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FDA okays first extravascular ICD system
which uses a single lead implanted substernally to allow antitachycardia pacing and low-energy defibrillation while avoiding the vascular space for lead placement.
“The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology,” Bradley P. Knight, MD, medical director of electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute, Chicago, said in a company news release.
“Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology,” said Dr. Knight, who was involved in the pivotal trial that led to U.S. approval.
The approval, which includes the system’s proprietary procedure implant tools, was supported by results from a global pivotal study that demonstrated the safety and effectiveness of the system.
Results of the study were presented at the annual meeting of the European Society of Cardiology in 2022.
The study enrolled 356 patients who were at risk of sudden cardiac death and who had a class I or IIa indication for ICD. Participants were enrolled at 46 sites in 17 countries.
The device’s effectiveness in delivering defibrillation therapy at implant (primary efficacy endpoint) was 98.7%, compared with a prespecified target of 88%.
There were no major intraprocedural complications, nor were any unique complications observed that were related to the EV ICD procedure or system, compared with transvenous and subcutaneous ICDs.
Additionally, 33 defibrillation shocks were avoided by having antitachycardia pacing programmed “on.”
At 6 months, 92.6% of patients (Kaplan-Meier estimate) were free from major system- and/or procedure-related major complications, such as hospitalization, system revision, or death.
The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, who have not previously undergone sternotomy, and who do not need long-term bradycardia pacing.
The Aurora EV-ICD system is similar in size, shape, and longevity to traditional transvenous ICDs.
Medtronic said the Aurora EV-ICD system will be commercially available on a limited basis in the United States in the coming weeks.
A version of this article first appeared on Medscape.com.
which uses a single lead implanted substernally to allow antitachycardia pacing and low-energy defibrillation while avoiding the vascular space for lead placement.
“The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology,” Bradley P. Knight, MD, medical director of electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute, Chicago, said in a company news release.
“Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology,” said Dr. Knight, who was involved in the pivotal trial that led to U.S. approval.
The approval, which includes the system’s proprietary procedure implant tools, was supported by results from a global pivotal study that demonstrated the safety and effectiveness of the system.
Results of the study were presented at the annual meeting of the European Society of Cardiology in 2022.
The study enrolled 356 patients who were at risk of sudden cardiac death and who had a class I or IIa indication for ICD. Participants were enrolled at 46 sites in 17 countries.
The device’s effectiveness in delivering defibrillation therapy at implant (primary efficacy endpoint) was 98.7%, compared with a prespecified target of 88%.
There were no major intraprocedural complications, nor were any unique complications observed that were related to the EV ICD procedure or system, compared with transvenous and subcutaneous ICDs.
Additionally, 33 defibrillation shocks were avoided by having antitachycardia pacing programmed “on.”
At 6 months, 92.6% of patients (Kaplan-Meier estimate) were free from major system- and/or procedure-related major complications, such as hospitalization, system revision, or death.
The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, who have not previously undergone sternotomy, and who do not need long-term bradycardia pacing.
The Aurora EV-ICD system is similar in size, shape, and longevity to traditional transvenous ICDs.
Medtronic said the Aurora EV-ICD system will be commercially available on a limited basis in the United States in the coming weeks.
A version of this article first appeared on Medscape.com.
which uses a single lead implanted substernally to allow antitachycardia pacing and low-energy defibrillation while avoiding the vascular space for lead placement.
“The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology,” Bradley P. Knight, MD, medical director of electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute, Chicago, said in a company news release.
“Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology,” said Dr. Knight, who was involved in the pivotal trial that led to U.S. approval.
The approval, which includes the system’s proprietary procedure implant tools, was supported by results from a global pivotal study that demonstrated the safety and effectiveness of the system.
Results of the study were presented at the annual meeting of the European Society of Cardiology in 2022.
The study enrolled 356 patients who were at risk of sudden cardiac death and who had a class I or IIa indication for ICD. Participants were enrolled at 46 sites in 17 countries.
The device’s effectiveness in delivering defibrillation therapy at implant (primary efficacy endpoint) was 98.7%, compared with a prespecified target of 88%.
There were no major intraprocedural complications, nor were any unique complications observed that were related to the EV ICD procedure or system, compared with transvenous and subcutaneous ICDs.
Additionally, 33 defibrillation shocks were avoided by having antitachycardia pacing programmed “on.”
At 6 months, 92.6% of patients (Kaplan-Meier estimate) were free from major system- and/or procedure-related major complications, such as hospitalization, system revision, or death.
The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, who have not previously undergone sternotomy, and who do not need long-term bradycardia pacing.
The Aurora EV-ICD system is similar in size, shape, and longevity to traditional transvenous ICDs.
Medtronic said the Aurora EV-ICD system will be commercially available on a limited basis in the United States in the coming weeks.
A version of this article first appeared on Medscape.com.
FDA approves fixed dose combination topical treatment for acne
vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.
The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.
The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.
Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.
The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.
vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.
The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.
The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.
Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.
The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.
vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.
The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.
The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.
Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.
The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.
COVID coronary plaque infection confirms CV risk
The findings may not only explain the link between COVID and the increased risk of cardiovascular events but mark a starting point for new therapeutic approaches.
“Our study shows there is persistence of viral debris in the artery,” senior investigator Chiara Giannarelli, MD, associate professor of medicine and pathology at NYU Langone Health, New York, said in an interview. “There is an important inflammatory response. We can now look at ways to control this inflammation,” she said.
Dr. Giannarelli says COVID is more than a respiratory virus and that it can affect the whole body. “Our study shows a remarkable ability of the virus to hijack the immune system,” she points out. “Our findings may explain how that happens.”
Dr. Giannarelli says it’s important for doctors and patients to be aware of an increased cardiovascular risk after a SARS-CoV-2 infection and to pay extra attention to traditional risk factors, such as blood pressure and cholesterol.
“This study showing that severe acute respiratory syndrome coronavirus directly infects coronary artery plaques, producing inflammatory substances, really joins the dots and helps our understanding on why we’re seeing so much heart disease in COVID patients,” Peter Hotez, MD, professor of molecular virology and microbiology at Baylor College of Medicine, Houston, said in an interview.
Asked whether this direct infection of vascular plaques was unique to SARS-CoV-2 or whether this may also occur with other viruses, both Dr. Giannarelli and Dr. Hotez said they believe this may be a specific COVID effect.
“I wouldn’t say it is likely that other viruses infect coronary arteries in this way, but I suppose it is possible,” Dr. Giannarelli said.
Dr. Hotez pointed out that other viruses can cause inflammation in the heart, such as myocarditis. “But I can’t think of another virus that stimulates the sequence of events in coronary artery inflammation like we’re seeing here.”
Dr. Giannarelli noted that influenza is also associated with an increased risk of cardiovascular events, but there has been no evidence to date that it directly affects coronary arteries.
Dr. Hotez added that the increased risk of cardiovascular events with influenza has also been reported to be prolonged after the acute infection. “These new findings with SARS-CoV-2 could stimulate a redoubling of efforts to look at this possibility with influenza,” he suggested.
Heart disease after COVID
In a recent article published online in Nature Cardiovascular Research, Dr. Giannarelli and colleagues analyzed human autopsy tissue samples from coronary arterial walls of patients who had died from COVID in the early stages of the pandemic in New York.
They found an accumulation of viral RNA in atherosclerotic plaques in the coronary arteries, which was particularly concentrated in lipid-rich macrophage foam cells present within the plaques.
“Our data conclusively demonstrate that severe acute respiratory syndrome coronavirus is capable of infecting and replicating in macrophages within the coronary vasculature,” the researchers report.
The virus preferentially replicates in foam cells, in comparison with other macrophages, they add, suggesting that these cells might act as a reservoir of viral debris in atherosclerotic plaque.
“We have shown that the virus is targeting lipid-rich macrophages in atherosclerotic lesions. This is the first time this has been shown, and we think this is a very important finding,” Dr. Giannarelli said in an interview.
“We also found that the virus persists in these foam cells that could be responsible for long-term, low-grade inflammation in the vasculature that could contribute to the long-term cardiovascular manifestations in patients who have recovered from COVID,” she said.
Viral reservoirs
Macrophages residing in vascular tissue can undergo self-renewal and can remain in the tissue for many years, the investigators point out. They suggest that these macrophages may act as viral reservoirs of SARS-CoV-2 RNA in atherosclerotic plaques.
