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Eyebrow hair loss
Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).
AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.
AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.
The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.
In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.
Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Papadopoulos AJ, Schwartz RA, Janniger C. Alopecia areata: pathogenesis, diagnosis, and therapy. Am J Clin Dermatol. 2000;1:101-105
Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).
AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.
AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.
The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.
In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.
Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Although it appeared that the hair loss was preceded by some dry skin, the patch of hair loss was smooth and nonscarring, consistent with a diagnosis of alopecia areata (AA).
AA typically is found on the scalp in solitary areas but can affect the whole body, including the eyelashes and eyebrows. Affected hair typically is narrower at the proximal end, resembling an exclamation point, as the hair fails to grow and falls out. Sometimes, patches of alopecia may coalesce into a larger area. Nail changes may be noted, as well. Nails may become brittle, with pitting and/or longitudinal ridges. Patients are usually asymptomatic but may complain of pruritus.
AA is believed to be an autoimmune disorder. It affects males and females of all ages but is more common in children and young adults. AA is believed to result from a T-cell–mediated immune response that transitions the hair follicles from the growth phase to the resting phase. This leads to sudden hair loss and inhibition of regrowth of the hair. However, the hair follicle is not permanently destroyed as in other processes of alopecia. There is also an association between AA and other autoimmune disorders such as vitiligo, thyroid disease, and lupus.
The diagnosis usually is made clinically, as in this patient, but a definitive diagnosis can be made by biopsy and pathology. Other differential diagnoses to consider are trichotillomania, tinea, traumatic alopecia, and lupus.
In almost half of cases, AA is self-resolving; therefore, in first episodes of localized disease, watchful waiting is appropriate. Treatment is tailored to the individual patient and may be difficult. Intralesional corticosteroids often are used for mild cases. Typically, 10 mg/mL of a glucocorticoid is injected into the mid-dermis every 4 to 6 weeks; however, this treatment carries a risk of transient or even permanent atrophy of the injection site. Potent topical corticosteroids often are used, especially in children who do not tolerate intralesional injections, and success can be variable. Other topical treatments to consider are photochemotherapy (psoralen plus UVA), or an irritant agent such as anthralin and a vasodilator such as minoxidil. Regrowth can be expected in a few months to a year, but recurrence is common.
Image courtesy of Stacy Nguy, MD, and text courtesy of Stacy Nguy, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Papadopoulos AJ, Schwartz RA, Janniger C. Alopecia areata: pathogenesis, diagnosis, and therapy. Am J Clin Dermatol. 2000;1:101-105
Papadopoulos AJ, Schwartz RA, Janniger C. Alopecia areata: pathogenesis, diagnosis, and therapy. Am J Clin Dermatol. 2000;1:101-105
Cardiogenic shock rate soars in COVID-positive ACS
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
FROM TCT 2020
Brazil confirms death of volunteer in COVID-19 vaccine trial
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
COVID-19 experience forced residents to quickly improve patient communication skills
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
FROM CHEST 2020
Bariatric surgery linked to longer life
A new analysis of the Swedish Obese Subjects (SOS) study shows that bariatric surgery is associated with about a 3-year increase in lifespan, compared with obese patients who do not undergo surgery. Still, surgery did not restore normal lifespan: Surgical patients’ lifespan remained less than that of a sample from the general Swedish population. The study follows other reports suggesting reduced mortality after bariatric surgery, but with a longer follow-up.
“These data add even more evidence to the growing literature showing that patients who undergo bariatric surgery experience a reduction in all-cause long-term mortality. In making decisions around bariatric surgical procedures and care, patients and their health care providers need to understand the trade-offs between improved weight, health, and longer-term survival versus the surgical risks and problems over time,” said Anita P. Courcoulas, MD, MPH, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center, said in an interview. Dr. Courcoulas was not involved in the study.
The results appeared in the New England Journal of Medicine.
The SOS study drew from 25 surgical departments and 480 primary health care centers in Sweden. The researchers examined data from 2,007 patients who underwent bariatric surgery between 1987 and 2001, and compared their outcomes to 2,040 matched controls. All were between age 37 and 60 years, with a body mass index (BMI) of at least 34 kg/m2 for men and 38 for women. They also compared outcomes with 1,135 randomly sampled from the Swedish population registry.
Procedures included banding (18%), vertical banded gastroplasty (69%), and gastric bypass (13%). After an initial BMI reduction of about 11, the surgery group stabilized by year 8 at a BMI about 7 lower than baseline, and there was little change in BMI among controls.
After a mean follow-up of 24 years (interquartile range, 22-27 years), there were 10.7 deaths per 1,000 person-years in the surgery group, 13.2 among obese controls, and 5.2 in the general population (hazard ratio, 0.77 for surgery versus no surgery; P < .001). The general population had a lower mortality than nonsurgical controls (HR, 0.44; P < .001).
The surgery group had a higher median life expectancy than controls (median, 2.4 years; adjusted difference, 3.0 years; P < .001). The general population group had a median life expectancy that was 7.4 years higher than the control group (adjusted difference, 8.5 years; P < .001). The surgery group’s median life expectancy was still shorter than the general population reference (adjusted difference, 5.5 years; P < .001).
