CHEST Physician

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.

“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.

With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”

The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.

The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.

In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.

“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.

They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.

However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”

This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.

SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

On March 26, 2020, it’s hard to write or think of anything beyond the COVID-19 pandemic. Those of you who are on the front lines of the battle may find it strange that I am just a bit envious. Having stepped back from clinical medicine nearly a decade ago, it is frustrating to feel that there is little I can do to help other than offering to venture into the grocery store to shop for friends and neighbors who feel more vulnerable than I do.

jacoblund/iStock/Getty Images

Here in Maine, we are blessed by geographic isolation that for the moment seems to have damped the surge from the metropolitan centers to our south. But, the virus is here and, as the state with the oldest population, we are beginning to be affected.

For nearly a century, we could count on the outhouses here in Maine would be stocked with outdated Sears Roebucks catalogs when toilet paper was in short supply. Many outhouses remain but Sears Roebucks and its catalogs have disappeared from the landscape. I take a little comfort in the learning that I’m not the only human on the planet who can envision the horror of a week or even a day without toilet paper.

So I am left to sit on the sidelines and watch how my fellow Mainers are coping with the anxiety, depression, and loneliness that come with the forced social isolation. It is pretty clear that walking outside has become the coping strategy of choice. On a usual March day the walkers comprise a skimpy mix of dog walkers and wannabe arctic explorers testing the weather-defying capabilities of their high-tech outerwear. But, to say the least, this is not a usual March and the number of walkers has surged bolstered by gym rats forced off their sweat-drenched ellipticals and treadmills.

This increase in outdoor activity is clearly perceptible even on an overcast day, but it is far less than one would expect given the magnitude of the disruption to everyone’s routines. But, when the sun comes out! The doors fly open and onto the sidewalks and quiet rural roads spill scores of people I haven’t seen for months and in some cases decades. One can almost hear John Denver singing “sunshine on my shoulders makes me happy.” Everyone is smiling and waving to each other. It feels as though the community has, at least for a few hours, been able to throw off the burden of angst that the pandemic laid on us.

There has been a good bit of research about seasonal affective disorder, and I suspect that almost everyone has heard about the value of sunshine for depression. But it is unfortunate that the psychological benefits of just being outdoors – even on an overcast day – has gone pretty much unpublicized. As part of their marketing strategy, a local company that specializes in recreational clothing and gear is encouraging its customers to become “outsiders.” It may be that the pandemic will make more people realize the psychological benefits of being active outside. As physicians we should continue to encourage our patients to be more active and remind them that they don’t need to wait for a sunny day to do so.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no relevant financial disclosures. Email him at [email protected].
 

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

[email protected]

A meme has been going around the Internet in which a Muppet is dressed as a doctor, and the caption declares: “If you don’t want to be intubated by a psychiatrist, stay home!” This meme is meant as a commentary on health care worker shortages. But it also touches on the concerns of psychiatrists who might be questioning our role in the pandemic, given that we are physicians who do not regularly rely on labs or imaging to guide treatment. And we rarely even touch our patients.

As observed by Henry A. Nasrallah, MD, editor in chief of Current Psychiatry, who referred to anxiety as endemic during a viral pandemic (Current Psychiatry. 2020 April;19[4]:e3-5), our society is experiencing intense psychological repercussions from the pandemic. These repercussions will evolve from anxiety to despair, and for some, to resilience.

All jokes aside about the medical knowledge of psychiatrists, we are on the cutting edge of how to address the pandemic of fear and uncertainty gripping individuals and society across the nation.

Isn’t it our role as psychiatrists to help people face the reality of personal and societal crises? Aren’t we trained to help people find their internal reserves, bolster them with medications and/or psychotherapy, and prepare them to respond to challenges? I propose that our training and particular experience of hearing patients’ stories has indeed prepared us to receive surreal information and package it into a palatable, even therapeutic, form for our patients.

I’d like to present two cases I’ve recently seen during the first stages of the COVID-19 pandemic juxtaposed with patients I saw during “normal” times. These cases show that, as psychiatrists, we are prepared to face the psychological impact of this crisis.

