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Liberalized European sports cardiology guidelines break new ground
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
FROM ESC CONGRESS 2020
COVID-19 and the psychological side effects of PPE
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
Novel calculator predicts cancer risk in patients with CVD
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
FROM ESC CONGRESS 2020
Worry over family, friends the main driver of COVID-19 stress
Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.
Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.
Close to half of participants were worried about family members contracting the virus, one third were worried about unknowingly infecting others, and 20% were worried about contracting the virus themselves.
“We were a little surprised to see that people were more concerned about others than about themselves, specifically worrying about whether a family member would contract COVID-19 and whether they might unintentionally infect others,” lead author Ran Barzilay, MD, PhD, child and adolescent psychiatrist at the Children’s Hospital of Philadelphia (CHOP), told Medscape Medical News.
The study was published online August 20 in Translational Psychiatry.
Interactive platform
“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.
“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.
Survey participants then shared it with their contacts.
“To date, over 7000 people have completed it – mostly from the US but also from Israel,” Barzilay said.
The survey was anonymous, but participants could choose to have follow-up contact. The survey included an interactive 21-item resilience questionnaire and an assessment of COVID-19-related items related to worries concerning the following: contracting, dying from, or currently having the illness; having a family member contract the illness; unknowingly infecting others; and experiencing significant financial burden.
A total of 1350 participants took a second survey on anxiety and depression that utilized the Generalized Anxiety Disorder–7 and the Patient Health Questionnaire–2.
“What makes the survey unique is that it’s not just a means of collecting data but also an interactive platform that gives participants immediate personalized feedback, based on their responses to the resilience and well-being surveys, with practical tips and recommendations for stress management and ways of boosting resilience,” Barzilay said.
Tend and befriend
Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).
After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).
Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.
Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).
On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).
Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.
Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.
The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”
This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
Demographic biases
Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”
Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.
“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.
Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.
E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”
Holman, who was not involved with the study, told Medscape Medical News that the “findings do not address the real impact of COVID-19 on the hardest-hit communities in America – poor, Black, and Latinx communities, where a large proportion of essential workers live.”
Barzilay acknowledged that, “unfortunately, because of the way the study was circulated, it did not reach minorities, which is one of the things we want to improve.”
The study is ongoing and has been translated into Spanish, French, and Hebrew. The team plans to collect data on diverse populations.
The study was supported by grants from the National Institute of Mental Health, the Lifespan Brain Institute of Children’s Hospital of Philadelphia, Penn Medicine, the University of Pennsylvania, and in part by the Zuckerman STEM Leadership Program. Barzilay serves on the scientific board and reports stock ownership in Taliaz Health. The other authors, Golnaz, Vinkers, and Holman have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.
Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.
Close to half of participants were worried about family members contracting the virus, one third were worried about unknowingly infecting others, and 20% were worried about contracting the virus themselves.
“We were a little surprised to see that people were more concerned about others than about themselves, specifically worrying about whether a family member would contract COVID-19 and whether they might unintentionally infect others,” lead author Ran Barzilay, MD, PhD, child and adolescent psychiatrist at the Children’s Hospital of Philadelphia (CHOP), told Medscape Medical News.
The study was published online August 20 in Translational Psychiatry.
Interactive platform
“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.
“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.
Survey participants then shared it with their contacts.
“To date, over 7000 people have completed it – mostly from the US but also from Israel,” Barzilay said.
The survey was anonymous, but participants could choose to have follow-up contact. The survey included an interactive 21-item resilience questionnaire and an assessment of COVID-19-related items related to worries concerning the following: contracting, dying from, or currently having the illness; having a family member contract the illness; unknowingly infecting others; and experiencing significant financial burden.
A total of 1350 participants took a second survey on anxiety and depression that utilized the Generalized Anxiety Disorder–7 and the Patient Health Questionnaire–2.
“What makes the survey unique is that it’s not just a means of collecting data but also an interactive platform that gives participants immediate personalized feedback, based on their responses to the resilience and well-being surveys, with practical tips and recommendations for stress management and ways of boosting resilience,” Barzilay said.
Tend and befriend
Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).
After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).
Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.
Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).
On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).
Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.
Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.
The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”
This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
Demographic biases
Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”
Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.
“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.
Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.
E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”
Holman, who was not involved with the study, told Medscape Medical News that the “findings do not address the real impact of COVID-19 on the hardest-hit communities in America – poor, Black, and Latinx communities, where a large proportion of essential workers live.”
Barzilay acknowledged that, “unfortunately, because of the way the study was circulated, it did not reach minorities, which is one of the things we want to improve.”
The study is ongoing and has been translated into Spanish, French, and Hebrew. The team plans to collect data on diverse populations.
The study was supported by grants from the National Institute of Mental Health, the Lifespan Brain Institute of Children’s Hospital of Philadelphia, Penn Medicine, the University of Pennsylvania, and in part by the Zuckerman STEM Leadership Program. Barzilay serves on the scientific board and reports stock ownership in Taliaz Health. The other authors, Golnaz, Vinkers, and Holman have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.
Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.
Close to half of participants were worried about family members contracting the virus, one third were worried about unknowingly infecting others, and 20% were worried about contracting the virus themselves.
“We were a little surprised to see that people were more concerned about others than about themselves, specifically worrying about whether a family member would contract COVID-19 and whether they might unintentionally infect others,” lead author Ran Barzilay, MD, PhD, child and adolescent psychiatrist at the Children’s Hospital of Philadelphia (CHOP), told Medscape Medical News.
The study was published online August 20 in Translational Psychiatry.
Interactive platform
“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.
“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.
Survey participants then shared it with their contacts.
“To date, over 7000 people have completed it – mostly from the US but also from Israel,” Barzilay said.
The survey was anonymous, but participants could choose to have follow-up contact. The survey included an interactive 21-item resilience questionnaire and an assessment of COVID-19-related items related to worries concerning the following: contracting, dying from, or currently having the illness; having a family member contract the illness; unknowingly infecting others; and experiencing significant financial burden.
A total of 1350 participants took a second survey on anxiety and depression that utilized the Generalized Anxiety Disorder–7 and the Patient Health Questionnaire–2.
“What makes the survey unique is that it’s not just a means of collecting data but also an interactive platform that gives participants immediate personalized feedback, based on their responses to the resilience and well-being surveys, with practical tips and recommendations for stress management and ways of boosting resilience,” Barzilay said.
Tend and befriend
Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).
After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).
Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.
Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).
On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).
Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.
Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.
The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”
This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
Demographic biases
Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”
Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.
“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.
Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.
E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”
Holman, who was not involved with the study, told Medscape Medical News that the “findings do not address the real impact of COVID-19 on the hardest-hit communities in America – poor, Black, and Latinx communities, where a large proportion of essential workers live.”
Barzilay acknowledged that, “unfortunately, because of the way the study was circulated, it did not reach minorities, which is one of the things we want to improve.”
The study is ongoing and has been translated into Spanish, French, and Hebrew. The team plans to collect data on diverse populations.
The study was supported by grants from the National Institute of Mental Health, the Lifespan Brain Institute of Children’s Hospital of Philadelphia, Penn Medicine, the University of Pennsylvania, and in part by the Zuckerman STEM Leadership Program. Barzilay serves on the scientific board and reports stock ownership in Taliaz Health. The other authors, Golnaz, Vinkers, and Holman have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The earlier the better for colchicine post-MI: COLCOT
The earlier the anti-inflammatory drug colchicine is initiated after a myocardial infarction (MI) the greater the benefit, a new COLCOT analysis suggests.
The parent trial was conducted in patients with a recent MI because of the intense inflammation present at that time, and added colchicine 0.5 mg daily to standard care within 30 days following MI.
As previously reported, colchicine significantly reduced the risk of the primary end point – a composite of cardiovascular (CV) death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring revascularization – by 23% compared with placebo.
