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COVID-19: New group stands up for health professionals facing retaliation
Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.
Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.
“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”
The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.
In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.
“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
Letter highlights hospitals’ obligations
As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.
Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”
“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”
Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.
“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”
Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.
Workplace rights, legal options
Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.
“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”
In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.
“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.
Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.
“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”
While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.
Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.
“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”
Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.
Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.
“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”
The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.
In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.
“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
Letter highlights hospitals’ obligations
As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.
Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”
“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”
Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.
“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”
Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.
Workplace rights, legal options
Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.
“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”
In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.
“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.
Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.
“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”
While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.
Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.
“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”
Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.
Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.
“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”
The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.
In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.
“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
Letter highlights hospitals’ obligations
As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.
Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”
“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”
Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.
“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”
Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.
Workplace rights, legal options
Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.
“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”
In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.
“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.
Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.
“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”
While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.
Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.
“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”
FDA okays emergency use for Impella RP in COVID-19 right heart failure
The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.
“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.
It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.
“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”
Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.
The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.
The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.
The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.
Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.
“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.
It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.
“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”
Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.
The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.
The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.
The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.
Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.
“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.
It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.
“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”
Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.
The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.
The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.
The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.
Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.
A version of this article originally appeared on Medscape.com.
Poziotinib provides ‘modest but meaningful’ efficacy in NSCLC subgroup
The overall response rate (ORR) in the 115 patients was 14.8%, according to Xiuning Le, MD, PhD, of MD Anderson Cancer Center in Houston, who reported these results at the AACR virtual meeting I.
The ORR fell short of the greater than 17% required to meet the primary endpoint, but 65% of patients experienced tumor shrinkage, Dr. Le noted.
Overall, 17 patients had a confirmed partial response, 5 had an unconfirmed partial response, and 62 had stable disease, for a disease control rate of 68.7%.
Responses occurred early and were durable, Dr. Le said. The median duration of response was 7.4 months.
Responses were also consistent across subgroups based on the number of prior lines of therapy and prior EGFR tyrosine kinase inhibitor (TKI) therapy.
The median progression-free survival was 4.2 months.
Patients, treatment, and safety
The patients, who were enrolled in the first cohort of the ZENITH20 study, had a median age of 61 years. They had received a median of two prior therapies, with most having received both chemotherapy and immunotherapy.
Poziotinib was given at a once-daily dose of 16 mg for 28-day cycles, with follow-up of 24 months. Dose reductions were allowed for adverse events (AEs).
AEs were on target and consistent with EGFR TKI class effects. The most common AEs were rash, diarrhea, stomatitis, and paronychia.
Grade 3 AEs included rash (28%) and diarrhea (25%). No grade 5 treatment-related AEs occurred.
Dose reductions were common, occurring in 68% of patients. The median relative poziotinib dose intensity was 72%, suggesting that response can be maintained at lower dose levels, Dr. Le said.
Drug interruptions were also common, occurring in 88% of patients. Ten percent of patients discontinued treatment permanently, Dr. Le said, noting that this is consistent with findings in prior large trials of second-generation TKIs.
Implications
The results of this study are of note because EGFR is a known driver of NSCLC, Dr. Le said. She explained that, while effective treatments exist for more common EGFR mutations, such as the classic sensitizing exon 21 mutation L858R and exon 19 deletion, no approved targeted therapies are available for the approximately 10% of lung cancer patients whose tumors harbor EGFR exon 20 insertions.
“Those EGFR exon 20 insertions are not sensitive to most of the approved EGFR inhibitors,” Dr. Le said. She noted that, in one study, the median progression-free survival following treatment with an approved agent was 14 months in patients with classical mutations, compared with 2 months in those with exon 20 insertions.
The difference is attributable to molecular structural differences. Exon 20 insertions create a smaller and more shallow EGFR protein interaction surface, Dr. Le explained. “So some of the approved inhibitors don’t fit well into the oncogenic molecule,” she said.
Poziotinib has a small size and shape that can fit into the binding pocket of exon 20, and that, along with its mechanism of action, made it a promising candidate for this population, Dr. Le said. She referenced a study of 44 patients at MD Anderson Cancer Center in which poziotinib produced an ORR of 43%.
In the current study, “[p]oziotinib has further demonstrated clinical activity in previously treated lung cancer patients with EGFR exon 20 insertions ... with a toxicity profile similar to that of other second-generation TKIs,” she said.
The findings underscore the promise of EGFR exon 20 insertions as targets for therapeutic intervention, said invited discussant Taofeek Owonikoko, MD, PhD, of Winship Cancer Institute of Emory University in Atlanta.
“Poziotinib showed modest but meaningful efficacy,” he said. “However, its safety remains a challenge. It is expected that ongoing modifications in the dosing schedule will make it a more tolerable agent.”
“Future studies to systematically explore differential sensitivity of various exon 20 insertion mutations by location will be informative, as will [elucidation of] mechanisms of resistance to prioritize combinatorial strategies to further enhance the efficacy of this drug,” Dr. Owonikoko added.