A patient called me about worsened anxiety after she’d been sidelined at home from her job as a waitress and was currently spending 12 hours a day with her overbearing mother. She had always used her work to buffer her anxiety, as the fast pace of the restaurant kept her from ruminating.

The call reminded me of ones I’d receive from female patients during the MeToo movement and particularly during the Brett Kavanaugh confirmation hearings for the Supreme Court, in which a sexual assault victim and alleged perpetrator faced off on television. During therapy and medication management sessions alike, I would talk to women struggling with the number of news stories about victims coming forward after sexual assault. They were reliving their humiliations, and despite the empowering nature of the movement, they felt vulnerable in the shadow of memories of their perpetrators.

The advice I gave then is similar to the guidance I give now, and also is closely related to the Centers for Disease Control and Prevention advice on its website on how to manage the mental health impact of COVID-19. People can be informed without suffering by taking these steps:

• Limit the amount of news and social media consumed, and if possible, try to schedule news consumption into discrete periods that are not close to bedtime or other periods meant for relaxation.
• Reach out to loved ones and friends who remind you of strength and better times.
• Make time to relax and unwind, either through resting or engaging in an activity you enjoy.
• Take care of your body and mind with exercise.
• Try for 8 hours of sleep a night (even if it doesn’t happen).
• Use techniques such as meditating, doing yoga, or breathing to practice focusing your attention somewhere.

During this crisis, tactful self-disclosure might be appropriate and therapeutic. All of our lives have been disrupted by COVID-19 and acknowledging this to patients can help them feel less isolated and vulnerable. Our patients with diagnosed psychiatric disorders will be more susceptible to crippling anxiety, exacerbations in panic attacks, obsessive-compulsive disorder symptoms, and resurgence of suicidal ideation in the face of uncertainty and despair. They may also be more likely to experience the socioeconomic fallout of this pandemic. But it’s not just these individuals who will be hit with intense feelings as we wonder what the next day, month, or 6 months hold for us, our families, our friends, our country, and our world.

Recently, I had one of the more surreal experiences of my professional life. I work as a consulation-liaison psychiatrist on the medical wards, and I was consulted to treat a young woman from Central America with schizophrenia who made a serious suicide attempt in mid-February before COVID-19 was part of the lexicon.

After an overdose, she developed aspiration pneumonia and acute respiratory distress syndrome and ended up in the ICU on a respirator for 3 weeks. Her doctors and family were certain she would die, but she miraculously survived. By the time she was extubated and less delirious from her medically induced coma, the hospital had restricted all visitors because of COVID-19.

Because I speak Spanish, we developed as decent a working relationship as we could, considering the patient’s delirium and blunted affect. On top of restarting her antipsychotics, I had to inform her that her family was no longer allowed to come visit her. Outside of this room, I vacillated on how to tell a woman with a history of paranoia that the hospital would not allow her family to visit because we were in the middle of a pandemic. A contagious virus had quickly spread around the world, cases were now spiking in the United States, much of the country was on lockdown, and the hospital was limiting visitors because asymptomatic individuals could bring the virus into the hospital or be infected by asymptomatic staff.

As the words came out of my mouth, she looked at me as I have looked at psychotic individuals as they spin me yarns of impossible explanation for their symptoms when I know they’re simply psychotic and living in an alternate reality. Imagine just waking up from a coma and your doctor coming in to tell you: “The U.S. is on lockdown because a deadly virus is spreading throughout our country.” You’d think you’ve woken up in a zombie film. Yet, the patient simply nodded and asked: “Will I be able to use the phone to call my family?” I sighed with relief and helped her dial her brother’s number.

Haven’t we all listened to insane stories while keeping a straight face and then answered with a politely bland question? Just a few months ago, I treated a homeless woman with schizophrenia who calmly explained to me that her large malignant ovarian tumor (which I could see protruding under her gown) was the unborn heir of Queen Victoria and Prince Albert. If she allowed the doctors to take it out (that is, treat her cancer) she’d be assassinated by the Russian intelligence agency. She refused to let the doctors sentence her to death. Ultimately, we allowed her to refuse treatment. Despite a month of treatment with antipsychotic medication, her psychotic beliefs did not change, and we could not imagine forcing her through surgery and chemotherapy. She died in hospice.

