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Mini-sponge stops postpartum hemorrhage quickly and safely
Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.
The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.
“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.
In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.
The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.
The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
Evidence of safety
No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.
The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.
“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.
A larger study comparing the sponge and condom uterine balloon tamponade is planned.
“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
Rigorous research needed
“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.
The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.
Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.
“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.
The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.
“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.
Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.
SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.
Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.
The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.
“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.
In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.
The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.
The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
Evidence of safety
No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.
The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.
“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.
A larger study comparing the sponge and condom uterine balloon tamponade is planned.
“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
Rigorous research needed
“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.
The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.
Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.
“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.
The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.
“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.
Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.
SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.
Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.
The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.
“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.
In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.
The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.
The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
Evidence of safety
No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.
The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.
“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.
A larger study comparing the sponge and condom uterine balloon tamponade is planned.
“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
Rigorous research needed
“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.
The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.
Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.
“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.
The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.
“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.
Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.
SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.
FROM OBSTETRICS & GYNECOLOGY
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.
EMA panel backs peanut allergy desensitizing powder Palforzia
The product is intended for desensitizing children and adolescents to peanut allergy.
Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.
Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.
According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.
The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.
It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.
The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.
The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.
“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”
The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.
This article originally appeared on Medscape.com.
The product is intended for desensitizing children and adolescents to peanut allergy.
Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.
Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.
According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.
The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.
It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.
The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.
The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.
“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”
The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.
This article originally appeared on Medscape.com.
The product is intended for desensitizing children and adolescents to peanut allergy.
Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.
Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.
According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.
The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.
It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.
The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.
The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.
“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”
The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.
This article originally appeared on Medscape.com.
When the only clinical choices are ‘lose-lose’
Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.
The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.
Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.
For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.
However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.
Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.
Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.
- Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
- Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
- Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.
Every one of us is affected by these stressors. I certainly am.
What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.
Common emotions that occur in response to moral injuries are: feelings of guilt, shame, anger, sadness, anxiety, and disgust; intrapersonal outcomes, including lowered self-esteem, high self-criticism, and beliefs about being bad, damaged, unworthy, failing, or weak; interpersonal outcomes, including loss of faith in people, avoidance of intimacy, and lack of trust in authority figures; and existential and spiritual outcomes, including loss of faith in previous religious beliefs and no longer believing in a just world.
Moral injuries tend to originate primarily from systems-based problems, as we have seen with the lack of concerted national approaches to the pandemic. On the positive side, solutions typically also involve systems-based changes, which in this case may mean changes in leadership styles nationally and locally, as well as changes in the culture of medicine and the way healthcare is practiced and managed in the modern era. We are starting to see some of those changes with the increased use of telemedicine and health technologies, as well as more of a focus on the well-being of health care workers, now deemed “essential.”
As individuals, we are not helpless. There are things we can do in our workplaces to create change. I suggest:
- Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
- Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
- Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
- Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
- Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
- Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
- Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
- Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
- Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.
Remember, we are in this together and will find strength in each other. This too will pass.
This article first appeared on Medscape.com.
Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.
The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.
Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.
For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.
However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.
Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.
Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.
- Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
- Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
- Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.
Every one of us is affected by these stressors. I certainly am.
What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.
Common emotions that occur in response to moral injuries are: feelings of guilt, shame, anger, sadness, anxiety, and disgust; intrapersonal outcomes, including lowered self-esteem, high self-criticism, and beliefs about being bad, damaged, unworthy, failing, or weak; interpersonal outcomes, including loss of faith in people, avoidance of intimacy, and lack of trust in authority figures; and existential and spiritual outcomes, including loss of faith in previous religious beliefs and no longer believing in a just world.
Moral injuries tend to originate primarily from systems-based problems, as we have seen with the lack of concerted national approaches to the pandemic. On the positive side, solutions typically also involve systems-based changes, which in this case may mean changes in leadership styles nationally and locally, as well as changes in the culture of medicine and the way healthcare is practiced and managed in the modern era. We are starting to see some of those changes with the increased use of telemedicine and health technologies, as well as more of a focus on the well-being of health care workers, now deemed “essential.”
As individuals, we are not helpless. There are things we can do in our workplaces to create change. I suggest:
- Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
- Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
- Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
- Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
- Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
- Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
- Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
- Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
- Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.
Remember, we are in this together and will find strength in each other. This too will pass.
This article first appeared on Medscape.com.
Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.
The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.
Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.
For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.
However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.
Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.
Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.
- Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
- Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
- Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.
Every one of us is affected by these stressors. I certainly am.
What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.
Common emotions that occur in response to moral injuries are: feelings of guilt, shame, anger, sadness, anxiety, and disgust; intrapersonal outcomes, including lowered self-esteem, high self-criticism, and beliefs about being bad, damaged, unworthy, failing, or weak; interpersonal outcomes, including loss of faith in people, avoidance of intimacy, and lack of trust in authority figures; and existential and spiritual outcomes, including loss of faith in previous religious beliefs and no longer believing in a just world.
Moral injuries tend to originate primarily from systems-based problems, as we have seen with the lack of concerted national approaches to the pandemic. On the positive side, solutions typically also involve systems-based changes, which in this case may mean changes in leadership styles nationally and locally, as well as changes in the culture of medicine and the way healthcare is practiced and managed in the modern era. We are starting to see some of those changes with the increased use of telemedicine and health technologies, as well as more of a focus on the well-being of health care workers, now deemed “essential.”
As individuals, we are not helpless. There are things we can do in our workplaces to create change. I suggest:
- Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
- Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
- Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
- Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
- Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
- Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
- Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
- Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
- Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.
Remember, we are in this together and will find strength in each other. This too will pass.
This article first appeared on Medscape.com.
Scrubs ad that insulted women and DOs pulled after outcry
A video that advertised scrubs but denigrated women and DOs has been removed from the company’s website after fierce backlash.
On Tuesday Kevin Klauer, DO, EJD, directed this tweet to the medical uniform company Figs: “@wearfigs REMOVE YOUR DO offensive web ad immediately or the @AOAforDOs will proceed promptly with a defamation lawsuit on behalf of our members and profession.”
Also on Tuesday, the American Association of Colleges of Osteopathic Medicine demanded a public apology.
The video ad featured a woman carrying a “Medical Terminology for Dummies” book upside down while modeling the pink scrubs from all angles and dancing. At one point in the ad, the camera zooms in on the badge clipped to her waistband that read “DO.”
Agnieszka Solberg, MD, a vascular and interventional radiologist and assistant clinical professor at the University of North Dakota in Grand Forks, was among those voicing pointed criticism on social media.
“This was another hit for our DO colleagues,” she said in an interview, emphasizing that MDs and DOs provide the same level of care.
AACOM tweeted: “We are outraged women physicians & doctors of osteopathic medicine are still attacked in ignorant marketing campaigns. A company like @wearfigs should be ashamed for promoting these stereotypes. We demand the respect we’ve earned AND a public apology.”
Dr. Solberg says this is not the first offense by the company. She said she had stopped buying the company’s scrubs a year ago because the ads “have been portraying female providers as dumb and silly. This was the final straw.”
She said the timing of the ad is suspect as DOs had been swept into a storm of negativity earlier this month, as Medscape Medical News reported, when some questioned the qualifications of President Donald Trump’s physician, Sean Conley, who is a DO.
The scrubs ad ignited criticism across specialties, provider levels, and genders.
Jessica K. Willett, MD, tweeted: “As women physicians in 2020, we still struggle to be taken seriously compared to our male counterparts, as we battle stereotypes like THIS EXACT ONE. We expect the brands we support to reflect the badasses we are.”
The company responded to her tweet: “Thank you so much for the feedback! Totally not our intent – we’re taking down both the men’s and women’s versions of this ASAP! I really appreciate you taking the time to share this.”
The company did not respond to a request for comment but issued an apology on social media: “A lot of you guys have pointed out an insensitive video we had on our site – we are incredibly sorry for any hurt this has caused you, especially our female DOs (who are amazing!) FIGS is a female founded company whose only mission is to make you guys feel awesome.”
The Los Angeles–based company, which Forbes estimated will make $250 million in sales this year, was founded by co-CEOs Heather Hasson and Trina Spear.
A med student wrote on Twitter: “As a female and a DO student, how would I ever “feel awesome” about myself knowing that this is how you view me??? And how you want others to view me??? Women and DO’s have fought stereotypes way too long for you to go ahead and put this out there. Do better.”
Even the company’s apology was tinged with disrespect, some noted, with the use of “you guys” and for what it didn’t include.
