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Seven hours of sleep is ideal for middle aged and older

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Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

 

 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

Dr. Noel Deep

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
 

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Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

 

 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

Dr. Noel Deep

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
 

Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

 

 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

Dr. Noel Deep

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
 

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Severe COVID-19 adds 20 years of cognitive aging: Study

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Cognitive impairment from severe COVID-19 is equivalent to 20 years of aging, report scientists behind a new study, adding that the impairment is “equivalent to losing 10 IQ points.”

In their study, published in eClinicalMedicine, a team of scientists from the University of Cambridge and Imperial College London said there is growing evidence that COVID-19 can cause lasting cognitive and mental health problems. Patients report fatigue, “brain fog,” problems recalling words, sleep disturbances, anxiety, and even posttraumatic stress disorder months after infection.

The researchers analyzed data from 46 individuals who received critical care for COVID-19 at Addenbrooke’s Hospital between March and July 2020 (27 females, 19 males, mean age 51 years, 16 of whom had mechanical ventilation) and were recruited to the NIHR COVID-19 BioResource project.

At an average of 6 months after acute COVID-19 illness, the study participants underwent detailed computerized cognitive tests via the Cognitron platform,  comprising eight tasks deployed on an iPad measuring mental function such as memory, attention, and reasoning. Also assessed were anxiety, depression, and posttraumatic stress disorder via standard mood, anxiety, and posttraumatic stress scales – specifically the Generalized Anxiety Disorder 7 (GAD-7), the Patient Health Questionnaire 9 (PHQ-9), and the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). Their data were compared against 460 controls – matched for age, sex, education, and first language – and the pattern of deficits across tasks was qualitatively compared with normal age-related decline and early-stage dementia.
 

Less accurate and slower response times

The authors highlighted how this was the first time a “rigorous assessment and comparison” had been carried out in relation to the after-effects of severe COVID-19.

“Cognitive impairment is common to a wide range of neurological disorders, including dementia, and even routine aging, but the patterns we saw – the cognitive ‘fingerprint’ of COVID-19 – was distinct from all of these,” said David Menon, MD, division of anesthesia at the University of Cambridge, England, and the study’s senior author.

The scientists found that COVID-19 survivors were less accurate and had slower response times than the control population, and added that survivors scored particularly poorly on verbal analogical reasoning and showed slower processing speeds.

Critically, the scale of the cognitive deficits correlated with acute illness severity, but not fatigue or mental health status at the time of cognitive assessment, said the authors.
 

Recovery ‘at best gradual’

The effects were strongest for those with more severe acute illness, and who required mechanical ventilation, said the authors, who found that acute illness severity was “better at predicting the cognitive deficits.”

The authors pointed out how these deficits were still detectable when patients were followed up 6 months later, and that, although patients’ scores and reaction times began to improve over time, any recovery was “at best gradual” and likely to be influenced by factors such as illness severity and its neurological or psychological impacts.

“We followed some patients up as late as 10 months after their acute infection, so were able to see a very slow improvement,” Dr. Menon said. He explained how, while this improvement was not statistically significant, it was “at least heading in the right direction.”

However, he warned it is very possible that some of these individuals “will never fully recover.”

The cognitive deficits observed may be due to several factors in combination, said the authors, including inadequate oxygen or blood supply to the brain, blockage of large or small blood vessels due to clotting, and microscopic bleeds. They highlighted how the most important mechanism, however, may be “damage caused by the body’s own inflammatory response and immune system.”

Adam Hampshire, PhD, of the department of brain sciences at Imperial College London, one of the study’s authors, described how around 40,000 people have been through intensive care with COVID-19 in England alone, with many more despite having been very sick not admitted to hospital. This means there is a “large number of people out there still experiencing problems with cognition many months later,” he said. “We urgently need to look at what can be done to help these people.”

A version of this article first appeared on Univadis.

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Cognitive impairment from severe COVID-19 is equivalent to 20 years of aging, report scientists behind a new study, adding that the impairment is “equivalent to losing 10 IQ points.”

In their study, published in eClinicalMedicine, a team of scientists from the University of Cambridge and Imperial College London said there is growing evidence that COVID-19 can cause lasting cognitive and mental health problems. Patients report fatigue, “brain fog,” problems recalling words, sleep disturbances, anxiety, and even posttraumatic stress disorder months after infection.

The researchers analyzed data from 46 individuals who received critical care for COVID-19 at Addenbrooke’s Hospital between March and July 2020 (27 females, 19 males, mean age 51 years, 16 of whom had mechanical ventilation) and were recruited to the NIHR COVID-19 BioResource project.

At an average of 6 months after acute COVID-19 illness, the study participants underwent detailed computerized cognitive tests via the Cognitron platform,  comprising eight tasks deployed on an iPad measuring mental function such as memory, attention, and reasoning. Also assessed were anxiety, depression, and posttraumatic stress disorder via standard mood, anxiety, and posttraumatic stress scales – specifically the Generalized Anxiety Disorder 7 (GAD-7), the Patient Health Questionnaire 9 (PHQ-9), and the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). Their data were compared against 460 controls – matched for age, sex, education, and first language – and the pattern of deficits across tasks was qualitatively compared with normal age-related decline and early-stage dementia.
 

Less accurate and slower response times

The authors highlighted how this was the first time a “rigorous assessment and comparison” had been carried out in relation to the after-effects of severe COVID-19.

“Cognitive impairment is common to a wide range of neurological disorders, including dementia, and even routine aging, but the patterns we saw – the cognitive ‘fingerprint’ of COVID-19 – was distinct from all of these,” said David Menon, MD, division of anesthesia at the University of Cambridge, England, and the study’s senior author.

The scientists found that COVID-19 survivors were less accurate and had slower response times than the control population, and added that survivors scored particularly poorly on verbal analogical reasoning and showed slower processing speeds.

Critically, the scale of the cognitive deficits correlated with acute illness severity, but not fatigue or mental health status at the time of cognitive assessment, said the authors.
 

Recovery ‘at best gradual’

The effects were strongest for those with more severe acute illness, and who required mechanical ventilation, said the authors, who found that acute illness severity was “better at predicting the cognitive deficits.”

The authors pointed out how these deficits were still detectable when patients were followed up 6 months later, and that, although patients’ scores and reaction times began to improve over time, any recovery was “at best gradual” and likely to be influenced by factors such as illness severity and its neurological or psychological impacts.

“We followed some patients up as late as 10 months after their acute infection, so were able to see a very slow improvement,” Dr. Menon said. He explained how, while this improvement was not statistically significant, it was “at least heading in the right direction.”

However, he warned it is very possible that some of these individuals “will never fully recover.”

The cognitive deficits observed may be due to several factors in combination, said the authors, including inadequate oxygen or blood supply to the brain, blockage of large or small blood vessels due to clotting, and microscopic bleeds. They highlighted how the most important mechanism, however, may be “damage caused by the body’s own inflammatory response and immune system.”

Adam Hampshire, PhD, of the department of brain sciences at Imperial College London, one of the study’s authors, described how around 40,000 people have been through intensive care with COVID-19 in England alone, with many more despite having been very sick not admitted to hospital. This means there is a “large number of people out there still experiencing problems with cognition many months later,” he said. “We urgently need to look at what can be done to help these people.”

A version of this article first appeared on Univadis.

Cognitive impairment from severe COVID-19 is equivalent to 20 years of aging, report scientists behind a new study, adding that the impairment is “equivalent to losing 10 IQ points.”

