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U.S. lifts visa halt to boost COVID-19 physician workforce
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.
Sunshine on my shoulders
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.
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 pdnews@mdedge.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.
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 pdnews@mdedge.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.
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 pdnews@mdedge.com.
New guidance on management of acute CVD during COVID-19
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.
FDA issues EUA allowing hydroxychloroquine sulfate, chloroquine phosphate treatment in COVID-19
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.
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.
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.
Are psychiatrists more prepared for COVID-19 than we think?
Helping patients navigate surreal situations is what we do
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.
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.
Helping patients navigate surreal situations is what we do
Helping patients navigate surreal situations is what we do
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.
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.
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.
New lipid-lowering drug class slashes LDL in HoFH patients
Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.
Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).
Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.
“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.
The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.
The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.
In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.
Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”
Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.
“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.
The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.
SOURCE: Raal F. ACC 20. Abstract 411-12.
Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.
Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).
Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.
“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.
The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.
The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.
In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.
Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”
Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.
“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.
The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.
SOURCE: Raal F. ACC 20. Abstract 411-12.
Evinacumab, the first agent from a new class of lipid-lowering drugs, showed a “remarkable” and unprecedented level of LDL-cholesterol lowering in a pivotal trial with 65 patients with homozygous familial hypercholesterolemia.
Monthly intravenous infusions of evinacumab cut LDL cholesterol levels by an average of 135 mg/dL from baseline, a 47% mean reduction, after 24 weeks of treatment in 43 homozygous familial hypercholesterolemia (HoFH) patients, Frederick Raal, MBChB, said on March 30 in a video presentation of his research at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
Evinacumab is a human monoclonal antibody inhibitor of angiopoietin-like 3, a liver protein that boosts levels of LDL cholesterol and triglycerides (TG).
Another notable effect of the novel agent was that it was equally effective in the roughly one-third of patients with a minimal residual level of LDL receptor activity, patients know as having “null/null” mutations. “For the first time, we see HoFH patients getting to [lipid] targets that we never thought would be possible,” said Dr. Raal, professor and head of endocrinology and metabolism at the University of Witwatersrand in Johannesburg, South Africa. “This works in patients without residual LDL receptor function.” The drug was also generally very well tolerated, he said, causing no treatment-related serious adverse events during the brief treatment period of 24 weeks.
“One of the major, remarkable findings in this study was the effect on null/null patients,” which contrasts with the effects of other, more established drugs for treating dyslipidemia like statins and PCSK9 inhibitors, which work by increasing the number of LDL receptors on cells. The demonstrated efficacy and safety of evinacumab in null/null patients “is a definite advance,” commented Anne C. Goldberg, MD, a lipidologist and professor of medicine at Washington University in St. Louis.
The placebo-controlled trial randomized patients at 30 sites in 11 countries who were at least 12 years old and had documented mutations in both of their LDL receptor genes and a serum level of LDL cholesterol that was at least 500 mg/dL on no treatment. Patients averaged about 40 years of age; about 30% had null/null mutations, more than 90% were on statin treatment, and about three-quarters were receiving regular treatment with a PCSK9 inhibitor. At baseline, LDL cholesterol levels averaged about 250 mg/dL.
The study’s primary endpoint was the between-group percentage change in LDL cholesterol level after 24 weeks, which fell by 47% from baseline with evinacumab treatment and increased by an average of 2% among 22 patients who received placebo injections; so evinacumab cut this measure by 49%, compared with placebo after 24 weeks, a statistically significant difference. A cut of baseline LDL cholesterol by at least 50% occurred in 56% of the evinacumab-treated patients and in 5% of controls.
In addition to its LDL reduction, another notable effect of evinacumab was that it trimmed baseline triglyceride levels by half, consistent with prior reports of the drug’s effect on this measure, although average triglyceride levels in the enrolled patients fell within the normal range prior to treatment.
Evinacumab “will probably be very effective in treating patients with hypertriglyceridemia; those studies are ongoing,” noted Dr. Raal. But, he added, “this drug will probably be reserved for severe” dyslipidemia cases, not for “the garden variety of moderate hypertriglyceridemia or hypercholesterolemia.”
Evinacumab “may be a fairly broad-spectrum lipid-lowering drug, but it should be reserved for severe cases,” agreed Dirk Blom, MBChB, head of lipidology at the University of Capetown, South Africa. “This will likely remain a fairly expensive drug, and we wouldn’t want to use it across the board, but for difficult to treat patients with either severe hypercholesterolemia or hypertriglyceridemia, I think this will have very significant advantages,” he commented.
