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Combo respiratory pathogen tests miss pertussis
BALTIMORE – Ann Arbor.
Respiratory pathogen panels are popular because they test for many things at once, but providers have to know their limits, said lead investigator Colleen Mayhew, MD, a pediatric emergency medicine fellow at the University of Michigan.
“Should RPAN be used to diagnosis pertussis? No,” she said at the Pediatric Academic Societies annual meeting. RPAN was negative for confirmed pertussis 44% of the time in the study.
“In our cohort, [it] was no better than a coin flip for detecting pertussis,” she said. Also, even when it missed pertussis, it still detected other pathogens, which raises the risk that symptoms might be attributed to a different infection. “This has serious public health implications.”
“The bottom line is, if you are concerned about pertussis, it’s important to use a dedicated pertussis PCR [polymerase chain reaction] assay, and to use comprehensive respiratory pathogen testing only if there are other, specific targets that will change your clinical management,” such as mycoplasma or the flu, Dr. Mayhew said.
In the study, 102 nasopharyngeal swabs positive for pertussis on standalone PCR testing – the university uses an assay from Focus Diagnostics – were thawed and tested with RPAN.
RPAN was negative for pertussis on 45 swabs (44%). “These are the potential missed pertussis cases if RPAN is used alone,” Dr. Mayhew said. RPAN detected other pathogens, such as coronavirus, about half the time, whether or not it tested positive for pertussis. “Those additional pathogens might represent coinfection, but might also represent asymptomatic carriage.” It’s impossible to differentiate between the two, she noted.
In short, “neither positive testing for other respiratory pathogens, nor negative testing for pertussis by RPAN, is reliable for excluding the diagnosis of pertussis. Dedicated pertussis PCR testing should be used for diagnosis,” she and her team concluded.
RPAN also is a PCR test, but with a different, perhaps less robust, genetic target.
The 102 positive swabs were from patients aged 1 month to 73 years, so “it’s important for all of us to keep pertussis on our differential diagnose” no matter how old patients are, Dr. Mayhew said.
Freezing and thawing the swabs shouldn’t have degraded the genetic material, but it might have; that was one of the limits of the study.
The team hopes to run a quality improvement project to encourage the use of standalone pertussis PCR in Ann Arbor.
There was no industry funding. Dr. Mayhew didn’t report any disclosures.
BALTIMORE – Ann Arbor.
Respiratory pathogen panels are popular because they test for many things at once, but providers have to know their limits, said lead investigator Colleen Mayhew, MD, a pediatric emergency medicine fellow at the University of Michigan.
“Should RPAN be used to diagnosis pertussis? No,” she said at the Pediatric Academic Societies annual meeting. RPAN was negative for confirmed pertussis 44% of the time in the study.
“In our cohort, [it] was no better than a coin flip for detecting pertussis,” she said. Also, even when it missed pertussis, it still detected other pathogens, which raises the risk that symptoms might be attributed to a different infection. “This has serious public health implications.”
“The bottom line is, if you are concerned about pertussis, it’s important to use a dedicated pertussis PCR [polymerase chain reaction] assay, and to use comprehensive respiratory pathogen testing only if there are other, specific targets that will change your clinical management,” such as mycoplasma or the flu, Dr. Mayhew said.
In the study, 102 nasopharyngeal swabs positive for pertussis on standalone PCR testing – the university uses an assay from Focus Diagnostics – were thawed and tested with RPAN.
RPAN was negative for pertussis on 45 swabs (44%). “These are the potential missed pertussis cases if RPAN is used alone,” Dr. Mayhew said. RPAN detected other pathogens, such as coronavirus, about half the time, whether or not it tested positive for pertussis. “Those additional pathogens might represent coinfection, but might also represent asymptomatic carriage.” It’s impossible to differentiate between the two, she noted.
In short, “neither positive testing for other respiratory pathogens, nor negative testing for pertussis by RPAN, is reliable for excluding the diagnosis of pertussis. Dedicated pertussis PCR testing should be used for diagnosis,” she and her team concluded.
RPAN also is a PCR test, but with a different, perhaps less robust, genetic target.
The 102 positive swabs were from patients aged 1 month to 73 years, so “it’s important for all of us to keep pertussis on our differential diagnose” no matter how old patients are, Dr. Mayhew said.
Freezing and thawing the swabs shouldn’t have degraded the genetic material, but it might have; that was one of the limits of the study.
The team hopes to run a quality improvement project to encourage the use of standalone pertussis PCR in Ann Arbor.
There was no industry funding. Dr. Mayhew didn’t report any disclosures.
BALTIMORE – Ann Arbor.
Respiratory pathogen panels are popular because they test for many things at once, but providers have to know their limits, said lead investigator Colleen Mayhew, MD, a pediatric emergency medicine fellow at the University of Michigan.
