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FDA: Safety signal emerged with higher dose of tofacitinib in RA study
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
U.S. sesame allergy prevalence estimated at 750,000
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
REPORTING FROM AAAAI 2019
Key clinical point: The U.S. prevalence of allergy to sesame is roughly similar to other foods that require food labeling.
Major finding: The prevalence of sesame allergy was 0.23% of U.S. adults and children.
Study details: A detailed survey of food allergies completed for 53,575 U.S. households that included 78,851 people.
Disclosures: Mr. Warren had no disclosures. Dr. Gupta had been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she had received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
Source: Chadha AS et al. AAAAI 2019, Abstract 615.
Influenza activity continues to increase
The 2018-2019 flu season is showing no signs of decline as activity measures continued to increase into mid-February, according to the Centers for Disease Control and Prevention.
Eight of the last 10 flu seasons had already reached their peak before mid-February, but another rise brought the proportion of outpatient visits for influenza-like illness (ILI) to 5.1% for the week ending Feb. 16, compared with 4.8% the week before, the CDC’s influenza division reported Feb. 22. ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.
The week also brought more ILI to more states, as the number reporting an activity level of 10 on the CDC’s 1-10 scale rose from 21 to 24 and the number in the high range of 8-10 increased from 26 to 30. Another seven states – including California, which was at level 5 the previous week – and the District of Columbia were at level 7 for the current reporting week, the CDC said.
Two flu-related pediatric deaths occurred during the week ending Feb. 16 and another five were reported from previous weeks, which brings the total to 41 for the 2018-2019 season. Data for influenza deaths at all ages, which are reported a week later, show that 205 occurred in the week ending Feb. 9, with reporting 75% complete. There were 236 total deaths for the week ending Feb. 2 (94% reporting) and 218 deaths during the week ending Jan. 26 (99% reporting), the CDC said.
The 2018-2019 flu season is showing no signs of decline as activity measures continued to increase into mid-February, according to the Centers for Disease Control and Prevention.
Eight of the last 10 flu seasons had already reached their peak before mid-February, but another rise brought the proportion of outpatient visits for influenza-like illness (ILI) to 5.1% for the week ending Feb. 16, compared with 4.8% the week before, the CDC’s influenza division reported Feb. 22. ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.
The week also brought more ILI to more states, as the number reporting an activity level of 10 on the CDC’s 1-10 scale rose from 21 to 24 and the number in the high range of 8-10 increased from 26 to 30. Another seven states – including California, which was at level 5 the previous week – and the District of Columbia were at level 7 for the current reporting week, the CDC said.
Two flu-related pediatric deaths occurred during the week ending Feb. 16 and another five were reported from previous weeks, which brings the total to 41 for the 2018-2019 season. Data for influenza deaths at all ages, which are reported a week later, show that 205 occurred in the week ending Feb. 9, with reporting 75% complete. There were 236 total deaths for the week ending Feb. 2 (94% reporting) and 218 deaths during the week ending Jan. 26 (99% reporting), the CDC said.
The 2018-2019 flu season is showing no signs of decline as activity measures continued to increase into mid-February, according to the Centers for Disease Control and Prevention.
Eight of the last 10 flu seasons had already reached their peak before mid-February, but another rise brought the proportion of outpatient visits for influenza-like illness (ILI) to 5.1% for the week ending Feb. 16, compared with 4.8% the week before, the CDC’s influenza division reported Feb. 22. ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.
The week also brought more ILI to more states, as the number reporting an activity level of 10 on the CDC’s 1-10 scale rose from 21 to 24 and the number in the high range of 8-10 increased from 26 to 30. Another seven states – including California, which was at level 5 the previous week – and the District of Columbia were at level 7 for the current reporting week, the CDC said.
Two flu-related pediatric deaths occurred during the week ending Feb. 16 and another five were reported from previous weeks, which brings the total to 41 for the 2018-2019 season. Data for influenza deaths at all ages, which are reported a week later, show that 205 occurred in the week ending Feb. 9, with reporting 75% complete. There were 236 total deaths for the week ending Feb. 2 (94% reporting) and 218 deaths during the week ending Jan. 26 (99% reporting), the CDC said.
Bag-mask ventilation during intubation reduces severe hypoxemia
, according to data presented at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
A multicenter study, published simultaneously in the Feb. 18 issue of the New England Journal of Medicine, randomized 401 critically-ill patients in the ICU who were undergoing tracheal intubation to receive either ventilation with a bag-mask device during induction for intubation or no ventilation.
The median lowest oxygen saturation between induction and 2 minutes after intubation was 96% in the bag-mask ventilated patients and 93% in the no-ventilation group, representing a 4.7% difference after adjusting for prespecified covariates (P = .01).
In a post-hoc analysis that adjusted for other factors such as the provision of preoxygenation, the preoxygenation device, pneumonia, and gastrointestinal bleeding, there was a 5.2% difference between the two groups in median lowest oxygen saturation, favoring the bag-mask group.
Bag-mask ventilation was also associated with almost a halving in the incidence of severe hypoxemia – defined as an oxygen saturation below 80% – compared with no-ventilation (10.9% vs. 22.8%; relative risk = 0.48). There was also a lower incidence of patients with an oxygen saturation below 90% and below 70% in the bag-mask ventilation group, compared with the no-ventilation group.
Overall, the median decrease in oxygen saturation from induction to the lowest point was 1% in the bag-mask group, and 5% in the no-ventilation group.
The study saw no effects of factors such as body-mass index, operator experience, or Acute Physiology and Chronic Health Evaluation (APACHE II) score. The patients had a median age of 60 years, about half had sepsis or septic shock, and close to 60% had hypoxemic respiratory failure as an indication for tracheal intubation.
Jonathan D. Casey, MD, of Vanderbilt University, Nashville, Tenn., and his coauthors wrote that their results suggested for every nine critically ill patients undergoing tracheal intubation, bag-mask ventilation would prevent severe hypoxemia in one patient.
“These findings are important because oxygen saturation is an established endpoint in airway management trials and is a contributing factor to periprocedural cardiac arrest and death,” they wrote.
They noted that there are conflicting guidelines on the use of bag-mask ventilation during tracheal intubation, with some recommending its use for all patients – even those who are not hypoxemic – and others advising their use only for patients with hypoxemia. This study excluded patients who were identified as hypoxemic or in whom bag-mask ventilation was contraindicated.
Despite concerns about bag-mask ventilation increasing the risk the aspiration, the study showed no significant difference between the two groups in the incidence of operator-reported aspiration or the presence of a new opacity on chest radiograph in the 48 hours after intubation.
The authors acknowledged that, given the low incidence of operator-reported aspiration during tracheal intubation, a much larger study would be needed to show whether bag-mask ventilation did increase the risk of aspiration.
“However, our trial provides some reassurance, since the incidence of operator-reported aspiration was numerically lower in the bag-mask ventilation group than in the no-ventilation group,” they wrote.
There were also no significant differences between the two groups in oxygen saturation, fraction of inspired oxygen or positive end-expiratory pressure in the 24 hours after intubation. Bag-mask ventilation was also associated with similar rates of in-hospital mortality, number of ventilator-free days, and days out of the ICU as no-ventilation.
The authors noted that their trial focused on critically-ill patients in the ICU, so the results may not be generalizable to patients in the emergency department or in a prehospital setting.
The study and some authors were supported by the National Institutes of Health. Two authors declared personal fees from the pharmaceutical industry unrelated to the study, and no other conflicts of interest were declared.
