TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

TOPLINE:

Men exposed to either job-related stress or an imbalance between the effort they put in and the rewards they reap at work have a 50% increased risk for coronary heart disease (CHD), and those facing both stressors have double the risk compared with colleagues not suffering from these stressors, new research shows. Results in women were inconclusive, suggesting a more complex relationship of these factors, the researchers noted.

METHODOLOGY:

• Evidence suggests psychosocial stressors at work, from job strain related to level of demand and control in workload and decision-making responsibilities, and an effort-reward imbalance (ERI) in areas such as salary, promotion, and job stability, increase CHD risk, with the effect of both types of stressors together possibly being especially harmful.
• The study, which included 6,465 participants in the cardiovascular component of PROQ, a Canadian prospective cohort of white-collar workers initially free of cardiovascular disease, mean age 45 years, estimated that the separate and combined effect of job strain and ERI on CHD incidence.
• Researchers used the Job Content Questionnaire to assess psychological demands and job control; various measures; scales to determine job strain, reward, and effort at work; and the sum of both effort and reward to calculate the ERI ratio.
• They assessed CHD using medico-administrative databases and an algorithm validated by medical records.

TAKEAWAY:

• After a median follow-up of 18.7 years, there were 571 and 265 incident CHD cases among men and women, respectively.
• Men with either job strain or ERI had a 49% increased risk for CHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.07-2.09), an estimate comparable to that of several lifestyle risk factors for CHD.
• Male workers facing both job strain and ERI had a 103% increased risk for CHD (HR, 2.03; 95% CI, 1.38-2.97), which is comparable to the increased risk associated with obesity.
• Associations were robust to adjustments for demographic, socioeconomic, psychosocial, personality, stressful life events, and biomedical and lifestyle factors.
• Among women, results were inconclusive because the CIs were wide enough to encompass both protective and detrimental effects, suggesting more research is needed into the complex interplay of various stressors and women’s heart health.

IN PRACTICE:

“Integrative and interdisciplinary approaches should be used to tackle psychosocial stressors at work,” the authors wrote, adding this involves “going beyond traditional modifiable individual behaviors” and should include “population-based prevention strategies taking into consideration both the individual and their work environment.” 

SOURCE:

The study was conducted by Mathilde Lavigne-Robichaud, Population Health and Optimal Health Practices Research Unit, CHU de Québec-Laval University, Quebec City, Canada. It was published online in Circulation: Cardiovascular Quality and Outcomes. 

LIMITATIONS:

There was a risk for chance associations due to multiple testing. The exposure may have changed over the course of the study. Using medical databases for CHD event definition may have led to misclassification and underestimation of outcomes. The study population is limited to white-collar workers.

DISCLOSURES:

The study received funding from the Canadian Institute of Health Research. Lavigne-Robichaud was supported by a PhD grant from les Fonds de Recherche du Québec-Santé. See paper for disclosures of other authors.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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

Multiple emerging risk factors for cardiovascular disease in women must be recognized and assessed to provide timely diagnosis and treatment, according to Dipti N. Itchhaporia, MD, an interventional cardiologist in southern California. These risk factors include pregnancy complications, autoimmune diseases, depression, breast cancer, and breast arterial calcification.

During the session titled “Cardiac Care in Women: Emerging Risk Factors” at CardioAcademic 2023, the former president of the American College of Cardiology emphasized that gender equity in care for cardiovascular disease will be achieved only when risk factors are evaluated from a gender-dependent perspective and when assessments are broadened to include novel and unrecognized risk factors, not just traditional risk factors.

Dr. Itchhaporia also remarked that women and primary care clinicians must be educated on the symptoms of heart disease so that they can be on the alert and provide patients with comprehensive treatments when necessary.

“Cardiovascular disease remains the leading cause of death in women, at least in the United States, and globally the outlook is similar,” she explained. “That’s why we need to provide our patients with guidance and carefully investigate when they experience chest pain. We need to remember that smoking and obesity pose a higher risk for cardiovascular disease in women than in men. Taking these risk factors into account will really make a difference by allowing us to provide more timely and targeted care.”

In her presentation, Dr. Itchhaporia noted that cardiovascular disease accounts for 35% of deaths in women worldwide. She reminded her audience that, according to The Lancet Women and Cardiovascular Disease Commission, heart diseases in this population remain “understudied, underrecognized, underdiagnosed, and undertreated. Furthermore, women are underrepresented in cardiovascular [clinical practice].”

She mentioned this because, despite U.S. legislation enacted between 1980 and 1990 that mandated the inclusion of women in clinical trials, women accounted for less than 39% of participants in cardiovascular clinical trials between 2010 and 2017. According to Dr. Itchhaporia, this situation limits the potential for developing tailored strategies and recommendations to treat the cardiovascular diseases affecting women.
 

Emerging risk factors

Dr. Itchhaporia pointed out that traditional risk factors have been known for many years. For example, 80% of women aged 75 years or younger have arterial hypertension. Only 29% receive adequate blood pressure control, those living with diabetes have a 45% greater risk of suffering ischemic heart disease, and obesity confers a 64% higher risk of developing ischemic heart disease in women versus 46% in men.

In addition to these factors, she noted that emerging factors must be assessed carefully. For example, women who experience pregnancy complications like gestational diabetes have a higher risk for ischemic heart disease and type 2 diabetes. Women with hypertension and preeclampsia are at a threefold higher risk of developing ischemic heart disease.

“Pregnancy can really be a major stress test for the heart, and I believe that, as health care professionals, we should all be asking women if they have had pregnancy-related complications. I don’t think that’s something we’ve been doing on a regular basis. Statistically, we know that 10%-20% of pregnant women report complications during pregnancy, and strong associations have been shown between gestational hypertension [and] preeclampsia.”

Dr. Itchhaporia explained that depression, a condition that globally affects women twice as much as men, is another emerging factor (though it has received some increased recognition). She explained that, in women, depression is a significant risk factor for developing a major adverse cardiovascular event or a combined event of cardiac death and myocardial infarction related to the target lesion and revascularization of the target lesion because of ischemia. Furthermore, women who have experienced a cardiac-related event are more likely to have depression than men.

“If we look into it in more detail, depression leads to changes in behavioral habits and physiological mechanisms,” she said. “Women living with depression are at higher risk of smoking, not exercising as much, are perhaps less careful with their hygiene, are not likely to adhere to their medications, and don’t sleep as well. All this moves them in the direction of heart disease.”