“Should RPAN be used to diagnosis pertussis? No,” she said at the Pediatric Academic Societies annual meeting. RPAN was negative for confirmed pertussis 44% of the time in the study.
“In our cohort, [it] was no better than a coin flip for detecting pertussis,” she said. Also, even when it missed pertussis, it still detected other pathogens, which raises the risk that symptoms might be attributed to a different infection. “This has serious public health implications.”
“The bottom line is, if you are concerned about pertussis, it’s important to use a dedicated pertussis PCR [polymerase chain reaction] assay, and to use comprehensive respiratory pathogen testing only if there are other, specific targets that will change your clinical management,” such as mycoplasma or the flu, Dr. Mayhew said.
In the study, 102 nasopharyngeal swabs positive for pertussis on standalone PCR testing – the university uses an assay from Focus Diagnostics – were thawed and tested with RPAN.
RPAN was negative for pertussis on 45 swabs (44%). “These are the potential missed pertussis cases if RPAN is used alone,” Dr. Mayhew said. RPAN detected other pathogens, such as coronavirus, about half the time, whether or not it tested positive for pertussis. “Those additional pathogens might represent coinfection, but might also represent asymptomatic carriage.” It’s impossible to differentiate between the two, she noted.
In short, “neither positive testing for other respiratory pathogens, nor negative testing for pertussis by RPAN, is reliable for excluding the diagnosis of pertussis. Dedicated pertussis PCR testing should be used for diagnosis,” she and her team concluded.
RPAN also is a PCR test, but with a different, perhaps less robust, genetic target.
The 102 positive swabs were from patients aged 1 month to 73 years, so “it’s important for all of us to keep pertussis on our differential diagnose” no matter how old patients are, Dr. Mayhew said.
Freezing and thawing the swabs shouldn’t have degraded the genetic material, but it might have; that was one of the limits of the study.
The team hopes to run a quality improvement project to encourage the use of standalone pertussis PCR in Ann Arbor.
There was no industry funding. Dr. Mayhew didn’t report any disclosures.
REPORTING FROM PAS 2019
Long-term antibiotic use may heighten stroke, CHD risk
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
FROM THE EUROPEAN HEART JOURNAL
Key clinical point: Among middle-aged and older women, 2 or more months’ exposure to antibiotics is associated with an increased risk of coronary heart disease or stroke.
Major finding: Long-term antibiotic use in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Study details: An analysis of data from nearly 36,500 women in the Nurses’ Health Study.
Disclosures: The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
Source: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
Measles cases for 2019 now at postelimination high
according to the Centers for Disease Control and Prevention.
As of Wednesday, April 24, the case count for measles is 695, which eclipses the mark of 667 cases that had been the highest since the disease was declared to be eliminated from this country in 2000, the CDC reported.
“The high number of cases in 2019 is primarily the result of a few large outbreaks – one in Washington State and two large outbreaks in New York that started in late 2018. The outbreaks in New York City and New York State are among the largest and longest lasting since measles elimination in 2000. The longer these outbreaks continue, the greater the chance measles will again get a sustained foothold in the United States,” according to a written statement by the CDC.
Although these outbreaks began when the virus was brought into this country by unvaccinated travelers from other countries where there is widespread transmission, “a significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine. Some organizations are deliberately targeting these communities with inaccurate and misleading information about vaccines,” according to the statement.
“Measles is not a harmless childhood illness, but a highly contagious, potentially life-threatening disease,” Health and Human Services Secretary Alex Azar said in a separate statement. “We have the ability to safely protect our children and our communities. Vaccines are a safe, highly effective public health solution that can prevent this disease. The measles vaccines are among the most extensively studied medical products we have, and their safety has been firmly established over many years in some of the largest vaccine studies ever undertaken. With a safe and effective vaccine that protects against measles, the suffering we are seeing is avoidable.”
according to the Centers for Disease Control and Prevention.
As of Wednesday, April 24, the case count for measles is 695, which eclipses the mark of 667 cases that had been the highest since the disease was declared to be eliminated from this country in 2000, the CDC reported.
“The high number of cases in 2019 is primarily the result of a few large outbreaks – one in Washington State and two large outbreaks in New York that started in late 2018. The outbreaks in New York City and New York State are among the largest and longest lasting since measles elimination in 2000. The longer these outbreaks continue, the greater the chance measles will again get a sustained foothold in the United States,” according to a written statement by the CDC.
Although these outbreaks began when the virus was brought into this country by unvaccinated travelers from other countries where there is widespread transmission, “a significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine. Some organizations are deliberately targeting these communities with inaccurate and misleading information about vaccines,” according to the statement.
“Measles is not a harmless childhood illness, but a highly contagious, potentially life-threatening disease,” Health and Human Services Secretary Alex Azar said in a separate statement. “We have the ability to safely protect our children and our communities. Vaccines are a safe, highly effective public health solution that can prevent this disease. The measles vaccines are among the most extensively studied medical products we have, and their safety has been firmly established over many years in some of the largest vaccine studies ever undertaken. With a safe and effective vaccine that protects against measles, the suffering we are seeing is avoidable.”
according to the Centers for Disease Control and Prevention.