SOURCE: Casey J et al. N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMoa1812405
Debate around the question of whether to use bag-mask ventilation in critically-ill patients has been limited by the lack of high-quality evidence on the risk of aspiration or on the benefits of this approach. This study found no evidence of an increase in the incidence of aspiration, despite using multiple measures to detect it, which provide some reassurance that manual ventilation during tracheal intubation is not likely to cause significant harm.
One significant limitation of this trial, however, is that it did not standardize the preoxygenation strategy across the two groups, so significantly more patients in the bag-mask group received bag-mask ventilation before induction. Median oxygen saturation before induction was the same in the two groups, but this does not rule out the possibility of differences in the arterial pressure of oxygen.
This study may not settle the question of whether to use bag-mask ventilation during tracheal intubation, but it provides strong suggestion that the practice is not harmful.
Patricia A. Kritek, MD, and Andrew M. Luks, MD, are with the division of pulmonary, critical care, and sleep medicine at the University of Washington in Seattle. These comments are adapted from their editorial accompanying the paper by Casey et al. (N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMe1900708). Dr. Luks declared personal fees from private industry outside the submitted work. Dr. Kritek reported having nothing to disclose.
Debate around the question of whether to use bag-mask ventilation in critically-ill patients has been limited by the lack of high-quality evidence on the risk of aspiration or on the benefits of this approach. This study found no evidence of an increase in the incidence of aspiration, despite using multiple measures to detect it, which provide some reassurance that manual ventilation during tracheal intubation is not likely to cause significant harm.
One significant limitation of this trial, however, is that it did not standardize the preoxygenation strategy across the two groups, so significantly more patients in the bag-mask group received bag-mask ventilation before induction. Median oxygen saturation before induction was the same in the two groups, but this does not rule out the possibility of differences in the arterial pressure of oxygen.
This study may not settle the question of whether to use bag-mask ventilation during tracheal intubation, but it provides strong suggestion that the practice is not harmful.
Patricia A. Kritek, MD, and Andrew M. Luks, MD, are with the division of pulmonary, critical care, and sleep medicine at the University of Washington in Seattle. These comments are adapted from their editorial accompanying the paper by Casey et al. (N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMe1900708). Dr. Luks declared personal fees from private industry outside the submitted work. Dr. Kritek reported having nothing to disclose.
Debate around the question of whether to use bag-mask ventilation in critically-ill patients has been limited by the lack of high-quality evidence on the risk of aspiration or on the benefits of this approach. This study found no evidence of an increase in the incidence of aspiration, despite using multiple measures to detect it, which provide some reassurance that manual ventilation during tracheal intubation is not likely to cause significant harm.
One significant limitation of this trial, however, is that it did not standardize the preoxygenation strategy across the two groups, so significantly more patients in the bag-mask group received bag-mask ventilation before induction. Median oxygen saturation before induction was the same in the two groups, but this does not rule out the possibility of differences in the arterial pressure of oxygen.
This study may not settle the question of whether to use bag-mask ventilation during tracheal intubation, but it provides strong suggestion that the practice is not harmful.
Patricia A. Kritek, MD, and Andrew M. Luks, MD, are with the division of pulmonary, critical care, and sleep medicine at the University of Washington in Seattle. These comments are adapted from their editorial accompanying the paper by Casey et al. (N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMe1900708). Dr. Luks declared personal fees from private industry outside the submitted work. Dr. Kritek reported having nothing to disclose.
, according to data presented at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
A multicenter study, published simultaneously in the Feb. 18 issue of the New England Journal of Medicine, randomized 401 critically-ill patients in the ICU who were undergoing tracheal intubation to receive either ventilation with a bag-mask device during induction for intubation or no ventilation.
The median lowest oxygen saturation between induction and 2 minutes after intubation was 96% in the bag-mask ventilated patients and 93% in the no-ventilation group, representing a 4.7% difference after adjusting for prespecified covariates (P = .01).
In a post-hoc analysis that adjusted for other factors such as the provision of preoxygenation, the preoxygenation device, pneumonia, and gastrointestinal bleeding, there was a 5.2% difference between the two groups in median lowest oxygen saturation, favoring the bag-mask group.
Bag-mask ventilation was also associated with almost a halving in the incidence of severe hypoxemia – defined as an oxygen saturation below 80% – compared with no-ventilation (10.9% vs. 22.8%; relative risk = 0.48). There was also a lower incidence of patients with an oxygen saturation below 90% and below 70% in the bag-mask ventilation group, compared with the no-ventilation group.
Overall, the median decrease in oxygen saturation from induction to the lowest point was 1% in the bag-mask group, and 5% in the no-ventilation group.
The study saw no effects of factors such as body-mass index, operator experience, or Acute Physiology and Chronic Health Evaluation (APACHE II) score. The patients had a median age of 60 years, about half had sepsis or septic shock, and close to 60% had hypoxemic respiratory failure as an indication for tracheal intubation.
Jonathan D. Casey, MD, of Vanderbilt University, Nashville, Tenn., and his coauthors wrote that their results suggested for every nine critically ill patients undergoing tracheal intubation, bag-mask ventilation would prevent severe hypoxemia in one patient.
“These findings are important because oxygen saturation is an established endpoint in airway management trials and is a contributing factor to periprocedural cardiac arrest and death,” they wrote.
They noted that there are conflicting guidelines on the use of bag-mask ventilation during tracheal intubation, with some recommending its use for all patients – even those who are not hypoxemic – and others advising their use only for patients with hypoxemia. This study excluded patients who were identified as hypoxemic or in whom bag-mask ventilation was contraindicated.
Despite concerns about bag-mask ventilation increasing the risk the aspiration, the study showed no significant difference between the two groups in the incidence of operator-reported aspiration or the presence of a new opacity on chest radiograph in the 48 hours after intubation.
The authors acknowledged that, given the low incidence of operator-reported aspiration during tracheal intubation, a much larger study would be needed to show whether bag-mask ventilation did increase the risk of aspiration.
“However, our trial provides some reassurance, since the incidence of operator-reported aspiration was numerically lower in the bag-mask ventilation group than in the no-ventilation group,” they wrote.
There were also no significant differences between the two groups in oxygen saturation, fraction of inspired oxygen or positive end-expiratory pressure in the 24 hours after intubation. Bag-mask ventilation was also associated with similar rates of in-hospital mortality, number of ventilator-free days, and days out of the ICU as no-ventilation.
The authors noted that their trial focused on critically-ill patients in the ICU, so the results may not be generalizable to patients in the emergency department or in a prehospital setting.
The study and some authors were supported by the National Institutes of Health. Two authors declared personal fees from the pharmaceutical industry unrelated to the study, and no other conflicts of interest were declared.
SOURCE: Casey J et al. N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMoa1812405
, according to data presented at the Critical Care Congress, sponsored by the Society of Critical Care Medicine.
A multicenter study, published simultaneously in the Feb. 18 issue of the New England Journal of Medicine, randomized 401 critically-ill patients in the ICU who were undergoing tracheal intubation to receive either ventilation with a bag-mask device during induction for intubation or no ventilation.
The median lowest oxygen saturation between induction and 2 minutes after intubation was 96% in the bag-mask ventilated patients and 93% in the no-ventilation group, representing a 4.7% difference after adjusting for prespecified covariates (P = .01).
In a post-hoc analysis that adjusted for other factors such as the provision of preoxygenation, the preoxygenation device, pneumonia, and gastrointestinal bleeding, there was a 5.2% difference between the two groups in median lowest oxygen saturation, favoring the bag-mask group.