Cardiovascular disease risk was lower in the surgery group (HR, 0.70; 95% confidence interval, 0.57-0.85), as was risk of MI (HR, 0.51; 95% CI, 0.33-0.79), heart failure (HR, 0.52; 95% CI, 0.31-0.88), and stroke (HR, 0.45; 95% CI, 0.24-0.84). Cancer mortality was also lower (HR, 0.77; 95% CI, 0.61-0.96).
In the surgery group, causes of death that were elevated over the general population included cardiovascular causes (HR, 2.64; 95% CI, 1.78-3.91) and noncardiovascular causes, mainly infections; postsurgical complications; and factors such as alcoholism, suicide, or trauma (HR, 1.50; 95% CI, 1.18-1.91).
The study is limited by its retrospective nature, and because the surgical techniques used at the time are less effective than those used today, and could lead to weight gain over time. As a result, many patients who underwent surgery remained heavier than the general population. It’s also possible that negative health effects accumulated before surgery and persisted afterwards, according to Dr. Courcoulas.
The findings are likely generalizable to people with obesity, many of whom choose not to undergo bariatric surgery despite the potential benefits. “The population studied in SOS had a similar profile of underlying medical diseases to those groups who undergo bariatric surgery today and in the U.S. and around the world,” said Dr. Courcoulas.
The study was funded by the Swedish Research Council and others. Dr. Courcoulas has no relevant financial disclosures
SOURCE: Carlsson L et al. N Engl J Med. 2020 Oct 15. doi: 10.1056/NEJMoa2002449.
A new analysis of the Swedish Obese Subjects (SOS) study shows that bariatric surgery is associated with about a 3-year increase in lifespan, compared with obese patients who do not undergo surgery. Still, surgery did not restore normal lifespan: Surgical patients’ lifespan remained less than that of a sample from the general Swedish population. The study follows other reports suggesting reduced mortality after bariatric surgery, but with a longer follow-up.
“These data add even more evidence to the growing literature showing that patients who undergo bariatric surgery experience a reduction in all-cause long-term mortality. In making decisions around bariatric surgical procedures and care, patients and their health care providers need to understand the trade-offs between improved weight, health, and longer-term survival versus the surgical risks and problems over time,” said Anita P. Courcoulas, MD, MPH, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center, said in an interview. Dr. Courcoulas was not involved in the study.
The results appeared in the New England Journal of Medicine.
The SOS study drew from 25 surgical departments and 480 primary health care centers in Sweden. The researchers examined data from 2,007 patients who underwent bariatric surgery between 1987 and 2001, and compared their outcomes to 2,040 matched controls. All were between age 37 and 60 years, with a body mass index (BMI) of at least 34 kg/m2 for men and 38 for women. They also compared outcomes with 1,135 randomly sampled from the Swedish population registry.
Procedures included banding (18%), vertical banded gastroplasty (69%), and gastric bypass (13%). After an initial BMI reduction of about 11, the surgery group stabilized by year 8 at a BMI about 7 lower than baseline, and there was little change in BMI among controls.
After a mean follow-up of 24 years (interquartile range, 22-27 years), there were 10.7 deaths per 1,000 person-years in the surgery group, 13.2 among obese controls, and 5.2 in the general population (hazard ratio, 0.77 for surgery versus no surgery; P < .001). The general population had a lower mortality than nonsurgical controls (HR, 0.44; P < .001).
The surgery group had a higher median life expectancy than controls (median, 2.4 years; adjusted difference, 3.0 years; P < .001). The general population group had a median life expectancy that was 7.4 years higher than the control group (adjusted difference, 8.5 years; P < .001). The surgery group’s median life expectancy was still shorter than the general population reference (adjusted difference, 5.5 years; P < .001).
Cardiovascular disease risk was lower in the surgery group (HR, 0.70; 95% confidence interval, 0.57-0.85), as was risk of MI (HR, 0.51; 95% CI, 0.33-0.79), heart failure (HR, 0.52; 95% CI, 0.31-0.88), and stroke (HR, 0.45; 95% CI, 0.24-0.84). Cancer mortality was also lower (HR, 0.77; 95% CI, 0.61-0.96).
In the surgery group, causes of death that were elevated over the general population included cardiovascular causes (HR, 2.64; 95% CI, 1.78-3.91) and noncardiovascular causes, mainly infections; postsurgical complications; and factors such as alcoholism, suicide, or trauma (HR, 1.50; 95% CI, 1.18-1.91).
The study is limited by its retrospective nature, and because the surgical techniques used at the time are less effective than those used today, and could lead to weight gain over time. As a result, many patients who underwent surgery remained heavier than the general population. It’s also possible that negative health effects accumulated before surgery and persisted afterwards, according to Dr. Courcoulas.
The findings are likely generalizable to people with obesity, many of whom choose not to undergo bariatric surgery despite the potential benefits. “The population studied in SOS had a similar profile of underlying medical diseases to those groups who undergo bariatric surgery today and in the U.S. and around the world,” said Dr. Courcoulas.
The study was funded by the Swedish Research Council and others. Dr. Courcoulas has no relevant financial disclosures
SOURCE: Carlsson L et al. N Engl J Med. 2020 Oct 15. doi: 10.1056/NEJMoa2002449.
