Pulmonology

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

Areas that have adopted smoke-free policies in their restaurants, bars, and workplaces have seen a corresponding drop in systolic blood pressure, according to data from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

“Among a geographically diverse cohort of black and white nonsmoking adults followed for 15 years, we found that participants living in areas with smoke-free policies in restaurants, bars, and workplaces had lower systolic blood pressure at the end of follow-up, compared with participants living in areas without smoke-free policies,” wrote Stephanie L. Mayne, PhD, of the department of preventative medicine at Northwestern University, Chicago, and her coauthors in the Journal of the American Heart Association.

The study analyzed data from 2,606 CARDIA participants, all of whom enrolled in 1985-1986 and underwent follow-up exams after 2, 5, 7, 10, 15, 20, 25, and 30 years. Smoke-free policies were obtained from the American Non-Smokers’ Rights Foundation’s Local Ordinance Database and linked to participants based on their census tract and examination date. Systolic and diastolic blood pressure (SBP, DBP), along with physical activity and dietary quality, were measured at each examination.

By year 25, participants in areas with smoke-free restaurants had SBP values that were 1.14 mm Hg lower than participants who lived in areas with smoke-friendly restaurants (95% confidence interval, 2.15-0.12). Participants in areas with smoke-free bars returned similar results, with a SBP difference of 1.52 mm Hg (95% CI, 2.48-0.57). The data were less conclusive for DBP, though CARDIA indicated that SBP was more associated with cardiovascular disease risk than DBP and “even small reductions in SBP may result in meaningful reductions in CVD risk.”

The coauthors shared the study’s potential limitations, including an inability to control for antismoking campaigns and the possibility that participants did not report any infrequent smoking habits. However, they highlighted previous associations between smoke-free policies and reduced risk of hospitalization for CVD, noting the relation and suggesting “BP reduction as a potential mechanism through which smoke-free policies may reduce rates of CVD at the population level.”

This study was supported by the National Heart, Lung, and Blood Institute, in collaboration with the University of Alabama at Birmingham, Northwestern University, the University of Minnesota, Kaiser Foundation Research Institute, and Johns Hopkins University School of Medicine. It was partially supported by the Intramural Research Program of the National Institute on Aging. No conflicts of interest were reported.

SOURCE: Mayne SL et al. J Am Heart Assoc. 2018 Nov 21. doi: 10.1161/JAHA.118.009829.

Clinical question: Does testing procalcitonin for lower respiratory tract infections (LRTIs) decrease total antibiotic days without a resultant increase in adverse events?

Background: LRTIs are frequently overtreated with antibiotics. Procalcitonin may indicate bacterial infection and promote antibacterial stewardship. Studies to evaluate how testing procalcitonin affects antibiotic use for suspected lower respiratory tract infections are limited.

Study design: Randomized 1:1 intention-to-treat, multicenter trial.

Setting: 14 U.S. urban academic hospitals.

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Dr. Naderi is assistant professor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Does testing procalcitonin for lower respiratory tract infections (LRTIs) decrease total antibiotic days without a resultant increase in adverse events?

Background: LRTIs are frequently overtreated with antibiotics. Procalcitonin may indicate bacterial infection and promote antibacterial stewardship. Studies to evaluate how testing procalcitonin affects antibiotic use for suspected lower respiratory tract infections are limited.

Study design: Randomized 1:1 intention-to-treat, multicenter trial.

Setting: 14 U.S. urban academic hospitals.

Image

Dr. Naderi is assistant professor in the division of hospital medicine, University of Colorado, Denver.

Clinical question: Does testing procalcitonin for lower respiratory tract infections (LRTIs) decrease total antibiotic days without a resultant increase in adverse events?

Background: LRTIs are frequently overtreated with antibiotics. Procalcitonin may indicate bacterial infection and promote antibacterial stewardship. Studies to evaluate how testing procalcitonin affects antibiotic use for suspected lower respiratory tract infections are limited.

Study design: Randomized 1:1 intention-to-treat, multicenter trial.

Setting: 14 U.S. urban academic hospitals.

Image

Dr. Naderi is assistant professor in the division of hospital medicine, University of Colorado, Denver.

Kids with poor cardiorespiratory fitness are at increased risk of developing type 2 diabetes and cardiovascular disease, according to the analysis of an ongoing Finnish study of physical activity and dietary intervention in school children.

“Our results are in agreement with previous findings that cardiorespiratory fitness measured in exercise test laboratories or using field tests and scaled by body mass (BM) using the ratio standard method had a strong inverse association with cardiometabolic risk in children,” lead author Andrew O. Agbaje, MD, MPH, and his coauthors wrote in the Scandinavian Journal of Medicine & Science in Sports.

The coauthors assessed the cardiorespiratory fitness of 352 primary school children – 186 boys and 166 girls – from Kuopio, Finland, all of whom were already participating in the ongoing PANIC (Physical Activity and Nutrition in Children) Study. The children were asked to perform a maximal exercise test, upon which fitness was assessed by measuring peak oxygen uptake (VO_{2 peak}), noted Dr. Agbaje, a PhD student at the University of Eastern Finland’s Institute of Biomedicine in Kuopio, and his colleagues.

Body mass and lean mass were also measured by bioelectrical impedance and used to scale VO_{2 peak}, while variables such as waist circumference, insulin, glucose, HDL cholesterol, and triglycerides were used to calculate a continuous cardiometabolic risk score. Upon analysis, VO_{2 peak} less than 45.8 mL/kg BM^-1 min^-1 in boys and less than 44.1 mL/kg BM-¹ min-¹ in girls was associated with increased cardiometabolic risk.

The coauthors noted that cardiorespiratory fitness can be influenced by genetics and that adjustments for puberty had “no effect on the relationships between VO_{2 peak} and cardiometabolic risk.” As such, they recommended that “longitudinal studies are needed to clarify the role of CRF in cardiometabolic health during growth and maturation.”

That said, despite advocating caution in regard to determining proper CRF thresholds, the coauthors suggested that CRF scaled by BM could be used to screen children and improve prevention efforts. “Cardiometabolic risk tracks from childhood into adulthood and the early identification of individuals at increased risk is essential in developing public health actions targeted at preventing cardiometabolic diseases,” they wrote.

The study was funded by grants from the Ministry of Education and Culture of Finland, Ministry of Social Affairs and Health of Finland, Research Committee of the Kuopio University Hospital Catchment Area (State Research Funding), Finnish Innovation Fund Sitra, Social Insurance Institution of Finland, Finnish Cultural Foundation, Foundation for Paediatric Research, Diabetes Research Foundation in Finland, Finnish Foundation for Cardiovascular Research, Juho Vainio Foundation, Paavo Nurmi Foundation, and the Yrjö Jahnsson Foundation. Dr. Agbaje reported grant support from the Olvi Foundation and the Urho Känkanen Foundation.

SOURCE: Agbaje AO et al. Scand J Med Sci Sports. 2018 Sep 19. doi: 10.1111/sms.13307.

Kids with poor cardiorespiratory fitness are at increased risk of developing type 2 diabetes and cardiovascular disease, according to the analysis of an ongoing Finnish study of physical activity and dietary intervention in school children.