Next steps
Analyses of other cohorts in the ZENITH20 trial will be reported at upcoming conferences as the data mature, Dr. Le noted. Cohorts 2-4 include patients with previously treated HER2 exon 20 insertions and treatment-naive patients with EGFR and HER2 exon 20 insertions, respectively.
Additionally, three new cohorts are being added, including one with patients who have EGFR or HER2 exon 20 insertions, one with EGFR patients who failed prior osimertinib treatment, and one with patients who have atypical EGFR or HER2 mutations.
Rather than the once-daily dosing used in cohorts 1-4, twice-daily dosing will be evaluated in these cohorts, Dr. Le said, explaining that the half-life of poziotinib is about 8 hours.
“Recent pharmacological modeling showed that a [twice-daily] regimen would reduce the maximal serum concentration and increase trough, which could lead to optimized drug coverage,” she said. “This may potentially reduce toxicity and improve patient compliance and efficacy.”
ZENITH20 is sponsored by Spectrum Pharmaceuticals Inc. Dr. Le disclosed relationships with Spectrum as well as Eli Lilly, AstraZeneca, EMD Serono, and Boehringer Ingelheim. Dr. Owonikoko disclosed relationships with many companies, not including Spectrum.
SOURCE: Le X et al. AACR 2020, Abstract CT081.
The overall response rate (ORR) in the 115 patients was 14.8%, according to Xiuning Le, MD, PhD, of MD Anderson Cancer Center in Houston, who reported these results at the AACR virtual meeting I.
The ORR fell short of the greater than 17% required to meet the primary endpoint, but 65% of patients experienced tumor shrinkage, Dr. Le noted.
Overall, 17 patients had a confirmed partial response, 5 had an unconfirmed partial response, and 62 had stable disease, for a disease control rate of 68.7%.
Responses occurred early and were durable, Dr. Le said. The median duration of response was 7.4 months.
Responses were also consistent across subgroups based on the number of prior lines of therapy and prior EGFR tyrosine kinase inhibitor (TKI) therapy.
The median progression-free survival was 4.2 months.
Patients, treatment, and safety
The patients, who were enrolled in the first cohort of the ZENITH20 study, had a median age of 61 years. They had received a median of two prior therapies, with most having received both chemotherapy and immunotherapy.
Poziotinib was given at a once-daily dose of 16 mg for 28-day cycles, with follow-up of 24 months. Dose reductions were allowed for adverse events (AEs).
AEs were on target and consistent with EGFR TKI class effects. The most common AEs were rash, diarrhea, stomatitis, and paronychia.
Grade 3 AEs included rash (28%) and diarrhea (25%). No grade 5 treatment-related AEs occurred.
Dose reductions were common, occurring in 68% of patients. The median relative poziotinib dose intensity was 72%, suggesting that response can be maintained at lower dose levels, Dr. Le said.
Drug interruptions were also common, occurring in 88% of patients. Ten percent of patients discontinued treatment permanently, Dr. Le said, noting that this is consistent with findings in prior large trials of second-generation TKIs.
Implications
The results of this study are of note because EGFR is a known driver of NSCLC, Dr. Le said. She explained that, while effective treatments exist for more common EGFR mutations, such as the classic sensitizing exon 21 mutation L858R and exon 19 deletion, no approved targeted therapies are available for the approximately 10% of lung cancer patients whose tumors harbor EGFR exon 20 insertions.
“Those EGFR exon 20 insertions are not sensitive to most of the approved EGFR inhibitors,” Dr. Le said. She noted that, in one study, the median progression-free survival following treatment with an approved agent was 14 months in patients with classical mutations, compared with 2 months in those with exon 20 insertions.
The difference is attributable to molecular structural differences. Exon 20 insertions create a smaller and more shallow EGFR protein interaction surface, Dr. Le explained. “So some of the approved inhibitors don’t fit well into the oncogenic molecule,” she said.
Poziotinib has a small size and shape that can fit into the binding pocket of exon 20, and that, along with its mechanism of action, made it a promising candidate for this population, Dr. Le said. She referenced a study of 44 patients at MD Anderson Cancer Center in which poziotinib produced an ORR of 43%.
In the current study, “[p]oziotinib has further demonstrated clinical activity in previously treated lung cancer patients with EGFR exon 20 insertions ... with a toxicity profile similar to that of other second-generation TKIs,” she said.
The findings underscore the promise of EGFR exon 20 insertions as targets for therapeutic intervention, said invited discussant Taofeek Owonikoko, MD, PhD, of Winship Cancer Institute of Emory University in Atlanta.
“Poziotinib showed modest but meaningful efficacy,” he said. “However, its safety remains a challenge. It is expected that ongoing modifications in the dosing schedule will make it a more tolerable agent.”