As Liesl Young, MD, tweeted: “We are not “guys”, we are women. MD = DO. We stand together.”
Dr. Solberg said the apology came across as an apology that feelings were hurt. It should have detailed the changes the company would make to prevent another incident and address the processes that led to the video.
Dr. Solberg said she is seeing something positive come from the whole incident in that, “women are taking up the torch of feminism in such a volatile and divisive time.”
Dr. Solberg reported no relevant financial relationships.
This article first appeared on Medscape.com.
A video that advertised scrubs but denigrated women and DOs has been removed from the company’s website after fierce backlash.
On Tuesday Kevin Klauer, DO, EJD, directed this tweet to the medical uniform company Figs: “@wearfigs REMOVE YOUR DO offensive web ad immediately or the @AOAforDOs will proceed promptly with a defamation lawsuit on behalf of our members and profession.”
Also on Tuesday, the American Association of Colleges of Osteopathic Medicine demanded a public apology.
The video ad featured a woman carrying a “Medical Terminology for Dummies” book upside down while modeling the pink scrubs from all angles and dancing. At one point in the ad, the camera zooms in on the badge clipped to her waistband that read “DO.”
Agnieszka Solberg, MD, a vascular and interventional radiologist and assistant clinical professor at the University of North Dakota in Grand Forks, was among those voicing pointed criticism on social media.
“This was another hit for our DO colleagues,” she said in an interview, emphasizing that MDs and DOs provide the same level of care.
AACOM tweeted: “We are outraged women physicians & doctors of osteopathic medicine are still attacked in ignorant marketing campaigns. A company like @wearfigs should be ashamed for promoting these stereotypes. We demand the respect we’ve earned AND a public apology.”
Dr. Solberg says this is not the first offense by the company. She said she had stopped buying the company’s scrubs a year ago because the ads “have been portraying female providers as dumb and silly. This was the final straw.”
She said the timing of the ad is suspect as DOs had been swept into a storm of negativity earlier this month, as Medscape Medical News reported, when some questioned the qualifications of President Donald Trump’s physician, Sean Conley, who is a DO.
The scrubs ad ignited criticism across specialties, provider levels, and genders.
Jessica K. Willett, MD, tweeted: “As women physicians in 2020, we still struggle to be taken seriously compared to our male counterparts, as we battle stereotypes like THIS EXACT ONE. We expect the brands we support to reflect the badasses we are.”
The company responded to her tweet: “Thank you so much for the feedback! Totally not our intent – we’re taking down both the men’s and women’s versions of this ASAP! I really appreciate you taking the time to share this.”
The company did not respond to a request for comment but issued an apology on social media: “A lot of you guys have pointed out an insensitive video we had on our site – we are incredibly sorry for any hurt this has caused you, especially our female DOs (who are amazing!) FIGS is a female founded company whose only mission is to make you guys feel awesome.”
The Los Angeles–based company, which Forbes estimated will make $250 million in sales this year, was founded by co-CEOs Heather Hasson and Trina Spear.
A med student wrote on Twitter: “As a female and a DO student, how would I ever “feel awesome” about myself knowing that this is how you view me??? And how you want others to view me??? Women and DO’s have fought stereotypes way too long for you to go ahead and put this out there. Do better.”
Even the company’s apology was tinged with disrespect, some noted, with the use of “you guys” and for what it didn’t include.
As Liesl Young, MD, tweeted: “We are not “guys”, we are women. MD = DO. We stand together.”
Dr. Solberg said the apology came across as an apology that feelings were hurt. It should have detailed the changes the company would make to prevent another incident and address the processes that led to the video.
Dr. Solberg said she is seeing something positive come from the whole incident in that, “women are taking up the torch of feminism in such a volatile and divisive time.”
Dr. Solberg reported no relevant financial relationships.
This article first appeared on Medscape.com.
A video that advertised scrubs but denigrated women and DOs has been removed from the company’s website after fierce backlash.
On Tuesday Kevin Klauer, DO, EJD, directed this tweet to the medical uniform company Figs: “@wearfigs REMOVE YOUR DO offensive web ad immediately or the @AOAforDOs will proceed promptly with a defamation lawsuit on behalf of our members and profession.”
Also on Tuesday, the American Association of Colleges of Osteopathic Medicine demanded a public apology.
The video ad featured a woman carrying a “Medical Terminology for Dummies” book upside down while modeling the pink scrubs from all angles and dancing. At one point in the ad, the camera zooms in on the badge clipped to her waistband that read “DO.”
Agnieszka Solberg, MD, a vascular and interventional radiologist and assistant clinical professor at the University of North Dakota in Grand Forks, was among those voicing pointed criticism on social media.
“This was another hit for our DO colleagues,” she said in an interview, emphasizing that MDs and DOs provide the same level of care.
AACOM tweeted: “We are outraged women physicians & doctors of osteopathic medicine are still attacked in ignorant marketing campaigns. A company like @wearfigs should be ashamed for promoting these stereotypes. We demand the respect we’ve earned AND a public apology.”
Dr. Solberg says this is not the first offense by the company. She said she had stopped buying the company’s scrubs a year ago because the ads “have been portraying female providers as dumb and silly. This was the final straw.”
She said the timing of the ad is suspect as DOs had been swept into a storm of negativity earlier this month, as Medscape Medical News reported, when some questioned the qualifications of President Donald Trump’s physician, Sean Conley, who is a DO.
The scrubs ad ignited criticism across specialties, provider levels, and genders.
Jessica K. Willett, MD, tweeted: “As women physicians in 2020, we still struggle to be taken seriously compared to our male counterparts, as we battle stereotypes like THIS EXACT ONE. We expect the brands we support to reflect the badasses we are.”
The company responded to her tweet: “Thank you so much for the feedback! Totally not our intent – we’re taking down both the men’s and women’s versions of this ASAP! I really appreciate you taking the time to share this.”
The company did not respond to a request for comment but issued an apology on social media: “A lot of you guys have pointed out an insensitive video we had on our site – we are incredibly sorry for any hurt this has caused you, especially our female DOs (who are amazing!) FIGS is a female founded company whose only mission is to make you guys feel awesome.”
The Los Angeles–based company, which Forbes estimated will make $250 million in sales this year, was founded by co-CEOs Heather Hasson and Trina Spear.
A med student wrote on Twitter: “As a female and a DO student, how would I ever “feel awesome” about myself knowing that this is how you view me??? And how you want others to view me??? Women and DO’s have fought stereotypes way too long for you to go ahead and put this out there. Do better.”
Even the company’s apology was tinged with disrespect, some noted, with the use of “you guys” and for what it didn’t include.
As Liesl Young, MD, tweeted: “We are not “guys”, we are women. MD = DO. We stand together.”
Dr. Solberg said the apology came across as an apology that feelings were hurt. It should have detailed the changes the company would make to prevent another incident and address the processes that led to the video.
Dr. Solberg said she is seeing something positive come from the whole incident in that, “women are taking up the torch of feminism in such a volatile and divisive time.”
Dr. Solberg reported no relevant financial relationships.
This article first appeared on Medscape.com.
Experts tout immediate quadruple therapy for HFrEF patients
Gregg C. Fonarow, MD, recommended.
Less than 2 months before Dr. Fonarow made that striking statement during the virtual annual meeting of the Heart Failure Society of America, investigators first reported results from the EMPEROR-Reduced trial at the European Society of Cardiology’s virtual annual meeting, showing that the sodium-glucose transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) successfully cut events in patients with heart failure with reduced ejection fraction (HFrEF). That report, a year after results from a similar trial (DAPA-HF) showed the same outcome using a different drug from the same class, dapagliflozin (Farxiga), cemented the SGLT2 inhibitor drug class as the fourth pillar for treating HFrEF, joining the angiotensin receptor neprilysin inhibitor (ARNI) class (sacubitril valsartan), beta-blockers (like carvedilol), and mineralocorticoid receptor antagonists (like spironolactone).
This rejiggering of the consensus expert approach for treating HFrEF left cardiologists wondering what sequence to use when starting this quadruple therapy. Within weeks, the answer from heart failure opinion leaders was clear:
“Start all four pillars simultaneously. Most patients can tolerate, and will benefit from, a simultaneous start,” declared Dr. Fonarow, professor and chief of cardiology at the University of California, Los Angeles.
