Triple therapy helps control severe asthma

Asthma affects approximately 20 million adults in the US. It is a common cause of workplace and school absenteeism, and is one of the leading causes of hospitalizations in the US. Between 5% and 10% of asthmatics have frequent, persistent symptoms despite treatment with multiple medications, and are categorized as “difficult to treat” and “severe” asthmatics. In these patients, asthma can be life-threatening.

Identifying ways to control symptoms and asthma exacerbations in these patients is an important goal of asthma researchers.

Proper technique and particle size impact effectiveness of inhalers

Asthma symptoms result from a combination of airway inflammation and constriction, so asthma therapies are focused on relieving both processes. Asthma medications are frequently delivered via the airways using inhalers. This mode of delivery allows high doses to reach the airway surfaces without significant absorption of medication into the bloodstream.

But inhalers have some important drawbacks. First, patients must have meticulous technique in using their inhalers, to ensure adequate medicine is delivered to the airways. Indeed, patients who are thought to have uncontrolled asthma commonly have significant improvements in symptom control when they are taught how to properly use an inhaler. Second, the particle size delivered by an inhaler is an important determinant of what airways receive the medication. Larger particles are more likely to be deposited in the mouth and large upper airways. Smaller particles are more likely to make their way into in the small airways, which are the ones most involved in asthma. Inhalers that provide smaller particles may therefore provide more effective asthma control.

New research examines use of triple therapy in asthma

Two clinical trials, recently published in Lancet, have added to our knowledge about effective asthma therapies for adults. These large, well-designed, multinational studies were randomized and double-blind. In addition, the one-year duration of the studies provided adequate time to see if the initial responses were maintained over time, and for differences in the frequency of asthma exacerbations to be detected among the study groups.

The TRIMARAN study examined 1,155 patients from 16 countries who continued to have at least one serious asthma exacerbation a year, despite therapy with moderate-dose inhaled corticosteroids. One group of study subjects received treatment with inhaled corticosteroids and formoterol, and the other received inhaled corticosteroids, formoterol, and glycopyrronium using a single inhaler that delivered extremely small particles to the lung. Formoterol is a long-acting beta agonist, a mainstay of bronchodilator therapy in asthma. Glycopyrronium is a long-acting muscarinic antagonist (LAMA), which is another class of bronchodilators.

The TRIGGER study examined 1,437 patients from 17 countries who had severe asthma and who continued to have at least one serious asthma exacerbation a year, despite therapy with high-dose inhaled corticosteroids. TRIGGER compared three groups of patients. One group was treated with an inhaled corticosteroid and long-acting beta agonist given in a single inhaler. The second group was treated with the combination corticosteroid and long-acting beta agonist inhaler as well as tiotropium (a LAMA), delivered using a second inhaler. The third group was treated with a single inhaler that delivered extremely small particles of a corticosteroid, long-acting beta agonist, and glycopyrronium.

The two studies showed similar results. Subjects in both TRIMARAN and TRIGGER who received the LAMA in addition to the inhaled corticosteroid and long-acting beta agonist had improved lung function and decreased exacerbations, compared to subjects who received only the inhaled corticosteroid and long-acting beta agonist. Improvement in the number of asthma exacerbations was seen with both severe and moderate exacerbations. Additionally, the time to develop the first exacerbation was longer for the subjects receiving the LAMA in both TRIMARAN and TRIGGER. Those enrolled in TRIMARAN (but not those enrolled in TRIGGER) reported significantly improved asthma symptom control. Of note, the improvements seen with the LAMA did not depend on whether a separate inhaler was used to deliver the LAMA, suggesting that the positive results were likely due to the addition of the LAMA rather than the very small particle size.

A step forward in the treatment of severe asthma

TRIMARIN and TRIGGER provide a step forward in our understanding of how to manage patients with difficult-to-control asthma. These studies add to existing evidence that adding LAMA therapy to inhaled corticosteroids and beta agonists improves asthma control for patients with the most severe form of this disease. The use of one inhaler containing all three classes of medications (steroid, long-acting beta agonist, and LAMA) is an advance in asthma therapy. One inhaler is much easier to use and to remember than three inhalers. At the same time, it is reassuring that the benefits of LAMA use were seen whether the LAMA was given as a separate medication or as part of the triple inhaler.