Using an ex vivo model, the researchers also found that atherosclerotic tissue could be directly infected by the virus. And just as was seen in cultured macrophages and foam cells, infection of vascular tissue triggered an inflammatory response. That response induced the secretion of key proatherogenic cytokines, such as interleukin-6 and interleukin-1 beta, which have been implicated in the pathogenesis of atherosclerosis and in an increased risk of cardiovascular events.
“Considering that plaque inflammation promotes disease progression and contributes to plaque rupture, our results provide a molecular basis for how infection of coronary lesions can contribute to the acute cardiovascular manifestations of COVID-19, such as myocardial infarction,” the researchers report.
Another interesting finding was a higher accumulation of viral RNA in the coronary vasculature of the three patients with acute ischemic cardiovascular manifestations, which they say adds to evidence that infection may increase cardiovascular risk.
Dr. Giannarelli points out that the patients in their study died in New York early in the pandemic, before vaccines were available. “They were unvaccinated and likely had little immunity against initial viral strains.”
Dr. Hotez says that when COVID-19 first emerged, many in the medical and scientific communities thought it would closely resemble the original SARS viral infection, which was primarily a respiratory pathogen.
“But it became pretty clear early on this virus was causing a lot of cardiovascular and thromboembolic disease,” he says. “This study provides an insight into the mechanisms involved here.”
Affecting more than lungs
Dr. Hotez pointed out that a recent study reported a 5% increase in cardiovascular deaths during the years 2020-2022, compared with before the pandemic.
“Those peaks of cardiovascular deaths corresponded with specific waves of COVID – the first happening at the time of the initial wave with the original virus and second during the Delta wave. So, there’s no question that this virus is contributing to excess cardiovascular mortality, and this paper appears to explain the mechanism.”
Dr. Hotez pointed out that the new findings suggest the cardiovascular risk may be prolonged well after the acute infection resolves.
“In long COVID, a lot of people focus on the neurological effects – brain fog and depression. But cardiac insufficiency and other cardiovascular events can also be considered another element of long COVID,” he said.
Dr. Giannarelli says her group is now studying whether patients with long COVID have virus in their coronary arteries. She points out that the current studies were a result of a team effort between experts in cardiovascular disease and virology and infectious disease. “We need to collaborate more like this to understand better the impact of viral infection in patients and the clinical manifestations,” she said.
Dr. Hotez says he believes these new findings will have implications for the future.
“COVID hasn’t gone away. The numbers have been going up again steadily in the U.S. in the last few months. There are still a significant number of hospitalizations,” he said.
While it would be unwieldy to ask for a cardiology consult for every COVID patient, he acknowledged, “there is probably a subset of people – possibly those of older age and who have had a severe case of COVID – who we suspect are now going to be more prone to cardiovascular disease because of having COVID.
“We should be vigilant in looking for cardiovascular disease in these patients,” Dr. Hotez said, “and perhaps be a bit more aggressive about controlling their cardiovascular risk factors.”
The study was funded by the U.S. National Institutes of Health, the American Heart Association, and the Chan Zuckerberg Initiative.
A version of this article first appeared on Medscape.com .
The findings may not only explain the link between COVID and the increased risk of cardiovascular events but mark a starting point for new therapeutic approaches.
“Our study shows there is persistence of viral debris in the artery,” senior investigator Chiara Giannarelli, MD, associate professor of medicine and pathology at NYU Langone Health, New York, said in an interview. “There is an important inflammatory response. We can now look at ways to control this inflammation,” she said.
Dr. Giannarelli says COVID is more than a respiratory virus and that it can affect the whole body. “Our study shows a remarkable ability of the virus to hijack the immune system,” she points out. “Our findings may explain how that happens.”
Dr. Giannarelli says it’s important for doctors and patients to be aware of an increased cardiovascular risk after a SARS-CoV-2 infection and to pay extra attention to traditional risk factors, such as blood pressure and cholesterol.
“This study showing that severe acute respiratory syndrome coronavirus directly infects coronary artery plaques, producing inflammatory substances, really joins the dots and helps our understanding on why we’re seeing so much heart disease in COVID patients,” Peter Hotez, MD, professor of molecular virology and microbiology at Baylor College of Medicine, Houston, said in an interview.
Asked whether this direct infection of vascular plaques was unique to SARS-CoV-2 or whether this may also occur with other viruses, both Dr. Giannarelli and Dr. Hotez said they believe this may be a specific COVID effect.
“I wouldn’t say it is likely that other viruses infect coronary arteries in this way, but I suppose it is possible,” Dr. Giannarelli said.
Dr. Hotez pointed out that other viruses can cause inflammation in the heart, such as myocarditis. “But I can’t think of another virus that stimulates the sequence of events in coronary artery inflammation like we’re seeing here.”
Dr. Giannarelli noted that influenza is also associated with an increased risk of cardiovascular events, but there has been no evidence to date that it directly affects coronary arteries.
Dr. Hotez added that the increased risk of cardiovascular events with influenza has also been reported to be prolonged after the acute infection. “These new findings with SARS-CoV-2 could stimulate a redoubling of efforts to look at this possibility with influenza,” he suggested.
Heart disease after COVID
In a recent article published online in Nature Cardiovascular Research, Dr. Giannarelli and colleagues analyzed human autopsy tissue samples from coronary arterial walls of patients who had died from COVID in the early stages of the pandemic in New York.
They found an accumulation of viral RNA in atherosclerotic plaques in the coronary arteries, which was particularly concentrated in lipid-rich macrophage foam cells present within the plaques.
“Our data conclusively demonstrate that severe acute respiratory syndrome coronavirus is capable of infecting and replicating in macrophages within the coronary vasculature,” the researchers report.
The virus preferentially replicates in foam cells, in comparison with other macrophages, they add, suggesting that these cells might act as a reservoir of viral debris in atherosclerotic plaque.
“We have shown that the virus is targeting lipid-rich macrophages in atherosclerotic lesions. This is the first time this has been shown, and we think this is a very important finding,” Dr. Giannarelli said in an interview.
“We also found that the virus persists in these foam cells that could be responsible for long-term, low-grade inflammation in the vasculature that could contribute to the long-term cardiovascular manifestations in patients who have recovered from COVID,” she said.
Viral reservoirs
Macrophages residing in vascular tissue can undergo self-renewal and can remain in the tissue for many years, the investigators point out. They suggest that these macrophages may act as viral reservoirs of SARS-CoV-2 RNA in atherosclerotic plaques.
Using an ex vivo model, the researchers also found that atherosclerotic tissue could be directly infected by the virus. And just as was seen in cultured macrophages and foam cells, infection of vascular tissue triggered an inflammatory response. That response induced the secretion of key proatherogenic cytokines, such as interleukin-6 and interleukin-1 beta, which have been implicated in the pathogenesis of atherosclerosis and in an increased risk of cardiovascular events.
“Considering that plaque inflammation promotes disease progression and contributes to plaque rupture, our results provide a molecular basis for how infection of coronary lesions can contribute to the acute cardiovascular manifestations of COVID-19, such as myocardial infarction,” the researchers report.
Another interesting finding was a higher accumulation of viral RNA in the coronary vasculature of the three patients with acute ischemic cardiovascular manifestations, which they say adds to evidence that infection may increase cardiovascular risk.
Dr. Giannarelli points out that the patients in their study died in New York early in the pandemic, before vaccines were available. “They were unvaccinated and likely had little immunity against initial viral strains.”
Dr. Hotez says that when COVID-19 first emerged, many in the medical and scientific communities thought it would closely resemble the original SARS viral infection, which was primarily a respiratory pathogen.
“But it became pretty clear early on this virus was causing a lot of cardiovascular and thromboembolic disease,” he says. “This study provides an insight into the mechanisms involved here.”
Affecting more than lungs
Dr. Hotez pointed out that a recent study reported a 5% increase in cardiovascular deaths during the years 2020-2022, compared with before the pandemic.
“Those peaks of cardiovascular deaths corresponded with specific waves of COVID – the first happening at the time of the initial wave with the original virus and second during the Delta wave. So, there’s no question that this virus is contributing to excess cardiovascular mortality, and this paper appears to explain the mechanism.”
Dr. Hotez pointed out that the new findings suggest the cardiovascular risk may be prolonged well after the acute infection resolves.
“In long COVID, a lot of people focus on the neurological effects – brain fog and depression. But cardiac insufficiency and other cardiovascular events can also be considered another element of long COVID,” he said.
Dr. Giannarelli says her group is now studying whether patients with long COVID have virus in their coronary arteries. She points out that the current studies were a result of a team effort between experts in cardiovascular disease and virology and infectious disease. “We need to collaborate more like this to understand better the impact of viral infection in patients and the clinical manifestations,” she said.