Added to these factors are autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus, where the female-to-male ratio for rheumatoid arthritis is 2½:1 and for lupus it’s 9:1. Dr. Itchhaporia explained that patients with rheumatoid arthritis are at two- to threefold greater risk for myocardial infarction and have a 50% higher risk for stroke. In the case of systemic lupus, the risk of myocardial infarction is 7-50 times greater than in the general population. She noted that cardiovascular risk calculators underestimate the burden of risk in patients with these diseases.

Lastly, she brought up breast cancer and breast arterial calcification as additional emerging risk factors. She explained that women with breast cancer are more likely to develop hypertension and diabetes, compared with women without this diagnosis. Women with hypertension or diabetes before developing breast cancer have twice the risk for heart problems after cancer.

She added that 12.7% of women screened for breast cancer have some degree of breast calcification. She explained that this occurs when calcium accumulates in the middle layer of artery walls in the breast, which is linked to aging, type 2 diabetes, or arterial hypertension and may be a marker of arterial stiffening, which is a cardiovascular disease.

“It’s extremely important to take into consideration data suggesting a strong association between breast calcifications and cardiovascular disease, independent of other known risk factors of cardiovascular disease. We need to improve our tests for detecting cardiovascular disease in women and we need to ask specific questions and not overlook these emerging factors,” she noted.
 

Improving health outcomes

Panelist María Guadalupe Parra Machuca, MD, a cardiologist in Guadalajara, Mexico, specializing in women’s heart disease, agreed that it is high time that clinical practice reflect public health policies, so that efforts to diagnose and treat cardiovascular diseases in women more effectively can transition from theory to reality.

“As physicians, we cannot allow public policy to remain outside of the reality we face,” she stressed. “We need to let it impact the decisions we make. Everything we see day to day, the things we learn at these conferences – let’s put it into practice. Otherwise, all our discussions and all the steps taken to improve care, from primary to highly specialized care and to detect and treat cardiovascular disease in women, will be nothing but rhetoric.”

Clinical cardiology specialist Victor Leal, MD, noted that, according to preliminary results from the national survey of cardiovascular risk factors in Mexican women, Mexico is no exception to these emerging risk factors for cardiovascular disease in women. More than 50% of women in Mexico have traditional risk factors, most notably hypertension, obesity, and diabetes, while hypertensive disorders of pregnancy top the list of other sex-specific risk factors.

“Not only are these factors increasing, but also having them increases the risk of a worse prognosis, leaving us with a very challenging scenario,” said Dr. Leal. “Not only do we need to educate patients about the traditional risk factors, but also about factors that might not be on our radar. We need to get women to link these factors to cardiovascular disease and to the possibility of developing much more adverse outcomes. This will reinforce our diagnosis and treatment.”

In an interview, Dr. Itchhaporia emphasized the changing face of cardiovascular disease for women, who have worse short- and long-term outcomes than men because they are not asked sex-specific questions during initial encounters and they experience greater prehospital delays.

She noted that, while experts need to raise awareness of the emerging risk factors among health care professionals, they also need to use information campaigns to make women aware of what the risks are. Then, if they experience any of the emerging risk factors, they can discuss it with their treating physicians.

“We need to assess both the traditional risk factors and the novel ones, those that are underrecognized. We need to include the history of pregnancy and complications during this period and we need to educate women about symptoms of heart disease like chest pain, difficulty breathing, and increasing fatigue,” she emphasized. “We must also provide guidance as to lifestyle, diet, and levels of physical activity and be aware of stress and symptoms of depression. Only then will we bring greater awareness to the fact that cardiovascular disease is the leading cause of death among women, and then we can reverse these trends.”

Dr. Itchhaporia, Dr. Parra, and Dr. Leal reported no relevant financial relationships.

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

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

The Diagnosis: Scabies Infestation

Direct microscopy revealed the presence of a live scabies mite and numerous eggs (Figure), confirming the diagnosis of a scabies infestation. Scabies, caused by the Sarcoptes scabiei var hominis mite, characteristically presents in adults as pruritic hyperkeratotic plaques of the interdigital web spaces of the hands, flexor surfaces of the wrists and elbows, axillae, male genitalia, and breasts; however, an atypical presentation is common in immunocompromised or immunosuppressed individuals, such as our patient. In children, the palms, soles, and head (ie, face, scalp, neck) are common sites of involvement. Although dermatologists generally are familiar with severe atypical presentations such as Norwegian crusted scabies or bullous scabies, it is important that they are aware of other atypical presentations, such as the diffuse papulonodular variant observed in our patient.¹ As such, a low threshold of suspicion for scabies infestations should be employed in immunocompromised patients with new-onset pruritic eruptions.

Direct microscopy is widely accepted as the gold standard for the diagnosis of scabies infestations; it is a fast and low-cost diagnostic tool. However, this technique displays variable sensitivity in clinical practice, requiring experience and a skilled hand.^1,2 Other more sensitive diagnostic options for suspected scabies infestations include histopathology, serology, and molecular-based techniques such as DNA isolation and polymerase chain reaction. Although these tests do demonstrate greater sensitivity, they also are more invasive, time intensive, and costly.² Therefore, they typically are not the first choice for a suspected scabies infestation. Dermoscopy has emerged as another tool to aid in the diagnosis of a suspected scabies infestation, enabling visualization of scaly burrows, eggs, and live mites. Classically, findings resembling a delta wing with contrail are seen on dermoscopic examination. The delta wing represents the brown triangular structure of the pigmented scabies mite head and anterior legs; the contrail is the lighter linear structures streaming behind the scabies mite (similar to visible vapor streams occurring behind flying jets), representing the burrow of the mite.

Although treatment of scabies infestations typically can be accomplished with permethrin cream 5%, the diffuse nature of our patient’s lesions in combination with his immunocompromised state made oral therapy a more appropriate choice. Based on Centers for Disease Control and Prevention recommendations, the patient received 2 doses of oral weight-based ivermectin (200 μg/kg per dose) administered 1 week apart.^1,3 The initial dose at day 1 serves to eliminate any scabies mites that are present, while the second dose 1 week later eliminates any residual eggs. Our patient experienced complete resolution of the symptoms following this treatment regimen.

