Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Osteoporosis treatment with abaloparatide in postmenopausal women does not lead to increased cardiovascular risk, according to a post hoc analysis of the pivotal ACTIVE and ACTIVExtend trials.

iStock/Thinkstock

“Neither treatment with abaloparatide or teriparatide was associated with an increase in serious cardiac [adverse events],” wrote Felicia Cosman, MD, of Columbia University, New York, and coauthors. The study was published in the Journal of Clinical Endocrinology.

To assess the cardiovascular safety profile of abaloparatide, a synthetic analogue of parathyroid hormone–related peptide, the researchers analyzed data on heart rate, blood pressure and cardiovascular-related adverse events (AEs) from patients taking part in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and its ACTIVExtend extension study.

The 2,460 participants in the ACTIVE trial were postmenopausal women between the ages of 49 and 86 years with osteoporosis; they were given 80 mcg of daily subcutaneous abaloparatide, 20 mcg of open-label daily subcutaneous teriparatide, or placebo in roughly equal numbers for 18 months. After a 1-month treatment-free period, 1,133 eligible participants from either the abaloparatide or placebo groups were enrolled in ACTIVExtend and given 70 mg of open-label alendronate once a week for 24 months. Because heart rate was only assessed pre- and post dose in the ACTIVE trial, an additional pharmacology study of abaloparatide involving 55 healthy volunteers (32 men and 23 women) was undertaken. After a dose of either abaloparatide or placebo, heart rate was measured at 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 4, 6, 8, and 12 hours.

Overall, treatment-emergent AEs were higher in the abaloparatide (165, 20.1%) and teriparatide (106, 13%) groups, compared with placebo (74, 9%), as were AEs that led to discontinuation of the study and were potentially associated with changes in heart rate or BP (27 in abaloparatide, 11 in teriparatide, and 5 in placebo). However, the percentage of patients with serious cardiac AEs was similar across groups (1%, 1%, and 0.9%, respectively).

During the ACTIVE trial, major cardiac adverse events plus heart failure were more common in the placebo group (1.7%) than the abaloparatide (0.5%) or teriparatide (0.6%) groups. During ACTIVExtend, major cardiac adverse plus heart failure were similarly common in the abaloparatide/alendronate (1.6%) and the placebo/alendronate (1.6%) groups.

On day 1 of treatment during ACTIVE, the mean change in heart rate from pretreatment to an hour post treatment was 7.9 bpm, 5.3 bpm, and 1.2 bpm for abaloparatide, teriparatide, and placebo, respectively (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .05 for abaloparatide vs. teriparatide).

Subsequent visits saw similar changes. The mean maximum heart rate at 1 hour post dose was 80.7 bpm for abaloparatide, 79.0 bpm for teriparatide, and 73.7 bpm for placebo (P < .0001 for abaloparatide and teriparatide vs. placebo; P < .01 for abaloparatide vs. teriparatide). In the study of healthy volunteers, HR peaked at 15 minutes after dosing and then declined, resolving within 2.5-4 hours.

From predose to 1 hour post dose, small but significant decreases were observed in mean supine systolic and diastolic BP across groups (–2.7/–3.6 mm Hg with abaloparatide, –2.0/–3.6 with teriparatide, –1.5/–2.3 with placebo). During the first year of ACTIVE, the mean maximal decrease in BP from predose to 1 hour post dose was slightly higher (1-2 mm Hg) in the abaloparatide and teriparatide groups, compared with the placebo group (P < .05).

The authors acknowledged their study’s limitations, including the analysis of major cardiac adverse plus heart failure in ACTIVE being limited because of a low number of events and the trial not being designed in that regard.

Abaloparatide was approved by the Food and Drug Administration in 2017 on the basis of results from the ACTIVE and ACTIVExtend trials showing significant reductions in new vertebral and nonvertebral fractures, compared with placebo.

The analysis was partially funded by Radius Health. Its authors acknowledged numerous potential conflicts of interest, including receiving grants and research support from various organizations and pharmaceutical companies.

SOURCE: Cosman F et al. J Clin Endocrinol Metab. 2020 Jul 13. doi: 10.1210/clinem/dgaa450.

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

ED physicians and hospitalists should consider a diagnosis of e-cigarette associated lung injury (EVALI) across a broad range of nonspecific symptoms, according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.

Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.

Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”

Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.

“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.

These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.

E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.

Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.

Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.

“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.

“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”

For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.

Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.

Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.

Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.

The speakers reported no potential conflicts of interest relevant to this study.

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Patients on oral anticoagulants who experience a bleeding event may be able to discontinue therapy if certain circumstances apply, according to updated guidance from the American College of Cardiology.

