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New definitions of hypertension reveal new preeclampsia risks
according to results from a large retrospective cohort study.
In a 2017 guideline, the American College of Cardiology and American Heart Association changed clinical definitions of hypertension in adults. People previously deemed to have prehypertension were classed as having elevated blood pressure (systolic BP 120-129 mm Hg and diastolic BP >80 mm Hg) or stage 1 hypertension (systolic 130-139 mm Hg or diastolic 80-89 mm Hg).
And while hypertension as earlier defined (at or above systolic 140 mm Hg or at or above diastolic 90 mm Hg; now called stage 2 hypertension) has been long associated with adverse maternal and fetal effects, it was unclear whether lesser elevations in blood pressure also are linked to the same.
For their research published in Obstetrics & Gynecology, Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby and had two or more prenatal appointments before week 20 of pregnancy. The women in the study were seen at the same institution over a 3-year period ending in 2018. Three-quarters of the cohort had normal blood pressure, while 14% had elevated blood pressure and 5% had stage 1 hypertension before 20 weeks. Another 6% of the cohort had stage 2 hypertension.
The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did with 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Both term and preterm preeclampsia were factors in women with stage 1 and stage 2 hypertension, but preterm preeclampsia was associated with a higher risk. Although black race was associated with a higher risk of preeclampsia, the pattern of increasing risk with higher blood pressure category was similar in both black and white women.
Researchers also looked at gestational diabetes, severe maternal morbidity, neonatal morbidity, and placental abruption as secondary outcomes. They found the risk of gestational diabetes increased in a stepwise fashion as blood pressure increased, compared with normotensive women. Higher risk of severe maternal and neonatal morbidities was seen only in women with stage 2 hypertension. Placental abruption was rare in this cohort and the odds were not increased in any group.
The findings “highlight the importance of early pregnancy BP elevations, which may reflect prepregnancy BP status,” and suggest that the new guidelines “can identify women early in pregnancy who may benefit from increased surveillance,” Dr. Sutton and colleagues wrote.
Although randomized trials will be needed to identify the best prevention and management strategies for this patient group, they added, some clinicians may want to consider low-dose aspirin – an intervention shown to safely reduce preeclampsia risk among women with stage 2 hypertension – for women with elevated BP or stage 1 hypertension.
Dr. Sutton and colleagues acknowledged that its retrospective design is among the limitations of their study, and that use of antihypertensive medications could not be captured in their study.
Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy which are not well studied” in comparison to nonpregnant hypertensive states.
“Are these seemingly normal blood pressures associated with poor outcomes, maternal or neonatal? I think that this paper strongly tells us yes,” Dr. Santillan added. “But does that mean we have to do more aggressive blood pressure monitoring, seeing your doctor every month or so? Maybe we should change the way we’re treating people early on in gestation.”
The question of whether aspirin helps reduce preeclampsia risk in women with elevated blood pressure or stage 1 hypertension needs to be resolved in studies, Dr. Santillan said. But because of its favorable risk profile, “if I consider that if a patient has significant risk factors for developing preeclampsia, baby aspirin is fine.”
Postpregnancy blood pressure management is something that should also be reconsidered in light of the findings, Dr. Santillan said. Half of women with preeclampsia will have chronic hypertension after they deliver, increasing their risk of adverse cardiovascular outcomes later in life. But because most are young and otherwise healthy, they often are lost to follow-up.
“I think this paper has helped open up that conversation, that there is probably a link between what we’re doing in pregnancy to what we should be doing in the postpartum period,” he said.
Dr. Sutton and colleagues’ study received funding from the Richard King Mellon Foundation, the American Heart Association; and the National Institutes of Health. None of its authors had relevant disclosures. Dr. Santillan disclosed holding U.S. and international patents for preeclampsia prediction, diagnosis, and treatment.
SOURCE: Sutton et al. Obstet Gynecol. 2020;136:129-39.
according to results from a large retrospective cohort study.
