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BP load predicts cardiovascular damage in children
NEW ORLEANS – In children, ambulatory systolic daytime blood pressure load – the amount of time spent above the 95th blood pressure percentile for age and height – predicts cardiovascular target-organ damage, specifically diastolic dysfunction and arterial stiffness, according to an investigation from the American Heart Association Strategically Focused Research Network.
Blood pressure load is considered in the 2017 American Academy of Pediatrics BP guideline, but the new findings add granularity on how to use it in practice. It’s part of an effort “to supply data to guide future guidelines, rather than arbitrarily picking a number – the 95th percentile – out of the sky,” said lead investigator and pediatric cardiologist Elaine Urbina, MD, director of preventative cardiology at the Cincinnati Children’s Hospital Medical Center, and senior author on the 2017 guideline.
In the absence of data linking specific BP levels to hard cardiovascular outcomes, as in adults, “we feel that load is helpful in determining risk categories for kids as we make decisions about who should get lifestyle counseling and who should get medication. It gets a little bit at blood pressure variability” and supplements the arbitrary 95th-percentile threshold, she said.
“If I saw a child with only a mild elevation of mean ambulatory blood pressure but they had increased load, it would prompt me to order an echocardiogram to look for target organ damage, which may then change my therapy from lifestyle to medication,” Dr. Urbina said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
These conclusions come from an investigation of 339 healthy adolescents with a mean age of 15.6 years at six sites across the United States. Office BP was averaged over six readings during two visits, and ambulatory pressure was taken every 20 minutes over 26 hours. BP load was correlated with measures of left ventricular mass index (LVMI), systolic and diastolic function (E/e’ ratio), and pulse wave velocity (PWV), a gauge of arterial stiffness.
Overall, 215 subjects spent less than 25% of their time above the 95th percentile and were classified as the low-load group, 62 were above that mark 25%-49% of the time (mid-load group), and 62 were over it at least half of the time (high-load group).
Both load category and load as a continuous variable were significant predictors of arterial stiffness and diastolic dysfunction even after adjustment for age, sex, body mass index, and mean daytime ambulatory systolic blood pressure (P less than 0.0001).
Subjects in the high-load group, for instance, had a PWV above 5.5 m/sec, versus about 5.2 m/sec and less than 5 m/sec in the mid- and low-load groups, respectively. The high-load group had an E/e’ ratio above 7, versus 6 or less in the other groups. There was a trend for higher LVMI and reduced strain as well in the low- versus high-load groups.
Although the findings don’t indicate clinically relevant cardiovascular damage, children with higher loads seem to be “on the road to getting it,” Dr. Urbina said. Greater arterial stiffness means that high pulsatile pressures are transmitted to the microvasculature. Meanwhile, “the strength of the relationship with diastolic dysfunction worries me. It’s a precursor of heart failure with preserved ejection fraction, for which there are no effective therapies. We have to identify the precursors early and treat them so these kids don’t get heart failure later in life.”
Almost two-thirds of the subjects were white, most of the remainder were black, and 58% were boys. There were no statistically significant differences in age, race, sex, or body mass index across the groups, but overall, the children were overweight, and those with high BP load were more insulin resistant and had higher clinic and ambulatory BPs.
The team is assessing cognitive performance as a function of BP load.
Ambulatory pressures were taken by the Spacelabs OnTrak monitor.
The work was funded by the AHA and the National Institutes of Health. The investigators had no commercial disclosures.
SOURCE: Urbina E. Joint Hypertension 2019, Abstract P2056.
NEW ORLEANS – In children, ambulatory systolic daytime blood pressure load – the amount of time spent above the 95th blood pressure percentile for age and height – predicts cardiovascular target-organ damage, specifically diastolic dysfunction and arterial stiffness, according to an investigation from the American Heart Association Strategically Focused Research Network.
Blood pressure load is considered in the 2017 American Academy of Pediatrics BP guideline, but the new findings add granularity on how to use it in practice. It’s part of an effort “to supply data to guide future guidelines, rather than arbitrarily picking a number – the 95th percentile – out of the sky,” said lead investigator and pediatric cardiologist Elaine Urbina, MD, director of preventative cardiology at the Cincinnati Children’s Hospital Medical Center, and senior author on the 2017 guideline.
In the absence of data linking specific BP levels to hard cardiovascular outcomes, as in adults, “we feel that load is helpful in determining risk categories for kids as we make decisions about who should get lifestyle counseling and who should get medication. It gets a little bit at blood pressure variability” and supplements the arbitrary 95th-percentile threshold, she said.