I’ve walked the valleys of bizarro land many times. Working through the dark reality of COVID-19 should be no match for us psychiatrists who have listened to dark stories and responded with words of comfort or empathic silence. As mental health clinicians, I believe we are well equipped to fight on the front lines of the pandemic of fear that has arrested our country. We can make ourselves available to our patients, friends, family, and institutions – medical or otherwise – that are grappling with how to cope with the psychological impact of COVID-19.

Dr. Posada is a consultation-liaison psychiatry fellow with the Inova Fairfax Hospital/George Washington University program in Falls Church, Va., and associate producer of the MDedge Psychcast. She changed key details about the patients discussed to protect their confidentiality. Dr. Posada has no conflicts of interest.

A meme has been going around the Internet in which a Muppet is dressed as a doctor, and the caption declares: “If you don’t want to be intubated by a psychiatrist, stay home!” This meme is meant as a commentary on health care worker shortages. But it also touches on the concerns of psychiatrists who might be questioning our role in the pandemic, given that we are physicians who do not regularly rely on labs or imaging to guide treatment. And we rarely even touch our patients.

As observed by Henry A. Nasrallah, MD, editor in chief of Current Psychiatry, who referred to anxiety as endemic during a viral pandemic (Current Psychiatry. 2020 April;19[4]:e3-5), our society is experiencing intense psychological repercussions from the pandemic. These repercussions will evolve from anxiety to despair, and for some, to resilience.

All jokes aside about the medical knowledge of psychiatrists, we are on the cutting edge of how to address the pandemic of fear and uncertainty gripping individuals and society across the nation.

Isn’t it our role as psychiatrists to help people face the reality of personal and societal crises? Aren’t we trained to help people find their internal reserves, bolster them with medications and/or psychotherapy, and prepare them to respond to challenges? I propose that our training and particular experience of hearing patients’ stories has indeed prepared us to receive surreal information and package it into a palatable, even therapeutic, form for our patients.

I’d like to present two cases I’ve recently seen during the first stages of the COVID-19 pandemic juxtaposed with patients I saw during “normal” times. These cases show that, as psychiatrists, we are prepared to face the psychological impact of this crisis.

A patient called me about worsened anxiety after she’d been sidelined at home from her job as a waitress and was currently spending 12 hours a day with her overbearing mother. She had always used her work to buffer her anxiety, as the fast pace of the restaurant kept her from ruminating.

The call reminded me of ones I’d receive from female patients during the MeToo movement and particularly during the Brett Kavanaugh confirmation hearings for the Supreme Court, in which a sexual assault victim and alleged perpetrator faced off on television. During therapy and medication management sessions alike, I would talk to women struggling with the number of news stories about victims coming forward after sexual assault. They were reliving their humiliations, and despite the empowering nature of the movement, they felt vulnerable in the shadow of memories of their perpetrators.

The advice I gave then is similar to the guidance I give now, and also is closely related to the Centers for Disease Control and Prevention advice on its website on how to manage the mental health impact of COVID-19. People can be informed without suffering by taking these steps:

• Limit the amount of news and social media consumed, and if possible, try to schedule news consumption into discrete periods that are not close to bedtime or other periods meant for relaxation.
• Reach out to loved ones and friends who remind you of strength and better times.
• Make time to relax and unwind, either through resting or engaging in an activity you enjoy.
• Take care of your body and mind with exercise.
• Try for 8 hours of sleep a night (even if it doesn’t happen).
• Use techniques such as meditating, doing yoga, or breathing to practice focusing your attention somewhere.

