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Is Screen Time to Blame for Rising Rates of Myopia in Children?
TOPLINE:
More time spent exposed to screens is associated with a higher risk for myopia in children and adolescents; the use of computers and televisions appears to have the most significant effects on eye health.
METHODOLOGY:
- Researchers conducted a meta-analysis of 19 studies involving 102,360 children and adolescents to assess the association between screen time and myopia.
- Data were collected from studies published before June 1, 2023, in three databases: PubMed, Embase, and Web of Science.
- Screen time was categorized by device type, including computers, televisions, and smartphones, and analyzed using random or fixed-effect models.
- The analysis included both cohort and cross-sectional studies.
TAKEAWAY:
- High exposure to screen time was significantly associated with myopia in both cross-sectional (odds ratio [OR], 2.24; 95% confidence interval (CI), 1.47-3.42) and cohort studies (OR, 2.39; 95% CI, 2.07-2.76).
- In cohort studies, each extra hour per day spent using screens increased the risk for myopia by 7% (95% CI, 1.01-1.13).
- Subgroup analyses revealed significant associations between myopia and screen time on computers (OR, 8.19; 95% CI, 4.78-14.04) and televisions (OR, 1.46; 95% CI, 1.02-2.10), whereas time spent using smartphones was not significantly associated with myopia.
IN PRACTICE:
“With the development of technology and GDP [gross domestic product], educational pressure may lead students to use screen devices such as smartphones and computers for long periods of time to learn online courses, receive additional tutoring or practice, and increase the incidence of myopia,” wrote the authors.
SOURCE:
The study was led by Zhiqiang Zong of Anhui Medical University in Hefei, China. It was published online in BMC Public Health.
LIMITATIONS:
The majority of the studies included were cross-sectional, which cannot establish causality. High heterogeneity was found among the included studies, possibly due to differences in research design, population characteristics, and exposure levels. Some studies did not adjust for important confounding factors such as outdoor activities.
DISCLOSURES:
The study was supported by grants from the Educational Commission of Anhui Province of China, Research Fund of Anhui Institute of Translational Medicine, and National Natural Science Foundation of China. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
More time spent exposed to screens is associated with a higher risk for myopia in children and adolescents; the use of computers and televisions appears to have the most significant effects on eye health.
METHODOLOGY:
- Researchers conducted a meta-analysis of 19 studies involving 102,360 children and adolescents to assess the association between screen time and myopia.
- Data were collected from studies published before June 1, 2023, in three databases: PubMed, Embase, and Web of Science.
- Screen time was categorized by device type, including computers, televisions, and smartphones, and analyzed using random or fixed-effect models.
- The analysis included both cohort and cross-sectional studies.
TAKEAWAY:
- High exposure to screen time was significantly associated with myopia in both cross-sectional (odds ratio [OR], 2.24; 95% confidence interval (CI), 1.47-3.42) and cohort studies (OR, 2.39; 95% CI, 2.07-2.76).
- In cohort studies, each extra hour per day spent using screens increased the risk for myopia by 7% (95% CI, 1.01-1.13).
- Subgroup analyses revealed significant associations between myopia and screen time on computers (OR, 8.19; 95% CI, 4.78-14.04) and televisions (OR, 1.46; 95% CI, 1.02-2.10), whereas time spent using smartphones was not significantly associated with myopia.
IN PRACTICE:
“With the development of technology and GDP [gross domestic product], educational pressure may lead students to use screen devices such as smartphones and computers for long periods of time to learn online courses, receive additional tutoring or practice, and increase the incidence of myopia,” wrote the authors.
SOURCE:
The study was led by Zhiqiang Zong of Anhui Medical University in Hefei, China. It was published online in BMC Public Health.
LIMITATIONS:
The majority of the studies included were cross-sectional, which cannot establish causality. High heterogeneity was found among the included studies, possibly due to differences in research design, population characteristics, and exposure levels. Some studies did not adjust for important confounding factors such as outdoor activities.
DISCLOSURES:
The study was supported by grants from the Educational Commission of Anhui Province of China, Research Fund of Anhui Institute of Translational Medicine, and National Natural Science Foundation of China. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
More time spent exposed to screens is associated with a higher risk for myopia in children and adolescents; the use of computers and televisions appears to have the most significant effects on eye health.
METHODOLOGY:
- Researchers conducted a meta-analysis of 19 studies involving 102,360 children and adolescents to assess the association between screen time and myopia.
- Data were collected from studies published before June 1, 2023, in three databases: PubMed, Embase, and Web of Science.
- Screen time was categorized by device type, including computers, televisions, and smartphones, and analyzed using random or fixed-effect models.
- The analysis included both cohort and cross-sectional studies.
TAKEAWAY:
- High exposure to screen time was significantly associated with myopia in both cross-sectional (odds ratio [OR], 2.24; 95% confidence interval (CI), 1.47-3.42) and cohort studies (OR, 2.39; 95% CI, 2.07-2.76).
- In cohort studies, each extra hour per day spent using screens increased the risk for myopia by 7% (95% CI, 1.01-1.13).