In a 2017 guideline, the American College of Cardiology and American Heart Association changed clinical definitions of hypertension in adults. People previously deemed to have prehypertension were classed as having elevated blood pressure (systolic BP 120-129 mm Hg and diastolic BP >80 mm Hg) or stage 1 hypertension (systolic 130-139 mm Hg or diastolic 80-89 mm Hg).
And while hypertension as earlier defined (at or above systolic 140 mm Hg or at or above diastolic 90 mm Hg; now called stage 2 hypertension) has been long associated with adverse maternal and fetal effects, it was unclear whether lesser elevations in blood pressure also are linked to the same.
For their research published in Obstetrics & Gynecology, Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby and had two or more prenatal appointments before week 20 of pregnancy. The women in the study were seen at the same institution over a 3-year period ending in 2018. Three-quarters of the cohort had normal blood pressure, while 14% had elevated blood pressure and 5% had stage 1 hypertension before 20 weeks. Another 6% of the cohort had stage 2 hypertension.
The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did with 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Both term and preterm preeclampsia were factors in women with stage 1 and stage 2 hypertension, but preterm preeclampsia was associated with a higher risk. Although black race was associated with a higher risk of preeclampsia, the pattern of increasing risk with higher blood pressure category was similar in both black and white women.
Researchers also looked at gestational diabetes, severe maternal morbidity, neonatal morbidity, and placental abruption as secondary outcomes. They found the risk of gestational diabetes increased in a stepwise fashion as blood pressure increased, compared with normotensive women. Higher risk of severe maternal and neonatal morbidities was seen only in women with stage 2 hypertension. Placental abruption was rare in this cohort and the odds were not increased in any group.
The findings “highlight the importance of early pregnancy BP elevations, which may reflect prepregnancy BP status,” and suggest that the new guidelines “can identify women early in pregnancy who may benefit from increased surveillance,” Dr. Sutton and colleagues wrote.
Although randomized trials will be needed to identify the best prevention and management strategies for this patient group, they added, some clinicians may want to consider low-dose aspirin – an intervention shown to safely reduce preeclampsia risk among women with stage 2 hypertension – for women with elevated BP or stage 1 hypertension.
Dr. Sutton and colleagues acknowledged that its retrospective design is among the limitations of their study, and that use of antihypertensive medications could not be captured in their study.
Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy which are not well studied” in comparison to nonpregnant hypertensive states.
“Are these seemingly normal blood pressures associated with poor outcomes, maternal or neonatal? I think that this paper strongly tells us yes,” Dr. Santillan added. “But does that mean we have to do more aggressive blood pressure monitoring, seeing your doctor every month or so? Maybe we should change the way we’re treating people early on in gestation.”
The question of whether aspirin helps reduce preeclampsia risk in women with elevated blood pressure or stage 1 hypertension needs to be resolved in studies, Dr. Santillan said. But because of its favorable risk profile, “if I consider that if a patient has significant risk factors for developing preeclampsia, baby aspirin is fine.”
Postpregnancy blood pressure management is something that should also be reconsidered in light of the findings, Dr. Santillan said. Half of women with preeclampsia will have chronic hypertension after they deliver, increasing their risk of adverse cardiovascular outcomes later in life. But because most are young and otherwise healthy, they often are lost to follow-up.
“I think this paper has helped open up that conversation, that there is probably a link between what we’re doing in pregnancy to what we should be doing in the postpartum period,” he said.
Dr. Sutton and colleagues’ study received funding from the Richard King Mellon Foundation, the American Heart Association; and the National Institutes of Health. None of its authors had relevant disclosures. Dr. Santillan disclosed holding U.S. and international patents for preeclampsia prediction, diagnosis, and treatment.
SOURCE: Sutton et al. Obstet Gynecol. 2020;136:129-39.
according to results from a large retrospective cohort study.