“Drugs that reduce triglycerides by large amounts may prove to have cardiovascular disease benefits, but that remains to be proven in large, long-term outcome trials,” commented Deepak Bhatt, MD, professor of medicine at Harvard Medical School and executive director of interventional cardiology programs at Brigham and Women’s Hospital, both in Boston. “But for right now, for most patients with more common forms of elevated LDL cholesterol, the treatment options include statins, ezetimibe [Zetia], and PCSK9 inhibitors, and for more common levels of elevated triglycerides, it’s icosapent ethyl [Vascepa],” Dr. Bhatt said.
The study was sponsored by Regeneron, the company developing evinacumab and which is partially owned by Sanofi. Dr. Raal has received personal fees and/or research funding from Regeneron, Sanofi Aventis, Amgen, and The Medicines Company. Dr. Goldberg has received research funding and/or consulting fees from Regeneron and Sanofi, Akcea, Amarin, Amgen, Esperion, Ionis, Merck, Novartis, and Pfizer. Dr. Blom has been a consultant to and/or received research funding from Regeneron, Sanofi, Aegerium, Akcea, Amgen, Amryt, AstraZeneca, Eli Lilly, Esperion, Gemphire, MSD, and Novo Nordisk. Dr. Bhatt has received research funding from many companies including Regeneron and Sanofi.
SOURCE: Raal F. ACC 20. Abstract 411-12.
REPORTING FROM ACC 2020
Alirocumab effective in homozygous FH
Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We’re not getting most patients to goal, but we’re certainly getting them closer to goal. A lot of patients will still need further therapies that don’t rely on up-regulation of the LDL receptor, such as lipoprotein apheresis,” observed Dr. Blom, head of the division of lipidology at the University of Cape Town (South Africa).
Of the patients on alirocumab, 57%had at least a 30% reduction in LDL at 12 weeks, and 27% had a 50% reduction or more.
Alirocumab had salutary effects on other atherogenic lipids: roughly a 20% reduction from baseline in lipoprotein (a), a 23% decrease in apolipoprotein B, and a 25% reduction in non-HDL cholesterol.
Dr. Blom noted that, as is also the case for statins in HoFH, the LDL response to alirocumab in patients with this genetically complex disorder is more variable and generally weaker than in other hypercholesterolemic populations.
“We saw some patients getting up to 60%-70% LDL reduction in alirocumab, but a lot of patients getting much less,” he said.
Alirocumab was well tolerated in adults with HoFH, with the same favorable safety profile that’s been established in other patient populations.
Discussant Raul Santos, MD, commented that the ODYSSEY HoFH results are quite similar to those reported in patients with HoFH in an earlier study of evolocumab (Repatha), another PCSK9 inhibitor. The magnitude of LDL-lowering achieved with these biologic agents is such that, were treatment to start early in life, patients with HoFH might expect to experience an extra 10-15 years of life free of cardiovascular events.
“Certainly PCSK9 inhibitors should be the next step after statins and ezetimibe. They’re much less expensive and more available than apheresis,” said Dr. Santos, director of the lipid clinic at the Heart Institute of the University of São Paulo.
Since many patients with this rare disorder experience their first cardiovascular event in adolescence or young adulthood, Dr. Santos said, it’s very important to expand PCSK9 inhibitor therapy to the pediatric HoFH population. Two studies are ongoing in childlren.
The ODYSSEY HoFH trial was funded by Regeneron and Sanofi. Dr. Blom reported serving as a paid consultant to Sanofi, Akcea, Amgen, and Gemphire.
Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We’re not getting most patients to goal, but we’re certainly getting them closer to goal. A lot of patients will still need further therapies that don’t rely on up-regulation of the LDL receptor, such as lipoprotein apheresis,” observed Dr. Blom, head of the division of lipidology at the University of Cape Town (South Africa).
Of the patients on alirocumab, 57%had at least a 30% reduction in LDL at 12 weeks, and 27% had a 50% reduction or more.
Alirocumab had salutary effects on other atherogenic lipids: roughly a 20% reduction from baseline in lipoprotein (a), a 23% decrease in apolipoprotein B, and a 25% reduction in non-HDL cholesterol.
Dr. Blom noted that, as is also the case for statins in HoFH, the LDL response to alirocumab in patients with this genetically complex disorder is more variable and generally weaker than in other hypercholesterolemic populations.
“We saw some patients getting up to 60%-70% LDL reduction in alirocumab, but a lot of patients getting much less,” he said.
Alirocumab was well tolerated in adults with HoFH, with the same favorable safety profile that’s been established in other patient populations.