“Our results are in agreement with previous findings that cardiorespiratory fitness measured in exercise test laboratories or using field tests and scaled by body mass (BM) using the ratio standard method had a strong inverse association with cardiometabolic risk in children,” lead author Andrew O. Agbaje, MD, MPH, and his coauthors wrote in the Scandinavian Journal of Medicine & Science in Sports.

The coauthors assessed the cardiorespiratory fitness of 352 primary school children – 186 boys and 166 girls – from Kuopio, Finland, all of whom were already participating in the ongoing PANIC (Physical Activity and Nutrition in Children) Study. The children were asked to perform a maximal exercise test, upon which fitness was assessed by measuring peak oxygen uptake (VO_{2 peak}), noted Dr. Agbaje, a PhD student at the University of Eastern Finland’s Institute of Biomedicine in Kuopio, and his colleagues.

Body mass and lean mass were also measured by bioelectrical impedance and used to scale VO_{2 peak}, while variables such as waist circumference, insulin, glucose, HDL cholesterol, and triglycerides were used to calculate a continuous cardiometabolic risk score. Upon analysis, VO_{2 peak} less than 45.8 mL/kg BM^-1 min^-1 in boys and less than 44.1 mL/kg BM-¹ min-¹ in girls was associated with increased cardiometabolic risk.

The coauthors noted that cardiorespiratory fitness can be influenced by genetics and that adjustments for puberty had “no effect on the relationships between VO_{2 peak} and cardiometabolic risk.” As such, they recommended that “longitudinal studies are needed to clarify the role of CRF in cardiometabolic health during growth and maturation.”

That said, despite advocating caution in regard to determining proper CRF thresholds, the coauthors suggested that CRF scaled by BM could be used to screen children and improve prevention efforts. “Cardiometabolic risk tracks from childhood into adulthood and the early identification of individuals at increased risk is essential in developing public health actions targeted at preventing cardiometabolic diseases,” they wrote.

The study was funded by grants from the Ministry of Education and Culture of Finland, Ministry of Social Affairs and Health of Finland, Research Committee of the Kuopio University Hospital Catchment Area (State Research Funding), Finnish Innovation Fund Sitra, Social Insurance Institution of Finland, Finnish Cultural Foundation, Foundation for Paediatric Research, Diabetes Research Foundation in Finland, Finnish Foundation for Cardiovascular Research, Juho Vainio Foundation, Paavo Nurmi Foundation, and the Yrjö Jahnsson Foundation. Dr. Agbaje reported grant support from the Olvi Foundation and the Urho Känkanen Foundation.

SOURCE: Agbaje AO et al. Scand J Med Sci Sports. 2018 Sep 19. doi: 10.1111/sms.13307.

Kids with poor cardiorespiratory fitness are at increased risk of developing type 2 diabetes and cardiovascular disease, according to the analysis of an ongoing Finnish study of physical activity and dietary intervention in school children.

“Our results are in agreement with previous findings that cardiorespiratory fitness measured in exercise test laboratories or using field tests and scaled by body mass (BM) using the ratio standard method had a strong inverse association with cardiometabolic risk in children,” lead author Andrew O. Agbaje, MD, MPH, and his coauthors wrote in the Scandinavian Journal of Medicine & Science in Sports.

The coauthors assessed the cardiorespiratory fitness of 352 primary school children – 186 boys and 166 girls – from Kuopio, Finland, all of whom were already participating in the ongoing PANIC (Physical Activity and Nutrition in Children) Study. The children were asked to perform a maximal exercise test, upon which fitness was assessed by measuring peak oxygen uptake (VO_{2 peak}), noted Dr. Agbaje, a PhD student at the University of Eastern Finland’s Institute of Biomedicine in Kuopio, and his colleagues.

Body mass and lean mass were also measured by bioelectrical impedance and used to scale VO_{2 peak}, while variables such as waist circumference, insulin, glucose, HDL cholesterol, and triglycerides were used to calculate a continuous cardiometabolic risk score. Upon analysis, VO_{2 peak} less than 45.8 mL/kg BM^-1 min^-1 in boys and less than 44.1 mL/kg BM-¹ min-¹ in girls was associated with increased cardiometabolic risk.

The coauthors noted that cardiorespiratory fitness can be influenced by genetics and that adjustments for puberty had “no effect on the relationships between VO_{2 peak} and cardiometabolic risk.” As such, they recommended that “longitudinal studies are needed to clarify the role of CRF in cardiometabolic health during growth and maturation.”

That said, despite advocating caution in regard to determining proper CRF thresholds, the coauthors suggested that CRF scaled by BM could be used to screen children and improve prevention efforts. “Cardiometabolic risk tracks from childhood into adulthood and the early identification of individuals at increased risk is essential in developing public health actions targeted at preventing cardiometabolic diseases,” they wrote.

The study was funded by grants from the Ministry of Education and Culture of Finland, Ministry of Social Affairs and Health of Finland, Research Committee of the Kuopio University Hospital Catchment Area (State Research Funding), Finnish Innovation Fund Sitra, Social Insurance Institution of Finland, Finnish Cultural Foundation, Foundation for Paediatric Research, Diabetes Research Foundation in Finland, Finnish Foundation for Cardiovascular Research, Juho Vainio Foundation, Paavo Nurmi Foundation, and the Yrjö Jahnsson Foundation. Dr. Agbaje reported grant support from the Olvi Foundation and the Urho Känkanen Foundation.

SOURCE: Agbaje AO et al. Scand J Med Sci Sports. 2018 Sep 19. doi: 10.1111/sms.13307.

The Food and Drug Administration once again has upped the ante in its war on youth smoking and vaping.

Thinkstockphotos

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

First and foremost, the FDA wants to reduce the lure of e-cigarettes by limiting the variety of flavored products for sale in retail outlets. Under the proposal unveiled Nov. 15, only electronic nicotine delivery systems (ENDS) that are unflavored or have tobacco, mint, or menthol flavors would be widely available. Flavored products – think cherry, cotton candy, and mango – would be sold in age-restricted environments, such as stand-alone tobacco retailers like vape shops. The FDA also seeks more stringent enforcement of age verification on ENDS products sold online.

The proposal also would reexamine regulations governing flavored cigars, with the possible aim of banning them.

“These efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting,” Dr. Gottlieb said in a statement. “This policy framework reflects a redoubling of the FDA’s efforts to protect kids from all nicotine-containing products.”

In a move that seems to be aimed at youth-oriented products like Juul, the FDA will be seeking to remove from the market any ENDS product that is marketed specifically to young people.

Finally, the FDA intends to pursue regulation that would ban menthol from combustible tobacco products.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” Dr. Gottlieb said. “The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status.”

The policy shift comes as the Centers for Disease Control and Prevention released data from the 2018 National Youth Tobacco Survey showing that use of e-cigarettes among high schoolers is on the rise, growing from 1.5% in 2011 to 20.8% in 2018. Middle schoolers saw use over the same time period increase from 0.6% to 4.9%.

The rise of current use of e-cigarettes was enough to reverse a declining trend in overall tobacco use in recent years between 2015 and 2017.

“FDA’s enforcement efforts and policy framework would restrict access to most flavored e-cigarettes and limit the chances of youth beginning to use these products, while ensuring the products are available to adult smokers as an alternative to combustible cigarettes,” Alex M. Azar II, secretary of the Department of Health & Human Services, said in a statement supporting the FDA’s efforts. “Our obligation at HHS is always to the public health, and we believe FDA’s goals strike the right public health balance in addressing the multifaceted challenge we have before us today.”

