Daily Archives: June 28, 2021

The DARE-19 clinical trial explores the use of SGLT2 inhibitors for patients with hypertension, cardiovascular disease, heart failure, type 2 diabetes, or chronic kidney disease, and COVID-19.

A recent study found that dapagliflozin (Farxiga; AstraZeneca), a sodium-glucose cotransporter-2 (SGLT2) inhibitor, was well-tolerated in hospitalized patients with COVID-19, and participating patients had fewer serious adverse events than those taking placebo. Results of the DARE-19 trial (NCT04350593) were presented Sunday during the virtual 81st Scientific Sessions of the American Diabetes Association (ADA).1

According to the ADA, DARE-19 is the first large randomized clinical trial to assess SGLT2 inhibitors, a medication class initially used to help lower blood glucose, in patients with and without type 2 diabetes who are hospitalized with COVID-19. Funded by AstraZeneca, the study found that treatment with dapagliflozin did not achieve statistically significant reduction in organ failure or death, nor did it significantly improve clinical recovery, compared with placebo. However, fewer patients treated with dapagliflozin experienced organ failure or death compared to placebo (11.2% vs 13.8%, respectively).1

Previously, there were some concerns with using SGLT2 inhibitors in COVID-19 patients due to the potential risk for acute kidney injury and diabetic ketoacidosis. However, our results show dapagliflozin is well tolerated, with no new safety concerns, said the studys lead investigator Mikhail Kosiborod, cardiologist and vice president for research at Saint Luke's Health System; and professor of medicine, University of Missouri-Kansas City, in a press release. We believe that our findings do not support routine discontinuation of SGLT2 inhibitors in patients hospitalized with COVID-19 that have other indications for these agents, such as type 2 diabetes, heart failure and chronic kidney disease (CKD), as long as patients are monitored.

Patients with cardiometabolic risk factors, including type 2 diabetes, are at higher risk for developing serious COVID-19-related complications, such as organ failure and death. According to the ADA, Americans with diabetes and other related underlying health conditions are hospitalized 6 times more often and are 12 times more likely to die of COVID-19 than those without diabetes. Previous studies have shown SGLT2 inhibitors provide organ protection in patients with type 2 diabetes, heart failure, and chronic kidney disease.1

Dapagliflozin is indicated to reduce the risk of sustained glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adult patients with CKD at risk of progression, according to AstraZeneca. The drug is also indicated to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction, and to reduce the risk of hospitalization in adults with type 2 diabetes and either established CV disease or multiple CV risk factors. Dapagliflozin is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and is not recommended for patients with type 1 diabetes.2

DARE-19 compared dapagliflozin to placebo in 1250 patients hospitalized for COVID-19 who also had a history of hypertension, atherosclerotic cardiovascular disease, heart failure with either preserved or reduced ejection fraction, type 2 diabetes, or stage 3 to 4 chronic kidney disease with estimated eGFR between 25 and 60. Patients were recruited across 95 centers in seven countries between April 2020 and January 2021. Approximately half of the patients had a history of type 2 diabetes. Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.1

According to the investigators, future trials are needed to further evaluate the possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19. They also noted that DARE-19 has important implications for future research, as it raises a hypothesis that SGLT2 inhibitors may offer organ protection in other types of acute illness such as sepsis, which should be explored in future studies.1

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Dapaglifozin Found to be Well-Tolerated in Hospitalized Patients With COVID-19 - Pharmacy Times

ANNAPOLIS, Md. (WJZ) Maryland reported 37 new COVID-19 cases and two deaths Monday as hospitalizations increased slightly, according to state health department data.

More than 3.33 million Maryland adults are fully vaccinated. State officials also reported that the state positivity remained flat at 0.57%.

Hospitalizations went up by three cases to 115 people hospitalized for the virus. Of those hospitalized, 84 remain in acute care and 31 remain in the ICU.

Since the pandemic began, there were 462,181 total confirmed cases and 9,522 deaths.

There are 3,373,446 Marylanders fully vaccinated. The state has administered 6,827,163 doses. Of those, 3,453,717 are first doses with 3,787 administered in the past 24 hours. They have given out 3,114,145 second doses, 6,683 in the last day.