Dr. Hotez says he believes these new findings will have implications for the future.
“COVID hasn’t gone away. The numbers have been going up again steadily in the U.S. in the last few months. There are still a significant number of hospitalizations,” he said.
While it would be unwieldy to ask for a cardiology consult for every COVID patient, he acknowledged, “there is probably a subset of people – possibly those of older age and who have had a severe case of COVID – who we suspect are now going to be more prone to cardiovascular disease because of having COVID.
“We should be vigilant in looking for cardiovascular disease in these patients,” Dr. Hotez said, “and perhaps be a bit more aggressive about controlling their cardiovascular risk factors.”
The study was funded by the U.S. National Institutes of Health, the American Heart Association, and the Chan Zuckerberg Initiative.
A version of this article first appeared on Medscape.com .
The findings may not only explain the link between COVID and the increased risk of cardiovascular events but mark a starting point for new therapeutic approaches.
“Our study shows there is persistence of viral debris in the artery,” senior investigator Chiara Giannarelli, MD, associate professor of medicine and pathology at NYU Langone Health, New York, said in an interview. “There is an important inflammatory response. We can now look at ways to control this inflammation,” she said.
Dr. Giannarelli says COVID is more than a respiratory virus and that it can affect the whole body. “Our study shows a remarkable ability of the virus to hijack the immune system,” she points out. “Our findings may explain how that happens.”
Dr. Giannarelli says it’s important for doctors and patients to be aware of an increased cardiovascular risk after a SARS-CoV-2 infection and to pay extra attention to traditional risk factors, such as blood pressure and cholesterol.
“This study showing that severe acute respiratory syndrome coronavirus directly infects coronary artery plaques, producing inflammatory substances, really joins the dots and helps our understanding on why we’re seeing so much heart disease in COVID patients,” Peter Hotez, MD, professor of molecular virology and microbiology at Baylor College of Medicine, Houston, said in an interview.
Asked whether this direct infection of vascular plaques was unique to SARS-CoV-2 or whether this may also occur with other viruses, both Dr. Giannarelli and Dr. Hotez said they believe this may be a specific COVID effect.
“I wouldn’t say it is likely that other viruses infect coronary arteries in this way, but I suppose it is possible,” Dr. Giannarelli said.
Dr. Hotez pointed out that other viruses can cause inflammation in the heart, such as myocarditis. “But I can’t think of another virus that stimulates the sequence of events in coronary artery inflammation like we’re seeing here.”
Dr. Giannarelli noted that influenza is also associated with an increased risk of cardiovascular events, but there has been no evidence to date that it directly affects coronary arteries.
Dr. Hotez added that the increased risk of cardiovascular events with influenza has also been reported to be prolonged after the acute infection. “These new findings with SARS-CoV-2 could stimulate a redoubling of efforts to look at this possibility with influenza,” he suggested.
Heart disease after COVID
In a recent article published online in Nature Cardiovascular Research, Dr. Giannarelli and colleagues analyzed human autopsy tissue samples from coronary arterial walls of patients who had died from COVID in the early stages of the pandemic in New York.
They found an accumulation of viral RNA in atherosclerotic plaques in the coronary arteries, which was particularly concentrated in lipid-rich macrophage foam cells present within the plaques.
“Our data conclusively demonstrate that severe acute respiratory syndrome coronavirus is capable of infecting and replicating in macrophages within the coronary vasculature,” the researchers report.
The virus preferentially replicates in foam cells, in comparison with other macrophages, they add, suggesting that these cells might act as a reservoir of viral debris in atherosclerotic plaque.
“We have shown that the virus is targeting lipid-rich macrophages in atherosclerotic lesions. This is the first time this has been shown, and we think this is a very important finding,” Dr. Giannarelli said in an interview.
“We also found that the virus persists in these foam cells that could be responsible for long-term, low-grade inflammation in the vasculature that could contribute to the long-term cardiovascular manifestations in patients who have recovered from COVID,” she said.
Viral reservoirs
Macrophages residing in vascular tissue can undergo self-renewal and can remain in the tissue for many years, the investigators point out. They suggest that these macrophages may act as viral reservoirs of SARS-CoV-2 RNA in atherosclerotic plaques.
Using an ex vivo model, the researchers also found that atherosclerotic tissue could be directly infected by the virus. And just as was seen in cultured macrophages and foam cells, infection of vascular tissue triggered an inflammatory response. That response induced the secretion of key proatherogenic cytokines, such as interleukin-6 and interleukin-1 beta, which have been implicated in the pathogenesis of atherosclerosis and in an increased risk of cardiovascular events.
“Considering that plaque inflammation promotes disease progression and contributes to plaque rupture, our results provide a molecular basis for how infection of coronary lesions can contribute to the acute cardiovascular manifestations of COVID-19, such as myocardial infarction,” the researchers report.
Another interesting finding was a higher accumulation of viral RNA in the coronary vasculature of the three patients with acute ischemic cardiovascular manifestations, which they say adds to evidence that infection may increase cardiovascular risk.
Dr. Giannarelli points out that the patients in their study died in New York early in the pandemic, before vaccines were available. “They were unvaccinated and likely had little immunity against initial viral strains.”
Dr. Hotez says that when COVID-19 first emerged, many in the medical and scientific communities thought it would closely resemble the original SARS viral infection, which was primarily a respiratory pathogen.
“But it became pretty clear early on this virus was causing a lot of cardiovascular and thromboembolic disease,” he says. “This study provides an insight into the mechanisms involved here.”
Affecting more than lungs
Dr. Hotez pointed out that a recent study reported a 5% increase in cardiovascular deaths during the years 2020-2022, compared with before the pandemic.
“Those peaks of cardiovascular deaths corresponded with specific waves of COVID – the first happening at the time of the initial wave with the original virus and second during the Delta wave. So, there’s no question that this virus is contributing to excess cardiovascular mortality, and this paper appears to explain the mechanism.”
Dr. Hotez pointed out that the new findings suggest the cardiovascular risk may be prolonged well after the acute infection resolves.
“In long COVID, a lot of people focus on the neurological effects – brain fog and depression. But cardiac insufficiency and other cardiovascular events can also be considered another element of long COVID,” he said.
Dr. Giannarelli says her group is now studying whether patients with long COVID have virus in their coronary arteries. She points out that the current studies were a result of a team effort between experts in cardiovascular disease and virology and infectious disease. “We need to collaborate more like this to understand better the impact of viral infection in patients and the clinical manifestations,” she said.
Dr. Hotez says he believes these new findings will have implications for the future.
“COVID hasn’t gone away. The numbers have been going up again steadily in the U.S. in the last few months. There are still a significant number of hospitalizations,” he said.
While it would be unwieldy to ask for a cardiology consult for every COVID patient, he acknowledged, “there is probably a subset of people – possibly those of older age and who have had a severe case of COVID – who we suspect are now going to be more prone to cardiovascular disease because of having COVID.
“We should be vigilant in looking for cardiovascular disease in these patients,” Dr. Hotez said, “and perhaps be a bit more aggressive about controlling their cardiovascular risk factors.”
The study was funded by the U.S. National Institutes of Health, the American Heart Association, and the Chan Zuckerberg Initiative.
A version of this article first appeared on Medscape.com .
FROM NATURE CARDIOVASCULAR RESEARCH
How Does Military Service Impact Cancer Risk? It’s Complicated
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
CHICAGO—While it’s extremely difficult to link cancer rates to military service, researchers are starting to get some initial inklings of possible connections, a US Department of Veterans Affairs (VA) oncologist told an audience at the 2023 annual meeting of the Association of VA Hematology/Oncology.
One study found surprising levels of abnormal proteins and cancer in the blood of service members, said Christin DeStefano, MD, of David Grant US Air Force Medical Center at Travis Air Force Base in California. Another may have uncovered a link between military trauma and lymphoma. And an analysis of pilots found they have higher rates of certain kinds of cancer— but lower levels of other cancer types.
“It is hard to tell if service-related exposures heighten the risk of cancer. Some aspects of military service might increase cancer risk,” DeStefano said. “But other aspects of military service might decrease cancer risk.”
The VA has been especially focused on the possible link between military service and cancer since the passage of the PACT Act in 2022. The legislation prioritizes claims for cancer, terminal illnesses, and homelessness, and it’s sparked more than 4.1 million free toxic-exposure screenings for veterans.
VA Under Secretary for Health Shereef Elnahal, MD, MBA, noted in the keynote address at the 2023 AVAHO annual meeting that “Every type of solid tumor is now considered a presumptive condition associated with burden of exposure to veterans deployed anywhere in Central Command, either in the Persian Gulf War or the post-9/11 conflicts.”