“If I saw a child with only a mild elevation of mean ambulatory blood pressure but they had increased load, it would prompt me to order an echocardiogram to look for target organ damage, which may then change my therapy from lifestyle to medication,” Dr. Urbina said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
These conclusions come from an investigation of 339 healthy adolescents with a mean age of 15.6 years at six sites across the United States. Office BP was averaged over six readings during two visits, and ambulatory pressure was taken every 20 minutes over 26 hours. BP load was correlated with measures of left ventricular mass index (LVMI), systolic and diastolic function (E/e’ ratio), and pulse wave velocity (PWV), a gauge of arterial stiffness.
Overall, 215 subjects spent less than 25% of their time above the 95th percentile and were classified as the low-load group, 62 were above that mark 25%-49% of the time (mid-load group), and 62 were over it at least half of the time (high-load group).
Both load category and load as a continuous variable were significant predictors of arterial stiffness and diastolic dysfunction even after adjustment for age, sex, body mass index, and mean daytime ambulatory systolic blood pressure (P less than 0.0001).
Subjects in the high-load group, for instance, had a PWV above 5.5 m/sec, versus about 5.2 m/sec and less than 5 m/sec in the mid- and low-load groups, respectively. The high-load group had an E/e’ ratio above 7, versus 6 or less in the other groups. There was a trend for higher LVMI and reduced strain as well in the low- versus high-load groups.
Although the findings don’t indicate clinically relevant cardiovascular damage, children with higher loads seem to be “on the road to getting it,” Dr. Urbina said. Greater arterial stiffness means that high pulsatile pressures are transmitted to the microvasculature. Meanwhile, “the strength of the relationship with diastolic dysfunction worries me. It’s a precursor of heart failure with preserved ejection fraction, for which there are no effective therapies. We have to identify the precursors early and treat them so these kids don’t get heart failure later in life.”
Almost two-thirds of the subjects were white, most of the remainder were black, and 58% were boys. There were no statistically significant differences in age, race, sex, or body mass index across the groups, but overall, the children were overweight, and those with high BP load were more insulin resistant and had higher clinic and ambulatory BPs.
The team is assessing cognitive performance as a function of BP load.
Ambulatory pressures were taken by the Spacelabs OnTrak monitor.
The work was funded by the AHA and the National Institutes of Health. The investigators had no commercial disclosures.
SOURCE: Urbina E. Joint Hypertension 2019, Abstract P2056.
NEW ORLEANS – In children, ambulatory systolic daytime blood pressure load – the amount of time spent above the 95th blood pressure percentile for age and height – predicts cardiovascular target-organ damage, specifically diastolic dysfunction and arterial stiffness, according to an investigation from the American Heart Association Strategically Focused Research Network.
Blood pressure load is considered in the 2017 American Academy of Pediatrics BP guideline, but the new findings add granularity on how to use it in practice. It’s part of an effort “to supply data to guide future guidelines, rather than arbitrarily picking a number – the 95th percentile – out of the sky,” said lead investigator and pediatric cardiologist Elaine Urbina, MD, director of preventative cardiology at the Cincinnati Children’s Hospital Medical Center, and senior author on the 2017 guideline.
In the absence of data linking specific BP levels to hard cardiovascular outcomes, as in adults, “we feel that load is helpful in determining risk categories for kids as we make decisions about who should get lifestyle counseling and who should get medication. It gets a little bit at blood pressure variability” and supplements the arbitrary 95th-percentile threshold, she said.
“If I saw a child with only a mild elevation of mean ambulatory blood pressure but they had increased load, it would prompt me to order an echocardiogram to look for target organ damage, which may then change my therapy from lifestyle to medication,” Dr. Urbina said at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
These conclusions come from an investigation of 339 healthy adolescents with a mean age of 15.6 years at six sites across the United States. Office BP was averaged over six readings during two visits, and ambulatory pressure was taken every 20 minutes over 26 hours. BP load was correlated with measures of left ventricular mass index (LVMI), systolic and diastolic function (E/e’ ratio), and pulse wave velocity (PWV), a gauge of arterial stiffness.
Overall, 215 subjects spent less than 25% of their time above the 95th percentile and were classified as the low-load group, 62 were above that mark 25%-49% of the time (mid-load group), and 62 were over it at least half of the time (high-load group).
Both load category and load as a continuous variable were significant predictors of arterial stiffness and diastolic dysfunction even after adjustment for age, sex, body mass index, and mean daytime ambulatory systolic blood pressure (P less than 0.0001).