As of Wednesday, April 24, the case count for measles is 695, which eclipses the mark of 667 cases that had been the highest since the disease was declared to be eliminated from this country in 2000, the CDC reported.
“The high number of cases in 2019 is primarily the result of a few large outbreaks – one in Washington State and two large outbreaks in New York that started in late 2018. The outbreaks in New York City and New York State are among the largest and longest lasting since measles elimination in 2000. The longer these outbreaks continue, the greater the chance measles will again get a sustained foothold in the United States,” according to a written statement by the CDC.
Although these outbreaks began when the virus was brought into this country by unvaccinated travelers from other countries where there is widespread transmission, “a significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine. Some organizations are deliberately targeting these communities with inaccurate and misleading information about vaccines,” according to the statement.
“Measles is not a harmless childhood illness, but a highly contagious, potentially life-threatening disease,” Health and Human Services Secretary Alex Azar said in a separate statement. “We have the ability to safely protect our children and our communities. Vaccines are a safe, highly effective public health solution that can prevent this disease. The measles vaccines are among the most extensively studied medical products we have, and their safety has been firmly established over many years in some of the largest vaccine studies ever undertaken. With a safe and effective vaccine that protects against measles, the suffering we are seeing is avoidable.”
Teen e-cigarette use: A public health crisis
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
After 2 decades of steady decline in adolescent and young adult use of tobacco products, e-cigarettes have dramatically altered the landscape of substance use in youth. E-cigarette use among teens has been on the rise for years but the recent exponential increase is unprecedented. From 2017 to 2018, adolescent e-cigarette use had the largest year-to-year increase (78%, from 12% to 21%) of any individual substance or class of substances at any time during the past 2 decades of nationwide monitoring.1 This has appropriately caught the nation’s attention. In 2016, Surgeon General Vivek H. Murthy, MD, commissioned an extensive report about electronic cigarettes, and in 2018 Surgeon General Jerome Adams, MD, MPH, issued an advisory declaring e-cigarettes a public health crisis for adolescents.2
E-cigarettes have received attention as a possible boon to adult cigarette smokers seeking a less hazardous product. We can consider the use of tobacco products along a continuum from smoked tobacco, dual use (both smoked tobacco and electronic nicotine delivery), electronic nicotine delivery only, and finally, nonuse. For some adults, transitioning from smoked tobacco products to electronic delivery systems has been a step toward less overall harm from substance use, with a small minority of that population going on to achieve abstinence from all nicotine products.3 For youth and teens, the story has been the opposite. With the rapid rise of e-cigarettes, adolescents overwhelmingly have been moving in the wrong direction at each potential step along this continuum.4 Less than 8% of teens who use e-cigarettes indicated that smoking cessation is a factor in their use.5 An estimated 1.3 million U.S. teens now are dependent or at high risk for dependence upon nicotine because of e-cigarette use. Furthermore, these teens are at a fourfold higher risk of progression to cigarette use, compared with their peers.6
One product in particular gives us information as to why this trend has accelerated so rapidly. Juul, now the sales leader among electronic nicotine delivery systems, rose from approximately 25% to a dominant 75% of market share in just over 1 fiscal year after a social media campaign targeted toward youth and young adults. The device is shaped like an elongated flash drive, is marketed as “sleek,” “looking cool,” and being “super easy” to use. This product touts its use of nicotine salts that can deliver higher concentrations of nicotine more rapidly to mimic the experience of smoking a cigarette as closely as possible. The fruity flavors in Juul “pods” and many other devices also appeal to teens. Many youth are left misinformed, thinking they are using a relatively harmless alternative to cigarettes.
E-cigarette use in youth carries many risks. Among the physical risks is exposure to harmful chemicals (even if less numerous than smoked tobacco products) such as diacetyl (a known cause of bronchiolitis obliterans, or “popcorn lung”), formaldehyde, acrolein, benzene, and metals such as nickel, tin and lead.7 “Safer than cigarettes” is a low bar indeed. Cognitive and emotional risks of early nicotine exposure include poor focus and attention, permanent lowering of impulse control, and a higher risk of mood and anxiety disorders.