The emergence of direct-acting oral anticoagulants (DOACs) to prevent venous thromboembolism and the introduction of new reversal strategies for factor Xa inhibitors prompted the creation of an Expert Consensus Decision Pathway to update the version from 2017, according to the ACC. Expert consensus decision pathways (ECDPs) are a component of the solution sets issued by the ACC to “address key questions facing care teams and attempt to provide practical guidance to be applied at the point of care.”

In an ECDP published in the Journal of the American College of Cardiology, the writing committee members developed treatment algorithms for managing bleeding in patients on DOACs and vitamin K antagonists (VKAs).

Bleeding was classified as major or nonmajor, with major defined as “bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion of at least 2 units of packed red blood cells [RBCs]), or results in a hemoglobin drop greater than 2 g/dL. All other types of bleeding were classified as nonmajor.

The document includes a graphic algorithm for assessing bleed severity and managing major versus nonmajor bleeding, and a separate graphic describes considerations for reversal and use of hemostatic agents according to whether the patient is taking a VKA (warfarin and other coumarins), a direct thrombin inhibitor (dabigatran), the factor Xa inhibitors apixaban and rivaroxaban, or the factor Xa inhibitors betrixaban and edoxaban.

Another algorithm outlines whether to discontinue, delay, or restart anticoagulation. Considerations for restarting anticoagulation include whether the patient is pregnant, awaiting an invasive procedure, not able to receive medication by mouth, has a high risk of rebleeding, or is being bridged back to a vitamin K antagonist with high thrombotic risk.

In most cases of GI bleeding, for example, current data support restarting oral anticoagulants once hemostasis is achieved, but patients who experience intracranial hemorrhage should delay restarting any anticoagulation for at least 4 weeks if they are without high thrombotic risk, according to the document.

The report also recommends clinician-patient discussion before resuming anticoagulation, ideally with time allowed for patients to develop questions. Discussions should include the signs of bleeding, assessment of risk for a thromboembolic event, and the benefits of anticoagulation.

“The proliferation of oral anticoagulants (warfarin and DOACs) and growing indications for their use prompted the need for guidance on the management of these drugs,” said Gordon F. Tomaselli, MD, chair of the writing committee, in an interview. “This document provides guidance on management at the time of a bleeding complication. This includes acute management, starting and stopping drugs, and use of reversal agents,” he said. “This of course will be a dynamic document as the list of these drugs and their antidotes expand,” he noted.  

“The biggest change from the previous guidelines are twofold: an update on laboratory assessment to monitor drug levels and use of reversal agents,” while the acute management strategies have otherwise remained similar to previous documents, said Dr. Tomaselli.

Dr. Tomaselli said that he was not surprised by the biological aspects of recent research while developing the statement. However, “the extent of the use of multiple anticoagulants and antiplatelet agents was a bit surprising and complicates therapy with each of the agents,” he noted.

The way the pathways are presented may make them challenging to follow in clinical practice, said Dr. Tomaselli. “The pathways are described linearly and in practice often many things have to happen at once,” he said. “The other main issue may be limitations in the availability of some of the newer reversal agents,” he added.

“The complication of bleeding is difficult to avoid,” said Dr. Tomaselli, and for future research, “the focus needs to continue to refine the indications for anticoagulation and appropriate use with other drugs that predispose to bleeding. We also need better methods and testing to monitor drugs levels and the effect on coagulation,” he said.

In accordance with the ACC Solution Set Oversight Committee, the writing committee members, including Dr. Tomaselli, had no relevant relationships with industry to disclose.

SOURCE: Tomaselli GF et al. J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.053.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

Thousands of coronavirus patients risk going without treatment and support for debilitating symptoms lasting months because of a lack of awareness of ‘long COVID’, according to a group formed by clinicians with extended serious after-effects of the virus.

Many members of the 100-strong Facebook group UK doctors: COVID “Long tail” have been unable to work for weeks after failing to recover from an episode of COVID-19. They warn of the need for clinical recognition of “long COVID,” along with systems to log symptoms and manage patients in the community. Without this, there could be major consequences for return to work across all professions, as well as implications for disease prevention.
 

‘Weird symptoms’

Three of the group: Dr Amali Lokugamage, consultant obstetrician at the Whittington Hospital; Dr Sharon Taylor, child psychiatrist at St Mary’s Hospital London, and Dr Clare Rayner, a retired occupational health physician and lecturer at the University of Manchester, have highlighted their concerns in The BMJ and on social media groups. They say colleagues are observing a range of symptoms of long COVID in their practices.

These include cardiac, gut and respiratory symptoms, skin manifestations, neurological and psychiatric symptoms, severe fatigue, and relapsing fevers, sometimes continuing for more than 16 weeks, and which they say go well beyond definitions of chronic fatigue. The authors are also aware of a pattern of symptom clusters recurring every third or fourth day, which in some cases are so severe that people are having to take extended periods of sick leave.