His rationale? Patients get benefits from each of these drug classes “surprisingly early,” with improved outcomes in clinical trials appearing within a few weeks, compared with patients in control arms. The consequence is that any delay in starting treatment denies patients time with improved health status, function, and survival.
Study results documented that the four foundational drug classes can produce rapid improvements in health status, left ventricular size and shape, and make clinically meaningful cuts in both first and recurrent hospitalizations for heart failure and in mortality, Dr. Fonarow said. After 30 days on quadruple treatment, a patient’s relative risk for death drops by more than three-quarters, compared with patients not on these medications.
The benefits from each of the four classes involve distinct physiologic pathways and hence are not diminished by concurrent treatment. And immediate initiation avoids the risk of clinical inertia and a negligence to prescribe one or more of the four important drug classes. Introducing the four classes in a sequential manner could mean spending as long as a year to get all four on board and up-titrated to optimal therapeutic levels, he noted.
“Overcome inertia by prescribing [all four drug classes] at the time of diagnosis,” Dr. Fonarow admonished his audience.
The challenge of prescribing inertia
The risk for inertia in prescribing heart failure medications is real. Data collected in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry from more than 3,500 HFrEF patients managed at any of 150 U.S. primary care and cardiology practices starting in late 2015 and continuing through 2017 showed that, among patients eligible for treatment with renin-angiotensin system (RAS) inhibition (with either ARNI or a single RAS inhibiting drug), a beta-blocker, and a mineralocorticoid receptor antagonist (MRA), 22% received all three drug classes. A scant 1% were on target dosages of all three drug classes, noted Stephen J. Greene, MD, in a separate talk at the meeting when he cited his published findings.
The sole formulation currently in the ARNI class, sacubitril/valsartan (Entresto) has in recent years been the poster child for prescribing inertia in HFrEF patients after coming onto the U.S. market for routine use in 2015. A review run by Dr. Greene of more than 9,000 HFrEF patients who were at least 65 years old and discharged from a hospital participating in the Get With the Guidelines–Heart Failure registry during October 2015–September 2017 showed that 8% of eligible patients actually received a sacubitril/valsartan prescription. Separate assessment of outpatients with HFrEF from the same era showed 13% uptake, said D. Greene, a cardiologist at Duke University, Durham, N.C.
Substantial gaps in prescribing evidence-based treatments to HFrEF patients have existed for the past couple of decades, said Dr. Greene. “Even a blockbuster drug like sacubitril/valsartan has been slow to implement.”
Quadruple therapy adds an average of 6 years of life
One of the most strongest arguments favoring the start-four-at-once approach was detailed in what’s quickly become a widely cited analysis published in July 2020 by a team of researchers led by Muthiah Vaduganathan, MD. Using data from three key pivotal trials they estimated that timely treatment with all four drug classes would on average produce an extra 6 years of overall survival in a 55-year old HFrEF patient, and an added 8 years free from cardiovascular death or first hospitalization for heart failure, compared with less comprehensive treatment. The analysis also showed a significant 3-year average boost in overall survival among HFrEF patients who were 80 years old when using quadruple therapy compared with the “conventional medical therapy” used on control patients in the three trials examined.
Dr. Greene called these findings “remarkable.”
“Four drugs use five mechanistic pathways to produce 6 added years of survival,” summed up Dr. Vaduganathan during a separate talk at the virtual meeting.
In addition to this substantial potential for a meaningful impact on patents’ lives, he cited other factors that add to the case for early prescription of the pharmaceutical gauntlet: avoiding missed treatment opportunities that occur with slower, step-wise drug introduction; simplifying, streamlining, and standardizing the care pathway, which helps avoid care inequities and disrupts the potential for inertia; magnifying benefit when comprehensive treatment starts sooner; and providing additive benefits without drug-drug interactions.
“Upfront treatment at the time of [HFrEF] diagnosis or hospitalization is an approach that disrupts treatment inertia,” emphasized Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston.
New approaches needed to encourage quick uptake
“Efficacy alone has not been enough for efficient uptake in U.S. practice” of sacubitril/valsartan, other RAS inhibitors, beta-blockers, and MRAs, noted Dr. Greene.
He was more optimistic about prospects for relatively quick uptake of early SGLT2 inhibitor treatment as part of routine HFrEF management given all the positives that this new HFrEF treatment offers, including some “unique features” among HFrEF drugs. These include the simplicity of the regimen, which involves a single dosage for everyone that’s taken once daily; minimal blood pressure effects and no adverse renal effects while also producing substantial renal protection; and two SGLT2 inhibitors with proven HFrEF benefit (dapagliflozin and empagliflozin), which bodes well for an eventual price drop.
The SGLT2 inhibitors stack up as an “ideal” HFrEF treatment, concluded Dr. Greene, which should facilitate quick uptake. As far as getting clinicians to also add early on the other three members of the core four treatment classes in routine treatment, he conceded that “innovative and evidence-based approaches to improving real-world uptake of guideline-directed medical therapy are urgently needed.”
EMPEROR-Reduced was funded by Boehringer Ingelheim and Lilly, the companies that market empagliflozin (Jardiance). CHAMP-HF was funded by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Fonarow has been a consultant or adviser to Novartis, as well as to Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards, Janssen, Medtronic, and Merck. Dr. Greene has received research funding from Novartis, has been a consultant to Amgen and Merck, an adviser to Amgen and Cytokinetics, and has received research funding from Amgen, AstraZeneca, Bristol-Myers Squibb, and Merck. Dr. Vaduganathan has had financial relationships with Boehringer Ingelheim and Novartis, as well as with Amgen, AstraZeneca, Baxter Healthcare, Bayer, Cytokinetics, and Relypsa.
Gregg C. Fonarow, MD, recommended.
Less than 2 months before Dr. Fonarow made that striking statement during the virtual annual meeting of the Heart Failure Society of America, investigators first reported results from the EMPEROR-Reduced trial at the European Society of Cardiology’s virtual annual meeting, showing that the sodium-glucose transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) successfully cut events in patients with heart failure with reduced ejection fraction (HFrEF). That report, a year after results from a similar trial (DAPA-HF) showed the same outcome using a different drug from the same class, dapagliflozin (Farxiga), cemented the SGLT2 inhibitor drug class as the fourth pillar for treating HFrEF, joining the angiotensin receptor neprilysin inhibitor (ARNI) class (sacubitril valsartan), beta-blockers (like carvedilol), and mineralocorticoid receptor antagonists (like spironolactone).
This rejiggering of the consensus expert approach for treating HFrEF left cardiologists wondering what sequence to use when starting this quadruple therapy. Within weeks, the answer from heart failure opinion leaders was clear:
“Start all four pillars simultaneously. Most patients can tolerate, and will benefit from, a simultaneous start,” declared Dr. Fonarow, professor and chief of cardiology at the University of California, Los Angeles.
His rationale? Patients get benefits from each of these drug classes “surprisingly early,” with improved outcomes in clinical trials appearing within a few weeks, compared with patients in control arms. The consequence is that any delay in starting treatment denies patients time with improved health status, function, and survival.
Study results documented that the four foundational drug classes can produce rapid improvements in health status, left ventricular size and shape, and make clinically meaningful cuts in both first and recurrent hospitalizations for heart failure and in mortality, Dr. Fonarow said. After 30 days on quadruple treatment, a patient’s relative risk for death drops by more than three-quarters, compared with patients not on these medications.
The benefits from each of the four classes involve distinct physiologic pathways and hence are not diminished by concurrent treatment. And immediate initiation avoids the risk of clinical inertia and a negligence to prescribe one or more of the four important drug classes. Introducing the four classes in a sequential manner could mean spending as long as a year to get all four on board and up-titrated to optimal therapeutic levels, he noted.
“Overcome inertia by prescribing [all four drug classes] at the time of diagnosis,” Dr. Fonarow admonished his audience.
The challenge of prescribing inertia
The risk for inertia in prescribing heart failure medications is real. Data collected in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry from more than 3,500 HFrEF patients managed at any of 150 U.S. primary care and cardiology practices starting in late 2015 and continuing through 2017 showed that, among patients eligible for treatment with renin-angiotensin system (RAS) inhibition (with either ARNI or a single RAS inhibiting drug), a beta-blocker, and a mineralocorticoid receptor antagonist (MRA), 22% received all three drug classes. A scant 1% were on target dosages of all three drug classes, noted Stephen J. Greene, MD, in a separate talk at the meeting when he cited his published findings.
