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ASDSA warns of rogue insulin pen use for DIY fillers
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In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.
The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.
“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.
“TikTok is proving to be an extremely powerful platform to communicate, entertain, and even educate, which is why many physicians are getting involved and finding success there. Unfortunately, just like the World Wide Web, there is misinformation there and even dangerous lies,” Sandra Lee, MD, who practices in Upland, Calif. (and is also known as “Dr. Pimple Popper”), said in the statement.
“It’s very concerning to see young people posting a How To on injecting their own lips with hyaluronic acid serum using an ‘airgun’ pen, which acts much like a BB gun to push with force the product under the skin,” she added. “So many things can go wrong.”
The ASDSA has contacted the Food and Drug Administration to report these safety concerns. “In addition, the ASDSA is alerting state medical and estheticians’ boards regarding these patient safety concerns and alerting consumers directly about the risks through social media and other education materials,” according to the statement.
.
In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.
The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.
“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.
“TikTok is proving to be an extremely powerful platform to communicate, entertain, and even educate, which is why many physicians are getting involved and finding success there. Unfortunately, just like the World Wide Web, there is misinformation there and even dangerous lies,” Sandra Lee, MD, who practices in Upland, Calif. (and is also known as “Dr. Pimple Popper”), said in the statement.
“It’s very concerning to see young people posting a How To on injecting their own lips with hyaluronic acid serum using an ‘airgun’ pen, which acts much like a BB gun to push with force the product under the skin,” she added. “So many things can go wrong.”
The ASDSA has contacted the Food and Drug Administration to report these safety concerns. “In addition, the ASDSA is alerting state medical and estheticians’ boards regarding these patient safety concerns and alerting consumers directly about the risks through social media and other education materials,” according to the statement.
.
In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.
The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.
“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.
“TikTok is proving to be an extremely powerful platform to communicate, entertain, and even educate, which is why many physicians are getting involved and finding success there. Unfortunately, just like the World Wide Web, there is misinformation there and even dangerous lies,” Sandra Lee, MD, who practices in Upland, Calif. (and is also known as “Dr. Pimple Popper”), said in the statement.
“It’s very concerning to see young people posting a How To on injecting their own lips with hyaluronic acid serum using an ‘airgun’ pen, which acts much like a BB gun to push with force the product under the skin,” she added. “So many things can go wrong.”
The ASDSA has contacted the Food and Drug Administration to report these safety concerns. “In addition, the ASDSA is alerting state medical and estheticians’ boards regarding these patient safety concerns and alerting consumers directly about the risks through social media and other education materials,” according to the statement.
Short sleep predicts incident dementia and all-cause mortality
More evidence has emerged linking sleep deficiency, dementia, and mortality.
“Sleep disturbance and insufficiency have been shown to be associated with both the development and progression of Alzheimer’s disease and with all-cause mortality,” wrote Rebecca S. Robbins, PhD, of Brigham and Women’s Hospital, Boston, and colleagues. However, research on this topic has yielded conflicting results, and “few studies have included a comprehensive set of sleep characteristics in a single examination of incident dementia and all-cause mortality.”
In a study published in Aging, the researchers identified 2,812 adults aged 65 years and older from the National Health and Aging Trends Study (NHATS), a nationally representative longitudinal study of Medicare beneficiaries aged 65 years and older in the United States.
Participants completed surveys about sleep disturbance and duration in 2013 (1,575 individuals) and in 2014 (1,237 individuals), and the researchers examined the relationship between sleep disturbance and deficiency and incident dementia and all-cause mortality over the next 5 years. The average age of the study participants was 76.9 years, 60% were women, and 72% were White.
Overall, approximately 60% of the participants reported never or rarely having problems with alertness, approximately half said that they rarely or never napped, and more than half said they fell asleep in 15 minutes or less. Approximately 70% rated their sleep quality as good or very good, and more than 90% said they rarely or never snored.
The researchers examined the relationships between sleep characteristics and the development of incident dementia over 5 years. In a fully adjusted Cox multivariate analysis, individuals who slept 5 hours or less per night had approximately twice the risk for incident dementia as those who slept longer (hazard ratio, 2.04); risk of dementia also was higher among those who took 30 minutes or longer to fall asleep (HR, 1.45).
In addition, the risk of all-cause mortality was significantly higher among individuals who reported difficulty maintaining alertness some days or most days/every day (HR, 1.49 and HR, 1.65, respectively), routinely napping some days or most days/every day (HR, 1.38 and HR, 1.73, respectively), poor or very poor sleep quality (HR, 1.75), and sleeping 5 hours or less each night (HR, 2.38).
The study findings were limited by several factors including a population representing only one-quarter of the NHATS cohort, which prevented nationally representative estimates, the availability of only 2 years of sleep data, and small sample size for certain response categories, the researchers noted.
However, “our study offers a contribution to the literature on sleep among aging populations in its assessment of incident dementia and all-cause mortality and a range of sleep characteristics among older adults,” they said. In particular, “short sleep duration was a strong predictor of both incident dementia and all-cause mortality, suggesting this may be a sleep characteristic that is important – over and above the other predictors – of adverse outcomes among older adults,” and future areas for research include the development of novel behavioral interventions to improve sleep in this population.
The study was supported in part by the National Institute for Occupational Safety and Health; the National Heart, Lung, and Blood Institute; the National Institute on Aging; and the Brigham Research Institute Fund to Sustain Research Excellence. Lead author Dr. Robbins disclosed fees from Denihan Hospitality, Rituals Cosmetics, Dagmejan, Asystem, and SleepCycle. Several coauthors disclosed relationships with multiple pharmaceutical companies, and support from various philanthropic organizations.
More evidence has emerged linking sleep deficiency, dementia, and mortality.
“Sleep disturbance and insufficiency have been shown to be associated with both the development and progression of Alzheimer’s disease and with all-cause mortality,” wrote Rebecca S. Robbins, PhD, of Brigham and Women’s Hospital, Boston, and colleagues. However, research on this topic has yielded conflicting results, and “few studies have included a comprehensive set of sleep characteristics in a single examination of incident dementia and all-cause mortality.”
In a study published in Aging, the researchers identified 2,812 adults aged 65 years and older from the National Health and Aging Trends Study (NHATS), a nationally representative longitudinal study of Medicare beneficiaries aged 65 years and older in the United States.
Participants completed surveys about sleep disturbance and duration in 2013 (1,575 individuals) and in 2014 (1,237 individuals), and the researchers examined the relationship between sleep disturbance and deficiency and incident dementia and all-cause mortality over the next 5 years. The average age of the study participants was 76.9 years, 60% were women, and 72% were White.
Overall, approximately 60% of the participants reported never or rarely having problems with alertness, approximately half said that they rarely or never napped, and more than half said they fell asleep in 15 minutes or less. Approximately 70% rated their sleep quality as good or very good, and more than 90% said they rarely or never snored.
The researchers examined the relationships between sleep characteristics and the development of incident dementia over 5 years. In a fully adjusted Cox multivariate analysis, individuals who slept 5 hours or less per night had approximately twice the risk for incident dementia as those who slept longer (hazard ratio, 2.04); risk of dementia also was higher among those who took 30 minutes or longer to fall asleep (HR, 1.45).
In addition, the risk of all-cause mortality was significantly higher among individuals who reported difficulty maintaining alertness some days or most days/every day (HR, 1.49 and HR, 1.65, respectively), routinely napping some days or most days/every day (HR, 1.38 and HR, 1.73, respectively), poor or very poor sleep quality (HR, 1.75), and sleeping 5 hours or less each night (HR, 2.38).
The study findings were limited by several factors including a population representing only one-quarter of the NHATS cohort, which prevented nationally representative estimates, the availability of only 2 years of sleep data, and small sample size for certain response categories, the researchers noted.
However, “our study offers a contribution to the literature on sleep among aging populations in its assessment of incident dementia and all-cause mortality and a range of sleep characteristics among older adults,” they said. In particular, “short sleep duration was a strong predictor of both incident dementia and all-cause mortality, suggesting this may be a sleep characteristic that is important – over and above the other predictors – of adverse outcomes among older adults,” and future areas for research include the development of novel behavioral interventions to improve sleep in this population.