Under Dr. Gottlieb, the FDA has been aggressively pursuing ways to reduce tobacco consumption, targeting both ENDS and combustible tobacco regulations in an effort to limit nicotine exposure and reduce the number of people addicted to nicotine and the health issues that come with it.

The American College of Cardiology voiced its support of the FDA’s actions.

“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children,” ACC President C. Michael Valentine, MD, said in a statement, adding that the medical community needs to continue to do its part to make sure tobacco use continues to decline, especially in the nonadult population.

The FDA proposals were published as part of an advance notice of proposed rulemaking in the Federal Register. Comments can be made at www.regulations.gov through June 19.

gtwachtman@mdedge.com

The Food and Drug Administration once again has upped the ante in its war on youth smoking and vaping.

Thinkstockphotos

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

First and foremost, the FDA wants to reduce the lure of e-cigarettes by limiting the variety of flavored products for sale in retail outlets. Under the proposal unveiled Nov. 15, only electronic nicotine delivery systems (ENDS) that are unflavored or have tobacco, mint, or menthol flavors would be widely available. Flavored products – think cherry, cotton candy, and mango – would be sold in age-restricted environments, such as stand-alone tobacco retailers like vape shops. The FDA also seeks more stringent enforcement of age verification on ENDS products sold online.

The proposal also would reexamine regulations governing flavored cigars, with the possible aim of banning them.

“These efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting,” Dr. Gottlieb said in a statement. “This policy framework reflects a redoubling of the FDA’s efforts to protect kids from all nicotine-containing products.”

In a move that seems to be aimed at youth-oriented products like Juul, the FDA will be seeking to remove from the market any ENDS product that is marketed specifically to young people.

Finally, the FDA intends to pursue regulation that would ban menthol from combustible tobacco products.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” Dr. Gottlieb said. “The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status.”

The policy shift comes as the Centers for Disease Control and Prevention released data from the 2018 National Youth Tobacco Survey showing that use of e-cigarettes among high schoolers is on the rise, growing from 1.5% in 2011 to 20.8% in 2018. Middle schoolers saw use over the same time period increase from 0.6% to 4.9%.

The rise of current use of e-cigarettes was enough to reverse a declining trend in overall tobacco use in recent years between 2015 and 2017.

“FDA’s enforcement efforts and policy framework would restrict access to most flavored e-cigarettes and limit the chances of youth beginning to use these products, while ensuring the products are available to adult smokers as an alternative to combustible cigarettes,” Alex M. Azar II, secretary of the Department of Health & Human Services, said in a statement supporting the FDA’s efforts. “Our obligation at HHS is always to the public health, and we believe FDA’s goals strike the right public health balance in addressing the multifaceted challenge we have before us today.”

Under Dr. Gottlieb, the FDA has been aggressively pursuing ways to reduce tobacco consumption, targeting both ENDS and combustible tobacco regulations in an effort to limit nicotine exposure and reduce the number of people addicted to nicotine and the health issues that come with it.

The American College of Cardiology voiced its support of the FDA’s actions.

“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children,” ACC President C. Michael Valentine, MD, said in a statement, adding that the medical community needs to continue to do its part to make sure tobacco use continues to decline, especially in the nonadult population.

The FDA proposals were published as part of an advance notice of proposed rulemaking in the Federal Register. Comments can be made at www.regulations.gov through June 19.

gtwachtman@mdedge.com

The Food and Drug Administration once again has upped the ante in its war on youth smoking and vaping.

Thinkstockphotos

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

First and foremost, the FDA wants to reduce the lure of e-cigarettes by limiting the variety of flavored products for sale in retail outlets. Under the proposal unveiled Nov. 15, only electronic nicotine delivery systems (ENDS) that are unflavored or have tobacco, mint, or menthol flavors would be widely available. Flavored products – think cherry, cotton candy, and mango – would be sold in age-restricted environments, such as stand-alone tobacco retailers like vape shops. The FDA also seeks more stringent enforcement of age verification on ENDS products sold online.

The proposal also would reexamine regulations governing flavored cigars, with the possible aim of banning them.

“These efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting,” Dr. Gottlieb said in a statement. “This policy framework reflects a redoubling of the FDA’s efforts to protect kids from all nicotine-containing products.”

In a move that seems to be aimed at youth-oriented products like Juul, the FDA will be seeking to remove from the market any ENDS product that is marketed specifically to young people.

Finally, the FDA intends to pursue regulation that would ban menthol from combustible tobacco products.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” Dr. Gottlieb said. “The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status.”

The policy shift comes as the Centers for Disease Control and Prevention released data from the 2018 National Youth Tobacco Survey showing that use of e-cigarettes among high schoolers is on the rise, growing from 1.5% in 2011 to 20.8% in 2018. Middle schoolers saw use over the same time period increase from 0.6% to 4.9%.

The rise of current use of e-cigarettes was enough to reverse a declining trend in overall tobacco use in recent years between 2015 and 2017.

“FDA’s enforcement efforts and policy framework would restrict access to most flavored e-cigarettes and limit the chances of youth beginning to use these products, while ensuring the products are available to adult smokers as an alternative to combustible cigarettes,” Alex M. Azar II, secretary of the Department of Health & Human Services, said in a statement supporting the FDA’s efforts. “Our obligation at HHS is always to the public health, and we believe FDA’s goals strike the right public health balance in addressing the multifaceted challenge we have before us today.”

Under Dr. Gottlieb, the FDA has been aggressively pursuing ways to reduce tobacco consumption, targeting both ENDS and combustible tobacco regulations in an effort to limit nicotine exposure and reduce the number of people addicted to nicotine and the health issues that come with it.

The American College of Cardiology voiced its support of the FDA’s actions.

“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children,” ACC President C. Michael Valentine, MD, said in a statement, adding that the medical community needs to continue to do its part to make sure tobacco use continues to decline, especially in the nonadult population.

The FDA proposals were published as part of an advance notice of proposed rulemaking in the Federal Register. Comments can be made at www.regulations.gov through June 19.

gtwachtman@mdedge.com

ORLANDO – More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

ORLANDO – More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

ORLANDO – More therapies are becoming available for children for the treatment of influenza and multidrug-resistant infections such as Enterobacteriaceae and Acinetobacter, John S. Bradley, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Bradley, director of the division of infectious diseases at Rady Children’s Hospital–San Diego, discussed a therapy for influenza, baloxavir, which was recently approved as a fast-acting single-dose medication and currently is under study in children. Also, a recent double-blind, phase 3 trial in the New England Journal of Medicine recruited patients as young as 12 years old. In the study, patients in the intervention group resolved their fever in median 25 hours, compared with 42 hours in the placebo group. Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups. There was a greater incidence of nausea and vomiting among the oseltamivir group, while the baloxavir group had a higher rate of diarrhea (N Engl J Med 2018;379:913-23).

However, Dr. Bradley noted baloxavir is much more expensive than oseltamivir, which may not justify the better tolerance of the drug for influenza treatment.

You don’t get better with it faster, so I’m not going to be recommending you all run to baloxavir this flu season for kids 12 years of age and older,” Dr. Bradley said. “I think oseltamivir is still fine, unless we end up with oseltamivir resistance.”