The post Triple therapy helps control severe asthma appeared first on Harvard Health Blog.

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Stigma, a big obstacle to fighting drug abuse, is often perpetuated by health-care providers; more problematic in pandemic

By Nora D. Volkow
Director, National Institute on Drug Abuse
Republished from Scientific American magazine

Untreated drug and alcohol use contributes to tens of thousands of deaths every year and affects the lives of many more people. We have effective treatments, including medications for opioid and alcohol use disorders, that could prevent a significant number of these deaths, but they are not being utilized widely enough, and people who could benefit often do not even seek them out. One important reason is the stigma around those with addiction.

Nora D. Volkow, M.D.

Stigma is a problem for people with health conditions ranging from cancer and HIV to a variety of mental illnesses, but it is especially powerful in the context of substance use disorders. Even though medicine long ago reached the consensus that addiction is a complex brain disorder, those with addiction continue to be blamed for their condition. The public, as well as many people working in health care and in the justice system, continues to view addiction as a result of moral weakness and flawed character.

Stigma on the part of health care providers who see patients' drug or alcohol problems as their own fault can lead to substandard care or even to the rejection of individuals seeking treatment. Staff in emergency departments, for instance, may be dismissive of addicted people because they do not view treating drug problems as part of their job. As a result, those showing signs of acute intoxication or withdrawal symptoms are sometimes expelled from the ER by staff who are fearful of their behavior or who assume they are only seeking drugs. People with addiction can internalize this stigma, feeling shame and refusing to seek treatment.

During a visit to Puerto Rico several years ago, I visited a “shooting gallery”—a makeshift injection site—in San Juan, where I met a man who was injecting heroin into his leg. It was severely infected, and I urged him to visit an ER, but he had been treated horribly on previous occasions and preferred risking his life, or probable amputation, to the prospect of repeating his humiliation.

Beyond just impeding the provision or seeking of care, stigma may actually drive addicted people to continue using drugs. Research by Marco Venniro of the National Institute on Drug Abuse has shown that drug-dependent rodents choose social interaction over the drug when given the choice, but when the social choice is punished, the animals revert to drug use. Humans, too, are social beings, and some of us respond to both social and physical punishments by turning to substances to alleviate our pain. The humiliating rejection experienced by those who are stigmatized for their drug use acts as a powerful social punishment, driving them to continue and perhaps intensify their drug taking.

The stigmatization of people with substance use disorders may be even more problematic in the current covid-19 crisis. In addition to the greater risk associated with homelessness and with drug use itself, the legitimate fear around contagion may mean that bystanders or even first responders will be reluctant to administer lifesaving naloxone to people who have overdosed. And there is a danger that overtaxed hospitals will pass over those with obvious drug problems when making difficult decisions about where to direct limited personnel and resources.

Alleviating stigma is not easy, in part because the rejection of people with addiction or mental illness arises from unease over their violations of social norms. Even health care workers may be at a loss as to how to interact with someone acting threateningly because of withdrawal or because of the effects of certain drugs (for example, PCP) if they have not received training in caring for people with substance use disorders. It is crucial that health care personnel, from staff in emergency departments to physicians, nurses and physician assistants, be trained in caring competently for people with substance use disorders. Treating patients with dignity and compassion is the first step.

There must be wider recognition that susceptibility to the brain changes in addiction is substantially influenced by factors outside an individual's control, such as genetics and the environment in which one is born and raised, and that medical care is often necessary to facilitate recovery as well as to avert the worst outcomes, such as overdose. When people with addiction are stigmatized and rejected, especially by those in health care, it only contributes to the vicious cycle that makes their disease so entrenched.

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Over 800 new cases for second day, 18 deaths; Beshear says Ky. is in a 'dangerous place' as another holiday weekend approaches

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Dale Toney is new president of Kentucky Medical Association

Dale Toney, M.D.