Furthermore, nicotine is a gateway drug, with a clearly understood molecular basis for how it can potentiate the effects of later used substances, especially stimulants such as cocaine.8 The gateway and priming effect is compounded for youth because of ongoing brain development and plasticity during teen years. E-cigarette use also is associated with other risk behaviors including a manyfold higher likelihood of binge drinking, having multiple sexual partners in a short period of time, and using other substances such as cannabis, cocaine, methamphetamine, and heroin or nonprescribed opioids.9 An electronic system for vaporization also presents a risk for use of other substances. In just 1 year from 2017 to 2018, marijuana “vaping” increased by more than 50% among all ages surveyed.10
Pediatric health care providers are essential educators for both teens and parents regarding the risks of e-cigarette use. Many youth don’t know what they’re using; 66% of youth reported that the vapors they were inhaling contained only flavoring. Only 13% reported they were inhaling nicotine.10 In stark contrast to these self-reports, all Juul “pods” contain nicotine. As has been a pattern with nationwide surveys of substance use for decades, adolescent use is inversely correlated with perception of risk; 70% of 8th-12th graders do not foresee great harm in regular e-cigarette use. In addition, adolescents use substances less often when they know their parents disapprove. Parents also must be taught about the risks of e-cigarette use and can be provided with resources and taught effective strategies if they have difficulty communicating their disapproval to their children.
Age-appropriate screening in primary care settings must include specific language regarding the use of electronic cigarettes, with questions about “vaping” and “juuling.” Discussions with teens may be more effective with emphasis on issues that resonate with youth such as the financial cost, loss of freedom when dependence develops, and the fact that their generation is once again being targeted by the tobacco industry. Referral for further treatment, including individual and group therapy as well as family-focused interventions, should be considered for teens who use daily, use other substances regularly, or could benefit from treatment for co-occurring mental health disorders.
Electronic cigarette use should not be recommended as a smoking cessation strategy for teens.11 Pediatric health care providers must advocate for regulation of these products, including increasing the legal age of purchase and banning flavoring in e-cigarettes products, Internet sales, and advertisements targeted to youth.
The rapid rise in e-cigarette use among teens is of great concern. As with all classes of substances, early initiation of nicotine drastically increases the risk of developing a substance use disorder and portends a prolonged course and greater accumulation of adverse consequences. There is an urgent need for education, prevention, and early identification of e-cigarette use to protect the current and future well-being of children and adolescents.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at pdnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 2018;67:1276-7.
2. e-cigarettes.surgeongeneral.gov
3. N Engl J Med 2019;380:629-37.
4. Pediatrics. 2018 Dec; 142(6):e20180486.
5. MMWR Morb Mortal Wkly Rep 2018;67:196-200.
6. JAMA Pediatr. 2017 Aug 1;171(8):788-97.
7. “Public health consequences of e-cigarettes” (Washington, DC: National Academies Press, January 2018).
8. N Engl J Med 2014;371:932-43.
9. N Engl J Med 2019;380:689-90.
10. MMWR Morb Mortal Wkly Rep. 2016 Jan 8;64(52):1403-8.
11. Pediatrics. 2019 Feb;143(2). pii: e20183652.
Pulmonologist: In COPD, try dual therapy before adding corticosteroid
PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.
“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.
That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).
“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.
For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.
For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.
“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”
For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.
“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.
In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.
“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.
Dr. Dulohery Scrodin reported that she had no relevant disclosures.
PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.
“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.
That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).
“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.
For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.
For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.
“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”
For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.
“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.
In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.
“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.
Dr. Dulohery Scrodin reported that she had no relevant disclosures.
PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.
“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.
That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).
“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.
For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.
For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.
“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”
For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.
“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.
In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.
“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.
Dr. Dulohery Scrodin reported that she had no relevant disclosures.
REPORTING FROM INTERNAL MEDICINE 2019
New sleep apnea guidelines offer evidence-based recommendations
New guidelines on treating obstructive sleep apnea with positive airway pressure include recommendations for using positive airway pressure (PAP) versus no therapy, using either continuous PAP (CPAP) or automatic PAP (APAP) for ongoing treatment, and providing educational interventions to patients starting PAP. The complete guidelines, issued by the American Academy of Sleep Medicine, were published in the Journal of Clinical Sleep Medicine.
The guidelines were driven by improvements in PAP adherence and device technology, wrote lead author Susheel P. Patil, MD, of Johns Hopkins University, Baltimore, and his colleagues.
The guidelines begin with a pair of Good Practice Statements to ensure effective and appropriate management of obstructive sleep apnea (OSA) in adults. First, “Treatment of OSA with PAP therapy should be based on a diagnosis of OSA established using objective sleep apnea testing.” Second, “Adequate follow-up, including troubleshooting and monitoring of objective efficacy and usage data to ensure adequate treatment and adherence, should occur following PAP therapy initiation and during treatment of OSA.”
The nine recommendations, approved by the AASM board of directors, include four strong recommendations that clinicians should follow under most circumstances, and five conditional recommendations that are suggested but lack strong clinical support for their appropriateness for all patients in all circumstances.
The first of the strong recommendations, for using PAP versus no therapy to treat adults with OSA and excessive sleepiness, was based on a high level of evidence from a meta-analysis of 38 randomized, controlled trials and the conclusion that the benefits of PAP outweighed the harms.