Solithromycin, an intravenous and oral fluoroketolide, has shown promising results against gram-positive and gram-negative pathogens for community-acquired pneumonia and other infections. During the drug’s study period, Cempra sold solithromycin to Melinta. However, one trial showed elevated liver functions in a higher number of patients than expected, and the Food and Drug Administration asked Melinta to conduct additional studies. Investigations on solithromycin have currently stopped until Melinta secures funding. “Until they get better resources, this particular drug is on hold, but you’ll see it again, I’m sure,” said Dr. Bradley, who also is professor and chief of the division of infectious diseases at the University of California, San Diego.

Dr. Bradley also discussed the efficacy of tedizolid, a protein synthesis inhibitor similar to linezolid approved in adults for the treatment of skin infections. He noted tedizolid is more active than linezolid, but the treatment course is a shorter dose for a shorter amount of time. Compared with linezolid, which can cause thrombocytopenia or neutropenia if taken for more than 10 days to 14 days, there also are fewer side effects.

“The tedizolid is much, much safer,” Dr. Bradley said, who added that trials for efficacy of tedizolid are currently underway in pediatric patients. “We’re hoping that will end up being the pediatric oxazolidinone.”

Other investigative therapies approved for adults and under study for use in children include ceftazidime/avibactam for treatment of urinary tract and complicated intra-abdominal infections, which is effective against meropenem-resistant Enterobacteriaceae and resistant Escherichia coli with extended-spectrum beta-lactamases (ESBL); ceftolozane/tazobactam has also been approved for adults, is pending approval in pediatric patients, and is active against ESBLs such as Pseudomonas; and meropenem/vaborbactam, which is active against Klebsiella pneumoniae carbapenemase (KPC)–producing isolates. Plazomicin, an aminoglycoside similar to gentamicin used to treat KPC-producing isolates, is stable against enzymes that degrade gentamicin and tobramycin.

CDC/ Matthew J. Arduino

Therapies currently under study for adults and being considered for children include imipenem/relebactam for treatment against E. coli, Enterobacter species, and KPC-producing isolates, and cefiderocol, a siderophore cephalosporin antibiotic – commonly described as a “Trojan horse” antibiotic because it binds to iron and is actively transported into the organism – is effective against Pseudomonas and has finished phase 2 trials in adults, with researchers looking to do single-dose trials in children, Dr. Bradley noted.

More experimentally, phage therapy for multidrug-resistant Acinetobacter baumannii proved effective in a 68-year-old patient with necrotizing pancreatitis who continued to deteriorate over a 4-month period despite multiple courses of antibiotics and attempted drainage of a pancreatic pseudocyst. Researchers selected a phage-specific bacterium with specificity for A. baumannii and cured him. “This is like science fiction,” Dr. Bradley said.

Dr. Bradley reported no relevant conflicts of interest.

CHICAGO – Changes in quantitative lung CT scores for scleroderma-related interstitial lung disease independently validate the superiority of hematopoietic stem cell transplantation versus cyclophosphamide for severe systemic sclerosis, according to findings in a subset of patients from the SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial.

Mitchel L. Zoler/MDedge News

The recently published findings from the SCOT trial showed that myeloablation followed by autologous hematopoietic stem cell transplant (HSCT) significantly improved event-free and overall survival of systemic sclerosis patients at 54 months, compared with 12 monthly treatments with intravenous cyclophosphamide (N Engl J Med. 2018;378:35-47).

In a subset of 75 patients from the SCOT trial, the investigators analyzed changes in lung parenchymal abnormalities on high-resolution CT scans between baseline and serial follow-up exams performed yearly for up to 5 years. Follow-up scans at 14, 26, 48, and 54 months in available patients at each time point showed that whole-lung quantitative interstitial lung disease (QILD) scores – a validated measure that combines various CT texture-based characteristics to determine disease extent – decreased significantly by 7% at 54 months in patients who underwent HSCT, compared with no change in those who received cyclophosphamide (CYC; P = .024), Keith M. Sullivan, MD, reported at the annual meeting of the American College of Rheumatology.

Additionally, whole-lung quantitative lung fibrosis (QLF) scores were stable (–1%) in the HSCT patients, but increased 3% in the CYC patients (P = .047), said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.


Dr. Sullivan was the first author on the SCOT trial, and he reported the current study results on behalf of lead investigator Jonathan Goldin, MD, PhD, of the department of radiologic sciences at the University of California, Los Angeles.

“These are really kind of meaningful associations, especially since the worst of the [CYC] treatment group didn’t make it to month 54,” Dr. Sullivan said.

Quantitative scores of scleroderma-related interstitial lung disease were measured using computer-based quantitative image analysis of standardized, noncontrast, volumetric, thin-section, thoracic, high-resolution CT. The same CT machine was used for all time points (except for one subject) with careful attention to breath hold reproducibility and image quality. Baseline characteristics were not different between the HSCT and CYC groups, he noted, stressing the rigorous study design.

CT assessments were also compared for the most severe lobe in each patient and showed similar findings, with both QILD and QLF scores for that lobe improving in the HSCT patients relative to the CYC patients (P = .004 and P = .002, respectively), Dr. Sullivan said, adding that the direction of change in structural measures of QILD and QLF for both whole lung and most severe lobe CTs tracked with physiological pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide.

“The FVC improved while QILD decreased, and that’s what you would expect to see,” he said. “So for each of these ways of displaying data, there was an expected and sensible inverse correlation.”

Scleroderma-related interstitial lung disease is a major cause of morbidity and mortality in severe systemic sclerosis. In the wake of the SCOT trial findings, questions remained with respect to correlation between those findings and pulmonary function; if the improvements with HSCT are real and meaningful, they should have meaningful correlation with pulmonary function, and these findings demonstrate those correlates, he said.

“Changes in quantitative lung CT scoring of scleroderma lung disease provide an objective radiologic validation of the long-term benefits of transplant compared to cyclophosphamide in individuals with severe scleroderma and lung involvement. Improvement in imaging after transplant continues for up to 54 months after randomization, giving radiologic confirmation of a durable treatment benefit,” Dr. Sullivan concluded.

The investigators reported having no relevant disclosures.

sworcester@mdedge.com

SOURCE: Goldin J et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 901.

CHICAGO – Changes in quantitative lung CT scores for scleroderma-related interstitial lung disease independently validate the superiority of hematopoietic stem cell transplantation versus cyclophosphamide for severe systemic sclerosis, according to findings in a subset of patients from the SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial.

Mitchel L. Zoler/MDedge News

The recently published findings from the SCOT trial showed that myeloablation followed by autologous hematopoietic stem cell transplant (HSCT) significantly improved event-free and overall survival of systemic sclerosis patients at 54 months, compared with 12 monthly treatments with intravenous cyclophosphamide (N Engl J Med. 2018;378:35-47).

In a subset of 75 patients from the SCOT trial, the investigators analyzed changes in lung parenchymal abnormalities on high-resolution CT scans between baseline and serial follow-up exams performed yearly for up to 5 years. Follow-up scans at 14, 26, 48, and 54 months in available patients at each time point showed that whole-lung quantitative interstitial lung disease (QILD) scores – a validated measure that combines various CT texture-based characteristics to determine disease extent – decreased significantly by 7% at 54 months in patients who underwent HSCT, compared with no change in those who received cyclophosphamide (CYC; P = .024), Keith M. Sullivan, MD, reported at the annual meeting of the American College of Rheumatology.