A new analysis of the Swedish Obese Subjects (SOS) study shows that bariatric surgery is associated with about a 3-year increase in lifespan, compared with obese patients who do not undergo surgery. Still, surgery did not restore normal lifespan: Surgical patients’ lifespan remained less than that of a sample from the general Swedish population. The study follows other reports suggesting reduced mortality after bariatric surgery, but with a longer follow-up.
“These data add even more evidence to the growing literature showing that patients who undergo bariatric surgery experience a reduction in all-cause long-term mortality. In making decisions around bariatric surgical procedures and care, patients and their health care providers need to understand the trade-offs between improved weight, health, and longer-term survival versus the surgical risks and problems over time,” said Anita P. Courcoulas, MD, MPH, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center, said in an interview. Dr. Courcoulas was not involved in the study.
The results appeared in the New England Journal of Medicine.
The SOS study drew from 25 surgical departments and 480 primary health care centers in Sweden. The researchers examined data from 2,007 patients who underwent bariatric surgery between 1987 and 2001, and compared their outcomes to 2,040 matched controls. All were between age 37 and 60 years, with a body mass index (BMI) of at least 34 kg/m2 for men and 38 for women. They also compared outcomes with 1,135 randomly sampled from the Swedish population registry.
Procedures included banding (18%), vertical banded gastroplasty (69%), and gastric bypass (13%). After an initial BMI reduction of about 11, the surgery group stabilized by year 8 at a BMI about 7 lower than baseline, and there was little change in BMI among controls.
After a mean follow-up of 24 years (interquartile range, 22-27 years), there were 10.7 deaths per 1,000 person-years in the surgery group, 13.2 among obese controls, and 5.2 in the general population (hazard ratio, 0.77 for surgery versus no surgery; P < .001). The general population had a lower mortality than nonsurgical controls (HR, 0.44; P < .001).
The surgery group had a higher median life expectancy than controls (median, 2.4 years; adjusted difference, 3.0 years; P < .001). The general population group had a median life expectancy that was 7.4 years higher than the control group (adjusted difference, 8.5 years; P < .001). The surgery group’s median life expectancy was still shorter than the general population reference (adjusted difference, 5.5 years; P < .001).
Cardiovascular disease risk was lower in the surgery group (HR, 0.70; 95% confidence interval, 0.57-0.85), as was risk of MI (HR, 0.51; 95% CI, 0.33-0.79), heart failure (HR, 0.52; 95% CI, 0.31-0.88), and stroke (HR, 0.45; 95% CI, 0.24-0.84). Cancer mortality was also lower (HR, 0.77; 95% CI, 0.61-0.96).
In the surgery group, causes of death that were elevated over the general population included cardiovascular causes (HR, 2.64; 95% CI, 1.78-3.91) and noncardiovascular causes, mainly infections; postsurgical complications; and factors such as alcoholism, suicide, or trauma (HR, 1.50; 95% CI, 1.18-1.91).
The study is limited by its retrospective nature, and because the surgical techniques used at the time are less effective than those used today, and could lead to weight gain over time. As a result, many patients who underwent surgery remained heavier than the general population. It’s also possible that negative health effects accumulated before surgery and persisted afterwards, according to Dr. Courcoulas.
The findings are likely generalizable to people with obesity, many of whom choose not to undergo bariatric surgery despite the potential benefits. “The population studied in SOS had a similar profile of underlying medical diseases to those groups who undergo bariatric surgery today and in the U.S. and around the world,” said Dr. Courcoulas.
The study was funded by the Swedish Research Council and others. Dr. Courcoulas has no relevant financial disclosures
SOURCE: Carlsson L et al. N Engl J Med. 2020 Oct 15. doi: 10.1056/NEJMoa2002449.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Outpatient visits rebound for most specialties to pre-COVID-19 levels
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
Teen vaping in the time of COVID-19
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
Survey: Acceptance of COVID-19 vaccine dips below 50%
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Worldwide measles vaccination is flagging
After almost 2 decades of progress, the global state of measles vaccination and measles mortality is deteriorating.
One of the most serious concerns of measles infection is its long-term neurological complications, including the fatal subacute sclerosing panencephalitis (SSPE) and measles inclusion-body encephalitis (MIBE), which is usually seen in immune deficient children. Although some efforts are being made to determine which patients might be most vulnerable to these outcomes, and to treat them, the best approach is still prevention and vaccination, according to Banu Anlar, MD, of Hacettepe University, Ankara, Turkey, who spoke during a session at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.
Worldwide vaccination strategies have slipped in recent years, leading to upticks in measles cases and vaccination rates. As a result, in 2018 the World Health Organization postponed its goal of eliminating measles by 2020. Future eradication goals will likely need to be modified, according to Anaita Udwadia Hegde MD, a pediatric neurologist in Mumbai, India, who also presented at the session.
After measles deaths dropped 74% between 2000 and 2010, coinciding with widespread increases in vaccination, the WHO felt emboldened to deal the disease a knockout blow. In 2010, it held a Global Technical Consultation to determine the feasibility of an eradication campaign, which concluded it should be possible by 2020. Several characteristics of measles made that a reasonable goal: It is passed only among humans, with no known animal reservoir; natural infection grants lifelong immunity; there is only one serotype; the virus is genetically stable; the vaccine is safe and leads to 95%-97% seroconversion after two doses, which provides long-term protection against known genotypes; the disease is easily recognized and tested for; and it had been successfully eliminated already in some regions of the world.