During this crisis, tactful self-disclosure might be appropriate and therapeutic. All of our lives have been disrupted by COVID-19 and acknowledging this to patients can help them feel less isolated and vulnerable. Our patients with diagnosed psychiatric disorders will be more susceptible to crippling anxiety, exacerbations in panic attacks, obsessive-compulsive disorder symptoms, and resurgence of suicidal ideation in the face of uncertainty and despair. They may also be more likely to experience the socioeconomic fallout of this pandemic. But it’s not just these individuals who will be hit with intense feelings as we wonder what the next day, month, or 6 months hold for us, our families, our friends, our country, and our world.

Recently, I had one of the more surreal experiences of my professional life. I work as a consulation-liaison psychiatrist on the medical wards, and I was consulted to treat a young woman from Central America with schizophrenia who made a serious suicide attempt in mid-February before COVID-19 was part of the lexicon.

After an overdose, she developed aspiration pneumonia and acute respiratory distress syndrome and ended up in the ICU on a respirator for 3 weeks. Her doctors and family were certain she would die, but she miraculously survived. By the time she was extubated and less delirious from her medically induced coma, the hospital had restricted all visitors because of COVID-19.

Because I speak Spanish, we developed as decent a working relationship as we could, considering the patient’s delirium and blunted affect. On top of restarting her antipsychotics, I had to inform her that her family was no longer allowed to come visit her. Outside of this room, I vacillated on how to tell a woman with a history of paranoia that the hospital would not allow her family to visit because we were in the middle of a pandemic. A contagious virus had quickly spread around the world, cases were now spiking in the United States, much of the country was on lockdown, and the hospital was limiting visitors because asymptomatic individuals could bring the virus into the hospital or be infected by asymptomatic staff.

As the words came out of my mouth, she looked at me as I have looked at psychotic individuals as they spin me yarns of impossible explanation for their symptoms when I know they’re simply psychotic and living in an alternate reality. Imagine just waking up from a coma and your doctor coming in to tell you: “The U.S. is on lockdown because a deadly virus is spreading throughout our country.” You’d think you’ve woken up in a zombie film. Yet, the patient simply nodded and asked: “Will I be able to use the phone to call my family?” I sighed with relief and helped her dial her brother’s number.

Haven’t we all listened to insane stories while keeping a straight face and then answered with a politely bland question? Just a few months ago, I treated a homeless woman with schizophrenia who calmly explained to me that her large malignant ovarian tumor (which I could see protruding under her gown) was the unborn heir of Queen Victoria and Prince Albert. If she allowed the doctors to take it out (that is, treat her cancer) she’d be assassinated by the Russian intelligence agency. She refused to let the doctors sentence her to death. Ultimately, we allowed her to refuse treatment. Despite a month of treatment with antipsychotic medication, her psychotic beliefs did not change, and we could not imagine forcing her through surgery and chemotherapy. She died in hospice.

I’ve walked the valleys of bizarro land many times. Working through the dark reality of COVID-19 should be no match for us psychiatrists who have listened to dark stories and responded with words of comfort or empathic silence. As mental health clinicians, I believe we are well equipped to fight on the front lines of the pandemic of fear that has arrested our country. We can make ourselves available to our patients, friends, family, and institutions – medical or otherwise – that are grappling with how to cope with the psychological impact of COVID-19.

Dr. Posada is a consultation-liaison psychiatry fellow with the Inova Fairfax Hospital/George Washington University program in Falls Church, Va., and associate producer of the MDedge Psychcast. She changed key details about the patients discussed to protect their confidentiality. Dr. Posada has no conflicts of interest.

A meme has been going around the Internet in which a Muppet is dressed as a doctor, and the caption declares: “If you don’t want to be intubated by a psychiatrist, stay home!” This meme is meant as a commentary on health care worker shortages. But it also touches on the concerns of psychiatrists who might be questioning our role in the pandemic, given that we are physicians who do not regularly rely on labs or imaging to guide treatment. And we rarely even touch our patients.

As observed by Henry A. Nasrallah, MD, editor in chief of Current Psychiatry, who referred to anxiety as endemic during a viral pandemic (Current Psychiatry. 2020 April;19[4]:e3-5), our society is experiencing intense psychological repercussions from the pandemic. These repercussions will evolve from anxiety to despair, and for some, to resilience.