Discussant Raul Santos, MD, commented that the ODYSSEY HoFH results are quite similar to those reported in patients with HoFH in an earlier study of evolocumab (Repatha), another PCSK9 inhibitor. The magnitude of LDL-lowering achieved with these biologic agents is such that, were treatment to start early in life, patients with HoFH might expect to experience an extra 10-15 years of life free of cardiovascular events.
“Certainly PCSK9 inhibitors should be the next step after statins and ezetimibe. They’re much less expensive and more available than apheresis,” said Dr. Santos, director of the lipid clinic at the Heart Institute of the University of São Paulo.
Since many patients with this rare disorder experience their first cardiovascular event in adolescence or young adulthood, Dr. Santos said, it’s very important to expand PCSK9 inhibitor therapy to the pediatric HoFH population. Two studies are ongoing in childlren.
The ODYSSEY HoFH trial was funded by Regeneron and Sanofi. Dr. Blom reported serving as a paid consultant to Sanofi, Akcea, Amgen, and Gemphire.
Alirocumab achieved a mean 63-mg/dL reduction in LDL cholesterol in the ODYSSEY HoFH study, the largest-ever randomized, placebo-controlled clinical trial of lipid-lowering in adults with homozygous familial hypercholesterolemia (HoFH), Dirk Blom, MD, said in a video presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We’re not getting most patients to goal, but we’re certainly getting them closer to goal. A lot of patients will still need further therapies that don’t rely on up-regulation of the LDL receptor, such as lipoprotein apheresis,” observed Dr. Blom, head of the division of lipidology at the University of Cape Town (South Africa).
Of the patients on alirocumab, 57%had at least a 30% reduction in LDL at 12 weeks, and 27% had a 50% reduction or more.
Alirocumab had salutary effects on other atherogenic lipids: roughly a 20% reduction from baseline in lipoprotein (a), a 23% decrease in apolipoprotein B, and a 25% reduction in non-HDL cholesterol.
Dr. Blom noted that, as is also the case for statins in HoFH, the LDL response to alirocumab in patients with this genetically complex disorder is more variable and generally weaker than in other hypercholesterolemic populations.
“We saw some patients getting up to 60%-70% LDL reduction in alirocumab, but a lot of patients getting much less,” he said.
Alirocumab was well tolerated in adults with HoFH, with the same favorable safety profile that’s been established in other patient populations.
Discussant Raul Santos, MD, commented that the ODYSSEY HoFH results are quite similar to those reported in patients with HoFH in an earlier study of evolocumab (Repatha), another PCSK9 inhibitor. The magnitude of LDL-lowering achieved with these biologic agents is such that, were treatment to start early in life, patients with HoFH might expect to experience an extra 10-15 years of life free of cardiovascular events.
“Certainly PCSK9 inhibitors should be the next step after statins and ezetimibe. They’re much less expensive and more available than apheresis,” said Dr. Santos, director of the lipid clinic at the Heart Institute of the University of São Paulo.
Since many patients with this rare disorder experience their first cardiovascular event in adolescence or young adulthood, Dr. Santos said, it’s very important to expand PCSK9 inhibitor therapy to the pediatric HoFH population. Two studies are ongoing in childlren.
The ODYSSEY HoFH trial was funded by Regeneron and Sanofi. Dr. Blom reported serving as a paid consultant to Sanofi, Akcea, Amgen, and Gemphire.
REPORTING FROM ACC 2020
In the Phoenix area, we are in a lull before the coronavirus storm
“There is no sound save the throb of the blowers and the vibration of the hard-driven engines. There is little motion as the gun crews man their guns and the fire-control details stand with heads bent and their hands clapped over their headphones. Somewhere out there are the enemy planes.”
That’s from one of my favorite WW2 histories, “Torpedo Junction,” by Robert J. Casey. He was a reporter stationed on board the cruiser USS Salt Lake City. The entry is from a day in February 1942 when the ship was part of a force that bombarded the Japanese encampment on Wake Island. The excerpt describes the scene later that afternoon, as they awaited a counterattack from Japanese planes.
For some reason that paragraph kept going through my mind this past Sunday afternoon, in the comparatively mundane situation of sitting in the hospital library signing off on my dictations and reviewing test results. I certainly was in no danger of being bombed or strafed, yet ...
Around me, the hospital was preparing for battle. As I rounded, most of the beds were empty and many of the floors above me were shut down and darkened. Waiting rooms were empty. If you hadn’t read the news you’d think there was a sudden lull in the health care world.