The study was supported in part by the National Institute for Occupational Safety and Health; the National Heart, Lung, and Blood Institute; the National Institute on Aging; and the Brigham Research Institute Fund to Sustain Research Excellence. Lead author Dr. Robbins disclosed fees from Denihan Hospitality, Rituals Cosmetics, Dagmejan, Asystem, and SleepCycle. Several coauthors disclosed relationships with multiple pharmaceutical companies, and support from various philanthropic organizations.
More evidence has emerged linking sleep deficiency, dementia, and mortality.
“Sleep disturbance and insufficiency have been shown to be associated with both the development and progression of Alzheimer’s disease and with all-cause mortality,” wrote Rebecca S. Robbins, PhD, of Brigham and Women’s Hospital, Boston, and colleagues. However, research on this topic has yielded conflicting results, and “few studies have included a comprehensive set of sleep characteristics in a single examination of incident dementia and all-cause mortality.”
In a study published in Aging, the researchers identified 2,812 adults aged 65 years and older from the National Health and Aging Trends Study (NHATS), a nationally representative longitudinal study of Medicare beneficiaries aged 65 years and older in the United States.
Participants completed surveys about sleep disturbance and duration in 2013 (1,575 individuals) and in 2014 (1,237 individuals), and the researchers examined the relationship between sleep disturbance and deficiency and incident dementia and all-cause mortality over the next 5 years. The average age of the study participants was 76.9 years, 60% were women, and 72% were White.
Overall, approximately 60% of the participants reported never or rarely having problems with alertness, approximately half said that they rarely or never napped, and more than half said they fell asleep in 15 minutes or less. Approximately 70% rated their sleep quality as good or very good, and more than 90% said they rarely or never snored.
The researchers examined the relationships between sleep characteristics and the development of incident dementia over 5 years. In a fully adjusted Cox multivariate analysis, individuals who slept 5 hours or less per night had approximately twice the risk for incident dementia as those who slept longer (hazard ratio, 2.04); risk of dementia also was higher among those who took 30 minutes or longer to fall asleep (HR, 1.45).
In addition, the risk of all-cause mortality was significantly higher among individuals who reported difficulty maintaining alertness some days or most days/every day (HR, 1.49 and HR, 1.65, respectively), routinely napping some days or most days/every day (HR, 1.38 and HR, 1.73, respectively), poor or very poor sleep quality (HR, 1.75), and sleeping 5 hours or less each night (HR, 2.38).
The study findings were limited by several factors including a population representing only one-quarter of the NHATS cohort, which prevented nationally representative estimates, the availability of only 2 years of sleep data, and small sample size for certain response categories, the researchers noted.
However, “our study offers a contribution to the literature on sleep among aging populations in its assessment of incident dementia and all-cause mortality and a range of sleep characteristics among older adults,” they said. In particular, “short sleep duration was a strong predictor of both incident dementia and all-cause mortality, suggesting this may be a sleep characteristic that is important – over and above the other predictors – of adverse outcomes among older adults,” and future areas for research include the development of novel behavioral interventions to improve sleep in this population.
The study was supported in part by the National Institute for Occupational Safety and Health; the National Heart, Lung, and Blood Institute; the National Institute on Aging; and the Brigham Research Institute Fund to Sustain Research Excellence. Lead author Dr. Robbins disclosed fees from Denihan Hospitality, Rituals Cosmetics, Dagmejan, Asystem, and SleepCycle. Several coauthors disclosed relationships with multiple pharmaceutical companies, and support from various philanthropic organizations.
FROM AGING
Dried blood spot tests show sensitivity as cCMV screen
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
FROM JAMA PEDIATRICS
AAD announces diversity initiatives
not only within the academy itself, but also in the profession of dermatology overall.
“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.
“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.
“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”
“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”
As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”
The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:
“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.
- “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
- “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
- “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.
The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.
not only within the academy itself, but also in the profession of dermatology overall.
“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.
“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.
“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”
“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”
As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”
The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:
“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.
- “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
- “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
- “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.
The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.
not only within the academy itself, but also in the profession of dermatology overall.
“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.
“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.
“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”
“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”
As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”
The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:
“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.
- “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
- “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
- “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.
The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.
Ergonomic consultation spares endoscopists a pain in the neck
Assessment of position and posture by a physical therapist can help reduce and prevent injury in endoscopists, based on data from a pilot study of eight individuals.
Musculoskeletal injuries among endoscopists are gaining more attention: One technical review indicated that the “prevalence of musculoskeletal pain or injuries ranged from 29% to 89% of gastroenterologists.” While data on avoiding musculoskeletal injury related to endoscopy are limited, recognition of the role of ergonomics is increasing, Stacy A. Markwell, a physical therapist in Chapel Hill, N.C., and colleagues, wrote in a study published in Gastrointestinal Endoscopy.
The mental concentration required along with the physical demands on manipulating the scope have been shown to negatively impact posture, the researchers noted.
The researchers reviewed data from eight endoscopists who were aged 32-71 years; they had a range of clinical experience and were performing 6-30 colonoscopies and 3-21 upper endoscopies per week.
These endoscopists volunteered for an ergonomic intervention involving use of an individualized wellness plan. They completed the Nordic Musculoskeletal Questionnaire to evaluate musculoskeletal complaints during the past 12 months and the past 7 days. Three of the eight participants reported pain at work at initial assessment, which often worsened over the course of the day, and five mentioned fatigue while working. They specified 22 pain sites, mainly in the neck and back. In addition, participants were photographed to evaluate posture in a static position and self-selected “tired” positions.
“When frequent or consistent posturing resulted in suboptimal joint alignment, muscle length, loading at end range of muscle or joints, and/or prolonged static active positioning, participants were photographed to provide personalized feedback for wellness education,” the researchers wrote.
The physical therapist used information from the evaluation and photographs to develop individual plans to improve the ergonomics of the endoscopic suite with adjustments to the location of the bed and positioning of chairs, standing surfaces, and monitors and keyboards. In addition to adjusting the endoscopic suite, the physical therapist developed individual wellness plans including exercises to relieve pain and improve posture, as well as pain education to help clinicians recognize and manage pain and fatigue.
By the end of the study, in a follow-up 6-12 months after the wellness intervention, 63% of pain sites (14 of 22) reported by participants were reduced in intensity or resolved, 32% were unchanged (7 of 22), and 4% increased (1 of 22).
Overall, seven of the eight participants said that the pictures of their posture along with the movement analysis was helpful, and three participants asked for reassessment by the physical therapist. In this study, the average cost of the wellness program was $500.
“All endoscopists reported that the wellness plan was helpful, with procedure suite and posture recommendations being the most beneficial,” the researchers reported. “Upon gaining insight with visualization of their posture and movement during endoscopy, participants’ understanding and motivation to make corrections was intensified.”
The study findings were limited by several factors including the small size, use of a single physical therapist, short follow-up, lack of controls, and use of a single site, the researchers noted. However, “our study provides a detailed, pragmatic, and reproducible framework for performing an individualized physical therapist–directed comprehensive assessment and personalized wellness plan in the workplace to help meet the challenges of ergonomics in endoscopy.”
Recognition of the value of ergonomics is rising
“Endoscopy related injury and disability is a known hazard of our profession,” said Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Any studies to assess and, more importantly, offer ways to prevent such injury are immediately relevant. In this context, ergonomics for endoscopy is an increasing area of research.”
Dr. Ketwaroo said that the study results were not surprising. “I agree with authors that there is a paucity of general ergonomic training and assessment. Specific individualized wellness plans are rare. Developing an individual plan based on observation by physical therapists, and taking into account baseline injury or predisposition to injury would be expected to be more high yield for preventing injury and improving performance
“I believe the main take-home message from the study is that an individualized ergonomic plan based on assessment and feedback by physical therapists appears promising for optimizing endoscopic performance to minimize injury and reduce fatigue,” Dr. Ketwaroo said. However, “long-term studies in much larger samples will be needed to document objective findings of reduced injury or fatigue.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Assessment of position and posture by a physical therapist can help reduce and prevent injury in endoscopists, based on data from a pilot study of eight individuals.