- Subgroup analyses revealed significant associations between myopia and screen time on computers (OR, 8.19; 95% CI, 4.78-14.04) and televisions (OR, 1.46; 95% CI, 1.02-2.10), whereas time spent using smartphones was not significantly associated with myopia.
IN PRACTICE:
“With the development of technology and GDP [gross domestic product], educational pressure may lead students to use screen devices such as smartphones and computers for long periods of time to learn online courses, receive additional tutoring or practice, and increase the incidence of myopia,” wrote the authors.
SOURCE:
The study was led by Zhiqiang Zong of Anhui Medical University in Hefei, China. It was published online in BMC Public Health.
LIMITATIONS:
The majority of the studies included were cross-sectional, which cannot establish causality. High heterogeneity was found among the included studies, possibly due to differences in research design, population characteristics, and exposure levels. Some studies did not adjust for important confounding factors such as outdoor activities.
DISCLOSURES:
The study was supported by grants from the Educational Commission of Anhui Province of China, Research Fund of Anhui Institute of Translational Medicine, and National Natural Science Foundation of China. The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
AML: Shorter Venetoclax Course Shows Promise for Some
However, the azacitidine plus venetoclax therapy — the “7+7” regimen — was associated with lower platelet transfusion requirements and lower 8-week mortality, suggesting the regimen might be preferable in certain patient populations, Alexandre Bazinet, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The composite complete remission (CRc) rate, including complete remission with or without complete count recovery, was identical at 72% among 82 patients treated with the 7+7 regimen and 166 treated with standard therapy, and the complete remission (CR) rate was 57% and 55%, respectively, Dr. Bazinet said.
The median number of cycles to first response was one in both groups, but 42% of responders in the 7+7 group required more than one cycle to achieve their first response, compared with just 1% of those in the standard therapy group, he noted, adding that the median number of cycles to achieve best response was two in the 7+7 group and one in the standard therapy group.
The mortality rate at 4 weeks was similar in the groups (2% vs 5% for 7+7 vs standard therapy), but at 8 weeks, the mortality rate was significantly higher in the standard therapy group (6% vs 16%, respectively). Median overall survival (OS) was 11.2 months versus 10.3 months, and median 2-year survival was 27.7% versus 33.6% in the groups, respectively.
Event-free survival was 6.5 versus 7.4 months, and 2-year event-free survival was 24.5% versus 27.0%, respectively.
Of note, fewer patients in the 7+7 group required platelet transfusions during cycle 1 (62% vs 77%) and the cycle 1 rates of neutropenic fever and red cell transfusion requirements were similar in the two treatment groups, Dr. Bazinet said.
Study participants were 82 adults from seven centers in France who received the 7+7 regimen, and 166 adults from MD Anderson who received standard therapy with a hypomethylating agent plus venetoclax doublets given for 21-28 days during induction. Preliminary data on the 7+7 regimen in patients from the French centers were reported previously and “suggested preserved efficacy with potentially less toxicity,” he noted.
“A hypomethylating agent plus venetoclax doublets are standard-of-care in patients with AML who are older or ineligible for chemotherapy due to comorbidities,” Dr. Bazinet explained, adding that although the venetoclax label calls for 28 days of drug per cycle, shorter courses of 14 to 21 days are commonly used.
These findings are limited by the retrospective study design and by small patient numbers in many subgroups, he said.
“In addition, the cohorts were heterogeneous, consisting of patients treated with a variety of different regimens and across multiple centers and countries. The distribution of FLT3-ITD and NRAS/KRAS mutations differed significantly between cohorts,” he explained, also noting that prophylactic azole use differed across the cohort. “Furthermore, analysis of the toxicity results was also limited by likely differing transfusion polices in different centers.”
Overall, however, the findings suggest that reducing the duration of venetoclax is safe and results in similar CRc rates, although responses may be faster with standard dosing, he said, adding that “7+7 is potentially less toxic and is attractive in patients who are more frail or at risk for complications.”
“Our data support further study of shorter venetoclax duration, within emerging triplet regimens in patients with intermediate or low predictive benefit to mitigate toxicity,” he concluded.
Dr. Bazinet reported having no disclosures.
However, the azacitidine plus venetoclax therapy — the “7+7” regimen — was associated with lower platelet transfusion requirements and lower 8-week mortality, suggesting the regimen might be preferable in certain patient populations, Alexandre Bazinet, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The composite complete remission (CRc) rate, including complete remission with or without complete count recovery, was identical at 72% among 82 patients treated with the 7+7 regimen and 166 treated with standard therapy, and the complete remission (CR) rate was 57% and 55%, respectively, Dr. Bazinet said.
The median number of cycles to first response was one in both groups, but 42% of responders in the 7+7 group required more than one cycle to achieve their first response, compared with just 1% of those in the standard therapy group, he noted, adding that the median number of cycles to achieve best response was two in the 7+7 group and one in the standard therapy group.
The mortality rate at 4 weeks was similar in the groups (2% vs 5% for 7+7 vs standard therapy), but at 8 weeks, the mortality rate was significantly higher in the standard therapy group (6% vs 16%, respectively). Median overall survival (OS) was 11.2 months versus 10.3 months, and median 2-year survival was 27.7% versus 33.6% in the groups, respectively.