The sole formulation currently in the ARNI class, sacubitril/valsartan (Entresto) has in recent years been the poster child for prescribing inertia in HFrEF patients after coming onto the U.S. market for routine use in 2015. A review run by Dr. Greene of more than 9,000 HFrEF patients who were at least 65 years old and discharged from a hospital participating in the Get With the Guidelines–Heart Failure registry during October 2015–September 2017 showed that 8% of eligible patients actually received a sacubitril/valsartan prescription. Separate assessment of outpatients with HFrEF from the same era showed 13% uptake, said D. Greene, a cardiologist at Duke University, Durham, N.C.
Substantial gaps in prescribing evidence-based treatments to HFrEF patients have existed for the past couple of decades, said Dr. Greene. “Even a blockbuster drug like sacubitril/valsartan has been slow to implement.”
Quadruple therapy adds an average of 6 years of life
One of the most strongest arguments favoring the start-four-at-once approach was detailed in what’s quickly become a widely cited analysis published in July 2020 by a team of researchers led by Muthiah Vaduganathan, MD. Using data from three key pivotal trials they estimated that timely treatment with all four drug classes would on average produce an extra 6 years of overall survival in a 55-year old HFrEF patient, and an added 8 years free from cardiovascular death or first hospitalization for heart failure, compared with less comprehensive treatment. The analysis also showed a significant 3-year average boost in overall survival among HFrEF patients who were 80 years old when using quadruple therapy compared with the “conventional medical therapy” used on control patients in the three trials examined.
Dr. Greene called these findings “remarkable.”
“Four drugs use five mechanistic pathways to produce 6 added years of survival,” summed up Dr. Vaduganathan during a separate talk at the virtual meeting.
In addition to this substantial potential for a meaningful impact on patents’ lives, he cited other factors that add to the case for early prescription of the pharmaceutical gauntlet: avoiding missed treatment opportunities that occur with slower, step-wise drug introduction; simplifying, streamlining, and standardizing the care pathway, which helps avoid care inequities and disrupts the potential for inertia; magnifying benefit when comprehensive treatment starts sooner; and providing additive benefits without drug-drug interactions.
“Upfront treatment at the time of [HFrEF] diagnosis or hospitalization is an approach that disrupts treatment inertia,” emphasized Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston.
New approaches needed to encourage quick uptake
“Efficacy alone has not been enough for efficient uptake in U.S. practice” of sacubitril/valsartan, other RAS inhibitors, beta-blockers, and MRAs, noted Dr. Greene.
He was more optimistic about prospects for relatively quick uptake of early SGLT2 inhibitor treatment as part of routine HFrEF management given all the positives that this new HFrEF treatment offers, including some “unique features” among HFrEF drugs. These include the simplicity of the regimen, which involves a single dosage for everyone that’s taken once daily; minimal blood pressure effects and no adverse renal effects while also producing substantial renal protection; and two SGLT2 inhibitors with proven HFrEF benefit (dapagliflozin and empagliflozin), which bodes well for an eventual price drop.
The SGLT2 inhibitors stack up as an “ideal” HFrEF treatment, concluded Dr. Greene, which should facilitate quick uptake. As far as getting clinicians to also add early on the other three members of the core four treatment classes in routine treatment, he conceded that “innovative and evidence-based approaches to improving real-world uptake of guideline-directed medical therapy are urgently needed.”
EMPEROR-Reduced was funded by Boehringer Ingelheim and Lilly, the companies that market empagliflozin (Jardiance). CHAMP-HF was funded by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Fonarow has been a consultant or adviser to Novartis, as well as to Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards, Janssen, Medtronic, and Merck. Dr. Greene has received research funding from Novartis, has been a consultant to Amgen and Merck, an adviser to Amgen and Cytokinetics, and has received research funding from Amgen, AstraZeneca, Bristol-Myers Squibb, and Merck. Dr. Vaduganathan has had financial relationships with Boehringer Ingelheim and Novartis, as well as with Amgen, AstraZeneca, Baxter Healthcare, Bayer, Cytokinetics, and Relypsa.
Gregg C. Fonarow, MD, recommended.
Less than 2 months before Dr. Fonarow made that striking statement during the virtual annual meeting of the Heart Failure Society of America, investigators first reported results from the EMPEROR-Reduced trial at the European Society of Cardiology’s virtual annual meeting, showing that the sodium-glucose transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) successfully cut events in patients with heart failure with reduced ejection fraction (HFrEF). That report, a year after results from a similar trial (DAPA-HF) showed the same outcome using a different drug from the same class, dapagliflozin (Farxiga), cemented the SGLT2 inhibitor drug class as the fourth pillar for treating HFrEF, joining the angiotensin receptor neprilysin inhibitor (ARNI) class (sacubitril valsartan), beta-blockers (like carvedilol), and mineralocorticoid receptor antagonists (like spironolactone).
This rejiggering of the consensus expert approach for treating HFrEF left cardiologists wondering what sequence to use when starting this quadruple therapy. Within weeks, the answer from heart failure opinion leaders was clear:
“Start all four pillars simultaneously. Most patients can tolerate, and will benefit from, a simultaneous start,” declared Dr. Fonarow, professor and chief of cardiology at the University of California, Los Angeles.
His rationale? Patients get benefits from each of these drug classes “surprisingly early,” with improved outcomes in clinical trials appearing within a few weeks, compared with patients in control arms. The consequence is that any delay in starting treatment denies patients time with improved health status, function, and survival.
Study results documented that the four foundational drug classes can produce rapid improvements in health status, left ventricular size and shape, and make clinically meaningful cuts in both first and recurrent hospitalizations for heart failure and in mortality, Dr. Fonarow said. After 30 days on quadruple treatment, a patient’s relative risk for death drops by more than three-quarters, compared with patients not on these medications.
The benefits from each of the four classes involve distinct physiologic pathways and hence are not diminished by concurrent treatment. And immediate initiation avoids the risk of clinical inertia and a negligence to prescribe one or more of the four important drug classes. Introducing the four classes in a sequential manner could mean spending as long as a year to get all four on board and up-titrated to optimal therapeutic levels, he noted.
“Overcome inertia by prescribing [all four drug classes] at the time of diagnosis,” Dr. Fonarow admonished his audience.
The challenge of prescribing inertia
The risk for inertia in prescribing heart failure medications is real. Data collected in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry from more than 3,500 HFrEF patients managed at any of 150 U.S. primary care and cardiology practices starting in late 2015 and continuing through 2017 showed that, among patients eligible for treatment with renin-angiotensin system (RAS) inhibition (with either ARNI or a single RAS inhibiting drug), a beta-blocker, and a mineralocorticoid receptor antagonist (MRA), 22% received all three drug classes. A scant 1% were on target dosages of all three drug classes, noted Stephen J. Greene, MD, in a separate talk at the meeting when he cited his published findings.
The sole formulation currently in the ARNI class, sacubitril/valsartan (Entresto) has in recent years been the poster child for prescribing inertia in HFrEF patients after coming onto the U.S. market for routine use in 2015. A review run by Dr. Greene of more than 9,000 HFrEF patients who were at least 65 years old and discharged from a hospital participating in the Get With the Guidelines–Heart Failure registry during October 2015–September 2017 showed that 8% of eligible patients actually received a sacubitril/valsartan prescription. Separate assessment of outpatients with HFrEF from the same era showed 13% uptake, said D. Greene, a cardiologist at Duke University, Durham, N.C.
Substantial gaps in prescribing evidence-based treatments to HFrEF patients have existed for the past couple of decades, said Dr. Greene. “Even a blockbuster drug like sacubitril/valsartan has been slow to implement.”
Quadruple therapy adds an average of 6 years of life
One of the most strongest arguments favoring the start-four-at-once approach was detailed in what’s quickly become a widely cited analysis published in July 2020 by a team of researchers led by Muthiah Vaduganathan, MD. Using data from three key pivotal trials they estimated that timely treatment with all four drug classes would on average produce an extra 6 years of overall survival in a 55-year old HFrEF patient, and an added 8 years free from cardiovascular death or first hospitalization for heart failure, compared with less comprehensive treatment. The analysis also showed a significant 3-year average boost in overall survival among HFrEF patients who were 80 years old when using quadruple therapy compared with the “conventional medical therapy” used on control patients in the three trials examined.
Dr. Greene called these findings “remarkable.”