This new analysis shows the risk was reduced by 48% in patients receiving colchicine within 3 days of an MI (4.3% vs. 8.3%; adjusted hazard ratio, 0.52; 95% confidence interval, 0.32-0.84, P = .007).
Risk of a secondary efficacy end point – CV death, resuscitated cardiac arrest, MI, or stroke – was reduced by 45% over an average follow up of 22.7 months (3.3% vs 6.1%; adjusted HR, 0.55; 95% CI, 0.32-0.95, P = .031).
“We believe that our results support an early, in-hospital initiation of adjunctive colchicine for post-MI prevention,” Nadia Bouabdallaoui, MD, Montreal Heart Institute, Quebec, Canada, said during an online session devoted to colchicine at the European Society of Cardiology Congress 2020.
Session moderator Massimo Imazio, MD, professor of cardiology at the University of Turin, Italy, said the improved outcomes suggest that earlier treatment is better – a finding that parallels his own experience using colchicine in patients with pericarditis.
“This substudy is very important because this is probably also the year in cardiovascular applications [that] early use of the drug could improve outcomes,” he said.
Positive data have been accumulating for colchicine from COLCOT, LoDoCo, and, most recently, the LoDoCo2 trial, even as another anti-inflammatory drug, methotrexate, flamed out as secondary prevention in the CIRT trial.
The new COLCOT substudy included 4,661 of the 4,745 original patients and examined treatment initiation using three strata: within 0-3 days (n = 1,193), 4-7 days (n = 720), and 8-30 days (n = 2,748). Patients who received treatment within 3 days were slightly younger, more likely to be smokers, and to have a shorter time from MI to randomization (2.1 days vs 5.1 days vs. 20.8 days, respectively).
In the subset receiving treatment within 3 days, those assigned to colchicine had the same number of cardiac deaths as those given placebo (2 vs. 2) but fewer resuscitated cardiac arrests (1 vs. 3), MIs (17 vs. 29), strokes (1 vs. 5), and urgent hospitalizations for angina requiring revascularization (6 vs. 17).
“A larger trial might have allowed for a better assessment of individual endpoints and subgroups,” observed Bouabdallaoui.
Although there is growing support for colchicine, experts caution that the drug many not be for everyone. In COLCOT, 1 in 10 patients were unable to tolerate the drug, largely because of gastrointestinal (GI) issues.
Pharmacogenomics substudy
A second COLCOT substudy aimed to identify genetic markers predictive of colchicine response and to gain insights into the mechanisms behind this response. It included 767 patients treated with colchicine and another 755 treated with placebo – or about one-third the patients in the original trial.
A genome-wide association study did not find a significant association for the primary CV endpoint, although a prespecified subgroup analysis in men identified an interesting region on chromosome 9 (variant: rs10811106), which just missed reaching genomewide significance, said Marie-Pierre Dubé, PhD, director of the Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre at the Montreal Heart Institute.
In addition, the genomewide analysis found two significant regions for GI events: one on chromosome 6 (variant: rs6916345) and one on chromosome 10 (variant: rs74795203).
For each of the identified regions, the researchers then tested the effect of the allele in the placebo group and the interaction between the genetic variant and treatment with colchicine. For the chromosome 9 region in males, there was no effect in the placebo group and a significant interaction in the colchicine group.
For the significant GI event findings, there was a small effect for the chromosome 6 region in the placebo group and a very significant interaction with colchicine, Dubé said. Similarly, there was no effect for the chromosome 10 region in the placebo group and a significant interaction with colchicine.
Additional analyses in stratified patient populations showed that males with the protective allele (CC) for the chromosome 9 region represented 83% of the population. The primary CV endpoint occurred in 3.2% of these men treated with colchicine and 6.3% treated with placebo (HR, 0.46; 95% CI, 0.24 - 0.86).
For the gastrointestinal events, 25% of patients carried the risk allele (AA) for the chromosome 6 region and 36.9% of these had GI events when treated with colchicine versus 18.6% when treated with placebo (HR, 2.42; 95% CI, 1.57-3.72).
Similarly, 13% of individuals carried one or two copies of the risk allele (AG+GG) for the chromosome 10 region and the risk of GI events in these was nearly four times higher with colchicine (47.1% vs. 18.9%; HR, 3.98; 95% CI 2.24-7.07).
Functional genomic analyses of the identified regions were also performed and showed that the chromosome 9 locus overlaps with the SAXO1 gene, a stabilizer of axonemal microtubules 1.
“The leading variant at this locus (rs10811106 C allele) correlated with the expression of the HAUS6 gene, which is involved in microtubule generation from existing microtubules, and may interact with the effect of colchicine, which is known to inhibit microtubule formation,” observed Dubé.
Also, the chromosome 6 locus associated with gastrointestinal events was colocalizing with the Crohn’s disease locus, adding further support for this region.
“The results support potential personalized approaches to inflammation reduction for cardiovascular prevention,” Dubé said.
This is a post hoc subgroup analysis, however, and replication is necessary, ideally in prospective randomized trials, she noted.
The substudy is important because it provides further insights into the link between colchicine and microtubule polymerization, affecting the activation of the inflammasome, session moderator Imazio said.
“Second, it is important because pharmacogenomics can help us to better understand the optimal responder to colchicine and colchicine resistance,” he said. “So it can be useful for personalized medicine, leading to the proper use of the drug for the proper patient.”
COLCOT was supported by the government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Bouabdallaoui has disclosed no relevant financial relationships. Dubé reported grants from the government of Quebec; personal fees from DalCor and GlaxoSmithKline; research support from AstraZeneca, Pfizer, Servier, Sanofi; and minor equity interest in DalCor. Dubé is also coauthor of patents on pharmacogenomics-guided CETP inhibition, and pharmacogenomics markers of response to colchicine.
This article first appeared on Medscape.com.
The earlier the anti-inflammatory drug colchicine is initiated after a myocardial infarction (MI) the greater the benefit, a new COLCOT analysis suggests.
The parent trial was conducted in patients with a recent MI because of the intense inflammation present at that time, and added colchicine 0.5 mg daily to standard care within 30 days following MI.
As previously reported, colchicine significantly reduced the risk of the primary end point – a composite of cardiovascular (CV) death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring revascularization – by 23% compared with placebo.
This new analysis shows the risk was reduced by 48% in patients receiving colchicine within 3 days of an MI (4.3% vs. 8.3%; adjusted hazard ratio, 0.52; 95% confidence interval, 0.32-0.84, P = .007).
Risk of a secondary efficacy end point – CV death, resuscitated cardiac arrest, MI, or stroke – was reduced by 45% over an average follow up of 22.7 months (3.3% vs 6.1%; adjusted HR, 0.55; 95% CI, 0.32-0.95, P = .031).
“We believe that our results support an early, in-hospital initiation of adjunctive colchicine for post-MI prevention,” Nadia Bouabdallaoui, MD, Montreal Heart Institute, Quebec, Canada, said during an online session devoted to colchicine at the European Society of Cardiology Congress 2020.
Session moderator Massimo Imazio, MD, professor of cardiology at the University of Turin, Italy, said the improved outcomes suggest that earlier treatment is better – a finding that parallels his own experience using colchicine in patients with pericarditis.
“This substudy is very important because this is probably also the year in cardiovascular applications [that] early use of the drug could improve outcomes,” he said.
Positive data have been accumulating for colchicine from COLCOT, LoDoCo, and, most recently, the LoDoCo2 trial, even as another anti-inflammatory drug, methotrexate, flamed out as secondary prevention in the CIRT trial.
The new COLCOT substudy included 4,661 of the 4,745 original patients and examined treatment initiation using three strata: within 0-3 days (n = 1,193), 4-7 days (n = 720), and 8-30 days (n = 2,748). Patients who received treatment within 3 days were slightly younger, more likely to be smokers, and to have a shorter time from MI to randomization (2.1 days vs 5.1 days vs. 20.8 days, respectively).
