) is still much too small to give clear results,” said Martin Landray, a professor of medicine and epidemiology at Britain’s Oxford University.

“One could well imagine that the treatment might work particularly well in those earlier in the course of the disease or who have not been able to mount a good antibody response to the virus of their own,” he said. “But such speculation needs to be tested – we can’t just rely on an educated guess.”

While the United States and India have authorised convalescent plasma for emergency use, other countries, including Britain, are collecting donated plasma so that the treatment could be widely rolled out if it is shown to be effective.

The Indian researchers enrolled 464 adults with COVID-19 who were admitted to hospitals across India between April and July. They were randomly split into two groups – with one receiving two transfusions of convalescent plasma alongside best standard care, and the other getting best standard care only.

After seven days, use of convalescent plasma seemed to improve some symptoms, such as shortness of breath and fatigue, and led to higher rates of so-called negative conversion – a sign that the virus is being neutralised by antibodies.

But this did not translate into a reduction in deaths or progression to severe disease by 28 days.

Ian Jones, a Reading University professor of virology, agreed with Landray that plasma may be more likely to work very soon after someone contracts COVID-19.

He urged these and other researchers to continue to conduct trials, and to do so in newly diagnosed patients.

“We still do not have enough treatments for the early stage of disease to prevent severe disease and until this becomes an option, avoiding being infected with the virus remains the key message,” he said.

(Reporting by Kate Kelland; Editing by Peter Graff and Frances Kerry)

Copyright 2020 Thomson Reuters

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health

‘Modest’ Benefit for Post-MI Flash Glucose Monitoring in T2D

Following a heart attack, there appears to be a “modest” benefit of using flash glucose monitoring over fingerstick testing to monitor blood glucose levels in patients with type 2 diabetes being treated with insulin or a sulfonylurea, according to investigators of the LIBERATES trial.

The results showed a nonsignificant increase in the time that subjects’ blood glucose was spent in the target range of 3.9-10.00 mmol/L (70-180 mg/dL) 3 months after experiencing an acute coronary syndrome (ACS).
At best, flash monitoring using Abbott’s Freestyle Libre system was associated with an increase in time spent in range (TIR) of 17-28 or 48 minutes per day over self-monitoring of blood glucose (SMBG), depending on the type of statistical analysis used. There was no difference in glycated hemoglobin A1c levels between the two groups, but there was a trend for less time spent in hypoglycemia in the flash monitoring arm.

Viewers Underwhelmed

“My overall impression is that the effects were less pronounced than anticipated,” Kare Birkeland, MD, PhD, a specialist in internal medicine and endocrinology at Oslo University Hospital, Rikshospitalet, Norway, observed after the findings were presented at the virtual annual meeting of the European Association for the Study of Diabetes.

Others who had watched the live session seemed similarly underwhelmed by the findings, with one viewer questioning the value of devoting an hour-and-a-half session to the phase 2 trial.

However, the session chair Simon Heller, BA, MB, BChir, DM, professor of clinical diabetes at the University of Sheffield, and trial coinvestigator, defended the detailed look at the trial’s findings, noting that it was worthwhile to present the data from the trial as it “really helps explain why we do phase 2 and phase 3 trials.”

Strong Rationale for Monitoring Post-MI

There is a strong rationale for ensuring that blood glucose is well controlled in type 2 diabetes patients who have experienced a myocardial infarction, observed Robert Storey, BSc, BM, DM, professor of cardiology at the University of Sheffield. One way to do that potentially is through improved glucose monitoring.

“There’s clearly a close link between diabetes and the risk of MI: Both high and low HbA1c are associated with adverse outcome, and high and low glucose levels following MI are also associated with adverse outcome,” he observed, noting also that hypoglycemia was not given enough attention in post-ACS patients.