“Future studies to systematically explore differential sensitivity of various exon 20 insertion mutations by location will be informative, as will [elucidation of] mechanisms of resistance to prioritize combinatorial strategies to further enhance the efficacy of this drug,” Dr. Owonikoko added.
Next steps
Analyses of other cohorts in the ZENITH20 trial will be reported at upcoming conferences as the data mature, Dr. Le noted. Cohorts 2-4 include patients with previously treated HER2 exon 20 insertions and treatment-naive patients with EGFR and HER2 exon 20 insertions, respectively.
Additionally, three new cohorts are being added, including one with patients who have EGFR or HER2 exon 20 insertions, one with EGFR patients who failed prior osimertinib treatment, and one with patients who have atypical EGFR or HER2 mutations.
Rather than the once-daily dosing used in cohorts 1-4, twice-daily dosing will be evaluated in these cohorts, Dr. Le said, explaining that the half-life of poziotinib is about 8 hours.
“Recent pharmacological modeling showed that a [twice-daily] regimen would reduce the maximal serum concentration and increase trough, which could lead to optimized drug coverage,” she said. “This may potentially reduce toxicity and improve patient compliance and efficacy.”
ZENITH20 is sponsored by Spectrum Pharmaceuticals Inc. Dr. Le disclosed relationships with Spectrum as well as Eli Lilly, AstraZeneca, EMD Serono, and Boehringer Ingelheim. Dr. Owonikoko disclosed relationships with many companies, not including Spectrum.
SOURCE: Le X et al. AACR 2020, Abstract CT081.
The overall response rate (ORR) in the 115 patients was 14.8%, according to Xiuning Le, MD, PhD, of MD Anderson Cancer Center in Houston, who reported these results at the AACR virtual meeting I.
The ORR fell short of the greater than 17% required to meet the primary endpoint, but 65% of patients experienced tumor shrinkage, Dr. Le noted.
Overall, 17 patients had a confirmed partial response, 5 had an unconfirmed partial response, and 62 had stable disease, for a disease control rate of 68.7%.
Responses occurred early and were durable, Dr. Le said. The median duration of response was 7.4 months.
Responses were also consistent across subgroups based on the number of prior lines of therapy and prior EGFR tyrosine kinase inhibitor (TKI) therapy.
The median progression-free survival was 4.2 months.
Patients, treatment, and safety
The patients, who were enrolled in the first cohort of the ZENITH20 study, had a median age of 61 years. They had received a median of two prior therapies, with most having received both chemotherapy and immunotherapy.
Poziotinib was given at a once-daily dose of 16 mg for 28-day cycles, with follow-up of 24 months. Dose reductions were allowed for adverse events (AEs).
AEs were on target and consistent with EGFR TKI class effects. The most common AEs were rash, diarrhea, stomatitis, and paronychia.
Grade 3 AEs included rash (28%) and diarrhea (25%). No grade 5 treatment-related AEs occurred.
Dose reductions were common, occurring in 68% of patients. The median relative poziotinib dose intensity was 72%, suggesting that response can be maintained at lower dose levels, Dr. Le said.
Drug interruptions were also common, occurring in 88% of patients. Ten percent of patients discontinued treatment permanently, Dr. Le said, noting that this is consistent with findings in prior large trials of second-generation TKIs.
Implications
The results of this study are of note because EGFR is a known driver of NSCLC, Dr. Le said. She explained that, while effective treatments exist for more common EGFR mutations, such as the classic sensitizing exon 21 mutation L858R and exon 19 deletion, no approved targeted therapies are available for the approximately 10% of lung cancer patients whose tumors harbor EGFR exon 20 insertions.
“Those EGFR exon 20 insertions are not sensitive to most of the approved EGFR inhibitors,” Dr. Le said. She noted that, in one study, the median progression-free survival following treatment with an approved agent was 14 months in patients with classical mutations, compared with 2 months in those with exon 20 insertions.
The difference is attributable to molecular structural differences. Exon 20 insertions create a smaller and more shallow EGFR protein interaction surface, Dr. Le explained. “So some of the approved inhibitors don’t fit well into the oncogenic molecule,” she said.
Poziotinib has a small size and shape that can fit into the binding pocket of exon 20, and that, along with its mechanism of action, made it a promising candidate for this population, Dr. Le said. She referenced a study of 44 patients at MD Anderson Cancer Center in which poziotinib produced an ORR of 43%.
In the current study, “[p]oziotinib has further demonstrated clinical activity in previously treated lung cancer patients with EGFR exon 20 insertions ... with a toxicity profile similar to that of other second-generation TKIs,” she said.
The findings underscore the promise of EGFR exon 20 insertions as targets for therapeutic intervention, said invited discussant Taofeek Owonikoko, MD, PhD, of Winship Cancer Institute of Emory University in Atlanta.
“Poziotinib showed modest but meaningful efficacy,” he said. “However, its safety remains a challenge. It is expected that ongoing modifications in the dosing schedule will make it a more tolerable agent.”
