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Mental Health Worsens in Trans, Gender-Nonconforming Adults
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Climate Change’s Impact on Respiratory Care to Increase
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Study Evaluates CVD, Mortality Risks In Patients With Prurigo Nodularis
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
Whites Not the Predominant Victims of ‘Deaths of Despair’ Need to Address Inequality
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Docs Vent As Feds Investigate Private Equity, Consolidation in Medicine
As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.
“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia.
“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”
The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.
The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.
Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.
Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.
Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour.
A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD.
While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view.
“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.
Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”
The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.
“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire.
Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”
Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”
“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC.
The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.
A version of this article first appeared on Medscape.com.
As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.
“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia.
“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”
The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.
The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.
Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.
Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.
Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour.
A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD.
While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view.
“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.
Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”
The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.
“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire.
Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”
Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”
“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC.
The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.
A version of this article first appeared on Medscape.com.
As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.
“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia.
“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”
The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.
The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.
Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.
Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.
Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour.
A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD.
While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view.
“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.
Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”
The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.
“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire.
Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”
Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”
“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC.
The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.
A version of this article first appeared on Medscape.com.
Wider Waist Increases Risk for Asthma Attacks
A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.
BMI Earlier Tied to Asthma
Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.
The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.
The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
More Waist Inches = Asthma Attacks
The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.
The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
Importance of Waist Size
“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.
Limited to Data Available
The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.
The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.
The study received no outside funding. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.
BMI Earlier Tied to Asthma
Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.
The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.
The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
More Waist Inches = Asthma Attacks
The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.
The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
Importance of Waist Size
“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.
Limited to Data Available
The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.
The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.
The study received no outside funding. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.
BMI Earlier Tied to Asthma
Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.
The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.
The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
More Waist Inches = Asthma Attacks
The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.
The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
Importance of Waist Size
“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.
Limited to Data Available
The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.
The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.
The study received no outside funding. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Physical Activity Protective Against Inflammatory Bowel Disease, Meta-Analysis Shows
TOPLINE:
Higher levels of physical activity are associated with a decreased risk of developing inflammatory bowel disease (IBD), particularly Crohn’s disease (CD).
METHODOLOGY:
- Because previous observational studies on the association between physical activity and IBD risk have yielded a wide range of results and conclusions, researchers conducted a systematic review and meta-analysis to estimate the aggregate effect of physical activity on IBD risk across various demographics.
- The analysis included three large population-based cohort studies and seven small and large case-control studies from several global regions that were published before April 2023.
- The cohort studies included 1182 patients with CD, 2361 with ulcerative colitis (UC), and 860,992 individuals without IBD. The case-control studies involved 781 patients with CD and 2636 individuals without CD, and 1127 patients with UC and 3752 individuals without UC.
- The Grading of Recommendations Assessment, Development and Evaluation approach was used to determine the quality of evidence in the included studies.
TAKEAWAY:
- The risk for incident UC was 13% lower in the high vs low physical activity level groups in the cohort studies, but the reduction in the case-control studies did not reach statistical significance.
- The quality-of-evidence assessment found no serious limitations in the cohort studies but serious limitations in the case-control studies due to a high risk for bias and significant heterogeneity.
IN PRACTICE:
“There could be a role of physical activity as a prevention strategy against developing IBD. In addition to implementing public health interventions to increase physical activity level, there may be a place for physicians to advise increased physical activity level, especially to individuals at high risk of developing IBD, such as those with a strong family history of IBD,” the authors wrote.
SOURCE:
The study, led by Ho Tuan Tiong, MD, Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand, was published online in the Journal of Crohn’s and Colitis.
LIMITATIONS:
There may be a risk for residual confounding owing to the observational nature of the studies. There may also be a risk for reverse causality, as the individuals who had IBD symptoms before diagnosis may have been less physically active due to the disease. Except in two studies that measured physical activity directly, questionnaires were used to assess physical activity, possibly leading to misclassification of activity levels.
DISCLOSURES:
The study did not receive any funding. Two authors reported receiving grants and consulting fees from several pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher levels of physical activity are associated with a decreased risk of developing inflammatory bowel disease (IBD), particularly Crohn’s disease (CD).
METHODOLOGY:
- Because previous observational studies on the association between physical activity and IBD risk have yielded a wide range of results and conclusions, researchers conducted a systematic review and meta-analysis to estimate the aggregate effect of physical activity on IBD risk across various demographics.
- The analysis included three large population-based cohort studies and seven small and large case-control studies from several global regions that were published before April 2023.
- The cohort studies included 1182 patients with CD, 2361 with ulcerative colitis (UC), and 860,992 individuals without IBD. The case-control studies involved 781 patients with CD and 2636 individuals without CD, and 1127 patients with UC and 3752 individuals without UC.