Musculoskeletal injuries among endoscopists are gaining more attention: One technical review indicated that the “prevalence of musculoskeletal pain or injuries ranged from 29% to 89% of gastroenterologists.” While data on avoiding musculoskeletal injury related to endoscopy are limited, recognition of the role of ergonomics is increasing, Stacy A. Markwell, a physical therapist in Chapel Hill, N.C., and colleagues, wrote in a study published in Gastrointestinal Endoscopy.
The mental concentration required along with the physical demands on manipulating the scope have been shown to negatively impact posture, the researchers noted.
The researchers reviewed data from eight endoscopists who were aged 32-71 years; they had a range of clinical experience and were performing 6-30 colonoscopies and 3-21 upper endoscopies per week.
These endoscopists volunteered for an ergonomic intervention involving use of an individualized wellness plan. They completed the Nordic Musculoskeletal Questionnaire to evaluate musculoskeletal complaints during the past 12 months and the past 7 days. Three of the eight participants reported pain at work at initial assessment, which often worsened over the course of the day, and five mentioned fatigue while working. They specified 22 pain sites, mainly in the neck and back. In addition, participants were photographed to evaluate posture in a static position and self-selected “tired” positions.
“When frequent or consistent posturing resulted in suboptimal joint alignment, muscle length, loading at end range of muscle or joints, and/or prolonged static active positioning, participants were photographed to provide personalized feedback for wellness education,” the researchers wrote.
The physical therapist used information from the evaluation and photographs to develop individual plans to improve the ergonomics of the endoscopic suite with adjustments to the location of the bed and positioning of chairs, standing surfaces, and monitors and keyboards. In addition to adjusting the endoscopic suite, the physical therapist developed individual wellness plans including exercises to relieve pain and improve posture, as well as pain education to help clinicians recognize and manage pain and fatigue.
By the end of the study, in a follow-up 6-12 months after the wellness intervention, 63% of pain sites (14 of 22) reported by participants were reduced in intensity or resolved, 32% were unchanged (7 of 22), and 4% increased (1 of 22).
Overall, seven of the eight participants said that the pictures of their posture along with the movement analysis was helpful, and three participants asked for reassessment by the physical therapist. In this study, the average cost of the wellness program was $500.
“All endoscopists reported that the wellness plan was helpful, with procedure suite and posture recommendations being the most beneficial,” the researchers reported. “Upon gaining insight with visualization of their posture and movement during endoscopy, participants’ understanding and motivation to make corrections was intensified.”
The study findings were limited by several factors including the small size, use of a single physical therapist, short follow-up, lack of controls, and use of a single site, the researchers noted. However, “our study provides a detailed, pragmatic, and reproducible framework for performing an individualized physical therapist–directed comprehensive assessment and personalized wellness plan in the workplace to help meet the challenges of ergonomics in endoscopy.”
Recognition of the value of ergonomics is rising
“Endoscopy related injury and disability is a known hazard of our profession,” said Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Any studies to assess and, more importantly, offer ways to prevent such injury are immediately relevant. In this context, ergonomics for endoscopy is an increasing area of research.”
Dr. Ketwaroo said that the study results were not surprising. “I agree with authors that there is a paucity of general ergonomic training and assessment. Specific individualized wellness plans are rare. Developing an individual plan based on observation by physical therapists, and taking into account baseline injury or predisposition to injury would be expected to be more high yield for preventing injury and improving performance
“I believe the main take-home message from the study is that an individualized ergonomic plan based on assessment and feedback by physical therapists appears promising for optimizing endoscopic performance to minimize injury and reduce fatigue,” Dr. Ketwaroo said. However, “long-term studies in much larger samples will be needed to document objective findings of reduced injury or fatigue.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
Assessment of position and posture by a physical therapist can help reduce and prevent injury in endoscopists, based on data from a pilot study of eight individuals.
Musculoskeletal injuries among endoscopists are gaining more attention: One technical review indicated that the “prevalence of musculoskeletal pain or injuries ranged from 29% to 89% of gastroenterologists.” While data on avoiding musculoskeletal injury related to endoscopy are limited, recognition of the role of ergonomics is increasing, Stacy A. Markwell, a physical therapist in Chapel Hill, N.C., and colleagues, wrote in a study published in Gastrointestinal Endoscopy.
The mental concentration required along with the physical demands on manipulating the scope have been shown to negatively impact posture, the researchers noted.
The researchers reviewed data from eight endoscopists who were aged 32-71 years; they had a range of clinical experience and were performing 6-30 colonoscopies and 3-21 upper endoscopies per week.
These endoscopists volunteered for an ergonomic intervention involving use of an individualized wellness plan. They completed the Nordic Musculoskeletal Questionnaire to evaluate musculoskeletal complaints during the past 12 months and the past 7 days. Three of the eight participants reported pain at work at initial assessment, which often worsened over the course of the day, and five mentioned fatigue while working. They specified 22 pain sites, mainly in the neck and back. In addition, participants were photographed to evaluate posture in a static position and self-selected “tired” positions.
“When frequent or consistent posturing resulted in suboptimal joint alignment, muscle length, loading at end range of muscle or joints, and/or prolonged static active positioning, participants were photographed to provide personalized feedback for wellness education,” the researchers wrote.
The physical therapist used information from the evaluation and photographs to develop individual plans to improve the ergonomics of the endoscopic suite with adjustments to the location of the bed and positioning of chairs, standing surfaces, and monitors and keyboards. In addition to adjusting the endoscopic suite, the physical therapist developed individual wellness plans including exercises to relieve pain and improve posture, as well as pain education to help clinicians recognize and manage pain and fatigue.
By the end of the study, in a follow-up 6-12 months after the wellness intervention, 63% of pain sites (14 of 22) reported by participants were reduced in intensity or resolved, 32% were unchanged (7 of 22), and 4% increased (1 of 22).
Overall, seven of the eight participants said that the pictures of their posture along with the movement analysis was helpful, and three participants asked for reassessment by the physical therapist. In this study, the average cost of the wellness program was $500.
“All endoscopists reported that the wellness plan was helpful, with procedure suite and posture recommendations being the most beneficial,” the researchers reported. “Upon gaining insight with visualization of their posture and movement during endoscopy, participants’ understanding and motivation to make corrections was intensified.”
The study findings were limited by several factors including the small size, use of a single physical therapist, short follow-up, lack of controls, and use of a single site, the researchers noted. However, “our study provides a detailed, pragmatic, and reproducible framework for performing an individualized physical therapist–directed comprehensive assessment and personalized wellness plan in the workplace to help meet the challenges of ergonomics in endoscopy.”
Recognition of the value of ergonomics is rising
“Endoscopy related injury and disability is a known hazard of our profession,” said Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Any studies to assess and, more importantly, offer ways to prevent such injury are immediately relevant. In this context, ergonomics for endoscopy is an increasing area of research.”
Dr. Ketwaroo said that the study results were not surprising. “I agree with authors that there is a paucity of general ergonomic training and assessment. Specific individualized wellness plans are rare. Developing an individual plan based on observation by physical therapists, and taking into account baseline injury or predisposition to injury would be expected to be more high yield for preventing injury and improving performance
“I believe the main take-home message from the study is that an individualized ergonomic plan based on assessment and feedback by physical therapists appears promising for optimizing endoscopic performance to minimize injury and reduce fatigue,” Dr. Ketwaroo said. However, “long-term studies in much larger samples will be needed to document objective findings of reduced injury or fatigue.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.
FROM GASTROINTESTINAL ENDOSCOPY
Zika vaccine candidate shows promise in phase 1 trial
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
in a phase 1 study.
Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.
No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.
The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x1010 viral particles (low dose) or 1x1011 viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.
Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.
A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.
Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.
The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.
The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
Ad26 vector platform shows consistency
“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.
“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.
“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.
As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.