But the real truth is that it’s the calm before an anticipated storm. The elective procedures have all been canceled. Nonurgent outpatient tests are on hold. Only the sickest are being admitted, and they’re being sent out as soon as possible. Every bed possible is being kept open for the feared onslaught of coronavirus patients in the coming weeks. Protective equipment, already in short supply, is being stockpiled as it becomes available. Plans have been made to erect triage tents in the parking lots.
I sit in the library and think of this. It’s quiet except for the soft hum of the air conditioning blowers as Phoenix starts to warm up for another summer. The muted purr of the computer’s hard drive as I click away on the keys. On the floors above me the nurses and respiratory techs and doctors go about their daily business of patient care, wondering when the real battle will begin (probably 2-3 weeks from the time of this writing, if not sooner).
These are scary times. I’d be lying if I said I wasn’t frightened about what might happen to me, my family, my friends, my coworkers, my patients.
The people working in the hospital above me are in the same boat, all nervous about what’s going to happen. None of them is any more immune to coronavirus than the people they’ll be treating.
But, like the crew of the USS Salt Lake City, they’re ready to do their jobs. Because it’s part of what drove each of us into our own part of this field. Because we care and want to help. And health care doesn’t work unless the whole team does.
I respect them all for it. I always have and always will, and now more than ever.
Good luck.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
“There is no sound save the throb of the blowers and the vibration of the hard-driven engines. There is little motion as the gun crews man their guns and the fire-control details stand with heads bent and their hands clapped over their headphones. Somewhere out there are the enemy planes.”
That’s from one of my favorite WW2 histories, “Torpedo Junction,” by Robert J. Casey. He was a reporter stationed on board the cruiser USS Salt Lake City. The entry is from a day in February 1942 when the ship was part of a force that bombarded the Japanese encampment on Wake Island. The excerpt describes the scene later that afternoon, as they awaited a counterattack from Japanese planes.
For some reason that paragraph kept going through my mind this past Sunday afternoon, in the comparatively mundane situation of sitting in the hospital library signing off on my dictations and reviewing test results. I certainly was in no danger of being bombed or strafed, yet ...
Around me, the hospital was preparing for battle. As I rounded, most of the beds were empty and many of the floors above me were shut down and darkened. Waiting rooms were empty. If you hadn’t read the news you’d think there was a sudden lull in the health care world.
But the real truth is that it’s the calm before an anticipated storm. The elective procedures have all been canceled. Nonurgent outpatient tests are on hold. Only the sickest are being admitted, and they’re being sent out as soon as possible. Every bed possible is being kept open for the feared onslaught of coronavirus patients in the coming weeks. Protective equipment, already in short supply, is being stockpiled as it becomes available. Plans have been made to erect triage tents in the parking lots.
I sit in the library and think of this. It’s quiet except for the soft hum of the air conditioning blowers as Phoenix starts to warm up for another summer. The muted purr of the computer’s hard drive as I click away on the keys. On the floors above me the nurses and respiratory techs and doctors go about their daily business of patient care, wondering when the real battle will begin (probably 2-3 weeks from the time of this writing, if not sooner).
These are scary times. I’d be lying if I said I wasn’t frightened about what might happen to me, my family, my friends, my coworkers, my patients.
The people working in the hospital above me are in the same boat, all nervous about what’s going to happen. None of them is any more immune to coronavirus than the people they’ll be treating.
But, like the crew of the USS Salt Lake City, they’re ready to do their jobs. Because it’s part of what drove each of us into our own part of this field. Because we care and want to help. And health care doesn’t work unless the whole team does.
I respect them all for it. I always have and always will, and now more than ever.
Good luck.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
“There is no sound save the throb of the blowers and the vibration of the hard-driven engines. There is little motion as the gun crews man their guns and the fire-control details stand with heads bent and their hands clapped over their headphones. Somewhere out there are the enemy planes.”
That’s from one of my favorite WW2 histories, “Torpedo Junction,” by Robert J. Casey. He was a reporter stationed on board the cruiser USS Salt Lake City. The entry is from a day in February 1942 when the ship was part of a force that bombarded the Japanese encampment on Wake Island. The excerpt describes the scene later that afternoon, as they awaited a counterattack from Japanese planes.
For some reason that paragraph kept going through my mind this past Sunday afternoon, in the comparatively mundane situation of sitting in the hospital library signing off on my dictations and reviewing test results. I certainly was in no danger of being bombed or strafed, yet ...
Around me, the hospital was preparing for battle. As I rounded, most of the beds were empty and many of the floors above me were shut down and darkened. Waiting rooms were empty. If you hadn’t read the news you’d think there was a sudden lull in the health care world.