- The Grading of Recommendations Assessment, Development and Evaluation approach was used to determine the quality of evidence in the included studies.
TAKEAWAY:
- The risk for incident UC was 13% lower in the high vs low physical activity level groups in the cohort studies, but the reduction in the case-control studies did not reach statistical significance.
- The quality-of-evidence assessment found no serious limitations in the cohort studies but serious limitations in the case-control studies due to a high risk for bias and significant heterogeneity.
IN PRACTICE:
“There could be a role of physical activity as a prevention strategy against developing IBD. In addition to implementing public health interventions to increase physical activity level, there may be a place for physicians to advise increased physical activity level, especially to individuals at high risk of developing IBD, such as those with a strong family history of IBD,” the authors wrote.
SOURCE:
The study, led by Ho Tuan Tiong, MD, Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand, was published online in the Journal of Crohn’s and Colitis.
LIMITATIONS:
There may be a risk for residual confounding owing to the observational nature of the studies. There may also be a risk for reverse causality, as the individuals who had IBD symptoms before diagnosis may have been less physically active due to the disease. Except in two studies that measured physical activity directly, questionnaires were used to assess physical activity, possibly leading to misclassification of activity levels.
DISCLOSURES:
The study did not receive any funding. Two authors reported receiving grants and consulting fees from several pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher levels of physical activity are associated with a decreased risk of developing inflammatory bowel disease (IBD), particularly Crohn’s disease (CD).
METHODOLOGY:
- Because previous observational studies on the association between physical activity and IBD risk have yielded a wide range of results and conclusions, researchers conducted a systematic review and meta-analysis to estimate the aggregate effect of physical activity on IBD risk across various demographics.
- The analysis included three large population-based cohort studies and seven small and large case-control studies from several global regions that were published before April 2023.
- The cohort studies included 1182 patients with CD, 2361 with ulcerative colitis (UC), and 860,992 individuals without IBD. The case-control studies involved 781 patients with CD and 2636 individuals without CD, and 1127 patients with UC and 3752 individuals without UC.
- The Grading of Recommendations Assessment, Development and Evaluation approach was used to determine the quality of evidence in the included studies.
TAKEAWAY:
- The risk for incident UC was 13% lower in the high vs low physical activity level groups in the cohort studies, but the reduction in the case-control studies did not reach statistical significance.
- The quality-of-evidence assessment found no serious limitations in the cohort studies but serious limitations in the case-control studies due to a high risk for bias and significant heterogeneity.
IN PRACTICE:
“There could be a role of physical activity as a prevention strategy against developing IBD. In addition to implementing public health interventions to increase physical activity level, there may be a place for physicians to advise increased physical activity level, especially to individuals at high risk of developing IBD, such as those with a strong family history of IBD,” the authors wrote.
SOURCE:
The study, led by Ho Tuan Tiong, MD, Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand, was published online in the Journal of Crohn’s and Colitis.
LIMITATIONS:
There may be a risk for residual confounding owing to the observational nature of the studies. There may also be a risk for reverse causality, as the individuals who had IBD symptoms before diagnosis may have been less physically active due to the disease. Except in two studies that measured physical activity directly, questionnaires were used to assess physical activity, possibly leading to misclassification of activity levels.
DISCLOSURES:
The study did not receive any funding. Two authors reported receiving grants and consulting fees from several pharmaceutical companies.
A version of this article appeared on Medscape.com.
National Mine Safety Group Issues Rule to Reduce Silica Exposure
The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.
silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease.
The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule.
“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said.
The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.
In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release.
Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA.
“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.
A version of this article appeared on Medscape.com.
The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.
silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease.
The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule.
“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said.
The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.
In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release.
Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA.
“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.
A version of this article appeared on Medscape.com.
The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.
silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease.
The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule.
“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said.
The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.
In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release.
Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA.
“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.
A version of this article appeared on Medscape.com.
Satisfactory Results, Less Pain When Surface Anesthesia Used with Thermomechanical Fractional Injury Therapy
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
BALTIMORE — , a small study of the recently cleared device found.
The study enrolled 12 patients who were undergoing treatment for periorbital rhytides, or wrinkles, around the eyes. Seven of them received topical anesthetic cream 20 minutes before the procedure, while five were given ice packs to self-apply for 5 minutes beforehand. Patients received four treatment sessions with a month between sessions and were then evaluated up to 3 months after their last session. Study results were presented at the annual conference of the American Society for Laser Medicine and Surgery.
“Based on the approach that we had used, which was to keep the device parameters the same for those who received topical anesthetics and those who received ice, when we looked at the pain levels that the patients had relayed to us when we were doing the procedure, we found that both of them were almost exactly the same in terms of discomfort, a level of 3-4 out of 10, with 10 being the highest discomfort level,” lead investigator Jerome M. Garden, MD, said in an interview after the conference.