“Future studies to systematically explore differential sensitivity of various exon 20 insertion mutations by location will be informative, as will [elucidation of] mechanisms of resistance to prioritize combinatorial strategies to further enhance the efficacy of this drug,” Dr. Owonikoko added.
Next steps
Analyses of other cohorts in the ZENITH20 trial will be reported at upcoming conferences as the data mature, Dr. Le noted. Cohorts 2-4 include patients with previously treated HER2 exon 20 insertions and treatment-naive patients with EGFR and HER2 exon 20 insertions, respectively.
Additionally, three new cohorts are being added, including one with patients who have EGFR or HER2 exon 20 insertions, one with EGFR patients who failed prior osimertinib treatment, and one with patients who have atypical EGFR or HER2 mutations.
Rather than the once-daily dosing used in cohorts 1-4, twice-daily dosing will be evaluated in these cohorts, Dr. Le said, explaining that the half-life of poziotinib is about 8 hours.
“Recent pharmacological modeling showed that a [twice-daily] regimen would reduce the maximal serum concentration and increase trough, which could lead to optimized drug coverage,” she said. “This may potentially reduce toxicity and improve patient compliance and efficacy.”
ZENITH20 is sponsored by Spectrum Pharmaceuticals Inc. Dr. Le disclosed relationships with Spectrum as well as Eli Lilly, AstraZeneca, EMD Serono, and Boehringer Ingelheim. Dr. Owonikoko disclosed relationships with many companies, not including Spectrum.
SOURCE: Le X et al. AACR 2020, Abstract CT081.
FROM AACR 2020
Smokers who are unmotivated to quit smoke more with e-cigarettes
Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.
“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.
This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.
In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.
In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.
More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.
The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.
All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
Abstinence challenge
Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).
At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).
“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.
In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.
“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.
“But we now know that e-cigarettes are not necessarily safe,” she added.
Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.
“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
A meager reduction
Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”
After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.
“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”
A version of this article originally appeared on Medscape.com.
Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.
“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.
This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.
In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.
In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.
More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.
The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.
All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
Abstinence challenge
Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).
At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).
“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.
In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.
“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.
“But we now know that e-cigarettes are not necessarily safe,” she added.
Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.
“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
A meager reduction
Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”
After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.
“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”
A version of this article originally appeared on Medscape.com.
Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.
“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.
This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.
In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.
In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.
More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.
The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.
All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
Abstinence challenge
Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).
At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).
“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.
In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.
“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.
“But we now know that e-cigarettes are not necessarily safe,” she added.
Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.
“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
A meager reduction
Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”
After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.
“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”
A version of this article originally appeared on Medscape.com.
Distancing works, N95 respirators work better
A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.
The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.
“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.
The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.
The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.
A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).
The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).
Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.
The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.
Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”
The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.
Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.
“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”
Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”
While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”
Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.
SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .
A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.
The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.
“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.
The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.
The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.
A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).
The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).
Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.
The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.
Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”
The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.
Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.
“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”
Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”
While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”
Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.
SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .
A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.
The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.
“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.
The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.
The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.
A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).
The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).
Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.
The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.
Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”
The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.
Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.
“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”
Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”
While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”
Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.
SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .
FROM THE LANCET
Key clinical point: Meta-analysis confirms protective measures reduce risk of spread of COVID-19.
Major finding: Adjusted risk of infection was 3.1% with a face covering vs. 17.4% without.
Study details: Systematic review and meta-analysis of 172 observational studies with 25,697 participants assessing measures to prevent spread of respiratory disease up to May 3, 2020.
Disclosures: Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The study was in part funded by the World Health Organization.
Source: Chu DK et al. Lancet. 2020 Jun 1. doi. org/10.1016/ S0140-6736(20)31142-9.
COVID-19 ravaging the Navajo Nation
The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.
The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.1 The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.
These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.2
Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,3 and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.
Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
Resources are spread out
There are only 13 stores in this expansive reservation,4 so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.
Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.5
The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.6
Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.7 Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.8
The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.
Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.
Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,9 Doctors Without Borders, 10 and University of San Francisco.11
Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
References
1. Navaho Times. 2020 May 27.
2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.
3. U.S. Census 2010, as reported by discovernavajo.com.
4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.
5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”
6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.
7. IHS Profile Fact Sheet.
8. Wu X et al. medRxiv. 2020 Apr 27.
9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.
10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.
11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.
The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.
The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.1 The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.
These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.2
Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,3 and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.
Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
Resources are spread out
There are only 13 stores in this expansive reservation,4 so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.
Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.5
The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.6
Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.7 Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.8
The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.
Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.
Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,9 Doctors Without Borders, 10 and University of San Francisco.11
Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
References
1. Navaho Times. 2020 May 27.
2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.
3. U.S. Census 2010, as reported by discovernavajo.com.
4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.
5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”
6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.
7. IHS Profile Fact Sheet.
8. Wu X et al. medRxiv. 2020 Apr 27.
9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.
10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.
11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.
The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.
The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.1 The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.
These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.2
Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,3 and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.
Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
Resources are spread out
There are only 13 stores in this expansive reservation,4 so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.
Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.5
The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.6
Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.7 Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.8
The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.
Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.
Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,9 Doctors Without Borders, 10 and University of San Francisco.11
Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
References
1. Navaho Times. 2020 May 27.
2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.
3. U.S. Census 2010, as reported by discovernavajo.com.
4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.
5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”
6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.
7. IHS Profile Fact Sheet.
8. Wu X et al. medRxiv. 2020 Apr 27.
9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.
10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.
11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.
Today’s top news highlights: Protests and COVID-19 risk, avoidable epilepsy deaths, and more
Here are the stories our MDedge editors across specialties think you need to know about today:
Mass protests could cause COVID-19 outbreaks
As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.
“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”
The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.
“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
Diabetes: 1 in 10 hospitalized for COVID-19 die within a week
More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.
Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online in Diabetologia.
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
Most adult epilepsy-related deaths could be avoided
Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.
The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.
Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.
The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.
The next most common cause of death was circulatory disease, largely cardiac arrest.
“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
FDA approves combo treatment for hepatocellular cancer
The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.
The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Mass protests could cause COVID-19 outbreaks
As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.
“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”
The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.
“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
Diabetes: 1 in 10 hospitalized for COVID-19 die within a week
More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.
Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online in Diabetologia.
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
Most adult epilepsy-related deaths could be avoided
Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.
The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.
Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.
The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.
The next most common cause of death was circulatory disease, largely cardiac arrest.
“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
FDA approves combo treatment for hepatocellular cancer
The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.
The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Mass protests could cause COVID-19 outbreaks
As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.
“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”
The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.
“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
Diabetes: 1 in 10 hospitalized for COVID-19 die within a week
More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.
Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online in Diabetologia.
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
Most adult epilepsy-related deaths could be avoided
Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.
The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.
Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.
The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.
The next most common cause of death was circulatory disease, largely cardiac arrest.
“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
FDA approves combo treatment for hepatocellular cancer
The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.
The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
FDA approves ramucirumab-erlotinib combo for metastatic NSCLC
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
Sleep burden index predicts recurrent stroke
A sleep burden index that considers multiple sleep-wake disturbances (SWDs) predicts subsequent cardiocerebrovascular events during the 2 years after a stroke, preliminary results on an ongoing study suggest.
The index, which combines sleep duration, sleep disordered breathing, restless leg syndrome (RLS), insomnia, and sleep duration, is a better predictor of new events than a single sleep disorder alone.
With further evidence of its usefulness, “the sleep burden index could be integrated into clinical routine,” Simone B. Duss, PhD, of the department of neurology at Bern (Switzerland) University Hospital, told a press briefing.
The findings were presented online at the Congress of the European Academy of Neurology 2020, which transitioned to a virtual meeting because of the COVID-19 pandemic.
Sleep-wake disorders are very common in stroke patients and may preexist or appear de novo as a consequence of brain damage, said Dr. Duss. “They may also be a result of medical, psychological, or environmental challenges these patients face after a stroke.”
Clear Evidence
There’s “clear evidence” that sleep disordered breathing is a risk factor for stroke, and negatively affects stroke outcome if left untreated, said Dr. Duss.
But for other SWDs, such as insomnia, RLS, and long and short sleep duration, “the evidence is less compelling,” she said. “However, some studies still suggest they influence stroke risk and outcome.”
Experts believe that sleep disturbances after a stroke lead to sleep fragmentation, as well as decreased slow wave sleep and REM sleep.
“This negatively affects inflammatory neuroprotective and synaptic plasticity processes during the recovery process of a stroke,” said Dr. Duss. “In the end, this results in worse outcomes with regard to recurrent events but also in activities of daily living and mood.”
The new analysis aimed to assess the impact of sleep-wake disturbances on recurrent events and outcomes following a stroke or transient ischemic attack (TIA). It included 438 patients with acute stroke (85%) or TIA (15%). The mean age of the study population was 65 years, and 64% were male.
Researchers used the National Institutes of Health Stroke Scale (NIHSS) to assess stroke severity. At admission, the mean NIHSS score was 4. Most strokes (77.2%) were supratentorial.
About one-fifth of stroke patients and one-third of TIA patients had experienced a previous event.
Researchers used functional outcome scores to assess the clinical course of the stroke or TIA. In addition, they regularly asked patients about recurrence of cardiocerebrovascular events.
Investigators assessed sleep disordered breathing during the acute phase of stroke, so within the first few days, using respirography. They collected information on the presence of other sleep-wake disturbances from questionnaires and clinical interviews at 1 month, 3 months, 1 year, and 2 years after the event.
About 26% of subjects showed severe sleep disordered breathing, “meaning that they had more than 20 apnea-hypopnea events per hour,” said Dr. Duss.
More than a quarter of patients reported subclinical symptoms of insomnia (measured using the Insomnia Severity Index), and up to 10% reported severe insomnia symptoms corresponding to the clinical diagnosis of insomnia, she said.