It was important to differentiate our patient’s scabies infestation from other intensely pruritic conditions and morphologic mimics including papular urticaria, lichenoid drug eruptions, tinea corporis, and prurigo nodularis. Papular urticaria is an intensely pruritic hypersensitivity reaction to insect bites that commonly affects the extremities or other exposed areas. Visible puncta may be present.⁴ Our patient’s lesion distribution involved areas covered by clothing, no puncta were present, and he had no history of a recent arthropod assault, making the diagnosis of papular urticaria less likely.

Lichenoid drug eruptions classically present with symmetric, diffuse, pruritic, violaceous, scaling papules and plaques that present 2 to 3 months after exposure to an offending agent.⁵ Our patient’s eruption was papulonodular with no violaceous plaques, and he did not report changes to his medications, making a lichenoid drug eruption less likely.

Tinea corporis is another intensely pruritic condition that should be considered, especially in immunocompromised patients. It is caused by dermatophytes and classically presents as erythematous pruritic plaques with an annular, advancing, scaling border.⁶ Although immunocompromised patients may display extensive involvement, our patient’s lesions were papulonodular with no annular morphology or scale, rendering tinea corporis less likely.

Prurigo nodularis is a chronic condition characterized by pruritic, violaceous, dome-shaped, smooth or crusted nodules secondary to repeated scratching or pressure. Although prurigo nodules can develop as a secondary change due to chronic excoriations in scabies infestations, prurigo nodules usually do not develop in areas such as the midline of the back that are not easily reached by the fingernails,⁷ which made prurigo nodularis less likely in our patient.

This case describes a unique papulonodular variant of scabies presenting in an immunocompromised cancer patient. Timely recognition and diagnosis of atypical scabies infestations can decrease morbidity and improve the quality of life of these patients.

The Diagnosis: Scabies Infestation

Direct microscopy revealed the presence of a live scabies mite and numerous eggs (Figure), confirming the diagnosis of a scabies infestation. Scabies, caused by the Sarcoptes scabiei var hominis mite, characteristically presents in adults as pruritic hyperkeratotic plaques of the interdigital web spaces of the hands, flexor surfaces of the wrists and elbows, axillae, male genitalia, and breasts; however, an atypical presentation is common in immunocompromised or immunosuppressed individuals, such as our patient. In children, the palms, soles, and head (ie, face, scalp, neck) are common sites of involvement. Although dermatologists generally are familiar with severe atypical presentations such as Norwegian crusted scabies or bullous scabies, it is important that they are aware of other atypical presentations, such as the diffuse papulonodular variant observed in our patient.¹ As such, a low threshold of suspicion for scabies infestations should be employed in immunocompromised patients with new-onset pruritic eruptions.

Direct microscopy is widely accepted as the gold standard for the diagnosis of scabies infestations; it is a fast and low-cost diagnostic tool. However, this technique displays variable sensitivity in clinical practice, requiring experience and a skilled hand.^1,2 Other more sensitive diagnostic options for suspected scabies infestations include histopathology, serology, and molecular-based techniques such as DNA isolation and polymerase chain reaction. Although these tests do demonstrate greater sensitivity, they also are more invasive, time intensive, and costly.² Therefore, they typically are not the first choice for a suspected scabies infestation. Dermoscopy has emerged as another tool to aid in the diagnosis of a suspected scabies infestation, enabling visualization of scaly burrows, eggs, and live mites. Classically, findings resembling a delta wing with contrail are seen on dermoscopic examination. The delta wing represents the brown triangular structure of the pigmented scabies mite head and anterior legs; the contrail is the lighter linear structures streaming behind the scabies mite (similar to visible vapor streams occurring behind flying jets), representing the burrow of the mite.

Although treatment of scabies infestations typically can be accomplished with permethrin cream 5%, the diffuse nature of our patient’s lesions in combination with his immunocompromised state made oral therapy a more appropriate choice. Based on Centers for Disease Control and Prevention recommendations, the patient received 2 doses of oral weight-based ivermectin (200 μg/kg per dose) administered 1 week apart.^1,3 The initial dose at day 1 serves to eliminate any scabies mites that are present, while the second dose 1 week later eliminates any residual eggs. Our patient experienced complete resolution of the symptoms following this treatment regimen.

It was important to differentiate our patient’s scabies infestation from other intensely pruritic conditions and morphologic mimics including papular urticaria, lichenoid drug eruptions, tinea corporis, and prurigo nodularis. Papular urticaria is an intensely pruritic hypersensitivity reaction to insect bites that commonly affects the extremities or other exposed areas. Visible puncta may be present.⁴ Our patient’s lesion distribution involved areas covered by clothing, no puncta were present, and he had no history of a recent arthropod assault, making the diagnosis of papular urticaria less likely.

Lichenoid drug eruptions classically present with symmetric, diffuse, pruritic, violaceous, scaling papules and plaques that present 2 to 3 months after exposure to an offending agent.⁵ Our patient’s eruption was papulonodular with no violaceous plaques, and he did not report changes to his medications, making a lichenoid drug eruption less likely.

Tinea corporis is another intensely pruritic condition that should be considered, especially in immunocompromised patients. It is caused by dermatophytes and classically presents as erythematous pruritic plaques with an annular, advancing, scaling border.⁶ Although immunocompromised patients may display extensive involvement, our patient’s lesions were papulonodular with no annular morphology or scale, rendering tinea corporis less likely.

Prurigo nodularis is a chronic condition characterized by pruritic, violaceous, dome-shaped, smooth or crusted nodules secondary to repeated scratching or pressure. Although prurigo nodules can develop as a secondary change due to chronic excoriations in scabies infestations, prurigo nodules usually do not develop in areas such as the midline of the back that are not easily reached by the fingernails,⁷ which made prurigo nodularis less likely in our patient.

This case describes a unique papulonodular variant of scabies presenting in an immunocompromised cancer patient. Timely recognition and diagnosis of atypical scabies infestations can decrease morbidity and improve the quality of life of these patients.

The Diagnosis: Scabies Infestation

Direct microscopy revealed the presence of a live scabies mite and numerous eggs (Figure), confirming the diagnosis of a scabies infestation. Scabies, caused by the Sarcoptes scabiei var hominis mite, characteristically presents in adults as pruritic hyperkeratotic plaques of the interdigital web spaces of the hands, flexor surfaces of the wrists and elbows, axillae, male genitalia, and breasts; however, an atypical presentation is common in immunocompromised or immunosuppressed individuals, such as our patient. In children, the palms, soles, and head (ie, face, scalp, neck) are common sites of involvement. Although dermatologists generally are familiar with severe atypical presentations such as Norwegian crusted scabies or bullous scabies, it is important that they are aware of other atypical presentations, such as the diffuse papulonodular variant observed in our patient.¹ As such, a low threshold of suspicion for scabies infestations should be employed in immunocompromised patients with new-onset pruritic eruptions.