Additionally, whole-lung quantitative lung fibrosis (QLF) scores were stable (–1%) in the HSCT patients, but increased 3% in the CYC patients (P = .047), said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.


Dr. Sullivan was the first author on the SCOT trial, and he reported the current study results on behalf of lead investigator Jonathan Goldin, MD, PhD, of the department of radiologic sciences at the University of California, Los Angeles.

“These are really kind of meaningful associations, especially since the worst of the [CYC] treatment group didn’t make it to month 54,” Dr. Sullivan said.

Quantitative scores of scleroderma-related interstitial lung disease were measured using computer-based quantitative image analysis of standardized, noncontrast, volumetric, thin-section, thoracic, high-resolution CT. The same CT machine was used for all time points (except for one subject) with careful attention to breath hold reproducibility and image quality. Baseline characteristics were not different between the HSCT and CYC groups, he noted, stressing the rigorous study design.

CT assessments were also compared for the most severe lobe in each patient and showed similar findings, with both QILD and QLF scores for that lobe improving in the HSCT patients relative to the CYC patients (P = .004 and P = .002, respectively), Dr. Sullivan said, adding that the direction of change in structural measures of QILD and QLF for both whole lung and most severe lobe CTs tracked with physiological pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide.

“The FVC improved while QILD decreased, and that’s what you would expect to see,” he said. “So for each of these ways of displaying data, there was an expected and sensible inverse correlation.”

Scleroderma-related interstitial lung disease is a major cause of morbidity and mortality in severe systemic sclerosis. In the wake of the SCOT trial findings, questions remained with respect to correlation between those findings and pulmonary function; if the improvements with HSCT are real and meaningful, they should have meaningful correlation with pulmonary function, and these findings demonstrate those correlates, he said.

“Changes in quantitative lung CT scoring of scleroderma lung disease provide an objective radiologic validation of the long-term benefits of transplant compared to cyclophosphamide in individuals with severe scleroderma and lung involvement. Improvement in imaging after transplant continues for up to 54 months after randomization, giving radiologic confirmation of a durable treatment benefit,” Dr. Sullivan concluded.

The investigators reported having no relevant disclosures.

sworcester@mdedge.com

SOURCE: Goldin J et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 901.

CHICAGO – Changes in quantitative lung CT scores for scleroderma-related interstitial lung disease independently validate the superiority of hematopoietic stem cell transplantation versus cyclophosphamide for severe systemic sclerosis, according to findings in a subset of patients from the SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial.

Mitchel L. Zoler/MDedge News

The recently published findings from the SCOT trial showed that myeloablation followed by autologous hematopoietic stem cell transplant (HSCT) significantly improved event-free and overall survival of systemic sclerosis patients at 54 months, compared with 12 monthly treatments with intravenous cyclophosphamide (N Engl J Med. 2018;378:35-47).

In a subset of 75 patients from the SCOT trial, the investigators analyzed changes in lung parenchymal abnormalities on high-resolution CT scans between baseline and serial follow-up exams performed yearly for up to 5 years. Follow-up scans at 14, 26, 48, and 54 months in available patients at each time point showed that whole-lung quantitative interstitial lung disease (QILD) scores – a validated measure that combines various CT texture-based characteristics to determine disease extent – decreased significantly by 7% at 54 months in patients who underwent HSCT, compared with no change in those who received cyclophosphamide (CYC; P = .024), Keith M. Sullivan, MD, reported at the annual meeting of the American College of Rheumatology.

Additionally, whole-lung quantitative lung fibrosis (QLF) scores were stable (–1%) in the HSCT patients, but increased 3% in the CYC patients (P = .047), said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.


Dr. Sullivan was the first author on the SCOT trial, and he reported the current study results on behalf of lead investigator Jonathan Goldin, MD, PhD, of the department of radiologic sciences at the University of California, Los Angeles.

“These are really kind of meaningful associations, especially since the worst of the [CYC] treatment group didn’t make it to month 54,” Dr. Sullivan said.

Quantitative scores of scleroderma-related interstitial lung disease were measured using computer-based quantitative image analysis of standardized, noncontrast, volumetric, thin-section, thoracic, high-resolution CT. The same CT machine was used for all time points (except for one subject) with careful attention to breath hold reproducibility and image quality. Baseline characteristics were not different between the HSCT and CYC groups, he noted, stressing the rigorous study design.

CT assessments were also compared for the most severe lobe in each patient and showed similar findings, with both QILD and QLF scores for that lobe improving in the HSCT patients relative to the CYC patients (P = .004 and P = .002, respectively), Dr. Sullivan said, adding that the direction of change in structural measures of QILD and QLF for both whole lung and most severe lobe CTs tracked with physiological pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide.

“The FVC improved while QILD decreased, and that’s what you would expect to see,” he said. “So for each of these ways of displaying data, there was an expected and sensible inverse correlation.”

Scleroderma-related interstitial lung disease is a major cause of morbidity and mortality in severe systemic sclerosis. In the wake of the SCOT trial findings, questions remained with respect to correlation between those findings and pulmonary function; if the improvements with HSCT are real and meaningful, they should have meaningful correlation with pulmonary function, and these findings demonstrate those correlates, he said.

“Changes in quantitative lung CT scoring of scleroderma lung disease provide an objective radiologic validation of the long-term benefits of transplant compared to cyclophosphamide in individuals with severe scleroderma and lung involvement. Improvement in imaging after transplant continues for up to 54 months after randomization, giving radiologic confirmation of a durable treatment benefit,” Dr. Sullivan concluded.

The investigators reported having no relevant disclosures.

sworcester@mdedge.com

SOURCE: Goldin J et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 901.

Acute flaccid myelitis (AFM) has stricken 90 patients in the United States this year and another 252 cases are being investigated, according to new data from the Centers for Disease Control and Prevention.

Sasiistock/iStock/Getty Images Plus

The number of confirmed cases is triple that seen in 2017.

Nearly all of the patients (90%) were children aged 2-8 years, and 99% experienced a fever and /or respiratory illness 7-10 days before the onset of symptoms. But although the prodrome and seasonality of AFM suggest an infective process, only 54% of the patients tested positive for the virus, Nancy Messonnier, MD, said during a briefing held by CDC officials. The most common findings were the enteroviruses EV-A71 (29%) and EV-D68 (37%); other viruses were recovered in the remaining pathogen-positive cases.

It’s not at all clear that these were causative agents, said Dr. Messonnier, director of the National Center for Immunization and Respiratory Diseases.

“At this time of year lots of children have a fever and respiratory infections,” she said. AFM may be caused by one of the identified viruses, a still-undetected pathogen, or a pathogen hiding in untested tissue. “Or, it could be an infection that’s kicking off an immune process,” attacking gray matter in the spinal cord.

The reported increase in cases must be viewed cautiously, Dr. Messonnier said. Physicians are becoming more aware of AFM, so the spike could represent an increase in reporting as well as actual incidence.

It’s not clear why the disease manifests almost exclusively in children, Dr. Messonnier said. Nor do health officials have much of a grasp on AFM’s long-term sequelae.

“We know that patients can recover fully, but at least half don’t, and some of those have serious sequelae. Unfortunately, we have not been following every patient, so this is a gap in our knowledge.”