Subjects in the high-load group, for instance, had a PWV above 5.5 m/sec, versus about 5.2 m/sec and less than 5 m/sec in the mid- and low-load groups, respectively. The high-load group had an E/e’ ratio above 7, versus 6 or less in the other groups. There was a trend for higher LVMI and reduced strain as well in the low- versus high-load groups.
Although the findings don’t indicate clinically relevant cardiovascular damage, children with higher loads seem to be “on the road to getting it,” Dr. Urbina said. Greater arterial stiffness means that high pulsatile pressures are transmitted to the microvasculature. Meanwhile, “the strength of the relationship with diastolic dysfunction worries me. It’s a precursor of heart failure with preserved ejection fraction, for which there are no effective therapies. We have to identify the precursors early and treat them so these kids don’t get heart failure later in life.”
Almost two-thirds of the subjects were white, most of the remainder were black, and 58% were boys. There were no statistically significant differences in age, race, sex, or body mass index across the groups, but overall, the children were overweight, and those with high BP load were more insulin resistant and had higher clinic and ambulatory BPs.
The team is assessing cognitive performance as a function of BP load.
Ambulatory pressures were taken by the Spacelabs OnTrak monitor.
The work was funded by the AHA and the National Institutes of Health. The investigators had no commercial disclosures.
SOURCE: Urbina E. Joint Hypertension 2019, Abstract P2056.
REPORTING FROM JOINT HYPERTENSION 2019
CBD for sleep and anxiety – A brief review of the evidence
Grace is a 15-year-old girl in the 10th grade whom you have been treating for anxiety. Family history also is notable for her father having an anxiety disorder. She has been taking an SSRI and is engaged in therapy, which has resulted in some improvement in symptoms. She can become overwhelmed when taking tests, and she has breakthrough anxiety in social situations and occasional difficulties with sleep. She denies using any substances. Her parents, who have come to her appointment with her, noted that while they see some progress, they would like to try more natural interventions. They had done some research on cannabidiol (CBD), and Grace’s father said that using it has tremendously helped his sleep. They inquired about Grace using it as well.
Discussion
CBD use has dramatically increased over the past few years, and in many places can be found in gummies, chocolate, tinctures, and other forms at grocery and convenience stores, in addition to being widely available online. It is a nonpsychoactive compound (versus tetrahydrocannabinol or THC) found in the Cannabis sativa plant. The Farm Bill, which was passed in 2018, legalized production of hemp or the cannabis plant with a THC concentration less than 0.3%. This bill additionally maintained the Food and Drug Administration’s oversight with CBD. States may have laws that are more restrictive about use. CBD was approved in 2018 by the FDA for treatment of Lennox-Gastaut syndrome and Dravet syndrome in individuals 2 years of age and older, and is categorized as a schedule I substance due to its being derived from the cannabis plant.
In randomized, double-blind, placebo-controlled trials leading to CBD’s approval, the most common side effects were drowsiness, insomnia, disrupted sleep, sedation, malaise, weakness, decreased appetite, diarrhea, elevated liver enzymes, rash, and infections. CBD also carries a warning about the potential for suicidal ideation, agitation, new or worsening depression, aggression, and panic attacks.1 In in vitro and animal studies, CBD has been found to affect growth of tumor cell lines, to have no effects on embryonic development, and to potentially cause some drug-drug interactions through inhibition of CYP2C9, CYP2C19, and CYP3A4. However, the clinical relevance currently is unknown. Animal studies also indicate potential efficacy in decreasing anxiety.2
CBD has been promoted as being effective in treating a number of ailments including migraines, chronic pain, insomnia, ADHD, and anxiety. Multiple anecdotal reports tout the benefits. In a study exploring abuse potential, there were no significant findings, and CBD was generally well tolerated in open trials exploring potential clinical benefits. A retrospective feasibility study – conducted in Israel – exploring use of CBD to decrease problematic behaviors in youth with autism spectrum disorder demonstrated improvement in communication, anxiety, disruptive behaviors, and parental stress.3
- There is potential lack of clarity regarding legality of use in some states. Based on federal law, it is legal to possess CBD derived from hemp, but state laws may differ.
- There is lack of oversight regarding monitoring what is in each supplement. Lab testing for CBD to determine contents is not mandatory in every state. The amount of active compound as well as other ingredients may not be consistent or accurate. According to the FDA, CBD-containing products cannot claim to have health benefits, treat disease, or be sold as dietary supplements without its approval.