Direct microscopy is widely accepted as the gold standard for the diagnosis of scabies infestations; it is a fast and low-cost diagnostic tool. However, this technique displays variable sensitivity in clinical practice, requiring experience and a skilled hand.^1,2 Other more sensitive diagnostic options for suspected scabies infestations include histopathology, serology, and molecular-based techniques such as DNA isolation and polymerase chain reaction. Although these tests do demonstrate greater sensitivity, they also are more invasive, time intensive, and costly.² Therefore, they typically are not the first choice for a suspected scabies infestation. Dermoscopy has emerged as another tool to aid in the diagnosis of a suspected scabies infestation, enabling visualization of scaly burrows, eggs, and live mites. Classically, findings resembling a delta wing with contrail are seen on dermoscopic examination. The delta wing represents the brown triangular structure of the pigmented scabies mite head and anterior legs; the contrail is the lighter linear structures streaming behind the scabies mite (similar to visible vapor streams occurring behind flying jets), representing the burrow of the mite.

Although treatment of scabies infestations typically can be accomplished with permethrin cream 5%, the diffuse nature of our patient’s lesions in combination with his immunocompromised state made oral therapy a more appropriate choice. Based on Centers for Disease Control and Prevention recommendations, the patient received 2 doses of oral weight-based ivermectin (200 μg/kg per dose) administered 1 week apart.^1,3 The initial dose at day 1 serves to eliminate any scabies mites that are present, while the second dose 1 week later eliminates any residual eggs. Our patient experienced complete resolution of the symptoms following this treatment regimen.

It was important to differentiate our patient’s scabies infestation from other intensely pruritic conditions and morphologic mimics including papular urticaria, lichenoid drug eruptions, tinea corporis, and prurigo nodularis. Papular urticaria is an intensely pruritic hypersensitivity reaction to insect bites that commonly affects the extremities or other exposed areas. Visible puncta may be present.⁴ Our patient’s lesion distribution involved areas covered by clothing, no puncta were present, and he had no history of a recent arthropod assault, making the diagnosis of papular urticaria less likely.

Lichenoid drug eruptions classically present with symmetric, diffuse, pruritic, violaceous, scaling papules and plaques that present 2 to 3 months after exposure to an offending agent.⁵ Our patient’s eruption was papulonodular with no violaceous plaques, and he did not report changes to his medications, making a lichenoid drug eruption less likely.

Tinea corporis is another intensely pruritic condition that should be considered, especially in immunocompromised patients. It is caused by dermatophytes and classically presents as erythematous pruritic plaques with an annular, advancing, scaling border.⁶ Although immunocompromised patients may display extensive involvement, our patient’s lesions were papulonodular with no annular morphology or scale, rendering tinea corporis less likely.

Prurigo nodularis is a chronic condition characterized by pruritic, violaceous, dome-shaped, smooth or crusted nodules secondary to repeated scratching or pressure. Although prurigo nodules can develop as a secondary change due to chronic excoriations in scabies infestations, prurigo nodules usually do not develop in areas such as the midline of the back that are not easily reached by the fingernails,⁷ which made prurigo nodularis less likely in our patient.

This case describes a unique papulonodular variant of scabies presenting in an immunocompromised cancer patient. Timely recognition and diagnosis of atypical scabies infestations can decrease morbidity and improve the quality of life of these patients.

TOPLINE:

Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.

METHODOLOGY:

• Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
• Potential downsides of HIPEC include longer operative time and treatment-related complications.
• This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
• The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
• The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.

TAKEAWAY:

• During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
• Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
• The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
• Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).

IN PRACTICE:

“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”

SOURCE:

The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.

LIMITATIONS:

The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.

DISCLOSURES:

The authors reported no conflicts of interest. The study had no specific funding.

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

TOPLINE:

Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.

METHODOLOGY:

• Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
• Potential downsides of HIPEC include longer operative time and treatment-related complications.
• This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
• The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
• The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.

TAKEAWAY:

• During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
• Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
• The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
• Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).

IN PRACTICE:

“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”

SOURCE:

The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.

LIMITATIONS:

The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.

DISCLOSURES:

The authors reported no conflicts of interest. The study had no specific funding.

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

TOPLINE:

Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.

METHODOLOGY:

• Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
• Potential downsides of HIPEC include longer operative time and treatment-related complications.
• This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
• The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
• The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.

TAKEAWAY:

• During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
• Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
• The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
• Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).

IN PRACTICE:

“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”

SOURCE:

The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.

LIMITATIONS:

The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.

DISCLOSURES:

The authors reported no conflicts of interest. The study had no specific funding.

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

A nationwide dearth of the specialists known as classical hematologists (CHs), who are trained to treat noncancerous bleeding disorders, has left many patients stranded and health care systems struggling to cope.

Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
 

`Vicious cycle’

The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.

“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.

According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.

Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.

Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.

“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.

The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
 

Toll on patients

Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.

Dr. Mukul Singal

“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.

Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
 

A working care model, without enough doctors

In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.

“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.

Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.

The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.

The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
 

Beyond the paycheck: Supporting CHs and patients

As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”

Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.

“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.

The next PPA is taking place Sept. 18-22 in Indianapolis.

Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.

A nationwide dearth of the specialists known as classical hematologists (CHs), who are trained to treat noncancerous bleeding disorders, has left many patients stranded and health care systems struggling to cope.

Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
 

`Vicious cycle’

The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.

“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.

According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.

Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.

Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.

“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.

The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
 

Toll on patients

Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.

Dr. Mukul Singal

“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.

Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
 

A working care model, without enough doctors

In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.

“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.

Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.

The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.

The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
 

Beyond the paycheck: Supporting CHs and patients

As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”

Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.

“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.

The next PPA is taking place Sept. 18-22 in Indianapolis.

Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.

A nationwide dearth of the specialists known as classical hematologists (CHs), who are trained to treat noncancerous bleeding disorders, has left many patients stranded and health care systems struggling to cope.

Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
 

`Vicious cycle’

The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.

“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.

According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.

Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.

Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.

“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.

The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
 

Toll on patients

Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.