Writing in The BMJ the authors say: “Concerns have been raised about the lack of awareness among NHS doctors, nurses, paramedics, and other healthcare professionals with regard to the prolonged, varied, and weird symptoms [of COVID-19].”

Speaking to Medscape News UK, Dr. Clare Rayner said: “We see a huge need that is not being met, because these cases are just not being seen in hospital. All the attention has been on the acute illness.”

She pointed to the urgent need for government planning for a surge in people requiring support to return to work following long-term COVID-19 symptoms. According to occupational health research, only 10-40% of people who take 6 weeks off work return to work, dropping to 5%-10% after an absence of 6 months.

In her own case, she is recovering after 4 months of illness, including a hospital admission with gut symptoms and dehydration, and 2 weeks of social service home support. She has experienced a range of relapsing and remitting symptoms, which she describes as ‘bizarre and coming in phases’.
 

Stimulating recovery

The recently-announced NHS portal for COVID-19 patients has been welcomed by the authors as an opportunity for long-standing symptoms to reach the medical and Government radar. But Dr Taylor believes it should have been set up from the start with input from patients with symptoms, to make sure that any support provided reflects the nature of the problems experienced.

In her case, as a previously regular gym attender with a resting heart rate in the 50s, she has now been diagnosed as having multi-organ disease affecting her heart, spleen, lung, and autonomic system. She has fluid on the lungs and heart, and suffers from continuous chest pain and oxygen desaturation when lying down. She has not been able to work since she contracted COVID-19 in March.

“COVID patients with the chronic form of the disease need to be involved in research right from the start to ensure the right questions are asked - not just those who have had acute disease,” she insists to Medscape News UK. “We need to gather evidence, to inform the development of a multi-disciplinary approach and a range of rehabilitation options depending on the organs involved.

“The focus needs to be on stimulating recovery and preventing development of chronic problems. We still don’t know if those with chronic COVID disease are infectious, how long their prolonged cardio-respiratory and neurological complications will last, and crucially whether treatment will reduce the duration of their problems. The worry is that left unattended, these patients may develop irreversible damage leading to chronic illness.”
 

General practice

GPs have been at the forefront of management of the long-standing consequences of COVID-19. In its recent report General practice in the post-COVID world, the Royal College of General Practitioners highlights the need for urgent government planning and funding to prepare general practice services for facilitating the recovery of local communities.

The report calls on the four governments of the UK each to produce a comprehensive plan to support GPs in managing the longer-term effects of COVID-19 in the community, including costed proposals for additional funding for general practice; workforce solutions; reductions in regulatory burdens and ‘red tape’; a systematic approach for identifying patients most likely to need primary care support, and proposals for how health inequalities will be minimized to ensure all patients have access to the necessary post-COVID-19 care.

RCGP Chair Professor Martin Marshall said: “COVID-19 will leave a lingering and difficult legacy and it is GPs working with patients in their communities who will be picking up the pieces.”

One issue is the lack of a reliable estimate of the prevalence of post viral symptoms for other viruses, let alone for COVID-19. Even a 1% chance of long-term problems amongst survivors would suggest 2500 with a need for extra support, but experience with post-viral syndrome generally suggests the prevalence may be more like 3%.

The BMA has been carrying out tracker surveys of its own members at 2-week intervals since March. The most recent, involving more than 5000 doctors, indicated that around 30% of doctors who believed they’d had COVID-19 were still experiencing physical symptoms they thought were caused by the virus, 21% had taken sick leave, and a further 9% had taken annual leave to deal with ongoing symptoms.

Dr David Strain, chair of the BMA medical academic staff committee and clinical senior lecturer at the University of Exeter Medical School, has a particular interest in the after-effects of COVID-19. He said it was becoming evident that the virus was leaving a lasting legacy with a significant number of people, even younger ones.

He told Medscape News UK: “Once COVID-19 enters the nervous system, the lasting symptoms on people can range from a mild loss of sense of smell or taste, to more severe symptoms such as difficulties in concentration. A small number have also been left with chronic fatigue syndrome, which is poorly understood, and can be difficult to treat. This does not appear to be dependent on the initial severity of COVID-19 symptoms.

“Currently, it is impossible to predict the prevalence of longer-lasting effects. A full assessment of COVID-19’s impact will only be possible once people return to work on a regular basis and the effect on their physical health becomes evident. Of the doctors in the BMA survey who had experienced COVID-19, 15% took sick leave beyond their acute illness, and another 6% used annual leave allowance to extend their recovery time.

“Clearly, more research will be needed into the long-term consequences of COVID-19 and the future treatments needed to deal with them.”
 