In a 2017 guideline, the American College of Cardiology and American Heart Association changed clinical definitions of hypertension in adults. People previously deemed to have prehypertension were classed as having elevated blood pressure (systolic BP 120-129 mm Hg and diastolic BP >80 mm Hg) or stage 1 hypertension (systolic 130-139 mm Hg or diastolic 80-89 mm Hg).
And while hypertension as earlier defined (at or above systolic 140 mm Hg or at or above diastolic 90 mm Hg; now called stage 2 hypertension) has been long associated with adverse maternal and fetal effects, it was unclear whether lesser elevations in blood pressure also are linked to the same.
For their research published in Obstetrics & Gynecology, Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby and had two or more prenatal appointments before week 20 of pregnancy. The women in the study were seen at the same institution over a 3-year period ending in 2018. Three-quarters of the cohort had normal blood pressure, while 14% had elevated blood pressure and 5% had stage 1 hypertension before 20 weeks. Another 6% of the cohort had stage 2 hypertension.
The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks’ gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did with 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Both term and preterm preeclampsia were factors in women with stage 1 and stage 2 hypertension, but preterm preeclampsia was associated with a higher risk. Although black race was associated with a higher risk of preeclampsia, the pattern of increasing risk with higher blood pressure category was similar in both black and white women.
Researchers also looked at gestational diabetes, severe maternal morbidity, neonatal morbidity, and placental abruption as secondary outcomes. They found the risk of gestational diabetes increased in a stepwise fashion as blood pressure increased, compared with normotensive women. Higher risk of severe maternal and neonatal morbidities was seen only in women with stage 2 hypertension. Placental abruption was rare in this cohort and the odds were not increased in any group.
The findings “highlight the importance of early pregnancy BP elevations, which may reflect prepregnancy BP status,” and suggest that the new guidelines “can identify women early in pregnancy who may benefit from increased surveillance,” Dr. Sutton and colleagues wrote.
Although randomized trials will be needed to identify the best prevention and management strategies for this patient group, they added, some clinicians may want to consider low-dose aspirin – an intervention shown to safely reduce preeclampsia risk among women with stage 2 hypertension – for women with elevated BP or stage 1 hypertension.
Dr. Sutton and colleagues acknowledged that its retrospective design is among the limitations of their study, and that use of antihypertensive medications could not be captured in their study.
Preeclampsia researcher Mark Santillan, MD, PhD, of the University of Iowa in Iowa City, said in an interview that the results “open the door to considering these new blood pressure categories as a prognosticator” for preeclampsia. “This paper furthers the field by applying these new categories to hypertensive diseases in pregnancy which are not well studied” in comparison to nonpregnant hypertensive states.
“Are these seemingly normal blood pressures associated with poor outcomes, maternal or neonatal? I think that this paper strongly tells us yes,” Dr. Santillan added. “But does that mean we have to do more aggressive blood pressure monitoring, seeing your doctor every month or so? Maybe we should change the way we’re treating people early on in gestation.”
The question of whether aspirin helps reduce preeclampsia risk in women with elevated blood pressure or stage 1 hypertension needs to be resolved in studies, Dr. Santillan said. But because of its favorable risk profile, “if I consider that if a patient has significant risk factors for developing preeclampsia, baby aspirin is fine.”
Postpregnancy blood pressure management is something that should also be reconsidered in light of the findings, Dr. Santillan said. Half of women with preeclampsia will have chronic hypertension after they deliver, increasing their risk of adverse cardiovascular outcomes later in life. But because most are young and otherwise healthy, they often are lost to follow-up.
“I think this paper has helped open up that conversation, that there is probably a link between what we’re doing in pregnancy to what we should be doing in the postpartum period,” he said.
Dr. Sutton and colleagues’ study received funding from the Richard King Mellon Foundation, the American Heart Association; and the National Institutes of Health. None of its authors had relevant disclosures. Dr. Santillan disclosed holding U.S. and international patents for preeclampsia prediction, diagnosis, and treatment.