About 9% of patients in the acute phase of stroke, and 6% in the more chronic phase, fulfilled the diagnostic criteria of RLS.
More ‘skewed’
The results for sleep duration were relatively “skewed,” said Dr. Duss. More patients reported longer sleep duration (more than 9 hours) at 1 month than at month 3, and more reported shorter sleep duration (4.0 hours or less) at month 3 than at month 1.
The researchers built a sleep burden index for the combined impact of the various sleep-wake disturbances.
They used this index as a predictor of subsequent cardiocerebrovascular events within 3 months after an event. They used a composite outcome that included recurrent stroke or TIA, MI, heart failure, and urgent revascularization, as well as new cardiocerebrovascular events, from 3 to 24 months.
The analysis showed that the mean sleep burden index was higher for stroke patients with a recurrent event, compared with stroke or TIA patients without a recurrent event (P = .0002).
A multiple logistical regression model with the presence or absence of a recurrent event as an outcome showed that the sleep burden index is a significant predictor of recurrent events (odds ratio, 2.10; P = .001). This was true even after controlling for age, gender, and baseline stroke severity.
The baseline apnea/hypopnea index and sleep duration were also significant predictors of new events. Importantly, though, the sleep burden index remained a significant predictor of recurrent events even after excluding the apnea/hypopnea index component, said Dr. Duss. “So the predictive power of the sleep burden index is not only driven by the apnea-hypopnea index at the beginning of a stroke.”
Sleep-wake disturbances “should be more carefully assessed and considered in comprehensive treatment approaches,” not only in stroke patients, but in neurologic patients in general, said Dr. Duss
She noted that these are preliminary observations from an ongoing study. The results need to be confirmed and should be when the study is finalized, she said.
Researchers are also analyzing MRI data to assess whether certain brain lesions are associated with sleep disturbances.
Jesse Dawson, MD, professor of stroke medicine at the University of Glasgow, said the clinical scoring system the study included “will be a big help in design and conduct of clinical trials.”
Although he and other stroke experts are aware of the high prevalence of sleep disorders after stroke, “we don’t routinely look for them as we’re uncertain whether intervention is of benefit,” said Dr. Dawson.
This new study “suggests there is an association with adverse outcome,” he said.
The research was supported by grants from the Swiss National Science Foundation and the Swiss Heart Foundation. Dr. Duss and Dr. Dawson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A sleep burden index that considers multiple sleep-wake disturbances (SWDs) predicts subsequent cardiocerebrovascular events during the 2 years after a stroke, preliminary results on an ongoing study suggest.
The index, which combines sleep duration, sleep disordered breathing, restless leg syndrome (RLS), insomnia, and sleep duration, is a better predictor of new events than a single sleep disorder alone.
With further evidence of its usefulness, “the sleep burden index could be integrated into clinical routine,” Simone B. Duss, PhD, of the department of neurology at Bern (Switzerland) University Hospital, told a press briefing.
The findings were presented online at the Congress of the European Academy of Neurology 2020, which transitioned to a virtual meeting because of the COVID-19 pandemic.
Sleep-wake disorders are very common in stroke patients and may preexist or appear de novo as a consequence of brain damage, said Dr. Duss. “They may also be a result of medical, psychological, or environmental challenges these patients face after a stroke.”
Clear Evidence
There’s “clear evidence” that sleep disordered breathing is a risk factor for stroke, and negatively affects stroke outcome if left untreated, said Dr. Duss.
But for other SWDs, such as insomnia, RLS, and long and short sleep duration, “the evidence is less compelling,” she said. “However, some studies still suggest they influence stroke risk and outcome.”
Experts believe that sleep disturbances after a stroke lead to sleep fragmentation, as well as decreased slow wave sleep and REM sleep.
“This negatively affects inflammatory neuroprotective and synaptic plasticity processes during the recovery process of a stroke,” said Dr. Duss. “In the end, this results in worse outcomes with regard to recurrent events but also in activities of daily living and mood.”
The new analysis aimed to assess the impact of sleep-wake disturbances on recurrent events and outcomes following a stroke or transient ischemic attack (TIA). It included 438 patients with acute stroke (85%) or TIA (15%). The mean age of the study population was 65 years, and 64% were male.
Researchers used the National Institutes of Health Stroke Scale (NIHSS) to assess stroke severity. At admission, the mean NIHSS score was 4. Most strokes (77.2%) were supratentorial.
About one-fifth of stroke patients and one-third of TIA patients had experienced a previous event.
Researchers used functional outcome scores to assess the clinical course of the stroke or TIA. In addition, they regularly asked patients about recurrence of cardiocerebrovascular events.
Investigators assessed sleep disordered breathing during the acute phase of stroke, so within the first few days, using respirography. They collected information on the presence of other sleep-wake disturbances from questionnaires and clinical interviews at 1 month, 3 months, 1 year, and 2 years after the event.