But the real truth is that it’s the calm before an anticipated storm. The elective procedures have all been canceled. Nonurgent outpatient tests are on hold. Only the sickest are being admitted, and they’re being sent out as soon as possible. Every bed possible is being kept open for the feared onslaught of coronavirus patients in the coming weeks. Protective equipment, already in short supply, is being stockpiled as it becomes available. Plans have been made to erect triage tents in the parking lots.
I sit in the library and think of this. It’s quiet except for the soft hum of the air conditioning blowers as Phoenix starts to warm up for another summer. The muted purr of the computer’s hard drive as I click away on the keys. On the floors above me the nurses and respiratory techs and doctors go about their daily business of patient care, wondering when the real battle will begin (probably 2-3 weeks from the time of this writing, if not sooner).
These are scary times. I’d be lying if I said I wasn’t frightened about what might happen to me, my family, my friends, my coworkers, my patients.
The people working in the hospital above me are in the same boat, all nervous about what’s going to happen. None of them is any more immune to coronavirus than the people they’ll be treating.
But, like the crew of the USS Salt Lake City, they’re ready to do their jobs. Because it’s part of what drove each of us into our own part of this field. Because we care and want to help. And health care doesn’t work unless the whole team does.
I respect them all for it. I always have and always will, and now more than ever.
Good luck.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Physician couples draft wills, face tough questions amid COVID-19
Not long ago, weekends for Cornelia Griggs, MD, meant making trips to the grocery store, chasing after two active toddlers, and eating brunch with her husband after a busy work week. But life has changed dramatically for the family since the spread of COVID-19. On a recent weekend, Dr. Griggs and her husband, Robert Goldstone, MD, spent their days off drafting a will.
“We’re both doctors, and we know that health care workers have an increased risk of contracting COVID,” said Dr. Griggs, a pediatric surgery fellow at Columbia University Irving Medical Center in New York. “It felt like the responsible thing to do: Have a will in place to make sure our wishes are clear about who would manage our property and assets, and who would take care of our kids – God forbid.”
Outlining their final wishes is among many difficult decisions the doctors, both 36, have been forced to make in recent weeks. Dr. Goldstone, a general surgeon at Massachusetts General Hospital in Boston, is no longer returning to New York during his time off, said Dr. Griggs, who has had known COVID-19 exposures. The couple’s children, aged 4 and almost 2, are temporarily living with their grandparents in Connecticut to decrease their exposure risk.
“I felt like it was safer for all of them to be there while I was going back and forth from the hospital,” Dr. Griggs said. “My husband is in Boston. The kids are in Connecticut and I’m in New York. That inherently is hard because our whole family is split up. I don’t know when it will be safe for me to see them again.”
Health professional couples across the country are facing similar challenges as they navigate the risk of contracting COVID-19 at work, while trying to protect their families at home. From childcare dilemmas to quarantine quandaries to end-of-life considerations, partners who work in health care are confronting tough questions as the pandemic continues.
The biggest challenge is the uncertainty, says Angela Weyand, MD, an Ann Arbor, Mich.–based pediatric hematologist/oncologist who shares two young daughters with husband Ted Claflin, MD, a physical medicine and rehabilitation physician. Dr. Weyand said she and her husband are primarily working remotely now, but she knows that one or both could be deployed to the hospital to help care for patients, if the need arises. Nearby Detroit has been labeled a coronavirus “hot spot” by the U.S. Surgeon General.
“Right now, I think our biggest fear is spreading coronavirus to those we love, especially those in higher risk groups,” she said. “At the same time, we are also concerned about our own health and our future ability to be there for our children, a fear that, thankfully, neither one of us has ever had to face before. We are trying to take things one day at a time, acknowledging all that we have to be grateful for, and also learning to accept that many things right now are outside of our control.”
Dr. Weyand, 38, and her husband, 40, finalized their wills in March.
“We have been working on them for quite some time, but before now, there has never been any urgency,” Dr. Weyand said. “Hearing about the high rate of infection in health care workers and the increasing number of deaths in young healthy people made us realize that this should be a priority.”
Dallas internist Bethany Agusala, MD, 36, and her husband, Kartik Agusala, MD, 41, a cardiologist, recently spent time engaged in the same activity. The couple, who work for the University of Texas Southwestern Medical Center, have two children, aged 2 and 4.
“The chances are hopefully small that something bad would happen to either one of us, but it just seemed like a good time to get [a will] in place,” Dr. Bethany Agusala said in an interview. “It’s never an easy thing to think about.