SOURCE: Sutton et al. Obstet Gynecol. 2020;136:129-39.
FROM OBSTETRICS & GYNECOLOGY
Children with cystic fibrosis and their caregivers face sleep difficulties
, according to results from a new study.
Children aged 6-12 years had more sleep issues compared with preschoolers or teenagers, researchers also found, and the quality of sleep among caregivers was seen strongly linked to that of their children with CF.
For research published in the Journal of Cystic Fibrosis, Kelly C. Byars, PsyD, and colleagues at Cincinnati Children’s Medical Center and the University of Cincinnati surveyed parents of 91 medically stable patients with cystic fibrosis aged 18 and younger at a single CF treatment center between 2016 and 2017.
Fifty-four percent of the children in the study were female, the mean age was 9 years, and 90% of the caregivers were mothers. In addition to the sleep questionnaires, the researchers looked at the children’s available lung function data from around the time of the survey. Forced expiratory volume in one second (FEV1) measures showed the vast majority had no obstructive lung disease (73% of the cohort) or only mild symptoms (18%) at the time their caregivers were surveyed.
Overall, some 40% of caregivers said they had concerns about their own sleep, while 29% said they were concerned for their children’s sleep. Parents reported night waking, daytime sleepiness, and difficulty falling asleep as their main problems, and difficulty falling asleep as the top issue for their children, along with daytime sleepiness, night waking, and mouth breathing.
Sleep issues were most pronounced for children aged 6-12 and their caregivers, a group for which 44% of caregivers said they were concerned for their children’s sleep and 55% for their own sleep. For this same group only 8% of parents reported their children having nocturnal cough, and just 5% reported gastrointestinal problems at night.
Overall, the caregivers in the study reported inadequate sleep, with more than half saying they got less than 7 hours per night. Similarly, more than half of the school-age and adolescent patients with CF were getting less than the nightly minimum recommended by the American Academy of Sleep Medicine.
The researchers noted “large effects for parent and child associations for insomnia symptoms that may be amenable to treatment,” especially trouble returning to sleep and daytime sleepiness.
The study “is the first to examine parent reported sleep disturbances and sleep duration in both parents and their children with CF spanning a broad age range and including patients who were medically stable and predominantly free of lung dysfunction,” Dr. Byars and colleagues wrote in their analysis, adding that sleep health should be integrated into care protocols for CF patients and their families, and families of children with other chronic illnesses.
In a comment on Dr. Byars and colleagues’ study, Hovig Artinian, MD, a pediatric pulmonary and sleep medicine specialist at Helen DeVos Children’s Hospital in Grand Rapids, Mich., said the findings “highlight for all of us that we must regularly assess and address sleep disturbances in our children with CF specifically, but also in all children with chronic conditions.”
Children with CF “carry a heavy burden,” Dr. Artinian said, “balancing living their lives with daily interruptions to their typical day to complete multiple treatments. As a result, sleep can be impacted even when there are no other clinical or objective signs of illness, so that was not an entirely surprising finding.” Difficulties with sleep onset and maintenance can be prevalent in the absence of changes in children’s daytime behavior or any other psychological signs, Dr. Artinian said, noting that in his practice he routinely asks families whether children snore (something recommended by the American Academy of Pediatrics for all well-child checks) and whether they have any other concerns about their sleep.
“Even if the answer is ‘no’ the first time, the act of asking plants a seed in their minds to keep an eye open and to know they can discuss it with us at a future visit if concerns come up,” Dr. Artinian said.
Dr. Byars and colleagues noted several limitations to their study including its cross-sectional, single-center design, potential participant selection bias, reliance on parent reports of child sleep, and use of a novel, nonvalidated survey instrument.
The researchers received funding from the Boomer Esiason Foundation for their study and disclosed no financial conflicts of interest. Dr. Artinian had no relevant disclosures.
SOURCE: Byars K et al. J Cyst Fibros. 2020 May. doi: 10.1016/j.jcf.2020.04.003.