All jokes aside about the medical knowledge of psychiatrists, we are on the cutting edge of how to address the pandemic of fear and uncertainty gripping individuals and society across the nation.

Isn’t it our role as psychiatrists to help people face the reality of personal and societal crises? Aren’t we trained to help people find their internal reserves, bolster them with medications and/or psychotherapy, and prepare them to respond to challenges? I propose that our training and particular experience of hearing patients’ stories has indeed prepared us to receive surreal information and package it into a palatable, even therapeutic, form for our patients.

I’d like to present two cases I’ve recently seen during the first stages of the COVID-19 pandemic juxtaposed with patients I saw during “normal” times. These cases show that, as psychiatrists, we are prepared to face the psychological impact of this crisis.

A patient called me about worsened anxiety after she’d been sidelined at home from her job as a waitress and was currently spending 12 hours a day with her overbearing mother. She had always used her work to buffer her anxiety, as the fast pace of the restaurant kept her from ruminating.

The call reminded me of ones I’d receive from female patients during the MeToo movement and particularly during the Brett Kavanaugh confirmation hearings for the Supreme Court, in which a sexual assault victim and alleged perpetrator faced off on television. During therapy and medication management sessions alike, I would talk to women struggling with the number of news stories about victims coming forward after sexual assault. They were reliving their humiliations, and despite the empowering nature of the movement, they felt vulnerable in the shadow of memories of their perpetrators.

The advice I gave then is similar to the guidance I give now, and also is closely related to the Centers for Disease Control and Prevention advice on its website on how to manage the mental health impact of COVID-19. People can be informed without suffering by taking these steps:

• Limit the amount of news and social media consumed, and if possible, try to schedule news consumption into discrete periods that are not close to bedtime or other periods meant for relaxation.
• Reach out to loved ones and friends who remind you of strength and better times.
• Make time to relax and unwind, either through resting or engaging in an activity you enjoy.
• Take care of your body and mind with exercise.
• Try for 8 hours of sleep a night (even if it doesn’t happen).
• Use techniques such as meditating, doing yoga, or breathing to practice focusing your attention somewhere.

During this crisis, tactful self-disclosure might be appropriate and therapeutic. All of our lives have been disrupted by COVID-19 and acknowledging this to patients can help them feel less isolated and vulnerable. Our patients with diagnosed psychiatric disorders will be more susceptible to crippling anxiety, exacerbations in panic attacks, obsessive-compulsive disorder symptoms, and resurgence of suicidal ideation in the face of uncertainty and despair. They may also be more likely to experience the socioeconomic fallout of this pandemic. But it’s not just these individuals who will be hit with intense feelings as we wonder what the next day, month, or 6 months hold for us, our families, our friends, our country, and our world.

Recently, I had one of the more surreal experiences of my professional life. I work as a consulation-liaison psychiatrist on the medical wards, and I was consulted to treat a young woman from Central America with schizophrenia who made a serious suicide attempt in mid-February before COVID-19 was part of the lexicon.

After an overdose, she developed aspiration pneumonia and acute respiratory distress syndrome and ended up in the ICU on a respirator for 3 weeks. Her doctors and family were certain she would die, but she miraculously survived. By the time she was extubated and less delirious from her medically induced coma, the hospital had restricted all visitors because of COVID-19.

Because I speak Spanish, we developed as decent a working relationship as we could, considering the patient’s delirium and blunted affect. On top of restarting her antipsychotics, I had to inform her that her family was no longer allowed to come visit her. Outside of this room, I vacillated on how to tell a woman with a history of paranoia that the hospital would not allow her family to visit because we were in the middle of a pandemic. A contagious virus had quickly spread around the world, cases were now spiking in the United States, much of the country was on lockdown, and the hospital was limiting visitors because asymptomatic individuals could bring the virus into the hospital or be infected by asymptomatic staff.