A newly created national task force will examine AFM’s long-term effects, Dr. Messonnier said. The task force will also look at mortality; health departments across the country will examine mortality records to identify any past deaths preceded by AFM-like symptoms.

“One of the reasons we have convened this task force is to think about this hypothesis [of an autoimmune syndrome]. We have not backed off on the idea of an infectious organism causing it, but we are thinking more broadly,” Dr. Messonnier said.

Some anti-immunization groups are blaming vaccines for the disease, noting that several childhood vaccines list encephalomyelitis and transverse myelitis as possible adverse events.

“We are investigating every one of the cases in this and prior years and have a list of hypotheses based on the epidemiology,” Dr. Messonnier said. “I would say toxins are low on that list. Many of the children may have been vaccinated [before developing AFM] and that is something we will look at, but for now we recommend that all children should be vaccinated” according to the recommended schedule.

Additional details were published on 80 of the cases. Patients’ mean age was 4 years; 59% were male. Symptoms suggesting a viral illness occurred in 99%; these included fever (81%), cough, rhinorrhea, and congestion (78%), and vomiting and diarrhea (38%).

AFM symptoms varied; 47% had only upper limb involvement, 9% only lower limb, 15% two or three upper, and 29% all four limbs. All the patients with confirmed AFM were hospitalized, and 59% treated in intensive care units. There were no deaths (MMWR. 2018;ePub:13 November. DOI: http://dx.doi.org/10.15585/mmwr.mm6745e1).

AFM remains extremely rare, Dr. Messonnier said. But physicians should be alert for any signs of sudden limb weakness in children and report those immediately. The workup should include questions about recent fever with or without respiratory or gastrointestinal symptoms. Prompt collection of viral testing samples (cerebrospinal fluid, serum, respiratory, and stool specimens) is critical.

Additional information for health care professionals is available on the CDC AFM web page.

msullivan@mdedge.com

Acute flaccid myelitis (AFM) has stricken 90 patients in the United States this year and another 252 cases are being investigated, according to new data from the Centers for Disease Control and Prevention.

Sasiistock/iStock/Getty Images Plus

The number of confirmed cases is triple that seen in 2017.

Nearly all of the patients (90%) were children aged 2-8 years, and 99% experienced a fever and /or respiratory illness 7-10 days before the onset of symptoms. But although the prodrome and seasonality of AFM suggest an infective process, only 54% of the patients tested positive for the virus, Nancy Messonnier, MD, said during a briefing held by CDC officials. The most common findings were the enteroviruses EV-A71 (29%) and EV-D68 (37%); other viruses were recovered in the remaining pathogen-positive cases.

It’s not at all clear that these were causative agents, said Dr. Messonnier, director of the National Center for Immunization and Respiratory Diseases.

“At this time of year lots of children have a fever and respiratory infections,” she said. AFM may be caused by one of the identified viruses, a still-undetected pathogen, or a pathogen hiding in untested tissue. “Or, it could be an infection that’s kicking off an immune process,” attacking gray matter in the spinal cord.

The reported increase in cases must be viewed cautiously, Dr. Messonnier said. Physicians are becoming more aware of AFM, so the spike could represent an increase in reporting as well as actual incidence.

It’s not clear why the disease manifests almost exclusively in children, Dr. Messonnier said. Nor do health officials have much of a grasp on AFM’s long-term sequelae.

“We know that patients can recover fully, but at least half don’t, and some of those have serious sequelae. Unfortunately, we have not been following every patient, so this is a gap in our knowledge.”

A newly created national task force will examine AFM’s long-term effects, Dr. Messonnier said. The task force will also look at mortality; health departments across the country will examine mortality records to identify any past deaths preceded by AFM-like symptoms.

“One of the reasons we have convened this task force is to think about this hypothesis [of an autoimmune syndrome]. We have not backed off on the idea of an infectious organism causing it, but we are thinking more broadly,” Dr. Messonnier said.

Some anti-immunization groups are blaming vaccines for the disease, noting that several childhood vaccines list encephalomyelitis and transverse myelitis as possible adverse events.

“We are investigating every one of the cases in this and prior years and have a list of hypotheses based on the epidemiology,” Dr. Messonnier said. “I would say toxins are low on that list. Many of the children may have been vaccinated [before developing AFM] and that is something we will look at, but for now we recommend that all children should be vaccinated” according to the recommended schedule.

Additional details were published on 80 of the cases. Patients’ mean age was 4 years; 59% were male. Symptoms suggesting a viral illness occurred in 99%; these included fever (81%), cough, rhinorrhea, and congestion (78%), and vomiting and diarrhea (38%).

AFM symptoms varied; 47% had only upper limb involvement, 9% only lower limb, 15% two or three upper, and 29% all four limbs. All the patients with confirmed AFM were hospitalized, and 59% treated in intensive care units. There were no deaths (MMWR. 2018;ePub:13 November. DOI: http://dx.doi.org/10.15585/mmwr.mm6745e1).

AFM remains extremely rare, Dr. Messonnier said. But physicians should be alert for any signs of sudden limb weakness in children and report those immediately. The workup should include questions about recent fever with or without respiratory or gastrointestinal symptoms. Prompt collection of viral testing samples (cerebrospinal fluid, serum, respiratory, and stool specimens) is critical.

Additional information for health care professionals is available on the CDC AFM web page.

msullivan@mdedge.com

Acute flaccid myelitis (AFM) has stricken 90 patients in the United States this year and another 252 cases are being investigated, according to new data from the Centers for Disease Control and Prevention.

Sasiistock/iStock/Getty Images Plus

The number of confirmed cases is triple that seen in 2017.

Nearly all of the patients (90%) were children aged 2-8 years, and 99% experienced a fever and /or respiratory illness 7-10 days before the onset of symptoms. But although the prodrome and seasonality of AFM suggest an infective process, only 54% of the patients tested positive for the virus, Nancy Messonnier, MD, said during a briefing held by CDC officials. The most common findings were the enteroviruses EV-A71 (29%) and EV-D68 (37%); other viruses were recovered in the remaining pathogen-positive cases.

It’s not at all clear that these were causative agents, said Dr. Messonnier, director of the National Center for Immunization and Respiratory Diseases.

“At this time of year lots of children have a fever and respiratory infections,” she said. AFM may be caused by one of the identified viruses, a still-undetected pathogen, or a pathogen hiding in untested tissue. “Or, it could be an infection that’s kicking off an immune process,” attacking gray matter in the spinal cord.

The reported increase in cases must be viewed cautiously, Dr. Messonnier said. Physicians are becoming more aware of AFM, so the spike could represent an increase in reporting as well as actual incidence.

It’s not clear why the disease manifests almost exclusively in children, Dr. Messonnier said. Nor do health officials have much of a grasp on AFM’s long-term sequelae.

“We know that patients can recover fully, but at least half don’t, and some of those have serious sequelae. Unfortunately, we have not been following every patient, so this is a gap in our knowledge.”

A newly created national task force will examine AFM’s long-term effects, Dr. Messonnier said. The task force will also look at mortality; health departments across the country will examine mortality records to identify any past deaths preceded by AFM-like symptoms.

“One of the reasons we have convened this task force is to think about this hypothesis [of an autoimmune syndrome]. We have not backed off on the idea of an infectious organism causing it, but we are thinking more broadly,” Dr. Messonnier said.