Event-free survival was 6.5 versus 7.4 months, and 2-year event-free survival was 24.5% versus 27.0%, respectively.
Of note, fewer patients in the 7+7 group required platelet transfusions during cycle 1 (62% vs 77%) and the cycle 1 rates of neutropenic fever and red cell transfusion requirements were similar in the two treatment groups, Dr. Bazinet said.
Study participants were 82 adults from seven centers in France who received the 7+7 regimen, and 166 adults from MD Anderson who received standard therapy with a hypomethylating agent plus venetoclax doublets given for 21-28 days during induction. Preliminary data on the 7+7 regimen in patients from the French centers were reported previously and “suggested preserved efficacy with potentially less toxicity,” he noted.
“A hypomethylating agent plus venetoclax doublets are standard-of-care in patients with AML who are older or ineligible for chemotherapy due to comorbidities,” Dr. Bazinet explained, adding that although the venetoclax label calls for 28 days of drug per cycle, shorter courses of 14 to 21 days are commonly used.
These findings are limited by the retrospective study design and by small patient numbers in many subgroups, he said.
“In addition, the cohorts were heterogeneous, consisting of patients treated with a variety of different regimens and across multiple centers and countries. The distribution of FLT3-ITD and NRAS/KRAS mutations differed significantly between cohorts,” he explained, also noting that prophylactic azole use differed across the cohort. “Furthermore, analysis of the toxicity results was also limited by likely differing transfusion polices in different centers.”
Overall, however, the findings suggest that reducing the duration of venetoclax is safe and results in similar CRc rates, although responses may be faster with standard dosing, he said, adding that “7+7 is potentially less toxic and is attractive in patients who are more frail or at risk for complications.”
“Our data support further study of shorter venetoclax duration, within emerging triplet regimens in patients with intermediate or low predictive benefit to mitigate toxicity,” he concluded.
Dr. Bazinet reported having no disclosures.
However, the azacitidine plus venetoclax therapy — the “7+7” regimen — was associated with lower platelet transfusion requirements and lower 8-week mortality, suggesting the regimen might be preferable in certain patient populations, Alexandre Bazinet, MD, of the University of Texas MD Anderson Cancer Center, Houston, reported at the American Society of Clinical Oncology (ASCO) annual meeting.
The composite complete remission (CRc) rate, including complete remission with or without complete count recovery, was identical at 72% among 82 patients treated with the 7+7 regimen and 166 treated with standard therapy, and the complete remission (CR) rate was 57% and 55%, respectively, Dr. Bazinet said.
The median number of cycles to first response was one in both groups, but 42% of responders in the 7+7 group required more than one cycle to achieve their first response, compared with just 1% of those in the standard therapy group, he noted, adding that the median number of cycles to achieve best response was two in the 7+7 group and one in the standard therapy group.
The mortality rate at 4 weeks was similar in the groups (2% vs 5% for 7+7 vs standard therapy), but at 8 weeks, the mortality rate was significantly higher in the standard therapy group (6% vs 16%, respectively). Median overall survival (OS) was 11.2 months versus 10.3 months, and median 2-year survival was 27.7% versus 33.6% in the groups, respectively.
Event-free survival was 6.5 versus 7.4 months, and 2-year event-free survival was 24.5% versus 27.0%, respectively.
Of note, fewer patients in the 7+7 group required platelet transfusions during cycle 1 (62% vs 77%) and the cycle 1 rates of neutropenic fever and red cell transfusion requirements were similar in the two treatment groups, Dr. Bazinet said.
Study participants were 82 adults from seven centers in France who received the 7+7 regimen, and 166 adults from MD Anderson who received standard therapy with a hypomethylating agent plus venetoclax doublets given for 21-28 days during induction. Preliminary data on the 7+7 regimen in patients from the French centers were reported previously and “suggested preserved efficacy with potentially less toxicity,” he noted.
“A hypomethylating agent plus venetoclax doublets are standard-of-care in patients with AML who are older or ineligible for chemotherapy due to comorbidities,” Dr. Bazinet explained, adding that although the venetoclax label calls for 28 days of drug per cycle, shorter courses of 14 to 21 days are commonly used.
These findings are limited by the retrospective study design and by small patient numbers in many subgroups, he said.
“In addition, the cohorts were heterogeneous, consisting of patients treated with a variety of different regimens and across multiple centers and countries. The distribution of FLT3-ITD and NRAS/KRAS mutations differed significantly between cohorts,” he explained, also noting that prophylactic azole use differed across the cohort. “Furthermore, analysis of the toxicity results was also limited by likely differing transfusion polices in different centers.”
Overall, however, the findings suggest that reducing the duration of venetoclax is safe and results in similar CRc rates, although responses may be faster with standard dosing, he said, adding that “7+7 is potentially less toxic and is attractive in patients who are more frail or at risk for complications.”
“Our data support further study of shorter venetoclax duration, within emerging triplet regimens in patients with intermediate or low predictive benefit to mitigate toxicity,” he concluded.
Dr. Bazinet reported having no disclosures.