“The hypothesis of the LIBERATES study was that a modern glycemic monitoring strategy can optimize blood glucose levels in type 2 diabetes patients following MI with the potential to reduce mortality and morbidity and improve quality of life,” Storey said. “The main research question of LIBERATES says, ‘Do new approaches in glucose monitoring increase the time in range and reduce hypoglycemia?’ ”

Pragmatic Trial Design

LIBERATES was a prospective, multicenter, parallel group, randomized controlled trial, explained the study’s statistician Deborah Stocken, PhD, professor of clinical trials research at the University of Leeds. There was “limited ability to blind the interventions,” so it was an open-label design.

“The patient population in LIBERATES was kept

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health

Curbing COVID Brought Unexpected Benefit for Asthma Patients | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

TUESDAY, Oct. 20, 2020 (HealthDay News) — Measures enacted to slow the spread of the new coronavirus also appeared to reduce hospitalizations for asthma, a new study finds.

Researchers compared weekly data on hospitalizations at 272 hospitals in Japan in the first five months of 2020 to the same period in 2017, 2018 and 2019.

Asthma hospitalizations in 2017-19 and 2020 showed similar trends until week eight, but in 2020 hospitalizations began to decline in week nine, the study found.

Hospitalizations for COVID-19 were first recorded during week seven of 2020. Further analysis found a significant decrease in the average number of asthma hospitalizations during weeks nine to 22 of this year compared to 2017-19.

The findings were published Oct. 13 in The Journal of Allergy and Clinical Immunology: In Practice.

“Asthma hospitalizations usually indicate that an individual’s asthma is not currently under control,” corresponding author Dr. Atsushi Miyawaki, of the University of Tokyo, said in a journal news release. “This would suggest that asthma control improved during the pandemic. It illustrates the importance of environmental factors when it comes to treating and managing patients with asthma.”

One possible explanation is that increased hygiene to prevent COVID-19 would also reduce exposure to asthma triggers, according to the researchers. Enhanced precautions — such as frequent cleaning and reduced smoking — by people concerned that COVID-19 may trigger asthma may also have helped reduce triggers.

Other possible explanations include people being more likely to use preventative asthma medications, and community COVID-19 prevention measures helping reduce other respiratory infections, which can cause worsen asthma.

The U.S. National Heart, Lung, and Blood Institute has more on asthma.

Copyright © 2020 HealthDay. All rights reserved.

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health

Sentinel Uptake Wildly Variable, Brain Benefit Hazy

Use of the Sentinel (Boston Scientific) embolic protection device is highly variable and its ability to limit cerebral injury modest at best, a TVT Registry study suggests.

The primary analysis, using an instrumental variable approach, showed no significant reduction in in-hospital or 30-day stroke with the device among more than 120,000 transcatheter aortic valve replacements (TAVRs) performed in the United States since its approval.

“Nevertheless, the secondary propensity-weighted analysis and the confidence interval for the primary analysis are consistent with a possible modest relative risk reduction in stroke of about 20% and a number-needed-to-treat of about 300 to prevent one stroke,” David J. Cohen, MD, University of Missouri Kansas City School of Medicine.

“These findings support clinical equipoise and provide a strong rationale for ongoing large-scale randomized trials to test whether embolic protection devices provide meaningful clinical benefit,” he said during a late-breaking trial session at TCT Connect, the virtual meeting of Transcatheter Cardiovascular Therapeutics (TCT) 2020.

Stroke continues to occur in 2% to 5% of patients undergoing TAVR, however, embolic protection devices (EPDs) have only been tested in small randomized trials using primary imaging endpoints, Cohen observed. “Thus, there remains considerable uncertainty regarding the clinical benefits associated with these devices.”

The study included 123,186 elective or urgent transfemoral TAVR procedures between January 2018 and December 2019 in the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. Of these, 12,409 were performed with an EPD and 110,777 were not. Sites performing less than 20 TAVRs/year and emergent, alternative access, or concurrent mitral/TAVR procedures were excluded.

The proportion of hospitals using EPD rose steadily from 7% in the first quarter of 2018 to 28% in the fourth quarter of 2019. The proportion of patients receiving the device increased from 5% to 13% over the same period.