In their study, published in eClinicalMedicine, a team of scientists from the University of Cambridge and Imperial College London said there is growing evidence that COVID-19 can cause lasting cognitive and mental health problems. Patients report fatigue, “brain fog,” problems recalling words, sleep disturbances, anxiety, and even posttraumatic stress disorder months after infection.

The researchers analyzed data from 46 individuals who received critical care for COVID-19 at Addenbrooke’s Hospital between March and July 2020 (27 females, 19 males, mean age 51 years, 16 of whom had mechanical ventilation) and were recruited to the NIHR COVID-19 BioResource project.

At an average of 6 months after acute COVID-19 illness, the study participants underwent detailed computerized cognitive tests via the Cognitron platform,  comprising eight tasks deployed on an iPad measuring mental function such as memory, attention, and reasoning. Also assessed were anxiety, depression, and posttraumatic stress disorder via standard mood, anxiety, and posttraumatic stress scales – specifically the Generalized Anxiety Disorder 7 (GAD-7), the Patient Health Questionnaire 9 (PHQ-9), and the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). Their data were compared against 460 controls – matched for age, sex, education, and first language – and the pattern of deficits across tasks was qualitatively compared with normal age-related decline and early-stage dementia.
 

Less accurate and slower response times

The authors highlighted how this was the first time a “rigorous assessment and comparison” had been carried out in relation to the after-effects of severe COVID-19.

“Cognitive impairment is common to a wide range of neurological disorders, including dementia, and even routine aging, but the patterns we saw – the cognitive ‘fingerprint’ of COVID-19 – was distinct from all of these,” said David Menon, MD, division of anesthesia at the University of Cambridge, England, and the study’s senior author.

The scientists found that COVID-19 survivors were less accurate and had slower response times than the control population, and added that survivors scored particularly poorly on verbal analogical reasoning and showed slower processing speeds.

Critically, the scale of the cognitive deficits correlated with acute illness severity, but not fatigue or mental health status at the time of cognitive assessment, said the authors.
 

Recovery ‘at best gradual’

The effects were strongest for those with more severe acute illness, and who required mechanical ventilation, said the authors, who found that acute illness severity was “better at predicting the cognitive deficits.”

The authors pointed out how these deficits were still detectable when patients were followed up 6 months later, and that, although patients’ scores and reaction times began to improve over time, any recovery was “at best gradual” and likely to be influenced by factors such as illness severity and its neurological or psychological impacts.

“We followed some patients up as late as 10 months after their acute infection, so were able to see a very slow improvement,” Dr. Menon said. He explained how, while this improvement was not statistically significant, it was “at least heading in the right direction.”

However, he warned it is very possible that some of these individuals “will never fully recover.”

The cognitive deficits observed may be due to several factors in combination, said the authors, including inadequate oxygen or blood supply to the brain, blockage of large or small blood vessels due to clotting, and microscopic bleeds. They highlighted how the most important mechanism, however, may be “damage caused by the body’s own inflammatory response and immune system.”

Adam Hampshire, PhD, of the department of brain sciences at Imperial College London, one of the study’s authors, described how around 40,000 people have been through intensive care with COVID-19 in England alone, with many more despite having been very sick not admitted to hospital. This means there is a “large number of people out there still experiencing problems with cognition many months later,” he said. “We urgently need to look at what can be done to help these people.”

A version of this article first appeared on Univadis.

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‘Embarrassing’: High-intensity statin uptake in ASCVD patients ‘terrible’

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New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

  • Only one in five patients (22.5%) were taking a high-intensity statin.
  • 27.6% were taking a low- or moderate-intensity statin.
  • One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

Dr. Christopher B. Granger

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.



The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

 

 

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

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New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

  • Only one in five patients (22.5%) were taking a high-intensity statin.
  • 27.6% were taking a low- or moderate-intensity statin.
  • One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

Dr. Christopher B. Granger

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.



The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

 

 

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

New research suggests physicians face a Herculean task to get Americans with atherosclerotic cardiovascular disease (ASCVD) to take high-intensity statins, despite multiple professional guidelines giving the therapy their highest level recommendation.

Results from more 600,000 commercially insured patients with established ASCVD showed:

  • Only one in five patients (22.5%) were taking a high-intensity statin.
  • 27.6% were taking a low- or moderate-intensity statin.
  • One-half (49.9%) were not taking any statin.

“It’s embarrassing,” senior author Christopher B. Granger, MD, Duke Clinical Research Institute, Durham, N.C., told this news organization. “It should be embarrassing for anybody in health care that we do such a terrible job with something so simple and effective.”

Dr. Christopher B. Granger

The results were published in the Journal of the American College of Cardiology.

Statins have been shown to reduce the risk for ASCVD events by about 30%, with an added 15% reduction with a high-intensity formulation. The class I recommendation for high-intensity statin use in ASCVD patients younger than 75 years in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines prompted a jump in prescriptions that plateaued by 2017.

A class II recommendation was added to the 2018 guideline update for high-intensity statins in adults older than 75 years with ASCVD. But underuse persists, despite falling prices with generic availability and initiatives to improve statin adoption, the authors noted.

“There are a lot of barriers for patients to statin use, including the misinformation on the Internet and elsewhere that statins have all kinds of side effects,” Dr. Granger said. “They have uncommon side effects, but when we look at it carefully, only about 10% of patients, even with statin intolerance, have true intolerance.”

Efforts are needed to better understand and address these barriers, particularly for younger and female patients, he noted.

In multivariate analyses, patients who were middle-aged (odds ratio, 2.66) or at least 75 years of age (OR, 2.09) were more than twice as likely as patients younger than 45 years to be on any statin.

Not surprisingly, women were 30% less likely than men to receive a statin (OR, 0.70), Dr. Granger said. A high Charlson comorbidity score (OR, 0.72) and peripheral artery disease (OR, 0.55) also reduced the odds of a statin prescription.

Among statin users, middle-aged (OR, 0.83) and older (OR, 0.44) patients were less likely to be on a high-intensity statin, as were women (OR, 0.68) and patients with peripheral artery disease (OR, 0.43).

Visiting a cardiologist in the previous 12 months, however, increased the odds a patient was on a high-intensity statin (OR, 1.21), as did the use of other LDL-cholesterol-lowering drugs (OR, 1.44).

“With no evidence of heterogeneity in efficacy by sex, ongoing work must not only address misperceptions and barriers to the prescription of high-intensity statins in women, but also further understand (and address) differences in tolerability, which may be related to sex-based variation in statin metabolism,” wrote the authors, led by Adam J. Nelson, MBBS, MBA, MPH, also from Duke.



The study involved 601,934 patients (mean age, 67.5 years) who had a diagnosis of ASCVD between Jan. 31, 2018, and an index date of Jan. 31, 2019, and were enrolled in the HealthCore Integrated Research Environment database.

Two-thirds (70.9%) of patients visited a cardiologist in the 12 months prior to the index date, and three-fourths (81.3%) visited a primary care provider.

Pharmacy claims for the 12 months after the index date showed 82.8% of high-intensity users at index achieved coverage for at least 75% of days. Those with the least adherence (< 50% of days covered) included younger patients, as well as those with chronic kidney disease or depression.

“We need implementation research. What are the tools and the methods that we can use to improve the proportion of patients who are having the life-saving benefits from statins?” Dr. Granger said.

He noted that the team has submitted a National Institutes of Health grant to try to use pharmacists, as a mechanism within the context of health systems and payer systems, to improve the appropriate use of statins in a randomized trial. “I think that’s a win.”