- Clear information about appropriate dosing for children is limited.
- Varying delivery systems could affect absorption and bioavailability of CBD.
- Information is lacking regarding potential drug-drug interactions.
- There is a lack of information regarding effects of long-term use.
Use of CBD is an area with significant interest and potential for growth. Although risks are thought to be low overall, there likely is insufficient evidence at this time to actively recommend its use. Additional research in human subjects exploring effective and safe dosing, tolerability, as well as use in special populations (including children, pregnant women, elderly) is needed.
Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures. Email her at [email protected].
References
1. “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy,” FDA news release, June 25, 2018.
2. Cannabidiol (CBD) Critical Review Report. Expert Committee on Drug Dependence Fortieth Meeting. World Health Organization. Geneva June 4-7, 2018.
3. J Autism Dev Disord. 2019 Mar;49(3):1284-8.
Grace is a 15-year-old girl in the 10th grade whom you have been treating for anxiety. Family history also is notable for her father having an anxiety disorder. She has been taking an SSRI and is engaged in therapy, which has resulted in some improvement in symptoms. She can become overwhelmed when taking tests, and she has breakthrough anxiety in social situations and occasional difficulties with sleep. She denies using any substances. Her parents, who have come to her appointment with her, noted that while they see some progress, they would like to try more natural interventions. They had done some research on cannabidiol (CBD), and Grace’s father said that using it has tremendously helped his sleep. They inquired about Grace using it as well.
Discussion
CBD use has dramatically increased over the past few years, and in many places can be found in gummies, chocolate, tinctures, and other forms at grocery and convenience stores, in addition to being widely available online. It is a nonpsychoactive compound (versus tetrahydrocannabinol or THC) found in the Cannabis sativa plant. The Farm Bill, which was passed in 2018, legalized production of hemp or the cannabis plant with a THC concentration less than 0.3%. This bill additionally maintained the Food and Drug Administration’s oversight with CBD. States may have laws that are more restrictive about use. CBD was approved in 2018 by the FDA for treatment of Lennox-Gastaut syndrome and Dravet syndrome in individuals 2 years of age and older, and is categorized as a schedule I substance due to its being derived from the cannabis plant.
In randomized, double-blind, placebo-controlled trials leading to CBD’s approval, the most common side effects were drowsiness, insomnia, disrupted sleep, sedation, malaise, weakness, decreased appetite, diarrhea, elevated liver enzymes, rash, and infections. CBD also carries a warning about the potential for suicidal ideation, agitation, new or worsening depression, aggression, and panic attacks.1 In in vitro and animal studies, CBD has been found to affect growth of tumor cell lines, to have no effects on embryonic development, and to potentially cause some drug-drug interactions through inhibition of CYP2C9, CYP2C19, and CYP3A4. However, the clinical relevance currently is unknown. Animal studies also indicate potential efficacy in decreasing anxiety.2
CBD has been promoted as being effective in treating a number of ailments including migraines, chronic pain, insomnia, ADHD, and anxiety. Multiple anecdotal reports tout the benefits. In a study exploring abuse potential, there were no significant findings, and CBD was generally well tolerated in open trials exploring potential clinical benefits. A retrospective feasibility study – conducted in Israel – exploring use of CBD to decrease problematic behaviors in youth with autism spectrum disorder demonstrated improvement in communication, anxiety, disruptive behaviors, and parental stress.3
- There is potential lack of clarity regarding legality of use in some states. Based on federal law, it is legal to possess CBD derived from hemp, but state laws may differ.
- There is lack of oversight regarding monitoring what is in each supplement. Lab testing for CBD to determine contents is not mandatory in every state. The amount of active compound as well as other ingredients may not be consistent or accurate. According to the FDA, CBD-containing products cannot claim to have health benefits, treat disease, or be sold as dietary supplements without its approval.
- Clear information about appropriate dosing for children is limited.
- Varying delivery systems could affect absorption and bioavailability of CBD.
- Information is lacking regarding potential drug-drug interactions.
- There is a lack of information regarding effects of long-term use.
Use of CBD is an area with significant interest and potential for growth. Although risks are thought to be low overall, there likely is insufficient evidence at this time to actively recommend its use. Additional research in human subjects exploring effective and safe dosing, tolerability, as well as use in special populations (including children, pregnant women, elderly) is needed.
Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures. Email her at [email protected].
References
1. “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy,” FDA news release, June 25, 2018.
2. Cannabidiol (CBD) Critical Review Report. Expert Committee on Drug Dependence Fortieth Meeting. World Health Organization. Geneva June 4-7, 2018.