In the subset receiving treatment within 3 days, those assigned to colchicine had the same number of cardiac deaths as those given placebo (2 vs. 2) but fewer resuscitated cardiac arrests (1 vs. 3), MIs (17 vs. 29), strokes (1 vs. 5), and urgent hospitalizations for angina requiring revascularization (6 vs. 17).
“A larger trial might have allowed for a better assessment of individual endpoints and subgroups,” observed Bouabdallaoui.
Although there is growing support for colchicine, experts caution that the drug many not be for everyone. In COLCOT, 1 in 10 patients were unable to tolerate the drug, largely because of gastrointestinal (GI) issues.
Pharmacogenomics substudy
A second COLCOT substudy aimed to identify genetic markers predictive of colchicine response and to gain insights into the mechanisms behind this response. It included 767 patients treated with colchicine and another 755 treated with placebo – or about one-third the patients in the original trial.
A genome-wide association study did not find a significant association for the primary CV endpoint, although a prespecified subgroup analysis in men identified an interesting region on chromosome 9 (variant: rs10811106), which just missed reaching genomewide significance, said Marie-Pierre Dubé, PhD, director of the Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre at the Montreal Heart Institute.
In addition, the genomewide analysis found two significant regions for GI events: one on chromosome 6 (variant: rs6916345) and one on chromosome 10 (variant: rs74795203).
For each of the identified regions, the researchers then tested the effect of the allele in the placebo group and the interaction between the genetic variant and treatment with colchicine. For the chromosome 9 region in males, there was no effect in the placebo group and a significant interaction in the colchicine group.
For the significant GI event findings, there was a small effect for the chromosome 6 region in the placebo group and a very significant interaction with colchicine, Dubé said. Similarly, there was no effect for the chromosome 10 region in the placebo group and a significant interaction with colchicine.
Additional analyses in stratified patient populations showed that males with the protective allele (CC) for the chromosome 9 region represented 83% of the population. The primary CV endpoint occurred in 3.2% of these men treated with colchicine and 6.3% treated with placebo (HR, 0.46; 95% CI, 0.24 - 0.86).
For the gastrointestinal events, 25% of patients carried the risk allele (AA) for the chromosome 6 region and 36.9% of these had GI events when treated with colchicine versus 18.6% when treated with placebo (HR, 2.42; 95% CI, 1.57-3.72).
Similarly, 13% of individuals carried one or two copies of the risk allele (AG+GG) for the chromosome 10 region and the risk of GI events in these was nearly four times higher with colchicine (47.1% vs. 18.9%; HR, 3.98; 95% CI 2.24-7.07).
Functional genomic analyses of the identified regions were also performed and showed that the chromosome 9 locus overlaps with the SAXO1 gene, a stabilizer of axonemal microtubules 1.
“The leading variant at this locus (rs10811106 C allele) correlated with the expression of the HAUS6 gene, which is involved in microtubule generation from existing microtubules, and may interact with the effect of colchicine, which is known to inhibit microtubule formation,” observed Dubé.
Also, the chromosome 6 locus associated with gastrointestinal events was colocalizing with the Crohn’s disease locus, adding further support for this region.
“The results support potential personalized approaches to inflammation reduction for cardiovascular prevention,” Dubé said.
This is a post hoc subgroup analysis, however, and replication is necessary, ideally in prospective randomized trials, she noted.
The substudy is important because it provides further insights into the link between colchicine and microtubule polymerization, affecting the activation of the inflammasome, session moderator Imazio said.
“Second, it is important because pharmacogenomics can help us to better understand the optimal responder to colchicine and colchicine resistance,” he said. “So it can be useful for personalized medicine, leading to the proper use of the drug for the proper patient.”
COLCOT was supported by the government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Bouabdallaoui has disclosed no relevant financial relationships. Dubé reported grants from the government of Quebec; personal fees from DalCor and GlaxoSmithKline; research support from AstraZeneca, Pfizer, Servier, Sanofi; and minor equity interest in DalCor. Dubé is also coauthor of patents on pharmacogenomics-guided CETP inhibition, and pharmacogenomics markers of response to colchicine.
This article first appeared on Medscape.com.
The earlier the anti-inflammatory drug colchicine is initiated after a myocardial infarction (MI) the greater the benefit, a new COLCOT analysis suggests.
The parent trial was conducted in patients with a recent MI because of the intense inflammation present at that time, and added colchicine 0.5 mg daily to standard care within 30 days following MI.
As previously reported, colchicine significantly reduced the risk of the primary end point – a composite of cardiovascular (CV) death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring revascularization – by 23% compared with placebo.
This new analysis shows the risk was reduced by 48% in patients receiving colchicine within 3 days of an MI (4.3% vs. 8.3%; adjusted hazard ratio, 0.52; 95% confidence interval, 0.32-0.84, P = .007).
Risk of a secondary efficacy end point – CV death, resuscitated cardiac arrest, MI, or stroke – was reduced by 45% over an average follow up of 22.7 months (3.3% vs 6.1%; adjusted HR, 0.55; 95% CI, 0.32-0.95, P = .031).
“We believe that our results support an early, in-hospital initiation of adjunctive colchicine for post-MI prevention,” Nadia Bouabdallaoui, MD, Montreal Heart Institute, Quebec, Canada, said during an online session devoted to colchicine at the European Society of Cardiology Congress 2020.
Session moderator Massimo Imazio, MD, professor of cardiology at the University of Turin, Italy, said the improved outcomes suggest that earlier treatment is better – a finding that parallels his own experience using colchicine in patients with pericarditis.
“This substudy is very important because this is probably also the year in cardiovascular applications [that] early use of the drug could improve outcomes,” he said.
Positive data have been accumulating for colchicine from COLCOT, LoDoCo, and, most recently, the LoDoCo2 trial, even as another anti-inflammatory drug, methotrexate, flamed out as secondary prevention in the CIRT trial.
The new COLCOT substudy included 4,661 of the 4,745 original patients and examined treatment initiation using three strata: within 0-3 days (n = 1,193), 4-7 days (n = 720), and 8-30 days (n = 2,748). Patients who received treatment within 3 days were slightly younger, more likely to be smokers, and to have a shorter time from MI to randomization (2.1 days vs 5.1 days vs. 20.8 days, respectively).
In the subset receiving treatment within 3 days, those assigned to colchicine had the same number of cardiac deaths as those given placebo (2 vs. 2) but fewer resuscitated cardiac arrests (1 vs. 3), MIs (17 vs. 29), strokes (1 vs. 5), and urgent hospitalizations for angina requiring revascularization (6 vs. 17).
“A larger trial might have allowed for a better assessment of individual endpoints and subgroups,” observed Bouabdallaoui.
Although there is growing support for colchicine, experts caution that the drug many not be for everyone. In COLCOT, 1 in 10 patients were unable to tolerate the drug, largely because of gastrointestinal (GI) issues.
Pharmacogenomics substudy
A second COLCOT substudy aimed to identify genetic markers predictive of colchicine response and to gain insights into the mechanisms behind this response. It included 767 patients treated with colchicine and another 755 treated with placebo – or about one-third the patients in the original trial.
A genome-wide association study did not find a significant association for the primary CV endpoint, although a prespecified subgroup analysis in men identified an interesting region on chromosome 9 (variant: rs10811106), which just missed reaching genomewide significance, said Marie-Pierre Dubé, PhD, director of the Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre at the Montreal Heart Institute.
In addition, the genomewide analysis found two significant regions for GI events: one on chromosome 6 (variant: rs6916345) and one on chromosome 10 (variant: rs74795203).
For each of the identified regions, the researchers then tested the effect of the allele in the placebo group and the interaction between the genetic variant and treatment with colchicine. For the chromosome 9 region in males, there was no effect in the placebo group and a significant interaction in the colchicine group.