The second strong recommendation for using either CPAP or APAP for ongoing treatment was based on data from 26 trials that showed no clinically significant difference between the two. The third strong recommendation that PAP therapy be initiated using either APAP at home or in-laboratory PAP titration in adults with OSA and no significant comorbidities was supported by a meta-analysis of 10 trials that showed no clinically significant difference between at-home and laboratory initiation, and that each option has its benefits. The authors noted that “the majority of well-informed adult patients with OSA and without significant comorbidities would prefer initiation of PAP using the most rapid, convenient, and cost-effective strategy.” This comment supports the fourth strong recommendation for providing educational interventions to patients starting PAP.
The conditional recommendations include using PAP versus no therapy for adults with OSA and impaired quality of life related to poor sleep, such as insomnia, snoring, morning headaches, and daytime fatigue. Other conditional recommendations include using PAP versus no therapy for adults with OSA and comorbid hypertension, choosing CPAP or APAP over bilateral PAP for routine treatment of OSA in adults, providing behavioral interventions or troubleshooting during patients’ initial use of PAP, and using telemonitoring-guided interventions to monitor patients during their initial use of PAP.
“The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources,” the authors noted.
“When implementing the recommendations, providers should consider additional strategies that will maximize the individual patient’s comfort and adherence such as nasal/intranasal over oronasal mask interface and heated humidification,” they added.
The guidelines were developed by a task force commissioned by the AASM that included board-certified sleep specialists and experts in PAP use, and will be reviewed and updated as new information surfaces, the authors wrote.
Dr. Patil reported no financial conflicts; several coauthors reported conflicts that were managed by their not voting on guidelines related to those conflicts.
SOURCE: Patil SP et al. J Clin Sleep Med. 2018 Feb 15;15(2):335-43.
Octavian C. Ioachimescu, MD, FCCP, comments: The last guidelines and practice parameters for the use of positive airway pressure (PAP) as therapy for adult patients with obstructive sleep apnea, were published in 2006 and 2008, respectively. Since then, new technological advances, an ever-growing body of literature, and shifting practice patterns led to an acute need for a thorough reassessment, a comprehensive update of the previous recommendations, and the potential of issuing new ones for emerging areas. As such, the American Academy of Sleep Medicine commissioned a task force of content experts to review the existing evidence, to issue new guidelines and to publish an associated systematic review and a meta-analysis of the literature on this topic.
A welcome recommendation is the endorsement by the task force of the use of telemedicine capabilities in monitoring patients’ adherence to PAP therapy. Another interesting aspect is that, while our literature is represented by a mix of both randomized and nonrandomized controlled trials, occasionally there seems to be an interesting dichotomy in the results: Randomized trials tend to point in one direction, while nonrandomized studies pooled in the meta-analysis seem to point to the contrary or to give the impression of more definitive effects. While this is clearly not the place to make an extensive analysis of the strengths and the potential pitfalls of randomized versus nonrandomized studies, this clearly raises some issues. One is that our randomized studies are typically small, underpowered, and hence with nonconvincing risk or hazard reduction assessments. Second, the dichotomy in the results may be driven by publication bias, expense, and difficulty in performing adequately-powered, long-term trials that essentially may be studying small effects.
Guidelines are not intended to be used in an Occam’s razor approach, but in a fashion that would allow individualization of therapy while critically appraising the existing evidence for various interventions in specific conditions and maintaining a very stringent and critical view on generalizability, expected results, and adequate management of reasonable expectations. In addition, the areas that are unclear, with conflicting evidence or in which the guidelines allow “too much” latitude to the treating clinician, may be seen as either an invitation to remain “creative,” or one for abstaining from action in the name of equipoise. I would advise that both extremes are to be avoided.
Octavian C. Ioachimescu, MD, FCCP, comments: The last guidelines and practice parameters for the use of positive airway pressure (PAP) as therapy for adult patients with obstructive sleep apnea, were published in 2006 and 2008, respectively. Since then, new technological advances, an ever-growing body of literature, and shifting practice patterns led to an acute need for a thorough reassessment, a comprehensive update of the previous recommendations, and the potential of issuing new ones for emerging areas. As such, the American Academy of Sleep Medicine commissioned a task force of content experts to review the existing evidence, to issue new guidelines and to publish an associated systematic review and a meta-analysis of the literature on this topic.
A welcome recommendation is the endorsement by the task force of the use of telemedicine capabilities in monitoring patients’ adherence to PAP therapy. Another interesting aspect is that, while our literature is represented by a mix of both randomized and nonrandomized controlled trials, occasionally there seems to be an interesting dichotomy in the results: Randomized trials tend to point in one direction, while nonrandomized studies pooled in the meta-analysis seem to point to the contrary or to give the impression of more definitive effects. While this is clearly not the place to make an extensive analysis of the strengths and the potential pitfalls of randomized versus nonrandomized studies, this clearly raises some issues. One is that our randomized studies are typically small, underpowered, and hence with nonconvincing risk or hazard reduction assessments. Second, the dichotomy in the results may be driven by publication bias, expense, and difficulty in performing adequately-powered, long-term trials that essentially may be studying small effects.