As of 2017, analyses showed that the vaccination program saved the lives of about 1.5 million children. That was a cause for celebration, but the goal of eradication has remained elusive. Vaccination rates have trailed targets. In 2018, UNICEF and WHO estimated that 86% of children globally received the first measles vaccine, unchanged from 2010 and below the goal of 95%. Only 69% of children received the second dose, below the goal of 80%. Four countries in Europe lost their measles elimination status in 2018.
Other attempts to eradicate diseases have met with mixed results. The only full success was smallpox, eliminated in 1977. Similar efforts with polio, malaria, guinea worm, and now measles have all come up short. Those failures could complicate future efforts because global agencies and donors may be leery of past failures because of potential harm to their reputations, according to Dr. Hegde.
Such programs require sustained financial commitment and political support as well as local trust. Nevertheless, they must continue for ethical reasons, said Dr. Hegde, but also for economic ones: Every $1 spent on vaccination programs saves $58 in future costs in low- and middle-income countries. Missed childhood vaccination also results in future vulnerable teenagers and young adults, and these populations are much harder to reach and can drive large outbreaks.
Several factors are contributing to the global regression in vaccine coverage, according to Kristen Feemster, MD, MPH, a pediatric infectious disease physician and the global director of medical affairs at Merck. Globalization has enabled the spread of the disease. Most cases in the United States are imported by travelers to countries where the disease is endemic. “Measles can happen anywhere in the world, and when it does it can travel and spread. If you have an unvaccinated traveler who is exposed to measles abroad, they can return home and spread it to anyone else who is unvaccinated or not otherwise immune. When we see cases they’ve been sporadic, but if you return to a community where immunization rates are low, you have the potential for more sustained spread,” Dr. Feemster said during her presentation.
Why are so many travelers unvaccinated? A key reason is that vaccine hesitance is growing. Most affected individuals involved in outbreaks are unvaccinated, usually by choice rather than for medical reasons. Concerns continue over the measles vaccine and autism, growing out of the debunked studies of Andrew Wakefield. In one example, a Somali community in Minnesota experienced a higher than usual number of autism cases and parents sought reasons to explain it. They discovered the supposed connection between vaccination and autism, and Wakefield himself met with a group of them. The result was a drop in vaccination and, in 2011 and 2017, sizable measles outbreaks.
2020 has of course brought a fresh challenge to measles vaccine with the COVID-19 pandemic, which has reduced access to health care and shifted scientific and health care interest away from measles and other vaccine-preventable diseases. On the positive side, social distancing, mask wearing, and restricted movement are likely reducing exposure to measles, but reduced vaccination rates are likely to result in future outbreaks. “There’s been a significant decrease in rates for routine immunizations globally, so there’s a potential for yet another resurgence of measles and other vaccine-preventable diseases,” said Dr. Feemster.
Dr. Feemster is an employee of Merck. Dr. Anlar and Dr. Hegde did not disclose any relevant financial relationships.
After almost 2 decades of progress, the global state of measles vaccination and measles mortality is deteriorating.
One of the most serious concerns of measles infection is its long-term neurological complications, including the fatal subacute sclerosing panencephalitis (SSPE) and measles inclusion-body encephalitis (MIBE), which is usually seen in immune deficient children. Although some efforts are being made to determine which patients might be most vulnerable to these outcomes, and to treat them, the best approach is still prevention and vaccination, according to Banu Anlar, MD, of Hacettepe University, Ankara, Turkey, who spoke during a session at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.
Worldwide vaccination strategies have slipped in recent years, leading to upticks in measles cases and vaccination rates. As a result, in 2018 the World Health Organization postponed its goal of eliminating measles by 2020. Future eradication goals will likely need to be modified, according to Anaita Udwadia Hegde MD, a pediatric neurologist in Mumbai, India, who also presented at the session.
After measles deaths dropped 74% between 2000 and 2010, coinciding with widespread increases in vaccination, the WHO felt emboldened to deal the disease a knockout blow. In 2010, it held a Global Technical Consultation to determine the feasibility of an eradication campaign, which concluded it should be possible by 2020. Several characteristics of measles made that a reasonable goal: It is passed only among humans, with no known animal reservoir; natural infection grants lifelong immunity; there is only one serotype; the virus is genetically stable; the vaccine is safe and leads to 95%-97% seroconversion after two doses, which provides long-term protection against known genotypes; the disease is easily recognized and tested for; and it had been successfully eliminated already in some regions of the world.
As of 2017, analyses showed that the vaccination program saved the lives of about 1.5 million children. That was a cause for celebration, but the goal of eradication has remained elusive. Vaccination rates have trailed targets. In 2018, UNICEF and WHO estimated that 86% of children globally received the first measles vaccine, unchanged from 2010 and below the goal of 95%. Only 69% of children received the second dose, below the goal of 80%. Four countries in Europe lost their measles elimination status in 2018.
Other attempts to eradicate diseases have met with mixed results. The only full success was smallpox, eliminated in 1977. Similar efforts with polio, malaria, guinea worm, and now measles have all come up short. Those failures could complicate future efforts because global agencies and donors may be leery of past failures because of potential harm to their reputations, according to Dr. Hegde.