Salim S. Virani, MD, PhD, Baylor College of Medicine, and Michael DeBakey VA Medical Center, Houston, and colleagues point out in a related editorial that the rates of statin usage in the study are “considerably lower” than in other contemporary studies, where about 80% and 50% of ASCVD patients are receiving statins and high-intensity statins, respectively.

Possible explanations are the use of rule-out codes, a short medication fill window from the index date, or issues with medication capture, they said. “Nevertheless, the findings are largely consistent with other work highlighting low use of statin therapy.”

The editorialists said social media, statin-related adverse effects, and therapeutic inertia are key drivers of non–guideline-concordant statin use. Possible solutions include improving guideline dissemination, leveraging team-based care, using smart clinical decision-support tools at the point of care, and identifying trustworthy and easily understood sources of information for patients.

“We can only hope that the fate of statin therapy is not repeated with sodium-glucose cotranspoerter-2 inhibitors or glucagon-like peptide-1 receptor agonists in another 30 years, or worse yet, that continued gaps in statin therapy use in patients with ASCVD persist 30 years from now,” Dr. Virani and colleagues concluded.

 

 

A sliver of optimism?

A research letter by Colantonio et al. in the same issue of JACC points to some positive steps, at least among patients having a myocardial infarction (MI). It reported that the percentage of patients who received a high-intensity statin as their first statin prescription 30 days after MI jumped from 30.7% in the first quarter of 2011 to 78.6% in the fourth quarter of 2019.

Similar increases were reported by race/ethnicity, despite statin use previously shown to be lower among non-Hispanic Black patients with ASCVD. In each calendar year, however, high-intensity statin therapy was lower among patients older than 75 years and among women.

Dr. Granger disclosed ties with Boehringer Ingelheim, Bristol Myers Squibb, Janssen Pharmaceuticals, Pfizer, AKROS, Apple, AstraZeneca, Daiichi Sankyo, Food and Drug Administration, GlaxoSmithKline, Medtronic Foundation, Novartis Pharmaceuticals, AbbVie, Bayer, Boston Scientific, CeleCor Therapeutics, Correvio, Espero BioPharma, Medscape, Medtronic, Merck, National Institutes of Health, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Virani disclosed ties with the Department of Veterans Affairs, the National Institutes of Health, the World Heart Federation, and the Jooma and Tahir Family, and the American College of Cardiology.

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

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When it’s not long, but medium COVID?

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Symptom timelines surrounding COVID infection tend to center on either the immediate 5-day quarantine protocols for acute infection or the long-COVID symptoms that can last a month or potentially far longer.

But some patients report a “middle-range” COVID that will resolve before it becomes long COVID, yet still lasts longer than is typical for viral infections. People may return to work or daily routines, but something is off: What had been simple exercise regimens become onerous. Everyday tasks take more effort.

Does this ill-defined subset point to a “medium COVID?”

Farha Ikramuddin, MD, MHA, a physiatrist and rehabilitation specialist at the University of Minnesota and M Health Fairview in Minneapolis, points out there is no definition or diagnostic code or shared official understanding of a middle category for COVID.

“But am I seeing that? Absolutely,” she said in an interview.

“I have seen patients who are younger, healthier, [and] with not so many comorbidities have either persistence of symptoms or reappearance after the initial infection is done,” she said.

Some patients report they had very low infection or were nonsymptomatic and returned to their normal health fairly quickly after infection. Then a week later they began experiencing fatigue, lost appetite, loss of smell, and feeling full after a few bites, Dr. Ikramuddin said.

Part of the trouble in categorizing the space between returning to normal after a week and having symptoms for months is that organizations can’t agree on a timeline for when symptoms warrant a “long-COVID” label.

For instance, the Centers for Disease Control and Prevention defines it as 4 or more weeks after infection. The World Health Organization defines it as starting 3 months after COVID-19 symptom onset.

“I’m seeing ‘medium COVID’ – as one would call it – in younger and healthier patients. I’m also noticing that these symptoms are not severe enough to warrant stopping their job or changing their job schedules,” Dr. Ikramuddin said.

They go back to work, she said, but start noticing something is off.

“I am seeing that.”

“I discharge at least two patients a week from my clinic because they have moved on and no longer have symptoms,” Dr. Ikramuddin said.

In a story from Kaiser Health News published last month, WHYY health reporter Nina Feldman writes: “What I’ve come to think of as my ‘medium COVID’ affected my life. I couldn’t socialize much, drink, or stay up past 9:30 p.m. It took me 10 weeks to go for my first run – I’d been too afraid to try.”

She described a dinner with a friend after ending initial isolation protocols: “One glass of wine left me feeling like I’d had a whole bottle. I was bone-achingly exhausted but couldn’t sleep.”
 

Medical mystery

Dr. Ikramuddin notes the mechanism behind prolonged COVID-19 symptoms is still a medical mystery.

“In one scenario,” she said, “the question is being asked about whether the virus is staying dormant, similar to herpes zoster or HIV.”

“Right now, instead of getting more answers, we’re getting more questions,” Dr. Ikramuddin  said.

Mouhib Naddour, MD, a pulmonary specialist with Sharp HealthCare in San Diego, said he’s seeing that it’s taking some patients who have had COVID longer to recover than it would for other viral infections.

Some patients fall between those recovering within 2-3 weeks and patients having long COVID. Those patients in the gap could be lumped into a middle-range COVID, he told this news organization.

“We try to put things into tables and boxes but it is hard with this disease,” Dr. Naddour said.

He agrees there’s no medical definition for “medium” COVID, but he said the idea should bring hope for patients to know that, if their symptoms are persisting they don’t necessarily have long COVID – and their symptoms may still disappear.

“This is an illness that may take longer to completely recover from,” he said. “The majority of patients we’re seeing in this group could be healthy young patients who get COVID, then 2-3 weeks after they test negative, still have lingering symptoms.”
 

 

 

Common symptoms

Some commonly reported symptoms of those with enduring illness, which often overlap with other stages of COVID, are difficulty breathing, chest tightness, dry cough, chest pain, muscle and joint pain, fatigue, difficulty sleeping, and mood swings, Dr. Naddour said. 

“We need to do an extensive assessment to make sure there’s no other problem causing these symptoms,” he said.

Still, there is no set timeline for the medium-COVID range, he noted, so checking in with a primary care physician is important for people experiencing symptoms.
 

It’s a continuum, not a category

Fernando Carnavali, MD, coordinator for Mount Sinai’s Center for Post-COVID Care in New York, said he is not ready to recognize a separate category for a “medium” COVID.

He noted that science can’t even agree on a name for lasting post-COVID symptoms, whether it’s “long COVID” or “long-haul COVID,” “post-COVID syndrome” or “post-acute sequelae of COVID-19 (PASC ).” There’s no agreed-upon pathophysiology or biomarker.

“That creates these gaps of understanding on where we are,” Dr. Carnavali said in an interview.

He said he understands people’s need to categorize symptoms, but rather than a middle ground he sees a continuum.

It doesn’t mean what others may call COVID’s middle ground doesn’t exist, Dr. Carnavali said: “We are in the infancy of defining this. Trying to classify them may create more anxiety.”

The clinicians interviewed for this story report no relevant financial relationships.

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

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Symptom timelines surrounding COVID infection tend to center on either the immediate 5-day quarantine protocols for acute infection or the long-COVID symptoms that can last a month or potentially far longer.