Consider pregnant women in next phase of research
“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.
The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.
“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.
The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
Zika vaccine research is a challenge worth pursuing
“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said. “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.
Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.
The study was supported by Janssen Vaccines and Infectious Diseases.
Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG.
FROM ANNALS OF INTERNAL MEDICINE
Menopause transition affects heart health risks
Menopause is a key time to monitor women for the development or increase of cardiovascular risk factors, according to a new consensus statement developed by the Task Force on Gender of the European Society of Cardiology and a multidisciplinary ESC working group on Women’s Health in Menopause.
“After menopause, traditional cardiovascular risk factors are adversely affected – particularly hypertension,” wrote Angela H.E.M. Maas, MD, of Radboud University Medical Center, Nijmegen, Netherlands, and colleagues.
“Since the first ESC consensus paper on the management of cardiovascular risk in perimenopausal women was published in 2007, we have a greater understanding on the role of female-specific risk factors for cardiovascular disease (CVD),” they said.
In a consensus statement published in the European Heart Journal, the authors presented clinical guidance for diagnosis and management of cardiovascular risk factors during the menopause transition. The transition to menopause increases a woman’s risk for developing several CVD risk factors, including central adiposity, increased insulin resistance, a proatherogenic lipid profile, and autonomic dysfunction that can contribute to increased heart rate variability, according to the statement.
Estrogen changes may affect ischemic disease
In general, obstructive coronary artery disease (CAD) strikes women later than men, but coronary vasomotor conditions are a common cause of ischemic heart disease in women with or without CAD, the authors noted.
“Lower estrogen levels after menopause are related to altered vascular function, enhanced inflammation, and up-regulation of other hormonal systems such as the renin–angiotensin–aldosterone system, the sympathetic nervous system, and reduced nitric oxide–dependent vasodilation,” they wrote. They recommended use of the coronary artery calcium score for screening middle-aged women who are symptomatic or at intermediate cardiovascular risk.
The transition to menopause causes changes in lipid profiles, and a rise in blood pressure in particular “may be both a direct effect of hormonal changes on the vasculature and metabolic changes with aging,” but hypertension in early post menopause is “often poorly managed,” the authors noted.
Compared with asymptomatic women, women who suffer from severe menopausal symptoms often have increased cardiovascular disease risk factors. For example, the Women’s Health Initiative (WHI) study showed a 48% increased risk of incident diabetes at follow-up in women with severe symptoms of hot flashes and night sweats, the authors wrote. Clinicians should also be aware of the increased immune reactivity that occurs during and after menopause and the increased CVD risk associated with autoimmune and endocrine disorders, they said.
Multiple strategies to reduce risk
Strategies to address the cardiovascular risk in menopause include assessing glucose, lipid levels, and blood pressure during the transition to menopause, according to the statement.
In addition, they recommended increasing employer awareness of menopause, as changes may interfere with working ability. A healthy lifestyle including healthy diet and regular exercise can help reduce cardiovascular risks and relieve symptoms. Menopausal hormone therapy (MHT) may be indicated to relieve symptoms, including symptoms of depression, and provide cardioprotection for younger women around the time of menopause, according to the statement.
However, “MHT is not recommended in women at high CV risk and after a previous CVD event,” and all women should be assessed for cardiovascular risk factors before starting MHT, they emphasized.
Results raise awareness of cardiovascular health and menopause link
“Over the past 20 years, our knowledge of how menopause might contribute to cardiovascular disease has dramatically evolved,” said Samar El Khoudary, MD, of the University of Pittsburg, in an interview.
“We have accumulated data that consistently point to the menopause transition as a time of change in cardiovascular health. As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” she said. “The goal is to raise awareness for both health care providers and women of the significant adverse cardiovascular health changes accompanying the menopause transition and to point out the importance of adopting prevention strategies early during this stage,” she explained.
The impact of the hormonal changes of menopause on CVD risk “is very complex,” Dr. El Khoudary said. “Until now, we could not prove that using estrogen therapy is cardioprotective,” she emphasized. “Studies point to the need to consider the timing of hormone use, as well as types and route of administration,” she noted. “The truth is that, although the menopause transition is associated with an acceleration in CVD risk, the exact mechanism still is not completely clear. Hormone changes contribute, but they are not the ultimate contributor,” she added.
Research gaps include data on lifestyle and behavioral interventions
“Irrespective of the accumulating findings showing adverse changes in multiple cardiovascular health parameters, as women transition through menopause, we do not have data documenting current status of ideal cardiovascular health components during the menopause transition among women,” said Dr. El Khoudary. “The limited data we have [suggest] that a very small proportion of women transitioning through menopause eat a healthy diet (less than 20%) or practice physical activity (about7.2%) at a level that matches the current recommendations,” she noted.
“Lifestyle and behavioral interventions are critical to maintain a healthy heart and reduce heart disease; we do not have adequate randomized clinical trials testing these interventions specifically during the menopause transition,” she said.
“Similarly, we are in need of randomized clinical trials of therapeutic interventions such as lipid-lowering medications and menopause hormone therapy in women transitioning through menopause,” said Dr. El Khoudary. “This high-risk population has not been the focus of previous clinical trials, leaving us with questions of how the results from these studies might apply to women during the menopause transition,” she said.
Consensus invites collaboration
“I commend the group for putting together a statement that crosses practice and specialty boundaries,” said Lubna Pal, MD, of Yale School of Medicine, New Haven, Conn., in an interview. Although the statement does not present novel information, it “has the power of unifying the various providers by bringing focus on the individual elements spanning a woman’s life that cumulatively determine her lifetime health risk,” she said. Preeclampsia may be a risk factor for cardiovascular disease later in life, and events in reproductive age may determine a woman’s trajectory during the transition to menopause and beyond, Dr. Pal noted.
“The consensus statement will likely be read by internists and family medicine providers as well as ob.gyns.; it encourages all those involved in caring for female patients to take on the responsibility of ‘passing on the baton,’ such that all women who are deemed at an enhanced risk for cardiovascular disease are assured due diligence in care through stringent surveillance and timely interventions,” said Dr. Pal. “It is a call for the various providers who care for women at distinct stages of life to work together toward a shared goal of optimizing every woman’s health across her lifespan,” she said.
“More research is needed for us to better understand the mechanisms at play” in the development of cardiovascular risk and in understanding the continuity of changes across women’s lifespans, Dr. Pal said. “We have associations, but not much information about causation,” she emphasized. However, the statement promotes the dissemination of information about women’s health and sensitizes providers to the potential and the power of preventive care. “We should be much more liberal and loud in holding conversations about risk quantification and risk reduction, and this statement is a resounding effort toward identifying and mitigating long-term cardiovascular risk, even if only through promoting a healthier lifestyle in those deemed at risk,” she added.
The statement received no outside funding. Lead author Dr. Maas had no financial conflicts to disclose. Dr. El Khoudary had no financial conflicts to disclose. Dr. Pal had no relevant financial conflicts to disclose.
Menopause is a key time to monitor women for the development or increase of cardiovascular risk factors, according to a new consensus statement developed by the Task Force on Gender of the European Society of Cardiology and a multidisciplinary ESC working group on Women’s Health in Menopause.
“After menopause, traditional cardiovascular risk factors are adversely affected – particularly hypertension,” wrote Angela H.E.M. Maas, MD, of Radboud University Medical Center, Nijmegen, Netherlands, and colleagues.
“Since the first ESC consensus paper on the management of cardiovascular risk in perimenopausal women was published in 2007, we have a greater understanding on the role of female-specific risk factors for cardiovascular disease (CVD),” they said.
In a consensus statement published in the European Heart Journal, the authors presented clinical guidance for diagnosis and management of cardiovascular risk factors during the menopause transition. The transition to menopause increases a woman’s risk for developing several CVD risk factors, including central adiposity, increased insulin resistance, a proatherogenic lipid profile, and autonomic dysfunction that can contribute to increased heart rate variability, according to the statement.
Estrogen changes may affect ischemic disease
In general, obstructive coronary artery disease (CAD) strikes women later than men, but coronary vasomotor conditions are a common cause of ischemic heart disease in women with or without CAD, the authors noted.