Further research

The National Institute for Health Research (NIHR) has called for applications for research to enhance understanding and management of the health and social care consequences of the global COVID-19 pandemic beyond the acute phase, with a particular focus on ‘health outcomes, public health, social care and health service delivery and to mitigate the impact of subsequent phases and aftermath’.

The authors of The BMJ article stress the wide-ranging nature of  ‘long COVID’ symptoms and warn of the dangers of treating them for research purposes under the banner of chronic fatigue. They say: “These wide-ranging, unusual, and potentially very serious symptoms can be anxiety-provoking, particularly secondary to a virus that has only been known to the world for 8 months and which we have barely begun to understand. However, it is dismissive solely to attribute such symptoms to anxiety in the thousands of patients like ourselves who have attended hospital or general practice with chronic COVID-19.”

This article first appeared on Medscape.com.

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

The combination of ticagrelor and aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor/aspirin group than in the aspirin-only group.

“We found that ticagrelor plus aspirin reduced the risk of stroke or death, compared to aspirin alone in patients presenting acutely with stroke or TIA,” reported lead author S. Claiborne Johnston, MD, PhD, dean and vice president for medical affairs, Dell Medical School, the University of Texas, Austin.

Although the combination also increased the risk for major hemorrhage, that increase was small and would not overwhelm the benefit, he said.

The study was published online July 16 in The New England Journal of Medicine.
 

Attractive properties

“Lots of patients have stroke in the days to weeks after first presenting with a stroke or TIA,” said Dr. Johnston, who is also the Frank and Charmaine Denius Distinguished Dean’s Chair at Dell Medical School. “Aspirin has been the standard of care but is only partially effective. Clopidogrel plus aspirin is another option that has recently been proven, [but] ticagrelor has attractive properties as an antiplatelet agent and works synergistically with aspirin,” he added.

Ticagrelor is a direct-acting antiplatelet agent that does not depend on metabolic activation and that “reversibly binds” and inhibits the P2Y12 receptor on platelets. Previous research has evaluated clopidogrel and aspirin for the secondary prevention of ischemic stroke or TIA. In an earlier trial, ticagrelor was no better than aspirin in preventing these subsequent events. However, the investigators noted that the combination of the two drugs has not been well studied.

The randomized, placebo-controlled, double-blind trial involved 11,016 patients at 414 sites in 28 countries. Patients who had experienced mild to moderate acute noncardioembolic ischemic stroke (mean age, 65 years; 39% women; roughly 54% White) were randomly assigned to receive either ticagrelor plus aspirin (n = 5,523) or aspirin alone (n = 5,493) for 30 days. Of these patients, 91% had sustained a stroke, and 9% had sustained a TIA.

Thirty days was chosen as the treatment period because the risk for subsequent stroke tends to occur mainly in the first month after an acute ischemic stroke or TIA. The primary outcome was “a composite of stroke or death in a time-to-first-event analysis from randomization to 30 days of follow-up.” For the study, “stroke” encompassed ischemic, hemorrhagic, or stroke of undetermined type, and “death” included deaths of all causes. Secondary outcomes included first subsequent ischemic stroke and disability (defined as a score of >1 on the Rankin Scale).

Almost all patients (99.5%) were taking aspirin during the treatment period, and most were also taking an antihypertensive and a statin (74% and 83%, respectively).

Patients in the ticagrelor/aspirin group had fewer primary-outcome events in comparison with those in the aspirin-only group (303 patients [5.5%] vs. 362 patients [6.6%]; hazard ratio, 0.83; 95% confidence interval, 0.71-0.96; P = 0.02). Incidence of subsequent ischemic stroke were similarly lower in the ticagrelor/aspirin group in comparison with the aspirin-only group (276 patients [5.0%] vs. 345 patients [6.3%]; HR, 0.79; 95% CI, 0.68-0.93; P = .004).

On the other hand, there was no significant difference between the groups in the incidence of overall disability (23.8% of the patients in the ticagrelor/aspirin group and in 24.1% of the patients in the aspirin group; odds ratio, 0.98; 95% CI, 0.89-1.07; P = .61).

There were differences between the groups in severe bleeding, which occurred in 28 patients (0.5%) in the ticagrelor/aspirin group and in seven patients (0.15) in the ticagrelor group (HR, 3.99; 95% CI, 1.74-9.14; P = .001). Moreover, more patients in the ticagrelor/aspirin group experienced a composite of intracranial hemorrhage or fatal bleeding compared with the aspirin-only group (0.4% vs 0.1%). Fatal bleeding occurred in 0.2% of patients in the ticagrelor/aspirin group versus 0.1% of patients in the aspirin group. More patients in the ticagrelor-aspirin group permanently discontinued the treatment because of bleeding than in the aspirin-only group (2.8% vs. 0.6%).