For the significant GI event findings, there was a small effect for the chromosome 6 region in the placebo group and a very significant interaction with colchicine, Dubé said. Similarly, there was no effect for the chromosome 10 region in the placebo group and a significant interaction with colchicine.
Additional analyses in stratified patient populations showed that males with the protective allele (CC) for the chromosome 9 region represented 83% of the population. The primary CV endpoint occurred in 3.2% of these men treated with colchicine and 6.3% treated with placebo (HR, 0.46; 95% CI, 0.24 - 0.86).
For the gastrointestinal events, 25% of patients carried the risk allele (AA) for the chromosome 6 region and 36.9% of these had GI events when treated with colchicine versus 18.6% when treated with placebo (HR, 2.42; 95% CI, 1.57-3.72).
Similarly, 13% of individuals carried one or two copies of the risk allele (AG+GG) for the chromosome 10 region and the risk of GI events in these was nearly four times higher with colchicine (47.1% vs. 18.9%; HR, 3.98; 95% CI 2.24-7.07).
Functional genomic analyses of the identified regions were also performed and showed that the chromosome 9 locus overlaps with the SAXO1 gene, a stabilizer of axonemal microtubules 1.
“The leading variant at this locus (rs10811106 C allele) correlated with the expression of the HAUS6 gene, which is involved in microtubule generation from existing microtubules, and may interact with the effect of colchicine, which is known to inhibit microtubule formation,” observed Dubé.
Also, the chromosome 6 locus associated with gastrointestinal events was colocalizing with the Crohn’s disease locus, adding further support for this region.
“The results support potential personalized approaches to inflammation reduction for cardiovascular prevention,” Dubé said.
This is a post hoc subgroup analysis, however, and replication is necessary, ideally in prospective randomized trials, she noted.
The substudy is important because it provides further insights into the link between colchicine and microtubule polymerization, affecting the activation of the inflammasome, session moderator Imazio said.
“Second, it is important because pharmacogenomics can help us to better understand the optimal responder to colchicine and colchicine resistance,” he said. “So it can be useful for personalized medicine, leading to the proper use of the drug for the proper patient.”
COLCOT was supported by the government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Bouabdallaoui has disclosed no relevant financial relationships. Dubé reported grants from the government of Quebec; personal fees from DalCor and GlaxoSmithKline; research support from AstraZeneca, Pfizer, Servier, Sanofi; and minor equity interest in DalCor. Dubé is also coauthor of patents on pharmacogenomics-guided CETP inhibition, and pharmacogenomics markers of response to colchicine.
This article first appeared on Medscape.com.
COVID-19: New guidance to stem mental health crisis in frontline HCPs
A new review offers fresh guidance to help stem the mental health toll of the COVID-19 pandemic on frontline clinicians.
Investigators gathered practice guidelines and resources from a wide range of health care organizations and professional societies to develop a conceptual framework of mental health support for health care professionals (HCPs) caring for COVID-19 patients.
“Support needs to be deployed in multiple dimensions – including individual, organizational, and societal levels – and include training in resilience, stress reduction, emotional awareness, and self-care strategies,” lead author Rachel Schwartz, PhD, health services researcher, Stanford (Calif.) University, said in an interview.
The review was published Aug. 21 in the Annals of Internal Medicine.
An opportune moment
Coauthor Rebecca Margolis, DO, director of well-being in the division of medical education and faculty development, Children’s Hospital of Los Angeles, said that this is “an opportune moment to look at how we treat frontline providers in this country.”
Studies of previous pandemics have shown heightened distress in HCPs, even years after the pandemic, and the unique challenges posed by the COVID-19 pandemic surpass those of previous pandemics, Dr. Margolis said in an interview.
Dr. Schwartz, Dr. Margolis, and coauthors Uma Anand, PhD, LP, and Jina Sinskey, MD, met through the Collaborative for Healing and Renewal in Medicine network, a group of medical educators, leaders in academic medicine, experts in burnout research and interventions, and trainees working together to promote well-being among trainees and practicing physicians.
“We were brought together on a conference call in March, when things were particularly bad in New York, and started looking to see what resources we could get to frontline providers who were suffering. It was great to lean on each other and stand on the shoulders of colleagues in New York, who were the ones we learned from on these calls,” said Dr. Margolis.
The authors recommended addressing clinicians’ basic practical needs, including ensuring essentials like meals and transportation, establishing a “well-being area” within hospitals for staff to rest, and providing well-stocked living quarters so clinicians can safely quarantine from family, as well as personal protective equipment and child care.
Clinicians are often asked to “assume new professional roles to meet evolving needs” during a pandemic, which can increase stress. The authors recommended targeted training, assessment of clinician skills before redeployment to a new clinical role, and clear communication practices around redeployment.
Recognition from hospital and government leaders improves morale and supports clinicians’ ability to continue delivering care. Leadership should “leverage communication strategies to provide clinicians with up-to-date information and reassurance,” they wrote.
‘Uniquely isolated’
Dr. Margolis noted that
“My colleagues feel a sense of moral injury, putting their lives on the line at work, performing the most perilous job, and their kids can’t hang out with other kids, which just puts salt on the wound,” she said.
Additional sources of moral injury are deciding which patients should receive life support in the event of inadequate resources and bearing witness to, or enforcing, policies that lead to patients dying alone.
Leaders should encourage clinicians to “seek informal support from colleagues, managers, or chaplains” and to “provide rapid access to professional help,” the authors noted.
Furthermore, they contended that leaders should “proactively and routinely monitor the psychological well-being of their teams,” since guilt and shame often prevent clinicians from disclosing feelings of moral injury.
“Being provided with routine mental health support should be normalized and it should be part of the job – not only during COVID-19 but in general,” Dr. Schwartz said.
‘Battle buddies’
Dr. Margolis recommended the “battle buddy” model for mutual peer support.
Dr. Anand, a mental health clinician at Mayo Medical School, Rochester, Minn., elaborated.
“We connect residents with each other, and they form pairs to support each other and watch for warning signs such as withdrawal from colleagues, being frequently tearful, not showing up at work or showing up late, missing assignments, making mistakes at work, increased use of alcohol, or verbalizing serious concerns,” Dr. Anand said.
If the buddy shows any of these warning signs, he or she can be directed to appropriate resources to get help.
Since the pandemic has interfered with the ability to connect with colleagues and family members, attention should be paid to addressing the social support needs of clinicians.
Dr. Anand suggested that clinicians maintain contact with counselors, friends, and family, even if they cannot be together in person and must connect “virtually.”
Resilience and strength training are “key” components of reducing clinician distress, but trainings as well as processing groups and support workshops should be offered during protected time, Dr. Margolis advised, since it can be burdensome for clinicians to wake up early or stay late to attend these sessions.
Leaders and administrators should “model self-care and well-being,” she noted. For example, sending emails to clinicians late at night or on weekends creates an expectation of a rapid reply, which leads to additional pressure for the clinician.
“This is of the most powerful unspoken curricula we can develop,” Dr. Margolis emphasized.
Self-care critical
Marcus S. Shaker, MD, MSc, associate professor of pediatrics, medicine, and community and family medicine, Children’s Hospital at Dartmouth-Hitchcock in Lebanon, N.H., and Geisel School of Medicine at Dartmouth, Hanover, N.H., said the study was “a much appreciated, timely reminder of the importance of clinician wellness.”
Moreover, “without self-care, our ability to help our patients withers. This article provides a useful conceptual framework for individuals and organizations to provide the right care at the right time in these unprecedented times,” said Dr. Shaker, who was not involved with the study.
The authors agreed, stating that clinicians “require proactive psychological protection specifically because they are a population known for putting others’ needs before their own.”
They recommended several resources for HCPs, including the Physician Support Line; Headspace, a mindfulness Web-based app for reducing stress and anxiety; the National Suicide Prevention Lifeline; and the Crisis Text Line.