Guidelines are not intended to be used in an Occam’s razor approach, but in a fashion that would allow individualization of therapy while critically appraising the existing evidence for various interventions in specific conditions and maintaining a very stringent and critical view on generalizability, expected results, and adequate management of reasonable expectations. In addition, the areas that are unclear, with conflicting evidence or in which the guidelines allow “too much” latitude to the treating clinician, may be seen as either an invitation to remain “creative,” or one for abstaining from action in the name of equipoise. I would advise that both extremes are to be avoided.
Octavian C. Ioachimescu, MD, FCCP, comments: The last guidelines and practice parameters for the use of positive airway pressure (PAP) as therapy for adult patients with obstructive sleep apnea, were published in 2006 and 2008, respectively. Since then, new technological advances, an ever-growing body of literature, and shifting practice patterns led to an acute need for a thorough reassessment, a comprehensive update of the previous recommendations, and the potential of issuing new ones for emerging areas. As such, the American Academy of Sleep Medicine commissioned a task force of content experts to review the existing evidence, to issue new guidelines and to publish an associated systematic review and a meta-analysis of the literature on this topic.
A welcome recommendation is the endorsement by the task force of the use of telemedicine capabilities in monitoring patients’ adherence to PAP therapy. Another interesting aspect is that, while our literature is represented by a mix of both randomized and nonrandomized controlled trials, occasionally there seems to be an interesting dichotomy in the results: Randomized trials tend to point in one direction, while nonrandomized studies pooled in the meta-analysis seem to point to the contrary or to give the impression of more definitive effects. While this is clearly not the place to make an extensive analysis of the strengths and the potential pitfalls of randomized versus nonrandomized studies, this clearly raises some issues. One is that our randomized studies are typically small, underpowered, and hence with nonconvincing risk or hazard reduction assessments. Second, the dichotomy in the results may be driven by publication bias, expense, and difficulty in performing adequately-powered, long-term trials that essentially may be studying small effects.
Guidelines are not intended to be used in an Occam’s razor approach, but in a fashion that would allow individualization of therapy while critically appraising the existing evidence for various interventions in specific conditions and maintaining a very stringent and critical view on generalizability, expected results, and adequate management of reasonable expectations. In addition, the areas that are unclear, with conflicting evidence or in which the guidelines allow “too much” latitude to the treating clinician, may be seen as either an invitation to remain “creative,” or one for abstaining from action in the name of equipoise. I would advise that both extremes are to be avoided.
New guidelines on treating obstructive sleep apnea with positive airway pressure include recommendations for using positive airway pressure (PAP) versus no therapy, using either continuous PAP (CPAP) or automatic PAP (APAP) for ongoing treatment, and providing educational interventions to patients starting PAP. The complete guidelines, issued by the American Academy of Sleep Medicine, were published in the Journal of Clinical Sleep Medicine.
The guidelines were driven by improvements in PAP adherence and device technology, wrote lead author Susheel P. Patil, MD, of Johns Hopkins University, Baltimore, and his colleagues.
The guidelines begin with a pair of Good Practice Statements to ensure effective and appropriate management of obstructive sleep apnea (OSA) in adults. First, “Treatment of OSA with PAP therapy should be based on a diagnosis of OSA established using objective sleep apnea testing.” Second, “Adequate follow-up, including troubleshooting and monitoring of objective efficacy and usage data to ensure adequate treatment and adherence, should occur following PAP therapy initiation and during treatment of OSA.”
The nine recommendations, approved by the AASM board of directors, include four strong recommendations that clinicians should follow under most circumstances, and five conditional recommendations that are suggested but lack strong clinical support for their appropriateness for all patients in all circumstances.
The first of the strong recommendations, for using PAP versus no therapy to treat adults with OSA and excessive sleepiness, was based on a high level of evidence from a meta-analysis of 38 randomized, controlled trials and the conclusion that the benefits of PAP outweighed the harms.
The second strong recommendation for using either CPAP or APAP for ongoing treatment was based on data from 26 trials that showed no clinically significant difference between the two. The third strong recommendation that PAP therapy be initiated using either APAP at home or in-laboratory PAP titration in adults with OSA and no significant comorbidities was supported by a meta-analysis of 10 trials that showed no clinically significant difference between at-home and laboratory initiation, and that each option has its benefits. The authors noted that “the majority of well-informed adult patients with OSA and without significant comorbidities would prefer initiation of PAP using the most rapid, convenient, and cost-effective strategy.” This comment supports the fourth strong recommendation for providing educational interventions to patients starting PAP.