As the words came out of my mouth, she looked at me as I have looked at psychotic individuals as they spin me yarns of impossible explanation for their symptoms when I know they’re simply psychotic and living in an alternate reality. Imagine just waking up from a coma and your doctor coming in to tell you: “The U.S. is on lockdown because a deadly virus is spreading throughout our country.” You’d think you’ve woken up in a zombie film. Yet, the patient simply nodded and asked: “Will I be able to use the phone to call my family?” I sighed with relief and helped her dial her brother’s number.

Haven’t we all listened to insane stories while keeping a straight face and then answered with a politely bland question? Just a few months ago, I treated a homeless woman with schizophrenia who calmly explained to me that her large malignant ovarian tumor (which I could see protruding under her gown) was the unborn heir of Queen Victoria and Prince Albert. If she allowed the doctors to take it out (that is, treat her cancer) she’d be assassinated by the Russian intelligence agency. She refused to let the doctors sentence her to death. Ultimately, we allowed her to refuse treatment. Despite a month of treatment with antipsychotic medication, her psychotic beliefs did not change, and we could not imagine forcing her through surgery and chemotherapy. She died in hospice.

I’ve walked the valleys of bizarro land many times. Working through the dark reality of COVID-19 should be no match for us psychiatrists who have listened to dark stories and responded with words of comfort or empathic silence. As mental health clinicians, I believe we are well equipped to fight on the front lines of the pandemic of fear that has arrested our country. We can make ourselves available to our patients, friends, family, and institutions – medical or otherwise – that are grappling with how to cope with the psychological impact of COVID-19.

Dr. Posada is a consultation-liaison psychiatry fellow with the Inova Fairfax Hospital/George Washington University program in Falls Church, Va., and associate producer of the MDedge Psychcast. She changed key details about the patients discussed to protect their confidentiality. Dr. Posada has no conflicts of interest.

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Durvalumab plus chemotherapy “can be considered a new standard in ES-SCLC,” said Myung-Ju Ahn, MD, Sungkyunkwan University, Seoul, South Korea, last year at the European Society of Medical Oncology (ESMO) annual meeting, where he discussed results from the phase 3 trial known as CASPIAN.

The new approval is based on efficacy and safety data from that trial, conducted in patients with previously untreated ES-SCLC. In the experimental group (n = 268), durvalumab plus etoposide and a platinum agent (EP) was followed by maintenance durvalumab, and in the control group (n = 269) patients received the EP regimen alone.

Median overall survival (OS) was 13 months in the durvalumab plus chemotherapy group compared with 10.3 months in the chemotherapy alone group (hazard ratio 0.73; 95% confidence interval, 0.59-0.91; P = .0047).

Reporting these results, trial investigator Luis Paz-Ares, MD, Hospital Universitario 12 de Octubre, Madrid, put the new survival benefit in the context of standard treatments at the ESMO meeting last year.

“Initial response rates to etoposide plus a platinum are high, but responses are not durable and patients treated with EP typically relapse within 6 months of starting treatment with a median OS of approximately 10 months,” he said.

In addition to the primary endpoint of OS, additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR).

Median PFS was not statistically significant with immunotherapy; it was 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy group and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone group (HR, 0.78; 95% CI, 0.65-0.94).

The investigator-assessed ORR was 68% in the durvalumab plus chemotherapy group and 58% in the chemotherapy alone group.

The most common adverse reactions (≥ 20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia, according to the FDA.

At ESMO, Paz-Ares reported that rates of serious adverse events (AEs) were comparable at 30.9% and 36.1% for the durvalumab plus EP group vs. EP alone, respectively; rates of AEs leading to discontinuation were identical in both groups at 9.4%. Unsurprisingly, immune-mediated AEs were higher at 19.6% in the durvalumab combination group vs. 2.6% in the EP alone group.

In this setting, durvalumab is administered prior to chemotherapy on the same day. The recommended durvalumab dose (when administered with etoposide and carboplatin or cisplatin) is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single-agent maintenance therapy.

Durvalumab is already approved for metastatic non–small cell lung cancer in patients whose tumors have only spread in the chest, and is also approved for use in urothelial cancer.

This article first appeared on Medscape.com.