About 26% of subjects showed severe sleep disordered breathing, “meaning that they had more than 20 apnea-hypopnea events per hour,” said Dr. Duss.
More than a quarter of patients reported subclinical symptoms of insomnia (measured using the Insomnia Severity Index), and up to 10% reported severe insomnia symptoms corresponding to the clinical diagnosis of insomnia, she said.
About 9% of patients in the acute phase of stroke, and 6% in the more chronic phase, fulfilled the diagnostic criteria of RLS.
More ‘skewed’
The results for sleep duration were relatively “skewed,” said Dr. Duss. More patients reported longer sleep duration (more than 9 hours) at 1 month than at month 3, and more reported shorter sleep duration (4.0 hours or less) at month 3 than at month 1.
The researchers built a sleep burden index for the combined impact of the various sleep-wake disturbances.
They used this index as a predictor of subsequent cardiocerebrovascular events within 3 months after an event. They used a composite outcome that included recurrent stroke or TIA, MI, heart failure, and urgent revascularization, as well as new cardiocerebrovascular events, from 3 to 24 months.
The analysis showed that the mean sleep burden index was higher for stroke patients with a recurrent event, compared with stroke or TIA patients without a recurrent event (P = .0002).
A multiple logistical regression model with the presence or absence of a recurrent event as an outcome showed that the sleep burden index is a significant predictor of recurrent events (odds ratio, 2.10; P = .001). This was true even after controlling for age, gender, and baseline stroke severity.
The baseline apnea/hypopnea index and sleep duration were also significant predictors of new events. Importantly, though, the sleep burden index remained a significant predictor of recurrent events even after excluding the apnea/hypopnea index component, said Dr. Duss. “So the predictive power of the sleep burden index is not only driven by the apnea-hypopnea index at the beginning of a stroke.”
Sleep-wake disturbances “should be more carefully assessed and considered in comprehensive treatment approaches,” not only in stroke patients, but in neurologic patients in general, said Dr. Duss
She noted that these are preliminary observations from an ongoing study. The results need to be confirmed and should be when the study is finalized, she said.
Researchers are also analyzing MRI data to assess whether certain brain lesions are associated with sleep disturbances.
Jesse Dawson, MD, professor of stroke medicine at the University of Glasgow, said the clinical scoring system the study included “will be a big help in design and conduct of clinical trials.”
Although he and other stroke experts are aware of the high prevalence of sleep disorders after stroke, “we don’t routinely look for them as we’re uncertain whether intervention is of benefit,” said Dr. Dawson.
This new study “suggests there is an association with adverse outcome,” he said.
The research was supported by grants from the Swiss National Science Foundation and the Swiss Heart Foundation. Dr. Duss and Dr. Dawson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A sleep burden index that considers multiple sleep-wake disturbances (SWDs) predicts subsequent cardiocerebrovascular events during the 2 years after a stroke, preliminary results on an ongoing study suggest.
The index, which combines sleep duration, sleep disordered breathing, restless leg syndrome (RLS), insomnia, and sleep duration, is a better predictor of new events than a single sleep disorder alone.
With further evidence of its usefulness, “the sleep burden index could be integrated into clinical routine,” Simone B. Duss, PhD, of the department of neurology at Bern (Switzerland) University Hospital, told a press briefing.
The findings were presented online at the Congress of the European Academy of Neurology 2020, which transitioned to a virtual meeting because of the COVID-19 pandemic.
Sleep-wake disorders are very common in stroke patients and may preexist or appear de novo as a consequence of brain damage, said Dr. Duss. “They may also be a result of medical, psychological, or environmental challenges these patients face after a stroke.”
Clear Evidence
There’s “clear evidence” that sleep disordered breathing is a risk factor for stroke, and negatively affects stroke outcome if left untreated, said Dr. Duss.
But for other SWDs, such as insomnia, RLS, and long and short sleep duration, “the evidence is less compelling,” she said. “However, some studies still suggest they influence stroke risk and outcome.”
Experts believe that sleep disturbances after a stroke lead to sleep fragmentation, as well as decreased slow wave sleep and REM sleep.
“This negatively affects inflammatory neuroprotective and synaptic plasticity processes during the recovery process of a stroke,” said Dr. Duss. “In the end, this results in worse outcomes with regard to recurrent events but also in activities of daily living and mood.”
The new analysis aimed to assess the impact of sleep-wake disturbances on recurrent events and outcomes following a stroke or transient ischemic attack (TIA). It included 438 patients with acute stroke (85%) or TIA (15%). The mean age of the study population was 65 years, and 64% were male.
Researchers used the National Institutes of Health Stroke Scale (NIHSS) to assess stroke severity. At admission, the mean NIHSS score was 4. Most strokes (77.2%) were supratentorial.
About one-fifth of stroke patients and one-third of TIA patients had experienced a previous event.