The state began to administer the Johnson & Johnson vaccine again in April, after the CDC and FDA lifted their pause on the vaccine due to a rare blood clot found in some women.

A total of 259,301 Marylanders have received the Johnson & Johnson vaccine, 318 in the last day.

The state reported 74.4% of all adults in Maryland have received at least one dose of the vaccine.

CORONAVIRUS RESOURCES:

Heres a breakdown of the numbers:

By County

By Age Range and Gender

By Race and Ethnicity

For the latest information on coronavirus go to the Maryland Health Departments website or call 211. You can find all of WJZs coverage on coronavirus in Maryland here.

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COVID-19 In Maryland: More Than 74% Of Adults Have Received At Least One Vaccine Dose - CBS Baltimore

Michigans total active COVID-19 outbreaks being tracked by health officials has dropped to 123, including 11 new clusters reported within the last week.

The total has declined 37% since the prior weekly report, and 75% over the last three weeks. Its a trend that has followed the decline in new coronavirus infections, hospitalizations and deaths, as well as the increase in COVID-19 vaccinations.

New outbreaks were reported from seven different settings, including a pair from manufacturing/construction sites, office settings, social gatherings and agricultural/food processing settings. The June 28 report marked the first time in months that there were no new outbreaks reported in school settings.

In addition to the new outbreaks, the state is tracking 112 ongoing active outbreaks that were noted in previous weekly reports. The Department of Health and Human Services updates its outbreaks report each Monday, with data as recent as the prior Thursday.

An outbreak is generally defined as an instance in which two or more cases are linked by a place and time, indicating a shared exposure outside of a household.

K-12 schools and colleges accounted for 22 ongoing clusters. Once the top setting for outbreaks, school clusters have dipped significantly as the calendar has flipped to summer vacation for many.

A total of 1,200 students and staff remain effected from the 22 school outbreaks, including 930 linked to outbreaks at Western Michigan University in Kalamazoo. The next largest clusters involved 67 students and staff at Lapeer High School, and 41 students and staff at Bay City Central High School.

Below is an online database that allows readers to search outbreak data by school name or by city or county. The number of those infected is a cumulative total since the original outbreak. (Note: Washtenaw County only reports cumulative totals for the past 28 days.)

Below is an interactive map showing both new and ongoing outbreaks listed in the Monday, June 18, report. It shows outbreaks reported as of Thursday, June 24. You can put your cursor over a dot to see the underlying data.

Outside of K-12 schools and colleges, MDHHS is not identifying specific locations or the number of coronavirus cases. However, it is listing the information by the states eight health district regions. (Note those regions have different numbers than the MI Safe Start Plan.)

By region, the breakdown of the clusters:

By category, the outbreaks totaled:

Outbreaks will be removed from the database if there are no additional cases through a 14-day period, state MDHHS officials have said.

State officials note that the chart does not provide a complete picture of outbreaks in Michigan, and an absence of identified outbreak in a particular setting is not evidence that the setting is not having outbreaks.

Many factors, including the lack of ability to conduct effective contact tracing in certain settings, may result in significant under-reporting of outbreaks, the states website reads.

For more statewide data, visit MLives coronavirus data page, here. To find a testing site near you, check out the states online test finder, here, send an email to COVID19@michigan.gov, or call 888-535-6136 between 8 a.m. and 5 p.m. on weekdays.

Read more on MLive:

Delta variant symptoms in children: What are they? Are they different from other COVID strains?

Final numbers on Michigans spring COVID-19 surge: 4,000 dead, 30,000 hospitalized

Benefits of COVID-19 vaccines outweigh risk of rare reactions in adolescents, doctors say

Why northern Michigan has both highest vaccinated counties and big pockets of vaccine hesitancy

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COVID-19 outbreaks dip further in Michigans June 28 report - MLive.com

On June 14, 1940, the day the German army invaded and occupied Paris, a small group of scientists marched to the White House with grave news for President Franklin D. Roosevelt. U.S. military technology, they said, was utterly unprepared to take on the Axis powers. They urged the president to create a new agencya dream team of techies and scientiststo help win the war.