DeStefano noted that there are a variety of challenges to analyzing data regarding connections between military exposure and cancer. For one, “it’s hard to include people from the time they enter the military to postmilitary service. Some are getting their health care in the civilian health care systems.” In addition, “There are a lot of problems with ICD-9 and ICD-10 codes, which can be very erroneous. Maybe somebody came in with a mass, the doctor or the nurse practitioner was busy and they put down ‘suspected cancer,’ and now they have that ICD code in their chart where they never actually had cancer.” This is why more reliable cancer registries are so important, she said.
Another challenge is figuring out when exposures occurred and whether they actually occurred in the military at all. “There are multiple studies suggesting that a first driver event is often acquired 20 to 40 years before a cancer diagnosis, often in one’s 20s and 30s,” she said. “It's hard to quantify an exposure, since there can be exposures before military service and exposures after military service. The amount of exposure and duration of exposure might differ, and individuals might metabolize the exposures differently from each other.”
To make matters more complicated, research is pointing in surprising directions. DeStefano highlighted her not-yet-published study of monoclonal gammopathy (MG), a condition in which abnormal proteins are found in the blood, in 534 service members. MG can be a cancer precursor. Those exposed to burn pits in Iraq had similar risks of MG (6.7%) vs an unexposed, matched control group (5.4%; P = .22), Dr. DeStefano said. Over a mean follow-up of 14 years and 10 years, respectively, 7% of participants in each group developed cancer.
“You might think, ‘this is a negative study. There's no difference.’ However, it is very notable that the prevalence of monoclonal gammopathy was 6.1%. That is 3 times as high as we would expect in somebody in their 40s,” she said. “Also, 7% having a cancer diagnosis is not insignificant.” She added: “It is very possible that many of these service members already have full-blown multiple myeloma or something associated with monoclonal gammopathy that just has not been diagnosed yet.”
In another study, this one published in 2021, Dr. DeStefano and colleagues tracked 8834 injured Iraq/Afghanistan veterans and compared them with matched controls to see if there was a link between severe trauma and cancer. There wasn’t except for lymphoma (22 vs 7 cases, respectively; odds ratio = 3.1; 95% CI, 1.34-7.37; P = .008). The connection remained after adjustment for confounders.
What’s going on? “It’s possible that blast injury might induce some alterations to the immune system that might set the stage for lymphoma genesis,” she said. “Or maybe that blast injury is a surrogate for a toxic exposure: Maybe carcinogens are released during a blast injury.”
Dr. DeStefano also highlighted a 2022 study that tracked 386,190 Air Force officers. The study found that combat pilots (9.1% of the total) had greater adjusted odds of testicular and prostate cancers and melanoma than the other officers. Why? “Military pilots have exposure to cosmic ionizing radiation as well as ultraviolet radiation,” she said.
But while “these are scary, sobering things,” she noted that combat pilots were less likely to develop several cancers than the general population, including kidney, testicular, colorectal, bladder and thyroid cancer, and they were less likely to die from colorectal cancer.
Recombinant IL-2 shows potential in atopic dermatitis
BERLIN – A novel regulatory T cell–stimulating therapy appears to significantly improve atopic dermatitis in patients with moderate to severe disease and may even benefit quality of life, suggest results from a phase 1b trial.
The research was presented at the annual congress of the European Academy of Dermatology and Venereology.
, after which responders were observed out to 48 weeks. The higher dosage was associated with significant improvements in Eczema Area and Severity Index (EASI) and Body Surface Area (BSA) scores, which were maintained over the course of the study, as well as trends for improved patient-reported outcomes.
“This is the first study to demonstrate the therapeutic potential of rezpegaldesleukin,” said presenter Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at George Washington University, Washington. He added, “These may be some of the most compelling data to date for the field, proving that, at a high level, if you causally increase regulator T cells, you will take down inflammation and improve a disease state.
“For me, this is proof of concept for so many things, and it gets me very excited.”
Dr. Silverberg noted that with the response maintained out to 48 weeks, despite stopping therapy at week 12, the “hope” with the approach of inducing regulator T cells “is that we could induce tolerance and that we could have some potential for disease modification.”
He continued, “Maybe I daren’t use the word ‘cure,’ but can we at least get to something that is truly remitted, where they can stop the drug and maintain that response?”
Dr. Silverberg said rezpegaldesleukin is now being evaluated in a phase 2b study for moderate to severe atopic dermatitis, and a phase 2b trial for alopecia areata is in development.
Tiago dos Reis Matos, MD, PhD, MSc, Amsterdam University Medical Centers, who was not involved in the study, told this news organization that “recombinant human interleukin-2 is an original therapy.”
Instead of blocking or inhibiting inflammation, it stimulates the patient’s immune system to “restore a healthy balance.”
He explained that it “stimulates regulatory T cells, which can be seen as the Peace Corps of the immune system, responsible for maintaining the equilibrium and avoiding uncontrolled inflammation.”
At the meeting, Dr. Silverberg told the audience that although they are the “beneficiaries of riches of new advances” in atopic dermatitis, “still, many observational studies have shown that the majority of patients do not achieve adequate control by the end of their induction periods and clinical trials, in the real world,” with currently available treatments.
Moreover, “there are challenges that come up with any of the different therapies,” he said, with adverse effects an important issue. For example, biologic therapies are associated with conjunctivitis, facial erythema, and arthralgia, and there are boxed warnings for Janus kinase inhibitors.
Dr. Silverberg continued, “Even patients with a favorable response can experience a loss of disease control when they come off therapy.” Consequently, “new strategies are certainly welcome that could potentially induce both deep and potentially therapy-free remission.”
To those ends, he explained that regulatory T cells play a central role in immune homeostasis but have not been “therapeutically relevant until very recently,” when it was posited that increasing their function can “induce that homeostasis, to normalize the inflammatory cascades” seen in a range of conditions, including atopic dermatitis.
Rezpegaldesleukin has high selectivity for regulatory T cells, without causing activation of effector T cells, and has been shown to increase cell numbers in a dose-dependent manner that is sustained for up to 30 days.
The current study involved patients aged 18-70 years with moderate to severe atopic dermatitis and a history of inadequate responses or intolerance to topical medications, and an EASI score ≥ 16.
Participants were randomly assigned to receive subcutaneous rezpegaldesleukin 12 mcg/kg or 24 mcg/kg or placebo every 2 weeks for 12 weeks. They then discontinued treatment and were followed up until week 19, when responders, defined as having a reduction in EASI score ≥ 50%, continued follow-up out to week 48.
Seventeen patients were randomized to higher-dose rezpegaldesleukin, whereas 16 received the lower dose and 10 were assigned to placebo. Dr. Silverberg said that the three groups were “fairly well balanced,” with “fairly good representation” across age, race, and ethnicity groups.
The mean baseline EASI score was between 21.9 and 23.7, and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) suggested that there was an even split between moderate and severe atopic dermatitis, although the higher-dose rezpegaldesleukin group had more patients with moderate disease.
By week 12, rezpegaldesleukin was associated with significantly greater improvements in EASI scores vs. placebo. Patients on the higher dose had a mean 83% improvement over baseline vs. 65% with the lower dose and 47% with placebo (P = .002 for the higher dose vs. placebo).
Crucially, these differences were maintained up to week 48 in patients, particularly in the higher-dose group.
There was also a nonsignificant increase in the proportion of patients who achieved a reduction in EASI scores ≥ 75% over baseline with the active drug: 41% at week 12 with higher-dose rezpegaldesleukin, 25% with the lower dose, and 20% with placebo. Again, the benefit was maintained up to week 48.
The mean improvement in BSA score from baseline with rezpegaldesleukin was significantly greater than that seen with placebo, at 72% with the higher dose, 55% with the lower dose, and 36% with placebo (P = .0158 for the higher dose vs. placebo).
Although improvements in vIGA-AD scores over baseline with rezpegaldesleukin were not substantial at week 12, by week 48 there was a marked difference between higher-dose rezpegaldesleukin and placebo, with 40.0% of patients responding to the drug vs. 0% in the latter group.
A similar pattern was seen for the Itch Numeric Rating Scale, in which 55.6% of patients treated with higher-dose rezpegaldesleukin responding by week 48, compared with 0% of those who received placebo.
Greater improvements in the Dermatology Life Quality Index (DLQI) and Patient Oriented Eczema Measure (POEM) over baseline with higher-dose rezpegaldesleukin vs. plain placebo were also noted, despite a strong response in the latter group.