“In terms of patient satisfaction using a range of 0-5, again it was fairly equivalent” between the two groups, said Dr. Garden, professor of clinical dermatology and biomedical engineering at Northwestern University, Chicago. “And the overall satisfaction rate was high.”
The same device settings were used for all procedures: A pulse duration of 10 milliseconds and a protrusion depth of 400 micrometers. Double passes were applied using the standard device tip, with the smaller tip used in tighter areas, Dr. Garden said. Three patients were Fitzpatrick skin type (FST) I, six were FST II, and three were FST III.
Study Results
The results for the different anesthetic methods were almost identical. Those using ice reported a 0-10 average pain level of 3.95 ± 1.5, while those who received the topical anesthetic reported a pain level of 3.92 ± 1.5. In terms of self-graded improvement at 3-month follow-up, using a scale of 1-4, with 1 representing up to a 25% improvement and 4 a 75%-100% improvement, the patients using ice had a 2.6 ± 0.5 improvement and those using topical cream a 2.8 ± 0.5 improvement, Dr. Garden said during his presentation.
In terms of patient satisfaction, rated on a scale of 1-5, with 5 being very satisfied, the average grade was 3.9 ± 0.9, Dr. Garden added, with 70% rating ≥ 4.
“This is a relatively new device, which uses an approach to help texture changes in wrinkling on the skin in a different fashion than any of the other devices that are currently out there,” Dr. Garden told this news organization after the conference. “I wanted to understand more in depth the different parameters that may impact the outcome” with this device, he added.
The thermomechanical fractional injury device, originally cleared by the US Food and Drug Administration (FDA) in 2021, with a second-generation device cleared in June 2023, deposits heat into the skin, producing controlled thermal injury to promote collagen and elastin production. The device uses only heat, not a laser, which penetrates the skin. A heat sensation on the skin during the procedure can affect patients differently depending on their level of tolerance, Dr. Garden said during his presentation.
Managing Patient Discomfort
Kachiu C. Lee, MD, MPH, of the Main Line Center for Laser Surgery in Ardmore, Pennsylvania, has used the device in her own practice and found that “it can definitely get a little bit uncomfortable for patients,” she said in an interview after the conference.
“I would say that as the doctor, my number one priority is to always make sure my patients are comfortable, especially when treating a sensitive area like the eyes,” added Dr. Lee, who was not involved with the study. “I don’t want them to suddenly jump or move from the discomfort when I have a device right next to their eye. I think that the patient comfort is very important to make sure that we’re managing their discomfort so that the procedure is tolerable.”
She added, “Dr. Garden’s study was effective at showing that surface anesthesia, whether it be with an ice pack 5 minutes before or a topical numbing cream, can be very effective in reducing the pain level while also not interfering with the efficacy of the treatment itself.”
Dr. Garden serves on the medical advisory board for Novoxel, maker of the device. Dr. Lee had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ASLMS 2024
Beyond Increased Risk: Is APOE4 a Direct Cause of Alzheimer’s disease?
, a new study suggests.
More than 95% of those with two copies of the gene (APOE4 homozygotes) in a large multicohort study had higher levels of Alzheimer’s disease biomarkers by age 55 years than did those with other APOE gene variants. By age 65 years, most had developed Alzheimer’s disease symptoms and showed abnormal amyloid levels in cerebrospinal fluid and on PET.
Investigators said that such a high penetrance of Alzheimer’s disease pathology in this group suggests that APOE4 may not be just a risk factor for Alzheimer’s disease but also a distinct genetic form of the disease.
“Sometimes, we say we don’t know the cause of Alzheimer’s disease, but this would be behind 15%-20% of the population of people with Alzheimer’s disease,” lead investigator Juan Fortea, MD, PhD, director of the Memory Unit of the Neurology Department at the Hospital of Sant Pau, Barcelona, Spain, said at a press briefing.
Although some experts urge caution in interpreting these results, investigators and others say the findings, published online in Nature Medicine, could lead to calls for more widespread testing for APOE4 and may spur drug development.
High AD Penetrance
Mutations in the APP, PSEN1, and PSEN2 genes are linked to risk for early-onset autosomal-dominant Alzheimer’s disease, and dozens of other genes are associated with greater odds of late-onset disease. Among all these genes, APOE is considered the strongest genetic risk factor for late-onset Alzheimer’s disease.
Prior studies found that APOE4 homozygotes have a 60% lifetime risk for Alzheimer’s disease by age 85 years, a risk higher than that found with other gene variants or in single APOE carriers or noncarriers.
Despite that, no previous study had examined the predictability of symptom onset in APOE4 homozygotes, which make up about 2%-3% of the general population and 15-20% of those with Alzheimer’s disease. And because most biomarker studies have combined single- and double-carrier APOE4 carriers into one group, very little was known about the penetrance or disease progression in APOE4 homozygotes.