Dr. Dale Toney, a Lexington internist, is the new president of the Kentucky Medical Association. He was elected last weekend at the organization’s annual meeting, which was held virtually due to the pandemic.

Also elected were President-Elect Neal Moser of Crestview Hills, Vice President Michael Kuduk of Winchester and Secretary-Treasurer Jiapeng Huang of Louisville.

Toney is a board-certified specialist in internal medicine at the University of Kentucky hospital, an associate professor in UK's College of Medicine, and interim chief of the General Internal Medicine and Women’s Health division. He was President of the Lexington Medical Society in 2004 and a member of the Kentucky Board of Medical Licensure from 2016 to 2019.

Toney said his goals for the year included the promotion of the “Be Well. Stay Well.” campaign, which encourages Kentuckians to take simple steps to protect and improve their health. The campaign began in August with the launch of the “Raise Your Guard, KY” initiative, which is a partnership with the Foundation for a Healthy Kentucky and Anthem Blue Cross and Blue Shield.

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Contract tracer at UK describes how the process works

University of Kentucky contact tracers work in the Boone Center, the former faculty club, which has been closed. (UK photo by Pete Camparoni)

By Lindsey Piercy
University of Kentucky

It’s 8 a.m., and it’s time for Eryn Clayton to pick up the phone and begin dialing.

There’s a pause as the call connects.

A University of Kentucky student is on the other end. Clayton smiles sympathetically as she introduces herself; she will be the first to inform them they have tested positive for covid-19.

“That call can be really hard for some to receive, and expected for others,” says Clayton, part of Health Corps, UK's main tool for keeping the pandemic from closing the campus again.

Clayton is trying to keep the mood light — not because the call isn’t serious. In fact, it’s just the opposite, and getting a stranger to trust you is a monumental task.

“I have to be ready throughout the day to have open conversations, provide guidance as best I can and ultimately make sure the person on the other end, and their friends and families, are safe,” she says.

As the conversation continues, Clayton works to educate the patient — inform them of what their test result means, and provide them with important resources. She details symptoms, high-risk pre-existing medical conditions, what to do if more severe symptoms develop, and helps to create an isolation plan. (Those who test positive are in isolation; those who come into close contact with a positive case are quarantined to prevent the spread of the virus in case they have contracted it.)

Who gets a call and who doesn’t?

Then comes the contact tracing. Clayton tries find out where they’ve been, and more specifically, who they’ve been around. With each interaction, the web widens.

Clayton picks up the phone again, explaining, “We start reaching out to the UK-affiliated contacts and inform them they came into close contact with someone who tested positive for covid-19.”

All students, faculty and staff at UK are considered a contact when they have high-risk exposure (close contact) with a positive case. The Centers for Disease Control and Prevention defines "close contact" as within six feet for more than 15 minutes, “but there are also various extensions of this, as you can imagine the multitude of circumstances where respiratory droplets could pass from one person to another,” Clayton says. “As a basis though, this is how we determine who is a contact and who is not.”

If the infected person has contacts who are not members of the UK community, Health Corps sends those names to the individual’s local health department, which reaches out to them about testing and isolation.

Those who get a call from any contact tracer are not told the name of the person they came into contact with; that information remains confidential.

“The difficult part is that so much of this is a waiting game — but it’s powerful,” Clayton says. “It’s difficult in the scenario where a contact can feel perfectly healthy but must quarantine for a full 14 days. A negative test result following close contact does not mean someone is free from developing the virus within that 14-day period. But if a person in quarantine does develop the virus due to their close contact, then they won’t be able to spread it.”

Everyone Clayton contacts will receive documentation that they have been asked to isolate or quarantine, and they may use that dated material to make the necessary arrangements. In addition, Health Corps ensures every student has a plan to quarantine or isolate safely — regardless of whether a student lives on or off campus. Through this process, UK is offering students a unique level of support and options that non-university-goers may not have.

What happens after the initial conversation?