Bag-mask ventilation was also associated with almost a halving in the incidence of severe hypoxemia – defined as an oxygen saturation below 80% – compared with no-ventilation (10.9% vs. 22.8%; relative risk = 0.48). There was also a lower incidence of patients with an oxygen saturation below 90% and below 70% in the bag-mask ventilation group, compared with the no-ventilation group.
Overall, the median decrease in oxygen saturation from induction to the lowest point was 1% in the bag-mask group, and 5% in the no-ventilation group.
The study saw no effects of factors such as body-mass index, operator experience, or Acute Physiology and Chronic Health Evaluation (APACHE II) score. The patients had a median age of 60 years, about half had sepsis or septic shock, and close to 60% had hypoxemic respiratory failure as an indication for tracheal intubation.
Jonathan D. Casey, MD, of Vanderbilt University, Nashville, Tenn., and his coauthors wrote that their results suggested for every nine critically ill patients undergoing tracheal intubation, bag-mask ventilation would prevent severe hypoxemia in one patient.
“These findings are important because oxygen saturation is an established endpoint in airway management trials and is a contributing factor to periprocedural cardiac arrest and death,” they wrote.
They noted that there are conflicting guidelines on the use of bag-mask ventilation during tracheal intubation, with some recommending its use for all patients – even those who are not hypoxemic – and others advising their use only for patients with hypoxemia. This study excluded patients who were identified as hypoxemic or in whom bag-mask ventilation was contraindicated.
Despite concerns about bag-mask ventilation increasing the risk the aspiration, the study showed no significant difference between the two groups in the incidence of operator-reported aspiration or the presence of a new opacity on chest radiograph in the 48 hours after intubation.
The authors acknowledged that, given the low incidence of operator-reported aspiration during tracheal intubation, a much larger study would be needed to show whether bag-mask ventilation did increase the risk of aspiration.
“However, our trial provides some reassurance, since the incidence of operator-reported aspiration was numerically lower in the bag-mask ventilation group than in the no-ventilation group,” they wrote.
There were also no significant differences between the two groups in oxygen saturation, fraction of inspired oxygen or positive end-expiratory pressure in the 24 hours after intubation. Bag-mask ventilation was also associated with similar rates of in-hospital mortality, number of ventilator-free days, and days out of the ICU as no-ventilation.
The authors noted that their trial focused on critically-ill patients in the ICU, so the results may not be generalizable to patients in the emergency department or in a prehospital setting.
The study and some authors were supported by the National Institutes of Health. Two authors declared personal fees from the pharmaceutical industry unrelated to the study, and no other conflicts of interest were declared.
SOURCE: Casey J et al. N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMoa1812405
FROM CCC48
Key clinical point: Bag-mask ventilation during tracheal intubation reduces the risk of severe hypoxemia.
Major finding: For every nine patients who receive bag-mask ventilation during tracheal intubation, one case of severe hypoxemia is avoided.
Study details: Randomized, controlled trial in 401 critically-ill patients undergoing tracheal intubation.
Disclosures: The study and some authors were supported by the National Institutes of Health. Two authors declared personal fees from the pharmaceutical industry unrelated to the study.
Source: Casey J et al. N Engl J Med. 2019 Feb 18. doi: 10.1056/NEJMoa1812405
Flu season showing its staying power
Like an unwelcome guest, the 2018-2019 flu season seems to be settling in for a lengthy stay as three more states have reached the highest level of influenza-like illness (ILI) activity, according to the Centers for Disease Control and Prevention.
There are now 21 states at level 10 on the CDC’s 1-10 scale, with the South showing up almost solidly red on the flu activity map for the week ending Feb. 9. Another five states are at levels 8 and 9, bringing the total in the high range to 26 for the week, compared with 24 the previous week, the CDC’s influenza division reported Feb. 15.
National activity, reflected in the proportion of outpatient visits involving ILI, took a step up from 4.3% the week before to 4.8% for the week ending Feb. 9. The national baseline rate is 2.2% for ILI, which the CDC defines “as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.”
Two flu-related pediatric deaths occurred during the week ending Feb. 9, and another four were reported from earlier weeks, which brings the total for the 2018-2019 season to 34, the CDC said. At the same point in last year’s flu season, there had been 84 flu-related deaths in children.
In a separate report, the CDC said that, based on data collected from Nov. 23, 2018 to Feb. 2, 2019, “the influenza vaccine has been 47% effective in preventing medically attended acute respiratory virus infection across all age groups and specifically was 46% effective in preventing medical visits associated with influenza A(H1N1)pdm09.” The effectiveness of the vaccine was 61% for children aged 6 months to 17 years, the CDC said (MMWR. 2019 Feb 15;68[6];135-9).
Flu vaccination during the 2017-2018 season prevented 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 flu-related deaths, the CDC said, adding that “vaccination has been found to reduce deaths, intensive care unit admissions and length of stay, and overall duration of hospitalization among hospitalized influenza patients.”
Forecasts for the rest of the 2018-2019 season “predict that elevated influenza activity in parts of the United States will continue for several more weeks,” the CDC said.
Like an unwelcome guest, the 2018-2019 flu season seems to be settling in for a lengthy stay as three more states have reached the highest level of influenza-like illness (ILI) activity, according to the Centers for Disease Control and Prevention.
There are now 21 states at level 10 on the CDC’s 1-10 scale, with the South showing up almost solidly red on the flu activity map for the week ending Feb. 9. Another five states are at levels 8 and 9, bringing the total in the high range to 26 for the week, compared with 24 the previous week, the CDC’s influenza division reported Feb. 15.
National activity, reflected in the proportion of outpatient visits involving ILI, took a step up from 4.3% the week before to 4.8% for the week ending Feb. 9. The national baseline rate is 2.2% for ILI, which the CDC defines “as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.”
Two flu-related pediatric deaths occurred during the week ending Feb. 9, and another four were reported from earlier weeks, which brings the total for the 2018-2019 season to 34, the CDC said. At the same point in last year’s flu season, there had been 84 flu-related deaths in children.
In a separate report, the CDC said that, based on data collected from Nov. 23, 2018 to Feb. 2, 2019, “the influenza vaccine has been 47% effective in preventing medically attended acute respiratory virus infection across all age groups and specifically was 46% effective in preventing medical visits associated with influenza A(H1N1)pdm09.” The effectiveness of the vaccine was 61% for children aged 6 months to 17 years, the CDC said (MMWR. 2019 Feb 15;68[6];135-9).
Flu vaccination during the 2017-2018 season prevented 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 flu-related deaths, the CDC said, adding that “vaccination has been found to reduce deaths, intensive care unit admissions and length of stay, and overall duration of hospitalization among hospitalized influenza patients.”
Forecasts for the rest of the 2018-2019 season “predict that elevated influenza activity in parts of the United States will continue for several more weeks,” the CDC said.
Like an unwelcome guest, the 2018-2019 flu season seems to be settling in for a lengthy stay as three more states have reached the highest level of influenza-like illness (ILI) activity, according to the Centers for Disease Control and Prevention.
There are now 21 states at level 10 on the CDC’s 1-10 scale, with the South showing up almost solidly red on the flu activity map for the week ending Feb. 9. Another five states are at levels 8 and 9, bringing the total in the high range to 26 for the week, compared with 24 the previous week, the CDC’s influenza division reported Feb. 15.