3. J Autism Dev Disord. 2019 Mar;49(3):1284-8.
Grace is a 15-year-old girl in the 10th grade whom you have been treating for anxiety. Family history also is notable for her father having an anxiety disorder. She has been taking an SSRI and is engaged in therapy, which has resulted in some improvement in symptoms. She can become overwhelmed when taking tests, and she has breakthrough anxiety in social situations and occasional difficulties with sleep. She denies using any substances. Her parents, who have come to her appointment with her, noted that while they see some progress, they would like to try more natural interventions. They had done some research on cannabidiol (CBD), and Grace’s father said that using it has tremendously helped his sleep. They inquired about Grace using it as well.
Discussion
CBD use has dramatically increased over the past few years, and in many places can be found in gummies, chocolate, tinctures, and other forms at grocery and convenience stores, in addition to being widely available online. It is a nonpsychoactive compound (versus tetrahydrocannabinol or THC) found in the Cannabis sativa plant. The Farm Bill, which was passed in 2018, legalized production of hemp or the cannabis plant with a THC concentration less than 0.3%. This bill additionally maintained the Food and Drug Administration’s oversight with CBD. States may have laws that are more restrictive about use. CBD was approved in 2018 by the FDA for treatment of Lennox-Gastaut syndrome and Dravet syndrome in individuals 2 years of age and older, and is categorized as a schedule I substance due to its being derived from the cannabis plant.
In randomized, double-blind, placebo-controlled trials leading to CBD’s approval, the most common side effects were drowsiness, insomnia, disrupted sleep, sedation, malaise, weakness, decreased appetite, diarrhea, elevated liver enzymes, rash, and infections. CBD also carries a warning about the potential for suicidal ideation, agitation, new or worsening depression, aggression, and panic attacks.1 In in vitro and animal studies, CBD has been found to affect growth of tumor cell lines, to have no effects on embryonic development, and to potentially cause some drug-drug interactions through inhibition of CYP2C9, CYP2C19, and CYP3A4. However, the clinical relevance currently is unknown. Animal studies also indicate potential efficacy in decreasing anxiety.2
CBD has been promoted as being effective in treating a number of ailments including migraines, chronic pain, insomnia, ADHD, and anxiety. Multiple anecdotal reports tout the benefits. In a study exploring abuse potential, there were no significant findings, and CBD was generally well tolerated in open trials exploring potential clinical benefits. A retrospective feasibility study – conducted in Israel – exploring use of CBD to decrease problematic behaviors in youth with autism spectrum disorder demonstrated improvement in communication, anxiety, disruptive behaviors, and parental stress.3
- There is potential lack of clarity regarding legality of use in some states. Based on federal law, it is legal to possess CBD derived from hemp, but state laws may differ.
- There is lack of oversight regarding monitoring what is in each supplement. Lab testing for CBD to determine contents is not mandatory in every state. The amount of active compound as well as other ingredients may not be consistent or accurate. According to the FDA, CBD-containing products cannot claim to have health benefits, treat disease, or be sold as dietary supplements without its approval.
- Clear information about appropriate dosing for children is limited.
- Varying delivery systems could affect absorption and bioavailability of CBD.
- Information is lacking regarding potential drug-drug interactions.
- There is a lack of information regarding effects of long-term use.
Use of CBD is an area with significant interest and potential for growth. Although risks are thought to be low overall, there likely is insufficient evidence at this time to actively recommend its use. Additional research in human subjects exploring effective and safe dosing, tolerability, as well as use in special populations (including children, pregnant women, elderly) is needed.
Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures. Email her at [email protected].
References
1. “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy,” FDA news release, June 25, 2018.
2. Cannabidiol (CBD) Critical Review Report. Expert Committee on Drug Dependence Fortieth Meeting. World Health Organization. Geneva June 4-7, 2018.
3. J Autism Dev Disord. 2019 Mar;49(3):1284-8.
Educating teens, young adults about dangers of vaping
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Latest suicide prevention research highlights roles for clinicians, teachers, and parents
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
FROM A SCIENCE TALKS WEBINAR
For trans children, early gender ID conversion efforts damage lifelong mental health
Gender identity conversion efforts during early childhood quadruple lifetime risk of suicidal behavior for transgender people, a study of almost 28,000 adults has determined.
The findings prompted the authors to issue a blanket warning against the controversial treatment, which already has been decried by several medical associations.