Usage varied widely, with 66% of hospitals never using an EPD over the study period and only 5% using it more than 50% of the time, Cohen observed. “By Q4 2019, this had increased to 8% but was still an extreme minority of hospitals in the United States.”

In the instrumental variable analysis, the adjusted rate of the primary endpoint of in-hospital stroke was in 1.39% in patients treated with EPD and 1.54% in those with no EPD (relative risk [RR], 0.90; 95% CI, 0.68 – 1.13; P = .41).

Rates were also similar for in-hospital death or stroke (2.4% vs 2.6%), major bleeding (4.0% vs 4.4%), device success (97% vs 97.2%), 30-day stroke (2.0% vs 2.1%), and 30-day mortality (1.9% vs 2.2%).

In the propensity-weighted analysis, which accounted for 30 demographic, clinical, and hospital-level characteristics, however, in-hospital stroke occurred in 1.30% of patients with EPD and 1.58% without (RR, 0.82; 95% CI, 0.69 – 0.97; P = .02).

Significant differences were also observed in in-hospital death or stroke (2.1% vs 2.5%) and 30-day stroke (1.9% vs 2.2%) as well as mortality (1.7% vs 2.2%).

Accounting for Patient/Site Differences

EPD was more likely to be used in patients with bicuspid valves (6.8%), and less

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fitness

Peloton Set to Benefit from Structural Shift in Fitness Industry, Says 5-Star Analyst

The fitness industry has changed, and Peloton (PTON) stands to reap the benefits. Truist Securities’ Youssef Squali recently surveyed 1,500 consumers to gain insights on exercise habits and related preferences, with the findings only reaffirming the analyst’s confidence in PTON.

Throughout most of the U.S., gyms have reopened, but consumers aren’t hitting the locker room. Still nervous about going back to fitness centers, only 45% of respondents have been to a gym or an exercise class since the onset of the pandemic. Additionally, 33% are visiting the gym less frequently than before COVID-19.

Going forward, most survey participants noted that their longer-term exercise plans will incorporate a larger at-home component. Nearly 60% of gym-goers plan to cancel at least one gym membership as a result of COVID, including 33% who have already done so, while 55% plan to exercise at home more often even if a vaccine is widely-available.

Calling the number of gym-goers that have already canceled at least one membership “striking,” Squali thinks it could “portend greater pressure for gyms ahead.”

Expounding on this, the analyst stated, “This also suggests that the shift towards at-home fitness is likely to continue into 2021 and beyond. We believe many gym-goers, when faced with the reality of not being able to visit their fitness centers for an indefinite amount of time, have experienced and warmed to the benefits of working out from home (convenience, cost, time savings, etc.). We anticipate that this dynamic will outlive COVID.” To this end, Squali sees this trend as a tailwind for PTON.

Of the 1,169 respondents who worked out at least once a month, 54% made a fitness equipment or services related purchase for home use. It should be noted that out of this group, 40% had no plans to make an at-home fitness-related purchase before the pandemic.

“We believe this is a trend that helped drive better than expected earnings these last few quarters for Peloton. This also supports Peloton’s thesis that its serviceable addressable market (SAM) has expanded beyond its initial 14 million estimate to 20 million, as consumers who may not have considered purchasing at-home equipment previously are now a growing base of customers… With a very strong NPS, expanding product line and geographies, and continued brand marketing pushes, we believe that the TAM/SAM opportunities are likely to continue to expand over time,” Squali explained.

What’s more, Peloton was cited as the top brand that consumers would buy. “This speaks to the strength of the Peloton brand among younger, less affluent consumers, and runs contrary to the thesis held by some that that Peloton remains an exclusive brand and therefore targeting a niche segment (see page 3/4 for figures),” in Squali’s opinion.

As bikes are gaining share in the at-home exercise equipment market and PTON’s lower-priced products are attracting major interest, Squali remains on board this fitness train.

Accordingly, Squali reiterated a Buy rating. He also bumped up the price target from $115 to $144. This target puts

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