Investigators analyzed data from 3200 brain donors from the National Alzheimer’s Coordinating Center and more than 10,000 people with Alzheimer’s disease biomarkers from five multicenter cohorts in the United States and Europe.
Nearly all APOE4 homozygotes had either high or intermediate Alzheimer’s disease neuropathologic change scores compared with about 50% among APOE3 homozygotes and was the same regardless of age at time of death.
Beginning at age 55 years, APOE4 homozygotes exhibited higher levels of abnormal Alzheimer’s disease biomarkers than did APOE3 homozygotes. By age 65 years, nearly everyone with two copies of APOE4 showed abnormal levels of amyloid in cerebrospinal fluid and 75% had positive amyloid scans.
Other biomarkers showed a biologic penetrance of Alzheimer’s disease that increased with age. By age 80 years, penetrance for all amyloid and tau biomarkers reached 88%.
Postmortem analysis revealed Alzheimer’s disease and dementia symptoms were evident in APOE4 homozygotes 7-10 years before APOE3 homozygotes, with Alzheimer’s disease symptoms present at age 65 years, minor cognitive impairment at 72 years, dementia at 74 years, and death at 77 years (P <.05 differences).
When they limited analysis to only those who developed Alzheimer’s disease dementia, investigators found no difference in amyloid or tau accumulation between APOE3 and APOE4 homozygotes. That was surprising given the much earlier presentation of clinical symptoms and biomarkers in those who carried two copies of APOE4.
More Than a Risk Factor
Overall, study findings provide evidence that APOE4 homozygotes represent another form of genetically determined Alzheimer’s disease, similar to autosomal-dominant Alzheimer’s disease and down syndrome-associated Alzheimer’s disease, investigators said.
“Our work showed that APOE4 homozygotes meet the three main characteristics of genetically determined Alzheimer’s disease, namely near-full penetrance, symptom onset predictability and a predictable sequence of biomarker and clinical changes,” they wrote.
Based on the results, investigators recommend that future clinical trials avoid combining single and double APOE4 carriers into one study group.
Because the global average proportion of APOE4 homozygotes is estimated to be approximately 2%, APOE4-homozygous Alzheimer’s disease may represent one of the most frequently occurring Mendelian diseases worldwide. This could have implications for genetic counseling and genetic screening recommendations, they said.
“We may need to start treating these homozygotes as a separate group in our research so we can really understand the relation between amyloid and tau and symptoms in E4 homozygotes in a way that we have not been able to because of our practice in the field of thinking that APOE4 is this unitary risk effect,” co-investigator Sterling Johnson, PhD, professor of geriatrics and dementia, University of Wisconsin-Madison, said at a press briefing.
The findings may also have implications for Alzheimer’s disease prevention, investigators added.
“What’s particularly important is the promise that perhaps we could treat people before symptoms, particularly in people who already have the disease in their brain such as APOE4 homozygotes, which reliably predicts that they will have impairment and try to treat them beforehand,” co-investigator Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment at Brigham and Women›s Hospital and Massachusetts General Hospital, Boston, said at a press briefing.
“This is important for preventing Alzheimer’s-related dementia and a real movement forward in defining the disease on the basis of genetics and biomarkers,” she added.
Experts Offer Mixed Reactions
Commenting on the findings, Paul Mathews, MD, DPhil, group leader of the UK Dementia Research Institute Centre at Imperial College, said that the data point to a need to look at APOE4 differently.
“One implication of this work is that testing for APOE4 gene homozygosity should be assessed for use clinically, when late middle-aged people present to their doctors with symptoms of dementia,” Dr. Mathews, who was not part of the study, said in a statement.
In an accompany editorial, Yadong Huang, MD, PhD, Departments of Neurology and Pathology, University of California, San Francisco, and co-authors noted that the findings also have implications for clinical drug trials.
“So far, APOE4 homozygotes have not been treated as a separate predefined treatment group in clinical trials,” they wrote. “Following this study, APOE4 status must be recognized as a crucial parameter in trial design, patient recruitment and data analysis, with APOE4 homozygotes and heterozygotes being clearly separated. Such an approach may enhance the treatment efficacy and help tailor therapeutic interventions more effectively towards genetically defined patient populations.”
Other experts urge caution when interpreting the findings.
“It is clear that APOE4 homozygosity is tightly linked to the appearance of Alzheimer’s-related pathology, but even at age 80, 12% of people with APOE4/E4 did not have amyloid/tau biomarkers,” said Yuko Hara, PhD, director of aging and Alzheimer’s disease prevention at the Alzheimer’s Drug Discovery Foundation. “Also, having two copies of APOE4 does not mean you will definitely develop symptoms of Alzheimer’s disease in your lifetime,” Dr. Hara added.