“Four drugs use five mechanistic pathways to produce 6 added years of survival,” summed up Dr. Vaduganathan during a separate talk at the virtual meeting.
In addition to this substantial potential for a meaningful impact on patents’ lives, he cited other factors that add to the case for early prescription of the pharmaceutical gauntlet: avoiding missed treatment opportunities that occur with slower, step-wise drug introduction; simplifying, streamlining, and standardizing the care pathway, which helps avoid care inequities and disrupts the potential for inertia; magnifying benefit when comprehensive treatment starts sooner; and providing additive benefits without drug-drug interactions.
“Upfront treatment at the time of [HFrEF] diagnosis or hospitalization is an approach that disrupts treatment inertia,” emphasized Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston.
New approaches needed to encourage quick uptake
“Efficacy alone has not been enough for efficient uptake in U.S. practice” of sacubitril/valsartan, other RAS inhibitors, beta-blockers, and MRAs, noted Dr. Greene.
He was more optimistic about prospects for relatively quick uptake of early SGLT2 inhibitor treatment as part of routine HFrEF management given all the positives that this new HFrEF treatment offers, including some “unique features” among HFrEF drugs. These include the simplicity of the regimen, which involves a single dosage for everyone that’s taken once daily; minimal blood pressure effects and no adverse renal effects while also producing substantial renal protection; and two SGLT2 inhibitors with proven HFrEF benefit (dapagliflozin and empagliflozin), which bodes well for an eventual price drop.
The SGLT2 inhibitors stack up as an “ideal” HFrEF treatment, concluded Dr. Greene, which should facilitate quick uptake. As far as getting clinicians to also add early on the other three members of the core four treatment classes in routine treatment, he conceded that “innovative and evidence-based approaches to improving real-world uptake of guideline-directed medical therapy are urgently needed.”
EMPEROR-Reduced was funded by Boehringer Ingelheim and Lilly, the companies that market empagliflozin (Jardiance). CHAMP-HF was funded by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Fonarow has been a consultant or adviser to Novartis, as well as to Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards, Janssen, Medtronic, and Merck. Dr. Greene has received research funding from Novartis, has been a consultant to Amgen and Merck, an adviser to Amgen and Cytokinetics, and has received research funding from Amgen, AstraZeneca, Bristol-Myers Squibb, and Merck. Dr. Vaduganathan has had financial relationships with Boehringer Ingelheim and Novartis, as well as with Amgen, AstraZeneca, Baxter Healthcare, Bayer, Cytokinetics, and Relypsa.
FROM HFSA 2020
‘Modest’ benefit for post-MI T2D glucose monitoring
Following a heart attack, there appears to be a “modest” benefit of using flash glucose monitoring over fingerstick testing to monitor blood glucose levels in patients with type 2 diabetes being treated with insulin or a sulfonylurea, according to investigators of the LIBERATES trial.
The results showed a nonsignificant increase in the time that subjects’ blood glucose was spent in the target range of 3.9-10.00 mmol/L (70-180 mg/dL) 3 months after experiencing an acute coronary syndrome (ACS).
At best, flash monitoring using Abbott’s Freestyle Libre system was associated with an increase in time spent in range (TIR) of 17-28 or 48 minutes per day over self-monitoring of blood glucose (SMBG), depending on the type of statistical analysis used. There was no difference in glycated hemoglobin A1c levels between the two groups, but there was a trend for less time spent in hypoglycemia in the flash monitoring arm.
Viewers underwhelmed
“My overall impression is that the effects were less pronounced than anticipated,” Kare Birkeland, MD, PhD, a specialist in internal medicine and endocrinology at Oslo University Hospital, Rikshospitalet, Norway, observed after the findings were presented at the virtual annual meeting of the European Association for the Study of Diabetes.
Others who had watched the live session seemed similarly underwhelmed by the findings, with one viewer questioning the value of devoting an hour-and-a-half session to the phase 2 trial.
However, the session chair Simon Heller, BA, MB, BChir, DM, professor of clinical diabetes at the University of Sheffield, and trial coinvestigator, defended the detailed look at the trial’s findings, noting that it was worthwhile to present the data from the trial as it “really helps explain why we do phase 2 and phase 3 trials.”
Strong rationale for monitoring post-MI
There is a strong rationale for ensuring that blood glucose is well controlled in type 2 diabetes patients who have experienced a myocardial infarction, observed Robert Storey, BSc, BM, DM, professor of cardiology at the University of Sheffield. One way to do that potentially is through improved glucose monitoring.
“There’s clearly a close link between diabetes and the risk of MI: Both high and low HbA1c are associated with adverse outcome, and high and low glucose levels following MI are also associated with adverse outcome,” he observed, noting also that hypoglycemia was not given enough attention in post-ACS patients.
“The hypothesis of the LIBERATES study was that a modern glycemic monitoring strategy can optimize blood glucose levels in type 2 diabetes patients following MI with the potential to reduce mortality and morbidity and improve quality of life,” Dr. Storey said. “The main research question of LIBERATES says, ‘Do new approaches in glucose monitoring increase the time in range and reduce hypoglycemia?’ ”
Pragmatic trial design
LIBERATES was a prospective, multicenter, parallel group, randomized controlled trial, explained the study’s statistician Deborah Stocken, PhD, professor of clinical trials research at the University of Leeds. There was “limited ability to blind the interventions,” so it was an open-label design.
“The patient population in LIBERATES was kept as inclusive and as pragmatic as possible to ensure that the results at the end of the trial are generalizable,” said Dr. Stocken. Patients with type 2 diabetes were recruited within 5 days of hospital admission for ACS, which could include both ST- and non-ST elevation MI. In all, 141 of a calculated 150 patients that would be needed were recruited and randomized to the flash monitoring (69) or SMBG (72) arm.
Dr. Stocken noted that early in the recruitment phase, the trials oversight committee recommended that Bayesian methodology should be used as the most robust analytical approach.
“Essentially, a Bayesian approach would avoid a hypothesis test, and instead would provide a probability of there being a treatment benefit for continuous monitoring. And if this probability was high enough, this would warrant further research in the phase 3 setting,” Dr. Stocken said.
What else was shown?
“We had a number of prespecified secondary endpoints, which to me are equally important,” said Ramzi Ajjan, MD, MMed.Sci, PhD, associate professor and consultant in diabetes and endocrinology at Leeds University and Leeds Teaching Hospitals Trust.
Among these was the TIR at days 16-30, which showed a 90-minute increase per day in favor of flash monitoring over SMBG. This “seems to be driven by those who are an insulin,” Dr. Ajjan said, adding that “you get almost a 3-hour increase in time in range in people who are on insulin at baseline, and you don’t see that in people who are on sulfonylurea.”
Conversely, sulfonylurea treatment seemed to drive the reduction in the time spent in hypoglycemia defined as 3.9 mmol/L (70 g/dL) at 3 months. For the whole group, there was a 1.3-hour reduction in hypoglycemia per day with flash monitoring versus SMBG, which increased to 2 hours for those on sulfonylureas.
There also was a “pattern of reduction” in time spent in hypoglycemia defined as less than 3.0 mmol/L (54 g/dL) both early on and becoming more pronounced with time.
“Flash glucose monitoring is associated with higher treatment satisfaction score, compared with SMBG,” Dr. Ajjan said.
Although A1c dropped in both groups to a similar extent, he noted that the reduction seen in the flash monitoring group was associated with a decrease in hypoglycemia.
There was a huge amount of data collected during the trial and there are many more analyses that could be done, Dr. Ajjan said. The outcome of those may determine whether a phase 3 trial is likely, assuming sponsorship can be secured.
The LIBERATES Trial was funded by grants from the UK National Institute for Health Research and Abbott Diabetes Care. None of the investigators were additionally compensated for their work within the trial. Dr. Stocken had no disclosures in relation to this trial. Dr. Ajjan has received research funding and other financial support from Abbott, Bayer, Eli Lilly, Johnson & Johnson, and Novo Nordisk.
SOURCE: Ajjan R et al. EASD 2020. S11 – The LIBERATES Trial.
Following a heart attack, there appears to be a “modest” benefit of using flash glucose monitoring over fingerstick testing to monitor blood glucose levels in patients with type 2 diabetes being treated with insulin or a sulfonylurea, according to investigators of the LIBERATES trial.
The results showed a nonsignificant increase in the time that subjects’ blood glucose was spent in the target range of 3.9-10.00 mmol/L (70-180 mg/dL) 3 months after experiencing an acute coronary syndrome (ACS).