National activity, reflected in the proportion of outpatient visits involving ILI, took a step up from 4.3% the week before to 4.8% for the week ending Feb. 9. The national baseline rate is 2.2% for ILI, which the CDC defines “as fever (temperature of 100°F [37.8°C] or greater) and cough and/or sore throat.”
Two flu-related pediatric deaths occurred during the week ending Feb. 9, and another four were reported from earlier weeks, which brings the total for the 2018-2019 season to 34, the CDC said. At the same point in last year’s flu season, there had been 84 flu-related deaths in children.
In a separate report, the CDC said that, based on data collected from Nov. 23, 2018 to Feb. 2, 2019, “the influenza vaccine has been 47% effective in preventing medically attended acute respiratory virus infection across all age groups and specifically was 46% effective in preventing medical visits associated with influenza A(H1N1)pdm09.” The effectiveness of the vaccine was 61% for children aged 6 months to 17 years, the CDC said (MMWR. 2019 Feb 15;68[6];135-9).
Flu vaccination during the 2017-2018 season prevented 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 flu-related deaths, the CDC said, adding that “vaccination has been found to reduce deaths, intensive care unit admissions and length of stay, and overall duration of hospitalization among hospitalized influenza patients.”
Forecasts for the rest of the 2018-2019 season “predict that elevated influenza activity in parts of the United States will continue for several more weeks,” the CDC said.
Conservatism spreads in prostate cancer
, the United States now has more than 100 measles cases for the year, e-cigarette use reverses progress in reducing teens’ tobacco use, and consider adopting the MESA 10-year coronary heart disease risk calculator.
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, the United States now has more than 100 measles cases for the year, e-cigarette use reverses progress in reducing teens’ tobacco use, and consider adopting the MESA 10-year coronary heart disease risk calculator.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
, the United States now has more than 100 measles cases for the year, e-cigarette use reverses progress in reducing teens’ tobacco use, and consider adopting the MESA 10-year coronary heart disease risk calculator.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Venous thromboembolism risk elevated in ankylosing spondylitis patients
Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 7,190 incident cases of AS among adults using a health care database of residents of British Columbia and matched them for age, sex, and entry time into the cohort with 71,900 healthy individuals from the general population over a mean follow-up time of 6.2 years.
The incidence rate of VTE overall per 1,000 person-years was 1.56 among AS patients, compared with 0.77 in a control cohort from the general population. The incidence rates for DVT were 1.06 in AS patients and 0.50 in controls; incidence rates for PE were 0.79 in AS patients and 0.40 in controls.
The adjusted hazard ratios for VTE overall and DVT were similar and statistically significant in AS patients at 1.53 and 1.62, respectively, versus controls. But the adjusted hazard ratio of 1.36 for PE did not reach statistical significance. The adjusted risks of VTE overall, PE, and DVT were highest in the first year of diagnosis, reaching twofold greater risk for all, but none of the risks were statistically significant.
More research is needed to better identify subsets of AS patients at increased risk for VTE, and to assess whether treatment of inflammation can mitigate this risk, but in the meantime clinicians should be alert to the possibility of life-threatening complications from DVT and PE in their AS patients, especially soon after diagnosis, the researchers said.
The findings are supported by the study’s large sample size but are also limited by several factors, including the observational nature of the study and an inability to account for use of NSAIDs, the researchers noted.
“These results call for awareness of this complication, increased vigilance, and preventive intervention by controlling the inflammatory process or by anticoagulation in a high-risk AS population,” they concluded.
The study was supported in part by grants from the Canadian Arthritis Network, the Arthritis Society of Canada, the British Columbia Lupus Society, and the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.
Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 7,190 incident cases of AS among adults using a health care database of residents of British Columbia and matched them for age, sex, and entry time into the cohort with 71,900 healthy individuals from the general population over a mean follow-up time of 6.2 years.
The incidence rate of VTE overall per 1,000 person-years was 1.56 among AS patients, compared with 0.77 in a control cohort from the general population. The incidence rates for DVT were 1.06 in AS patients and 0.50 in controls; incidence rates for PE were 0.79 in AS patients and 0.40 in controls.
The adjusted hazard ratios for VTE overall and DVT were similar and statistically significant in AS patients at 1.53 and 1.62, respectively, versus controls. But the adjusted hazard ratio of 1.36 for PE did not reach statistical significance. The adjusted risks of VTE overall, PE, and DVT were highest in the first year of diagnosis, reaching twofold greater risk for all, but none of the risks were statistically significant.
More research is needed to better identify subsets of AS patients at increased risk for VTE, and to assess whether treatment of inflammation can mitigate this risk, but in the meantime clinicians should be alert to the possibility of life-threatening complications from DVT and PE in their AS patients, especially soon after diagnosis, the researchers said.
The findings are supported by the study’s large sample size but are also limited by several factors, including the observational nature of the study and an inability to account for use of NSAIDs, the researchers noted.
“These results call for awareness of this complication, increased vigilance, and preventive intervention by controlling the inflammatory process or by anticoagulation in a high-risk AS population,” they concluded.
The study was supported in part by grants from the Canadian Arthritis Network, the Arthritis Society of Canada, the British Columbia Lupus Society, and the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.
Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.
In a study published in Annals of the Rheumatic Diseases, the researchers identified 7,190 incident cases of AS among adults using a health care database of residents of British Columbia and matched them for age, sex, and entry time into the cohort with 71,900 healthy individuals from the general population over a mean follow-up time of 6.2 years.
The incidence rate of VTE overall per 1,000 person-years was 1.56 among AS patients, compared with 0.77 in a control cohort from the general population. The incidence rates for DVT were 1.06 in AS patients and 0.50 in controls; incidence rates for PE were 0.79 in AS patients and 0.40 in controls.
The adjusted hazard ratios for VTE overall and DVT were similar and statistically significant in AS patients at 1.53 and 1.62, respectively, versus controls. But the adjusted hazard ratio of 1.36 for PE did not reach statistical significance. The adjusted risks of VTE overall, PE, and DVT were highest in the first year of diagnosis, reaching twofold greater risk for all, but none of the risks were statistically significant.
More research is needed to better identify subsets of AS patients at increased risk for VTE, and to assess whether treatment of inflammation can mitigate this risk, but in the meantime clinicians should be alert to the possibility of life-threatening complications from DVT and PE in their AS patients, especially soon after diagnosis, the researchers said.
The findings are supported by the study’s large sample size but are also limited by several factors, including the observational nature of the study and an inability to account for use of NSAIDs, the researchers noted.
“These results call for awareness of this complication, increased vigilance, and preventive intervention by controlling the inflammatory process or by anticoagulation in a high-risk AS population,” they concluded.
The study was supported in part by grants from the Canadian Arthritis Network, the Arthritis Society of Canada, the British Columbia Lupus Society, and the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: Newly diagnosed AS patients demonstrated increased risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, compared with controls.
Major finding: The relative risk for deep vein thrombosis was 63% higher for AS patients versus controls, but a 39% higher risk of pulmonary embolism did not reach statistical significance.
Study details: A population-based study including 7,190 incident AS cases and 71,900 matched controls from a health care database of residents of British Columbia.
Disclosures: The study was supported in part by grants from the Canadian Arthritis Network, the Arthritis Society of Canada, the British Columbia Lupus Society, and the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
Source: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.
Adult HIV patients should receive standard vaccinations, with caveats
Patients infected with HIV have an increased risk of mortality and morbidity from diseases that are preventable with vaccines. Undervaccination of these patients poses a major concern, according to a literature review of the vaccine response in the adult patient with HIV published in The American Journal of Medicine.