FROM ASCO 2024
Climate Change, Climate Anxiety, Climate Hope
Clinical Case: Sol is a 10 year-old cisgender White girl who appears sad at her annual well visit. On further inquiry she describes that her father is angry that there is no snow, her mother keeps talking about the forests disappearing, and local flooding closed down her favorite family restaurant for good. She is worried “the planet is in trouble and there’s nothing we can do” so much that she gets stomachaches when she thinks about it.
Climate Anxiety
Climate change is a complex phenomenon that has been subject to decades of political disagreement. Lobbying by groups like the fossil fuel industry, state legislation to implement recycling, oil spills and pollution disasters, and outspoken icons like former US Vice President Al Gore and Swedish activist Greta Thunberg have kept the climate crisis a hot topic. What was once a slow burn has begun to boil as climate-related disasters occur — wildfires, droughts, floods, and increasingly powerful and frequent severe weather events — alongside increasing temperatures globally. With heroic efforts, the UN-convened Paris Agreement was adopted by 196 nations in 2015 with ambitious goals to reduce global greenhouse emissions and limit Earth’s rising temperature.1 Yet doomsday headlines on this topic remain a regular occurrence.
Between sensationalized news coverage, political controversy, and international disasters, it is no wonder some youth are overwhelmed. .2 Direct effects could include a family losing their home to flooding or wildfires, resulting in post-traumatic stress symptoms or an anxiety disorder. Indirect effects might include a drought that results in loss of agricultural income leading to a forced migration, family stress and/or separation, and disordered substance use.
Add to these direct and indirect effects the cultural and media pressures, such as frequent debate about the consequences of failure to reduce greenhouse gas emissions by 2030,3 and youth can encounter a sense of existential dread that intersects squarely with their developmental trajectory. “Climate anxiety,” also called eco-anxiety or solastalgia, refers to “distress about climate change and its impacts on the landscape and human existence.”4 Eco-anxiety is not a formal psychiatric diagnosis and is not found in the DSM-5-TR.
In practice, existential climate-centered fears range from worrying about what to do to help with the climate crisis all the way to being overwhelmed about humanity’s future to the point of dysfunction. Some argue that this is not pathological, but rather a practical response to real-world phenomena.5 An international survey of youth found 59% were “very or extremely” worried about climate change with a mix of associated emotions, and almost half described eco-anxiety as something that affects their daily functioning.6 The climate crisis often amplifies the inequities already experienced by youth from historically marginalized groups.
Managing Climate Anxiety
Climate anxiety presents with many of the typical features of other anxieties. These include worries that cycle repetitively and intrusively through the mind, somatic distress such as headaches or stomachaches, and avoidance of things that remind one of the uncertainty and distress associated with climate change. Because the climate crisis is so global and complex, hopelessness and fatigue are not uncommon.
However, climate anxiety can often be ameliorated with the typical approaches to treating anxiety. Borrowing from cognitive-behavioral and mindfulness-based interventions, many recommendations have been offered to help with eco-anxiety. External validation of youth’s concerns and fears is a starting point that might build a teen’s capacity to tolerate distressing emotions about global warming.
Once reactions to climate change are acknowledged and accepted, space is created for reflection. This might include a balance of hope and pragmatic action. For example, renewable energy sources have made up an increasing share of the market over time with the world adding 50% more renewable capacity in 2023.7 Seventy-two percent of Americans acknowledge global warming, 75% feel schools should teach about consequences and solutions for global warming, and 79% support investment in renewable energy.8
Climate activism itself has been shown to buffer climate anxiety, particularly when implemented collectively rather than individually.4 Nature connectedness, or cognitive and emotional connections with nature, not only has many direct mental health benefits, but is also associated with climate activism.9 Many other integrative interventions can improve well-being while reducing ecological harm. Nutrition, physical activity, mindfulness, and sleep are youth mental health interventions with a strong evidence base that also reduce the carbon footprint and pollution attributable to psychiatric pharmaceuticals. Moreover, these climate-friendly interventions can improve family-connectedness, thus boosting resilience.
Without needing to become eco-warriors, healthcare providers can model sustainable practices while caring for patients. This might include having more plants in the office, recycling and composting at work, adding solar panels to the rooftop, or joining local parks prescription programs (see mygreendoctor.org, a nonprofit owned by the Florida Medical Association).
Next Steps
Sol is relieved to hear that many kids her age share her family’s concerns. A conversation about how to manage distressing emotions and physical feelings leads to a referral for brief cognitive behavioral interventions. Her parents join your visit to hear her concerns. They want to begin a family plan for climate action. You recommend the books How to Change Everything: The Young Human’s Guide to Protecting the Planet and Each Other by Naomi Klein and The Parents’ Guide to Climate Revolution: 100 Ways to Build a Fossil-Free Future, Raise Empowered Kids, and Still Get a Good Night’s Sleep by Mary DeMocker.
Dr. Rosenfeld is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington.
References
1. Maizland L. Global Climate Agreements: Successes and Failures. Council on Foreign Relations. https://www.cfr.org/backgrounder/paris-global-climate-change-agreements.
2. van Nieuwenhuizen A et al. The effects of climate change on child and adolescent mental health: Clinical considerations. Curr Psychiatry Rep. 2021 Dec 7;23(12):88. doi: 10.1007/s11920-021-01296-y.