At best, flash monitoring using Abbott’s Freestyle Libre system was associated with an increase in time spent in range (TIR) of 17-28 or 48 minutes per day over self-monitoring of blood glucose (SMBG), depending on the type of statistical analysis used. There was no difference in glycated hemoglobin A1c levels between the two groups, but there was a trend for less time spent in hypoglycemia in the flash monitoring arm.
Viewers underwhelmed
“My overall impression is that the effects were less pronounced than anticipated,” Kare Birkeland, MD, PhD, a specialist in internal medicine and endocrinology at Oslo University Hospital, Rikshospitalet, Norway, observed after the findings were presented at the virtual annual meeting of the European Association for the Study of Diabetes.
Others who had watched the live session seemed similarly underwhelmed by the findings, with one viewer questioning the value of devoting an hour-and-a-half session to the phase 2 trial.
However, the session chair Simon Heller, BA, MB, BChir, DM, professor of clinical diabetes at the University of Sheffield, and trial coinvestigator, defended the detailed look at the trial’s findings, noting that it was worthwhile to present the data from the trial as it “really helps explain why we do phase 2 and phase 3 trials.”
Strong rationale for monitoring post-MI
There is a strong rationale for ensuring that blood glucose is well controlled in type 2 diabetes patients who have experienced a myocardial infarction, observed Robert Storey, BSc, BM, DM, professor of cardiology at the University of Sheffield. One way to do that potentially is through improved glucose monitoring.
“There’s clearly a close link between diabetes and the risk of MI: Both high and low HbA1c are associated with adverse outcome, and high and low glucose levels following MI are also associated with adverse outcome,” he observed, noting also that hypoglycemia was not given enough attention in post-ACS patients.
“The hypothesis of the LIBERATES study was that a modern glycemic monitoring strategy can optimize blood glucose levels in type 2 diabetes patients following MI with the potential to reduce mortality and morbidity and improve quality of life,” Dr. Storey said. “The main research question of LIBERATES says, ‘Do new approaches in glucose monitoring increase the time in range and reduce hypoglycemia?’ ”
Pragmatic trial design
LIBERATES was a prospective, multicenter, parallel group, randomized controlled trial, explained the study’s statistician Deborah Stocken, PhD, professor of clinical trials research at the University of Leeds. There was “limited ability to blind the interventions,” so it was an open-label design.
“The patient population in LIBERATES was kept as inclusive and as pragmatic as possible to ensure that the results at the end of the trial are generalizable,” said Dr. Stocken. Patients with type 2 diabetes were recruited within 5 days of hospital admission for ACS, which could include both ST- and non-ST elevation MI. In all, 141 of a calculated 150 patients that would be needed were recruited and randomized to the flash monitoring (69) or SMBG (72) arm.
Dr. Stocken noted that early in the recruitment phase, the trials oversight committee recommended that Bayesian methodology should be used as the most robust analytical approach.
“Essentially, a Bayesian approach would avoid a hypothesis test, and instead would provide a probability of there being a treatment benefit for continuous monitoring. And if this probability was high enough, this would warrant further research in the phase 3 setting,” Dr. Stocken said.
What else was shown?
“We had a number of prespecified secondary endpoints, which to me are equally important,” said Ramzi Ajjan, MD, MMed.Sci, PhD, associate professor and consultant in diabetes and endocrinology at Leeds University and Leeds Teaching Hospitals Trust.
Among these was the TIR at days 16-30, which showed a 90-minute increase per day in favor of flash monitoring over SMBG. This “seems to be driven by those who are an insulin,” Dr. Ajjan said, adding that “you get almost a 3-hour increase in time in range in people who are on insulin at baseline, and you don’t see that in people who are on sulfonylurea.”
Conversely, sulfonylurea treatment seemed to drive the reduction in the time spent in hypoglycemia defined as 3.9 mmol/L (70 g/dL) at 3 months. For the whole group, there was a 1.3-hour reduction in hypoglycemia per day with flash monitoring versus SMBG, which increased to 2 hours for those on sulfonylureas.
There also was a “pattern of reduction” in time spent in hypoglycemia defined as less than 3.0 mmol/L (54 g/dL) both early on and becoming more pronounced with time.
“Flash glucose monitoring is associated with higher treatment satisfaction score, compared with SMBG,” Dr. Ajjan said.
Although A1c dropped in both groups to a similar extent, he noted that the reduction seen in the flash monitoring group was associated with a decrease in hypoglycemia.
There was a huge amount of data collected during the trial and there are many more analyses that could be done, Dr. Ajjan said. The outcome of those may determine whether a phase 3 trial is likely, assuming sponsorship can be secured.
The LIBERATES Trial was funded by grants from the UK National Institute for Health Research and Abbott Diabetes Care. None of the investigators were additionally compensated for their work within the trial. Dr. Stocken had no disclosures in relation to this trial. Dr. Ajjan has received research funding and other financial support from Abbott, Bayer, Eli Lilly, Johnson & Johnson, and Novo Nordisk.
SOURCE: Ajjan R et al. EASD 2020. S11 – The LIBERATES Trial.
Following a heart attack, there appears to be a “modest” benefit of using flash glucose monitoring over fingerstick testing to monitor blood glucose levels in patients with type 2 diabetes being treated with insulin or a sulfonylurea, according to investigators of the LIBERATES trial.
The results showed a nonsignificant increase in the time that subjects’ blood glucose was spent in the target range of 3.9-10.00 mmol/L (70-180 mg/dL) 3 months after experiencing an acute coronary syndrome (ACS).
At best, flash monitoring using Abbott’s Freestyle Libre system was associated with an increase in time spent in range (TIR) of 17-28 or 48 minutes per day over self-monitoring of blood glucose (SMBG), depending on the type of statistical analysis used. There was no difference in glycated hemoglobin A1c levels between the two groups, but there was a trend for less time spent in hypoglycemia in the flash monitoring arm.
Viewers underwhelmed
“My overall impression is that the effects were less pronounced than anticipated,” Kare Birkeland, MD, PhD, a specialist in internal medicine and endocrinology at Oslo University Hospital, Rikshospitalet, Norway, observed after the findings were presented at the virtual annual meeting of the European Association for the Study of Diabetes.
Others who had watched the live session seemed similarly underwhelmed by the findings, with one viewer questioning the value of devoting an hour-and-a-half session to the phase 2 trial.
However, the session chair Simon Heller, BA, MB, BChir, DM, professor of clinical diabetes at the University of Sheffield, and trial coinvestigator, defended the detailed look at the trial’s findings, noting that it was worthwhile to present the data from the trial as it “really helps explain why we do phase 2 and phase 3 trials.”
Strong rationale for monitoring post-MI
There is a strong rationale for ensuring that blood glucose is well controlled in type 2 diabetes patients who have experienced a myocardial infarction, observed Robert Storey, BSc, BM, DM, professor of cardiology at the University of Sheffield. One way to do that potentially is through improved glucose monitoring.
“There’s clearly a close link between diabetes and the risk of MI: Both high and low HbA1c are associated with adverse outcome, and high and low glucose levels following MI are also associated with adverse outcome,” he observed, noting also that hypoglycemia was not given enough attention in post-ACS patients.
“The hypothesis of the LIBERATES study was that a modern glycemic monitoring strategy can optimize blood glucose levels in type 2 diabetes patients following MI with the potential to reduce mortality and morbidity and improve quality of life,” Dr. Storey said. “The main research question of LIBERATES says, ‘Do new approaches in glucose monitoring increase the time in range and reduce hypoglycemia?’ ”
Pragmatic trial design
LIBERATES was a prospective, multicenter, parallel group, randomized controlled trial, explained the study’s statistician Deborah Stocken, PhD, professor of clinical trials research at the University of Leeds. There was “limited ability to blind the interventions,” so it was an open-label design.
“The patient population in LIBERATES was kept as inclusive and as pragmatic as possible to ensure that the results at the end of the trial are generalizable,” said Dr. Stocken. Patients with type 2 diabetes were recruited within 5 days of hospital admission for ACS, which could include both ST- and non-ST elevation MI. In all, 141 of a calculated 150 patients that would be needed were recruited and randomized to the flash monitoring (69) or SMBG (72) arm.
Dr. Stocken noted that early in the recruitment phase, the trials oversight committee recommended that Bayesian methodology should be used as the most robust analytical approach.