Despite the fact that data are limited, patients infected with HIV are advised to receive their age-specific and risk group−based vaccines, according to Firas El Chaer, MD, of the University of Maryland, Baltimore, and his colleague.
HIV patients are of particular concern regarding vaccination, because, despite the use of retroviral therapy, CD4+ T-lymphocytes in individuals infected with HIV remain lower than in those without HIV. In addition, HIV causes an inappropriate response to B-cell stimulation, which results in suboptimal primary and secondary response to vaccination, according to Dr. El Chaer and his colleague. Despite this and initial concerns about vaccine safety in this population, it is now recommended that adult patients infected with HIV receive their age-specific and risk group−based vaccines, they stated.
Inactivated or subunit vaccines
Haemophilus influenzae type b vaccine is not recommended under current guidelines for individuals older than age 18 with HIV infection, unless they have a clinical indication.
Vaccination against hepatitis A virus is recommended for HIV-infected patients who are hepatitis A virus seronegative and have chronic liver disease, men who have sex with men, intravenous drug users, and travelers to endemic regions. However, research has shown that the immunogenicity of the vaccine is lower in patients with HIV than in uninfected individuals. It was found that the CD4 count at the time of vaccination, not the CD4 low point, was the major predictor of the immune response.
Patients coinfected with HIV and hepatitis B virus have an 8-fold and 19-fold increase in mortality, respectively, compared with either virus monoinfection. Although vaccination is recommended, the optimal hepatitis B virus vaccination schedule in patients with HIV remains controversial, according to the authors. They indicated that new strategies to improve hepatitis B virus vaccine immunogenicity for those infected with HIV are needed.
Individuals infected with HIV have been found to have a higher risk of human papillomavirus (HPV) infection. The safety and immunogenicity results and prospect of benefits has led to a consensus on the benefit of vaccinating HIV-infected patients who meet the HPV vaccine age criteria, the authors indicated.
With regard to standard flu vaccinations: “An annual inactivated influenza vaccine is recommended during the influenza season for all adult individuals with HIV; however, a live attenuated influenza vaccine is contraindicated in this population,” according to the review.
Patients with HIV have a more than 10-fold increased risk of invasive meningococcal disease, compared with the general population, with the risk being particularly higher in those individuals with CD4 counts less than 200 cells/mm3 and in men who have sex with men in cities with meningococcal outbreaks. For these reasons, the “quadrivalent meningococcal vaccine is recommended for all patients with HIV regardless of their CD4 count, with 2-dose primary series at least 2 months apart and with a booster every 5 years.”
Pneumonia is known to be especially dangerous in the HIV-infected population. With regard to pneumonia vaccination, the 13-valent pneumococcal conjugate vaccine is recommended for all patients with HIV, regardless of their CD4 cell counts. According to Dr. El Chaer and his colleague, it should be followed by the 23-valent pneumococcal polysaccharide vaccine at least 8 weeks later as a prime-boost regimen, preferably when CD4 counts are greater than 200 cells/mm3 and in patients receiving ART.
“Tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccines are recommended once for all individuals infected with HIV, regardless of the CD4 count, with a tetanus toxoid and diphtheria toxoid booster every 10 years,” according to the review.
Live vaccines
Live vaccines are a concerning issue for HIV-infected adults and recommendations for use are generally tied to the CD4 T-cell count. The measles, mumps, and rubella vaccine seems to be safe in patients infected with HIV with a CD4 count greater than 200 cells/mm3, according to Dr. El Chaer and his colleague. Similarly, patients with HIV with CD4 counts greater than 200 cells/mm3 and no evidence of documented immunity to varicella should receive the varicella vaccine.
In contrast, the live, attenuated varicella zoster virus vaccine is not recommended for patients infected with HIV, and it is contraindicated if CD4 count is less than 200 cells/mm3. Recently, a herpes zoster subunit vaccine (HZ/su) was tested in a phase 1/2a randomized, placebo-controlled study and was found to be safe and immunogenic regardless of CD4 count, although it has not yet been given a specific recommendation for immunocompromised patients.
“With the widespread use of ART resulting in better HIV control, ,” the authors concluded.
The study was not sponsored. Dr. El Chaer and his colleague reported that they had no conflicts.
SOURCE: El Chaer F et al. Am J Med. 2019. doi: 10.1016/j.amjmed.2018.12.011.
Patients infected with HIV have an increased risk of mortality and morbidity from diseases that are preventable with vaccines. Undervaccination of these patients poses a major concern, according to a literature review of the vaccine response in the adult patient with HIV published in The American Journal of Medicine.
Despite the fact that data are limited, patients infected with HIV are advised to receive their age-specific and risk group−based vaccines, according to Firas El Chaer, MD, of the University of Maryland, Baltimore, and his colleague.
HIV patients are of particular concern regarding vaccination, because, despite the use of retroviral therapy, CD4+ T-lymphocytes in individuals infected with HIV remain lower than in those without HIV. In addition, HIV causes an inappropriate response to B-cell stimulation, which results in suboptimal primary and secondary response to vaccination, according to Dr. El Chaer and his colleague. Despite this and initial concerns about vaccine safety in this population, it is now recommended that adult patients infected with HIV receive their age-specific and risk group−based vaccines, they stated.
Inactivated or subunit vaccines
Haemophilus influenzae type b vaccine is not recommended under current guidelines for individuals older than age 18 with HIV infection, unless they have a clinical indication.
Vaccination against hepatitis A virus is recommended for HIV-infected patients who are hepatitis A virus seronegative and have chronic liver disease, men who have sex with men, intravenous drug users, and travelers to endemic regions. However, research has shown that the immunogenicity of the vaccine is lower in patients with HIV than in uninfected individuals. It was found that the CD4 count at the time of vaccination, not the CD4 low point, was the major predictor of the immune response.
Patients coinfected with HIV and hepatitis B virus have an 8-fold and 19-fold increase in mortality, respectively, compared with either virus monoinfection. Although vaccination is recommended, the optimal hepatitis B virus vaccination schedule in patients with HIV remains controversial, according to the authors. They indicated that new strategies to improve hepatitis B virus vaccine immunogenicity for those infected with HIV are needed.
Individuals infected with HIV have been found to have a higher risk of human papillomavirus (HPV) infection. The safety and immunogenicity results and prospect of benefits has led to a consensus on the benefit of vaccinating HIV-infected patients who meet the HPV vaccine age criteria, the authors indicated.
With regard to standard flu vaccinations: “An annual inactivated influenza vaccine is recommended during the influenza season for all adult individuals with HIV; however, a live attenuated influenza vaccine is contraindicated in this population,” according to the review.
Patients with HIV have a more than 10-fold increased risk of invasive meningococcal disease, compared with the general population, with the risk being particularly higher in those individuals with CD4 counts less than 200 cells/mm3 and in men who have sex with men in cities with meningococcal outbreaks. For these reasons, the “quadrivalent meningococcal vaccine is recommended for all patients with HIV regardless of their CD4 count, with 2-dose primary series at least 2 months apart and with a booster every 5 years.”
Pneumonia is known to be especially dangerous in the HIV-infected population. With regard to pneumonia vaccination, the 13-valent pneumococcal conjugate vaccine is recommended for all patients with HIV, regardless of their CD4 cell counts. According to Dr. El Chaer and his colleague, it should be followed by the 23-valent pneumococcal polysaccharide vaccine at least 8 weeks later as a prime-boost regimen, preferably when CD4 counts are greater than 200 cells/mm3 and in patients receiving ART.
“Tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccines are recommended once for all individuals infected with HIV, regardless of the CD4 count, with a tetanus toxoid and diphtheria toxoid booster every 10 years,” according to the review.
Live vaccines
Live vaccines are a concerning issue for HIV-infected adults and recommendations for use are generally tied to the CD4 T-cell count. The measles, mumps, and rubella vaccine seems to be safe in patients infected with HIV with a CD4 count greater than 200 cells/mm3, according to Dr. El Chaer and his colleague. Similarly, patients with HIV with CD4 counts greater than 200 cells/mm3 and no evidence of documented immunity to varicella should receive the varicella vaccine.
In contrast, the live, attenuated varicella zoster virus vaccine is not recommended for patients infected with HIV, and it is contraindicated if CD4 count is less than 200 cells/mm3. Recently, a herpes zoster subunit vaccine (HZ/su) was tested in a phase 1/2a randomized, placebo-controlled study and was found to be safe and immunogenic regardless of CD4 count, although it has not yet been given a specific recommendation for immunocompromised patients.
“With the widespread use of ART resulting in better HIV control, ,” the authors concluded.
The study was not sponsored. Dr. El Chaer and his colleague reported that they had no conflicts.
SOURCE: El Chaer F et al. Am J Med. 2019. doi: 10.1016/j.amjmed.2018.12.011.
Patients infected with HIV have an increased risk of mortality and morbidity from diseases that are preventable with vaccines. Undervaccination of these patients poses a major concern, according to a literature review of the vaccine response in the adult patient with HIV published in The American Journal of Medicine.
Despite the fact that data are limited, patients infected with HIV are advised to receive their age-specific and risk group−based vaccines, according to Firas El Chaer, MD, of the University of Maryland, Baltimore, and his colleague.
HIV patients are of particular concern regarding vaccination, because, despite the use of retroviral therapy, CD4+ T-lymphocytes in individuals infected with HIV remain lower than in those without HIV. In addition, HIV causes an inappropriate response to B-cell stimulation, which results in suboptimal primary and secondary response to vaccination, according to Dr. El Chaer and his colleague. Despite this and initial concerns about vaccine safety in this population, it is now recommended that adult patients infected with HIV receive their age-specific and risk group−based vaccines, they stated.
Inactivated or subunit vaccines
Haemophilus influenzae type b vaccine is not recommended under current guidelines for individuals older than age 18 with HIV infection, unless they have a clinical indication.
Vaccination against hepatitis A virus is recommended for HIV-infected patients who are hepatitis A virus seronegative and have chronic liver disease, men who have sex with men, intravenous drug users, and travelers to endemic regions. However, research has shown that the immunogenicity of the vaccine is lower in patients with HIV than in uninfected individuals. It was found that the CD4 count at the time of vaccination, not the CD4 low point, was the major predictor of the immune response.
Patients coinfected with HIV and hepatitis B virus have an 8-fold and 19-fold increase in mortality, respectively, compared with either virus monoinfection. Although vaccination is recommended, the optimal hepatitis B virus vaccination schedule in patients with HIV remains controversial, according to the authors. They indicated that new strategies to improve hepatitis B virus vaccine immunogenicity for those infected with HIV are needed.
Individuals infected with HIV have been found to have a higher risk of human papillomavirus (HPV) infection. The safety and immunogenicity results and prospect of benefits has led to a consensus on the benefit of vaccinating HIV-infected patients who meet the HPV vaccine age criteria, the authors indicated.
With regard to standard flu vaccinations: “An annual inactivated influenza vaccine is recommended during the influenza season for all adult individuals with HIV; however, a live attenuated influenza vaccine is contraindicated in this population,” according to the review.
Patients with HIV have a more than 10-fold increased risk of invasive meningococcal disease, compared with the general population, with the risk being particularly higher in those individuals with CD4 counts less than 200 cells/mm3 and in men who have sex with men in cities with meningococcal outbreaks. For these reasons, the “quadrivalent meningococcal vaccine is recommended for all patients with HIV regardless of their CD4 count, with 2-dose primary series at least 2 months apart and with a booster every 5 years.”
Pneumonia is known to be especially dangerous in the HIV-infected population. With regard to pneumonia vaccination, the 13-valent pneumococcal conjugate vaccine is recommended for all patients with HIV, regardless of their CD4 cell counts. According to Dr. El Chaer and his colleague, it should be followed by the 23-valent pneumococcal polysaccharide vaccine at least 8 weeks later as a prime-boost regimen, preferably when CD4 counts are greater than 200 cells/mm3 and in patients receiving ART.
“Tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccines are recommended once for all individuals infected with HIV, regardless of the CD4 count, with a tetanus toxoid and diphtheria toxoid booster every 10 years,” according to the review.
Live vaccines
Live vaccines are a concerning issue for HIV-infected adults and recommendations for use are generally tied to the CD4 T-cell count. The measles, mumps, and rubella vaccine seems to be safe in patients infected with HIV with a CD4 count greater than 200 cells/mm3, according to Dr. El Chaer and his colleague. Similarly, patients with HIV with CD4 counts greater than 200 cells/mm3 and no evidence of documented immunity to varicella should receive the varicella vaccine.
In contrast, the live, attenuated varicella zoster virus vaccine is not recommended for patients infected with HIV, and it is contraindicated if CD4 count is less than 200 cells/mm3. Recently, a herpes zoster subunit vaccine (HZ/su) was tested in a phase 1/2a randomized, placebo-controlled study and was found to be safe and immunogenic regardless of CD4 count, although it has not yet been given a specific recommendation for immunocompromised patients.
“With the widespread use of ART resulting in better HIV control, ,” the authors concluded.
The study was not sponsored. Dr. El Chaer and his colleague reported that they had no conflicts.
SOURCE: El Chaer F et al. Am J Med. 2019. doi: 10.1016/j.amjmed.2018.12.011.
FROM THE AMERICAN JOURNAL OF MEDICINE
Key clinical point: Undervaccination is too common among HIV-infected patients.
Major finding: Data on vaccine effectiveness in HIV patients are limited, but do not contraindicate the need for vaccination.
Study details: Literature review of immunogenicity and vaccine efficacy in HIV-infected adults.
Disclosures: The study was unsponsored and the authors reported they had no conflicts.
Source: El Chaer F et al. Am J Med. 2019. doi: 10.1016/j.amjmed.2018.12.011.
Adenovirus: More than just another viral illness
The mother of three looked tired and little worried. She wasn’t one to bring her kids to the pediatrician’s office with every minor illness, but her youngest had 3 days of fever, runny nose, cough, and little of her normal energy.
The pediatrician entered the room and smiled sympathetically.
“We ran tests for flu and RSV [respiratory syncytial virus] and it’s neither of those so. ...”
“So it’s just a virus that we don’t routinely test for and it’s going to need to run its course,” the mother finished his sentence. She knew the drill.
Before the doctor could leave the room though, the mother had one more question. “You don’t think it could be adenovirus do you?”
Most years, influenza and RSV command center stage, and adenovirus is relegated to the wings. It is not so much lack of disease or morbidity, but rather lack of recognition. Yes, we all learned in medical school that it is a cause of epidemic keratoconjunctivitis, but many adenoviral infections are clinically indistinguishable from infections caused by other viruses. Common symptoms – fever, cough, sore throat, and malaise – overlap with those caused by influenza. Like rhinovirus, adenovirus can cause common cold symptoms. Like RSV, it can cause bronchiolitis. Just like parainfluenza, it can cause croup. It can cause a pertussislike syndrome with prolonged cough, and enteric adenoviruses, especially types 40 and 41, cause gastroenteritis that mimics norovirus or rotavirus infection.