“The benefit from treatment with ticagrelor/aspirin, as compared with aspirin alone, would be expected to result in a number needed to treat of 92 to prevent one primary outcome event, and a number needed to harm of 263 for severe bleeding,” the authors noted.
 

Risks versus benefits

Commenting on the study, Konark Malhotra, MD, a vascular neurologist at Allegheny Health Network, Pittsburgh, noted that ticagrelor is an antiplatelet medication “that adds to the armamentarium of stroke neurologists for the treatment of mild acute ischemic or high-risk TIA patients.” Dr. Malhotra, who was not involved with the study, added that the “combined use of ticagrelor and aspirin is effective in the reduction of ischemic events, however, at the expense of increased risk of bleeding events.”

In an accompanying editorial, Peter Rothwell, MD, PhD, of the Wolfson Center for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences at the University of Oxford (England) who was not involved with the study, suggested that the “bleeding risk associated with ticagrelor and aspirin might exceed the benefit among lower-risk patients who make up the majority in practice, and so the results should not be overgeneralized.” Moreover, “regardless of which combination of antiplatelet therapy is favored for the high-risk minority, all patients should receive aspirin immediately after TIA, unless aspirin is contraindicated.”

He noted that “too many patients are sent home from emergency departments without this simple treatment that substantially reduces the risk and severity of early recurrent stroke.”

The study was supported by AstraZeneca. Dr. Johnston has received a grant from AstraZeneca and nonfinancial support from SANOFI. Dr. Rothwell has received personal fees from Bayer and BMS. Dr. Malhotra has disclosed no relevant financial relationships.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

AGA fosters and promotes involvement and advancement of women members and addresses concerns relative to their professional endeavors. Visit www.gastro.org to learn more.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

Work-life balance was the top concern for female physicians who responded to a new Medscape survey, far outpacing concerns about pay.

A psychiatrist who responded to the survey commented, “I’ve been trying to use all my vacation to spend time with my spouse. I’m always apologizing for being late, not being able to go to an event due to my work schedule, and missing out on life with my husband.”

Nearly two thirds (64%) said the balance was their top concern whereas 43% put pay at the top.

Medscape surveyed more than 3,000 women physicians about how they deal with parenthood, work pressures, and relationships in Women Physicians 2020: The Issues They Care About.
 

Almost all are making personal trade-offs

An overwhelming percentage (94%) said they have had to make personal trade-offs for work obligations.

“Women are more likely to make work compromises to benefit their families,” a cardiologist responded. “I won’t/can’t take a position that would disrupt my husband’s community ties, my children’s schooling, and relationships with family.”

More than one-third of women (36%) said that being a woman had a negative or very negative impact on their compensation. Only 4% said their gender had a positive or very positive impact on pay and 59% said gender had no effect.

The Medscape Physician Compensation Report 2020 showed male specialists made 31% more than their female counterparts and male primary care physicians earned 25% more.

Some factors may help explain some of the difference, but others remain unclear.

Poor negotiating skills have long been cited as a reason women get paid less; in this survey 39% said they were unskilled or very unskilled in salary negotiations, compared with 28% who said they were skilled or very skilled in those talks.

Katie Donovan, founder of Equal Pay Negotiations, reports that only 30% of women negotiate pay at all, compared with 46% of men.

Additionally, women tend to gravitate in specialties that don’t pay as well.

They are poorly represented in some of the highest-paying specialties: orthopedics (9%), urology (12%), and cardiology (14%).

“Society’s view of women as caretaker is powerful,” a radiologist commented. “Women feel like they need to choose specialties where they can work part-time or flexible time in order to be the primary caretaker at home.”
 

Confidence high in leadership abilities

The survey asked women about their confidence in taking a leadership role, and 90% answered that they were confident about taking such a role. However, only half said they had a leadership or supervisory role.

According to the American Medical Association, women make up 3% of healthcare chief medical officers, 6% of department chairs, and 9% of division leaders.

Asked whether women have experienced gender inequity in the workplace, respondents were almost evenly split, but hospital-based physicians at 61% were more likely to report inequity than were 42% of office-based physicians.

A family physician responded, “I have experienced gender inequality more from administrators than from my male colleagues. I think it’s coming from corporate more than from medical professionals.”

In this survey, 3% said their male colleagues were unsupportive of gender equality in the workplace.

The survey responses indicate most women physicians who have children are also conflicted as parents regarding their careers. Almost two-thirds (64%) said they were always or often conflicted with these dueling priorities; only 8% said they sometimes or rarely are.

Those conflicts start even before having children. More than half in this survey (52%) said their career influenced the number of children they have.

A family physician said, “I delayed starting a family because of my career. That affected my fertility and made it hard to complete [in-vitro fertilization].”
 