“Lower estrogen levels after menopause are related to altered vascular function, enhanced inflammation, and up-regulation of other hormonal systems such as the renin–angiotensin–aldosterone system, the sympathetic nervous system, and reduced nitric oxide–dependent vasodilation,” they wrote. They recommended use of the coronary artery calcium score for screening middle-aged women who are symptomatic or at intermediate cardiovascular risk.
The transition to menopause causes changes in lipid profiles, and a rise in blood pressure in particular “may be both a direct effect of hormonal changes on the vasculature and metabolic changes with aging,” but hypertension in early post menopause is “often poorly managed,” the authors noted.
Compared with asymptomatic women, women who suffer from severe menopausal symptoms often have increased cardiovascular disease risk factors. For example, the Women’s Health Initiative (WHI) study showed a 48% increased risk of incident diabetes at follow-up in women with severe symptoms of hot flashes and night sweats, the authors wrote. Clinicians should also be aware of the increased immune reactivity that occurs during and after menopause and the increased CVD risk associated with autoimmune and endocrine disorders, they said.
Multiple strategies to reduce risk
Strategies to address the cardiovascular risk in menopause include assessing glucose, lipid levels, and blood pressure during the transition to menopause, according to the statement.
In addition, they recommended increasing employer awareness of menopause, as changes may interfere with working ability. A healthy lifestyle including healthy diet and regular exercise can help reduce cardiovascular risks and relieve symptoms. Menopausal hormone therapy (MHT) may be indicated to relieve symptoms, including symptoms of depression, and provide cardioprotection for younger women around the time of menopause, according to the statement.
However, “MHT is not recommended in women at high CV risk and after a previous CVD event,” and all women should be assessed for cardiovascular risk factors before starting MHT, they emphasized.
Results raise awareness of cardiovascular health and menopause link
“Over the past 20 years, our knowledge of how menopause might contribute to cardiovascular disease has dramatically evolved,” said Samar El Khoudary, MD, of the University of Pittsburg, in an interview.
“We have accumulated data that consistently point to the menopause transition as a time of change in cardiovascular health. As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” she said. “The goal is to raise awareness for both health care providers and women of the significant adverse cardiovascular health changes accompanying the menopause transition and to point out the importance of adopting prevention strategies early during this stage,” she explained.
The impact of the hormonal changes of menopause on CVD risk “is very complex,” Dr. El Khoudary said. “Until now, we could not prove that using estrogen therapy is cardioprotective,” she emphasized. “Studies point to the need to consider the timing of hormone use, as well as types and route of administration,” she noted. “The truth is that, although the menopause transition is associated with an acceleration in CVD risk, the exact mechanism still is not completely clear. Hormone changes contribute, but they are not the ultimate contributor,” she added.
Research gaps include data on lifestyle and behavioral interventions
“Irrespective of the accumulating findings showing adverse changes in multiple cardiovascular health parameters, as women transition through menopause, we do not have data documenting current status of ideal cardiovascular health components during the menopause transition among women,” said Dr. El Khoudary. “The limited data we have [suggest] that a very small proportion of women transitioning through menopause eat a healthy diet (less than 20%) or practice physical activity (about7.2%) at a level that matches the current recommendations,” she noted.
“Lifestyle and behavioral interventions are critical to maintain a healthy heart and reduce heart disease; we do not have adequate randomized clinical trials testing these interventions specifically during the menopause transition,” she said.
“Similarly, we are in need of randomized clinical trials of therapeutic interventions such as lipid-lowering medications and menopause hormone therapy in women transitioning through menopause,” said Dr. El Khoudary. “This high-risk population has not been the focus of previous clinical trials, leaving us with questions of how the results from these studies might apply to women during the menopause transition,” she said.
Consensus invites collaboration
“I commend the group for putting together a statement that crosses practice and specialty boundaries,” said Lubna Pal, MD, of Yale School of Medicine, New Haven, Conn., in an interview. Although the statement does not present novel information, it “has the power of unifying the various providers by bringing focus on the individual elements spanning a woman’s life that cumulatively determine her lifetime health risk,” she said. Preeclampsia may be a risk factor for cardiovascular disease later in life, and events in reproductive age may determine a woman’s trajectory during the transition to menopause and beyond, Dr. Pal noted.
“The consensus statement will likely be read by internists and family medicine providers as well as ob.gyns.; it encourages all those involved in caring for female patients to take on the responsibility of ‘passing on the baton,’ such that all women who are deemed at an enhanced risk for cardiovascular disease are assured due diligence in care through stringent surveillance and timely interventions,” said Dr. Pal. “It is a call for the various providers who care for women at distinct stages of life to work together toward a shared goal of optimizing every woman’s health across her lifespan,” she said.
“More research is needed for us to better understand the mechanisms at play” in the development of cardiovascular risk and in understanding the continuity of changes across women’s lifespans, Dr. Pal said. “We have associations, but not much information about causation,” she emphasized. However, the statement promotes the dissemination of information about women’s health and sensitizes providers to the potential and the power of preventive care. “We should be much more liberal and loud in holding conversations about risk quantification and risk reduction, and this statement is a resounding effort toward identifying and mitigating long-term cardiovascular risk, even if only through promoting a healthier lifestyle in those deemed at risk,” she added.
The statement received no outside funding. Lead author Dr. Maas had no financial conflicts to disclose. Dr. El Khoudary had no financial conflicts to disclose. Dr. Pal had no relevant financial conflicts to disclose.
Menopause is a key time to monitor women for the development or increase of cardiovascular risk factors, according to a new consensus statement developed by the Task Force on Gender of the European Society of Cardiology and a multidisciplinary ESC working group on Women’s Health in Menopause.
“After menopause, traditional cardiovascular risk factors are adversely affected – particularly hypertension,” wrote Angela H.E.M. Maas, MD, of Radboud University Medical Center, Nijmegen, Netherlands, and colleagues.
“Since the first ESC consensus paper on the management of cardiovascular risk in perimenopausal women was published in 2007, we have a greater understanding on the role of female-specific risk factors for cardiovascular disease (CVD),” they said.
In a consensus statement published in the European Heart Journal, the authors presented clinical guidance for diagnosis and management of cardiovascular risk factors during the menopause transition. The transition to menopause increases a woman’s risk for developing several CVD risk factors, including central adiposity, increased insulin resistance, a proatherogenic lipid profile, and autonomic dysfunction that can contribute to increased heart rate variability, according to the statement.
Estrogen changes may affect ischemic disease
In general, obstructive coronary artery disease (CAD) strikes women later than men, but coronary vasomotor conditions are a common cause of ischemic heart disease in women with or without CAD, the authors noted.
“Lower estrogen levels after menopause are related to altered vascular function, enhanced inflammation, and up-regulation of other hormonal systems such as the renin–angiotensin–aldosterone system, the sympathetic nervous system, and reduced nitric oxide–dependent vasodilation,” they wrote. They recommended use of the coronary artery calcium score for screening middle-aged women who are symptomatic or at intermediate cardiovascular risk.
The transition to menopause causes changes in lipid profiles, and a rise in blood pressure in particular “may be both a direct effect of hormonal changes on the vasculature and metabolic changes with aging,” but hypertension in early post menopause is “often poorly managed,” the authors noted.
Compared with asymptomatic women, women who suffer from severe menopausal symptoms often have increased cardiovascular disease risk factors. For example, the Women’s Health Initiative (WHI) study showed a 48% increased risk of incident diabetes at follow-up in women with severe symptoms of hot flashes and night sweats, the authors wrote. Clinicians should also be aware of the increased immune reactivity that occurs during and after menopause and the increased CVD risk associated with autoimmune and endocrine disorders, they said.
Multiple strategies to reduce risk
Strategies to address the cardiovascular risk in menopause include assessing glucose, lipid levels, and blood pressure during the transition to menopause, according to the statement.