In response, Roosevelt assembled an agency that became known as the Office of Scientific Research and Development, or OSRD. Led by Vannevar Bush, the former dean of the MIT School of Engineering, the office ultimately employed more than 1,500 people and directed thousands of projects around the country. By the end of the war, it had spawned military inventions such as the proximity fuse, radar, andafter one of its programs spun off to become the Manhattan Projectthe atomic bomb.

OSRDs breakthroughs went far beyond missiles and bombs. It supported the first-ever mass production of penicillin in part by contracting with the chemical manufacturer Pfizer (yep, that one) to produce key antibiotic materials. The agency invested in malaria treatments and developed an early influenza vaccine. It invested in microwave communications and built the foundations for early computing. Not many people today have ever heard of OSRDwhich was dissolved in 1947 and whose peacetime responsibilities were strewn across a range of government agenciesbut its fingerprints are all over some of the most important breakthroughs of the 20th century.

And then, 80 years later, a new crisis struck.

Read: How science beat the virus

COVID-19 posed another global challenge for which the United States was utterly unprepared. This time, too, the countrys initial response was staggered and delayed, but when the U.S. finally trained its scientific ingenuity toward a clear problemthe development of COVID-19 vaccinesAmericans did extraordinary things with breathtaking speed. Once more, the U.S. government contracted with U.S. companieshello again, Pfizerto save American lives. And with the darkness of this global crisis fading (at least in the U.S.), some commentators predict a new era of optimism in science and technology.

Maybe. To understand how the United States can turn a crisis into a golden age of science and discovery, compare and contrast the countrys responses to World War II and COVID-19. Fortunately, a new paper, by Daniel Gross at Duke University and Bhaven Sampat at Columbia University, does just that. Why are crises so fertile for innovation? is a question Ive been asking throughout my research, Gross told me. And I think were starting to get a clearer idea.

During the war, the Office of Scientific Research and Development did for defense research what a point guard does on a basketball court: controlling the pace of the game, setting up plays, and deciding which other player is best positioned to shoot a basket. The OSRDs priorities came directly from military leaders needs. Then the agency farmed out contracts to universities (for research, mostly) and companies (for manufacturing production, mostly). Finally, it reported its progress directly to the White House. The agency nurtured new ideas throughout their entire life cyclefrom the research lab to the factory to the battlefront.

Compared with OSRD, the U.S. strategy during COVID-19 was somewhere between diffused and nonexistent. Operation Warp Speed was probably the closest parallel, and it clearly accelerated the development of several vaccines. But beyond that, the U.S. government set few priorities for COVID-19 medicine and research. It never identified the key questions that researchers should be trying to answer. (For instance, whats the best way for an indoor business, such as a restaurant, to stay open while protecting customers?) The government made little effort to organize or synthesize research. The main exception was the tragically inept CDC, whose guidance was often misleading, or months late.

Overall, our scientific response to COVID-19 was the opposite of OSRDs response to World War II: not a centralized mobilization of applied research, but the decentralized emergence of basic research. Thats an important distinction. Since the pandemic began, more than 130,000 academic articles on the disease have been published online, and many different researchers have helped figure out how the coronavirus works. But the U.S. lacked an OSRD-like agency to determine which new technologies should be sent to the front lines to help health-care workers and sick patients stop an advancing enemy. Outside of Operation Warp Speed, Gross told me, the federal government seems to have abdicated a lot of responsibility. Goals were never clearly articulated.

Why was our response to COVID-19 so different from our response to World War II? One simple answer is: focus.

During the war, people within the U.S. government broadly agreed that the Nazis existed; that they posed a real threat; and that Americans could trust military leadership to articulate useful goals for beating the enemy. As a result, clear lines of communication developed among the military, OSRD, and the White House. So when the military said it needed better navigating technology, OSRD delivered huge breakthroughs in sonar and radar.

During the pandemic, however, no similar top-down consensus existed about the threat that the novel coronavirus posed. Clear lines of communication didnt exist within the government. Worse yet, the Trump administration went out of its way to scramble the wires, lie about the pandemic, sow confusion throughout the public-health establishment, and publicly attest that the whole thing might just go away imminently. Instead, the most important breakthroughs came from the bottom up: Thousands of scientists clamored to understand the nature of the virus; hundreds of hospital networks gradually learned how to help severely ill patients; a ragtag team built the COVID Tracking Project; and a start-up Fast Grants program accelerated the funding of overlooked projects.