Some anti-immunization groups are blaming vaccines for the disease, noting that several childhood vaccines list encephalomyelitis and transverse myelitis as possible adverse events.

“We are investigating every one of the cases in this and prior years and have a list of hypotheses based on the epidemiology,” Dr. Messonnier said. “I would say toxins are low on that list. Many of the children may have been vaccinated [before developing AFM] and that is something we will look at, but for now we recommend that all children should be vaccinated” according to the recommended schedule.

Additional details were published on 80 of the cases. Patients’ mean age was 4 years; 59% were male. Symptoms suggesting a viral illness occurred in 99%; these included fever (81%), cough, rhinorrhea, and congestion (78%), and vomiting and diarrhea (38%).

AFM symptoms varied; 47% had only upper limb involvement, 9% only lower limb, 15% two or three upper, and 29% all four limbs. All the patients with confirmed AFM were hospitalized, and 59% treated in intensive care units. There were no deaths (MMWR. 2018;ePub:13 November. DOI: http://dx.doi.org/10.15585/mmwr.mm6745e1).

AFM remains extremely rare, Dr. Messonnier said. But physicians should be alert for any signs of sudden limb weakness in children and report those immediately. The workup should include questions about recent fever with or without respiratory or gastrointestinal symptoms. Prompt collection of viral testing samples (cerebrospinal fluid, serum, respiratory, and stool specimens) is critical.

Additional information for health care professionals is available on the CDC AFM web page.

msullivan@mdedge.com

Bronchoscope reprocessing was ineffective for eliminating all residual biocontamination even when done in accordance with endoscope reprocessing standards, according to results of a prospective, multisite investigation.

CDC/Elizabeth H. White, MS

All clinically used bronchoscopes evaluated in the study had residual contamination after reprocessing, and more than half showed microbial growth, the researchers reported in the journal CHEST.

These findings suggest that systematic changes are needed to improve cleaning and disinfection and to avoid the retention of bioburden, said researcher Cori L. Ofstead, MSPH, and her coinvestigators (Chest 2018 Nov;154[5]:1024-34).

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Ms. Ofstead and her colleagues said in their report.

Institutions also should consider shifting from high-level disinfection (HLD) to sterilization to reduce patient exposure to contaminated bronchoscopes, they added.

The study was conducted in three large, tertiary hospitals that contributed a total of 24 clinically used devices. That total comprised nine therapeutic, nine pediatric, and six endobronchial ultrasound (EBUS) bronchoscopes that were all reprocessed in accordance with each institution’s standard practices.

Proteins were detected in 100% of the bronchoscopes after HLD, according to researchers.

Looking at 20 paired postcleaning and post-HLD samples, the researchers found microbial growth in 11 of 20 (55%) manually-cleaned bronchoscopes and 14 of 24 (58%) bronchoscopes after HLD. The post-HLD samples included mold and recognized pathogens such as Escherichia coli, as well as normal flora and environmental bacteria, they said.

All 24 of the bronchoscopes had visible irregularities, including brown, red, or oily residue, retained fluid, debris in channels, scratches, or damage at insertion tubes and distal ends, they added.

Substandard reprocessing practices were found at two of the three participating institutions, according to the investigators. At one site, technicians reused syringes to flush channels with alcohol stored in an uncovered bowl during the day, according to the report, and bronchoscopes at that site were dried with reused towels and stored in a cabinet without active ventilation.

“Nursing staff were observed handling patient-ready bronchoscopes with bare hands,” the investigators reported.

Although clinical outcomes were not measured, the contamination, microbial growth, and defects observed in this study are “worrisome,” according to authors, because of the high infection risk in many patients undergoing bronchoscopy, and because of the infectious outbreaks and patient deaths linked to contaminated bronchoscopes in previous investigations.

Research funding for the study was provided by 3M Company. Study materials were provided by 3M Company and Healthmark Industries. Ms. Ofstead and several coauthors reported employment with Ofstead & Associates, which has received research funding and speaking fees related to infection prevention from 3M Company, Healthmark Industries, Advanced Sterilization Products (Johnson & Johnson), and others.

The senior author of the study was J. Scott Ferguson, MD, of the division of pulmonary and critical care medicine at the University of Wisconsin School of Medicine and Public Health, Madison. Dr. Ferguson provided disclosures related to NewWave Medical, Pharmaceutical Product Development, Oncocyte, Concordia, and PneumRx.

SOURCE: Ofstead C et al. Chest. 2018 Nov;154(5):1024-34.

Bronchoscope reprocessing was ineffective for eliminating all residual biocontamination even when done in accordance with endoscope reprocessing standards, according to results of a prospective, multisite investigation.

CDC/Elizabeth H. White, MS

All clinically used bronchoscopes evaluated in the study had residual contamination after reprocessing, and more than half showed microbial growth, the researchers reported in the journal CHEST.

These findings suggest that systematic changes are needed to improve cleaning and disinfection and to avoid the retention of bioburden, said researcher Cori L. Ofstead, MSPH, and her coinvestigators (Chest 2018 Nov;154[5]:1024-34).

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Ms. Ofstead and her colleagues said in their report.

Institutions also should consider shifting from high-level disinfection (HLD) to sterilization to reduce patient exposure to contaminated bronchoscopes, they added.

The study was conducted in three large, tertiary hospitals that contributed a total of 24 clinically used devices. That total comprised nine therapeutic, nine pediatric, and six endobronchial ultrasound (EBUS) bronchoscopes that were all reprocessed in accordance with each institution’s standard practices.

Proteins were detected in 100% of the bronchoscopes after HLD, according to researchers.

Looking at 20 paired postcleaning and post-HLD samples, the researchers found microbial growth in 11 of 20 (55%) manually-cleaned bronchoscopes and 14 of 24 (58%) bronchoscopes after HLD. The post-HLD samples included mold and recognized pathogens such as Escherichia coli, as well as normal flora and environmental bacteria, they said.

All 24 of the bronchoscopes had visible irregularities, including brown, red, or oily residue, retained fluid, debris in channels, scratches, or damage at insertion tubes and distal ends, they added.

Substandard reprocessing practices were found at two of the three participating institutions, according to the investigators. At one site, technicians reused syringes to flush channels with alcohol stored in an uncovered bowl during the day, according to the report, and bronchoscopes at that site were dried with reused towels and stored in a cabinet without active ventilation.

“Nursing staff were observed handling patient-ready bronchoscopes with bare hands,” the investigators reported.

Although clinical outcomes were not measured, the contamination, microbial growth, and defects observed in this study are “worrisome,” according to authors, because of the high infection risk in many patients undergoing bronchoscopy, and because of the infectious outbreaks and patient deaths linked to contaminated bronchoscopes in previous investigations.

Research funding for the study was provided by 3M Company. Study materials were provided by 3M Company and Healthmark Industries. Ms. Ofstead and several coauthors reported employment with Ofstead & Associates, which has received research funding and speaking fees related to infection prevention from 3M Company, Healthmark Industries, Advanced Sterilization Products (Johnson & Johnson), and others.

The senior author of the study was J. Scott Ferguson, MD, of the division of pulmonary and critical care medicine at the University of Wisconsin School of Medicine and Public Health, Madison. Dr. Ferguson provided disclosures related to NewWave Medical, Pharmaceutical Product Development, Oncocyte, Concordia, and PneumRx.

SOURCE: Ofstead C et al. Chest. 2018 Nov;154(5):1024-34.