In addition, they recommended increasing employer awareness of menopause, as changes may interfere with working ability. A healthy lifestyle including healthy diet and regular exercise can help reduce cardiovascular risks and relieve symptoms. Menopausal hormone therapy (MHT) may be indicated to relieve symptoms, including symptoms of depression, and provide cardioprotection for younger women around the time of menopause, according to the statement.
However, “MHT is not recommended in women at high CV risk and after a previous CVD event,” and all women should be assessed for cardiovascular risk factors before starting MHT, they emphasized.
Results raise awareness of cardiovascular health and menopause link
“Over the past 20 years, our knowledge of how menopause might contribute to cardiovascular disease has dramatically evolved,” said Samar El Khoudary, MD, of the University of Pittsburg, in an interview.
“We have accumulated data that consistently point to the menopause transition as a time of change in cardiovascular health. As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” she said. “The goal is to raise awareness for both health care providers and women of the significant adverse cardiovascular health changes accompanying the menopause transition and to point out the importance of adopting prevention strategies early during this stage,” she explained.
The impact of the hormonal changes of menopause on CVD risk “is very complex,” Dr. El Khoudary said. “Until now, we could not prove that using estrogen therapy is cardioprotective,” she emphasized. “Studies point to the need to consider the timing of hormone use, as well as types and route of administration,” she noted. “The truth is that, although the menopause transition is associated with an acceleration in CVD risk, the exact mechanism still is not completely clear. Hormone changes contribute, but they are not the ultimate contributor,” she added.
Research gaps include data on lifestyle and behavioral interventions
“Irrespective of the accumulating findings showing adverse changes in multiple cardiovascular health parameters, as women transition through menopause, we do not have data documenting current status of ideal cardiovascular health components during the menopause transition among women,” said Dr. El Khoudary. “The limited data we have [suggest] that a very small proportion of women transitioning through menopause eat a healthy diet (less than 20%) or practice physical activity (about7.2%) at a level that matches the current recommendations,” she noted.
“Lifestyle and behavioral interventions are critical to maintain a healthy heart and reduce heart disease; we do not have adequate randomized clinical trials testing these interventions specifically during the menopause transition,” she said.
“Similarly, we are in need of randomized clinical trials of therapeutic interventions such as lipid-lowering medications and menopause hormone therapy in women transitioning through menopause,” said Dr. El Khoudary. “This high-risk population has not been the focus of previous clinical trials, leaving us with questions of how the results from these studies might apply to women during the menopause transition,” she said.
Consensus invites collaboration
“I commend the group for putting together a statement that crosses practice and specialty boundaries,” said Lubna Pal, MD, of Yale School of Medicine, New Haven, Conn., in an interview. Although the statement does not present novel information, it “has the power of unifying the various providers by bringing focus on the individual elements spanning a woman’s life that cumulatively determine her lifetime health risk,” she said. Preeclampsia may be a risk factor for cardiovascular disease later in life, and events in reproductive age may determine a woman’s trajectory during the transition to menopause and beyond, Dr. Pal noted.
“The consensus statement will likely be read by internists and family medicine providers as well as ob.gyns.; it encourages all those involved in caring for female patients to take on the responsibility of ‘passing on the baton,’ such that all women who are deemed at an enhanced risk for cardiovascular disease are assured due diligence in care through stringent surveillance and timely interventions,” said Dr. Pal. “It is a call for the various providers who care for women at distinct stages of life to work together toward a shared goal of optimizing every woman’s health across her lifespan,” she said.
“More research is needed for us to better understand the mechanisms at play” in the development of cardiovascular risk and in understanding the continuity of changes across women’s lifespans, Dr. Pal said. “We have associations, but not much information about causation,” she emphasized. However, the statement promotes the dissemination of information about women’s health and sensitizes providers to the potential and the power of preventive care. “We should be much more liberal and loud in holding conversations about risk quantification and risk reduction, and this statement is a resounding effort toward identifying and mitigating long-term cardiovascular risk, even if only through promoting a healthier lifestyle in those deemed at risk,” she added.
The statement received no outside funding. Lead author Dr. Maas had no financial conflicts to disclose. Dr. El Khoudary had no financial conflicts to disclose. Dr. Pal had no relevant financial conflicts to disclose.
FROM THE EUROPEAN HEART JOURNAL
Updated WIC in pregnancy boosts infant outcomes
Developmental outcomes in the first 2 years of life improved in children whose mothers received the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) while pregnant, based on data from approximately 1,200 women.
Maternal nutrition is essential to healthy fetal development, and the WIC was revised in 2009 to align with current dietary guidelines and to support the health of women and children in low-income households, wrote Alice Guan, MPH, of the University of California, San Francisco, and colleagues.
“However, no researchers, to our knowledge, have evaluated effects of this revision on downstream child health or development,” they said.
In a study published in Pediatrics, the researchers reviewed data from mothers and their children who participated in the Conditions Affecting Neurocognitive Development and Learning in Early Childhood (CANDLE) longitudinal cohort study conducted in Tennessee between 2006 and 2011. Their quasi-experimental analysis included 700 women who received WIC during pregnancy and 525 women who did not.
The researchers considered core developmental outcomes of child growth, cognitive development, and socioemotional development at age 12 months and 24 months, and age 4-6 years.
Overall, infants of women who received the WIC food package showed significant increases in length-for-age z scores at 12 months of age (.33, representing approximately one-fifth of a standard deviation), compared to infants of women who did not receive the revised WIC package.
In addition, the Bayley Scales of Infant Development cognitive composite score showed a 4.3-point increase at 24 months of age (approximately one-third of a standard deviation) compared to infants of women who did not receive the revised WIC package.
No effects on growth at age 24 months or on cognitive development at age 4-6 years were noted, which suggests that the impact of the WIC program during pregnancy may fade over time, the researchers said.
“The magnitude of the findings in this study represents clinically relevant effect sizes and provides evidence that one of the largest U.S. safety net policies improves developmental outcomes among low-income and marginalized children,” they noted.
The study findings were limited by several factors including the statistical, quasi-experimental design; the reliance on self-reports for information on income, receipt of WIC, and other variables; and a potential lack of generalizability to other states, the researchers noted. However, the results support findings from previous studies and were strengthened by the review of multiple outcomes and use of a longitudinal database, they said.
“These findings provide timely and critical evidence for the role that WIC plays in improving the health of the nation’s most vulnerable populations, suggesting meaningful impacts of the revised WIC food package on child development,” the researchers said. In addition, “considering the relatively modest scope of the 2009 revision, more substantial updates to the program based on up-to-date nutritional guidance may have substantial effects on improving the health of WIC recipients,” they concluded.
Findings support program’s value
“Pediatrics has always had a commitment to reducing disparities in health care, and we are the main clinicians to see many Medicaid patients on a regular basis,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.
“We all know that pregnant women eating nutritiously ought to help child outcomes, but the current study provides an evidence base for something that seems like common sense,” he noted.
Having such an evidence base is helpful to reinforce the value of the WIC program for its intended recipients, especially in the wake of the COVID-19 pandemic when many funding sources are stretched thin, Dr. Lessin said.
The WIC is intended to try to reduce racial and socioeconomic disparities in the most basic form possible, by helping people who are disadvantaged get enough high-quality food to eat, but results of the program’s impact have not been well studied, he said.
“Outcomes are fiendishly difficult to measure,” and the study is subject to the limitations of its statistical nature, he said. But the large sample size adds support to the findings, which are encouraging, Dr. Lessin noted.
Other potential areas for research include comparing the quality of WIC programs in different states, but such research is very difficult, Dr. Lessin noted. However, the findings might encourage states with less robust WIC programs to consider increasing support, he said.
The study was funded by the National Institutes of Health (National Heart, Lung, and Blood Institute); the National Institute on Aging; the University of California, San Francisco, National Center of Excellence in Women’s Health; and the Urban Child Institute. The researchers had no financial conflicts to disclose. Dr. Lessin serves on the editorial advisory board of Pediatric News and had no relevant financial conflicts to disclose.
Developmental outcomes in the first 2 years of life improved in children whose mothers received the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) while pregnant, based on data from approximately 1,200 women.