Dr. Mukul Singal

“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.

Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
 

A working care model, without enough doctors

In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.

“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.

Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.

The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.

The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
 

Beyond the paycheck: Supporting CHs and patients

As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”

Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.

“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.

The next PPA is taking place Sept. 18-22 in Indianapolis.

Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.

Most available drugs for eosinophilic esophagitis (EoE) demonstrate greater efficacy than placebo, but data are too heterogenous to determine a reliable therapeutic hierarchy, shows a meta-analysis published in Gut.

Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.

The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.

The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.

This approach yielded a litany of efficacy findings.

Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.

The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.

Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.

“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”

Michigan Medicine

Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.

“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.

Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.

“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.

The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
 

Most available drugs for eosinophilic esophagitis (EoE) demonstrate greater efficacy than placebo, but data are too heterogenous to determine a reliable therapeutic hierarchy, shows a meta-analysis published in Gut.

Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.

The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.

The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.

This approach yielded a litany of efficacy findings.

Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.

The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.

Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.

“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”

Michigan Medicine

Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.

“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.

Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.

“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.

The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
 

Most available drugs for eosinophilic esophagitis (EoE) demonstrate greater efficacy than placebo, but data are too heterogenous to determine a reliable therapeutic hierarchy, shows a meta-analysis published in Gut.

Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.

The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.

The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.

This approach yielded a litany of efficacy findings.

Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.

The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.

Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.

“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”

Michigan Medicine

Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.

“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.

Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.

“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.

The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
 

Except possibly for colorectal cancer screening with sigmoidoscopy, common cancer screening tests do not extend life, according to a new study published in JAMA Internal Medicine.

The study, which was a systematic review and meta-analysis of 18 long-term randomized clinical trials involving 2.1 million individuals, found that colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using CT. The study involved more than 1 decade of follow-up reporting all-cause mortality of people who had undergone mammography screening for breast cancer; colonoscopy, sigmoidoscopy, or fecal occult blood testing for colorectal cancer; CT screening for lung cancer in smokers and former smokers; or prostate-specific antigen testing for prostate cancer.

AGA

The study received a fair amount of attention in the press, but the American Gastroenterological Association (AGA) believes the premise of the study is flawed because cancer screening is not intended to increase longevity, but it can prevent premature death.

“Cancer prevention and earlier stage diagnoses through colorectal cancer screening provides significant morbidity and cost benefits, even if all-cause mortality is not reduced,” said Lawrence Kim, MD, AGAF, AGA vice president.

The authors of the study, who were led by Michael Bretthauer, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, are not suggesting that cancer screenings be abandoned. However, they do suggest that “organizations, institutions, and policy makers who promote cancer screening tests by their effect to save lives may find other ways of encouraging screening. It might be wise to reconsider priorities and dispassionately inform interested people about the absolute benefits, harms, and burden of screening tests that they consider undertaking.”

Except possibly for colorectal cancer screening with sigmoidoscopy, common cancer screening tests do not extend life, according to a new study published in JAMA Internal Medicine.

The study, which was a systematic review and meta-analysis of 18 long-term randomized clinical trials involving 2.1 million individuals, found that colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using CT. The study involved more than 1 decade of follow-up reporting all-cause mortality of people who had undergone mammography screening for breast cancer; colonoscopy, sigmoidoscopy, or fecal occult blood testing for colorectal cancer; CT screening for lung cancer in smokers and former smokers; or prostate-specific antigen testing for prostate cancer.

AGA

The study received a fair amount of attention in the press, but the American Gastroenterological Association (AGA) believes the premise of the study is flawed because cancer screening is not intended to increase longevity, but it can prevent premature death.

“Cancer prevention and earlier stage diagnoses through colorectal cancer screening provides significant morbidity and cost benefits, even if all-cause mortality is not reduced,” said Lawrence Kim, MD, AGAF, AGA vice president.

The authors of the study, who were led by Michael Bretthauer, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, are not suggesting that cancer screenings be abandoned. However, they do suggest that “organizations, institutions, and policy makers who promote cancer screening tests by their effect to save lives may find other ways of encouraging screening. It might be wise to reconsider priorities and dispassionately inform interested people about the absolute benefits, harms, and burden of screening tests that they consider undertaking.”

Except possibly for colorectal cancer screening with sigmoidoscopy, common cancer screening tests do not extend life, according to a new study published in JAMA Internal Medicine.

The study, which was a systematic review and meta-analysis of 18 long-term randomized clinical trials involving 2.1 million individuals, found that colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life. An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using CT. The study involved more than 1 decade of follow-up reporting all-cause mortality of people who had undergone mammography screening for breast cancer; colonoscopy, sigmoidoscopy, or fecal occult blood testing for colorectal cancer; CT screening for lung cancer in smokers and former smokers; or prostate-specific antigen testing for prostate cancer.

AGA

The study received a fair amount of attention in the press, but the American Gastroenterological Association (AGA) believes the premise of the study is flawed because cancer screening is not intended to increase longevity, but it can prevent premature death.

“Cancer prevention and earlier stage diagnoses through colorectal cancer screening provides significant morbidity and cost benefits, even if all-cause mortality is not reduced,” said Lawrence Kim, MD, AGAF, AGA vice president.

The authors of the study, who were led by Michael Bretthauer, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, are not suggesting that cancer screenings be abandoned. However, they do suggest that “organizations, institutions, and policy makers who promote cancer screening tests by their effect to save lives may find other ways of encouraging screening. It might be wise to reconsider priorities and dispassionately inform interested people about the absolute benefits, harms, and burden of screening tests that they consider undertaking.”

In a new statement, five professional gastroenterology organizations caution that there are currently no data to support stopping glucagonlike peptide 1 (GLP-1) receptor agonists prior to elective endoscopy

The medications, which include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), and liraglutide (Saxenda), among others, are used for the treatment of diabetes or for weight loss and may be associated with delayed gastric emptying.

Penn Medicine

Patients taking GLP-1 receptor agonists for diabetes management “need to be cautious about withholding these medications because doing so can adversely impact blood glucose control,” said Octavia Pickett-Blakely, MD, a gastroenterologist with University of Pennsylvania in Philadelphia and spokesperson for the American Gastroenterological Association (AGA). “In patients undergoing endoscopic procedures, poorly controlled blood glucose could raise the risk of complications.”

In a commentary on Medscape, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, urges clinicians to learn about the topic and inform patients when prescribing GLP-1 receptor agonists.