Anne Applebaum: What Americas vaccine campaign proves to the world

Ironically, the more diffuse nature of American innovation today might be the direct legacy of OSRD and its impresario, Vannevar Bush. After the war, Bush published an influential report, Science: The Endless Frontier, which encouraged the U.S. to expand its investment in basic science under the theory that all human progress is a tree that blossoms from the seeds of scientific research. Skeptical of industrial policythat is, of the government actively working to advance its favorite technologies and industriesBushs thesis pushed for the government to expand basic-science funding and leave the rest to the private sector.

Bushs vision is our 21st-century reality. Since the end of World War II, Americas inflation-adjusted spending on science and technology has increased by a factor of 50. Federal support for basic science has dramatically expanded, and major universities have shifted their focus from teaching to research. OSRDs components are currently scattered among an alphabet soup of research agencies. The National Institutes of Health is the world leader in funding scientific research. But its strategy is very, well, Bushian. Unlike OSRDs focused medical research, the NIH leaves priority-setting to many thousands of individual researchers. (Disease advocates and Congress have at times questioned the wisdom of this, Gross and Sampat write, especially in the context of health crises such as cancer and AIDS.)

Focus can be a double-edged sword. Having clear priorities is no good if those priorities are also terrible. A national mask ban would have been a very focused and very bad idea in 2020. A national declaration that COVID-19 is less dangerous than a typical influenza virus would have been a bold national policyand a deadly one. Meanwhile, the triumph of mRNA technology was a beautiful story of how basic research can languish for 40 years before revealing its own worth. It was precisely the nonfocused research on mRNA over the last few decades that allowed us to get these vaccines, Sampat told me.

Yet OSRDs work during World War II teaches important lessons about how to launch a new golden age of progress. Gross and Sampat told me that perhaps the most important takeaway from their paper might be the overlooked value of applied researchthat forgotten middle child of technological progress, where nascent ideas begin to be deployed to solve real-world problems. OSRD was unique in its support for new technologies all the way through their life cycle. In the past few decades, funding for basic science has ballooned, but in many cases that research never reaches the next stage in the assembly line.

Consider, for example, the history of solar energy. In the 1950s, American researchers invented silicon solar cells. Through the 1980s, the U.S. spent more on research and development than any other country. But then it ceded that technological advantage, as my colleague Robinson Meyer has written, when Japan and other countries urged their firms to invest in solar technology, incorporate solar into an array of products, and bring down costs. The U.S., for its part, had no national plan to cross the valley of death from neat new idea to mass-produced product.

Uri Friedman: The pandemic is revealing a new form of national power

OSRD taught a lesson that was too soon forgotten: You get more from the seeds of new ideas if youre willing to invest a bit in the planting stage. NSF and NIH are really focused on supporting basic scientific investigation, but they dont really fund, for example, early manufacturing capacity, or efforts to reduce drug costs, Gross said. Thats a market failure. There might be a productive role in government funding of clinical trials and manufacturing capacity.

There is an interesting irony here. World War IIs highly focused innovation policy led to a postwar innovation system that is almost proudly unfocused.

I came away from my conversation with Gross and Sampat with a question I had never quite thought of before: What would an NIH for applied research look like? In other words, what if, in addition to using NIH to give grants to scientists who set their own priorities for basic researchstage one on the assembly lineAmericans put the weight of government funding behind solving high-priority problems? We could do this by investing in the translation of basic research into practical technology, as Japan seems to have done, effectively, with solar power. A National Institute of Applied Science wouldnt bring the U.S. all the way back to wartime industrial policy. But it might be the sort of institution that could kick-start a new golden age of innovationby drawing on the last one.

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How COVID-19 Could Lead to a Golden Age of Innovation - The Atlantic

Why is Japan going ahead with the Summer Olympics?