Maternal nutrition is essential to healthy fetal development, and the WIC was revised in 2009 to align with current dietary guidelines and to support the health of women and children in low-income households, wrote Alice Guan, MPH, of the University of California, San Francisco, and colleagues.
“However, no researchers, to our knowledge, have evaluated effects of this revision on downstream child health or development,” they said.
In a study published in Pediatrics, the researchers reviewed data from mothers and their children who participated in the Conditions Affecting Neurocognitive Development and Learning in Early Childhood (CANDLE) longitudinal cohort study conducted in Tennessee between 2006 and 2011. Their quasi-experimental analysis included 700 women who received WIC during pregnancy and 525 women who did not.
The researchers considered core developmental outcomes of child growth, cognitive development, and socioemotional development at age 12 months and 24 months, and age 4-6 years.
Overall, infants of women who received the WIC food package showed significant increases in length-for-age z scores at 12 months of age (.33, representing approximately one-fifth of a standard deviation), compared to infants of women who did not receive the revised WIC package.
In addition, the Bayley Scales of Infant Development cognitive composite score showed a 4.3-point increase at 24 months of age (approximately one-third of a standard deviation) compared to infants of women who did not receive the revised WIC package.
No effects on growth at age 24 months or on cognitive development at age 4-6 years were noted, which suggests that the impact of the WIC program during pregnancy may fade over time, the researchers said.
“The magnitude of the findings in this study represents clinically relevant effect sizes and provides evidence that one of the largest U.S. safety net policies improves developmental outcomes among low-income and marginalized children,” they noted.
The study findings were limited by several factors including the statistical, quasi-experimental design; the reliance on self-reports for information on income, receipt of WIC, and other variables; and a potential lack of generalizability to other states, the researchers noted. However, the results support findings from previous studies and were strengthened by the review of multiple outcomes and use of a longitudinal database, they said.
“These findings provide timely and critical evidence for the role that WIC plays in improving the health of the nation’s most vulnerable populations, suggesting meaningful impacts of the revised WIC food package on child development,” the researchers said. In addition, “considering the relatively modest scope of the 2009 revision, more substantial updates to the program based on up-to-date nutritional guidance may have substantial effects on improving the health of WIC recipients,” they concluded.
Findings support program’s value
“Pediatrics has always had a commitment to reducing disparities in health care, and we are the main clinicians to see many Medicaid patients on a regular basis,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.
“We all know that pregnant women eating nutritiously ought to help child outcomes, but the current study provides an evidence base for something that seems like common sense,” he noted.
Having such an evidence base is helpful to reinforce the value of the WIC program for its intended recipients, especially in the wake of the COVID-19 pandemic when many funding sources are stretched thin, Dr. Lessin said.
The WIC is intended to try to reduce racial and socioeconomic disparities in the most basic form possible, by helping people who are disadvantaged get enough high-quality food to eat, but results of the program’s impact have not been well studied, he said.
“Outcomes are fiendishly difficult to measure,” and the study is subject to the limitations of its statistical nature, he said. But the large sample size adds support to the findings, which are encouraging, Dr. Lessin noted.
Other potential areas for research include comparing the quality of WIC programs in different states, but such research is very difficult, Dr. Lessin noted. However, the findings might encourage states with less robust WIC programs to consider increasing support, he said.
The study was funded by the National Institutes of Health (National Heart, Lung, and Blood Institute); the National Institute on Aging; the University of California, San Francisco, National Center of Excellence in Women’s Health; and the Urban Child Institute. The researchers had no financial conflicts to disclose. Dr. Lessin serves on the editorial advisory board of Pediatric News and had no relevant financial conflicts to disclose.
Developmental outcomes in the first 2 years of life improved in children whose mothers received the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) while pregnant, based on data from approximately 1,200 women.
Maternal nutrition is essential to healthy fetal development, and the WIC was revised in 2009 to align with current dietary guidelines and to support the health of women and children in low-income households, wrote Alice Guan, MPH, of the University of California, San Francisco, and colleagues.
“However, no researchers, to our knowledge, have evaluated effects of this revision on downstream child health or development,” they said.
In a study published in Pediatrics, the researchers reviewed data from mothers and their children who participated in the Conditions Affecting Neurocognitive Development and Learning in Early Childhood (CANDLE) longitudinal cohort study conducted in Tennessee between 2006 and 2011. Their quasi-experimental analysis included 700 women who received WIC during pregnancy and 525 women who did not.
The researchers considered core developmental outcomes of child growth, cognitive development, and socioemotional development at age 12 months and 24 months, and age 4-6 years.
Overall, infants of women who received the WIC food package showed significant increases in length-for-age z scores at 12 months of age (.33, representing approximately one-fifth of a standard deviation), compared to infants of women who did not receive the revised WIC package.
In addition, the Bayley Scales of Infant Development cognitive composite score showed a 4.3-point increase at 24 months of age (approximately one-third of a standard deviation) compared to infants of women who did not receive the revised WIC package.
No effects on growth at age 24 months or on cognitive development at age 4-6 years were noted, which suggests that the impact of the WIC program during pregnancy may fade over time, the researchers said.
“The magnitude of the findings in this study represents clinically relevant effect sizes and provides evidence that one of the largest U.S. safety net policies improves developmental outcomes among low-income and marginalized children,” they noted.
The study findings were limited by several factors including the statistical, quasi-experimental design; the reliance on self-reports for information on income, receipt of WIC, and other variables; and a potential lack of generalizability to other states, the researchers noted. However, the results support findings from previous studies and were strengthened by the review of multiple outcomes and use of a longitudinal database, they said.
“These findings provide timely and critical evidence for the role that WIC plays in improving the health of the nation’s most vulnerable populations, suggesting meaningful impacts of the revised WIC food package on child development,” the researchers said. In addition, “considering the relatively modest scope of the 2009 revision, more substantial updates to the program based on up-to-date nutritional guidance may have substantial effects on improving the health of WIC recipients,” they concluded.
Findings support program’s value
“Pediatrics has always had a commitment to reducing disparities in health care, and we are the main clinicians to see many Medicaid patients on a regular basis,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.
“We all know that pregnant women eating nutritiously ought to help child outcomes, but the current study provides an evidence base for something that seems like common sense,” he noted.
Having such an evidence base is helpful to reinforce the value of the WIC program for its intended recipients, especially in the wake of the COVID-19 pandemic when many funding sources are stretched thin, Dr. Lessin said.
The WIC is intended to try to reduce racial and socioeconomic disparities in the most basic form possible, by helping people who are disadvantaged get enough high-quality food to eat, but results of the program’s impact have not been well studied, he said.
“Outcomes are fiendishly difficult to measure,” and the study is subject to the limitations of its statistical nature, he said. But the large sample size adds support to the findings, which are encouraging, Dr. Lessin noted.
Other potential areas for research include comparing the quality of WIC programs in different states, but such research is very difficult, Dr. Lessin noted. However, the findings might encourage states with less robust WIC programs to consider increasing support, he said.
The study was funded by the National Institutes of Health (National Heart, Lung, and Blood Institute); the National Institute on Aging; the University of California, San Francisco, National Center of Excellence in Women’s Health; and the Urban Child Institute. The researchers had no financial conflicts to disclose. Dr. Lessin serves on the editorial advisory board of Pediatric News and had no relevant financial conflicts to disclose.
FROM PEDIATRICS
TNF inhibitors may slow spinal progression in axial spondyloarthritis
Patients with axial spondyloarthritis showed reduced spinal radiographic progression after treatment with tumor necrosis factor (TNF) inhibitors, based on data from 314 adults in a prospective cohort study.
Evidence of a link between inflammation and axial damage in patients with axial spondyloarthritis (axSpA) has been reported, and these patients are routinely treated with NSAIDs and TNF inhibitors (TNFi), wrote Alexandre Sepriano, MD, PhD, of Leiden (the Netherlands) University Medical Center, and colleagues.
“However, and despite significant efforts, it remains to be clarified whether there is also an effect of these drugs on axial damage accrual,” they noted.