Pediatric surgeon Chethan Sathya, MD, 34, and his wife, 31, a physician assistant, have vastly altered their home routine to prevent the risk of exposure to their 16-month-old daughter. Dr. Sathya works for the Northwell Health System in New York, which has hundreds of hospitalized patients with COVID-19, Dr. Sathya said in an interview. He did not want to disclose his wife's name or institution, but said she works in a COVID-19 unit at a New York hospital.
When his wife returns home, she removes all of her clothes and places them in a bag, showers, and then isolates herself in the bedroom. Dr. Sathya brings his wife meals and then remains in a different room with their baby.
“It’s only been a few days,” he said. “We’re going to decide: Does she just stay in one room at all times or when she doesn’t work for a few days then after 1 day, can she come out? Should she get a hotel room elsewhere? These are the considerations.”
They employ an older nanny whom they also worry about, and with whom they try to limit contact, said Dr. Sathya, who practices at Cohen Children’s Medical Center. In a matter of weeks, Dr. Sathya anticipates he will be called upon to assist in some form with the COVID crisis.
“We haven’t figured that out. I’m not sure what we’ll do,” he said. “There is no perfect solution. You have to adapt. It’s very difficult to do so when you’re living in a condo in New York.”
For Dr. Griggs, life is much quieter at home without her husband and two “laughing, wiggly,” toddlers. Weekends are now defined by resting, video calls with her family, and exercising, when it’s safe, said Dr. Griggs, who recently penned a New York Times opinion piece about the pandemic and is also active on social media regarding personal protective equipment. She calls her husband her “rock” who never fails to put a smile on her face when they chat from across the miles. Her advice for other health care couples is to take it “one day at a time.”
“Don’t try to make plans weeks in advance or let your mind go to a dark place,” she said. “It’s so easy to feel overwhelmed. The only way to get through this is to focus on surviving each day.”
Editor's Note, 3/31/20: Due to incorrect information provided, the hospital where Dr. Sathya's wife works was misidentified. We have removed the name of that hospital. The story does not include his wife's employer, because Dr. Sathya did not have permission to disclose her workplace and she wishes to remain anonymous.
Not long ago, weekends for Cornelia Griggs, MD, meant making trips to the grocery store, chasing after two active toddlers, and eating brunch with her husband after a busy work week. But life has changed dramatically for the family since the spread of COVID-19. On a recent weekend, Dr. Griggs and her husband, Robert Goldstone, MD, spent their days off drafting a will.
“We’re both doctors, and we know that health care workers have an increased risk of contracting COVID,” said Dr. Griggs, a pediatric surgery fellow at Columbia University Irving Medical Center in New York. “It felt like the responsible thing to do: Have a will in place to make sure our wishes are clear about who would manage our property and assets, and who would take care of our kids – God forbid.”
Outlining their final wishes is among many difficult decisions the doctors, both 36, have been forced to make in recent weeks. Dr. Goldstone, a general surgeon at Massachusetts General Hospital in Boston, is no longer returning to New York during his time off, said Dr. Griggs, who has had known COVID-19 exposures. The couple’s children, aged 4 and almost 2, are temporarily living with their grandparents in Connecticut to decrease their exposure risk.
“I felt like it was safer for all of them to be there while I was going back and forth from the hospital,” Dr. Griggs said. “My husband is in Boston. The kids are in Connecticut and I’m in New York. That inherently is hard because our whole family is split up. I don’t know when it will be safe for me to see them again.”
Health professional couples across the country are facing similar challenges as they navigate the risk of contracting COVID-19 at work, while trying to protect their families at home. From childcare dilemmas to quarantine quandaries to end-of-life considerations, partners who work in health care are confronting tough questions as the pandemic continues.
The biggest challenge is the uncertainty, says Angela Weyand, MD, an Ann Arbor, Mich.–based pediatric hematologist/oncologist who shares two young daughters with husband Ted Claflin, MD, a physical medicine and rehabilitation physician. Dr. Weyand said she and her husband are primarily working remotely now, but she knows that one or both could be deployed to the hospital to help care for patients, if the need arises. Nearby Detroit has been labeled a coronavirus “hot spot” by the U.S. Surgeon General.
“Right now, I think our biggest fear is spreading coronavirus to those we love, especially those in higher risk groups,” she said. “At the same time, we are also concerned about our own health and our future ability to be there for our children, a fear that, thankfully, neither one of us has ever had to face before. We are trying to take things one day at a time, acknowledging all that we have to be grateful for, and also learning to accept that many things right now are outside of our control.”
Dr. Weyand, 38, and her husband, 40, finalized their wills in March.
“We have been working on them for quite some time, but before now, there has never been any urgency,” Dr. Weyand said. “Hearing about the high rate of infection in health care workers and the increasing number of deaths in young healthy people made us realize that this should be a priority.”