Such programs require sustained financial commitment and political support as well as local trust. Nevertheless, they must continue for ethical reasons, said Dr. Hegde, but also for economic ones: Every $1 spent on vaccination programs saves $58 in future costs in low- and middle-income countries. Missed childhood vaccination also results in future vulnerable teenagers and young adults, and these populations are much harder to reach and can drive large outbreaks.
Several factors are contributing to the global regression in vaccine coverage, according to Kristen Feemster, MD, MPH, a pediatric infectious disease physician and the global director of medical affairs at Merck. Globalization has enabled the spread of the disease. Most cases in the United States are imported by travelers to countries where the disease is endemic. “Measles can happen anywhere in the world, and when it does it can travel and spread. If you have an unvaccinated traveler who is exposed to measles abroad, they can return home and spread it to anyone else who is unvaccinated or not otherwise immune. When we see cases they’ve been sporadic, but if you return to a community where immunization rates are low, you have the potential for more sustained spread,” Dr. Feemster said during her presentation.
Why are so many travelers unvaccinated? A key reason is that vaccine hesitance is growing. Most affected individuals involved in outbreaks are unvaccinated, usually by choice rather than for medical reasons. Concerns continue over the measles vaccine and autism, growing out of the debunked studies of Andrew Wakefield. In one example, a Somali community in Minnesota experienced a higher than usual number of autism cases and parents sought reasons to explain it. They discovered the supposed connection between vaccination and autism, and Wakefield himself met with a group of them. The result was a drop in vaccination and, in 2011 and 2017, sizable measles outbreaks.
2020 has of course brought a fresh challenge to measles vaccine with the COVID-19 pandemic, which has reduced access to health care and shifted scientific and health care interest away from measles and other vaccine-preventable diseases. On the positive side, social distancing, mask wearing, and restricted movement are likely reducing exposure to measles, but reduced vaccination rates are likely to result in future outbreaks. “There’s been a significant decrease in rates for routine immunizations globally, so there’s a potential for yet another resurgence of measles and other vaccine-preventable diseases,” said Dr. Feemster.
Dr. Feemster is an employee of Merck. Dr. Anlar and Dr. Hegde did not disclose any relevant financial relationships.
After almost 2 decades of progress, the global state of measles vaccination and measles mortality is deteriorating.
One of the most serious concerns of measles infection is its long-term neurological complications, including the fatal subacute sclerosing panencephalitis (SSPE) and measles inclusion-body encephalitis (MIBE), which is usually seen in immune deficient children. Although some efforts are being made to determine which patients might be most vulnerable to these outcomes, and to treat them, the best approach is still prevention and vaccination, according to Banu Anlar, MD, of Hacettepe University, Ankara, Turkey, who spoke during a session at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.
Worldwide vaccination strategies have slipped in recent years, leading to upticks in measles cases and vaccination rates. As a result, in 2018 the World Health Organization postponed its goal of eliminating measles by 2020. Future eradication goals will likely need to be modified, according to Anaita Udwadia Hegde MD, a pediatric neurologist in Mumbai, India, who also presented at the session.
After measles deaths dropped 74% between 2000 and 2010, coinciding with widespread increases in vaccination, the WHO felt emboldened to deal the disease a knockout blow. In 2010, it held a Global Technical Consultation to determine the feasibility of an eradication campaign, which concluded it should be possible by 2020. Several characteristics of measles made that a reasonable goal: It is passed only among humans, with no known animal reservoir; natural infection grants lifelong immunity; there is only one serotype; the virus is genetically stable; the vaccine is safe and leads to 95%-97% seroconversion after two doses, which provides long-term protection against known genotypes; the disease is easily recognized and tested for; and it had been successfully eliminated already in some regions of the world.
As of 2017, analyses showed that the vaccination program saved the lives of about 1.5 million children. That was a cause for celebration, but the goal of eradication has remained elusive. Vaccination rates have trailed targets. In 2018, UNICEF and WHO estimated that 86% of children globally received the first measles vaccine, unchanged from 2010 and below the goal of 95%. Only 69% of children received the second dose, below the goal of 80%. Four countries in Europe lost their measles elimination status in 2018.
Other attempts to eradicate diseases have met with mixed results. The only full success was smallpox, eliminated in 1977. Similar efforts with polio, malaria, guinea worm, and now measles have all come up short. Those failures could complicate future efforts because global agencies and donors may be leery of past failures because of potential harm to their reputations, according to Dr. Hegde.
Such programs require sustained financial commitment and political support as well as local trust. Nevertheless, they must continue for ethical reasons, said Dr. Hegde, but also for economic ones: Every $1 spent on vaccination programs saves $58 in future costs in low- and middle-income countries. Missed childhood vaccination also results in future vulnerable teenagers and young adults, and these populations are much harder to reach and can drive large outbreaks.
Several factors are contributing to the global regression in vaccine coverage, according to Kristen Feemster, MD, MPH, a pediatric infectious disease physician and the global director of medical affairs at Merck. Globalization has enabled the spread of the disease. Most cases in the United States are imported by travelers to countries where the disease is endemic. “Measles can happen anywhere in the world, and when it does it can travel and spread. If you have an unvaccinated traveler who is exposed to measles abroad, they can return home and spread it to anyone else who is unvaccinated or not otherwise immune. When we see cases they’ve been sporadic, but if you return to a community where immunization rates are low, you have the potential for more sustained spread,” Dr. Feemster said during her presentation.