“Essentially, a Bayesian approach would avoid a hypothesis test, and instead would provide a probability of there being a treatment benefit for continuous monitoring. And if this probability was high enough, this would warrant further research in the phase 3 setting,” Dr. Stocken said.
What else was shown?
“We had a number of prespecified secondary endpoints, which to me are equally important,” said Ramzi Ajjan, MD, MMed.Sci, PhD, associate professor and consultant in diabetes and endocrinology at Leeds University and Leeds Teaching Hospitals Trust.
Among these was the TIR at days 16-30, which showed a 90-minute increase per day in favor of flash monitoring over SMBG. This “seems to be driven by those who are an insulin,” Dr. Ajjan said, adding that “you get almost a 3-hour increase in time in range in people who are on insulin at baseline, and you don’t see that in people who are on sulfonylurea.”
Conversely, sulfonylurea treatment seemed to drive the reduction in the time spent in hypoglycemia defined as 3.9 mmol/L (70 g/dL) at 3 months. For the whole group, there was a 1.3-hour reduction in hypoglycemia per day with flash monitoring versus SMBG, which increased to 2 hours for those on sulfonylureas.
There also was a “pattern of reduction” in time spent in hypoglycemia defined as less than 3.0 mmol/L (54 g/dL) both early on and becoming more pronounced with time.
“Flash glucose monitoring is associated with higher treatment satisfaction score, compared with SMBG,” Dr. Ajjan said.
Although A1c dropped in both groups to a similar extent, he noted that the reduction seen in the flash monitoring group was associated with a decrease in hypoglycemia.
There was a huge amount of data collected during the trial and there are many more analyses that could be done, Dr. Ajjan said. The outcome of those may determine whether a phase 3 trial is likely, assuming sponsorship can be secured.
The LIBERATES Trial was funded by grants from the UK National Institute for Health Research and Abbott Diabetes Care. None of the investigators were additionally compensated for their work within the trial. Dr. Stocken had no disclosures in relation to this trial. Dr. Ajjan has received research funding and other financial support from Abbott, Bayer, Eli Lilly, Johnson & Johnson, and Novo Nordisk.
SOURCE: Ajjan R et al. EASD 2020. S11 – The LIBERATES Trial.
FROM EASD 2020
COVID-19 antibody response not reduced with diabetes
Neither diabetes per se nor hyperglycemia appear to impair the antibody response to SARS-CoV-2, suggesting that a COVID-19 vaccine would be just as effective in people with diabetes as in those without, new research finds.
Results from a study involving 480 patients with confirmed COVID-19 seen at an Italian hospital between February 25 and April 19 were published online October 8 in Diabetologia by Vito Lampasona, MD, and colleagues.
Antibody responses against multiple SARS-CoV-2 antigens among the 27% of patients with COVID-19 and diabetes (preexisting and newly diagnosed) were similar with regard to timing, titers, and classes to those of patients with COVID-19 and without diabetes, and the results did not differ by glucose levels.
Moreover, positivity for immunoglobulin G (IgG) against the SARS-CoV-2 spike receptor-binding domain (RBD) was associated with improved survival regardless of diabetes status.
And as previously shown, high blood glucose levels were strongly associated with greater COVID-19 mortality even in those without diabetes.
This is the first study of the immunologic humoral response against SARS-CoV-2 in patients with hyperglycemia, the authors say.
“The immunological response to a future SARS-CoV-2 vaccine will be assessed when the vaccine becomes available. However, our data allow a cautious optimism regarding effective immunization in individuals with diabetes, as well as in the general population,” wrote Dr. Lampasona of San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele in Milan, and colleagues.
Diabetes and hyperglycemia worsen COVID-19 outcomes
The investigators analyzed the presence of three types of antibody to multiple SARS-CoV-2 antigens in 509 participants: IgG, which is evidence of past infection; IgM, which indicates more recent or current infection; and IgA, which is involved in the mucosal immune response, for example, in the nose where the virus enters the body.
Overall, 452 (88.8%) patients were hospitalized, 79 (15.5%) patients were admitted to intensive care, and 93 (18.3%) patients died during follow-up.
Of the 139 patients with diabetes, 90 (17.7% of the study cohort) already had a diagnosis of diabetes, and 49 (9.6%) were newly diagnosed.
Those with diabetes were older, had a higher body mass index (BMI), and were more likely to have cardiovascular comorbidities, hypertension, and chronic kidney disease. As has been previously reported for diabetes and COVID-19, diabetes was also associated with increased levels of inflammatory biomarkers, hypercoagulopathy, leukocytosis, and neutrophilia.
In multivariate analysis, diabetes status (hazard ratio, 2.32; P = .001), mean fasting plasma glucose (P < .001), and glucose variability (P = .002) were all independently associated with increased mortality and ICU admission. And fasting plasma glucose was associated with increased mortality risk even among those without diabetes (P < .001).
Antibody response similar in patients with and without diabetes
The humoral response against SARS-CoV-2 in patients with diabetes was present and superimposable in terms of timing and antibody titers to that of patients without diabetes, with marginal differences, and was not influenced by glucose levels.
After adjustment for sex, age, and diabetes status and stratification by symptom duration at time of sampling, the development of SARS-CoV-2 RBD IgG antibodies was associated with improved survival, with an HR for time to death of 0.4 (P = .002).
“Of the measured antibody responses, positivity for IgG against the SARS-CoV-2 spike RBD was predictive of survival rate, both in the presence or absence of diabetes,” the authors stressed, with similar HRs for those with diabetes (0.37; P = .013) and without diabetes (0.43; P = .038).
These data confirm “the relevance for patient survival rate of the specific antigen response against spike RBD even in the presence of diabetes, and it underlines how the mechanism explaining the worse clinical outcome in patients with diabetes is unrelated to the antibody response,” they explain.
They added, “This, together with evidence that increased blood glucose levels do predict a poor prognosis even in nondiabetic individuals and the association with increased levels of inflammatory biomarkers and hypercoagulopathy, as well as leukocytosis and neutrophilia, support the speculation that glucose per se could be an independent biological negative factor, acting as a direct regulator of innate immunity.”
“The observed increased severity and mortality risk of COVID-19 pneumonia in patients with hyperglycemia was not the result of an impaired humoral response against SARS-CoV-2.”
“RBD IgG positivity was associated with a remarkable protective effect, allowing for a cautious optimism about the efficacy of future vaccines against SARS-COV-2 in people with diabetes,” they reiterated.
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Neither diabetes per se nor hyperglycemia appear to impair the antibody response to SARS-CoV-2, suggesting that a COVID-19 vaccine would be just as effective in people with diabetes as in those without, new research finds.
Results from a study involving 480 patients with confirmed COVID-19 seen at an Italian hospital between February 25 and April 19 were published online October 8 in Diabetologia by Vito Lampasona, MD, and colleagues.
Antibody responses against multiple SARS-CoV-2 antigens among the 27% of patients with COVID-19 and diabetes (preexisting and newly diagnosed) were similar with regard to timing, titers, and classes to those of patients with COVID-19 and without diabetes, and the results did not differ by glucose levels.
Moreover, positivity for immunoglobulin G (IgG) against the SARS-CoV-2 spike receptor-binding domain (RBD) was associated with improved survival regardless of diabetes status.
And as previously shown, high blood glucose levels were strongly associated with greater COVID-19 mortality even in those without diabetes.
This is the first study of the immunologic humoral response against SARS-CoV-2 in patients with hyperglycemia, the authors say.
“The immunological response to a future SARS-CoV-2 vaccine will be assessed when the vaccine becomes available. However, our data allow a cautious optimism regarding effective immunization in individuals with diabetes, as well as in the general population,” wrote Dr. Lampasona of San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele in Milan, and colleagues.
Diabetes and hyperglycemia worsen COVID-19 outcomes
The investigators analyzed the presence of three types of antibody to multiple SARS-CoV-2 antigens in 509 participants: IgG, which is evidence of past infection; IgM, which indicates more recent or current infection; and IgA, which is involved in the mucosal immune response, for example, in the nose where the virus enters the body.
Overall, 452 (88.8%) patients were hospitalized, 79 (15.5%) patients were admitted to intensive care, and 93 (18.3%) patients died during follow-up.
Of the 139 patients with diabetes, 90 (17.7% of the study cohort) already had a diagnosis of diabetes, and 49 (9.6%) were newly diagnosed.