“These are new and changing issues. In our world as gastroenterologists, we should be considering – very strongly – mitigating strategies to protect the patients on this wonderful class of therapy,” he says. “Sometimes these drugs can have significant side effects that we need to at least be aware of. Nothing is perfect, but let us be better informed.”

“We really don’t know what the risks are yet. With endoscopy, they could be significant, but perhaps they’re not,” Jonathan Leighton, MD, a gastroenterologist with Mayo Clinic Arizona in Phoenix and president-elect of the American College of Gastroenterology (ACG), told this news organization. “There are a lot of factors that go into this, and we just want to proceed cautiously and carefully until we know more.”

The ACG, AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition released the statement on Aug. 11.

It was issued in response to recent guidance on the preoperative management of adults and children on GLP-1 receptor agonists put forth by the American Society of Anesthesiologists.

In a separate statement, the AGA stated that there is little, or no data on complications from aspiration.

“While there is anecdotal experience that increased gastroparesis risk may be dose dependent or related to whether it is being used for diabetes control versus weight loss, we also acknowledge that there is little, or no data related to the relative risk of complications from aspiration. As a result, the impact associated with stopping these therapies prior to undergoing upper GI endoscopy (EGD) or other moderate to deep sedated procedures is unknown at this time. 

“As clinical gastroenterologists and hepatologists, we are very familiar with safety issues regarding the performance of endoscopy in our patients suffering from gastroparesis as well as unexplained nausea, vomiting, and epigastric pain, particularly in emergency situations. As patient safety will always be paramount, and in the absence of actionable data, we encourage our members to exercise best practices when performing endoscopy on these patients who are taking GLP-1 receptor agonists. More data are needed to understand if and when these medications should be held prior to elective endoscopy. Given the need for further data regarding the emerging use of these novel compounds, we encourage our anesthesiology, endocrinology, and industry partners to work collaboratively with our members to develop the necessary evidence to appropriately inform medication adjustments prior to elective endoscopy.”

ASA recommendations

The ASA Task Force on Preoperative Fasting reviewed the available literature on GLP-1 receptor agonists and associated gastrointestinal adverse effects, including the consequences of delayed gastric emptying.

The task force acknowledges that the evidence to provide guidance for preoperative management of these drugs to prevent regurgitation and pulmonary aspiration of gastric contents is “sparse, limited only to several case reports.”

Nevertheless, given the concerns of GLP-1 receptor agonist–induced delayed gastric emptying and associated high risk for regurgitation and aspiration of gastric contents, the task force made these recommendations for elective procedures.

The day before the procedure

For patients on daily dosing, consider holding GLP-1 agonists on the day of the procedure/surgery. For patients on weekly dosing, consider holding GLP-1 agonists a week prior to the procedure/surgery.

This suggestion is irrespective of the indication (type 2 diabetes or weight loss), dose, or the type of procedure/surgery.

If GLP-1 agonists prescribed for diabetes are held for longer than the dosing schedule, consider consulting an endocrinologist for bridging the antidiabetic therapy to avoid hyperglycemia.

The day of the procedure

If GI symptoms such as severe nausea/vomiting/retching, abdominal bloating, or abdominal pain are present, consider delaying the elective procedure and discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

If the patient has no GI symptoms and the GLP-1 agonists have been held as advised, proceed as usual.

If the patient has no GI symptoms but the GLP-1 agonists were not held as advised, proceed with “full stomach” precautions or consider evaluating gastric volume by ultrasound, if possible and if proficient with the technique. If the stomach is empty, proceed as usual. If the stomach is full or if gastric ultrasound is inconclusive or not possible, consider delaying the procedure or treat the patient as “full stomach” and manage accordingly. Discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

There is no evidence to suggest the optimal duration of fasting for patients on GLP-1 agonists. Therefore, until we have adequate evidence, we suggest following the current ASA fasting guidelines.

For patients on GLP-1 receptor agonists who need urgent or emergent procedures, the ASA advises proceeding and treating the patient as “full stomach” and managing accordingly.

Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Pickett-Blakely has no relevant disclosures. Dr. Johnson is an adviser to ISOTHRIVE and Johnson & Johnson.

This story was adapted for GI&Hepatology News from Medscape.

In a new statement, five professional gastroenterology organizations caution that there are currently no data to support stopping glucagonlike peptide 1 (GLP-1) receptor agonists prior to elective endoscopy

The medications, which include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), and liraglutide (Saxenda), among others, are used for the treatment of diabetes or for weight loss and may be associated with delayed gastric emptying.

Penn Medicine

Patients taking GLP-1 receptor agonists for diabetes management “need to be cautious about withholding these medications because doing so can adversely impact blood glucose control,” said Octavia Pickett-Blakely, MD, a gastroenterologist with University of Pennsylvania in Philadelphia and spokesperson for the American Gastroenterological Association (AGA). “In patients undergoing endoscopic procedures, poorly controlled blood glucose could raise the risk of complications.”

In a commentary on Medscape, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, urges clinicians to learn about the topic and inform patients when prescribing GLP-1 receptor agonists.

“These are new and changing issues. In our world as gastroenterologists, we should be considering – very strongly – mitigating strategies to protect the patients on this wonderful class of therapy,” he says. “Sometimes these drugs can have significant side effects that we need to at least be aware of. Nothing is perfect, but let us be better informed.”

“We really don’t know what the risks are yet. With endoscopy, they could be significant, but perhaps they’re not,” Jonathan Leighton, MD, a gastroenterologist with Mayo Clinic Arizona in Phoenix and president-elect of the American College of Gastroenterology (ACG), told this news organization. “There are a lot of factors that go into this, and we just want to proceed cautiously and carefully until we know more.”

The ACG, AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition released the statement on Aug. 11.

It was issued in response to recent guidance on the preoperative management of adults and children on GLP-1 receptor agonists put forth by the American Society of Anesthesiologists.

In a separate statement, the AGA stated that there is little, or no data on complications from aspiration.

“While there is anecdotal experience that increased gastroparesis risk may be dose dependent or related to whether it is being used for diabetes control versus weight loss, we also acknowledge that there is little, or no data related to the relative risk of complications from aspiration. As a result, the impact associated with stopping these therapies prior to undergoing upper GI endoscopy (EGD) or other moderate to deep sedated procedures is unknown at this time. 