Why are so many travelers unvaccinated? A key reason is that vaccine hesitance is growing. Most affected individuals involved in outbreaks are unvaccinated, usually by choice rather than for medical reasons. Concerns continue over the measles vaccine and autism, growing out of the debunked studies of Andrew Wakefield. In one example, a Somali community in Minnesota experienced a higher than usual number of autism cases and parents sought reasons to explain it. They discovered the supposed connection between vaccination and autism, and Wakefield himself met with a group of them. The result was a drop in vaccination and, in 2011 and 2017, sizable measles outbreaks.
2020 has of course brought a fresh challenge to measles vaccine with the COVID-19 pandemic, which has reduced access to health care and shifted scientific and health care interest away from measles and other vaccine-preventable diseases. On the positive side, social distancing, mask wearing, and restricted movement are likely reducing exposure to measles, but reduced vaccination rates are likely to result in future outbreaks. “There’s been a significant decrease in rates for routine immunizations globally, so there’s a potential for yet another resurgence of measles and other vaccine-preventable diseases,” said Dr. Feemster.
Dr. Feemster is an employee of Merck. Dr. Anlar and Dr. Hegde did not disclose any relevant financial relationships.
FROM CNS-ICNA 2020
Baricitinib reduces adult atopic dermatitis severity in phase 3 study
in the phase 3, double-blind, placebo-controlled, BREEZE-AD7 study.
The study enrolled patients with inadequate responses to topical corticosteroids, according to Kristian Reich, MD, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, and his coauthors.
First test of baricitinib plus topical steroids
Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, inhibits several cytokines in AD pathogenesis, and in two monotherapy studies (BREEZE-AD1 and BREEZE-AD2), it was superior to placebo for reducing several AD clinical signs and symptoms. The current BREEZE-AD7 study is the first to test baricitinib plus background topical corticosteroid therapy, more closely mirroring clinical practice, the authors noted.
BREEZE-AD7 was conducted at 68 centers in 10 countries in Asia, Australia, Europe, and South America. It included 329 adults with moderate to severe AD (mean age around 34 years, and around 34% were female) with inadequate responses to topical corticosteroids documented within the last 6 months. They were randomized 1:1:1 to daily baricitinib 4 mg, daily baricitinib 2 mg, or placebo for 16 weeks. All patients received moderate- and/or low-potency topical corticosteroids (such as 0.1%triamcinolone cream and 2.5% hydrocortisone ointment, respectively) for active lesions.
Significant benefit at 4 mg
At week 16, 31% of AD patients receiving baricitinib 4 mg achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) versus 15% in the placebo group (odds ratio, 2.8; 95% confidence interval, 1.4-5.6; P = .004). Among patients receiving baricitinib 2 mg, 24% achieved vI-GA-AD scores of 0 or 1 (OR, 1.9; 95% CI, 0.9-3.9; P = .08).
The same pattern of improving scores from placebo to baricitinib 2 mg to baricitinib 4 mg persisted, as reflected with secondary endpoints at week 16. Among patients receiving baricitinib 4 mg, 48% achieved Eczema Area Severity Index (EASI) 75 responses, versus 43% and 23% in 2 mg and placebo groups, respectively. Percent changes from baseline in total EASI score were –67%, –58%, –45% for baricitinib 4 mg, baricitinib 2 mg, and placebo, respectively; the proportion of patients achieving 4-point or greater improvements in Itch Numeric Rating Scale (NRS) was 44%, 38%, and 20% for baricitinib 4 mg, baricitinib 2 mg and placebo, respectively.
Similarly, mean change from baseline on the Skin Pain numeric rating scale was –3.7, –3.2, and –2.1 for baricitinib 4 mg, baricitinib 2 mg and placebo. Nighttime itch awakenings were also reduced in a similar progression from placebo to the higher baricitinib dose.
Adverse events dose related
Treatment-related adverse events were reported more frequently in the baricitinib groups (58% baricitinib 4 mg, 56% baricitinib 2 mg) versus placebo 38%. Nasopharyngitis was most common, followed by oral herpes, upper respiratory tract infection, acne, diarrhea, and back pain. Serious adverse event rates were similar across treatment groups. Permanent discontinuation rates were low at 5% for baricitinib 4 mg, 0% for baricitinib 2 mg, and 1% for placebo. The side-effect profile for baricitinib was consistent with prior studies, Dr. Reich and his coauthors reported.
The authors noted further, “data in this study suggest that patients with AD treated with baricitinib may be able to reduce the frequency and total quantity of concomitant TCSs [topical corticosteroids] used, thus mitigating concerns associated with continual or sustained application of topical treatments.”
“Overall, this study provides further evidence to support the efficacy and safety profile of baricitinib for the treatment of moderate-severe AD,” commented one of the authors, Jonathan I. Silverberg, MD, PhD, MPH, of the department of dermatology at George Washington University in Washington.
“In particular, this study shows that adding topical corticosteroids to baricitinib increases the rate of treatment success compared with the efficacy seen in baricitinib monotherapy studies. These data will be important to guide the use of baricitinib with topical corticosteroids in clinical practice. I think these data are also important because they show that baricitinib 4 mg may be more effective than 2 mg in some patients,” he said in an interview.