Testing for adenovirus is not readily available or routine in most pediatricians’ offices, and while many hospitals and reference labs offer adenovirus polymerase chain reaction testing as part of a comprehensive respiratory virus panel, the test can be expensive and unlikely to change management in most ambulatory patients. This makes it difficult to count the number of adenoviruses annually.
This winter though, adenovirus was in the news ... repeatedly. In November 2018, CBS News reported that a University of Maryland freshman had died of an adenovirus-related illness. The family of Olivia Paregol told reporters that she was being treated for Crohn’s disease. Immune suppression is one recognized risk factor for more severe adenoviral disease; underlying heart and lung disease are others. Testing at the Centers for Disease Control and Prevention revealed that the student and several others on campus were infected with adenovirus type 7, a strain that has been associated with outbreaks of acute, severe respiratory illness in military recruits. As of Jan. 24, 2019, university officials reported 42 confirmed cases of adenovirus in University of Maryland students, 13 of which were confirmed as adenovirus 7.
Adenovirus type 7 also caused an outbreak at a pediatric long-term care facility in New Jersey late last year. Between Sept. 26 and Nov. 11, 2018, 36 residents and 1 staff member became ill. Eleven individuals died. In an unrelated outbreak at a second pediatric long-term care facility, 17 residents were affected between Oct. 20 and Dec. 10, 2018. Adenovirus 3 was identified and all children recovered.
Between October 2013 and July 2014, public health officials in Oregon identified an increase in adenoviral infections in people with respiratory illness. Sixty-nine percent were hospitalized (136/198), 31% needed intensive care, and 18% were mechanically ventilated. Multiple types of adenovirus were recovered but the most common was adenovirus 7 (Emerg Infect Dis. 2016. doi: 10.3201/eid2206.151898).
Depending on your perspective, measures to prevent the spread of adenovirus are elegantly simple, evidence-based, public health intervention or maddeningly little more than common sense. Wash your hands often with soap and water. Avoid touching your eyes, mouth, and nose with unwashed hands. Avoid close contact with people who are sick. The latter is easier if those who are sick stay home. Prior to the start of the most recent academic semester at the University of Maryland, university officials urged students who were sick not to return to campus but to stay at home to rest and recover. Those who fell ill on campus were urged to return home via nonpublic transportation if possible. Those who stayed on campus were advised to stay in their living spaces and clean high-touch surfaces with bleach. Like other nonenveloped viruses, adenovirus is not easily destroyed by many commonly used disinfectants. Under ideal conditions, it can survive on surfaces – remaining infectious – for up to 3 months.
Back at the pediatrician’s office, “We need an adenovirus vaccine,” the mother said as she picked up her child and headed for the door.
There is, in fact, a live oral vaccine that protects against adenovirus types 4 and 7. It is only approved for use in United States military personnel aged 17-50 years and it is given to all recruits as soon as they enter basic training. It works too. Before vaccine was available, up to 80% of recruits became infected during their initial training, half of those developing significant illness and a quarter being hospitalized. When the current vaccine was introduced in 2011, there was a 100-fold decrease in adenovirus-related disease burden (from 5.8 to 0.02 cases per 1,000 person-weeks, P less than .0001). That translates to 1 death, 1,100-2,700 hospitalizations and 13,000 febrile illnesses prevented each year (Clin Infect Dis. 2014 Oct 1. doi: 10.1093/cid/ciu507).
Some experts have suggested that adenovirus vaccine could be useful in civilian populations, too, but I question what the public reception would be. We have safe influenza vaccines that reduce the need for hospitalization and reduce mortality from influenza, but we still can’t convince some people to immunize themselves and their children. In the last 4 years, flu vaccination rates among children have remained just shy of 60% and adult rates are even lower. Collectively, we don’t seem to be ready to relinquish – or at least diminish – the annual suffering that goes with flu. I have to wonder if the same would be true for adenovirus.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
The mother of three looked tired and little worried. She wasn’t one to bring her kids to the pediatrician’s office with every minor illness, but her youngest had 3 days of fever, runny nose, cough, and little of her normal energy.
The pediatrician entered the room and smiled sympathetically.
“We ran tests for flu and RSV [respiratory syncytial virus] and it’s neither of those so. ...”
“So it’s just a virus that we don’t routinely test for and it’s going to need to run its course,” the mother finished his sentence. She knew the drill.
Before the doctor could leave the room though, the mother had one more question. “You don’t think it could be adenovirus do you?”
Most years, influenza and RSV command center stage, and adenovirus is relegated to the wings. It is not so much lack of disease or morbidity, but rather lack of recognition. Yes, we all learned in medical school that it is a cause of epidemic keratoconjunctivitis, but many adenoviral infections are clinically indistinguishable from infections caused by other viruses. Common symptoms – fever, cough, sore throat, and malaise – overlap with those caused by influenza. Like rhinovirus, adenovirus can cause common cold symptoms. Like RSV, it can cause bronchiolitis. Just like parainfluenza, it can cause croup. It can cause a pertussislike syndrome with prolonged cough, and enteric adenoviruses, especially types 40 and 41, cause gastroenteritis that mimics norovirus or rotavirus infection.
Testing for adenovirus is not readily available or routine in most pediatricians’ offices, and while many hospitals and reference labs offer adenovirus polymerase chain reaction testing as part of a comprehensive respiratory virus panel, the test can be expensive and unlikely to change management in most ambulatory patients. This makes it difficult to count the number of adenoviruses annually.
This winter though, adenovirus was in the news ... repeatedly. In November 2018, CBS News reported that a University of Maryland freshman had died of an adenovirus-related illness. The family of Olivia Paregol told reporters that she was being treated for Crohn’s disease. Immune suppression is one recognized risk factor for more severe adenoviral disease; underlying heart and lung disease are others. Testing at the Centers for Disease Control and Prevention revealed that the student and several others on campus were infected with adenovirus type 7, a strain that has been associated with outbreaks of acute, severe respiratory illness in military recruits. As of Jan. 24, 2019, university officials reported 42 confirmed cases of adenovirus in University of Maryland students, 13 of which were confirmed as adenovirus 7.
Adenovirus type 7 also caused an outbreak at a pediatric long-term care facility in New Jersey late last year. Between Sept. 26 and Nov. 11, 2018, 36 residents and 1 staff member became ill. Eleven individuals died. In an unrelated outbreak at a second pediatric long-term care facility, 17 residents were affected between Oct. 20 and Dec. 10, 2018. Adenovirus 3 was identified and all children recovered.
Between October 2013 and July 2014, public health officials in Oregon identified an increase in adenoviral infections in people with respiratory illness. Sixty-nine percent were hospitalized (136/198), 31% needed intensive care, and 18% were mechanically ventilated. Multiple types of adenovirus were recovered but the most common was adenovirus 7 (Emerg Infect Dis. 2016. doi: 10.3201/eid2206.151898).