Dallas internist Bethany Agusala, MD, 36, and her husband, Kartik Agusala, MD, 41, a cardiologist, recently spent time engaged in the same activity. The couple, who work for the University of Texas Southwestern Medical Center, have two children, aged 2 and 4.
“The chances are hopefully small that something bad would happen to either one of us, but it just seemed like a good time to get [a will] in place,” Dr. Bethany Agusala said in an interview. “It’s never an easy thing to think about.
Pediatric surgeon Chethan Sathya, MD, 34, and his wife, 31, a physician assistant, have vastly altered their home routine to prevent the risk of exposure to their 16-month-old daughter. Dr. Sathya works for the Northwell Health System in New York, which has hundreds of hospitalized patients with COVID-19, Dr. Sathya said in an interview. He did not want to disclose his wife's name or institution, but said she works in a COVID-19 unit at a New York hospital.
When his wife returns home, she removes all of her clothes and places them in a bag, showers, and then isolates herself in the bedroom. Dr. Sathya brings his wife meals and then remains in a different room with their baby.
“It’s only been a few days,” he said. “We’re going to decide: Does she just stay in one room at all times or when she doesn’t work for a few days then after 1 day, can she come out? Should she get a hotel room elsewhere? These are the considerations.”
They employ an older nanny whom they also worry about, and with whom they try to limit contact, said Dr. Sathya, who practices at Cohen Children’s Medical Center. In a matter of weeks, Dr. Sathya anticipates he will be called upon to assist in some form with the COVID crisis.
“We haven’t figured that out. I’m not sure what we’ll do,” he said. “There is no perfect solution. You have to adapt. It’s very difficult to do so when you’re living in a condo in New York.”
For Dr. Griggs, life is much quieter at home without her husband and two “laughing, wiggly,” toddlers. Weekends are now defined by resting, video calls with her family, and exercising, when it’s safe, said Dr. Griggs, who recently penned a New York Times opinion piece about the pandemic and is also active on social media regarding personal protective equipment. She calls her husband her “rock” who never fails to put a smile on her face when they chat from across the miles. Her advice for other health care couples is to take it “one day at a time.”
“Don’t try to make plans weeks in advance or let your mind go to a dark place,” she said. “It’s so easy to feel overwhelmed. The only way to get through this is to focus on surviving each day.”
Editor's Note, 3/31/20: Due to incorrect information provided, the hospital where Dr. Sathya's wife works was misidentified. We have removed the name of that hospital. The story does not include his wife's employer, because Dr. Sathya did not have permission to disclose her workplace and she wishes to remain anonymous.
Not long ago, weekends for Cornelia Griggs, MD, meant making trips to the grocery store, chasing after two active toddlers, and eating brunch with her husband after a busy work week. But life has changed dramatically for the family since the spread of COVID-19. On a recent weekend, Dr. Griggs and her husband, Robert Goldstone, MD, spent their days off drafting a will.
“We’re both doctors, and we know that health care workers have an increased risk of contracting COVID,” said Dr. Griggs, a pediatric surgery fellow at Columbia University Irving Medical Center in New York. “It felt like the responsible thing to do: Have a will in place to make sure our wishes are clear about who would manage our property and assets, and who would take care of our kids – God forbid.”
Outlining their final wishes is among many difficult decisions the doctors, both 36, have been forced to make in recent weeks. Dr. Goldstone, a general surgeon at Massachusetts General Hospital in Boston, is no longer returning to New York during his time off, said Dr. Griggs, who has had known COVID-19 exposures. The couple’s children, aged 4 and almost 2, are temporarily living with their grandparents in Connecticut to decrease their exposure risk.
“I felt like it was safer for all of them to be there while I was going back and forth from the hospital,” Dr. Griggs said. “My husband is in Boston. The kids are in Connecticut and I’m in New York. That inherently is hard because our whole family is split up. I don’t know when it will be safe for me to see them again.”
Health professional couples across the country are facing similar challenges as they navigate the risk of contracting COVID-19 at work, while trying to protect their families at home. From childcare dilemmas to quarantine quandaries to end-of-life considerations, partners who work in health care are confronting tough questions as the pandemic continues.
The biggest challenge is the uncertainty, says Angela Weyand, MD, an Ann Arbor, Mich.–based pediatric hematologist/oncologist who shares two young daughters with husband Ted Claflin, MD, a physical medicine and rehabilitation physician. Dr. Weyand said she and her husband are primarily working remotely now, but she knows that one or both could be deployed to the hospital to help care for patients, if the need arises. Nearby Detroit has been labeled a coronavirus “hot spot” by the U.S. Surgeon General.