Following their conversation with a contact tracer, those who test positive will receive a call from a wellness connector.

If symptoms are mild, the individual will be asked to continue communicating with their local health department. If concerns are noted, the patient receives immediate follow-up depending on needs.

The health department where the individual is isolating will provide the written release from isolation to those who tested positive. That documentation must be sent to Health Corps. Once that document has been received, a team member will respond through email with a final release.

While not required, Clayton says she encourages those who test positive to have conversations with those who might be affected — such as roommates, professors or bosses.

Contact tracers will only notify those who were within close contact to a positive case and are at the highest risk of spreading the virus. “That being said, we are not reporting to faculty that someone will not be in class due to testing positive," Clayton says. "That is the responsibility of the student.”

While each day is never quite the same, one goal remains constant — to keep the UK community as safe as possible.

“I love that as a contact tracer, I get to talk to students one-on-one every day,” Clayton says. “UK is a big school, but every person who tests positive gets a call from someone who wants to help and understand how their feeling. Personal interaction, individual care and education is what ultimately makes a huge impact here.”

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Beshear voices worry about increased virus cases in children; 7-day average of new Ky. cases sets a record; 15 more deaths

New York Times graphic; for a larger, clearer version, click on it.

By Mary Meehan

Kentucky Health News

 

Gov. Andy Beshear expressed concern Tuesday at the rising number of young Kentuckians testing positive for the novel coronavirus, a trend following some recent school openings and a worrying sign for others that are planning to have students in class before the governor’s Sept. 28 recommendation. 

During his daily press briefing, Beshear also urged people to wear masks and take precautions during the upcoming Labor Day weekend, and said he would not present the winner’s trophy at the Kentucky Derby at Churchill Downs this Saturday to in order to model responsible behavior. Since other spectators can’t be at the track, he said, he would present the trophy virtually. 

“What we want to see from other people that are out there, small groups of 10 or less for Labor Day,” he said. “Two, we need people to be careful. Remember the Fourth of July? Remember Memorial Day? Those led to more cases. Let's make sure we don't do that right now when people want to do high school sports, and we want to get our kids back in school.” 

Beshear said the trend showing more young people testing positive needs to change. 

“We think that's two things,” he said. “Younger Kentuckians are getting out more, we're doing more, and then they're getting tested more.” But, to his main point: “The virus is certainly spreading more in and through our kids." 

An American Academy of Pediatrics report shows the share of positive coronavirus cases among children has increased in every state since spring, and nearly doubled from 5 percent in May to over 9% mid-August, The Hill reports. In Kentucky, the report shows that as of Aug. 27, 13.5% of cases were in people under 20. 

Of the 807 new cases of the coronavirus Beshear reported Tuesday, 150 in Kentuckians under 18 and of those, 50 were 17 or 18. The youngest was only 27 days old.

The 807 daily total was the sixth highest of the pandemic. More importantly, it raised the seven-day rolling average, a key metric, to 677, a record. Beshear reported 15 deaths, one of the higher numbers of the pandemic.

Health Commissioner Steven Stack said the state is having about 150 new daily cases per million people in the state. “We're operating really kind of hot, meaning that there's a lot of disease spread widely throughout the state,” he said. “It's absolutely imperative that you wear your masks, you watch your space and [are] social distancing more than six feet, and that you wash or sanitize your hands often.” 

Stack said there is good news in that the rate of Kentuckians who have tested positive for the virus in the past seven days remains below the danger level of 5%. It was 4.4% Tuesday and has been under 5% for a week.

The daily K-12 report shows 15 new students and 9 new school staff tested positive for the virus and 174 students and 68 employees have active cases. This report has been updated with data for individual schools.

The daily report for colleges and universities shows 410 more students and two more employees testing positive, and 647 students and 19 staff with active cases. Most new cases, 372, are at the University of Kentucky.

The editor of UK's student newspaper, the Kentucky Kernel, put together a detailed "data explainer" regarding coronavirus cases at UK. Natalie Parks writes, "Positive cases among UK's student body are on the rise, but the actual data on the number of cases can be confusing." 