The authors and Dr. Shaker disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new review offers fresh guidance to help stem the mental health toll of the COVID-19 pandemic on frontline clinicians.
Investigators gathered practice guidelines and resources from a wide range of health care organizations and professional societies to develop a conceptual framework of mental health support for health care professionals (HCPs) caring for COVID-19 patients.
“Support needs to be deployed in multiple dimensions – including individual, organizational, and societal levels – and include training in resilience, stress reduction, emotional awareness, and self-care strategies,” lead author Rachel Schwartz, PhD, health services researcher, Stanford (Calif.) University, said in an interview.
The review was published Aug. 21 in the Annals of Internal Medicine.
An opportune moment
Coauthor Rebecca Margolis, DO, director of well-being in the division of medical education and faculty development, Children’s Hospital of Los Angeles, said that this is “an opportune moment to look at how we treat frontline providers in this country.”
Studies of previous pandemics have shown heightened distress in HCPs, even years after the pandemic, and the unique challenges posed by the COVID-19 pandemic surpass those of previous pandemics, Dr. Margolis said in an interview.
Dr. Schwartz, Dr. Margolis, and coauthors Uma Anand, PhD, LP, and Jina Sinskey, MD, met through the Collaborative for Healing and Renewal in Medicine network, a group of medical educators, leaders in academic medicine, experts in burnout research and interventions, and trainees working together to promote well-being among trainees and practicing physicians.
“We were brought together on a conference call in March, when things were particularly bad in New York, and started looking to see what resources we could get to frontline providers who were suffering. It was great to lean on each other and stand on the shoulders of colleagues in New York, who were the ones we learned from on these calls,” said Dr. Margolis.
The authors recommended addressing clinicians’ basic practical needs, including ensuring essentials like meals and transportation, establishing a “well-being area” within hospitals for staff to rest, and providing well-stocked living quarters so clinicians can safely quarantine from family, as well as personal protective equipment and child care.
Clinicians are often asked to “assume new professional roles to meet evolving needs” during a pandemic, which can increase stress. The authors recommended targeted training, assessment of clinician skills before redeployment to a new clinical role, and clear communication practices around redeployment.
Recognition from hospital and government leaders improves morale and supports clinicians’ ability to continue delivering care. Leadership should “leverage communication strategies to provide clinicians with up-to-date information and reassurance,” they wrote.
‘Uniquely isolated’
Dr. Margolis noted that
“My colleagues feel a sense of moral injury, putting their lives on the line at work, performing the most perilous job, and their kids can’t hang out with other kids, which just puts salt on the wound,” she said.
Additional sources of moral injury are deciding which patients should receive life support in the event of inadequate resources and bearing witness to, or enforcing, policies that lead to patients dying alone.
Leaders should encourage clinicians to “seek informal support from colleagues, managers, or chaplains” and to “provide rapid access to professional help,” the authors noted.
Furthermore, they contended that leaders should “proactively and routinely monitor the psychological well-being of their teams,” since guilt and shame often prevent clinicians from disclosing feelings of moral injury.
“Being provided with routine mental health support should be normalized and it should be part of the job – not only during COVID-19 but in general,” Dr. Schwartz said.
‘Battle buddies’
Dr. Margolis recommended the “battle buddy” model for mutual peer support.
Dr. Anand, a mental health clinician at Mayo Medical School, Rochester, Minn., elaborated.
“We connect residents with each other, and they form pairs to support each other and watch for warning signs such as withdrawal from colleagues, being frequently tearful, not showing up at work or showing up late, missing assignments, making mistakes at work, increased use of alcohol, or verbalizing serious concerns,” Dr. Anand said.
If the buddy shows any of these warning signs, he or she can be directed to appropriate resources to get help.
Since the pandemic has interfered with the ability to connect with colleagues and family members, attention should be paid to addressing the social support needs of clinicians.
Dr. Anand suggested that clinicians maintain contact with counselors, friends, and family, even if they cannot be together in person and must connect “virtually.”
Resilience and strength training are “key” components of reducing clinician distress, but trainings as well as processing groups and support workshops should be offered during protected time, Dr. Margolis advised, since it can be burdensome for clinicians to wake up early or stay late to attend these sessions.
Leaders and administrators should “model self-care and well-being,” she noted. For example, sending emails to clinicians late at night or on weekends creates an expectation of a rapid reply, which leads to additional pressure for the clinician.
“This is of the most powerful unspoken curricula we can develop,” Dr. Margolis emphasized.
Self-care critical
Marcus S. Shaker, MD, MSc, associate professor of pediatrics, medicine, and community and family medicine, Children’s Hospital at Dartmouth-Hitchcock in Lebanon, N.H., and Geisel School of Medicine at Dartmouth, Hanover, N.H., said the study was “a much appreciated, timely reminder of the importance of clinician wellness.”
Moreover, “without self-care, our ability to help our patients withers. This article provides a useful conceptual framework for individuals and organizations to provide the right care at the right time in these unprecedented times,” said Dr. Shaker, who was not involved with the study.
The authors agreed, stating that clinicians “require proactive psychological protection specifically because they are a population known for putting others’ needs before their own.”
They recommended several resources for HCPs, including the Physician Support Line; Headspace, a mindfulness Web-based app for reducing stress and anxiety; the National Suicide Prevention Lifeline; and the Crisis Text Line.
The authors and Dr. Shaker disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new review offers fresh guidance to help stem the mental health toll of the COVID-19 pandemic on frontline clinicians.
Investigators gathered practice guidelines and resources from a wide range of health care organizations and professional societies to develop a conceptual framework of mental health support for health care professionals (HCPs) caring for COVID-19 patients.
“Support needs to be deployed in multiple dimensions – including individual, organizational, and societal levels – and include training in resilience, stress reduction, emotional awareness, and self-care strategies,” lead author Rachel Schwartz, PhD, health services researcher, Stanford (Calif.) University, said in an interview.
The review was published Aug. 21 in the Annals of Internal Medicine.
An opportune moment
Coauthor Rebecca Margolis, DO, director of well-being in the division of medical education and faculty development, Children’s Hospital of Los Angeles, said that this is “an opportune moment to look at how we treat frontline providers in this country.”
Studies of previous pandemics have shown heightened distress in HCPs, even years after the pandemic, and the unique challenges posed by the COVID-19 pandemic surpass those of previous pandemics, Dr. Margolis said in an interview.
Dr. Schwartz, Dr. Margolis, and coauthors Uma Anand, PhD, LP, and Jina Sinskey, MD, met through the Collaborative for Healing and Renewal in Medicine network, a group of medical educators, leaders in academic medicine, experts in burnout research and interventions, and trainees working together to promote well-being among trainees and practicing physicians.
“We were brought together on a conference call in March, when things were particularly bad in New York, and started looking to see what resources we could get to frontline providers who were suffering. It was great to lean on each other and stand on the shoulders of colleagues in New York, who were the ones we learned from on these calls,” said Dr. Margolis.
The authors recommended addressing clinicians’ basic practical needs, including ensuring essentials like meals and transportation, establishing a “well-being area” within hospitals for staff to rest, and providing well-stocked living quarters so clinicians can safely quarantine from family, as well as personal protective equipment and child care.
Clinicians are often asked to “assume new professional roles to meet evolving needs” during a pandemic, which can increase stress. The authors recommended targeted training, assessment of clinician skills before redeployment to a new clinical role, and clear communication practices around redeployment.
Recognition from hospital and government leaders improves morale and supports clinicians’ ability to continue delivering care. Leadership should “leverage communication strategies to provide clinicians with up-to-date information and reassurance,” they wrote.
‘Uniquely isolated’
Dr. Margolis noted that
“My colleagues feel a sense of moral injury, putting their lives on the line at work, performing the most perilous job, and their kids can’t hang out with other kids, which just puts salt on the wound,” she said.
Additional sources of moral injury are deciding which patients should receive life support in the event of inadequate resources and bearing witness to, or enforcing, policies that lead to patients dying alone.