But some patients report a “middle-range” COVID that will resolve before it becomes long COVID, yet still lasts longer than is typical for viral infections. People may return to work or daily routines, but something is off: What had been simple exercise regimens become onerous. Everyday tasks take more effort.

Does this ill-defined subset point to a “medium COVID?”

Farha Ikramuddin, MD, MHA, a physiatrist and rehabilitation specialist at the University of Minnesota and M Health Fairview in Minneapolis, points out there is no definition or diagnostic code or shared official understanding of a middle category for COVID.

“But am I seeing that? Absolutely,” she said in an interview.

“I have seen patients who are younger, healthier, [and] with not so many comorbidities have either persistence of symptoms or reappearance after the initial infection is done,” she said.

Some patients report they had very low infection or were nonsymptomatic and returned to their normal health fairly quickly after infection. Then a week later they began experiencing fatigue, lost appetite, loss of smell, and feeling full after a few bites, Dr. Ikramuddin said.

Part of the trouble in categorizing the space between returning to normal after a week and having symptoms for months is that organizations can’t agree on a timeline for when symptoms warrant a “long-COVID” label.

For instance, the Centers for Disease Control and Prevention defines it as 4 or more weeks after infection. The World Health Organization defines it as starting 3 months after COVID-19 symptom onset.

“I’m seeing ‘medium COVID’ – as one would call it – in younger and healthier patients. I’m also noticing that these symptoms are not severe enough to warrant stopping their job or changing their job schedules,” Dr. Ikramuddin said.

They go back to work, she said, but start noticing something is off.

“I am seeing that.”

“I discharge at least two patients a week from my clinic because they have moved on and no longer have symptoms,” Dr. Ikramuddin said.

In a story from Kaiser Health News published last month, WHYY health reporter Nina Feldman writes: “What I’ve come to think of as my ‘medium COVID’ affected my life. I couldn’t socialize much, drink, or stay up past 9:30 p.m. It took me 10 weeks to go for my first run – I’d been too afraid to try.”

She described a dinner with a friend after ending initial isolation protocols: “One glass of wine left me feeling like I’d had a whole bottle. I was bone-achingly exhausted but couldn’t sleep.”
 

Medical mystery

Dr. Ikramuddin notes the mechanism behind prolonged COVID-19 symptoms is still a medical mystery.

“In one scenario,” she said, “the question is being asked about whether the virus is staying dormant, similar to herpes zoster or HIV.”

“Right now, instead of getting more answers, we’re getting more questions,” Dr. Ikramuddin  said.

Mouhib Naddour, MD, a pulmonary specialist with Sharp HealthCare in San Diego, said he’s seeing that it’s taking some patients who have had COVID longer to recover than it would for other viral infections.

Some patients fall between those recovering within 2-3 weeks and patients having long COVID. Those patients in the gap could be lumped into a middle-range COVID, he told this news organization.

“We try to put things into tables and boxes but it is hard with this disease,” Dr. Naddour said.

He agrees there’s no medical definition for “medium” COVID, but he said the idea should bring hope for patients to know that, if their symptoms are persisting they don’t necessarily have long COVID – and their symptoms may still disappear.

“This is an illness that may take longer to completely recover from,” he said. “The majority of patients we’re seeing in this group could be healthy young patients who get COVID, then 2-3 weeks after they test negative, still have lingering symptoms.”
 

 

 

Common symptoms

Some commonly reported symptoms of those with enduring illness, which often overlap with other stages of COVID, are difficulty breathing, chest tightness, dry cough, chest pain, muscle and joint pain, fatigue, difficulty sleeping, and mood swings, Dr. Naddour said. 

“We need to do an extensive assessment to make sure there’s no other problem causing these symptoms,” he said.

Still, there is no set timeline for the medium-COVID range, he noted, so checking in with a primary care physician is important for people experiencing symptoms.
 

It’s a continuum, not a category

Fernando Carnavali, MD, coordinator for Mount Sinai’s Center for Post-COVID Care in New York, said he is not ready to recognize a separate category for a “medium” COVID.

He noted that science can’t even agree on a name for lasting post-COVID symptoms, whether it’s “long COVID” or “long-haul COVID,” “post-COVID syndrome” or “post-acute sequelae of COVID-19 (PASC ).” There’s no agreed-upon pathophysiology or biomarker.

“That creates these gaps of understanding on where we are,” Dr. Carnavali said in an interview.

He said he understands people’s need to categorize symptoms, but rather than a middle ground he sees a continuum.

It doesn’t mean what others may call COVID’s middle ground doesn’t exist, Dr. Carnavali said: “We are in the infancy of defining this. Trying to classify them may create more anxiety.”

The clinicians interviewed for this story report no relevant financial relationships.

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

Symptom timelines surrounding COVID infection tend to center on either the immediate 5-day quarantine protocols for acute infection or the long-COVID symptoms that can last a month or potentially far longer.

But some patients report a “middle-range” COVID that will resolve before it becomes long COVID, yet still lasts longer than is typical for viral infections. People may return to work or daily routines, but something is off: What had been simple exercise regimens become onerous. Everyday tasks take more effort.

Does this ill-defined subset point to a “medium COVID?”

Farha Ikramuddin, MD, MHA, a physiatrist and rehabilitation specialist at the University of Minnesota and M Health Fairview in Minneapolis, points out there is no definition or diagnostic code or shared official understanding of a middle category for COVID.

“But am I seeing that? Absolutely,” she said in an interview.

“I have seen patients who are younger, healthier, [and] with not so many comorbidities have either persistence of symptoms or reappearance after the initial infection is done,” she said.

Some patients report they had very low infection or were nonsymptomatic and returned to their normal health fairly quickly after infection. Then a week later they began experiencing fatigue, lost appetite, loss of smell, and feeling full after a few bites, Dr. Ikramuddin said.

Part of the trouble in categorizing the space between returning to normal after a week and having symptoms for months is that organizations can’t agree on a timeline for when symptoms warrant a “long-COVID” label.

For instance, the Centers for Disease Control and Prevention defines it as 4 or more weeks after infection. The World Health Organization defines it as starting 3 months after COVID-19 symptom onset.

“I’m seeing ‘medium COVID’ – as one would call it – in younger and healthier patients. I’m also noticing that these symptoms are not severe enough to warrant stopping their job or changing their job schedules,” Dr. Ikramuddin said.

They go back to work, she said, but start noticing something is off.

“I am seeing that.”

“I discharge at least two patients a week from my clinic because they have moved on and no longer have symptoms,” Dr. Ikramuddin said.

In a story from Kaiser Health News published last month, WHYY health reporter Nina Feldman writes: “What I’ve come to think of as my ‘medium COVID’ affected my life. I couldn’t socialize much, drink, or stay up past 9:30 p.m. It took me 10 weeks to go for my first run – I’d been too afraid to try.”

She described a dinner with a friend after ending initial isolation protocols: “One glass of wine left me feeling like I’d had a whole bottle. I was bone-achingly exhausted but couldn’t sleep.”
 

Medical mystery

Dr. Ikramuddin notes the mechanism behind prolonged COVID-19 symptoms is still a medical mystery.

“In one scenario,” she said, “the question is being asked about whether the virus is staying dormant, similar to herpes zoster or HIV.”

“Right now, instead of getting more answers, we’re getting more questions,” Dr. Ikramuddin  said.