“Right now, I think our biggest fear is spreading coronavirus to those we love, especially those in higher risk groups,” she said. “At the same time, we are also concerned about our own health and our future ability to be there for our children, a fear that, thankfully, neither one of us has ever had to face before. We are trying to take things one day at a time, acknowledging all that we have to be grateful for, and also learning to accept that many things right now are outside of our control.”
Dr. Weyand, 38, and her husband, 40, finalized their wills in March.
“We have been working on them for quite some time, but before now, there has never been any urgency,” Dr. Weyand said. “Hearing about the high rate of infection in health care workers and the increasing number of deaths in young healthy people made us realize that this should be a priority.”
Dallas internist Bethany Agusala, MD, 36, and her husband, Kartik Agusala, MD, 41, a cardiologist, recently spent time engaged in the same activity. The couple, who work for the University of Texas Southwestern Medical Center, have two children, aged 2 and 4.
“The chances are hopefully small that something bad would happen to either one of us, but it just seemed like a good time to get [a will] in place,” Dr. Bethany Agusala said in an interview. “It’s never an easy thing to think about.
Pediatric surgeon Chethan Sathya, MD, 34, and his wife, 31, a physician assistant, have vastly altered their home routine to prevent the risk of exposure to their 16-month-old daughter. Dr. Sathya works for the Northwell Health System in New York, which has hundreds of hospitalized patients with COVID-19, Dr. Sathya said in an interview. He did not want to disclose his wife's name or institution, but said she works in a COVID-19 unit at a New York hospital.
When his wife returns home, she removes all of her clothes and places them in a bag, showers, and then isolates herself in the bedroom. Dr. Sathya brings his wife meals and then remains in a different room with their baby.
“It’s only been a few days,” he said. “We’re going to decide: Does she just stay in one room at all times or when she doesn’t work for a few days then after 1 day, can she come out? Should she get a hotel room elsewhere? These are the considerations.”
They employ an older nanny whom they also worry about, and with whom they try to limit contact, said Dr. Sathya, who practices at Cohen Children’s Medical Center. In a matter of weeks, Dr. Sathya anticipates he will be called upon to assist in some form with the COVID crisis.
“We haven’t figured that out. I’m not sure what we’ll do,” he said. “There is no perfect solution. You have to adapt. It’s very difficult to do so when you’re living in a condo in New York.”
For Dr. Griggs, life is much quieter at home without her husband and two “laughing, wiggly,” toddlers. Weekends are now defined by resting, video calls with her family, and exercising, when it’s safe, said Dr. Griggs, who recently penned a New York Times opinion piece about the pandemic and is also active on social media regarding personal protective equipment. She calls her husband her “rock” who never fails to put a smile on her face when they chat from across the miles. Her advice for other health care couples is to take it “one day at a time.”
“Don’t try to make plans weeks in advance or let your mind go to a dark place,” she said. “It’s so easy to feel overwhelmed. The only way to get through this is to focus on surviving each day.”
Editor's Note, 3/31/20: Due to incorrect information provided, the hospital where Dr. Sathya's wife works was misidentified. We have removed the name of that hospital. The story does not include his wife's employer, because Dr. Sathya did not have permission to disclose her workplace and she wishes to remain anonymous.
Dapagliflozin trial in CKD halted because of high efficacy
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.
AstraZeneca has announced that the phase 3 DAPA-CKD trial for dapagliflozin (Farxiga) in patients with chronic kidney disease has been halted early because of overwhelming efficacy of the drug, at the recommendation of an independent data monitoring committee.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4,245 patients with stage 2-4 chronic kidney disease. Patients received either 10 mg of the dapagliflozin once-daily or a placebo. The primary composite endpoint is worsening of renal function, defined as a composite of an estimated glomerular filtration rate decline of at least 50%, onset of end-stage kidney disease, and death from cardiovascular or renal cause.
The decision to stop the trial came after a routine assessment of efficacy and safety that showed dapagliflozin’s benefits significantly earlier than expected. AstraZeneca will initiate closure of the study, and results will be published and submitted for presentation at a forthcoming medical meeting.
Dapagliflozin is a sodium-glucose transporter 2 inhibitor currently indicated for the treatment type 2 diabetes patients with inadequately controlled type 2 diabetes and for reduction of the risk of hospitalization for heart failure. In August 2019, the drug was granted Fast Track status by the Food and Drug Administration for the treatment of chronic kidney disease. In January 2020, the agency also granted Fast Track status for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients, regardless of diabetes status, with heart failure with reduced ejection fraction.
“Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said in the press release.