, according to results from a new study.
Children aged 6-12 years had more sleep issues compared with preschoolers or teenagers, researchers also found, and the quality of sleep among caregivers was seen strongly linked to that of their children with CF.
For research published in the Journal of Cystic Fibrosis, Kelly C. Byars, PsyD, and colleagues at Cincinnati Children’s Medical Center and the University of Cincinnati surveyed parents of 91 medically stable patients with cystic fibrosis aged 18 and younger at a single CF treatment center between 2016 and 2017.
Fifty-four percent of the children in the study were female, the mean age was 9 years, and 90% of the caregivers were mothers. In addition to the sleep questionnaires, the researchers looked at the children’s available lung function data from around the time of the survey. Forced expiratory volume in one second (FEV1) measures showed the vast majority had no obstructive lung disease (73% of the cohort) or only mild symptoms (18%) at the time their caregivers were surveyed.
Overall, some 40% of caregivers said they had concerns about their own sleep, while 29% said they were concerned for their children’s sleep. Parents reported night waking, daytime sleepiness, and difficulty falling asleep as their main problems, and difficulty falling asleep as the top issue for their children, along with daytime sleepiness, night waking, and mouth breathing.
Sleep issues were most pronounced for children aged 6-12 and their caregivers, a group for which 44% of caregivers said they were concerned for their children’s sleep and 55% for their own sleep. For this same group only 8% of parents reported their children having nocturnal cough, and just 5% reported gastrointestinal problems at night.
Overall, the caregivers in the study reported inadequate sleep, with more than half saying they got less than 7 hours per night. Similarly, more than half of the school-age and adolescent patients with CF were getting less than the nightly minimum recommended by the American Academy of Sleep Medicine.
The researchers noted “large effects for parent and child associations for insomnia symptoms that may be amenable to treatment,” especially trouble returning to sleep and daytime sleepiness.
The study “is the first to examine parent reported sleep disturbances and sleep duration in both parents and their children with CF spanning a broad age range and including patients who were medically stable and predominantly free of lung dysfunction,” Dr. Byars and colleagues wrote in their analysis, adding that sleep health should be integrated into care protocols for CF patients and their families, and families of children with other chronic illnesses.
In a comment on Dr. Byars and colleagues’ study, Hovig Artinian, MD, a pediatric pulmonary and sleep medicine specialist at Helen DeVos Children’s Hospital in Grand Rapids, Mich., said the findings “highlight for all of us that we must regularly assess and address sleep disturbances in our children with CF specifically, but also in all children with chronic conditions.”
Children with CF “carry a heavy burden,” Dr. Artinian said, “balancing living their lives with daily interruptions to their typical day to complete multiple treatments. As a result, sleep can be impacted even when there are no other clinical or objective signs of illness, so that was not an entirely surprising finding.” Difficulties with sleep onset and maintenance can be prevalent in the absence of changes in children’s daytime behavior or any other psychological signs, Dr. Artinian said, noting that in his practice he routinely asks families whether children snore (something recommended by the American Academy of Pediatrics for all well-child checks) and whether they have any other concerns about their sleep.
“Even if the answer is ‘no’ the first time, the act of asking plants a seed in their minds to keep an eye open and to know they can discuss it with us at a future visit if concerns come up,” Dr. Artinian said.
Dr. Byars and colleagues noted several limitations to their study including its cross-sectional, single-center design, potential participant selection bias, reliance on parent reports of child sleep, and use of a novel, nonvalidated survey instrument.
The researchers received funding from the Boomer Esiason Foundation for their study and disclosed no financial conflicts of interest. Dr. Artinian had no relevant disclosures.
SOURCE: Byars K et al. J Cyst Fibros. 2020 May. doi: 10.1016/j.jcf.2020.04.003.
, according to results from a new study.