Mouhib Naddour, MD, a pulmonary specialist with Sharp HealthCare in San Diego, said he’s seeing that it’s taking some patients who have had COVID longer to recover than it would for other viral infections.

Some patients fall between those recovering within 2-3 weeks and patients having long COVID. Those patients in the gap could be lumped into a middle-range COVID, he told this news organization.

“We try to put things into tables and boxes but it is hard with this disease,” Dr. Naddour said.

He agrees there’s no medical definition for “medium” COVID, but he said the idea should bring hope for patients to know that, if their symptoms are persisting they don’t necessarily have long COVID – and their symptoms may still disappear.

“This is an illness that may take longer to completely recover from,” he said. “The majority of patients we’re seeing in this group could be healthy young patients who get COVID, then 2-3 weeks after they test negative, still have lingering symptoms.”
 

 

 

Common symptoms

Some commonly reported symptoms of those with enduring illness, which often overlap with other stages of COVID, are difficulty breathing, chest tightness, dry cough, chest pain, muscle and joint pain, fatigue, difficulty sleeping, and mood swings, Dr. Naddour said. 

“We need to do an extensive assessment to make sure there’s no other problem causing these symptoms,” he said.

Still, there is no set timeline for the medium-COVID range, he noted, so checking in with a primary care physician is important for people experiencing symptoms.
 

It’s a continuum, not a category

Fernando Carnavali, MD, coordinator for Mount Sinai’s Center for Post-COVID Care in New York, said he is not ready to recognize a separate category for a “medium” COVID.

He noted that science can’t even agree on a name for lasting post-COVID symptoms, whether it’s “long COVID” or “long-haul COVID,” “post-COVID syndrome” or “post-acute sequelae of COVID-19 (PASC ).” There’s no agreed-upon pathophysiology or biomarker.

“That creates these gaps of understanding on where we are,” Dr. Carnavali said in an interview.

He said he understands people’s need to categorize symptoms, but rather than a middle ground he sees a continuum.

It doesn’t mean what others may call COVID’s middle ground doesn’t exist, Dr. Carnavali said: “We are in the infancy of defining this. Trying to classify them may create more anxiety.”

The clinicians interviewed for this story report no relevant financial relationships.

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

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New data confirm risk of Guillain-Barré with J&J COVID shot

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New surveillance data from the Vaccine Adverse Event Reporting System (VAERS) confirm a small but statistically significant increased risk for Guillain-Barré syndrome (GBS) in the 3 weeks after receipt of the Janssen/Johnson & Johnson COVID-19 vaccine.

The Janssen vaccine (Ad26.COV2.S) is a replication-incompetent adenoviral vector vaccine.

The data show no increased risk of GBS with the Pfizer (BNT162b2) or Moderna (mRNA-1273) shots – both mRNA vaccines.

“Our findings support the current guidance from U.S. health officials that preferentially recommend use of mRNA COVID-19 vaccines for primary and booster doses,” Nicola Klein, MD, PhD, with Kaiser Permanente Vaccine Study Center, Oakland, Calif., told this news organization.

“Individuals who choose to receive Janssen/J&J COVID-19 vaccine should be informed of the potential safety risks, including GBS,” Dr. Klein said.

The study was published online in JAMA Network Open.
 

Eleven cases

Between mid-December 2020 and mid-November 2021, roughly 15.1 million doses of COVID-19 vaccine were administered to nearly 7.9 million adults in the United States.

This includes roughly 483,000 doses of the Janssen vaccine, 8.8 million doses of the Pfizer vaccine, and 5.8 million doses of the Moderna vaccine.

The researchers confirmed 11 cases of GBS after the Janssen vaccine.

The unadjusted incidence of GBS (per 100,000 person-years) was 32.4 in the first 21 days after the Janssen vaccine – substantially higher than the expected background rate of 1 to 2 cases per 100,000 person-years.

There were 36 confirmed cases of GBS after mRNA vaccines. The unadjusted incidence in the first 21 days after mRNA vaccination was 1.3 per 100,000 person-years, similar to the overall expected background rate.

In an adjusted head-to-head comparison, GBS incidence during the 21 days after receipt of the Janssen vaccine was 20.6 times higher than the GBS incidence during the 21 days after the Pfizer or Moderna mRNA vaccines, amounting to 15.5 excess cases per million Janssen vaccine recipients.

Most cases of GBS after the Janssen vaccine occurred during the 1- to 21-day risk interval, with the period of greatest risk in the 1-14 days after vaccination.

The findings of this analysis of surveillance data of COVID-19 vaccines are “consistent with an elevated risk of GBS after primary Ad26.COV2.S vaccination,” the authors wrote.
 

Novel presentation?

The researchers note that nearly all individuals who developed GBS after the Janssen vaccine had facial weakness or paralysis, in addition to weakness and decreased reflexes in the limbs, suggesting that the presentation of GBS after COVID-19 adenoviral vector vaccine may be novel.

“More research is needed to determine if the presentation of GBS after adenoviral vector vaccine differs from GBS after other exposures such as Campylobacter jejuni, and to investigate the mechanism for how adenoviral vector vaccines may cause GBS,” Dr. Klein and colleagues said.

“The Vaccine Safety Datalink continues to conduct safety surveillance for all COVID-19 vaccines, including monitoring for GBS and other serious health outcomes after vaccination,” Dr. Klein said in an interview.

This study was supported by the Centers for Disease Control and Prevention. Dr. Klein reported receiving grants from Pfizer research support for a COVID vaccine clinical trial as well as other unrelated studies, grants from Merck, grants from GlaxoSmithKline, grants from Sanofi Pasteur, and grants from Protein Science (now Sanofi Pasteur) outside the submitted work.

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

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New surveillance data from the Vaccine Adverse Event Reporting System (VAERS) confirm a small but statistically significant increased risk for Guillain-Barré syndrome (GBS) in the 3 weeks after receipt of the Janssen/Johnson & Johnson COVID-19 vaccine.

The Janssen vaccine (Ad26.COV2.S) is a replication-incompetent adenoviral vector vaccine.

The data show no increased risk of GBS with the Pfizer (BNT162b2) or Moderna (mRNA-1273) shots – both mRNA vaccines.

“Our findings support the current guidance from U.S. health officials that preferentially recommend use of mRNA COVID-19 vaccines for primary and booster doses,” Nicola Klein, MD, PhD, with Kaiser Permanente Vaccine Study Center, Oakland, Calif., told this news organization.

“Individuals who choose to receive Janssen/J&J COVID-19 vaccine should be informed of the potential safety risks, including GBS,” Dr. Klein said.

The study was published online in JAMA Network Open.
 

Eleven cases

Between mid-December 2020 and mid-November 2021, roughly 15.1 million doses of COVID-19 vaccine were administered to nearly 7.9 million adults in the United States.

This includes roughly 483,000 doses of the Janssen vaccine, 8.8 million doses of the Pfizer vaccine, and 5.8 million doses of the Moderna vaccine.

The researchers confirmed 11 cases of GBS after the Janssen vaccine.

The unadjusted incidence of GBS (per 100,000 person-years) was 32.4 in the first 21 days after the Janssen vaccine – substantially higher than the expected background rate of 1 to 2 cases per 100,000 person-years.

There were 36 confirmed cases of GBS after mRNA vaccines. The unadjusted incidence in the first 21 days after mRNA vaccination was 1.3 per 100,000 person-years, similar to the overall expected background rate.