Those with diabetes were older, had a higher body mass index (BMI), and were more likely to have cardiovascular comorbidities, hypertension, and chronic kidney disease. As has been previously reported for diabetes and COVID-19, diabetes was also associated with increased levels of inflammatory biomarkers, hypercoagulopathy, leukocytosis, and neutrophilia.
In multivariate analysis, diabetes status (hazard ratio, 2.32; P = .001), mean fasting plasma glucose (P < .001), and glucose variability (P = .002) were all independently associated with increased mortality and ICU admission. And fasting plasma glucose was associated with increased mortality risk even among those without diabetes (P < .001).
Antibody response similar in patients with and without diabetes
The humoral response against SARS-CoV-2 in patients with diabetes was present and superimposable in terms of timing and antibody titers to that of patients without diabetes, with marginal differences, and was not influenced by glucose levels.
After adjustment for sex, age, and diabetes status and stratification by symptom duration at time of sampling, the development of SARS-CoV-2 RBD IgG antibodies was associated with improved survival, with an HR for time to death of 0.4 (P = .002).
“Of the measured antibody responses, positivity for IgG against the SARS-CoV-2 spike RBD was predictive of survival rate, both in the presence or absence of diabetes,” the authors stressed, with similar HRs for those with diabetes (0.37; P = .013) and without diabetes (0.43; P = .038).
These data confirm “the relevance for patient survival rate of the specific antigen response against spike RBD even in the presence of diabetes, and it underlines how the mechanism explaining the worse clinical outcome in patients with diabetes is unrelated to the antibody response,” they explain.
They added, “This, together with evidence that increased blood glucose levels do predict a poor prognosis even in nondiabetic individuals and the association with increased levels of inflammatory biomarkers and hypercoagulopathy, as well as leukocytosis and neutrophilia, support the speculation that glucose per se could be an independent biological negative factor, acting as a direct regulator of innate immunity.”
“The observed increased severity and mortality risk of COVID-19 pneumonia in patients with hyperglycemia was not the result of an impaired humoral response against SARS-CoV-2.”
“RBD IgG positivity was associated with a remarkable protective effect, allowing for a cautious optimism about the efficacy of future vaccines against SARS-COV-2 in people with diabetes,” they reiterated.
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Neither diabetes per se nor hyperglycemia appear to impair the antibody response to SARS-CoV-2, suggesting that a COVID-19 vaccine would be just as effective in people with diabetes as in those without, new research finds.
Results from a study involving 480 patients with confirmed COVID-19 seen at an Italian hospital between February 25 and April 19 were published online October 8 in Diabetologia by Vito Lampasona, MD, and colleagues.
Antibody responses against multiple SARS-CoV-2 antigens among the 27% of patients with COVID-19 and diabetes (preexisting and newly diagnosed) were similar with regard to timing, titers, and classes to those of patients with COVID-19 and without diabetes, and the results did not differ by glucose levels.
Moreover, positivity for immunoglobulin G (IgG) against the SARS-CoV-2 spike receptor-binding domain (RBD) was associated with improved survival regardless of diabetes status.
And as previously shown, high blood glucose levels were strongly associated with greater COVID-19 mortality even in those without diabetes.
This is the first study of the immunologic humoral response against SARS-CoV-2 in patients with hyperglycemia, the authors say.
“The immunological response to a future SARS-CoV-2 vaccine will be assessed when the vaccine becomes available. However, our data allow a cautious optimism regarding effective immunization in individuals with diabetes, as well as in the general population,” wrote Dr. Lampasona of San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele in Milan, and colleagues.
Diabetes and hyperglycemia worsen COVID-19 outcomes
The investigators analyzed the presence of three types of antibody to multiple SARS-CoV-2 antigens in 509 participants: IgG, which is evidence of past infection; IgM, which indicates more recent or current infection; and IgA, which is involved in the mucosal immune response, for example, in the nose where the virus enters the body.
Overall, 452 (88.8%) patients were hospitalized, 79 (15.5%) patients were admitted to intensive care, and 93 (18.3%) patients died during follow-up.
Of the 139 patients with diabetes, 90 (17.7% of the study cohort) already had a diagnosis of diabetes, and 49 (9.6%) were newly diagnosed.
Those with diabetes were older, had a higher body mass index (BMI), and were more likely to have cardiovascular comorbidities, hypertension, and chronic kidney disease. As has been previously reported for diabetes and COVID-19, diabetes was also associated with increased levels of inflammatory biomarkers, hypercoagulopathy, leukocytosis, and neutrophilia.
In multivariate analysis, diabetes status (hazard ratio, 2.32; P = .001), mean fasting plasma glucose (P < .001), and glucose variability (P = .002) were all independently associated with increased mortality and ICU admission. And fasting plasma glucose was associated with increased mortality risk even among those without diabetes (P < .001).
Antibody response similar in patients with and without diabetes
The humoral response against SARS-CoV-2 in patients with diabetes was present and superimposable in terms of timing and antibody titers to that of patients without diabetes, with marginal differences, and was not influenced by glucose levels.
After adjustment for sex, age, and diabetes status and stratification by symptom duration at time of sampling, the development of SARS-CoV-2 RBD IgG antibodies was associated with improved survival, with an HR for time to death of 0.4 (P = .002).
“Of the measured antibody responses, positivity for IgG against the SARS-CoV-2 spike RBD was predictive of survival rate, both in the presence or absence of diabetes,” the authors stressed, with similar HRs for those with diabetes (0.37; P = .013) and without diabetes (0.43; P = .038).
These data confirm “the relevance for patient survival rate of the specific antigen response against spike RBD even in the presence of diabetes, and it underlines how the mechanism explaining the worse clinical outcome in patients with diabetes is unrelated to the antibody response,” they explain.
They added, “This, together with evidence that increased blood glucose levels do predict a poor prognosis even in nondiabetic individuals and the association with increased levels of inflammatory biomarkers and hypercoagulopathy, as well as leukocytosis and neutrophilia, support the speculation that glucose per se could be an independent biological negative factor, acting as a direct regulator of innate immunity.”
“The observed increased severity and mortality risk of COVID-19 pneumonia in patients with hyperglycemia was not the result of an impaired humoral response against SARS-CoV-2.”
“RBD IgG positivity was associated with a remarkable protective effect, allowing for a cautious optimism about the efficacy of future vaccines against SARS-COV-2 in people with diabetes,” they reiterated.
The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Link between vitamin D and ICU outcomes unclear
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.
“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.
Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.
We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”
Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?
When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.
In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.
“Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.
In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.
“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
Maintenance dose needed?
One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.
In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.
The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”
“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”
Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.
Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).
Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.
“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.
Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.
“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”
However, “we’re not really sure that it improves outcomes,” he said.
A chronic issue?
“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.
“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.
“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.
Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM CHEST 2020
Sleepless nights, hair loss, and cracked teeth: Pandemic stress takes its toll
In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.
“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.
She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.
“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.
After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.
Then he asked: “Are you under a lot of stress?”
excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.
Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.
Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.
“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.
Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.
Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.
In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).
Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.
Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.
Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.
In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.
Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.
“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
How mental stress becomes physical
Stress causes physical changes in the body that can affect nearly every organ system.
Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.
When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.
When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.
Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.
The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).
“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
The day-to-day impact
In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.
For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.
He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.
“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.
Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.
Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.
“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
How to mitigate chronic stress
When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.
That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:
- Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
- Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
- Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
- Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.
“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.
“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.
She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.
“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.
After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.
Then he asked: “Are you under a lot of stress?”
excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.
Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.
Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.
“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.
Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.
Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.
In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).
Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.
Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.
Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.
In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.
Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.
“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
How mental stress becomes physical
Stress causes physical changes in the body that can affect nearly every organ system.
Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.
When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.
When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.
Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.
The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).
“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
The day-to-day impact
In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.
For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.
He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.
“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.
Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.
Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.
“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
How to mitigate chronic stress
When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.
That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:
- Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
- Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
- Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
- Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.
“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.
“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.
She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.
“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.
After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.
Then he asked: “Are you under a lot of stress?”
excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.
Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.
Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.
“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.
Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.
Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.
In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).
Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.
Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.
Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.
In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.
Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.
“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
How mental stress becomes physical
Stress causes physical changes in the body that can affect nearly every organ system.
Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.
When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.
When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.
Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.
The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).
“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
The day-to-day impact
In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.
For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.
He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.
“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.
Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.
Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.
“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
How to mitigate chronic stress
When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.
That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:
- Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
- Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
- Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
- Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.
“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.