Beshear urged universities to continue to work on contingency plans if there is an outbreak on campus.

“There is a debate right now . . . even in public health, about . . . whether the kids go home or stay, and I just don't think it can be as simple as go or stay, which is what we hear,” he said. “Everything seems to be oversimplified right now.” 

One concern is that students might carry the virus into their home community, putting vulnerable friends and family at risk. 

Asked about a school district requiring parents to sign a waiver of liability for coronavirus infection, Beshear was incredulous: “I don't see how we make a family sign a waiver to go to a public school which is theirs to go to by right, not by privilege. I just, I don't think you can make somebody sign a waiver of liability to attend a public school.” 

He had an equally strong response when asked about a high-risk teacher feeling forced to return to the classroom. “That's just plain awful,” he said. “Let's not put hard-working public servants in harm's way when we know they are at risk. He added later, “We want to get back to in-person learning and classes. We can't be putting people in situations where they might die.” 

Stack, a physician, cautioned that our actions have consequences when it comes to the spread of the virus. 

“So, enjoy Labor Day weekend, but wash your hands, watch your distance and wear a mask,” he said. “This is important because after these other holidays, we've seen explosions of this disease so what you choose to do this weekend could have impacts for months to come.”

Beshear echoed those sentiments near the end of his briefing, in which he had noted that he had read an article about a group of legislators a public meeting where few wore masks. 

Stack stressed that Kentuckians should get tested for the virus. “If you have symptoms, [or a]very high risk exposure, you should get tested. That's still very, very important.” 

The Centers for Disease Control and Prevention last week issued guidance that downplayed the need for testing but quickly walked it back. 

“In my dialogues with the state health officials around the country, I think it's fair to say that there's universal frustration, that the way that the guidance was changed,” he said. 

In other covid-19 news Tuesday:

• Beshear reported 15 more deaths from the disease, bringing the state's confirmed death toll to 939. The fatalities were a 78-year-old woman from Calloway County; two women, ages 71 and 85, and two men, ages 87 and 88, from Campbell County; a 73-year-old man from Fayette County; a 55-year-old woman from Grayson County; a 70-year-old man from Harlan County; a 77-year-old woman and an 83-year-old man from Jefferson County; two men, ages 73 and 81, from Lincoln County; a 79-year-old woman from Monroe County; a 67-year-old man from Owen County; and an 80-year-old woman from Pulaski County.
• State data shows 552 people are hospitalized in Kentucky with covid-19 and 138 are in intensive care. Beshear did not report the number on ventilators. “We've known that we're going to see these numbers and we're going to continue to see numbers like this, because even with a 1.9% mortality rate, if you have over 4,000 cases a week, we're losing people we care about.” He said people who continue to believe only the elderly should pay attention to the death of a 55-year-old woman in Grayson County. 
• In long-term care, 6 new residents and 13 new staff have tested positive for the virus and 610 residents and 354 staff have active cases of it. Four more resident deaths can be attributed to covid-19, Beshear said. 
• The daily report listed counties with more than 10 cases: Jefferson, 155; Fayette, 74; Madison, 65; Warren, 39; Hardin, 22: Laurel, 19; Daviess, Jackson, Oldham, 17; Franklin, 15; Scott, 14; McCracken, 13; Boone, Greenup, Pulaski, and Russell, 11; Bullitt and Mercer, 10; Christian, 9.
• Deputy Secretary of the Labor Cabinet Amy Cubbage said the state had extended a contract with Ernst & Young to help with about 70,000 disputed unemployment claims awaiting adjudication. She said the new contract is worth about $4.9 million and will continue until the end of the year. Cubbage said the original contract and extensions are funded through Coronavirus Aid, Relief and Economic Security (CARES) Act and would not affect the state’s normal budget. 
• The Louisville Courier-Journal reports that Norton Healthcare is beginning specialized clinics to provide post-covid-19 care. Grace Schneider wrote that “to sharpen the focus on treatment and care for former covid-19 patients, Norton Healthcare said Monday it's launching two clinics in mid-September — one for adults, another for children — to evaluate patients’ ongoing symptoms and develop treatment plans.” An estimated 87% of adult survivors, even those who weren't hospitalized, deal with ongoing health problems — chief among them are chronic lung issues. Another 20% have long-term heart conditions, as well as neurological, vascular and renal medical distress. Less is known about long-term effects on children. 
• World Health Organization Director General Tedros Adhanom Ghebreyesus has urged people to continue taking steps to prevent the vulnerable from contracting the coronavirus, while condemning those who dismiss the loss of life among the elderly. In a multi-bylined story from the Washington Post Ghebreyesus said Monday, dismissing the loss of life as “a moral bankruptcy,” adding that the virus was a real threat to society and that when elderly people die, “it’s not fine.” Tony Abbott, the former Australian prime minister, said in a Tuesday speech to the Policy Exchange thinktank in London that not enough politicians were posing “uncomfortable questions about the level of deaths we might have to live with," particularly among the elderly.
• The Kentucky Board of Education sent a letter to the Kentucky High School Athletic Association Board of Control Monday urging the committee to meet and consider expanding covid-19 guidance for student athletes, Jason Frakes reports for the Louisville Courier Journal. High school sports competition is scheduled to begin next Monday in cross country, field hockey, soccer and volleyball and in football on Sept. 11, he reports. 
• More than 40 people at the Nelson County Detention Center have tested positive for the coronavirus, according to the judge-executive, Dalton Godbey reports for
• Paige Noel with WYMT provides a list of coronavirus cases and new deaths from health departments in Eastern Kentucky. 
• Each day this week WKYT News at 6 will present a series about misinformation and the pandemic. Click here to see Part I: Misinformation overload: It's everywhere. Why? Click here to see Part II: Combating common coronavirus myths. Part III, on Wednesday, will be : Parsing political misinformation; Part IV, on Thursday: Lies about covid and kids; and Part V, on Friday: Separating fact from fiction. 
• The United States Department of Agriculture has extended the school food waivers until the end of 2020, according to a news release from Senate Majority Leader Mitch McConnell's office. These waivers allow flexibility in how school nutrition programs can be delivered to students in need during the pandemic.