3. Window to Reach Climate Goals ‘Rapidly Closing’, UN Report Warns. United Nations. https://news.un.org/en/story/2023/09/1140527.
4. Schwartz SEO et al. Climate change anxiety and mental health: Environmental activism as buffer. Curr Psychol. 2022 Feb 28:1-14. doi: 10.1007/s12144-022-02735-6.
5. Pihkala P. Anxiety and the ecological crisis: an analysis of eco-anxiety and climate anxiety. Sustainability. 2020;12:7836. doi: 10.3390/su12197836.
6. Hickman C et al. Climate Anxiety in Children and Young People and Their Beliefs About Government Responses to Climate Change: A Global Survey. Lancet Planet Health. 2021 Dec;5(12):e863-e873. doi: 10.1016/S2542-5196(21)00278-3.
7. IEA (2021), Global Energy Review 2021, IEA, Paris. https://www.iea.org/reports/global-energy-review-2021/renewables.
8. Marlon J et al. Yale Climate Opinion Maps 2023. https://climatecommunication.yale.edu/visualizations-data/ycom-us/.
9. Thomson EE, Roach SP. The Relationships Among Nature Connectedness, Climate Anxiety, Climate Action, Climate Knowledge, and Mental Health. Front Psychol. 2023 Nov 15:14:1241400. doi: 10.3389/fpsyg.2023.1241400.
Clinical Case: Sol is a 10 year-old cisgender White girl who appears sad at her annual well visit. On further inquiry she describes that her father is angry that there is no snow, her mother keeps talking about the forests disappearing, and local flooding closed down her favorite family restaurant for good. She is worried “the planet is in trouble and there’s nothing we can do” so much that she gets stomachaches when she thinks about it.
Climate Anxiety
Climate change is a complex phenomenon that has been subject to decades of political disagreement. Lobbying by groups like the fossil fuel industry, state legislation to implement recycling, oil spills and pollution disasters, and outspoken icons like former US Vice President Al Gore and Swedish activist Greta Thunberg have kept the climate crisis a hot topic. What was once a slow burn has begun to boil as climate-related disasters occur — wildfires, droughts, floods, and increasingly powerful and frequent severe weather events — alongside increasing temperatures globally. With heroic efforts, the UN-convened Paris Agreement was adopted by 196 nations in 2015 with ambitious goals to reduce global greenhouse emissions and limit Earth’s rising temperature.1 Yet doomsday headlines on this topic remain a regular occurrence.
Between sensationalized news coverage, political controversy, and international disasters, it is no wonder some youth are overwhelmed. .2 Direct effects could include a family losing their home to flooding or wildfires, resulting in post-traumatic stress symptoms or an anxiety disorder. Indirect effects might include a drought that results in loss of agricultural income leading to a forced migration, family stress and/or separation, and disordered substance use.
Add to these direct and indirect effects the cultural and media pressures, such as frequent debate about the consequences of failure to reduce greenhouse gas emissions by 2030,3 and youth can encounter a sense of existential dread that intersects squarely with their developmental trajectory. “Climate anxiety,” also called eco-anxiety or solastalgia, refers to “distress about climate change and its impacts on the landscape and human existence.”4 Eco-anxiety is not a formal psychiatric diagnosis and is not found in the DSM-5-TR.
In practice, existential climate-centered fears range from worrying about what to do to help with the climate crisis all the way to being overwhelmed about humanity’s future to the point of dysfunction. Some argue that this is not pathological, but rather a practical response to real-world phenomena.5 An international survey of youth found 59% were “very or extremely” worried about climate change with a mix of associated emotions, and almost half described eco-anxiety as something that affects their daily functioning.6 The climate crisis often amplifies the inequities already experienced by youth from historically marginalized groups.
Managing Climate Anxiety
Climate anxiety presents with many of the typical features of other anxieties. These include worries that cycle repetitively and intrusively through the mind, somatic distress such as headaches or stomachaches, and avoidance of things that remind one of the uncertainty and distress associated with climate change. Because the climate crisis is so global and complex, hopelessness and fatigue are not uncommon.
However, climate anxiety can often be ameliorated with the typical approaches to treating anxiety. Borrowing from cognitive-behavioral and mindfulness-based interventions, many recommendations have been offered to help with eco-anxiety. External validation of youth’s concerns and fears is a starting point that might build a teen’s capacity to tolerate distressing emotions about global warming.
Once reactions to climate change are acknowledged and accepted, space is created for reflection. This might include a balance of hope and pragmatic action. For example, renewable energy sources have made up an increasing share of the market over time with the world adding 50% more renewable capacity in 2023.7 Seventy-two percent of Americans acknowledge global warming, 75% feel schools should teach about consequences and solutions for global warming, and 79% support investment in renewable energy.8
Climate activism itself has been shown to buffer climate anxiety, particularly when implemented collectively rather than individually.4 Nature connectedness, or cognitive and emotional connections with nature, not only has many direct mental health benefits, but is also associated with climate activism.9 Many other integrative interventions can improve well-being while reducing ecological harm. Nutrition, physical activity, mindfulness, and sleep are youth mental health interventions with a strong evidence base that also reduce the carbon footprint and pollution attributable to psychiatric pharmaceuticals. Moreover, these climate-friendly interventions can improve family-connectedness, thus boosting resilience.