Family responsibilities meet stigma

Half of the respondents said women physicians are stigmatized for taking a full maternity leave (6 weeks or longer). An even higher percentage (65%) said women are stigmatized for taking more flexible or fewer hours to accommodate family responsibilities.

A 2019 survey of 844 physician mothers found that physicians who took maternity leave received lower peer evaluation scores, lost potential income, and reported experiencing discrimination. One-quarter of the participants (25.8%) reported experiencing discrimination related to breastfeeding or breast milk pumping upon their return to work.

Burnout at work puts stress on primary relationships, 63% of respondents said, although 24% said it did not strain those relationships. Thirteen percent of women gave the response “not applicable.”

“I try to be present when I’m home, but to be honest, I don’t deal with it very well,” a family physician commented.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

The COVID-19 pandemic and resulting lockdown are associated with increased depression and lower levels of life satisfaction – but primarily in specific demographic and socioeconomic groups, new research shows.

A survey of more than 72,000 individuals in the United Kingdom shows that young adults, those in lower-income groups, and those who had been diagnosed with a mental illness were most affected. Interestingly, anxiety increased during the lead-up to the lockdown for the overall group but decreased during the lockdown itself.

A second survey showed that the pandemic triggered poorer mental health among more than 1,400 patients with mental illness or their caregivers. However, individuals found ways of coping despite the increased stress.

Commenting on the findings, David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University, noted that expectations of a “tidal wave” of mental health problems during the pandemic may have been wide of the mark.

Instead, the pandemic seems to have caused “an exacerbation” of preexisting mental health conditions, Dr. Spiegel said in an interview.

The studies were presented during a dedicated session at the European Psychiatric Association 2020 Congress, which was virtual this year because of COVID-19.
 

Underrepresented groups

The first presentation was given by Daisy Fancourt, PhD, associate professor of psychobiology and epidemiology, University College London. She described the COVID-19 Social Study, which included more than 72,000 individuals.

Participants were recruited via research databases, media communications, and “more targeted sampling at underrepresented groups, including people from low educational backgrounds and low-income households,” Dr. Fancourt noted.

The respondents took part in the study once a week. This resulted in more than 500,000 completed surveys at a rate of between 3,000 and 6,000 responses per day. Sixteen weeks of data have been gathered so far.

The samples were weighted so they “aligned with population proportions in the U.K. for demographic factors such as age, ethnicity, gender, geographical location, and educational attainment,” said Dr. Fancourt.

Results showed that mental health decreased in the lead-up to lockdown, with decreases in happiness and increases in fear, stress, and sadness.

At the start of lockdown, approximately 60% of people reported that they were stressed about COVID-19 itself, whether catching it or becoming seriously ill. During lockdown, there was little change in levels of depression, but anxiety decreased and life satisfaction increased during this period.
 

‘We’re not all in this together’

The lower stress level wasn’t surprising, “because people were at home much more. But what is particularly surprising is that it’s continued to drop even though lockdown easing has now been taking place for a number of weeks,” Dr. Fancourt said.

“A big question is: Has mental health been equally affected across this period? And our data seem to suggest that’s very much not the case,” she added.

After assessing different demographic and socioeconomic groups, the investigators found that participants aged 18-29 years had much higher levels of anxiety, depression, and thoughts of death or self-harm and much lower levels of life satisfaction than older participants.

A similar pattern was found for lower-income groups in comparison with those earning more and for individuals in Black, Asian, and minority ethnic groups, compared with White individuals.

For patients who had been diagnosed with a mental illness, levels of depression, anxiety, and thoughts of death or self-harm, as well as life satisfaction, generally ran parallel to those of the general population, although at a far worse level.

Overall, the results suggest that “we’ve not all been ‘in this together,’ as we heard in some of the media,” Dr. Fancourt said. “In fact, it’s been a very different experience, depending on people’s demographic and socioeconomic characteristics.”
 

Increased loneliness, economic worry

Further analysis into loneliness showed that twice as many respondents described themselves as lonely during the COVID-19 pandemic in comparison with beforehand (18.3% vs. 8.5%).

There was very little improvement in loneliness across the study period, “so whilst it might be higher than normal, we’ve not really seen any reduction, even when there’s been easing of lockdown,” Dr. Fancourt said.

A possible reason could be that some of the most lonely respondents were not able to come out of lockdown because of being in a higher-risk group, she noted.

As with the main findings, loneliness during the pandemic was worse for younger adults as well as for those of low income, those who lived alone, and those who had a mental illness.