Dr. Silverberg reported that all treatment-emergent adverse effects in the two rezpegaldesleukin treatment arms were mild to moderate, with no severe or serious events observed.
The most common adverse events were mild to moderate injection-site reactions, seen in 75.0% of the lower-dose rezpegaldesleukin group and 58.8% the of higher-dose group. There were no cases of conjunctivitis.
The study was sponsored by Eli Lilly and Company in collaboration with Nektar Therapeutics.
Dr. Silverberg declares relationships with AbbVie, Alamar, Aldena, Amgen, AOBiome, Arcutis, Arena, Asana, ASLAN, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, DermTech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, LEO Pharma, Nektar, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, Target RWE, Union, and UpToDate.
A version of this article appeared on Medscape.com.
BERLIN – A novel regulatory T cell–stimulating therapy appears to significantly improve atopic dermatitis in patients with moderate to severe disease and may even benefit quality of life, suggest results from a phase 1b trial.
The research was presented at the annual congress of the European Academy of Dermatology and Venereology.
, after which responders were observed out to 48 weeks. The higher dosage was associated with significant improvements in Eczema Area and Severity Index (EASI) and Body Surface Area (BSA) scores, which were maintained over the course of the study, as well as trends for improved patient-reported outcomes.
“This is the first study to demonstrate the therapeutic potential of rezpegaldesleukin,” said presenter Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at George Washington University, Washington. He added, “These may be some of the most compelling data to date for the field, proving that, at a high level, if you causally increase regulator T cells, you will take down inflammation and improve a disease state.
“For me, this is proof of concept for so many things, and it gets me very excited.”
Dr. Silverberg noted that with the response maintained out to 48 weeks, despite stopping therapy at week 12, the “hope” with the approach of inducing regulator T cells “is that we could induce tolerance and that we could have some potential for disease modification.”
He continued, “Maybe I daren’t use the word ‘cure,’ but can we at least get to something that is truly remitted, where they can stop the drug and maintain that response?”
Dr. Silverberg said rezpegaldesleukin is now being evaluated in a phase 2b study for moderate to severe atopic dermatitis, and a phase 2b trial for alopecia areata is in development.
Tiago dos Reis Matos, MD, PhD, MSc, Amsterdam University Medical Centers, who was not involved in the study, told this news organization that “recombinant human interleukin-2 is an original therapy.”
Instead of blocking or inhibiting inflammation, it stimulates the patient’s immune system to “restore a healthy balance.”
He explained that it “stimulates regulatory T cells, which can be seen as the Peace Corps of the immune system, responsible for maintaining the equilibrium and avoiding uncontrolled inflammation.”
At the meeting, Dr. Silverberg told the audience that although they are the “beneficiaries of riches of new advances” in atopic dermatitis, “still, many observational studies have shown that the majority of patients do not achieve adequate control by the end of their induction periods and clinical trials, in the real world,” with currently available treatments.
Moreover, “there are challenges that come up with any of the different therapies,” he said, with adverse effects an important issue. For example, biologic therapies are associated with conjunctivitis, facial erythema, and arthralgia, and there are boxed warnings for Janus kinase inhibitors.
Dr. Silverberg continued, “Even patients with a favorable response can experience a loss of disease control when they come off therapy.” Consequently, “new strategies are certainly welcome that could potentially induce both deep and potentially therapy-free remission.”
To those ends, he explained that regulatory T cells play a central role in immune homeostasis but have not been “therapeutically relevant until very recently,” when it was posited that increasing their function can “induce that homeostasis, to normalize the inflammatory cascades” seen in a range of conditions, including atopic dermatitis.
Rezpegaldesleukin has high selectivity for regulatory T cells, without causing activation of effector T cells, and has been shown to increase cell numbers in a dose-dependent manner that is sustained for up to 30 days.
The current study involved patients aged 18-70 years with moderate to severe atopic dermatitis and a history of inadequate responses or intolerance to topical medications, and an EASI score ≥ 16.
Participants were randomly assigned to receive subcutaneous rezpegaldesleukin 12 mcg/kg or 24 mcg/kg or placebo every 2 weeks for 12 weeks. They then discontinued treatment and were followed up until week 19, when responders, defined as having a reduction in EASI score ≥ 50%, continued follow-up out to week 48.
Seventeen patients were randomized to higher-dose rezpegaldesleukin, whereas 16 received the lower dose and 10 were assigned to placebo. Dr. Silverberg said that the three groups were “fairly well balanced,” with “fairly good representation” across age, race, and ethnicity groups.
The mean baseline EASI score was between 21.9 and 23.7, and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) suggested that there was an even split between moderate and severe atopic dermatitis, although the higher-dose rezpegaldesleukin group had more patients with moderate disease.
By week 12, rezpegaldesleukin was associated with significantly greater improvements in EASI scores vs. placebo. Patients on the higher dose had a mean 83% improvement over baseline vs. 65% with the lower dose and 47% with placebo (P = .002 for the higher dose vs. placebo).
Crucially, these differences were maintained up to week 48 in patients, particularly in the higher-dose group.
There was also a nonsignificant increase in the proportion of patients who achieved a reduction in EASI scores ≥ 75% over baseline with the active drug: 41% at week 12 with higher-dose rezpegaldesleukin, 25% with the lower dose, and 20% with placebo. Again, the benefit was maintained up to week 48.
The mean improvement in BSA score from baseline with rezpegaldesleukin was significantly greater than that seen with placebo, at 72% with the higher dose, 55% with the lower dose, and 36% with placebo (P = .0158 for the higher dose vs. placebo).
Although improvements in vIGA-AD scores over baseline with rezpegaldesleukin were not substantial at week 12, by week 48 there was a marked difference between higher-dose rezpegaldesleukin and placebo, with 40.0% of patients responding to the drug vs. 0% in the latter group.
A similar pattern was seen for the Itch Numeric Rating Scale, in which 55.6% of patients treated with higher-dose rezpegaldesleukin responding by week 48, compared with 0% of those who received placebo.
Greater improvements in the Dermatology Life Quality Index (DLQI) and Patient Oriented Eczema Measure (POEM) over baseline with higher-dose rezpegaldesleukin vs. plain placebo were also noted, despite a strong response in the latter group.
Dr. Silverberg reported that all treatment-emergent adverse effects in the two rezpegaldesleukin treatment arms were mild to moderate, with no severe or serious events observed.
The most common adverse events were mild to moderate injection-site reactions, seen in 75.0% of the lower-dose rezpegaldesleukin group and 58.8% the of higher-dose group. There were no cases of conjunctivitis.
The study was sponsored by Eli Lilly and Company in collaboration with Nektar Therapeutics.
Dr. Silverberg declares relationships with AbbVie, Alamar, Aldena, Amgen, AOBiome, Arcutis, Arena, Asana, ASLAN, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, DermTech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, LEO Pharma, Nektar, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, Target RWE, Union, and UpToDate.
A version of this article appeared on Medscape.com.
BERLIN – A novel regulatory T cell–stimulating therapy appears to significantly improve atopic dermatitis in patients with moderate to severe disease and may even benefit quality of life, suggest results from a phase 1b trial.
The research was presented at the annual congress of the European Academy of Dermatology and Venereology.
, after which responders were observed out to 48 weeks. The higher dosage was associated with significant improvements in Eczema Area and Severity Index (EASI) and Body Surface Area (BSA) scores, which were maintained over the course of the study, as well as trends for improved patient-reported outcomes.
“This is the first study to demonstrate the therapeutic potential of rezpegaldesleukin,” said presenter Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at George Washington University, Washington. He added, “These may be some of the most compelling data to date for the field, proving that, at a high level, if you causally increase regulator T cells, you will take down inflammation and improve a disease state.
“For me, this is proof of concept for so many things, and it gets me very excited.”
Dr. Silverberg noted that with the response maintained out to 48 weeks, despite stopping therapy at week 12, the “hope” with the approach of inducing regulator T cells “is that we could induce tolerance and that we could have some potential for disease modification.”
He continued, “Maybe I daren’t use the word ‘cure,’ but can we at least get to something that is truly remitted, where they can stop the drug and maintain that response?”
Dr. Silverberg said rezpegaldesleukin is now being evaluated in a phase 2b study for moderate to severe atopic dermatitis, and a phase 2b trial for alopecia areata is in development.
Tiago dos Reis Matos, MD, PhD, MSc, Amsterdam University Medical Centers, who was not involved in the study, told this news organization that “recombinant human interleukin-2 is an original therapy.”
Instead of blocking or inhibiting inflammation, it stimulates the patient’s immune system to “restore a healthy balance.”