Leaders should encourage clinicians to “seek informal support from colleagues, managers, or chaplains” and to “provide rapid access to professional help,” the authors noted.
Furthermore, they contended that leaders should “proactively and routinely monitor the psychological well-being of their teams,” since guilt and shame often prevent clinicians from disclosing feelings of moral injury.
“Being provided with routine mental health support should be normalized and it should be part of the job – not only during COVID-19 but in general,” Dr. Schwartz said.
‘Battle buddies’
Dr. Margolis recommended the “battle buddy” model for mutual peer support.
Dr. Anand, a mental health clinician at Mayo Medical School, Rochester, Minn., elaborated.
“We connect residents with each other, and they form pairs to support each other and watch for warning signs such as withdrawal from colleagues, being frequently tearful, not showing up at work or showing up late, missing assignments, making mistakes at work, increased use of alcohol, or verbalizing serious concerns,” Dr. Anand said.
If the buddy shows any of these warning signs, he or she can be directed to appropriate resources to get help.
Since the pandemic has interfered with the ability to connect with colleagues and family members, attention should be paid to addressing the social support needs of clinicians.
Dr. Anand suggested that clinicians maintain contact with counselors, friends, and family, even if they cannot be together in person and must connect “virtually.”
Resilience and strength training are “key” components of reducing clinician distress, but trainings as well as processing groups and support workshops should be offered during protected time, Dr. Margolis advised, since it can be burdensome for clinicians to wake up early or stay late to attend these sessions.
Leaders and administrators should “model self-care and well-being,” she noted. For example, sending emails to clinicians late at night or on weekends creates an expectation of a rapid reply, which leads to additional pressure for the clinician.
“This is of the most powerful unspoken curricula we can develop,” Dr. Margolis emphasized.
Self-care critical
Marcus S. Shaker, MD, MSc, associate professor of pediatrics, medicine, and community and family medicine, Children’s Hospital at Dartmouth-Hitchcock in Lebanon, N.H., and Geisel School of Medicine at Dartmouth, Hanover, N.H., said the study was “a much appreciated, timely reminder of the importance of clinician wellness.”
Moreover, “without self-care, our ability to help our patients withers. This article provides a useful conceptual framework for individuals and organizations to provide the right care at the right time in these unprecedented times,” said Dr. Shaker, who was not involved with the study.
The authors agreed, stating that clinicians “require proactive psychological protection specifically because they are a population known for putting others’ needs before their own.”
They recommended several resources for HCPs, including the Physician Support Line; Headspace, a mindfulness Web-based app for reducing stress and anxiety; the National Suicide Prevention Lifeline; and the Crisis Text Line.
The authors and Dr. Shaker disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Five reasons why medical meetings will never be the same
In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.
Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.
In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.
And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.
Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
Reshaping the medical meeting
Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.
This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.
Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.
Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.
Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.
Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.
I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.
Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.
We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.
H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.
This article first appeared on Medscape.com.
In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.
Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.
In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.
And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.
Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
Reshaping the medical meeting
Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.
This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.
Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.
Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.
Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.
Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.
I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.
Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.
We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.
H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.
This article first appeared on Medscape.com.
In the wake of the COVID-19 pandemic, the virtual medical meeting is now the norm. And while it’s admirable that key data are being disseminated (often for free), there is no escaping the fact that it is a fundamentally different and lesser experience.
Watching from home, most of us split our attention between live streams of the meeting and work and family obligations. There is far less urgency when early live presentations are recorded and can be viewed later.
In terms of discussing the data, Twitter may offer broader participation than a live meeting, yet only a small number of attendees actively engage online.
And the exhibit halls for these online meetings? With neither free coffee nor company-branded tchotchkes, I expect that they have virtual tumbleweeds blowing through and crickets chirping.
Even still, the virtual meeting experience, while inferior to the live one, is a tremendous advance. It should never be banished as a historical footnote but rather should remain an option. It’s analogous to watching the Super Bowl at home: Obviously, it’s not the same as being there, but it’s a terrific alternative. Like telemedicine, this pandemic has provided a critical proof of concept that there is a better model.
Reshaping the medical meeting
Let’s consider five reasons why medical meetings should be permanently reshaped by this pandemic.
This pandemic isn’t going away in 2020. While nearly every country has done a far better job than the United States of containing COVID-19 thus far, outbreaks remain a problem wherever crowds assemble. You’d be hard-pressed to devise a setting more conducive to mass spread than a conference of 20,000 attendees from all over the world sitting alongside each other cheek to jowl for 5 days. Worse yet is the thought of them returning home and infecting their patients, families, and friends. What medical society wants to be remembered for creating a COVID-19 superspreader event? Professional medical societies will need to offer this option as the safest alternative moving forward.
Virtual learning still conveys the most important content. Despite the many social benefits of a live meeting, its core purpose is to disseminate new research and current and emerging treatment options. Virtual meetings have proven that this format can effectively deliver the content, and not as a secondary offering but as the sole platform in real time.
Virtual learning levels the playing field. Traveling to attend conferences typically costs thousands of dollars, accounting for the registration fees, inflated hotel rates, ground transportation, and meals out for days on end. Most meetings also demand several days away from our work and families, forcing many of us to work extra in the days before we leave and upon our return. Parents and those with commitments at home also face special challenges. For international participants, the financial and time costs are even greater. A virtual meeting helps overcome these hurdles and erases barriers that have long precluded many from attending a conference.
Virtual learning is efficient and comfortable. Virtual meetings over the past 6 months have given us a glimpse of an astonishingly more efficient form. If the content seems of a lower magnitude without the fanfare of a live conference, it is in part because so much of a live meeting is spent walking a mile between session rooms, waiting in concession or taxi lines, sitting in traffic between venues, or simply waiting for a session to begin. All of that has been replaced with time that you can use productively in between video sessions viewed either live or on demand. And with a virtual meeting, you can comfortably watch the sessions. There’s no need to stand along the back wall of an overcrowded room or step over 10 people to squeeze into an open middle seat. You can be focused, rather than having an end-of-day presentation wash over you as your eyes cross because you’ve been running around for the past 12 hours.
Virtual learning and social media will only improve. While virtual meetings unquestionably have limitations, it’s important to acknowledge that the successes thus far still represent only the earliest forays into this endeavor. In-person meetings evolved to their present form over centuries. In contrast, virtual meetings are being cobbled together within a few weeks or months. They can only be expected to improve as presenters adapt their skills to the online audience and new tools improve virtual discussions.
I am not implying that live meetings will or should be replaced by virtual ones. We still need that experience of trainees and experts presenting to a live audience and discussing the results together, all while sharing the energy of the moment. But there should be room for both a live conference and a virtual version.
Practically speaking, it is unclear whether professional societies could forgo the revenue they receive from registration fees, meeting sponsorships, and corporate exhibits. Yet, there are certainly ways to obtain sponsorship revenue for a virtual program. Even if the virtual version of a conference costs far less than attending in person, there is plenty of room between that number and free. It costs remarkably little for a professional society to share its content, and virtual offerings further the mission of distributing this content broadly.
We should not rush to return to the previous status quo. Despite their limitations, virtual meetings have brought a new, higher standard of access and efficiency for sharing important new data and treatment options in medicine.
H. Jack West, MD, associate clinical professor and executive director of employer services at City of Hope Comprehensive Cancer Center in Duarte, Calif., regularly comments on lung cancer for Medscape. West serves as web editor for JAMA Oncology, edits and writes several sections on lung cancer for UpToDate, and leads a wide range of continuing education programs and other educational programs, including hosting the audio podcast West Wind.
This article first appeared on Medscape.com.
MIS-C cardiac evaluation requires more than EF
Patients with multisystem inflammatory syndrome caused by COVID-19 typically seem to avoid coronary artery dilation early on, but they may be prone to cardiac injury and dysfunction longer term that requires a more discerning diagnostic approach to sort out.