Children aged 6-12 years had more sleep issues compared with preschoolers or teenagers, researchers also found, and the quality of sleep among caregivers was seen strongly linked to that of their children with CF.
For research published in the Journal of Cystic Fibrosis, Kelly C. Byars, PsyD, and colleagues at Cincinnati Children’s Medical Center and the University of Cincinnati surveyed parents of 91 medically stable patients with cystic fibrosis aged 18 and younger at a single CF treatment center between 2016 and 2017.
Fifty-four percent of the children in the study were female, the mean age was 9 years, and 90% of the caregivers were mothers. In addition to the sleep questionnaires, the researchers looked at the children’s available lung function data from around the time of the survey. Forced expiratory volume in one second (FEV1) measures showed the vast majority had no obstructive lung disease (73% of the cohort) or only mild symptoms (18%) at the time their caregivers were surveyed.
Overall, some 40% of caregivers said they had concerns about their own sleep, while 29% said they were concerned for their children’s sleep. Parents reported night waking, daytime sleepiness, and difficulty falling asleep as their main problems, and difficulty falling asleep as the top issue for their children, along with daytime sleepiness, night waking, and mouth breathing.
Sleep issues were most pronounced for children aged 6-12 and their caregivers, a group for which 44% of caregivers said they were concerned for their children’s sleep and 55% for their own sleep. For this same group only 8% of parents reported their children having nocturnal cough, and just 5% reported gastrointestinal problems at night.
Overall, the caregivers in the study reported inadequate sleep, with more than half saying they got less than 7 hours per night. Similarly, more than half of the school-age and adolescent patients with CF were getting less than the nightly minimum recommended by the American Academy of Sleep Medicine.
The researchers noted “large effects for parent and child associations for insomnia symptoms that may be amenable to treatment,” especially trouble returning to sleep and daytime sleepiness.
The study “is the first to examine parent reported sleep disturbances and sleep duration in both parents and their children with CF spanning a broad age range and including patients who were medically stable and predominantly free of lung dysfunction,” Dr. Byars and colleagues wrote in their analysis, adding that sleep health should be integrated into care protocols for CF patients and their families, and families of children with other chronic illnesses.
In a comment on Dr. Byars and colleagues’ study, Hovig Artinian, MD, a pediatric pulmonary and sleep medicine specialist at Helen DeVos Children’s Hospital in Grand Rapids, Mich., said the findings “highlight for all of us that we must regularly assess and address sleep disturbances in our children with CF specifically, but also in all children with chronic conditions.”
Children with CF “carry a heavy burden,” Dr. Artinian said, “balancing living their lives with daily interruptions to their typical day to complete multiple treatments. As a result, sleep can be impacted even when there are no other clinical or objective signs of illness, so that was not an entirely surprising finding.” Difficulties with sleep onset and maintenance can be prevalent in the absence of changes in children’s daytime behavior or any other psychological signs, Dr. Artinian said, noting that in his practice he routinely asks families whether children snore (something recommended by the American Academy of Pediatrics for all well-child checks) and whether they have any other concerns about their sleep.
“Even if the answer is ‘no’ the first time, the act of asking plants a seed in their minds to keep an eye open and to know they can discuss it with us at a future visit if concerns come up,” Dr. Artinian said.
Dr. Byars and colleagues noted several limitations to their study including its cross-sectional, single-center design, potential participant selection bias, reliance on parent reports of child sleep, and use of a novel, nonvalidated survey instrument.
The researchers received funding from the Boomer Esiason Foundation for their study and disclosed no financial conflicts of interest. Dr. Artinian had no relevant disclosures.
SOURCE: Byars K et al. J Cyst Fibros. 2020 May. doi: 10.1016/j.jcf.2020.04.003.
FROM THE JOURNAL OF CYSTIC FIBROSIS
Fracture risk higher for children with anxiety on benzodiazepines
a new study found, which offers further argument for caution with this class of drugs in young patients.