Researchers have long known that APOE4 is a strong risk factor for Alzheimer’s disease and that people with two copies of the gene are at especially high risk, David Curtis, MD, PhD, Genetics Institute at University of College London, England, said in a statement.
“I do not see anything in this paper to justify the claim that carrying two copies of APOE4 represents some ‘distinct genetic form’ of Alzheimer’s disease,” Dr. Curtis said. “No matter how many alleles of APOE4 one carries, the underlying disease processes seem similar across cases of Alzheimer’s disease, suggesting that any effective treatment and prevention strategies, which have yet to be developed would have broad applicability.”
Study funders included Fondo de Investigaciones Sanitario, Carlos III Health Institute, Fondo Europeo de Desarrollo Regional, Unión Europea, National Institutes of Health, the Department de Salut de la Generalitat de Catalunya, Horizon 2020–Research and Innovation Framework Programme from the European Union, La Caixa Foundation, EIT Digital, and the Alzheimer Association. Dr. Fortea reported receiving personal fees for service on the advisory boards, adjudication committees or speaker honoraria from AC Immune, Adamed, Alzheon, Biogen, Eisai, Esteve, Fujirebio, Ionis, Laboratorios Carnot, Life Molecular Imaging, Lilly, Lundbeck, Perha, Roche, and outside the submitted work. Dr. Johnson has served at scientific advisory boards for ALZPath, Enigma and Roche Diagnostics. Dr. Sperling has received personal consulting fees from AbbVie, AC Immune, Acumen, Alector, Bristol Myers Squibb, Janssen, Genentech, Ionis and Vaxxinity outside the submitted work. Dr. Huang is a co-founder and scientific advisory board member of GABAeron, Inc. Dr. Mathews reports consultancies with Sudo Biosciences, Nimbus, Redburn. Dr. Hara and Dr. Curtis reported no conflicts. Complete funding sources and disclosures are included in the original articles.
A version of this article appeared on Medscape.com.
, a new study suggests.
More than 95% of those with two copies of the gene (APOE4 homozygotes) in a large multicohort study had higher levels of Alzheimer’s disease biomarkers by age 55 years than did those with other APOE gene variants. By age 65 years, most had developed Alzheimer’s disease symptoms and showed abnormal amyloid levels in cerebrospinal fluid and on PET.
Investigators said that such a high penetrance of Alzheimer’s disease pathology in this group suggests that APOE4 may not be just a risk factor for Alzheimer’s disease but also a distinct genetic form of the disease.
“Sometimes, we say we don’t know the cause of Alzheimer’s disease, but this would be behind 15%-20% of the population of people with Alzheimer’s disease,” lead investigator Juan Fortea, MD, PhD, director of the Memory Unit of the Neurology Department at the Hospital of Sant Pau, Barcelona, Spain, said at a press briefing.
Although some experts urge caution in interpreting these results, investigators and others say the findings, published online in Nature Medicine, could lead to calls for more widespread testing for APOE4 and may spur drug development.
High AD Penetrance
Mutations in the APP, PSEN1, and PSEN2 genes are linked to risk for early-onset autosomal-dominant Alzheimer’s disease, and dozens of other genes are associated with greater odds of late-onset disease. Among all these genes, APOE is considered the strongest genetic risk factor for late-onset Alzheimer’s disease.
Prior studies found that APOE4 homozygotes have a 60% lifetime risk for Alzheimer’s disease by age 85 years, a risk higher than that found with other gene variants or in single APOE carriers or noncarriers.
Despite that, no previous study had examined the predictability of symptom onset in APOE4 homozygotes, which make up about 2%-3% of the general population and 15-20% of those with Alzheimer’s disease. And because most biomarker studies have combined single- and double-carrier APOE4 carriers into one group, very little was known about the penetrance or disease progression in APOE4 homozygotes.
Investigators analyzed data from 3200 brain donors from the National Alzheimer’s Coordinating Center and more than 10,000 people with Alzheimer’s disease biomarkers from five multicenter cohorts in the United States and Europe.
Nearly all APOE4 homozygotes had either high or intermediate Alzheimer’s disease neuropathologic change scores compared with about 50% among APOE3 homozygotes and was the same regardless of age at time of death.
Beginning at age 55 years, APOE4 homozygotes exhibited higher levels of abnormal Alzheimer’s disease biomarkers than did APOE3 homozygotes. By age 65 years, nearly everyone with two copies of APOE4 showed abnormal levels of amyloid in cerebrospinal fluid and 75% had positive amyloid scans.
Other biomarkers showed a biologic penetrance of Alzheimer’s disease that increased with age. By age 80 years, penetrance for all amyloid and tau biomarkers reached 88%.