The findings were revealed in a study of 28 children with COVID-19–related multisystem inflammatory syndrome (MIS-C) at Children’s Hospital of Philadelphia. The study reported that cardiac injury and dysfunction are common in these patients – even those who have preserved ejection fraction – and that diastolic dysfunction is persistent. For comparison, the study also included 20 healthy controls and 20 patients with classic Kawasaki disease (KD).
The study analyzed echocardiography findings in the patients, reporting left ventricular (LV) systolic and diastolic function were worse than in classic Kawasaki disease (KD), which MIS-C mimics. Lead author Daisuke Matsubara, MD, PhD, and colleagues reported that four markers – LV global longitudinal strain, LV circumferential strain rate, right ventricular strain, and left atrial strain – were the strongest predictors of myocardial injury in these patients. After the acute phase, systolic function tended to recover, but diastolic dysfunction persisted.
‘Strain’ measurement boosts accuracy
While echocardiography has been reported to be valuable in evaluating coronary artery function in MIS-C patients, Dr. Matsubara of the division of cardiology at CHOP, said in an interview that study is the first to use the newer echocardiography indexes, known as “strain,” to assess heart function.
“Strain is a more sensitive tool than more conventional indexes and can detect subtle decrease in heart function, even when ejection fraction is preserved,” he said. “Numerous publications have reached conclusions that strain improves the prognostic and diagnostic accuracy of echocardiography in a wide variety of cardiac pathologies causing LV dysfunction.”
Dr. Matsubara noted that the coronary arteries were mostly unaffected in the acute stage of MIS-C, as only one patient in their MIS-C cohort had coronary artery involvement, which normalized during early follow-up. “On the other hand, 20% of our classic KD patients had coronary abnormalities, including two with aneurysms.”
By using positive troponin I or elevated brain natriuretic peptide (BNP) to assess cardiac injury, they found a “high” (60%) incidence of myocardial injury in their MIS-C cohort. During early follow-up, most of the MIS-C patients showed normalization of systolic function, although diastolic dysfunction persisted.
When compared with the classic KD group, MIS-C patients had higher rates of mitral regurgitation (46% vs. 15%, P = .06), more pericardial effusion (32% vs. 15%, P = 0.46), and more pleural effusion (39% vs. 0%, P = .004). MIS-C patients with suspected myocardial injury show these findings more frequently than those with actual myocardial injury.
Compared with the healthy controls, the MIS-C patients showed both LV systolic and diastolic dysfunction as well as significantly lower left atrium (LA) strain and peak right ventricle (RV) free-wall longitudinal strain.
“In addition to the left ventricle, two other chambers of the heart, the LA and the RV that are often labeled as the ‘forgotten chambers’ of the heart, were also affected by MIS-C,” Dr. Matsubara said. “Both LA and RV strains were markedly reduced in MIS-C patients, compared to normal and KD patients.”
The study also indicates that elevated troponin I levels may not be as dire in children as they are in adults. Dr. Matsubara cited a study of more than 2,700 adult COVID-19 patients that found that even mild increases in troponin I level were associated with increased death during hospitalization (J Am Coll Cardiol. 2020;76:533-46).
However, most of the patients in the CHOP study, even those with elevated troponin I levels, recovered systolic function quickly. “We speculate that the elevation in cardiac troponins may have less dire implications in children, likely due to a more transient type of cardiac injury and less comorbidities in children,” he said. “Clearly further studies are needed before a definitive statement can be made.”
Dr. Matsubara added that recovered COVID-19 patients may be able to participate in sports as some schools reopen. “We are not saying restrict sport participation, but we are merely urging caution.”
Comprehensive LV evaluation needed
The findings reinforce that myocardial involvement is more frequent and sometimes more severe in MIS-C than previously thought, said Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital. “We are underestimating it by using just traditional measures like ejection fraction. It requires a comprehensive evaluation of left ventricular function; it really affects all aspects of the ventricle, both the systolic function and the diastolic function.”
This study supports that MIS-C patients should have a more detailed analysis than EF on echocardiography, including strain imaging. “Probably these patients should all be followed at centers where they can evaluate a more detailed analysis of the LV and RV function,” he said. Patients with ongoing CA enlargement and LV dysfunction should have follow-up cardiac care indefinitely. Patients who have no cardiac symptoms during the acute phase probably don’t need long-term follow-up.
“We’re just trying to learn more about this disease, and it’s certainly concerning that so many kids are having cardiac involvement,” Dr. Friedman said. “Fortunately they’re getting better; we’re just trying to find out what this means for the long term.”
Dr. Matsubara and Dr. Friedman have no relevant financial disclosures.
SOURCE: Matsubara D et al. J Am Coll Cardiol. 2020 Sep 2. doi: 10.1016/j.jacc.2020.08.056.
Patients with multisystem inflammatory syndrome caused by COVID-19 typically seem to avoid coronary artery dilation early on, but they may be prone to cardiac injury and dysfunction longer term that requires a more discerning diagnostic approach to sort out.
The findings were revealed in a study of 28 children with COVID-19–related multisystem inflammatory syndrome (MIS-C) at Children’s Hospital of Philadelphia. The study reported that cardiac injury and dysfunction are common in these patients – even those who have preserved ejection fraction – and that diastolic dysfunction is persistent. For comparison, the study also included 20 healthy controls and 20 patients with classic Kawasaki disease (KD).
The study analyzed echocardiography findings in the patients, reporting left ventricular (LV) systolic and diastolic function were worse than in classic Kawasaki disease (KD), which MIS-C mimics. Lead author Daisuke Matsubara, MD, PhD, and colleagues reported that four markers – LV global longitudinal strain, LV circumferential strain rate, right ventricular strain, and left atrial strain – were the strongest predictors of myocardial injury in these patients. After the acute phase, systolic function tended to recover, but diastolic dysfunction persisted.
‘Strain’ measurement boosts accuracy
While echocardiography has been reported to be valuable in evaluating coronary artery function in MIS-C patients, Dr. Matsubara of the division of cardiology at CHOP, said in an interview that study is the first to use the newer echocardiography indexes, known as “strain,” to assess heart function.
“Strain is a more sensitive tool than more conventional indexes and can detect subtle decrease in heart function, even when ejection fraction is preserved,” he said. “Numerous publications have reached conclusions that strain improves the prognostic and diagnostic accuracy of echocardiography in a wide variety of cardiac pathologies causing LV dysfunction.”
Dr. Matsubara noted that the coronary arteries were mostly unaffected in the acute stage of MIS-C, as only one patient in their MIS-C cohort had coronary artery involvement, which normalized during early follow-up. “On the other hand, 20% of our classic KD patients had coronary abnormalities, including two with aneurysms.”
By using positive troponin I or elevated brain natriuretic peptide (BNP) to assess cardiac injury, they found a “high” (60%) incidence of myocardial injury in their MIS-C cohort. During early follow-up, most of the MIS-C patients showed normalization of systolic function, although diastolic dysfunction persisted.
When compared with the classic KD group, MIS-C patients had higher rates of mitral regurgitation (46% vs. 15%, P = .06), more pericardial effusion (32% vs. 15%, P = 0.46), and more pleural effusion (39% vs. 0%, P = .004). MIS-C patients with suspected myocardial injury show these findings more frequently than those with actual myocardial injury.
Compared with the healthy controls, the MIS-C patients showed both LV systolic and diastolic dysfunction as well as significantly lower left atrium (LA) strain and peak right ventricle (RV) free-wall longitudinal strain.
“In addition to the left ventricle, two other chambers of the heart, the LA and the RV that are often labeled as the ‘forgotten chambers’ of the heart, were also affected by MIS-C,” Dr. Matsubara said. “Both LA and RV strains were markedly reduced in MIS-C patients, compared to normal and KD patients.”