He explained that it “stimulates regulatory T cells, which can be seen as the Peace Corps of the immune system, responsible for maintaining the equilibrium and avoiding uncontrolled inflammation.”
At the meeting, Dr. Silverberg told the audience that although they are the “beneficiaries of riches of new advances” in atopic dermatitis, “still, many observational studies have shown that the majority of patients do not achieve adequate control by the end of their induction periods and clinical trials, in the real world,” with currently available treatments.
Moreover, “there are challenges that come up with any of the different therapies,” he said, with adverse effects an important issue. For example, biologic therapies are associated with conjunctivitis, facial erythema, and arthralgia, and there are boxed warnings for Janus kinase inhibitors.
Dr. Silverberg continued, “Even patients with a favorable response can experience a loss of disease control when they come off therapy.” Consequently, “new strategies are certainly welcome that could potentially induce both deep and potentially therapy-free remission.”
To those ends, he explained that regulatory T cells play a central role in immune homeostasis but have not been “therapeutically relevant until very recently,” when it was posited that increasing their function can “induce that homeostasis, to normalize the inflammatory cascades” seen in a range of conditions, including atopic dermatitis.
Rezpegaldesleukin has high selectivity for regulatory T cells, without causing activation of effector T cells, and has been shown to increase cell numbers in a dose-dependent manner that is sustained for up to 30 days.
The current study involved patients aged 18-70 years with moderate to severe atopic dermatitis and a history of inadequate responses or intolerance to topical medications, and an EASI score ≥ 16.
Participants were randomly assigned to receive subcutaneous rezpegaldesleukin 12 mcg/kg or 24 mcg/kg or placebo every 2 weeks for 12 weeks. They then discontinued treatment and were followed up until week 19, when responders, defined as having a reduction in EASI score ≥ 50%, continued follow-up out to week 48.
Seventeen patients were randomized to higher-dose rezpegaldesleukin, whereas 16 received the lower dose and 10 were assigned to placebo. Dr. Silverberg said that the three groups were “fairly well balanced,” with “fairly good representation” across age, race, and ethnicity groups.
The mean baseline EASI score was between 21.9 and 23.7, and the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) suggested that there was an even split between moderate and severe atopic dermatitis, although the higher-dose rezpegaldesleukin group had more patients with moderate disease.
By week 12, rezpegaldesleukin was associated with significantly greater improvements in EASI scores vs. placebo. Patients on the higher dose had a mean 83% improvement over baseline vs. 65% with the lower dose and 47% with placebo (P = .002 for the higher dose vs. placebo).
Crucially, these differences were maintained up to week 48 in patients, particularly in the higher-dose group.
There was also a nonsignificant increase in the proportion of patients who achieved a reduction in EASI scores ≥ 75% over baseline with the active drug: 41% at week 12 with higher-dose rezpegaldesleukin, 25% with the lower dose, and 20% with placebo. Again, the benefit was maintained up to week 48.
The mean improvement in BSA score from baseline with rezpegaldesleukin was significantly greater than that seen with placebo, at 72% with the higher dose, 55% with the lower dose, and 36% with placebo (P = .0158 for the higher dose vs. placebo).
Although improvements in vIGA-AD scores over baseline with rezpegaldesleukin were not substantial at week 12, by week 48 there was a marked difference between higher-dose rezpegaldesleukin and placebo, with 40.0% of patients responding to the drug vs. 0% in the latter group.
A similar pattern was seen for the Itch Numeric Rating Scale, in which 55.6% of patients treated with higher-dose rezpegaldesleukin responding by week 48, compared with 0% of those who received placebo.
Greater improvements in the Dermatology Life Quality Index (DLQI) and Patient Oriented Eczema Measure (POEM) over baseline with higher-dose rezpegaldesleukin vs. plain placebo were also noted, despite a strong response in the latter group.
Dr. Silverberg reported that all treatment-emergent adverse effects in the two rezpegaldesleukin treatment arms were mild to moderate, with no severe or serious events observed.
The most common adverse events were mild to moderate injection-site reactions, seen in 75.0% of the lower-dose rezpegaldesleukin group and 58.8% the of higher-dose group. There were no cases of conjunctivitis.
The study was sponsored by Eli Lilly and Company in collaboration with Nektar Therapeutics.
Dr. Silverberg declares relationships with AbbVie, Alamar, Aldena, Amgen, AOBiome, Arcutis, Arena, Asana, ASLAN, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, DermTech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, LEO Pharma, Nektar, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, Target RWE, Union, and UpToDate.
A version of this article appeared on Medscape.com.
AT THE EADV CONGRESS
Study reveals potentially unnecessary CRC screening in older adults
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
TOPLINE:
Older adults with limited life expectancy are just as likely to undergo colorectal cancer (CRC) screening as those with longer life expectancy, a new study shows.
METHODOLOGY:
- Researchers used national survey data to estimate the prevalence and factors associated with CRC screening in 25,888 community-dwelling adults aged 65-84 according to their predicted 10-year mortality risk.
- They estimated 10-year mortality risk using a validated index. From the lowest to highest quintiles, mortality risk was 12%, 24%, 39%, 58%, and 79%, respectively.
- Investigators determined the proportion of screening performed in adults with life expectancy less than 10 years, defined as 10-year mortality risk ≥ 50% (that is, quintiles 4 and 5).
TAKEAWAY:
- In this cohort of older adults previously not up to date with CRC screening, the overall prevalence of past-year screening was 38.5%.
- The prevalence of past-year CRC screening decreased with advancing age but did not differ significantly by 10-year mortality risk. From lowest to highest quintile, prevalence was 39.5%, 40.6%, 38.7%, 36.4%, and 35.4%, respectively.
- The likelihood of CRC screening did not differ between adults in the lowest vs. highest quintile of 10-year mortality risk (adjusted odds ratio, 1.05).
- More than one-quarter (27.9%) of past-year screening occurred in adults with life expectancy less than 10 years, and 50.7% of adults aged 75-84 years had life expectancy less than 10 years at the time of screening.
- Paradoxically, the prevalence of invasive screening increased with lowered life expectancy among adults aged 70-79 years.
IN PRACTICE:
“Our results suggest that health status and life expectancy may be overlooked in current CRC screening programs, and personalized screening incorporating individual life expectancy may improve the value of screening,” the authors write.
SOURCE:
The study, with first author Po-Hong Liu, MD, MPH, division of digestive and liver diseases, University of Texas Southwestern Medical Center, Dallas, was published online in the American Journal of Gastroenterology.
LIMITATIONS:
The survey data were self-reported and were not validated by medical records. The data did not include information to identify individuals who were at higher risk for CRC or to trace prior CRC screening history. It was not possible to reliably classify test indication (screening vs. surveillance vs. diagnostic).
DISCLOSURES:
The study was supported by the National Institutes of Health. One author disclosed serving as a consultant or on advisory boards for Exact Sciences, Universal Dx, Roche, and Freenome. Another disclosed consulting for Freenome.
A version of this article first appeared on Medscape.com.
Here’s how to help Black smokers quit
Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.
This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.
Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.
To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.
Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
The reasons behind the attempts
Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.
One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.
“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.
Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.
“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.
In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.
According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.
Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.
Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.
These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.
“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
Tailoring treatment to Black smokers
Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.
Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.
Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.
“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.
Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.
If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.
Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.
“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”
Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
Move past the ‘advise’ stage
While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.
Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.
Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.
“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.
In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.
“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.
Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.
A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.
“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”
A version of this article first appeared on Medscape.com.
Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.
This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.
Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.
To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.
Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
The reasons behind the attempts
Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.
One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.
“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.
Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.
“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.
In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.
According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.
Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.
Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.
These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.
“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
Tailoring treatment to Black smokers
Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.
Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.
Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.
“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.
Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.
If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.
Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.
“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”
Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
Move past the ‘advise’ stage
While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.
Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.
Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.
“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.
In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.
“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.
Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.
A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.
“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”
A version of this article first appeared on Medscape.com.
Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.
This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.
Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.
To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.
Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
The reasons behind the attempts
Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.
One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.
“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.
Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.
“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.
In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.
According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.
Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.
Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.
These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.
“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
Tailoring treatment to Black smokers
Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.
Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.
Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.
“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.
Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.
If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.
Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.
“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”
Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
Move past the ‘advise’ stage
While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.
Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.
Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.
“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.
In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.
“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.
Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.
A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.
“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”
A version of this article first appeared on Medscape.com.
Fathers’ postpartum depression linked to children’s adversity
WASHINGTON – , according to research presented at the annual meeting of the American Academy of Pediatrics.
The findings held even after taking into account postpartum depression in the child’s mother and other factors that might increase risk of adverse childhood experiences, reported Kristine H. Schmitz, MD, an assistant professor of pediatrics at Robert Wood Johnson Medical School, New Brunswick, N.J.