Researchers used functional outcome scores to assess the clinical course of the stroke or TIA. In addition, they regularly asked patients about recurrence of cardiocerebrovascular events.
Investigators assessed sleep disordered breathing during the acute phase of stroke, so within the first few days, using respirography. They collected information on the presence of other sleep-wake disturbances from questionnaires and clinical interviews at 1 month, 3 months, 1 year, and 2 years after the event.
About 26% of subjects showed severe sleep disordered breathing, “meaning that they had more than 20 apnea-hypopnea events per hour,” said Dr. Duss.
More than a quarter of patients reported subclinical symptoms of insomnia (measured using the Insomnia Severity Index), and up to 10% reported severe insomnia symptoms corresponding to the clinical diagnosis of insomnia, she said.
About 9% of patients in the acute phase of stroke, and 6% in the more chronic phase, fulfilled the diagnostic criteria of RLS.
More ‘skewed’
The results for sleep duration were relatively “skewed,” said Dr. Duss. More patients reported longer sleep duration (more than 9 hours) at 1 month than at month 3, and more reported shorter sleep duration (4.0 hours or less) at month 3 than at month 1.
The researchers built a sleep burden index for the combined impact of the various sleep-wake disturbances.
They used this index as a predictor of subsequent cardiocerebrovascular events within 3 months after an event. They used a composite outcome that included recurrent stroke or TIA, MI, heart failure, and urgent revascularization, as well as new cardiocerebrovascular events, from 3 to 24 months.
The analysis showed that the mean sleep burden index was higher for stroke patients with a recurrent event, compared with stroke or TIA patients without a recurrent event (P = .0002).
A multiple logistical regression model with the presence or absence of a recurrent event as an outcome showed that the sleep burden index is a significant predictor of recurrent events (odds ratio, 2.10; P = .001). This was true even after controlling for age, gender, and baseline stroke severity.
The baseline apnea/hypopnea index and sleep duration were also significant predictors of new events. Importantly, though, the sleep burden index remained a significant predictor of recurrent events even after excluding the apnea/hypopnea index component, said Dr. Duss. “So the predictive power of the sleep burden index is not only driven by the apnea-hypopnea index at the beginning of a stroke.”
Sleep-wake disturbances “should be more carefully assessed and considered in comprehensive treatment approaches,” not only in stroke patients, but in neurologic patients in general, said Dr. Duss
She noted that these are preliminary observations from an ongoing study. The results need to be confirmed and should be when the study is finalized, she said.
Researchers are also analyzing MRI data to assess whether certain brain lesions are associated with sleep disturbances.
Jesse Dawson, MD, professor of stroke medicine at the University of Glasgow, said the clinical scoring system the study included “will be a big help in design and conduct of clinical trials.”
Although he and other stroke experts are aware of the high prevalence of sleep disorders after stroke, “we don’t routinely look for them as we’re uncertain whether intervention is of benefit,” said Dr. Dawson.
This new study “suggests there is an association with adverse outcome,” he said.
The research was supported by grants from the Swiss National Science Foundation and the Swiss Heart Foundation. Dr. Duss and Dr. Dawson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
10% with diabetes hospitalized for COVID-19 die within a week
Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
First study to examine specific characteristics at time of admission
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.
“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.
Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”
But he urged caution regarding the A1c finding. “A1c might be associated with admission to hospital but other factors far beyond A1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”
And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.
“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
Yet again, high BMI emerges as a major risk factor
The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.
Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.
The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).
Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.
On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.
In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m2; P = .0009),
Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.
Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.
Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.
Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.
When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
Analysis ongoing, ‘some new messages might pop up’
After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A1c wasn’t associated with either outcome.
In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.
And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).
In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.
Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”
“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.
But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.
The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.
A version of this article originally appeared on Medscape.com.
Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
First study to examine specific characteristics at time of admission
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.
“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.
Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”
But he urged caution regarding the A1c finding. “A1c might be associated with admission to hospital but other factors far beyond A1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”
And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.
“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
Yet again, high BMI emerges as a major risk factor
The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.
Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.
The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).
Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.
On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.
In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m2; P = .0009),
Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.
Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.
Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.
Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.
When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
Analysis ongoing, ‘some new messages might pop up’
After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A1c wasn’t associated with either outcome.
In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.
And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).
In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.
Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”
“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.
But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.
The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.
A version of this article originally appeared on Medscape.com.
Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.
The presence of diabetes-related complications and older age also increased the risk of death.
The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
First study to examine specific characteristics at time of admission
Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.
“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.
Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”
But he urged caution regarding the A1c finding. “A1c might be associated with admission to hospital but other factors far beyond A1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”
And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.
“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
Yet again, high BMI emerges as a major risk factor
The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.
Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.
The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).
Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.
On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.
In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m2; P = .0009),
Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.
Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.
Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.
Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.
When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
Analysis ongoing, ‘some new messages might pop up’
After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A1c wasn’t associated with either outcome.
In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.
And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).
In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.
Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”
“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.
But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.
The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.
A version of this article originally appeared on Medscape.com.