“As clinical gastroenterologists and hepatologists, we are very familiar with safety issues regarding the performance of endoscopy in our patients suffering from gastroparesis as well as unexplained nausea, vomiting, and epigastric pain, particularly in emergency situations. As patient safety will always be paramount, and in the absence of actionable data, we encourage our members to exercise best practices when performing endoscopy on these patients who are taking GLP-1 receptor agonists. More data are needed to understand if and when these medications should be held prior to elective endoscopy. Given the need for further data regarding the emerging use of these novel compounds, we encourage our anesthesiology, endocrinology, and industry partners to work collaboratively with our members to develop the necessary evidence to appropriately inform medication adjustments prior to elective endoscopy.”

ASA recommendations

The ASA Task Force on Preoperative Fasting reviewed the available literature on GLP-1 receptor agonists and associated gastrointestinal adverse effects, including the consequences of delayed gastric emptying.

The task force acknowledges that the evidence to provide guidance for preoperative management of these drugs to prevent regurgitation and pulmonary aspiration of gastric contents is “sparse, limited only to several case reports.”

Nevertheless, given the concerns of GLP-1 receptor agonist–induced delayed gastric emptying and associated high risk for regurgitation and aspiration of gastric contents, the task force made these recommendations for elective procedures.

The day before the procedure

For patients on daily dosing, consider holding GLP-1 agonists on the day of the procedure/surgery. For patients on weekly dosing, consider holding GLP-1 agonists a week prior to the procedure/surgery.

This suggestion is irrespective of the indication (type 2 diabetes or weight loss), dose, or the type of procedure/surgery.

If GLP-1 agonists prescribed for diabetes are held for longer than the dosing schedule, consider consulting an endocrinologist for bridging the antidiabetic therapy to avoid hyperglycemia.

The day of the procedure

If GI symptoms such as severe nausea/vomiting/retching, abdominal bloating, or abdominal pain are present, consider delaying the elective procedure and discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

If the patient has no GI symptoms and the GLP-1 agonists have been held as advised, proceed as usual.

If the patient has no GI symptoms but the GLP-1 agonists were not held as advised, proceed with “full stomach” precautions or consider evaluating gastric volume by ultrasound, if possible and if proficient with the technique. If the stomach is empty, proceed as usual. If the stomach is full or if gastric ultrasound is inconclusive or not possible, consider delaying the procedure or treat the patient as “full stomach” and manage accordingly. Discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

There is no evidence to suggest the optimal duration of fasting for patients on GLP-1 agonists. Therefore, until we have adequate evidence, we suggest following the current ASA fasting guidelines.

For patients on GLP-1 receptor agonists who need urgent or emergent procedures, the ASA advises proceeding and treating the patient as “full stomach” and managing accordingly.

Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Pickett-Blakely has no relevant disclosures. Dr. Johnson is an adviser to ISOTHRIVE and Johnson & Johnson.

This story was adapted for GI&Hepatology News from Medscape.

In a new statement, five professional gastroenterology organizations caution that there are currently no data to support stopping glucagonlike peptide 1 (GLP-1) receptor agonists prior to elective endoscopy

The medications, which include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), and liraglutide (Saxenda), among others, are used for the treatment of diabetes or for weight loss and may be associated with delayed gastric emptying.

Penn Medicine

Patients taking GLP-1 receptor agonists for diabetes management “need to be cautious about withholding these medications because doing so can adversely impact blood glucose control,” said Octavia Pickett-Blakely, MD, a gastroenterologist with University of Pennsylvania in Philadelphia and spokesperson for the American Gastroenterological Association (AGA). “In patients undergoing endoscopic procedures, poorly controlled blood glucose could raise the risk of complications.”

In a commentary on Medscape, David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, urges clinicians to learn about the topic and inform patients when prescribing GLP-1 receptor agonists.

“These are new and changing issues. In our world as gastroenterologists, we should be considering – very strongly – mitigating strategies to protect the patients on this wonderful class of therapy,” he says. “Sometimes these drugs can have significant side effects that we need to at least be aware of. Nothing is perfect, but let us be better informed.”

“We really don’t know what the risks are yet. With endoscopy, they could be significant, but perhaps they’re not,” Jonathan Leighton, MD, a gastroenterologist with Mayo Clinic Arizona in Phoenix and president-elect of the American College of Gastroenterology (ACG), told this news organization. “There are a lot of factors that go into this, and we just want to proceed cautiously and carefully until we know more.”

The ACG, AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition released the statement on Aug. 11.

It was issued in response to recent guidance on the preoperative management of adults and children on GLP-1 receptor agonists put forth by the American Society of Anesthesiologists.

In a separate statement, the AGA stated that there is little, or no data on complications from aspiration.

“While there is anecdotal experience that increased gastroparesis risk may be dose dependent or related to whether it is being used for diabetes control versus weight loss, we also acknowledge that there is little, or no data related to the relative risk of complications from aspiration. As a result, the impact associated with stopping these therapies prior to undergoing upper GI endoscopy (EGD) or other moderate to deep sedated procedures is unknown at this time. 

“As clinical gastroenterologists and hepatologists, we are very familiar with safety issues regarding the performance of endoscopy in our patients suffering from gastroparesis as well as unexplained nausea, vomiting, and epigastric pain, particularly in emergency situations. As patient safety will always be paramount, and in the absence of actionable data, we encourage our members to exercise best practices when performing endoscopy on these patients who are taking GLP-1 receptor agonists. More data are needed to understand if and when these medications should be held prior to elective endoscopy. Given the need for further data regarding the emerging use of these novel compounds, we encourage our anesthesiology, endocrinology, and industry partners to work collaboratively with our members to develop the necessary evidence to appropriately inform medication adjustments prior to elective endoscopy.”

ASA recommendations

The ASA Task Force on Preoperative Fasting reviewed the available literature on GLP-1 receptor agonists and associated gastrointestinal adverse effects, including the consequences of delayed gastric emptying.

The task force acknowledges that the evidence to provide guidance for preoperative management of these drugs to prevent regurgitation and pulmonary aspiration of gastric contents is “sparse, limited only to several case reports.”

Nevertheless, given the concerns of GLP-1 receptor agonist–induced delayed gastric emptying and associated high risk for regurgitation and aspiration of gastric contents, the task force made these recommendations for elective procedures.

The day before the procedure

For patients on daily dosing, consider holding GLP-1 agonists on the day of the procedure/surgery. For patients on weekly dosing, consider holding GLP-1 agonists a week prior to the procedure/surgery.