Postmortem analysis revealed Alzheimer’s disease and dementia symptoms were evident in APOE4 homozygotes 7-10 years before APOE3 homozygotes, with Alzheimer’s disease symptoms present at age 65 years, minor cognitive impairment at 72 years, dementia at 74 years, and death at 77 years (P <.05 differences).
When they limited analysis to only those who developed Alzheimer’s disease dementia, investigators found no difference in amyloid or tau accumulation between APOE3 and APOE4 homozygotes. That was surprising given the much earlier presentation of clinical symptoms and biomarkers in those who carried two copies of APOE4.
More Than a Risk Factor
Overall, study findings provide evidence that APOE4 homozygotes represent another form of genetically determined Alzheimer’s disease, similar to autosomal-dominant Alzheimer’s disease and down syndrome-associated Alzheimer’s disease, investigators said.
“Our work showed that APOE4 homozygotes meet the three main characteristics of genetically determined Alzheimer’s disease, namely near-full penetrance, symptom onset predictability and a predictable sequence of biomarker and clinical changes,” they wrote.
Based on the results, investigators recommend that future clinical trials avoid combining single and double APOE4 carriers into one study group.
Because the global average proportion of APOE4 homozygotes is estimated to be approximately 2%, APOE4-homozygous Alzheimer’s disease may represent one of the most frequently occurring Mendelian diseases worldwide. This could have implications for genetic counseling and genetic screening recommendations, they said.
“We may need to start treating these homozygotes as a separate group in our research so we can really understand the relation between amyloid and tau and symptoms in E4 homozygotes in a way that we have not been able to because of our practice in the field of thinking that APOE4 is this unitary risk effect,” co-investigator Sterling Johnson, PhD, professor of geriatrics and dementia, University of Wisconsin-Madison, said at a press briefing.
The findings may also have implications for Alzheimer’s disease prevention, investigators added.
“What’s particularly important is the promise that perhaps we could treat people before symptoms, particularly in people who already have the disease in their brain such as APOE4 homozygotes, which reliably predicts that they will have impairment and try to treat them beforehand,” co-investigator Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment at Brigham and Women›s Hospital and Massachusetts General Hospital, Boston, said at a press briefing.
“This is important for preventing Alzheimer’s-related dementia and a real movement forward in defining the disease on the basis of genetics and biomarkers,” she added.
Experts Offer Mixed Reactions
Commenting on the findings, Paul Mathews, MD, DPhil, group leader of the UK Dementia Research Institute Centre at Imperial College, said that the data point to a need to look at APOE4 differently.
“One implication of this work is that testing for APOE4 gene homozygosity should be assessed for use clinically, when late middle-aged people present to their doctors with symptoms of dementia,” Dr. Mathews, who was not part of the study, said in a statement.
In an accompany editorial, Yadong Huang, MD, PhD, Departments of Neurology and Pathology, University of California, San Francisco, and co-authors noted that the findings also have implications for clinical drug trials.
“So far, APOE4 homozygotes have not been treated as a separate predefined treatment group in clinical trials,” they wrote. “Following this study, APOE4 status must be recognized as a crucial parameter in trial design, patient recruitment and data analysis, with APOE4 homozygotes and heterozygotes being clearly separated. Such an approach may enhance the treatment efficacy and help tailor therapeutic interventions more effectively towards genetically defined patient populations.”
Other experts urge caution when interpreting the findings.
“It is clear that APOE4 homozygosity is tightly linked to the appearance of Alzheimer’s-related pathology, but even at age 80, 12% of people with APOE4/E4 did not have amyloid/tau biomarkers,” said Yuko Hara, PhD, director of aging and Alzheimer’s disease prevention at the Alzheimer’s Drug Discovery Foundation. “Also, having two copies of APOE4 does not mean you will definitely develop symptoms of Alzheimer’s disease in your lifetime,” Dr. Hara added.
Researchers have long known that APOE4 is a strong risk factor for Alzheimer’s disease and that people with two copies of the gene are at especially high risk, David Curtis, MD, PhD, Genetics Institute at University of College London, England, said in a statement.
“I do not see anything in this paper to justify the claim that carrying two copies of APOE4 represents some ‘distinct genetic form’ of Alzheimer’s disease,” Dr. Curtis said. “No matter how many alleles of APOE4 one carries, the underlying disease processes seem similar across cases of Alzheimer’s disease, suggesting that any effective treatment and prevention strategies, which have yet to be developed would have broad applicability.”