Without needing to become eco-warriors, healthcare providers can model sustainable practices while caring for patients. This might include having more plants in the office, recycling and composting at work, adding solar panels to the rooftop, or joining local parks prescription programs (see mygreendoctor.org, a nonprofit owned by the Florida Medical Association).
Next Steps
Sol is relieved to hear that many kids her age share her family’s concerns. A conversation about how to manage distressing emotions and physical feelings leads to a referral for brief cognitive behavioral interventions. Her parents join your visit to hear her concerns. They want to begin a family plan for climate action. You recommend the books How to Change Everything: The Young Human’s Guide to Protecting the Planet and Each Other by Naomi Klein and The Parents’ Guide to Climate Revolution: 100 Ways to Build a Fossil-Free Future, Raise Empowered Kids, and Still Get a Good Night’s Sleep by Mary DeMocker.
Dr. Rosenfeld is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington.
References
1. Maizland L. Global Climate Agreements: Successes and Failures. Council on Foreign Relations. https://www.cfr.org/backgrounder/paris-global-climate-change-agreements.
2. van Nieuwenhuizen A et al. The effects of climate change on child and adolescent mental health: Clinical considerations. Curr Psychiatry Rep. 2021 Dec 7;23(12):88. doi: 10.1007/s11920-021-01296-y.
3. Window to Reach Climate Goals ‘Rapidly Closing’, UN Report Warns. United Nations. https://news.un.org/en/story/2023/09/1140527.
4. Schwartz SEO et al. Climate change anxiety and mental health: Environmental activism as buffer. Curr Psychol. 2022 Feb 28:1-14. doi: 10.1007/s12144-022-02735-6.
5. Pihkala P. Anxiety and the ecological crisis: an analysis of eco-anxiety and climate anxiety. Sustainability. 2020;12:7836. doi: 10.3390/su12197836.
6. Hickman C et al. Climate Anxiety in Children and Young People and Their Beliefs About Government Responses to Climate Change: A Global Survey. Lancet Planet Health. 2021 Dec;5(12):e863-e873. doi: 10.1016/S2542-5196(21)00278-3.
7. IEA (2021), Global Energy Review 2021, IEA, Paris. https://www.iea.org/reports/global-energy-review-2021/renewables.
8. Marlon J et al. Yale Climate Opinion Maps 2023. https://climatecommunication.yale.edu/visualizations-data/ycom-us/.
9. Thomson EE, Roach SP. The Relationships Among Nature Connectedness, Climate Anxiety, Climate Action, Climate Knowledge, and Mental Health. Front Psychol. 2023 Nov 15:14:1241400. doi: 10.3389/fpsyg.2023.1241400.
Clinical Case: Sol is a 10 year-old cisgender White girl who appears sad at her annual well visit. On further inquiry she describes that her father is angry that there is no snow, her mother keeps talking about the forests disappearing, and local flooding closed down her favorite family restaurant for good. She is worried “the planet is in trouble and there’s nothing we can do” so much that she gets stomachaches when she thinks about it.
Climate Anxiety
Climate change is a complex phenomenon that has been subject to decades of political disagreement. Lobbying by groups like the fossil fuel industry, state legislation to implement recycling, oil spills and pollution disasters, and outspoken icons like former US Vice President Al Gore and Swedish activist Greta Thunberg have kept the climate crisis a hot topic. What was once a slow burn has begun to boil as climate-related disasters occur — wildfires, droughts, floods, and increasingly powerful and frequent severe weather events — alongside increasing temperatures globally. With heroic efforts, the UN-convened Paris Agreement was adopted by 196 nations in 2015 with ambitious goals to reduce global greenhouse emissions and limit Earth’s rising temperature.1 Yet doomsday headlines on this topic remain a regular occurrence.
Between sensationalized news coverage, political controversy, and international disasters, it is no wonder some youth are overwhelmed. .2 Direct effects could include a family losing their home to flooding or wildfires, resulting in post-traumatic stress symptoms or an anxiety disorder. Indirect effects might include a drought that results in loss of agricultural income leading to a forced migration, family stress and/or separation, and disordered substance use.
Add to these direct and indirect effects the cultural and media pressures, such as frequent debate about the consequences of failure to reduce greenhouse gas emissions by 2030,3 and youth can encounter a sense of existential dread that intersects squarely with their developmental trajectory. “Climate anxiety,” also called eco-anxiety or solastalgia, refers to “distress about climate change and its impacts on the landscape and human existence.”4 Eco-anxiety is not a formal psychiatric diagnosis and is not found in the DSM-5-TR.
In practice, existential climate-centered fears range from worrying about what to do to help with the climate crisis all the way to being overwhelmed about humanity’s future to the point of dysfunction. Some argue that this is not pathological, but rather a practical response to real-world phenomena.5 An international survey of youth found 59% were “very or extremely” worried about climate change with a mix of associated emotions, and almost half described eco-anxiety as something that affects their daily functioning.6 The climate crisis often amplifies the inequities already experienced by youth from historically marginalized groups.