The researchers assessed lower socioeconomic position (SEP), which was defined by several indicators: annual household income less than £30,000 (about $38,000), high school or lower education, being unemployed, renting instead of owning one’s own home, or living in overcrowded accommodations

During the COVID-19 epidemic, having a lower SEP was associated with a 50%-100% increased risk of losing work in comparison with having a higher SEP. There was also a 300% increased risk of being unable to pay bills and a 600%-800% increased risk of not being able to access essentials, such as medication or sufficient food.

Interestingly, worrying about potential adversities during the pandemic had a similar impact on anxiety and depression. “In other words, worrying about what might be about to happen seems to be as bad for mental health as those things actually happening,” Dr. Fancourt said.

The majority of participants did not feel in control of their future plans and felt more out of control of their employment and mental health than they did their physical health.

Individuals aged 18-29 years felt least in control over finances, relationships, future plans, and mental health. Those aged 60 years or older were the most likely to report feeling in control on all measures.
 

Puzzling results

Dr. Spiegel described the results as “a little puzzling in some ways.” He noted that the easing of discomfort that participants felt during lockdown suggests that the idea of a lockdown being a terrible thing “is not necessarily the case.”

“People realize that their lives and lifestyles are being threatened, and it can be actually comforting to be doing something, even if what you’re doing is rather uncomfortable and disruptive of life,” said Dr. Spiegel, who was not involved with the research.

The lockdown may have led people “to think a little more deeply about what matters to them in life,” he added.

A big message from the study is that “the most anxious and depressed were young people in their late teens to late 20s,” Dr. Spiegel noted. That’s when individuals are most sociable, when they form their own social networks, and when they look for partners.

“What’s a little scarier is they also had higher levels of thoughts of death and self-harm and less life satisfaction. So I think the consequences of social disruption were most profound in this study for people for whom social life is the most important,” said Dr. Spiegel.

However, Roxane Cohen Silver, PhD, professor of psychological science, medicine, and public health, University of California, Irvine, noted that, despite the large number of participants, the study’s methodology left many questions unanswered.

She explained that to make sound public policy recommendations, “one needs to pay a great deal of attention to the methods that are used in collecting those data.” From the available information, the degree to which the sample is representative and the participation rate are unclear, which leaves the study open to selection bias, despite the weighting the researchers performed to generate the results.

“The methodological soundness of the studies on the mental health effect of COVID are just as important, I believe, as they are when we’re trying to understand the effect of treatment or a drug,” Dr. Cohen Silver said.
 

Relief during the pandemic?

The second presentation was given by Sara Simblett, PhD, department of psychology, King’s College London, who described the Coronavirus Outbreak Psychological Experiences study.

This was a two-part investigation in which 31 semistructured interviews with users of mental health services and carers formed the basis of a qualitative survey. It examined the impact of the pandemic on thoughts, emotions, behaviors, and life situations.

The survey was advertised via social media and mental health charities, yielding a total of 1,402 responses. These included responses from 968 individuals who had experience of a mental health condition. Of these, 266 were currently using mental health services, and 189 were informal carers.

Of those, 46.8% met the case threshold for anxiety, 40.3% met the threshold for depression, and 45.3% were determined to have “low resilience.”

The COVID-19 pandemic triggered poorer mental health in the majority of respondents, at 60.8% among those with a preexisting mental health condition and 64.1% among informal carers.

This was reflected in 95.3% of respondents saying that things were uncertain, 81.3% saying they felt restricted by the pandemic, and 71.9% saying that their day was less structured.

However, the survey also revealed that 79.8% felt relieved during the pandemic, 82.1% said that their memory was “much better,” and 62.9% found it easier to concentrate and make plans.

In addition, many people turned to coping mechanisms; 74.7% looked to religion and spirituality as a source of support, and 64.2% used health and wellness apps.

The COVID-19 Social Study is funded by the Wellcome Trust and the Nuffield Foundation. The Coronavirus Outbreak Psychological Experiences study is a collaboration with the McPin Foundation. The investigators and commentators reported no relevant financial relationships.

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

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu

THE CASE

A 50-year-old man presented to the primary care office for evaluation of foot pain. The day before, his left fifth toe had become exquisitely tender. He distinctly remembered that when he awoke, there was no discoloration or pain, but the toe later became “purple.” He denied any trauma. His medical record was notable for an extensive smoking history and a family history of early cardiovascular disease.

The patient appeared well but in obvious distress, secondary to the pain. His vital signs were unremarkable. His head, neck, lung, and cardiac exams revealed no abnormalities. Physical examination revealed a left fifth toe that was dusky purple and warm to the touch. Pain disproportionate to examination was noted on the anterior aspect of the toe, with limited range of motion. The patient walked with a compensated gait. Pulses were palpable on the posterior tibial (PT) and dorsalis pedis (DP) regions.

DIAGNOSIS

Based on our exam findings, we suspected a vascular injury and recommended an emergency consult by Podiatry, for which he was scheduled the following morning. The podiatric evaluation confirmed concern for a vascular injury and prompted a request for an emergent evaluation by Vascular Surgery.