Bronchoscope reprocessing was ineffective for eliminating all residual biocontamination even when done in accordance with endoscope reprocessing standards, according to results of a prospective, multisite investigation.

CDC/Elizabeth H. White, MS

All clinically used bronchoscopes evaluated in the study had residual contamination after reprocessing, and more than half showed microbial growth, the researchers reported in the journal CHEST.

These findings suggest that systematic changes are needed to improve cleaning and disinfection and to avoid the retention of bioburden, said researcher Cori L. Ofstead, MSPH, and her coinvestigators (Chest 2018 Nov;154[5]:1024-34).

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Ms. Ofstead and her colleagues said in their report.

Institutions also should consider shifting from high-level disinfection (HLD) to sterilization to reduce patient exposure to contaminated bronchoscopes, they added.

The study was conducted in three large, tertiary hospitals that contributed a total of 24 clinically used devices. That total comprised nine therapeutic, nine pediatric, and six endobronchial ultrasound (EBUS) bronchoscopes that were all reprocessed in accordance with each institution’s standard practices.

Proteins were detected in 100% of the bronchoscopes after HLD, according to researchers.

Looking at 20 paired postcleaning and post-HLD samples, the researchers found microbial growth in 11 of 20 (55%) manually-cleaned bronchoscopes and 14 of 24 (58%) bronchoscopes after HLD. The post-HLD samples included mold and recognized pathogens such as Escherichia coli, as well as normal flora and environmental bacteria, they said.

All 24 of the bronchoscopes had visible irregularities, including brown, red, or oily residue, retained fluid, debris in channels, scratches, or damage at insertion tubes and distal ends, they added.

Substandard reprocessing practices were found at two of the three participating institutions, according to the investigators. At one site, technicians reused syringes to flush channels with alcohol stored in an uncovered bowl during the day, according to the report, and bronchoscopes at that site were dried with reused towels and stored in a cabinet without active ventilation.

“Nursing staff were observed handling patient-ready bronchoscopes with bare hands,” the investigators reported.

Although clinical outcomes were not measured, the contamination, microbial growth, and defects observed in this study are “worrisome,” according to authors, because of the high infection risk in many patients undergoing bronchoscopy, and because of the infectious outbreaks and patient deaths linked to contaminated bronchoscopes in previous investigations.

Research funding for the study was provided by 3M Company. Study materials were provided by 3M Company and Healthmark Industries. Ms. Ofstead and several coauthors reported employment with Ofstead & Associates, which has received research funding and speaking fees related to infection prevention from 3M Company, Healthmark Industries, Advanced Sterilization Products (Johnson & Johnson), and others.

The senior author of the study was J. Scott Ferguson, MD, of the division of pulmonary and critical care medicine at the University of Wisconsin School of Medicine and Public Health, Madison. Dr. Ferguson provided disclosures related to NewWave Medical, Pharmaceutical Product Development, Oncocyte, Concordia, and PneumRx.

SOURCE: Ofstead C et al. Chest. 2018 Nov;154(5):1024-34.

The Food and Drug Administration has approved Yupelri (revefenacin) for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD).

Wikimedia Commons/FitzColinGerald/Creative Commons License

Revefenacin is a long-acting muscarinic antagonist aimed at improving the lung function of patients with COPD. Yupelri is an inhalation solution administered once daily through a standard jet nebulizer.

The most common adverse events associated with Yupelri are cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Patients receiving other anticholinergic-containing drugs or OATP1B1 and OATP1B3 inhibitors should not receive Yupelri.

“Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma [e.g., eye pain or discomfort, blurred vision, visual changes]. Patients should consult a healthcare professional immediately if any of these signs or symptoms develop,” the FDA said in the press release.

The expanded label for Yupelri can be found on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved Yupelri (revefenacin) for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD).

Wikimedia Commons/FitzColinGerald/Creative Commons License

Revefenacin is a long-acting muscarinic antagonist aimed at improving the lung function of patients with COPD. Yupelri is an inhalation solution administered once daily through a standard jet nebulizer.

The most common adverse events associated with Yupelri are cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Patients receiving other anticholinergic-containing drugs or OATP1B1 and OATP1B3 inhibitors should not receive Yupelri.

“Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma [e.g., eye pain or discomfort, blurred vision, visual changes]. Patients should consult a healthcare professional immediately if any of these signs or symptoms develop,” the FDA said in the press release.

The expanded label for Yupelri can be found on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved Yupelri (revefenacin) for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD).

Wikimedia Commons/FitzColinGerald/Creative Commons License

Revefenacin is a long-acting muscarinic antagonist aimed at improving the lung function of patients with COPD. Yupelri is an inhalation solution administered once daily through a standard jet nebulizer.

The most common adverse events associated with Yupelri are cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Patients receiving other anticholinergic-containing drugs or OATP1B1 and OATP1B3 inhibitors should not receive Yupelri.

“Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma [e.g., eye pain or discomfort, blurred vision, visual changes]. Patients should consult a healthcare professional immediately if any of these signs or symptoms develop,” the FDA said in the press release.

The expanded label for Yupelri can be found on the FDA website.

lfranki@mdedge.com

Background: An increasing body of literature suggests that hyperoxia may be harmful, yet liberal use of supplemental oxygen remains widespread.

Much like transfusion thresholds, more may not always be better when it comes to supplemental oxygen. Hospitalists should consider the harmful effects of hyperoxia when caring for patients on supplemental oxygen. Unfortunately, median blood oxygen saturation during therapy was not available for each group in this trial, so more research is needed to clearly define the upper limit of oxygen saturation at which harm outweighs benefit.

Bottom line: When compared to conservative oxygen administration, liberal oxygen therapy increases mortality in acutely ill adults.

Citation: Chu DK et al. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018;391:1693-705.

Dr. Metter is an assistant professor in the division of hospital medicine, University of Colorado, Denver.

Background: An increasing body of literature suggests that hyperoxia may be harmful, yet liberal use of supplemental oxygen remains widespread.

Much like transfusion thresholds, more may not always be better when it comes to supplemental oxygen. Hospitalists should consider the harmful effects of hyperoxia when caring for patients on supplemental oxygen. Unfortunately, median blood oxygen saturation during therapy was not available for each group in this trial, so more research is needed to clearly define the upper limit of oxygen saturation at which harm outweighs benefit.

Bottom line: When compared to conservative oxygen administration, liberal oxygen therapy increases mortality in acutely ill adults.

Citation: Chu DK et al. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018;391:1693-705.

Dr. Metter is an assistant professor in the division of hospital medicine, University of Colorado, Denver.

Background: An increasing body of literature suggests that hyperoxia may be harmful, yet liberal use of supplemental oxygen remains widespread.

Much like transfusion thresholds, more may not always be better when it comes to supplemental oxygen. Hospitalists should consider the harmful effects of hyperoxia when caring for patients on supplemental oxygen. Unfortunately, median blood oxygen saturation during therapy was not available for each group in this trial, so more research is needed to clearly define the upper limit of oxygen saturation at which harm outweighs benefit.

Bottom line: When compared to conservative oxygen administration, liberal oxygen therapy increases mortality in acutely ill adults.

Citation: Chu DK et al. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018;391:1693-705.

Dr. Metter is an assistant professor in the division of hospital medicine, University of Colorado, Denver.