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Baptist Health completes purchase of Elizabethtown, which it has managed for 20+ years; changes name to Baptist Health Hardin

Baptist Health, which has managed Hardin Memorial Hospital in Elizabethtown for more than 20 years, has completed a long-delayed purchase of the 300-bed facility and given it a new name: Baptist Health Hardin. It is the ninth hospital in the Baptist Health system.

"The transaction includes $361.4 million in payments and future investments," a Baptist Health press release said. "The closing came about three years after the Hardin Memorial Hospital Board of Trustees signed a letter of intent to pursue the sale," and five years after they started seeking a buyer. The release said they received "about three dozen proposals."

“This is a great day in the history of this community and our health system,” said Hardin County Judge-Executive Harry Berry, who was the hospital board's chair. “The hospital board sought the best solution to continue providing the excellent healthcare that our community -- and 10-county service area -- have come to expect. We found that solution in Baptist Health, which has helped guide us so successfully for more than 20 years.”

Baptist Health CEO Gerard Colman said, “You can expect the same quality healthcare you’ve come to know from familiar faces. You can also expect groundbreaking ceremonies, ribbon cuttings and announcements about new providers in the future as Baptist Health delivers on its promises to invest in the health of this community.”

In the purchase agreement, Baptist Health promised $235 million in investments over 10 years in operating and capital investments. The release said it would invest a minimum of $150 million in the first five years for new facilities, recruit more physicians and upgrade equipment and information technology.

At closing, Baptist paid the county $60 million, less the amount used in July to fully fund the Hardin Memorial defined benefit pension plan for current employees and retirees, plus another $66.4 million over 25 years. It will provide up to $150,000 per year for 25 years for health-care services historically provided to inmates of the county jail.

"President Dennis Johnson and other senior leaders have been retained," the release said. "Employment was offered to all employees at their current pay level."

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