Managing Climate Anxiety
Climate anxiety presents with many of the typical features of other anxieties. These include worries that cycle repetitively and intrusively through the mind, somatic distress such as headaches or stomachaches, and avoidance of things that remind one of the uncertainty and distress associated with climate change. Because the climate crisis is so global and complex, hopelessness and fatigue are not uncommon.
However, climate anxiety can often be ameliorated with the typical approaches to treating anxiety. Borrowing from cognitive-behavioral and mindfulness-based interventions, many recommendations have been offered to help with eco-anxiety. External validation of youth’s concerns and fears is a starting point that might build a teen’s capacity to tolerate distressing emotions about global warming.
Once reactions to climate change are acknowledged and accepted, space is created for reflection. This might include a balance of hope and pragmatic action. For example, renewable energy sources have made up an increasing share of the market over time with the world adding 50% more renewable capacity in 2023.7 Seventy-two percent of Americans acknowledge global warming, 75% feel schools should teach about consequences and solutions for global warming, and 79% support investment in renewable energy.8
Climate activism itself has been shown to buffer climate anxiety, particularly when implemented collectively rather than individually.4 Nature connectedness, or cognitive and emotional connections with nature, not only has many direct mental health benefits, but is also associated with climate activism.9 Many other integrative interventions can improve well-being while reducing ecological harm. Nutrition, physical activity, mindfulness, and sleep are youth mental health interventions with a strong evidence base that also reduce the carbon footprint and pollution attributable to psychiatric pharmaceuticals. Moreover, these climate-friendly interventions can improve family-connectedness, thus boosting resilience.
Without needing to become eco-warriors, healthcare providers can model sustainable practices while caring for patients. This might include having more plants in the office, recycling and composting at work, adding solar panels to the rooftop, or joining local parks prescription programs (see mygreendoctor.org, a nonprofit owned by the Florida Medical Association).
Next Steps
Sol is relieved to hear that many kids her age share her family’s concerns. A conversation about how to manage distressing emotions and physical feelings leads to a referral for brief cognitive behavioral interventions. Her parents join your visit to hear her concerns. They want to begin a family plan for climate action. You recommend the books How to Change Everything: The Young Human’s Guide to Protecting the Planet and Each Other by Naomi Klein and The Parents’ Guide to Climate Revolution: 100 Ways to Build a Fossil-Free Future, Raise Empowered Kids, and Still Get a Good Night’s Sleep by Mary DeMocker.
Dr. Rosenfeld is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington.
References
1. Maizland L. Global Climate Agreements: Successes and Failures. Council on Foreign Relations. https://www.cfr.org/backgrounder/paris-global-climate-change-agreements.
2. van Nieuwenhuizen A et al. The effects of climate change on child and adolescent mental health: Clinical considerations. Curr Psychiatry Rep. 2021 Dec 7;23(12):88. doi: 10.1007/s11920-021-01296-y.
3. Window to Reach Climate Goals ‘Rapidly Closing’, UN Report Warns. United Nations. https://news.un.org/en/story/2023/09/1140527.
4. Schwartz SEO et al. Climate change anxiety and mental health: Environmental activism as buffer. Curr Psychol. 2022 Feb 28:1-14. doi: 10.1007/s12144-022-02735-6.
5. Pihkala P. Anxiety and the ecological crisis: an analysis of eco-anxiety and climate anxiety. Sustainability. 2020;12:7836. doi: 10.3390/su12197836.
6. Hickman C et al. Climate Anxiety in Children and Young People and Their Beliefs About Government Responses to Climate Change: A Global Survey. Lancet Planet Health. 2021 Dec;5(12):e863-e873. doi: 10.1016/S2542-5196(21)00278-3.
7. IEA (2021), Global Energy Review 2021, IEA, Paris. https://www.iea.org/reports/global-energy-review-2021/renewables.
8. Marlon J et al. Yale Climate Opinion Maps 2023. https://climatecommunication.yale.edu/visualizations-data/ycom-us/.
9. Thomson EE, Roach SP. The Relationships Among Nature Connectedness, Climate Anxiety, Climate Action, Climate Knowledge, and Mental Health. Front Psychol. 2023 Nov 15:14:1241400. doi: 10.3389/fpsyg.2023.1241400.
Study Links Suicide to Missed Early Care After Discharge
TOPLINE:
A study found that patients who die by suicide within a year after discharge from inpatient mental health care are less likely to have primary care consultation in the first 2 weeks, highlighting a gap during the high-risk transition period.
METHODOLOGY:
- Researchers used a nested case-control study design, analyzing the records of 613 people who died by suicide within a year of being discharged from an inpatient psychiatric facility in England between 2001 and 2019.
- Of these, 93 (15.4%) died within 2 weeks of discharge.
- Each patient was matched with up to 20 control individuals who were discharged at a similar time but were living.
- Researchers evaluated primary care consultations after discharge.
TAKEAWAY:
- People who died by suicide within a year were less likely to have had a primary care consultation within 2 weeks of discharge (adjusted odds ratio [aOR], 0.61; P = .01).
- Those who died by suicide had higher odds for a consultation in the week preceding their death (aOR, 1.71; P < .001) and the prescription of three or more psychotropic medications (aOR, 1.73; P < .001).
- Evidence of discharge communication between the facility and primary care clinician was infrequent, highlighting a gap in continuity of care.