In an adjusted head-to-head comparison, GBS incidence during the 21 days after receipt of the Janssen vaccine was 20.6 times higher than the GBS incidence during the 21 days after the Pfizer or Moderna mRNA vaccines, amounting to 15.5 excess cases per million Janssen vaccine recipients.

Most cases of GBS after the Janssen vaccine occurred during the 1- to 21-day risk interval, with the period of greatest risk in the 1-14 days after vaccination.

The findings of this analysis of surveillance data of COVID-19 vaccines are “consistent with an elevated risk of GBS after primary Ad26.COV2.S vaccination,” the authors wrote.
 

Novel presentation?

The researchers note that nearly all individuals who developed GBS after the Janssen vaccine had facial weakness or paralysis, in addition to weakness and decreased reflexes in the limbs, suggesting that the presentation of GBS after COVID-19 adenoviral vector vaccine may be novel.

“More research is needed to determine if the presentation of GBS after adenoviral vector vaccine differs from GBS after other exposures such as Campylobacter jejuni, and to investigate the mechanism for how adenoviral vector vaccines may cause GBS,” Dr. Klein and colleagues said.

“The Vaccine Safety Datalink continues to conduct safety surveillance for all COVID-19 vaccines, including monitoring for GBS and other serious health outcomes after vaccination,” Dr. Klein said in an interview.

This study was supported by the Centers for Disease Control and Prevention. Dr. Klein reported receiving grants from Pfizer research support for a COVID vaccine clinical trial as well as other unrelated studies, grants from Merck, grants from GlaxoSmithKline, grants from Sanofi Pasteur, and grants from Protein Science (now Sanofi Pasteur) outside the submitted work.

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

New surveillance data from the Vaccine Adverse Event Reporting System (VAERS) confirm a small but statistically significant increased risk for Guillain-Barré syndrome (GBS) in the 3 weeks after receipt of the Janssen/Johnson & Johnson COVID-19 vaccine.

The Janssen vaccine (Ad26.COV2.S) is a replication-incompetent adenoviral vector vaccine.

The data show no increased risk of GBS with the Pfizer (BNT162b2) or Moderna (mRNA-1273) shots – both mRNA vaccines.

“Our findings support the current guidance from U.S. health officials that preferentially recommend use of mRNA COVID-19 vaccines for primary and booster doses,” Nicola Klein, MD, PhD, with Kaiser Permanente Vaccine Study Center, Oakland, Calif., told this news organization.

“Individuals who choose to receive Janssen/J&J COVID-19 vaccine should be informed of the potential safety risks, including GBS,” Dr. Klein said.

The study was published online in JAMA Network Open.
 

Eleven cases

Between mid-December 2020 and mid-November 2021, roughly 15.1 million doses of COVID-19 vaccine were administered to nearly 7.9 million adults in the United States.

This includes roughly 483,000 doses of the Janssen vaccine, 8.8 million doses of the Pfizer vaccine, and 5.8 million doses of the Moderna vaccine.

The researchers confirmed 11 cases of GBS after the Janssen vaccine.

The unadjusted incidence of GBS (per 100,000 person-years) was 32.4 in the first 21 days after the Janssen vaccine – substantially higher than the expected background rate of 1 to 2 cases per 100,000 person-years.

There were 36 confirmed cases of GBS after mRNA vaccines. The unadjusted incidence in the first 21 days after mRNA vaccination was 1.3 per 100,000 person-years, similar to the overall expected background rate.

In an adjusted head-to-head comparison, GBS incidence during the 21 days after receipt of the Janssen vaccine was 20.6 times higher than the GBS incidence during the 21 days after the Pfizer or Moderna mRNA vaccines, amounting to 15.5 excess cases per million Janssen vaccine recipients.

Most cases of GBS after the Janssen vaccine occurred during the 1- to 21-day risk interval, with the period of greatest risk in the 1-14 days after vaccination.

The findings of this analysis of surveillance data of COVID-19 vaccines are “consistent with an elevated risk of GBS after primary Ad26.COV2.S vaccination,” the authors wrote.
 

Novel presentation?

The researchers note that nearly all individuals who developed GBS after the Janssen vaccine had facial weakness or paralysis, in addition to weakness and decreased reflexes in the limbs, suggesting that the presentation of GBS after COVID-19 adenoviral vector vaccine may be novel.

“More research is needed to determine if the presentation of GBS after adenoviral vector vaccine differs from GBS after other exposures such as Campylobacter jejuni, and to investigate the mechanism for how adenoviral vector vaccines may cause GBS,” Dr. Klein and colleagues said.

“The Vaccine Safety Datalink continues to conduct safety surveillance for all COVID-19 vaccines, including monitoring for GBS and other serious health outcomes after vaccination,” Dr. Klein said in an interview.

This study was supported by the Centers for Disease Control and Prevention. Dr. Klein reported receiving grants from Pfizer research support for a COVID vaccine clinical trial as well as other unrelated studies, grants from Merck, grants from GlaxoSmithKline, grants from Sanofi Pasteur, and grants from Protein Science (now Sanofi Pasteur) outside the submitted work.

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

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FROM JAMA NETWORK OPEN

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Publish date: May 3, 2022
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Cutting dementia risk in AFib: Does rhythm control strategy matter?

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The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

Dr. David Conen


The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin-system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler discloses consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

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The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

Dr. David Conen


The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin-system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler discloses consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

Dr. David Conen


The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of stroke, myocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin-system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler discloses consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

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Children and COVID: New cases up for third straight week

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The latest upward trend in new COVID-19 cases among children picked up steam, but there was also some movement in the vaccination effort in the past week.

Moderna submitted a request to the Food and Drug administration for emergency use authorization of its COVID-19 vaccine in children under the age of 6 years, according to this news organization, and Pfizer/BioNTech officially applied for authorization of a booster dose in children aged 5-11, the companies announced.

The FDA has tentatively scheduled meetings of its Vaccines and Related Biological Products Advisory Committee in June to consider the applications, saying that it “understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly” to convene the necessary meetings.

The need for greater access to vaccines seems to be increasing, as new pediatric COVID cases rose for the third consecutive week. April 22-28 saw over 53,000 new cases reported in children, up 43.5% from the previous week and up 105% since cases started rising again after dipping under 26,000 during the week of April 1-7, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Hospital admissions involving diagnosed COVID also ticked up over the latter half of April, although the most recent 7-day average (April 24-30) of 112 per day was lower than the 117 reported for the previous week (April 17-23), the Centers for Disease Control and Prevention said, also noting that figures for the latest week “should be interpreted with caution.”

Vaccinations also were up slightly in children aged 5-11 years, with 52,000 receiving their first dose during the week of April 21-27, compared with 48,000 the week before. There was a slight dip, however, among 12- to 17-year-olds, who received 34,000 first doses during April 21-27, versus 35,000 the previous week, the AAP said in a separate report.

Cumulatively, almost 69% of all children aged 12-17 years have received at least one dose of the COVID-19 vaccine and 59% are fully vaccinated. Those aged 5-11 are well short of those figures, with just over 35% having received at least one dose and 28.5% fully vaccinated, the CDC said on its COVID Data Tracker.

A look at recent activity shows that children are not gaining on adults, who are much more likely to be vaccinated – full vaccination in those aged 50-64, for example, is 80%. During the 2 weeks from April 17-30, the 5- to 11-year-olds represented 10.5% of those who had initiated a first dose and 12.4% of those who gained full-vaccination status, both of which were well below the oldest age groups, the CDC reported.