Japans Olympics bid was about so much more than hosting the summer games. For Prime Minister Shinzo Abe, the 2020 Summer Olympics were to be a demonstration of renewal, one more statement to the world that Japan is back! Echoing the 1964 Tokyo Olympics, the themes were to be Japans technological prowess, its ability to recover from difficulty, and its hospitality. Though the games were postponed in 2020 and Abe stepped down last year due to health reasons, Prime Minister Yoshihide Suga has insisted that the Olympics proceed.

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A substantial financial investment has been made. Officially, Japan has spent $15.4 billion on the Olympic and Paralympic Games. Government audits put the bill much higher, however. Private companies have also invested a considerable sum, which the Mainichi Shimbun estimates to be an additional $3 billion.

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The International Olympic Committee (IOC) also had a hand in the decision to proceed. On May 21, the committees vice president confirmed that the games would go on despite the growing disgruntlement of the Japanese public.

By May, the publics concerns seemed to peak; polling by the Asahi Shimbun revealed that 83 percent of Japanese were against the governments plan to go ahead with the games this summer. About 40 percent wanted them postponed, while 43 percent wanted the Olympics canceled altogether. A citizen-led petition asking Suga to cancel the games garnered over 430,000 signatures. Even Olympics Minister Seiko Hashimoto complained that Japans hand was being forced by decision-makers outside the country.

Japans continuing struggle with the pandemic was the root cause of concern. Vaccinations were slow, in part due to negotiations with suppliers and the governments inability to adapt its own regulatory approach. Once begun, the rollout suffered from confusion and a lack of information about accessibility for the 28 percent of Japanese who are over the age of sixty-five. With the caseload rising, medical facilities were hard-pressed to ensure adequate treatment.

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Some business leaders also challenged the governments assurances that it could manage this risk. Masayoshi Son, president of SoftBank, tweeted, Does the IOC have the power to decide that the games will go ahead? Theres talk about huge penalties [if the games are canceled] but if one hundred thousand people from two hundred countries descend on vaccine-laggard Japan and the mutant variant spreads, I think we could lose a lot more. Hiroshi Mikitani of Rakuten, the largest online retailer in Japan, joined Son in criticizing the decision to hold the games. Even Japanese companies sponsoring the Olympics privately called for the games to be postponed to the fall.

However, by June, public resistance towardhosting the games this summer had softened somewhat.

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For starters, there is the health risk. The high case numbers in Tokyo and Osaka this spring raised concerns about the countrys medical infrastructure, and the coronaviruss Delta variant, discovered first in India, has epidemiologists around the world worried.

Suga has promised that vaccinations will be made available quickly, pledging that all Japanese who want to be vaccinated will have access by the end of October. The Prime Minister also vowed in early May that the country would be vaccinating at the rate of one million shots per day by the end of June.According to Bloombergs analysis, Japan reached that goal last week.

On June 22, Tokyo Olympics organizers announced that spectators will be allowed into the games. Hashimoto told NBC News the next day that a spectator ban is still possible if COVID-19 cases surge.

There could be political consequences as well. In October, Japan will hold its first Lower House election since Abe stepped down, and it will be a tough election for the Liberal Democratic Party of Japan (LDP) and its coalition partner, Komeito. The opposition Constitutional Democratic Party of Japan seems unlikely to take power, but it could damage the supermajority that the governing coalition has enjoyed in the Lower House since 2012. Sugas public approval rating plummeted to a low of 33 percent coming into the summer, and the next few months will be difficult. Both an accelerated vaccination schedule and a safe Olympics are necessary to boost his political standing.

Asias geopolitics will undoubtedly be on the minds of many in Tokyo. Coming up after Japans summer games are Beijings 2022 winter games. Japan will not want to be overshadowed by China.

South Koreas winter games in 2018 became the stage for President Moon Jae-ins high-stakes diplomatic gamble to embrace diplomacy with North Korea, and Abe attended at Moons request in a show of support for peace on the peninsula. Although there is little reason to expect that inter-Korean diplomacy will be on view in Tokyo this summer, Japan and South Korea could use the occasion to improve their relationship.

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Here's Why Tokyo Is Hosting the Summer Olympics Despite COVID-19 - Council on Foreign Relations