Depending on your perspective, measures to prevent the spread of adenovirus are elegantly simple, evidence-based, public health intervention or maddeningly little more than common sense. Wash your hands often with soap and water. Avoid touching your eyes, mouth, and nose with unwashed hands. Avoid close contact with people who are sick. The latter is easier if those who are sick stay home. Prior to the start of the most recent academic semester at the University of Maryland, university officials urged students who were sick not to return to campus but to stay at home to rest and recover. Those who fell ill on campus were urged to return home via nonpublic transportation if possible. Those who stayed on campus were advised to stay in their living spaces and clean high-touch surfaces with bleach. Like other nonenveloped viruses, adenovirus is not easily destroyed by many commonly used disinfectants. Under ideal conditions, it can survive on surfaces – remaining infectious – for up to 3 months.
Back at the pediatrician’s office, “We need an adenovirus vaccine,” the mother said as she picked up her child and headed for the door.
There is, in fact, a live oral vaccine that protects against adenovirus types 4 and 7. It is only approved for use in United States military personnel aged 17-50 years and it is given to all recruits as soon as they enter basic training. It works too. Before vaccine was available, up to 80% of recruits became infected during their initial training, half of those developing significant illness and a quarter being hospitalized. When the current vaccine was introduced in 2011, there was a 100-fold decrease in adenovirus-related disease burden (from 5.8 to 0.02 cases per 1,000 person-weeks, P less than .0001). That translates to 1 death, 1,100-2,700 hospitalizations and 13,000 febrile illnesses prevented each year (Clin Infect Dis. 2014 Oct 1. doi: 10.1093/cid/ciu507).
Some experts have suggested that adenovirus vaccine could be useful in civilian populations, too, but I question what the public reception would be. We have safe influenza vaccines that reduce the need for hospitalization and reduce mortality from influenza, but we still can’t convince some people to immunize themselves and their children. In the last 4 years, flu vaccination rates among children have remained just shy of 60% and adult rates are even lower. Collectively, we don’t seem to be ready to relinquish – or at least diminish – the annual suffering that goes with flu. I have to wonder if the same would be true for adenovirus.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
The mother of three looked tired and little worried. She wasn’t one to bring her kids to the pediatrician’s office with every minor illness, but her youngest had 3 days of fever, runny nose, cough, and little of her normal energy.
The pediatrician entered the room and smiled sympathetically.
“We ran tests for flu and RSV [respiratory syncytial virus] and it’s neither of those so. ...”
“So it’s just a virus that we don’t routinely test for and it’s going to need to run its course,” the mother finished his sentence. She knew the drill.
Before the doctor could leave the room though, the mother had one more question. “You don’t think it could be adenovirus do you?”
Most years, influenza and RSV command center stage, and adenovirus is relegated to the wings. It is not so much lack of disease or morbidity, but rather lack of recognition. Yes, we all learned in medical school that it is a cause of epidemic keratoconjunctivitis, but many adenoviral infections are clinically indistinguishable from infections caused by other viruses. Common symptoms – fever, cough, sore throat, and malaise – overlap with those caused by influenza. Like rhinovirus, adenovirus can cause common cold symptoms. Like RSV, it can cause bronchiolitis. Just like parainfluenza, it can cause croup. It can cause a pertussislike syndrome with prolonged cough, and enteric adenoviruses, especially types 40 and 41, cause gastroenteritis that mimics norovirus or rotavirus infection.
Testing for adenovirus is not readily available or routine in most pediatricians’ offices, and while many hospitals and reference labs offer adenovirus polymerase chain reaction testing as part of a comprehensive respiratory virus panel, the test can be expensive and unlikely to change management in most ambulatory patients. This makes it difficult to count the number of adenoviruses annually.
This winter though, adenovirus was in the news ... repeatedly. In November 2018, CBS News reported that a University of Maryland freshman had died of an adenovirus-related illness. The family of Olivia Paregol told reporters that she was being treated for Crohn’s disease. Immune suppression is one recognized risk factor for more severe adenoviral disease; underlying heart and lung disease are others. Testing at the Centers for Disease Control and Prevention revealed that the student and several others on campus were infected with adenovirus type 7, a strain that has been associated with outbreaks of acute, severe respiratory illness in military recruits. As of Jan. 24, 2019, university officials reported 42 confirmed cases of adenovirus in University of Maryland students, 13 of which were confirmed as adenovirus 7.
Adenovirus type 7 also caused an outbreak at a pediatric long-term care facility in New Jersey late last year. Between Sept. 26 and Nov. 11, 2018, 36 residents and 1 staff member became ill. Eleven individuals died. In an unrelated outbreak at a second pediatric long-term care facility, 17 residents were affected between Oct. 20 and Dec. 10, 2018. Adenovirus 3 was identified and all children recovered.
Between October 2013 and July 2014, public health officials in Oregon identified an increase in adenoviral infections in people with respiratory illness. Sixty-nine percent were hospitalized (136/198), 31% needed intensive care, and 18% were mechanically ventilated. Multiple types of adenovirus were recovered but the most common was adenovirus 7 (Emerg Infect Dis. 2016. doi: 10.3201/eid2206.151898).
Depending on your perspective, measures to prevent the spread of adenovirus are elegantly simple, evidence-based, public health intervention or maddeningly little more than common sense. Wash your hands often with soap and water. Avoid touching your eyes, mouth, and nose with unwashed hands. Avoid close contact with people who are sick. The latter is easier if those who are sick stay home. Prior to the start of the most recent academic semester at the University of Maryland, university officials urged students who were sick not to return to campus but to stay at home to rest and recover. Those who fell ill on campus were urged to return home via nonpublic transportation if possible. Those who stayed on campus were advised to stay in their living spaces and clean high-touch surfaces with bleach. Like other nonenveloped viruses, adenovirus is not easily destroyed by many commonly used disinfectants. Under ideal conditions, it can survive on surfaces – remaining infectious – for up to 3 months.
Back at the pediatrician’s office, “We need an adenovirus vaccine,” the mother said as she picked up her child and headed for the door.
There is, in fact, a live oral vaccine that protects against adenovirus types 4 and 7. It is only approved for use in United States military personnel aged 17-50 years and it is given to all recruits as soon as they enter basic training. It works too. Before vaccine was available, up to 80% of recruits became infected during their initial training, half of those developing significant illness and a quarter being hospitalized. When the current vaccine was introduced in 2011, there was a 100-fold decrease in adenovirus-related disease burden (from 5.8 to 0.02 cases per 1,000 person-weeks, P less than .0001). That translates to 1 death, 1,100-2,700 hospitalizations and 13,000 febrile illnesses prevented each year (Clin Infect Dis. 2014 Oct 1. doi: 10.1093/cid/ciu507).
Some experts have suggested that adenovirus vaccine could be useful in civilian populations, too, but I question what the public reception would be. We have safe influenza vaccines that reduce the need for hospitalization and reduce mortality from influenza, but we still can’t convince some people to immunize themselves and their children. In the last 4 years, flu vaccination rates among children have remained just shy of 60% and adult rates are even lower. Collectively, we don’t seem to be ready to relinquish – or at least diminish – the annual suffering that goes with flu. I have to wonder if the same would be true for adenovirus.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.
E-cig use reverses progress in reducing tobacco use in teens
A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.
E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*
In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.
“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.
The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.
“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.
Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.
Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”
The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.
“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.
In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”
In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.
One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.
Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.
The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.
SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.
*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.
A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.
E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*
In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.
“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.
The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.
“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.
Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.
Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”
The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.
“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.
In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”
In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.
One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.
Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.
The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.
SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.
*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.
A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.
E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*
In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.
“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.
The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.
“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.
Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.
Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”
The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.
“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.
In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”
In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.
One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.
Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.
The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.
SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.
*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.
FROM CDC VITAL SIGNS REPORT