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The latest upward trend in new COVID-19 cases among children picked up steam, but there was also some movement in the vaccination effort in the past week.

Moderna submitted a request to the Food and Drug administration for emergency use authorization of its COVID-19 vaccine in children under the age of 6 years, according to this news organization, and Pfizer/BioNTech officially applied for authorization of a booster dose in children aged 5-11, the companies announced.

The FDA has tentatively scheduled meetings of its Vaccines and Related Biological Products Advisory Committee in June to consider the applications, saying that it “understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly” to convene the necessary meetings.

The need for greater access to vaccines seems to be increasing, as new pediatric COVID cases rose for the third consecutive week. April 22-28 saw over 53,000 new cases reported in children, up 43.5% from the previous week and up 105% since cases started rising again after dipping under 26,000 during the week of April 1-7, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Hospital admissions involving diagnosed COVID also ticked up over the latter half of April, although the most recent 7-day average (April 24-30) of 112 per day was lower than the 117 reported for the previous week (April 17-23), the Centers for Disease Control and Prevention said, also noting that figures for the latest week “should be interpreted with caution.”

Vaccinations also were up slightly in children aged 5-11 years, with 52,000 receiving their first dose during the week of April 21-27, compared with 48,000 the week before. There was a slight dip, however, among 12- to 17-year-olds, who received 34,000 first doses during April 21-27, versus 35,000 the previous week, the AAP said in a separate report.

Cumulatively, almost 69% of all children aged 12-17 years have received at least one dose of the COVID-19 vaccine and 59% are fully vaccinated. Those aged 5-11 are well short of those figures, with just over 35% having received at least one dose and 28.5% fully vaccinated, the CDC said on its COVID Data Tracker.

A look at recent activity shows that children are not gaining on adults, who are much more likely to be vaccinated – full vaccination in those aged 50-64, for example, is 80%. During the 2 weeks from April 17-30, the 5- to 11-year-olds represented 10.5% of those who had initiated a first dose and 12.4% of those who gained full-vaccination status, both of which were well below the oldest age groups, the CDC reported.

The latest upward trend in new COVID-19 cases among children picked up steam, but there was also some movement in the vaccination effort in the past week.

Moderna submitted a request to the Food and Drug administration for emergency use authorization of its COVID-19 vaccine in children under the age of 6 years, according to this news organization, and Pfizer/BioNTech officially applied for authorization of a booster dose in children aged 5-11, the companies announced.

The FDA has tentatively scheduled meetings of its Vaccines and Related Biological Products Advisory Committee in June to consider the applications, saying that it “understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly” to convene the necessary meetings.

The need for greater access to vaccines seems to be increasing, as new pediatric COVID cases rose for the third consecutive week. April 22-28 saw over 53,000 new cases reported in children, up 43.5% from the previous week and up 105% since cases started rising again after dipping under 26,000 during the week of April 1-7, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Hospital admissions involving diagnosed COVID also ticked up over the latter half of April, although the most recent 7-day average (April 24-30) of 112 per day was lower than the 117 reported for the previous week (April 17-23), the Centers for Disease Control and Prevention said, also noting that figures for the latest week “should be interpreted with caution.”

Vaccinations also were up slightly in children aged 5-11 years, with 52,000 receiving their first dose during the week of April 21-27, compared with 48,000 the week before. There was a slight dip, however, among 12- to 17-year-olds, who received 34,000 first doses during April 21-27, versus 35,000 the previous week, the AAP said in a separate report.

Cumulatively, almost 69% of all children aged 12-17 years have received at least one dose of the COVID-19 vaccine and 59% are fully vaccinated. Those aged 5-11 are well short of those figures, with just over 35% having received at least one dose and 28.5% fully vaccinated, the CDC said on its COVID Data Tracker.

A look at recent activity shows that children are not gaining on adults, who are much more likely to be vaccinated – full vaccination in those aged 50-64, for example, is 80%. During the 2 weeks from April 17-30, the 5- to 11-year-olds represented 10.5% of those who had initiated a first dose and 12.4% of those who gained full-vaccination status, both of which were well below the oldest age groups, the CDC reported.

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Unexplained hepatitis cases in children reported in 10 U.S. states, more than 200 worldwide

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Health officials are investigating at least 30 cases of severe hepatitis in children across 10 U.S. states. The Minnesota Department of Health received two reports of severe hepatitis, one in an infant and another in a 2-year-old, the Associated Press reported on April 30. One child was treated “several months ago” and required a liver transplant, according to the article. 

Worldwide cases surpass 200, including 34 cases in the United Kingdom, the U.K. Health Security Agency announced on April 29. Most cases have occurred in the United Kingdom, but there have been more than 55 probable and confirmed hepatitis cases in children in 12 countries in the European Union or the European Economic Area. Cases have also been identified in Asia, with both Japan and Singapore reporting one case each of acute hepatitis, Bloomberg reported. Additionally, three children in Indonesia died from acute hepatitis in April, but the total number of cases in that country was not available.

Although the total number of worldwide cases remains small, the severity of the cases – as well as their unexplained cause – have health officials on alert, said David Lee Thomas, MD, MPH, of the Viral Hepatitis Center at Johns Hopkins Medicine in Baltimore. “There are some kids who would have died if not for liver transplants.”

In the United States, the only confirmed cases are in Alabama, where nine patients were admitted for severe hepatitis between October 2021 and February 2022. Beyond the two suspected cases in Minnesota, health officials are investigating at least 19 other potential cases in eight states, according to NBC News: Delaware (1), Georgia, Illinois (3), Louisiana (1), New York, North Carolina (2), Tennessee (6), and Wisconsin (4). (New York and Georgia did not specify the number of cases being investigated.)

Reported cases have occurred in patients aged between 1 month and 16 years old. Globally, at least 17 patients have needed liver transplants, according to a World Health Organization alert on April 23. While WHO officials said there has been at least one death globally linked to hepatitis, that does not include the three deaths in Indonesia. One death has also been reported in Wisconsin, but the state’s Department of Health Services did not confirm whether this death was included in the WHO announcement.

The cause of these severe hepatitis cases has yet to be identified, but these cases have tested negative for more common viruses that can cause hepatitis in children. There is no link between these cases and COVID-19 vaccination, according to WHO, because most affected children have not been vaccinated.

Adenovirus is a possible contributing factor in these cases, as many of the cases in Europe tested positive for the virus. In an analysis of the nine Alabama cases released by the Centers for Disease Control and Prevention, adenovirus was detected in the blood samples of all nine children. Five of the nine children tested positive for adenovirus type 41, which is a common cause of acute gastroenteritis in children. While the six liver biopsies performed showed varying degrees of hepatitis, there were “no viral inclusions observed, no immunohistochemical evidence of adenovirus, or no viral particles identified by electron microscopy,” according to the report. None of the children tested positive for COVID-19 or had a documented history of previous COVID-19 infection.

“At this time, we believe that adenovirus may be the cause for these reported cases, but other potential environmental and situational factors are still being investigated,” the CDC said in a media statement. The CDC added that the report was specific to the nine Alabama cases, and that the agency is working to investigate other potential cases with state and local public health officials.

While the “growing consensus” among experts is that adenovirus could be behind these severe cases, there are many unanswered questions, Dr. Thomas added, such as why this strain of adenovirus causes such severe hepatitis, and why the liver biopsies do not show classic signs of viral infection. That information will come as investigations continue.