“Our results support policy positions … which state that gender identity–conversion therapy should not be conducted for transgender patients at any age, Jack L. Turban, MD, and colleagues wrote in JAMA Psychiatry.
The American Academy of Child and Adolescent Psychiatry, the American Psychiatric Association, the American Academy of Pediatrics, and the American Medical Association all strongly warn against any kind of gender conversion efforts.
The significantly increased risk of suicidal behavior was similar whether the gender identity–conversion effort (GICE) was administered by a clinician or a cleric. “This suggests that any process of intervening to alter gender identity is associated with poorer mental health regardless of whether the intervention occurred within a secular or religious framework,” wrote Dr. Turban of Massachusetts General Hospital, Boston, and coauthors.
The study – the largest of its kind thus far – comprised 27,715 transgender adults included in the 2015 U.S. Transgender Survey, conducted by the National Center for Transgender Equality.
In the current study, investigators focused on the question: “Did any professional (such as a psychologist, counselor, or religious advisor) try to make you identify only with your sex assigned at birth (in other words, try to stop you being trans)?”
They compared responses among subjects who reported exposure to GICE before age 10 years with those who did not.
Subjects were aged a mean of 31 years when they participated in the survey. Slightly less than half (42.8%) were assigned male sex at birth. Most (19,751) had discussed their gender identity with a professional. Nearly 20% (3,869) reported some exposure to GICE; 35% said a religious adviser had conducted the effort.
In this group, exposure had significant negative lifetime effects on mental health. These subjects were at a 56% increased risk of psychological distress within the month before taking the survey (odds ratio, 1.56), and more than twice as likely to have tried at least once to end their lives by suicide (OR, 2.27).
But the negative effects were even more pronounced among the small group of 206 who reported exposure to GICE before they were 10 years old. In a multivariate analysis adjusted for demographics, GICE before age 10 more than quadrupled the risk of lifetime suicide attempts (OR, 4.15). Again, it didn’t matter whether a medical or religious professional administered GICE.
“A plausible association of these practices with poor mental health outcomes can be conceptualized through the minority stress framework; that is, elevated stigma-related stress from exposure to GICE may increase general emotion dysregulation, interpersonal dysfunction, and maladaptive cognitions,” the investigators wrote. “Although this study suggests that exposure to GICE is associated with increased odds of suicide attempts, GICE are not the only way in which minority group stress manifests, and thus, other factors are also likely to be associated with suicidality among gender-diverse people.”
“One potential explanation for this is that, compared with persons in the sexual-minority group, many persons in the gender-minority group must interact with clinical professionals to be medically and surgically affirmed in their identities. This higher prevalence of interactions with clinical professionals among people in the gender minority group may lead to greater risk of experiencing conversion effort.”
The authors cited the sample size of the study as one of its many strengths. One limitation includes the study’s cross-sectional design.
Dr. Turban reported collecting royalties from Springer for an upcoming textbook about pediatric gender identity. The other coauthors reported no disclosures.
SOURCE: Turban JL et al. JAMA Psychiatry. 2019 Sep 11. doi: 10.1001/jamapsychiatry.2019.2285.
Gender identity conversion efforts during early childhood quadruple lifetime risk of suicidal behavior for transgender people, a study of almost 28,000 adults has determined.
The findings prompted the authors to issue a blanket warning against the controversial treatment, which already has been decried by several medical associations.
“Our results support policy positions … which state that gender identity–conversion therapy should not be conducted for transgender patients at any age, Jack L. Turban, MD, and colleagues wrote in JAMA Psychiatry.
The American Academy of Child and Adolescent Psychiatry, the American Psychiatric Association, the American Academy of Pediatrics, and the American Medical Association all strongly warn against any kind of gender conversion efforts.
The significantly increased risk of suicidal behavior was similar whether the gender identity–conversion effort (GICE) was administered by a clinician or a cleric. “This suggests that any process of intervening to alter gender identity is associated with poorer mental health regardless of whether the intervention occurred within a secular or religious framework,” wrote Dr. Turban of Massachusetts General Hospital, Boston, and coauthors.
The study – the largest of its kind thus far – comprised 27,715 transgender adults included in the 2015 U.S. Transgender Survey, conducted by the National Center for Transgender Equality.
In the current study, investigators focused on the question: “Did any professional (such as a psychologist, counselor, or religious advisor) try to make you identify only with your sex assigned at birth (in other words, try to stop you being trans)?”
They compared responses among subjects who reported exposure to GICE before age 10 years with those who did not.