The study also indicates that elevated troponin I levels may not be as dire in children as they are in adults. Dr. Matsubara cited a study of more than 2,700 adult COVID-19 patients that found that even mild increases in troponin I level were associated with increased death during hospitalization (J Am Coll Cardiol. 2020;76:533-46).
However, most of the patients in the CHOP study, even those with elevated troponin I levels, recovered systolic function quickly. “We speculate that the elevation in cardiac troponins may have less dire implications in children, likely due to a more transient type of cardiac injury and less comorbidities in children,” he said. “Clearly further studies are needed before a definitive statement can be made.”
Dr. Matsubara added that recovered COVID-19 patients may be able to participate in sports as some schools reopen. “We are not saying restrict sport participation, but we are merely urging caution.”
Comprehensive LV evaluation needed
The findings reinforce that myocardial involvement is more frequent and sometimes more severe in MIS-C than previously thought, said Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital. “We are underestimating it by using just traditional measures like ejection fraction. It requires a comprehensive evaluation of left ventricular function; it really affects all aspects of the ventricle, both the systolic function and the diastolic function.”
This study supports that MIS-C patients should have a more detailed analysis than EF on echocardiography, including strain imaging. “Probably these patients should all be followed at centers where they can evaluate a more detailed analysis of the LV and RV function,” he said. Patients with ongoing CA enlargement and LV dysfunction should have follow-up cardiac care indefinitely. Patients who have no cardiac symptoms during the acute phase probably don’t need long-term follow-up.
“We’re just trying to learn more about this disease, and it’s certainly concerning that so many kids are having cardiac involvement,” Dr. Friedman said. “Fortunately they’re getting better; we’re just trying to find out what this means for the long term.”
Dr. Matsubara and Dr. Friedman have no relevant financial disclosures.
SOURCE: Matsubara D et al. J Am Coll Cardiol. 2020 Sep 2. doi: 10.1016/j.jacc.2020.08.056.
Patients with multisystem inflammatory syndrome caused by COVID-19 typically seem to avoid coronary artery dilation early on, but they may be prone to cardiac injury and dysfunction longer term that requires a more discerning diagnostic approach to sort out.
The findings were revealed in a study of 28 children with COVID-19–related multisystem inflammatory syndrome (MIS-C) at Children’s Hospital of Philadelphia. The study reported that cardiac injury and dysfunction are common in these patients – even those who have preserved ejection fraction – and that diastolic dysfunction is persistent. For comparison, the study also included 20 healthy controls and 20 patients with classic Kawasaki disease (KD).
The study analyzed echocardiography findings in the patients, reporting left ventricular (LV) systolic and diastolic function were worse than in classic Kawasaki disease (KD), which MIS-C mimics. Lead author Daisuke Matsubara, MD, PhD, and colleagues reported that four markers – LV global longitudinal strain, LV circumferential strain rate, right ventricular strain, and left atrial strain – were the strongest predictors of myocardial injury in these patients. After the acute phase, systolic function tended to recover, but diastolic dysfunction persisted.
‘Strain’ measurement boosts accuracy
While echocardiography has been reported to be valuable in evaluating coronary artery function in MIS-C patients, Dr. Matsubara of the division of cardiology at CHOP, said in an interview that study is the first to use the newer echocardiography indexes, known as “strain,” to assess heart function.
“Strain is a more sensitive tool than more conventional indexes and can detect subtle decrease in heart function, even when ejection fraction is preserved,” he said. “Numerous publications have reached conclusions that strain improves the prognostic and diagnostic accuracy of echocardiography in a wide variety of cardiac pathologies causing LV dysfunction.”
Dr. Matsubara noted that the coronary arteries were mostly unaffected in the acute stage of MIS-C, as only one patient in their MIS-C cohort had coronary artery involvement, which normalized during early follow-up. “On the other hand, 20% of our classic KD patients had coronary abnormalities, including two with aneurysms.”
By using positive troponin I or elevated brain natriuretic peptide (BNP) to assess cardiac injury, they found a “high” (60%) incidence of myocardial injury in their MIS-C cohort. During early follow-up, most of the MIS-C patients showed normalization of systolic function, although diastolic dysfunction persisted.
When compared with the classic KD group, MIS-C patients had higher rates of mitral regurgitation (46% vs. 15%, P = .06), more pericardial effusion (32% vs. 15%, P = 0.46), and more pleural effusion (39% vs. 0%, P = .004). MIS-C patients with suspected myocardial injury show these findings more frequently than those with actual myocardial injury.
Compared with the healthy controls, the MIS-C patients showed both LV systolic and diastolic dysfunction as well as significantly lower left atrium (LA) strain and peak right ventricle (RV) free-wall longitudinal strain.
“In addition to the left ventricle, two other chambers of the heart, the LA and the RV that are often labeled as the ‘forgotten chambers’ of the heart, were also affected by MIS-C,” Dr. Matsubara said. “Both LA and RV strains were markedly reduced in MIS-C patients, compared to normal and KD patients.”
The study also indicates that elevated troponin I levels may not be as dire in children as they are in adults. Dr. Matsubara cited a study of more than 2,700 adult COVID-19 patients that found that even mild increases in troponin I level were associated with increased death during hospitalization (J Am Coll Cardiol. 2020;76:533-46).
However, most of the patients in the CHOP study, even those with elevated troponin I levels, recovered systolic function quickly. “We speculate that the elevation in cardiac troponins may have less dire implications in children, likely due to a more transient type of cardiac injury and less comorbidities in children,” he said. “Clearly further studies are needed before a definitive statement can be made.”
Dr. Matsubara added that recovered COVID-19 patients may be able to participate in sports as some schools reopen. “We are not saying restrict sport participation, but we are merely urging caution.”
Comprehensive LV evaluation needed
The findings reinforce that myocardial involvement is more frequent and sometimes more severe in MIS-C than previously thought, said Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital. “We are underestimating it by using just traditional measures like ejection fraction. It requires a comprehensive evaluation of left ventricular function; it really affects all aspects of the ventricle, both the systolic function and the diastolic function.”
This study supports that MIS-C patients should have a more detailed analysis than EF on echocardiography, including strain imaging. “Probably these patients should all be followed at centers where they can evaluate a more detailed analysis of the LV and RV function,” he said. Patients with ongoing CA enlargement and LV dysfunction should have follow-up cardiac care indefinitely. Patients who have no cardiac symptoms during the acute phase probably don’t need long-term follow-up.
“We’re just trying to learn more about this disease, and it’s certainly concerning that so many kids are having cardiac involvement,” Dr. Friedman said. “Fortunately they’re getting better; we’re just trying to find out what this means for the long term.”
Dr. Matsubara and Dr. Friedman have no relevant financial disclosures.
SOURCE: Matsubara D et al. J Am Coll Cardiol. 2020 Sep 2. doi: 10.1016/j.jacc.2020.08.056.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
More U.S. states cap insulin cost, but activists will ‘fight harder’
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
Early evolocumab quickly lowers LDL cholesterol after primary PCI
Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.
Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.
In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.
“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.
In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.
The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.
A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.
Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.
All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.
Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.
In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.
Adverse events and serious adverse events were similar between the groups.
‘Early and strong’ LDL cholesterol lowering best for preventing repeat events
“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.
“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.
Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.
“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.
“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.
SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.
Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.
Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.
In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.
“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.
In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.
The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.
A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.
Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.
All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.
Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.
In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.
Adverse events and serious adverse events were similar between the groups.
‘Early and strong’ LDL cholesterol lowering best for preventing repeat events
“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.
“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.
Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.
“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.
“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.
SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.
Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.
Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.
In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.
“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.
In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.
The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.
A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.
Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.
All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.
Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.
In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.
Adverse events and serious adverse events were similar between the groups.
‘Early and strong’ LDL cholesterol lowering best for preventing repeat events
“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.
“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.
Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.
“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.
“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.
SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.
FROM ESC CONGRESS 2020