Paternal postpartum depression has not been studied very well, so it’s difficult to pin down its prevalence, but some research has found rates as high as 25%, Dr. Schmitz told attendees.
”We recognize that it’s very under-recognized and often under-reported, but we also know that it has lots of downstream effects on child outcomes, including difficulties with parenting, difficulties with child behavior, as well as school performance and school attainment and employment,” Dr. Schmitz said.
Paternal depression and adverse childhood experiences
The study involved an analysis of six waves of data from the Future of Families & Child Wellbeing Study, which follows a national cohort of children born in large U.S. cities between 1998 and 2000. The cohort includes an intentional over-representation of unmarried mothers, who make up about 75% of the overall population.
The researchers used the World Health Organization’s Composite International Diagnosis Interview Short Form (CIDI-SF) to assess fathers’ depression when their children were 1 year old. Then the researchers looked at the number of adverse childhood experiences (ACEs) children had at 5 years old.
The analysis was adjusted to account for the child’s sex and the father’s age, race/ethnicity, and education as well as whether he was born inside or outside the United States. The findings were also adjusted for the whether the child’s parents were married or cohabiting, whether the child had low birth weight, whether the birth was covered by Medicaid, and whether the mother had postpartum depression.
Among the 1,933 pairs of fathers and children in the analysis, nearly half the fathers were non-Hispanic Black (48%) and more than half (64%) had a high school education or lower level of education. Medicaid paid for half the children’s births.
Nine percent of the fathers experienced depression during their child’s first year, and 70% of the children had at least one ACE at 5 years old. Two in five children (39%) had two ACEs at age 5, and 21% of children had three ACEs.
Children were twice as likely to have three ACEs at 5 years old if their father had depression during the child’s first year (adjusted odds ratio, 2.04; 95% confidence interval, 1.42-2.93). Paternal depression was also significantly associated with children having one ACE (OR, 2.35; 95% CI, 1.45-3.81) and two ACES (OR, 1.89; 95% CI, 1.35-2.63) at age 5.
The ACE with the highest association with paternal depression was the father’s absence from children’s lives (aOR, 2.65; 95% CI, 1.74-4.04). In addition, children of fathers with depression had 60% greater odds of exposure to substance use (aOR, 1.6; 95% CI, 1.08-2.34).
Children also had greater odds of child maltreatment at age 5 if their father had depression in their child’s first year. Odds were greater for psychological maltreatment (aOR, 1.55; 95% CI, 1.02-2.34), neglect (aOR, 1.63; 95% CI, 1.08-2.46), and physical maltreatment (aOR, 1.56; 95% CI, 1.04-2.35). The researchers did not find any association between paternal depression and the ACEs of sexual maltreatment, maternal depression, incarceration of someone in the home, or violence toward the mother.
”We know that dads play a critical role in the family,” Dr. Schmitz said. “We as pediatricians have a really unique position with families, and we should capitalize on that opportunity to engage with fathers just like we do with mothers and postpartum depression. Hopefully by doing that, we’ll reduce hardships for children and families down the road.”
Dr. Schmitz also said it’s important for pediatricians to advocate at a policy level “to really include dads more explicitly in maternal and child health policy and advocate for better father-focused interventions from father-focused research.” She further acknowledged the stigma that exists around men’s mental health in general and the need to find out the best ways to help overcome that stigma.
‘Concerning’ findings may suggest a need for screening
Jason Terk, MD, a pediatrician practicing in north Texas and past president of the Texas Pediatric Society, was not surprised to see a link between depression in fathers and adversity in their children. Dr. Terk was not involved in the research but noted that the 9% rate of paternal depression seen in the study is similar to national rates of depression in U.S. adults.
“I think that the presence of paternal depression being associated with ACEs in their children in their first 5 years of life is certainly concerning and worthy of intervention for both the fathers and their children,” Dr. Terk said. “The key take-home message for clinicians who care for infants and small children is that the presence of paternal depression should increase awareness of adverse effects on those children. We need to consider screening for this at 12 months of age in much the same way we screen for maternal depression for younger infants.”
Dr. Terk noted one limitation of the study was that it didn’t suggest any specific risk factors pediatricians might look for to increase surveillance of potential depression in fathers.
“Also, unlike maternal depression, in which moms may be connected with their obstetricians if they screen positive on an Edinburgh questionnaire, we will be hard-pressed to know where to refer dads who are found to be depressed when their babies are 12 months old,” Dr. Terk said. “Screening must lead to helpful responses if the screening reveals a problem.”
The research was funded by the Robert Wood Johnson Foundation, the National Institutes of Health, and the Health Resources and Services Administration. Dr. Schmitz had no disclosures. Dr. Terk has been a speaker for Sanofi on a topic unrelated to this research.
WASHINGTON – , according to research presented at the annual meeting of the American Academy of Pediatrics.
The findings held even after taking into account postpartum depression in the child’s mother and other factors that might increase risk of adverse childhood experiences, reported Kristine H. Schmitz, MD, an assistant professor of pediatrics at Robert Wood Johnson Medical School, New Brunswick, N.J.
Paternal postpartum depression has not been studied very well, so it’s difficult to pin down its prevalence, but some research has found rates as high as 25%, Dr. Schmitz told attendees.
”We recognize that it’s very under-recognized and often under-reported, but we also know that it has lots of downstream effects on child outcomes, including difficulties with parenting, difficulties with child behavior, as well as school performance and school attainment and employment,” Dr. Schmitz said.
Paternal depression and adverse childhood experiences
The study involved an analysis of six waves of data from the Future of Families & Child Wellbeing Study, which follows a national cohort of children born in large U.S. cities between 1998 and 2000. The cohort includes an intentional over-representation of unmarried mothers, who make up about 75% of the overall population.
The researchers used the World Health Organization’s Composite International Diagnosis Interview Short Form (CIDI-SF) to assess fathers’ depression when their children were 1 year old. Then the researchers looked at the number of adverse childhood experiences (ACEs) children had at 5 years old.
The analysis was adjusted to account for the child’s sex and the father’s age, race/ethnicity, and education as well as whether he was born inside or outside the United States. The findings were also adjusted for the whether the child’s parents were married or cohabiting, whether the child had low birth weight, whether the birth was covered by Medicaid, and whether the mother had postpartum depression.
Among the 1,933 pairs of fathers and children in the analysis, nearly half the fathers were non-Hispanic Black (48%) and more than half (64%) had a high school education or lower level of education. Medicaid paid for half the children’s births.
Nine percent of the fathers experienced depression during their child’s first year, and 70% of the children had at least one ACE at 5 years old. Two in five children (39%) had two ACEs at age 5, and 21% of children had three ACEs.
Children were twice as likely to have three ACEs at 5 years old if their father had depression during the child’s first year (adjusted odds ratio, 2.04; 95% confidence interval, 1.42-2.93). Paternal depression was also significantly associated with children having one ACE (OR, 2.35; 95% CI, 1.45-3.81) and two ACES (OR, 1.89; 95% CI, 1.35-2.63) at age 5.
The ACE with the highest association with paternal depression was the father’s absence from children’s lives (aOR, 2.65; 95% CI, 1.74-4.04). In addition, children of fathers with depression had 60% greater odds of exposure to substance use (aOR, 1.6; 95% CI, 1.08-2.34).
Children also had greater odds of child maltreatment at age 5 if their father had depression in their child’s first year. Odds were greater for psychological maltreatment (aOR, 1.55; 95% CI, 1.02-2.34), neglect (aOR, 1.63; 95% CI, 1.08-2.46), and physical maltreatment (aOR, 1.56; 95% CI, 1.04-2.35). The researchers did not find any association between paternal depression and the ACEs of sexual maltreatment, maternal depression, incarceration of someone in the home, or violence toward the mother.
”We know that dads play a critical role in the family,” Dr. Schmitz said. “We as pediatricians have a really unique position with families, and we should capitalize on that opportunity to engage with fathers just like we do with mothers and postpartum depression. Hopefully by doing that, we’ll reduce hardships for children and families down the road.”
Dr. Schmitz also said it’s important for pediatricians to advocate at a policy level “to really include dads more explicitly in maternal and child health policy and advocate for better father-focused interventions from father-focused research.” She further acknowledged the stigma that exists around men’s mental health in general and the need to find out the best ways to help overcome that stigma.