Subjects were aged a mean of 31 years when they participated in the survey. Slightly less than half (42.8%) were assigned male sex at birth. Most (19,751) had discussed their gender identity with a professional. Nearly 20% (3,869) reported some exposure to GICE; 35% said a religious adviser had conducted the effort.
In this group, exposure had significant negative lifetime effects on mental health. These subjects were at a 56% increased risk of psychological distress within the month before taking the survey (odds ratio, 1.56), and more than twice as likely to have tried at least once to end their lives by suicide (OR, 2.27).
But the negative effects were even more pronounced among the small group of 206 who reported exposure to GICE before they were 10 years old. In a multivariate analysis adjusted for demographics, GICE before age 10 more than quadrupled the risk of lifetime suicide attempts (OR, 4.15). Again, it didn’t matter whether a medical or religious professional administered GICE.
“A plausible association of these practices with poor mental health outcomes can be conceptualized through the minority stress framework; that is, elevated stigma-related stress from exposure to GICE may increase general emotion dysregulation, interpersonal dysfunction, and maladaptive cognitions,” the investigators wrote. “Although this study suggests that exposure to GICE is associated with increased odds of suicide attempts, GICE are not the only way in which minority group stress manifests, and thus, other factors are also likely to be associated with suicidality among gender-diverse people.”
“One potential explanation for this is that, compared with persons in the sexual-minority group, many persons in the gender-minority group must interact with clinical professionals to be medically and surgically affirmed in their identities. This higher prevalence of interactions with clinical professionals among people in the gender minority group may lead to greater risk of experiencing conversion effort.”
The authors cited the sample size of the study as one of its many strengths. One limitation includes the study’s cross-sectional design.
Dr. Turban reported collecting royalties from Springer for an upcoming textbook about pediatric gender identity. The other coauthors reported no disclosures.
SOURCE: Turban JL et al. JAMA Psychiatry. 2019 Sep 11. doi: 10.1001/jamapsychiatry.2019.2285.
Gender identity conversion efforts during early childhood quadruple lifetime risk of suicidal behavior for transgender people, a study of almost 28,000 adults has determined.
The findings prompted the authors to issue a blanket warning against the controversial treatment, which already has been decried by several medical associations.
“Our results support policy positions … which state that gender identity–conversion therapy should not be conducted for transgender patients at any age, Jack L. Turban, MD, and colleagues wrote in JAMA Psychiatry.
The American Academy of Child and Adolescent Psychiatry, the American Psychiatric Association, the American Academy of Pediatrics, and the American Medical Association all strongly warn against any kind of gender conversion efforts.
The significantly increased risk of suicidal behavior was similar whether the gender identity–conversion effort (GICE) was administered by a clinician or a cleric. “This suggests that any process of intervening to alter gender identity is associated with poorer mental health regardless of whether the intervention occurred within a secular or religious framework,” wrote Dr. Turban of Massachusetts General Hospital, Boston, and coauthors.
The study – the largest of its kind thus far – comprised 27,715 transgender adults included in the 2015 U.S. Transgender Survey, conducted by the National Center for Transgender Equality.
In the current study, investigators focused on the question: “Did any professional (such as a psychologist, counselor, or religious advisor) try to make you identify only with your sex assigned at birth (in other words, try to stop you being trans)?”
They compared responses among subjects who reported exposure to GICE before age 10 years with those who did not.
Subjects were aged a mean of 31 years when they participated in the survey. Slightly less than half (42.8%) were assigned male sex at birth. Most (19,751) had discussed their gender identity with a professional. Nearly 20% (3,869) reported some exposure to GICE; 35% said a religious adviser had conducted the effort.
In this group, exposure had significant negative lifetime effects on mental health. These subjects were at a 56% increased risk of psychological distress within the month before taking the survey (odds ratio, 1.56), and more than twice as likely to have tried at least once to end their lives by suicide (OR, 2.27).
But the negative effects were even more pronounced among the small group of 206 who reported exposure to GICE before they were 10 years old. In a multivariate analysis adjusted for demographics, GICE before age 10 more than quadrupled the risk of lifetime suicide attempts (OR, 4.15). Again, it didn’t matter whether a medical or religious professional administered GICE.
“A plausible association of these practices with poor mental health outcomes can be conceptualized through the minority stress framework; that is, elevated stigma-related stress from exposure to GICE may increase general emotion dysregulation, interpersonal dysfunction, and maladaptive cognitions,” the investigators wrote. “Although this study suggests that exposure to GICE is associated with increased odds of suicide attempts, GICE are not the only way in which minority group stress manifests, and thus, other factors are also likely to be associated with suicidality among gender-diverse people.”