Study funders included Fondo de Investigaciones Sanitario, Carlos III Health Institute, Fondo Europeo de Desarrollo Regional, Unión Europea, National Institutes of Health, the Department de Salut de la Generalitat de Catalunya, Horizon 2020–Research and Innovation Framework Programme from the European Union, La Caixa Foundation, EIT Digital, and the Alzheimer Association. Dr. Fortea reported receiving personal fees for service on the advisory boards, adjudication committees or speaker honoraria from AC Immune, Adamed, Alzheon, Biogen, Eisai, Esteve, Fujirebio, Ionis, Laboratorios Carnot, Life Molecular Imaging, Lilly, Lundbeck, Perha, Roche, and outside the submitted work. Dr. Johnson has served at scientific advisory boards for ALZPath, Enigma and Roche Diagnostics. Dr. Sperling has received personal consulting fees from AbbVie, AC Immune, Acumen, Alector, Bristol Myers Squibb, Janssen, Genentech, Ionis and Vaxxinity outside the submitted work. Dr. Huang is a co-founder and scientific advisory board member of GABAeron, Inc. Dr. Mathews reports consultancies with Sudo Biosciences, Nimbus, Redburn. Dr. Hara and Dr. Curtis reported no conflicts. Complete funding sources and disclosures are included in the original articles.
A version of this article appeared on Medscape.com.
, a new study suggests.
More than 95% of those with two copies of the gene (APOE4 homozygotes) in a large multicohort study had higher levels of Alzheimer’s disease biomarkers by age 55 years than did those with other APOE gene variants. By age 65 years, most had developed Alzheimer’s disease symptoms and showed abnormal amyloid levels in cerebrospinal fluid and on PET.
Investigators said that such a high penetrance of Alzheimer’s disease pathology in this group suggests that APOE4 may not be just a risk factor for Alzheimer’s disease but also a distinct genetic form of the disease.
“Sometimes, we say we don’t know the cause of Alzheimer’s disease, but this would be behind 15%-20% of the population of people with Alzheimer’s disease,” lead investigator Juan Fortea, MD, PhD, director of the Memory Unit of the Neurology Department at the Hospital of Sant Pau, Barcelona, Spain, said at a press briefing.
Although some experts urge caution in interpreting these results, investigators and others say the findings, published online in Nature Medicine, could lead to calls for more widespread testing for APOE4 and may spur drug development.
High AD Penetrance
Mutations in the APP, PSEN1, and PSEN2 genes are linked to risk for early-onset autosomal-dominant Alzheimer’s disease, and dozens of other genes are associated with greater odds of late-onset disease. Among all these genes, APOE is considered the strongest genetic risk factor for late-onset Alzheimer’s disease.
Prior studies found that APOE4 homozygotes have a 60% lifetime risk for Alzheimer’s disease by age 85 years, a risk higher than that found with other gene variants or in single APOE carriers or noncarriers.
Despite that, no previous study had examined the predictability of symptom onset in APOE4 homozygotes, which make up about 2%-3% of the general population and 15-20% of those with Alzheimer’s disease. And because most biomarker studies have combined single- and double-carrier APOE4 carriers into one group, very little was known about the penetrance or disease progression in APOE4 homozygotes.
Investigators analyzed data from 3200 brain donors from the National Alzheimer’s Coordinating Center and more than 10,000 people with Alzheimer’s disease biomarkers from five multicenter cohorts in the United States and Europe.
Nearly all APOE4 homozygotes had either high or intermediate Alzheimer’s disease neuropathologic change scores compared with about 50% among APOE3 homozygotes and was the same regardless of age at time of death.
Beginning at age 55 years, APOE4 homozygotes exhibited higher levels of abnormal Alzheimer’s disease biomarkers than did APOE3 homozygotes. By age 65 years, nearly everyone with two copies of APOE4 showed abnormal levels of amyloid in cerebrospinal fluid and 75% had positive amyloid scans.
Other biomarkers showed a biologic penetrance of Alzheimer’s disease that increased with age. By age 80 years, penetrance for all amyloid and tau biomarkers reached 88%.
Postmortem analysis revealed Alzheimer’s disease and dementia symptoms were evident in APOE4 homozygotes 7-10 years before APOE3 homozygotes, with Alzheimer’s disease symptoms present at age 65 years, minor cognitive impairment at 72 years, dementia at 74 years, and death at 77 years (P <.05 differences).
When they limited analysis to only those who developed Alzheimer’s disease dementia, investigators found no difference in amyloid or tau accumulation between APOE3 and APOE4 homozygotes. That was surprising given the much earlier presentation of clinical symptoms and biomarkers in those who carried two copies of APOE4.
More Than a Risk Factor
Overall, study findings provide evidence that APOE4 homozygotes represent another form of genetically determined Alzheimer’s disease, similar to autosomal-dominant Alzheimer’s disease and down syndrome-associated Alzheimer’s disease, investigators said.
“Our work showed that APOE4 homozygotes meet the three main characteristics of genetically determined Alzheimer’s disease, namely near-full penetrance, symptom onset predictability and a predictable sequence of biomarker and clinical changes,” they wrote.