In a study published in Arthritis & Rheumatology, the researchers recruited consecutive patients from rheumatology practices in Northern Alberta to enroll in the Follow Up Research Cohort in Ankylosing Spondylitis Treatment (ALBERTA FORCAST) observational cohort study. The average age of the patients was 41 years, 74% were men, 83% were HLA-B27 positive, and the average duration of symptoms was 18 years.
Progression was measured via spine radiographs every 2 years for up to 10 years; the radiographs were scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). In addition, the researchers assessed the interaction between TNFi exposure and clinical disease activity using the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the impact on mSASSS every 2 years. The analysis included 442 2-year intervals.
Overall, the researchers found a significant interaction between ASDAS and TNFi at the start of the interval, followed by gradient effect of ASDAS at the start of the interval on mSASSS 2 years later, which was more than twice as high in patients never treated with TNFi (beta = 0.41), compared with patients who were continuously treated with a TNFi (beta = 0.16).
“Similarly, patients treated with TNFi were 30% less likely to develop a new syndesmophyte 2 years later compared to those not treated,” the researchers said.
TNFi also directly slowed progression, as treated patients averaged 0.85 mSASSS units less 2 years later, compared with untreated patients.
Of note, “treatment with NSAIDs during follow-up was neither associated with the outcome nor did it modify or confound the association between TNFi and mSASSS,” the researchers said. In addition, “the direct effect of TNFi on mSASSS was still present after adjusting for a propensity score,” they wrote.
The study results were limited by several factors including the observational design, lack of data on long-term treatment effects, and inability to assess individual TNFi drugs separately, the researchers noted.
However, “the present study informs the rheumatology community by addressing the question as to whether or not TNFi inhibit radiographic progression in axSpA and if this effect is mediated solely by their effects on inflammation, as measured by the ASDAS, or whether additional mechanisms may be relevant,” they emphasized.
“A better understanding of these mechanisms might open avenues to further treatment strategies that might finally lead to effective disease modification in axial SpA,” they concluded.
The ALBERTA FORCAST study was supported by AbbVie. Several authors disclosed financial relationships with AbbVie and other manufacturers of TNFi.
Patients with axial spondyloarthritis showed reduced spinal radiographic progression after treatment with tumor necrosis factor (TNF) inhibitors, based on data from 314 adults in a prospective cohort study.
Evidence of a link between inflammation and axial damage in patients with axial spondyloarthritis (axSpA) has been reported, and these patients are routinely treated with NSAIDs and TNF inhibitors (TNFi), wrote Alexandre Sepriano, MD, PhD, of Leiden (the Netherlands) University Medical Center, and colleagues.
“However, and despite significant efforts, it remains to be clarified whether there is also an effect of these drugs on axial damage accrual,” they noted.
In a study published in Arthritis & Rheumatology, the researchers recruited consecutive patients from rheumatology practices in Northern Alberta to enroll in the Follow Up Research Cohort in Ankylosing Spondylitis Treatment (ALBERTA FORCAST) observational cohort study. The average age of the patients was 41 years, 74% were men, 83% were HLA-B27 positive, and the average duration of symptoms was 18 years.
Progression was measured via spine radiographs every 2 years for up to 10 years; the radiographs were scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). In addition, the researchers assessed the interaction between TNFi exposure and clinical disease activity using the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the impact on mSASSS every 2 years. The analysis included 442 2-year intervals.
Overall, the researchers found a significant interaction between ASDAS and TNFi at the start of the interval, followed by gradient effect of ASDAS at the start of the interval on mSASSS 2 years later, which was more than twice as high in patients never treated with TNFi (beta = 0.41), compared with patients who were continuously treated with a TNFi (beta = 0.16).
“Similarly, patients treated with TNFi were 30% less likely to develop a new syndesmophyte 2 years later compared to those not treated,” the researchers said.
TNFi also directly slowed progression, as treated patients averaged 0.85 mSASSS units less 2 years later, compared with untreated patients.
Of note, “treatment with NSAIDs during follow-up was neither associated with the outcome nor did it modify or confound the association between TNFi and mSASSS,” the researchers said. In addition, “the direct effect of TNFi on mSASSS was still present after adjusting for a propensity score,” they wrote.
The study results were limited by several factors including the observational design, lack of data on long-term treatment effects, and inability to assess individual TNFi drugs separately, the researchers noted.
However, “the present study informs the rheumatology community by addressing the question as to whether or not TNFi inhibit radiographic progression in axSpA and if this effect is mediated solely by their effects on inflammation, as measured by the ASDAS, or whether additional mechanisms may be relevant,” they emphasized.
“A better understanding of these mechanisms might open avenues to further treatment strategies that might finally lead to effective disease modification in axial SpA,” they concluded.
The ALBERTA FORCAST study was supported by AbbVie. Several authors disclosed financial relationships with AbbVie and other manufacturers of TNFi.
Patients with axial spondyloarthritis showed reduced spinal radiographic progression after treatment with tumor necrosis factor (TNF) inhibitors, based on data from 314 adults in a prospective cohort study.
Evidence of a link between inflammation and axial damage in patients with axial spondyloarthritis (axSpA) has been reported, and these patients are routinely treated with NSAIDs and TNF inhibitors (TNFi), wrote Alexandre Sepriano, MD, PhD, of Leiden (the Netherlands) University Medical Center, and colleagues.
“However, and despite significant efforts, it remains to be clarified whether there is also an effect of these drugs on axial damage accrual,” they noted.
In a study published in Arthritis & Rheumatology, the researchers recruited consecutive patients from rheumatology practices in Northern Alberta to enroll in the Follow Up Research Cohort in Ankylosing Spondylitis Treatment (ALBERTA FORCAST) observational cohort study. The average age of the patients was 41 years, 74% were men, 83% were HLA-B27 positive, and the average duration of symptoms was 18 years.
Progression was measured via spine radiographs every 2 years for up to 10 years; the radiographs were scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). In addition, the researchers assessed the interaction between TNFi exposure and clinical disease activity using the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the impact on mSASSS every 2 years. The analysis included 442 2-year intervals.
Overall, the researchers found a significant interaction between ASDAS and TNFi at the start of the interval, followed by gradient effect of ASDAS at the start of the interval on mSASSS 2 years later, which was more than twice as high in patients never treated with TNFi (beta = 0.41), compared with patients who were continuously treated with a TNFi (beta = 0.16).
“Similarly, patients treated with TNFi were 30% less likely to develop a new syndesmophyte 2 years later compared to those not treated,” the researchers said.
TNFi also directly slowed progression, as treated patients averaged 0.85 mSASSS units less 2 years later, compared with untreated patients.
Of note, “treatment with NSAIDs during follow-up was neither associated with the outcome nor did it modify or confound the association between TNFi and mSASSS,” the researchers said. In addition, “the direct effect of TNFi on mSASSS was still present after adjusting for a propensity score,” they wrote.
The study results were limited by several factors including the observational design, lack of data on long-term treatment effects, and inability to assess individual TNFi drugs separately, the researchers noted.
However, “the present study informs the rheumatology community by addressing the question as to whether or not TNFi inhibit radiographic progression in axSpA and if this effect is mediated solely by their effects on inflammation, as measured by the ASDAS, or whether additional mechanisms may be relevant,” they emphasized.
“A better understanding of these mechanisms might open avenues to further treatment strategies that might finally lead to effective disease modification in axial SpA,” they concluded.
The ALBERTA FORCAST study was supported by AbbVie. Several authors disclosed financial relationships with AbbVie and other manufacturers of TNFi.
FROM ARTHRITIS & RHEUMATOLOGY
FDA alert confirms heart and cancer risks with tofacitinib (Xeljanz)
The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).
The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.
Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.
Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).
The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).
In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.
In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.
The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.
Until nuances revealed, no change in practice
The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).
This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.
The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).
The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.
Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.
Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).
The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).
In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.
In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.
The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.
Until nuances revealed, no change in practice
The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).
This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.
The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).
The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.
Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.
Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).
The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).
In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.
In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.
The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.
Until nuances revealed, no change in practice
The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).
This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.