- Approximately 40% of people who died within 2 weeks of discharge had a documented visit with a primary care clinician during that period.
IN PRACTICE:
“Primary care clinicians have opportunities to intervene and should prioritize patients experiencing transition from inpatient care,” the authors wrote.
SOURCE:
The study was led by Rebecca Musgrove, PhD, of the Centre for Mental Health and Safety at The University of Manchester in England, and published online on June 12 in BJGP Open.
LIMITATIONS:
The study’s reliance on individuals registered with the Clinical Practice Research Datalink may have caused some suicide cases to be excluded, limiting generalizability. Lack of linked up-to-date mental health records may have led to the omission of significant post-discharge care data. Incomplete discharge documentation may undercount informational continuity, affecting multivariable analysis.
DISCLOSURES:
The study was supported by the National Institute of Health and Care Research. Some authors declared serving as members of advisory groups and receiving grants and personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A study found that patients who die by suicide within a year after discharge from inpatient mental health care are less likely to have primary care consultation in the first 2 weeks, highlighting a gap during the high-risk transition period.
METHODOLOGY:
- Researchers used a nested case-control study design, analyzing the records of 613 people who died by suicide within a year of being discharged from an inpatient psychiatric facility in England between 2001 and 2019.
- Of these, 93 (15.4%) died within 2 weeks of discharge.
- Each patient was matched with up to 20 control individuals who were discharged at a similar time but were living.
- Researchers evaluated primary care consultations after discharge.
TAKEAWAY:
- People who died by suicide within a year were less likely to have had a primary care consultation within 2 weeks of discharge (adjusted odds ratio [aOR], 0.61; P = .01).
- Those who died by suicide had higher odds for a consultation in the week preceding their death (aOR, 1.71; P < .001) and the prescription of three or more psychotropic medications (aOR, 1.73; P < .001).
- Evidence of discharge communication between the facility and primary care clinician was infrequent, highlighting a gap in continuity of care.
- Approximately 40% of people who died within 2 weeks of discharge had a documented visit with a primary care clinician during that period.
IN PRACTICE:
“Primary care clinicians have opportunities to intervene and should prioritize patients experiencing transition from inpatient care,” the authors wrote.
SOURCE:
The study was led by Rebecca Musgrove, PhD, of the Centre for Mental Health and Safety at The University of Manchester in England, and published online on June 12 in BJGP Open.
LIMITATIONS:
The study’s reliance on individuals registered with the Clinical Practice Research Datalink may have caused some suicide cases to be excluded, limiting generalizability. Lack of linked up-to-date mental health records may have led to the omission of significant post-discharge care data. Incomplete discharge documentation may undercount informational continuity, affecting multivariable analysis.
DISCLOSURES:
The study was supported by the National Institute of Health and Care Research. Some authors declared serving as members of advisory groups and receiving grants and personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A study found that patients who die by suicide within a year after discharge from inpatient mental health care are less likely to have primary care consultation in the first 2 weeks, highlighting a gap during the high-risk transition period.
METHODOLOGY:
- Researchers used a nested case-control study design, analyzing the records of 613 people who died by suicide within a year of being discharged from an inpatient psychiatric facility in England between 2001 and 2019.
- Of these, 93 (15.4%) died within 2 weeks of discharge.
- Each patient was matched with up to 20 control individuals who were discharged at a similar time but were living.
- Researchers evaluated primary care consultations after discharge.
TAKEAWAY:
- People who died by suicide within a year were less likely to have had a primary care consultation within 2 weeks of discharge (adjusted odds ratio [aOR], 0.61; P = .01).
- Those who died by suicide had higher odds for a consultation in the week preceding their death (aOR, 1.71; P < .001) and the prescription of three or more psychotropic medications (aOR, 1.73; P < .001).
- Evidence of discharge communication between the facility and primary care clinician was infrequent, highlighting a gap in continuity of care.
- Approximately 40% of people who died within 2 weeks of discharge had a documented visit with a primary care clinician during that period.
IN PRACTICE:
“Primary care clinicians have opportunities to intervene and should prioritize patients experiencing transition from inpatient care,” the authors wrote.
SOURCE:
The study was led by Rebecca Musgrove, PhD, of the Centre for Mental Health and Safety at The University of Manchester in England, and published online on June 12 in BJGP Open.
LIMITATIONS:
The study’s reliance on individuals registered with the Clinical Practice Research Datalink may have caused some suicide cases to be excluded, limiting generalizability. Lack of linked up-to-date mental health records may have led to the omission of significant post-discharge care data. Incomplete discharge documentation may undercount informational continuity, affecting multivariable analysis.
DISCLOSURES:
The study was supported by the National Institute of Health and Care Research. Some authors declared serving as members of advisory groups and receiving grants and personal fees from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Thanks, But No Thanks
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
Eptinezumab Inhibitor Fails Cluster Headache Test
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
FROM AHS 2024
GLP-1 Receptor Agonists in Endoscopy
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dubious Medicine
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
For One Colorado GI, Private Practice Is Anything But Routine
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Psoriatic Arthritis Symptoms Relieved with TYK2 Inhibitor in Phase 2 Trial
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.