In late September, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of oral baricitinib for adults with moderate to severe AD who are candidates for systemic therapy. Baricitinib is approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis. If approved in Europe, it will be the first JAK inhibitor and first oral medication indicated to treat patients with AD.
The study was funded by Eli Lilly and Company under license from Incyte Corporation. Dr. Reich reported receiving fees to the institution for participation in clinical trials from Eli Lilly and Company during the conduct of the study and personal fees for lectures. Dr. Silverberg reported receiving fees from Eli Lilly and Company during the conduct of the study, and fees from companies outside of this work. Other authors also reported disclosures related to Eli Lilly and other pharmaceutical companies, and several authors were Eli Lilly employees.
SOURCE: Reich K et al. JAMA Dermatol. 2020 Sep 30. doi: 10.1001/jamadermatol.2020.3260.
in the phase 3, double-blind, placebo-controlled, BREEZE-AD7 study.
The study enrolled patients with inadequate responses to topical corticosteroids, according to Kristian Reich, MD, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, and his coauthors.
First test of baricitinib plus topical steroids
Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, inhibits several cytokines in AD pathogenesis, and in two monotherapy studies (BREEZE-AD1 and BREEZE-AD2), it was superior to placebo for reducing several AD clinical signs and symptoms. The current BREEZE-AD7 study is the first to test baricitinib plus background topical corticosteroid therapy, more closely mirroring clinical practice, the authors noted.
BREEZE-AD7 was conducted at 68 centers in 10 countries in Asia, Australia, Europe, and South America. It included 329 adults with moderate to severe AD (mean age around 34 years, and around 34% were female) with inadequate responses to topical corticosteroids documented within the last 6 months. They were randomized 1:1:1 to daily baricitinib 4 mg, daily baricitinib 2 mg, or placebo for 16 weeks. All patients received moderate- and/or low-potency topical corticosteroids (such as 0.1%triamcinolone cream and 2.5% hydrocortisone ointment, respectively) for active lesions.
Significant benefit at 4 mg
At week 16, 31% of AD patients receiving baricitinib 4 mg achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) versus 15% in the placebo group (odds ratio, 2.8; 95% confidence interval, 1.4-5.6; P = .004). Among patients receiving baricitinib 2 mg, 24% achieved vI-GA-AD scores of 0 or 1 (OR, 1.9; 95% CI, 0.9-3.9; P = .08).
The same pattern of improving scores from placebo to baricitinib 2 mg to baricitinib 4 mg persisted, as reflected with secondary endpoints at week 16. Among patients receiving baricitinib 4 mg, 48% achieved Eczema Area Severity Index (EASI) 75 responses, versus 43% and 23% in 2 mg and placebo groups, respectively. Percent changes from baseline in total EASI score were –67%, –58%, –45% for baricitinib 4 mg, baricitinib 2 mg, and placebo, respectively; the proportion of patients achieving 4-point or greater improvements in Itch Numeric Rating Scale (NRS) was 44%, 38%, and 20% for baricitinib 4 mg, baricitinib 2 mg and placebo, respectively.
Similarly, mean change from baseline on the Skin Pain numeric rating scale was –3.7, –3.2, and –2.1 for baricitinib 4 mg, baricitinib 2 mg and placebo. Nighttime itch awakenings were also reduced in a similar progression from placebo to the higher baricitinib dose.
Adverse events dose related
Treatment-related adverse events were reported more frequently in the baricitinib groups (58% baricitinib 4 mg, 56% baricitinib 2 mg) versus placebo 38%. Nasopharyngitis was most common, followed by oral herpes, upper respiratory tract infection, acne, diarrhea, and back pain. Serious adverse event rates were similar across treatment groups. Permanent discontinuation rates were low at 5% for baricitinib 4 mg, 0% for baricitinib 2 mg, and 1% for placebo. The side-effect profile for baricitinib was consistent with prior studies, Dr. Reich and his coauthors reported.
The authors noted further, “data in this study suggest that patients with AD treated with baricitinib may be able to reduce the frequency and total quantity of concomitant TCSs [topical corticosteroids] used, thus mitigating concerns associated with continual or sustained application of topical treatments.”
“Overall, this study provides further evidence to support the efficacy and safety profile of baricitinib for the treatment of moderate-severe AD,” commented one of the authors, Jonathan I. Silverberg, MD, PhD, MPH, of the department of dermatology at George Washington University in Washington.
“In particular, this study shows that adding topical corticosteroids to baricitinib increases the rate of treatment success compared with the efficacy seen in baricitinib monotherapy studies. These data will be important to guide the use of baricitinib with topical corticosteroids in clinical practice. I think these data are also important because they show that baricitinib 4 mg may be more effective than 2 mg in some patients,” he said in an interview.
In late September, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of oral baricitinib for adults with moderate to severe AD who are candidates for systemic therapy. Baricitinib is approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis. If approved in Europe, it will be the first JAK inhibitor and first oral medication indicated to treat patients with AD.