“One potential explanation for this is that, compared with persons in the sexual-minority group, many persons in the gender-minority group must interact with clinical professionals to be medically and surgically affirmed in their identities. This higher prevalence of interactions with clinical professionals among people in the gender minority group may lead to greater risk of experiencing conversion effort.”
The authors cited the sample size of the study as one of its many strengths. One limitation includes the study’s cross-sectional design.
Dr. Turban reported collecting royalties from Springer for an upcoming textbook about pediatric gender identity. The other coauthors reported no disclosures.
SOURCE: Turban JL et al. JAMA Psychiatry. 2019 Sep 11. doi: 10.1001/jamapsychiatry.2019.2285.
FROM JAMA PSYCHIATRY
Key clinical point: Gender identity–conversion efforts exert lifelong negative mental health impacts on transgender children.
Major finding: Exposure before age 10 years more than quadrupled the risk of lifetime suicidal behavior.
Study details: The cohort comprised 27,715 transgender adults.
Disclosures: Dr. Turban reported collecting royalties from Springer for an upcoming textbook about pediatric gender identity. No other financial disclosures were reported.
Source: Turban JL et al. JAMA Psychiatry. 2019 Sep 11. doi: 10.1001/jamapsychiatry.2019.2285.
Expert spotlights telltale clinical signs of xeroderma pigmentosum
AUSTIN, TEX. – If a child presents with acute (XP), a rare autosomal recessive disorder.
Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.
At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”
XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.
“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.
Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”
He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”
Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).
“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.
Dr. DiGiovanna reported having no financial disclosures.
AUSTIN, TEX. – If a child presents with acute (XP), a rare autosomal recessive disorder.
Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.
At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”
XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.
“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.
Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”
He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”
Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).
“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.
Dr. DiGiovanna reported having no financial disclosures.
AUSTIN, TEX. – If a child presents with acute (XP), a rare autosomal recessive disorder.
Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.
At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”
XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.
“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.
Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”
He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”
Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).
“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.
Dr. DiGiovanna reported having no financial disclosures.
REPORTING FROM SPD 2019
Two uveitis treatment options yield similar success
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
in an international, multicenter, open-label, randomized trial.
“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.
Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.
Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.
Overall, 64 patients given methotrexate (67%) and 56 of those given mycophenolate (57%) achieved treatment success at 6 months. Treatment success included inflammation control defined as “less than or equal to 0.5+ anterior chamber cells by Standardization of Uveitis Nomenclature criteria, less than or equal to 0.5+ vitreous haze clinical grading using the National Eye Institute scale, and no active retinal or choroidal lesions,” as well as needing no more than 7.5 mg of prednisone daily and two drops or less of prednisolone acetate 1% per day, and reporting no intolerability or safety concerns requiring study discontinuation.
Adverse events were similar between the groups. The most common nonserious adverse events were fatigue and headaches, and the most common nonserious laboratory adverse event was elevated liver enzymes. Fourteen serious adverse events occurred during the study period; three in the methotrexate group and two in the mycophenolate group were deemed drug related and all were elevated liver function tests.
The study findings had several limitations, including lack of masking of the patients to the medication and an inability to compare between types of uveitis, the researchers noted. Avenues for further research include whether one of the drugs is more effective based on the uveitis subtype, they added.
The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
FROM JAMA
Key clinical point: Mycophenolate mofetil and methotrexate were similar as corticosteroid-sparing treatment in patients with uveitis.
Major finding: Among uveitis patients, 67% of those given methotrexate and 57% of those given mycophenolate achieved corticosteroid-sparing control of inflammation.
Study details: The data come from a randomized trial of 216 adults with noninfectious uveitis at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico.
Disclosures: The study was supported in part by the National Eye Institute and study drugs were provided by the University of California San Francisco Pharmacy. Dr. Rathinam disclosed grants from Aravind Eye Hospital, and several coauthors disclosed relationships with AbbVie, Allergan, Novartis, Novotech, and Bayer.
Source: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.
Measles cases continue to decline
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
FDA issues warning to JUUL on illegal marketing of e-cigarettes
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
Chemotherapy may raise CVD risk in pediatric cancer survivors
Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.
Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.
Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).
With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m2 or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).
Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).
“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”
This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.
SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.
Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.
Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.
Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).
With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m2 or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).
Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).
“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”
This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.
SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.
Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.
Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.
Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).
With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m2 or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).
Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m2 or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).
“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”
This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.
SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.
FROM CIRCULATION