This suggestion is irrespective of the indication (type 2 diabetes or weight loss), dose, or the type of procedure/surgery.

If GLP-1 agonists prescribed for diabetes are held for longer than the dosing schedule, consider consulting an endocrinologist for bridging the antidiabetic therapy to avoid hyperglycemia.

The day of the procedure

If GI symptoms such as severe nausea/vomiting/retching, abdominal bloating, or abdominal pain are present, consider delaying the elective procedure and discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

If the patient has no GI symptoms and the GLP-1 agonists have been held as advised, proceed as usual.

If the patient has no GI symptoms but the GLP-1 agonists were not held as advised, proceed with “full stomach” precautions or consider evaluating gastric volume by ultrasound, if possible and if proficient with the technique. If the stomach is empty, proceed as usual. If the stomach is full or if gastric ultrasound is inconclusive or not possible, consider delaying the procedure or treat the patient as “full stomach” and manage accordingly. Discuss the concerns of potential risk of regurgitation and pulmonary aspiration of gastric contents with the proceduralist/surgeon and the patient.

There is no evidence to suggest the optimal duration of fasting for patients on GLP-1 agonists. Therefore, until we have adequate evidence, we suggest following the current ASA fasting guidelines.

For patients on GLP-1 receptor agonists who need urgent or emergent procedures, the ASA advises proceeding and treating the patient as “full stomach” and managing accordingly.

Dr. Leighton has financial relationships with Olympus and Pfizer. Dr. Pickett-Blakely has no relevant disclosures. Dr. Johnson is an adviser to ISOTHRIVE and Johnson & Johnson.

This story was adapted for GI&Hepatology News from Medscape.

A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.

The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.

Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
 

Atrium Health

Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”

The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.

For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.

Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.

Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.

When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.

Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.

“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.

For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.

Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.

Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.

A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.

The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.

Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
 

Atrium Health

Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”

The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.

For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.

Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.

Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.

When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.

Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.

“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.

For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.

Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.

Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.

A new Clinical Practice Update from the AGA on belching, abdominal bloating, and distention offers practical management strategies for a class of disorders that, while highly prevalent, can be confusing to clinicians because of their nonspecific and overlapping symptomatology and wide range of possible causes.

The expert review, published online in Gastroenterology, is dedicated to these specific disorders, which, when not caused by bacteria, food intolerance, or autoimmune disease, are increasingly viewed as stemming from dysregulation of the brain-gut axis, and therefore responsive to interventions such as biofeedback therapy and central nervous system modulators, including antidepressants referred to as neuromodulators due to their pain modulating effects in the gut.

Baharak Moshiree, MD, of Atrium Health, Wake Forest Medical University, Charlotte, N.C., the lead author, said the guidance is aimed at GI specialists as much as primary care physicians and other providers who treat patients with these disorders.
 

Atrium Health

Clinicians may not always know which diagnostic studies to order for a patient with bloating, distention, or belching, Dr. Moshiree said, and since large randomized controlled trials in these patient groups are not available, making evidence-based treatment recommendations is challenging. Because the disorders are ubiquitous, “there’s a lot of social media attention around them, and these include fad diets and drugs labeled as medical foods, like probiotics, that patients will often try.”

The guidance includes 15 best practice advice statements along with two diagnostic and treatment algorithms, one for belching and the other for bloating and distention.

For belching, the authors stress discerning between gastric and supragastric belching using clinical history and examination, and if needed, impedance Ph monitoring. For supragastric belching, or esophageal belching, treatment considerations may include cognitive behavioral therapy, biofeedback training, and neuromodulator (antidepressant) drugs either alone or combined with psychological therapies.

Abdominal bloating and distention should be diagnosed using the Rome IV criteria, and in patients with suspected carbohydrate enzyme deficiencies, dietary restriction of potentially problematic carbohydrates or breath testing may be used to rule out intolerance. In a subset of at-risk patients, “small bowel aspiration and glucose- or lactulose-based hydrogen breath testing may be used to evaluate for small intestinal bacterial overgrowth,” the guidance says. Blood testing may be used to rule out celiac disease, and, if positive, a definitive diagnosis should be confirmed with small bowel tissue biopsy obtained during an upper endoscopy, Dr. Moshiree and her colleagues wrote.

Endoscopy and imaging should be restricted to patients with alarm features such as vomiting or weight loss, rapid worsening of symptoms, or an abnormal physical exam. Tests such as gastric emptying transit studies should not be routinely ordered unless nausea and vomiting are present. Similarly, whole-gut motility studies should be ordered only if there are symptoms suggestive of motility disorders, with testing carried out at specialized centers.

When constipation occurs with bloating, clinicians should use anorectal physiology testing to rule out a pelvic-floor disorder, which, if present, can be treated with pelvic floor biofeedback training. Constipation in the context of bloating may also be treated with laxatives. Probiotics are not advised as treatment for bloating and distention in this guidance, given a lack of robust studies. However, neuromodulators may help reduce visceral or gut hypersensitivity and improve psychological comorbidities if these are present, the authors wrote.

Conditions treated with dietary modifications should be overseen by dietitians, and diaphragmatic breathing and neuromodulators can be used to treat a condition called abdominophrenic dyssynergia, the guidance says.

“We tried to make it clinically useful,” Dr. Moshiree said of the practice update, which was not the result of systematic reviews or meta-analyses of multicenter randomized controlled trials. The update contains no ratings on its recommendations and does not grade the evidence used. Rather, the three coauthors looked to results from published randomized trials and observational studies, along with their own expert opinion.

For example, the guidance’s best practice advice on abdominophrenic dyssynergia came from single center studies in Italy where bloating improved with use of biofeedback therapy for this condition. Although this was a single center study, experts have found that biofeedback therapy is helpful for relaxing the pelvic floor muscles which can help bloating and distension symptoms.

Dr. Moshiree also pointed to a 2021 narrative review by Brian E. Lacy, MD. and David Cangemi, MD, of the Mayo Clinic in Jacksonville, Fla., that helped inform the framework for this clinical practice update.

Dr. Moshiree disclosed financial relationships with several pharmaceutical companies including Salix, AbbVie, Medtronic, and Takeda. Her two coauthors, Douglas Drossman, MD, of the Rome Foundation and the University of North Carolina, Chapel Hill, and Aasma Shaukat, MD, of New York University, also disclosed industry support.