The study was funded by Eli Lilly and Company under license from Incyte Corporation. Dr. Reich reported receiving fees to the institution for participation in clinical trials from Eli Lilly and Company during the conduct of the study and personal fees for lectures. Dr. Silverberg reported receiving fees from Eli Lilly and Company during the conduct of the study, and fees from companies outside of this work. Other authors also reported disclosures related to Eli Lilly and other pharmaceutical companies, and several authors were Eli Lilly employees.
SOURCE: Reich K et al. JAMA Dermatol. 2020 Sep 30. doi: 10.1001/jamadermatol.2020.3260.
in the phase 3, double-blind, placebo-controlled, BREEZE-AD7 study.
The study enrolled patients with inadequate responses to topical corticosteroids, according to Kristian Reich, MD, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, and his coauthors.
First test of baricitinib plus topical steroids
Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, inhibits several cytokines in AD pathogenesis, and in two monotherapy studies (BREEZE-AD1 and BREEZE-AD2), it was superior to placebo for reducing several AD clinical signs and symptoms. The current BREEZE-AD7 study is the first to test baricitinib plus background topical corticosteroid therapy, more closely mirroring clinical practice, the authors noted.
BREEZE-AD7 was conducted at 68 centers in 10 countries in Asia, Australia, Europe, and South America. It included 329 adults with moderate to severe AD (mean age around 34 years, and around 34% were female) with inadequate responses to topical corticosteroids documented within the last 6 months. They were randomized 1:1:1 to daily baricitinib 4 mg, daily baricitinib 2 mg, or placebo for 16 weeks. All patients received moderate- and/or low-potency topical corticosteroids (such as 0.1%triamcinolone cream and 2.5% hydrocortisone ointment, respectively) for active lesions.
Significant benefit at 4 mg
At week 16, 31% of AD patients receiving baricitinib 4 mg achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) versus 15% in the placebo group (odds ratio, 2.8; 95% confidence interval, 1.4-5.6; P = .004). Among patients receiving baricitinib 2 mg, 24% achieved vI-GA-AD scores of 0 or 1 (OR, 1.9; 95% CI, 0.9-3.9; P = .08).
The same pattern of improving scores from placebo to baricitinib 2 mg to baricitinib 4 mg persisted, as reflected with secondary endpoints at week 16. Among patients receiving baricitinib 4 mg, 48% achieved Eczema Area Severity Index (EASI) 75 responses, versus 43% and 23% in 2 mg and placebo groups, respectively. Percent changes from baseline in total EASI score were –67%, –58%, –45% for baricitinib 4 mg, baricitinib 2 mg, and placebo, respectively; the proportion of patients achieving 4-point or greater improvements in Itch Numeric Rating Scale (NRS) was 44%, 38%, and 20% for baricitinib 4 mg, baricitinib 2 mg and placebo, respectively.
Similarly, mean change from baseline on the Skin Pain numeric rating scale was –3.7, –3.2, and –2.1 for baricitinib 4 mg, baricitinib 2 mg and placebo. Nighttime itch awakenings were also reduced in a similar progression from placebo to the higher baricitinib dose.
Adverse events dose related
Treatment-related adverse events were reported more frequently in the baricitinib groups (58% baricitinib 4 mg, 56% baricitinib 2 mg) versus placebo 38%. Nasopharyngitis was most common, followed by oral herpes, upper respiratory tract infection, acne, diarrhea, and back pain. Serious adverse event rates were similar across treatment groups. Permanent discontinuation rates were low at 5% for baricitinib 4 mg, 0% for baricitinib 2 mg, and 1% for placebo. The side-effect profile for baricitinib was consistent with prior studies, Dr. Reich and his coauthors reported.
The authors noted further, “data in this study suggest that patients with AD treated with baricitinib may be able to reduce the frequency and total quantity of concomitant TCSs [topical corticosteroids] used, thus mitigating concerns associated with continual or sustained application of topical treatments.”
“Overall, this study provides further evidence to support the efficacy and safety profile of baricitinib for the treatment of moderate-severe AD,” commented one of the authors, Jonathan I. Silverberg, MD, PhD, MPH, of the department of dermatology at George Washington University in Washington.
“In particular, this study shows that adding topical corticosteroids to baricitinib increases the rate of treatment success compared with the efficacy seen in baricitinib monotherapy studies. These data will be important to guide the use of baricitinib with topical corticosteroids in clinical practice. I think these data are also important because they show that baricitinib 4 mg may be more effective than 2 mg in some patients,” he said in an interview.
In late September, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of oral baricitinib for adults with moderate to severe AD who are candidates for systemic therapy. Baricitinib is approved in the European Union and the United States to treat moderate to severe active rheumatoid arthritis. If approved in Europe, it will be the first JAK inhibitor and first oral medication indicated to treat patients with AD.
The study was funded by Eli Lilly and Company under license from Incyte Corporation. Dr. Reich reported receiving fees to the institution for participation in clinical trials from Eli Lilly and Company during the conduct of the study and personal fees for lectures. Dr. Silverberg reported receiving fees from Eli Lilly and Company during the conduct of the study, and fees from companies outside of this work. Other authors also reported disclosures related to Eli Lilly and other pharmaceutical companies, and several authors were Eli Lilly employees.
SOURCE: Reich K et al. JAMA Dermatol. 2020 Sep 30. doi: 10.1001/jamadermatol.2020.3260.
FROM JAMA DERMATOLOGY