The conditional recommendations include using PAP versus no therapy for adults with OSA and impaired quality of life related to poor sleep, such as insomnia, snoring, morning headaches, and daytime fatigue. Other conditional recommendations include using PAP versus no therapy for adults with OSA and comorbid hypertension, choosing CPAP or APAP over bilateral PAP for routine treatment of OSA in adults, providing behavioral interventions or troubleshooting during patients’ initial use of PAP, and using telemonitoring-guided interventions to monitor patients during their initial use of PAP.
“The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources,” the authors noted.
“When implementing the recommendations, providers should consider additional strategies that will maximize the individual patient’s comfort and adherence such as nasal/intranasal over oronasal mask interface and heated humidification,” they added.
The guidelines were developed by a task force commissioned by the AASM that included board-certified sleep specialists and experts in PAP use, and will be reviewed and updated as new information surfaces, the authors wrote.
Dr. Patil reported no financial conflicts; several coauthors reported conflicts that were managed by their not voting on guidelines related to those conflicts.
SOURCE: Patil SP et al. J Clin Sleep Med. 2018 Feb 15;15(2):335-43.
New guidelines on treating obstructive sleep apnea with positive airway pressure include recommendations for using positive airway pressure (PAP) versus no therapy, using either continuous PAP (CPAP) or automatic PAP (APAP) for ongoing treatment, and providing educational interventions to patients starting PAP. The complete guidelines, issued by the American Academy of Sleep Medicine, were published in the Journal of Clinical Sleep Medicine.
The guidelines were driven by improvements in PAP adherence and device technology, wrote lead author Susheel P. Patil, MD, of Johns Hopkins University, Baltimore, and his colleagues.
The guidelines begin with a pair of Good Practice Statements to ensure effective and appropriate management of obstructive sleep apnea (OSA) in adults. First, “Treatment of OSA with PAP therapy should be based on a diagnosis of OSA established using objective sleep apnea testing.” Second, “Adequate follow-up, including troubleshooting and monitoring of objective efficacy and usage data to ensure adequate treatment and adherence, should occur following PAP therapy initiation and during treatment of OSA.”
The nine recommendations, approved by the AASM board of directors, include four strong recommendations that clinicians should follow under most circumstances, and five conditional recommendations that are suggested but lack strong clinical support for their appropriateness for all patients in all circumstances.
The first of the strong recommendations, for using PAP versus no therapy to treat adults with OSA and excessive sleepiness, was based on a high level of evidence from a meta-analysis of 38 randomized, controlled trials and the conclusion that the benefits of PAP outweighed the harms.
The second strong recommendation for using either CPAP or APAP for ongoing treatment was based on data from 26 trials that showed no clinically significant difference between the two. The third strong recommendation that PAP therapy be initiated using either APAP at home or in-laboratory PAP titration in adults with OSA and no significant comorbidities was supported by a meta-analysis of 10 trials that showed no clinically significant difference between at-home and laboratory initiation, and that each option has its benefits. The authors noted that “the majority of well-informed adult patients with OSA and without significant comorbidities would prefer initiation of PAP using the most rapid, convenient, and cost-effective strategy.” This comment supports the fourth strong recommendation for providing educational interventions to patients starting PAP.
The conditional recommendations include using PAP versus no therapy for adults with OSA and impaired quality of life related to poor sleep, such as insomnia, snoring, morning headaches, and daytime fatigue. Other conditional recommendations include using PAP versus no therapy for adults with OSA and comorbid hypertension, choosing CPAP or APAP over bilateral PAP for routine treatment of OSA in adults, providing behavioral interventions or troubleshooting during patients’ initial use of PAP, and using telemonitoring-guided interventions to monitor patients during their initial use of PAP.
“The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources,” the authors noted.
“When implementing the recommendations, providers should consider additional strategies that will maximize the individual patient’s comfort and adherence such as nasal/intranasal over oronasal mask interface and heated humidification,” they added.
The guidelines were developed by a task force commissioned by the AASM that included board-certified sleep specialists and experts in PAP use, and will be reviewed and updated as new information surfaces, the authors wrote.
Dr. Patil reported no financial conflicts; several coauthors reported conflicts that were managed by their not voting on guidelines related to those conflicts.
SOURCE: Patil SP et al. J Clin Sleep Med. 2018 Feb 15;15(2):335-43.
FROM THE JOURNAL OF CLINICAL SLEEP MEDICINE
Filamentous bacteriophage linked to lung infections in patients with cystic fibrosis
according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.
“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).
In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”
In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.
The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.
One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.
SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.
according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.
“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).
In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”
In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.
The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.
One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.
SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.
according to a study of the prevalence and clinical relevance of Pf phage in two patient cohorts.