The patient was seen emergently on Day 4 for a vascular surgery evaluation. Examination at that time showed a nearly absent femoral pulse on the left side and diminished and monophasic DP and PT pulses. His left foot demonstrated nonblanchable purpura that was clinically consistent with cholesterol embolization syndrome (CES).

We calculated the patient’s ankle-brachial index, and computed tomography angiography (CTA) was performed. While results were pending, the patient was started on aspirin 81 mg, clopidogrel 75 mg, and atorvastatin 40 mg, for a suspected slowly progressing iliac artery stenosis with a resulting acute atheroembolic event.

The CTA report showed a high-grade stenosis at the bifurcation of the left iliac artery, extending into both external and internal arteries. Of note, mild atherosclerotic disease without significant occlusion and runoff to the foot was observed into the tibial arteries. The stenosis extended into the profonda femoris artery, as well.

DISCUSSION

Atherosclerotic plaques are commonly encountered in patients with atherosclerotic disease; however, there are 2 varieties of emboli that arise from these plaques and one is often overlooked.^1-4 The more common of these variants, thromboemboli, originates from an atherosclerotic plaque and can become lodged in a medium or large vessel as a single embolus.

Continue to: By contrast...

By contrast, atheroemboli (commonly known as cholesterol emboli or cholesterol crystal embolization) originate from atherosclerotic plaques in the aorta or another large artery,⁵ which are prone to embolize if the underlying plaque experiences stress. As the plaque erodes, cholesterol crystals break off and embolize distally. These smaller crystals flood into the circulation, allowing a shower of emboli over time to occlude the arterioles. As occlusion spreads through the arterioles, multiple organ systems are affected. (It was previously thought that procedure-associated cases were common, but a literature review has not borne this out.⁵)

The shower of emboli often triggers a systemic inflammatory response, causing nondescript abnormalities of laboratory inflammatory markers.^6,7 Interestingly, hypereosinophilia is noted in about 80% of patients with CES.⁸It is not uncommon for atheroemboli of the lower extremity to manifest, as it did in this case, as “blue toe syndrome.”

No disease-specific testing. A confounding factor in validating the diagnosis of CES is the lack of disease-specific testing. However, CES should be considered in a patient with acute kidney injury and hypereosinophilia. Making the diagnosis requires a high degree of clinical suspicion. Any organ can be affected, although the brain, kidneys, gastrointestinal tract, skin, and skeletal muscles of the lower extremities are most frequently involved.⁹ If left undiagnosed, the results can be devastating: slow and chronic injury to a variety of organ systems over time, which may not be recognized as a harbinger of an insidious underlying process causing end-organ damage.

Technically, definitive diagnosis can be made by biopsy of an affected organ. However, biopsy’s utility is limited due to potential for sampling error, accessibility (as noted, the location of the involved organ[s] may make biopsy nearly impossible without additional surgical risk⁹), and risk of poor healing to the biopsy site.¹⁰

Treatment is two-fold: supportive care for the affected end organ and prevention of subsequent embolic events. The latter entails aggressive risk factor reduction strategies, such as smoking cessation, statin therapy, blood pressure control, and blood sugar control. Warfarin is not recommended for treatment of CES due to the risk of further plaque rupture, hemorrhage, acute and chronic renal failure, and cholesterol microembolization to other organs.^11,12

Continue to: Our patient

Our patient. After testing confirmed the diagnosis, the patient underwent an angioplasty. A stent was placed in his left iliac artery. He was continued on antiplatelet and statin therapy and was again counseled regarding smoking cessation.

THE TAKEAWAY

When patients present with symptoms suggestive of a vascular origin, consider CES. Although it can affect a multitude of organs, acute kidney injury and hypereosinophilia are the most common signs. Immediate intervention is required to save the affected organ; strategizing to reduce the risk for further embolic events is also key.

Warfarin is not recommended for treatment of cholesterol embolization syndrome due to the risk of further plaque rupture, hemorrhage, and cholesterol microembolization to other organs.

Prompt recognition of vascular emergencies, including those that are harbingers of atherosclerotic disease, is essential. As clinicians, it is imperative that we use all resources to address significant population health burdens. If CES is more prevalent than commonly thought, consideration should be given to increasing education about early detection and treatment of this disorder, including the reinforcement of primary prevention and aggressive treatment of risk factors for atherosclerotic cardiovascular disease.

CORRESPONDENCE
Meagan Vermeulen, MD, FAAFP, Department of Family Medicine, Rowan University School of Osteopathic Medicine, 42 East Laurel Road, Suite 2100A, Stratford, NJ 08084; vermeulen@rowan.edu