Based on the results, investigators recommend that future clinical trials avoid combining single and double APOE4 carriers into one study group.
Because the global average proportion of APOE4 homozygotes is estimated to be approximately 2%, APOE4-homozygous Alzheimer’s disease may represent one of the most frequently occurring Mendelian diseases worldwide. This could have implications for genetic counseling and genetic screening recommendations, they said.
“We may need to start treating these homozygotes as a separate group in our research so we can really understand the relation between amyloid and tau and symptoms in E4 homozygotes in a way that we have not been able to because of our practice in the field of thinking that APOE4 is this unitary risk effect,” co-investigator Sterling Johnson, PhD, professor of geriatrics and dementia, University of Wisconsin-Madison, said at a press briefing.
The findings may also have implications for Alzheimer’s disease prevention, investigators added.
“What’s particularly important is the promise that perhaps we could treat people before symptoms, particularly in people who already have the disease in their brain such as APOE4 homozygotes, which reliably predicts that they will have impairment and try to treat them beforehand,” co-investigator Reisa Sperling, MD, director of the Center for Alzheimer Research and Treatment at Brigham and Women›s Hospital and Massachusetts General Hospital, Boston, said at a press briefing.
“This is important for preventing Alzheimer’s-related dementia and a real movement forward in defining the disease on the basis of genetics and biomarkers,” she added.
Experts Offer Mixed Reactions
Commenting on the findings, Paul Mathews, MD, DPhil, group leader of the UK Dementia Research Institute Centre at Imperial College, said that the data point to a need to look at APOE4 differently.
“One implication of this work is that testing for APOE4 gene homozygosity should be assessed for use clinically, when late middle-aged people present to their doctors with symptoms of dementia,” Dr. Mathews, who was not part of the study, said in a statement.
In an accompany editorial, Yadong Huang, MD, PhD, Departments of Neurology and Pathology, University of California, San Francisco, and co-authors noted that the findings also have implications for clinical drug trials.
“So far, APOE4 homozygotes have not been treated as a separate predefined treatment group in clinical trials,” they wrote. “Following this study, APOE4 status must be recognized as a crucial parameter in trial design, patient recruitment and data analysis, with APOE4 homozygotes and heterozygotes being clearly separated. Such an approach may enhance the treatment efficacy and help tailor therapeutic interventions more effectively towards genetically defined patient populations.”
Other experts urge caution when interpreting the findings.
“It is clear that APOE4 homozygosity is tightly linked to the appearance of Alzheimer’s-related pathology, but even at age 80, 12% of people with APOE4/E4 did not have amyloid/tau biomarkers,” said Yuko Hara, PhD, director of aging and Alzheimer’s disease prevention at the Alzheimer’s Drug Discovery Foundation. “Also, having two copies of APOE4 does not mean you will definitely develop symptoms of Alzheimer’s disease in your lifetime,” Dr. Hara added.
Researchers have long known that APOE4 is a strong risk factor for Alzheimer’s disease and that people with two copies of the gene are at especially high risk, David Curtis, MD, PhD, Genetics Institute at University of College London, England, said in a statement.
“I do not see anything in this paper to justify the claim that carrying two copies of APOE4 represents some ‘distinct genetic form’ of Alzheimer’s disease,” Dr. Curtis said. “No matter how many alleles of APOE4 one carries, the underlying disease processes seem similar across cases of Alzheimer’s disease, suggesting that any effective treatment and prevention strategies, which have yet to be developed would have broad applicability.”
Study funders included Fondo de Investigaciones Sanitario, Carlos III Health Institute, Fondo Europeo de Desarrollo Regional, Unión Europea, National Institutes of Health, the Department de Salut de la Generalitat de Catalunya, Horizon 2020–Research and Innovation Framework Programme from the European Union, La Caixa Foundation, EIT Digital, and the Alzheimer Association. Dr. Fortea reported receiving personal fees for service on the advisory boards, adjudication committees or speaker honoraria from AC Immune, Adamed, Alzheon, Biogen, Eisai, Esteve, Fujirebio, Ionis, Laboratorios Carnot, Life Molecular Imaging, Lilly, Lundbeck, Perha, Roche, and outside the submitted work. Dr. Johnson has served at scientific advisory boards for ALZPath, Enigma and Roche Diagnostics. Dr. Sperling has received personal consulting fees from AbbVie, AC Immune, Acumen, Alector, Bristol Myers Squibb, Janssen, Genentech, Ionis and Vaxxinity outside the submitted work. Dr. Huang is a co-founder and scientific advisory board member of GABAeron, Inc. Dr. Mathews reports consultancies with Sudo Biosciences, Nimbus, Redburn. Dr. Hara and Dr. Curtis reported no conflicts. Complete funding sources and disclosures are included in the original articles.
A version of this article appeared on Medscape.com.
From Nature Medicine