“Our data from both the Stanford and Danish CF cohorts together suggest that either patients with CF acquire Pf phage–producing strains of P. aeruginosa or the Pf phage–negative P. aeruginosa become infected with Pf phage as patients age and their disease progresses,” wrote Elizabeth B. Burgener, MD, of Stanford (Calif.) University, and her coauthors. The study was published in Science Translational Medicine.The study analyzed a previous Danish longitudinal cohort of 34 patients and a prospective cross-sectional cohort of 76 patients at Stanford, 58 of which had P. aeruginosa. The researchers also reviewed a collection of genetic sequences called the Pseudomonas Genome Database to determine the prevalence of Pf phage, finding evidence in 1,159 of 2,226 P. aeruginosa sequences (52.1%).
In the Danish cohort, 21 of the 34 CF patients (61.8%; 95% confidence interval, 43.6%-77.8%) had at least one P. aeruginosa isolate containing Pf phage; 9 (26.5%) of the patients were found to be consistently positive for Pf phage. Those who were consistently positive were also older than those who never had Pf phage detected (19.1 years vs. 13.9 years; P = .046), suggesting that “there may be a tendency for P. aeruginosa strains that produce Pf phage to dominate in the sputum of individual patients with CF over time.”
In the Stanford cohort, the prevalence of Pf phage was 36.2% (21 of 58; 95% CI, 24.0%-49.9%) in patients with P. aeruginosa infection and 27.6% (21 of 76; 95% CI, 18.0%-39.1%) in all patients. No Pf phage was detected in any P. aeruginosa–negative samples. Patients positive for Pf phage in this cohort were also older than patients who were negative.
The authors acknowledged their study’s limitations, describing the methods used to collect and sequence the analyzed samples as “highly heterogeneous.” In addition, the two cohorts were CF specific while the Genome Database is not. Finally, the CF cohorts only had a single dominant strain sampled, though multiple P. aeruginosa lineages are often present in CF patients.
One author reported receiving grants from the Cystic Fibrosis Foundation, clinical trial support, and consulting fees from industry. Two other authors are inventors on a patent application that covers the development of a vaccine that targets Pf phage. The others reported no conflicts of interest.
SOURCE: Burgener EB et al. Sci Transl Med. 2019 Apr 17. doi: 10.1126/scitranslmed.aau9748.
FROM SCIENCE TRANSLATIONAL MEDICINE
Ibrexafungerp effective against C. auris in two early case reports
A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.
The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.
The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.
The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.
The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.
The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.
“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.
Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.
SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.
A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.
The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.
The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.
The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.
The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.
The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.
“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.
Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.
SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.
A novel antifungal successfully eradicated Candida auris in two critically ill patients with fungemia, according to data presented in a poster session at the European Congress of Clinical Microbiology & Infectious Diseases.
The case reports, drawn from the phase 3 CARES study of the oral formulation of ibrexafungerp, demonstrated complete response to the glucan synthase inhibitor, according to Deven Juneja, MD, and his coauthors of the Max Super Specialty Hospital, New Delhi.
The first patient was an Asian male, aged 58 years, who had a previous history of diabetes and experienced a protracted ICU stay after acute ischemic stroke. He developed septic shock after aspiration pneumonia, and also experienced a popliteal thrombosis and liver, spleen, and kidney infarcts.
The patient had received empiric antibiotics with the addition of fluconazole; the antifungal was later switched to micafungin after C. auris was identified from blood cultures. Despite clinical improvement on micafungin, blood cultures remained positive for C. auris, so ibrexafungerp was started and continued for 17 days. Blood cultures became negative by day 3 of ibrexafungerp and remained negative for the follow-up period. The patient later developed Klebsiella pneumonia and died.
The second patient, an Asian female, aged 64 years, presented with a lower respiratory tract infection accompanied by fever and hypotension. She had a previous history of diabetes, hypertension, and chronic kidney disease with maintenance hemodialysis. Her fever also persisted despite antibiotics, and C. auris was isolated from her blood cultures with the subsequent initiation of ibrexafungerp. Her blood cultures were still positive at day 3 of ibrexafungerp, but negative at day 9 and 21. She completed 22 days of ibrexafungerp therapy and was asymptomatic with no evidence of C. auris recurrence at a 6-week follow-up visit.
The male patient experienced 2 days of loose stools soon after initiating ibrexafungerp; the female patient had no adverse events.
“These cases provide initial evidence of efficacy and safety of ibrexafungerp in the treatment of candidemia caused by C. auris, including in patients who failed previous therapies,” wrote Dr. Juneja and his coauthors in the late-breaking poster.
Ibrexafungerp belongs to a novel class of glucan synthase inhibitors called triterpenoids. Scynexis funded the CARES study and also is evaluating it alone or in combination with other antifungals for treatment of vulvovaginal candidiasis, invasive pulmonary aspergillosis, and refractory invasive and/or severe fungal disease.
SOURCE: Juneja D et al. ECCMID 2019, Poster L0028.
FROM ECCMID 2019