“From a provider point of view, if you have a child with an unexplained liver problem, report it to the CDC,” he advised. “Right now, we have to learn more about [these cases],” and that requires more research like the investigations in Alabama, he noted.

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

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Health officials are investigating at least 30 cases of severe hepatitis in children across 10 U.S. states. The Minnesota Department of Health received two reports of severe hepatitis, one in an infant and another in a 2-year-old, the Associated Press reported on April 30. One child was treated “several months ago” and required a liver transplant, according to the article. 

Worldwide cases surpass 200, including 34 cases in the United Kingdom, the U.K. Health Security Agency announced on April 29. Most cases have occurred in the United Kingdom, but there have been more than 55 probable and confirmed hepatitis cases in children in 12 countries in the European Union or the European Economic Area. Cases have also been identified in Asia, with both Japan and Singapore reporting one case each of acute hepatitis, Bloomberg reported. Additionally, three children in Indonesia died from acute hepatitis in April, but the total number of cases in that country was not available.

Although the total number of worldwide cases remains small, the severity of the cases – as well as their unexplained cause – have health officials on alert, said David Lee Thomas, MD, MPH, of the Viral Hepatitis Center at Johns Hopkins Medicine in Baltimore. “There are some kids who would have died if not for liver transplants.”

In the United States, the only confirmed cases are in Alabama, where nine patients were admitted for severe hepatitis between October 2021 and February 2022. Beyond the two suspected cases in Minnesota, health officials are investigating at least 19 other potential cases in eight states, according to NBC News: Delaware (1), Georgia, Illinois (3), Louisiana (1), New York, North Carolina (2), Tennessee (6), and Wisconsin (4). (New York and Georgia did not specify the number of cases being investigated.)

Reported cases have occurred in patients aged between 1 month and 16 years old. Globally, at least 17 patients have needed liver transplants, according to a World Health Organization alert on April 23. While WHO officials said there has been at least one death globally linked to hepatitis, that does not include the three deaths in Indonesia. One death has also been reported in Wisconsin, but the state’s Department of Health Services did not confirm whether this death was included in the WHO announcement.

The cause of these severe hepatitis cases has yet to be identified, but these cases have tested negative for more common viruses that can cause hepatitis in children. There is no link between these cases and COVID-19 vaccination, according to WHO, because most affected children have not been vaccinated.

Adenovirus is a possible contributing factor in these cases, as many of the cases in Europe tested positive for the virus. In an analysis of the nine Alabama cases released by the Centers for Disease Control and Prevention, adenovirus was detected in the blood samples of all nine children. Five of the nine children tested positive for adenovirus type 41, which is a common cause of acute gastroenteritis in children. While the six liver biopsies performed showed varying degrees of hepatitis, there were “no viral inclusions observed, no immunohistochemical evidence of adenovirus, or no viral particles identified by electron microscopy,” according to the report. None of the children tested positive for COVID-19 or had a documented history of previous COVID-19 infection.

“At this time, we believe that adenovirus may be the cause for these reported cases, but other potential environmental and situational factors are still being investigated,” the CDC said in a media statement. The CDC added that the report was specific to the nine Alabama cases, and that the agency is working to investigate other potential cases with state and local public health officials.

While the “growing consensus” among experts is that adenovirus could be behind these severe cases, there are many unanswered questions, Dr. Thomas added, such as why this strain of adenovirus causes such severe hepatitis, and why the liver biopsies do not show classic signs of viral infection. That information will come as investigations continue.

“From a provider point of view, if you have a child with an unexplained liver problem, report it to the CDC,” he advised. “Right now, we have to learn more about [these cases],” and that requires more research like the investigations in Alabama, he noted.

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

Health officials are investigating at least 30 cases of severe hepatitis in children across 10 U.S. states. The Minnesota Department of Health received two reports of severe hepatitis, one in an infant and another in a 2-year-old, the Associated Press reported on April 30. One child was treated “several months ago” and required a liver transplant, according to the article. 

Worldwide cases surpass 200, including 34 cases in the United Kingdom, the U.K. Health Security Agency announced on April 29. Most cases have occurred in the United Kingdom, but there have been more than 55 probable and confirmed hepatitis cases in children in 12 countries in the European Union or the European Economic Area. Cases have also been identified in Asia, with both Japan and Singapore reporting one case each of acute hepatitis, Bloomberg reported. Additionally, three children in Indonesia died from acute hepatitis in April, but the total number of cases in that country was not available.

Although the total number of worldwide cases remains small, the severity of the cases – as well as their unexplained cause – have health officials on alert, said David Lee Thomas, MD, MPH, of the Viral Hepatitis Center at Johns Hopkins Medicine in Baltimore. “There are some kids who would have died if not for liver transplants.”

In the United States, the only confirmed cases are in Alabama, where nine patients were admitted for severe hepatitis between October 2021 and February 2022. Beyond the two suspected cases in Minnesota, health officials are investigating at least 19 other potential cases in eight states, according to NBC News: Delaware (1), Georgia, Illinois (3), Louisiana (1), New York, North Carolina (2), Tennessee (6), and Wisconsin (4). (New York and Georgia did not specify the number of cases being investigated.)

Reported cases have occurred in patients aged between 1 month and 16 years old. Globally, at least 17 patients have needed liver transplants, according to a World Health Organization alert on April 23. While WHO officials said there has been at least one death globally linked to hepatitis, that does not include the three deaths in Indonesia. One death has also been reported in Wisconsin, but the state’s Department of Health Services did not confirm whether this death was included in the WHO announcement.

The cause of these severe hepatitis cases has yet to be identified, but these cases have tested negative for more common viruses that can cause hepatitis in children. There is no link between these cases and COVID-19 vaccination, according to WHO, because most affected children have not been vaccinated.

Adenovirus is a possible contributing factor in these cases, as many of the cases in Europe tested positive for the virus. In an analysis of the nine Alabama cases released by the Centers for Disease Control and Prevention, adenovirus was detected in the blood samples of all nine children. Five of the nine children tested positive for adenovirus type 41, which is a common cause of acute gastroenteritis in children. While the six liver biopsies performed showed varying degrees of hepatitis, there were “no viral inclusions observed, no immunohistochemical evidence of adenovirus, or no viral particles identified by electron microscopy,” according to the report. None of the children tested positive for COVID-19 or had a documented history of previous COVID-19 infection.

“At this time, we believe that adenovirus may be the cause for these reported cases, but other potential environmental and situational factors are still being investigated,” the CDC said in a media statement. The CDC added that the report was specific to the nine Alabama cases, and that the agency is working to investigate other potential cases with state and local public health officials.

While the “growing consensus” among experts is that adenovirus could be behind these severe cases, there are many unanswered questions, Dr. Thomas added, such as why this strain of adenovirus causes such severe hepatitis, and why the liver biopsies do not show classic signs of viral infection. That information will come as investigations continue.

“From a provider point of view, if you have a child with an unexplained liver problem, report it to the CDC,” he advised. “Right now, we have to learn more about [these cases],” and that requires more research like the investigations in Alabama, he noted.

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

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Paxlovid doesn’t prevent infection in households, Pfizer says

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Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

A version of this article first appeared on WebMD.com.

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Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

A version of this article first appeared on WebMD.com.

Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

A version of this article first appeared on WebMD.com.

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CDC reports first human case of H5 bird flu in the U.S.

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A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

A version of this article first appeared on WebMD.com.

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A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

A version of this article first appeared on WebMD.com.

A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

A version of this article first appeared on WebMD.com.

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