‘Concerning’ findings may suggest a need for screening
Jason Terk, MD, a pediatrician practicing in north Texas and past president of the Texas Pediatric Society, was not surprised to see a link between depression in fathers and adversity in their children. Dr. Terk was not involved in the research but noted that the 9% rate of paternal depression seen in the study is similar to national rates of depression in U.S. adults.
“I think that the presence of paternal depression being associated with ACEs in their children in their first 5 years of life is certainly concerning and worthy of intervention for both the fathers and their children,” Dr. Terk said. “The key take-home message for clinicians who care for infants and small children is that the presence of paternal depression should increase awareness of adverse effects on those children. We need to consider screening for this at 12 months of age in much the same way we screen for maternal depression for younger infants.”
Dr. Terk noted one limitation of the study was that it didn’t suggest any specific risk factors pediatricians might look for to increase surveillance of potential depression in fathers.
“Also, unlike maternal depression, in which moms may be connected with their obstetricians if they screen positive on an Edinburgh questionnaire, we will be hard-pressed to know where to refer dads who are found to be depressed when their babies are 12 months old,” Dr. Terk said. “Screening must lead to helpful responses if the screening reveals a problem.”
The research was funded by the Robert Wood Johnson Foundation, the National Institutes of Health, and the Health Resources and Services Administration. Dr. Schmitz had no disclosures. Dr. Terk has been a speaker for Sanofi on a topic unrelated to this research.
WASHINGTON – , according to research presented at the annual meeting of the American Academy of Pediatrics.
The findings held even after taking into account postpartum depression in the child’s mother and other factors that might increase risk of adverse childhood experiences, reported Kristine H. Schmitz, MD, an assistant professor of pediatrics at Robert Wood Johnson Medical School, New Brunswick, N.J.
Paternal postpartum depression has not been studied very well, so it’s difficult to pin down its prevalence, but some research has found rates as high as 25%, Dr. Schmitz told attendees.
”We recognize that it’s very under-recognized and often under-reported, but we also know that it has lots of downstream effects on child outcomes, including difficulties with parenting, difficulties with child behavior, as well as school performance and school attainment and employment,” Dr. Schmitz said.
Paternal depression and adverse childhood experiences
The study involved an analysis of six waves of data from the Future of Families & Child Wellbeing Study, which follows a national cohort of children born in large U.S. cities between 1998 and 2000. The cohort includes an intentional over-representation of unmarried mothers, who make up about 75% of the overall population.
The researchers used the World Health Organization’s Composite International Diagnosis Interview Short Form (CIDI-SF) to assess fathers’ depression when their children were 1 year old. Then the researchers looked at the number of adverse childhood experiences (ACEs) children had at 5 years old.
The analysis was adjusted to account for the child’s sex and the father’s age, race/ethnicity, and education as well as whether he was born inside or outside the United States. The findings were also adjusted for the whether the child’s parents were married or cohabiting, whether the child had low birth weight, whether the birth was covered by Medicaid, and whether the mother had postpartum depression.
Among the 1,933 pairs of fathers and children in the analysis, nearly half the fathers were non-Hispanic Black (48%) and more than half (64%) had a high school education or lower level of education. Medicaid paid for half the children’s births.
Nine percent of the fathers experienced depression during their child’s first year, and 70% of the children had at least one ACE at 5 years old. Two in five children (39%) had two ACEs at age 5, and 21% of children had three ACEs.
Children were twice as likely to have three ACEs at 5 years old if their father had depression during the child’s first year (adjusted odds ratio, 2.04; 95% confidence interval, 1.42-2.93). Paternal depression was also significantly associated with children having one ACE (OR, 2.35; 95% CI, 1.45-3.81) and two ACES (OR, 1.89; 95% CI, 1.35-2.63) at age 5.
The ACE with the highest association with paternal depression was the father’s absence from children’s lives (aOR, 2.65; 95% CI, 1.74-4.04). In addition, children of fathers with depression had 60% greater odds of exposure to substance use (aOR, 1.6; 95% CI, 1.08-2.34).
Children also had greater odds of child maltreatment at age 5 if their father had depression in their child’s first year. Odds were greater for psychological maltreatment (aOR, 1.55; 95% CI, 1.02-2.34), neglect (aOR, 1.63; 95% CI, 1.08-2.46), and physical maltreatment (aOR, 1.56; 95% CI, 1.04-2.35). The researchers did not find any association between paternal depression and the ACEs of sexual maltreatment, maternal depression, incarceration of someone in the home, or violence toward the mother.
”We know that dads play a critical role in the family,” Dr. Schmitz said. “We as pediatricians have a really unique position with families, and we should capitalize on that opportunity to engage with fathers just like we do with mothers and postpartum depression. Hopefully by doing that, we’ll reduce hardships for children and families down the road.”
Dr. Schmitz also said it’s important for pediatricians to advocate at a policy level “to really include dads more explicitly in maternal and child health policy and advocate for better father-focused interventions from father-focused research.” She further acknowledged the stigma that exists around men’s mental health in general and the need to find out the best ways to help overcome that stigma.
‘Concerning’ findings may suggest a need for screening
Jason Terk, MD, a pediatrician practicing in north Texas and past president of the Texas Pediatric Society, was not surprised to see a link between depression in fathers and adversity in their children. Dr. Terk was not involved in the research but noted that the 9% rate of paternal depression seen in the study is similar to national rates of depression in U.S. adults.
“I think that the presence of paternal depression being associated with ACEs in their children in their first 5 years of life is certainly concerning and worthy of intervention for both the fathers and their children,” Dr. Terk said. “The key take-home message for clinicians who care for infants and small children is that the presence of paternal depression should increase awareness of adverse effects on those children. We need to consider screening for this at 12 months of age in much the same way we screen for maternal depression for younger infants.”
Dr. Terk noted one limitation of the study was that it didn’t suggest any specific risk factors pediatricians might look for to increase surveillance of potential depression in fathers.
“Also, unlike maternal depression, in which moms may be connected with their obstetricians if they screen positive on an Edinburgh questionnaire, we will be hard-pressed to know where to refer dads who are found to be depressed when their babies are 12 months old,” Dr. Terk said. “Screening must lead to helpful responses if the screening reveals a problem.”
The research was funded by the Robert Wood Johnson Foundation, the National Institutes of Health, and the Health Resources and Services Administration. Dr. Schmitz had no disclosures. Dr. Terk has been a speaker for Sanofi on a topic unrelated to this research.
AT AAP 2023
GI docs’ nutrition education deficit may shortchange patients
Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.
In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.
The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.
“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.
Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.
“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.
One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.
But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
Nutrition overlooked in procedure-heavy specialty
In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.
Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.
Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.
GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.
The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.
Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.
Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.
Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.
It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.
Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.
“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.
It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.
GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.
If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
Weaving more nutrition into training
To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.
Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.
“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.
GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.
The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.
But it hasn’t been as widely adopted as hoped, he said.
“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
Collaboration in practice
Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.
Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.
“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.
In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.
In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.
The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.
It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.
At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.
We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.
At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.
Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.
Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”
“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.
A version of this article first appeared on Medscape.com.
Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.
In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.
The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.
“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.
Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.
“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.
One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.
But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
Nutrition overlooked in procedure-heavy specialty
In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.
Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.
Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.
GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.
The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.
Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.
Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.
Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.
It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.
Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.
“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.
It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.
GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.
If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
Weaving more nutrition into training
To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.
Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.
“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.
GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.
The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.
But it hasn’t been as widely adopted as hoped, he said.
“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
Collaboration in practice
Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.
Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.
“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.
In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.
In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.
The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.
It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.
At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.
We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.
At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.
Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.
Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”
“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.
A version of this article first appeared on Medscape.com.
Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.
In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.
The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.
“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.
Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.
“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.
One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.
But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
Nutrition overlooked in procedure-heavy specialty
In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.
Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.
Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.
GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.
The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.
Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.
Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.
Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.
It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.
Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.
“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.
It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.
GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.
If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
Weaving more nutrition into training
To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.
Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.
“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.
GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.
The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.
But it hasn’t been as widely adopted as hoped, he said.
“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
Collaboration in practice
Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.
Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.
“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.
In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.
In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.
The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.
It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.
At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.
We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.
At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.
Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.
Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”
“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.
A version of this article first appeared on Medscape.com.
In ILD, ECMO linked to good outcomes as bridge to transplant
Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, , although the confidence in the finding was low.
ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).
The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.
The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).
The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).
“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.
The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.
Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.
Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.
Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.
Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”
The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.
Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.
Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, , although the confidence in the finding was low.
ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).
The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.
The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).
The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).
“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.
The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.
Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.
Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.
Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.
Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”
The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.
Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.
Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, , although the confidence in the finding was low.
ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).
The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.
The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).
The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).
“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.
The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.
Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.
Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.
Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.
Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”
The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.
Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.
FROM CHEST 2023