In research published in Pediatrics, Greta A. Bushnell, PhD, of Columbia University in New York and colleagues, looked at private insurance claims data including prescription records from 120,715 children aged 6-17 years diagnosed with an anxiety disorder and from 179,768 young adults aged 18-24 years also diagnosed with anxiety.
The investigators compared fracture incidence within 3 months of treatment initiation between the group prescribed benzodiazepines for anxiety and the group prescribed SSRIs. Subjects prescribed both classes of drugs were excluded from the analysis.
Of patients aged 6-17 years, 11% were prescribed benzodiazepines, with the remainder receiving SSRIs. Children on benzodiazepines saw 33 fractures per 1,000 person-years, compared with 25 of those on SSRIs, with an adjusted incidence rate ratio of 1.53. These were fractures in the upper and lower limbs.
Similar differences in fracture risk were not seen among the young adults in the study, of whom 32% were prescribed benzodiazepines and among whom fracture rates were low overall, 9 per 1,000 person-years in both medication groups.
Several SSRIs have been approved by the Food and Drug Administration to treat anxiety disorders in children, but benzodiazepines are used off label in youth. The drugs most commonly prescribed in the study were alprazolam and lorazepam, and 82% of the group in this study aged 6-17 years did not fill their prescriptions beyond 1 month.
In adults, benzodiazepine treatment has been shown to cause drowsiness, dizziness, and weakness, which can result in injury, and it also is associated with increased risk of car accidents, falls, and fractures. The higher fracture rate among children on benzodiazepine treatment seen in this study is similar to rates reported in studies of older adults, Dr. Bushnell and colleagues noted.
The researchers could not explain why the young adults in the study did not see a higher risk of fractures on benzodiazepines, compared with that among those taking SSRIs. They hypothesized that young adults are less active than children, with fewer opportunities for falls, and there were few fractures among the 18- to 24-year-old cohort in general.
David C. Rettew, MD, from the University of Vermont in Burlington, commented in an interview that, while there are plenty of reasons to be cautious about using benzodiazepines in youth, “fracture risk isn’t usually very prominent among them, so it is a nice reminder to have this on the radar screen.” Most clinicians, he said, already are quite wary of using benzodiazepines in children, which is suggested by the small proportion of children treated with them in this study.
“It seems quite possible that children and adolescents prescribed benzodiazepines are quite different clinically than the group prescribed SSRIs, despite the strong measures the study authors took to control for other variables between the two groups,” Dr. Rettew added. “I’d have to wonder if those clinical differences may be behind some of the fracture rate differences” seen in the study.
Dr. Bushnell and her colleagues acknowledged this among the study’s several limitations. “It is unclear how much unmeasured differences in psychiatric condition severity exist between youth initiating a benzodiazepine versus SSRI and how anxiety severity impacts fracture risk.” The researchers also noted that they could not measure use of the drugs beyond whether and when prescriptions were filled.
Dr. Bushnell and colleagues’ study was funded by the National Institute of Mental Health and by grants from the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, and the National Institutes of Health. One of its coauthors disclosed financial relationships with several pharmaceutical manufacturers. Dr. Rettew said he had no relevant financial disclosures
SOURCE: Bushnell GA et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2019-3478.
a new study found, which offers further argument for caution with this class of drugs in young patients.
In research published in Pediatrics, Greta A. Bushnell, PhD, of Columbia University in New York and colleagues, looked at private insurance claims data including prescription records from 120,715 children aged 6-17 years diagnosed with an anxiety disorder and from 179,768 young adults aged 18-24 years also diagnosed with anxiety.
The investigators compared fracture incidence within 3 months of treatment initiation between the group prescribed benzodiazepines for anxiety and the group prescribed SSRIs. Subjects prescribed both classes of drugs were excluded from the analysis.
Of patients aged 6-17 years, 11% were prescribed benzodiazepines, with the remainder receiving SSRIs. Children on benzodiazepines saw 33 fractures per 1,000 person-years, compared with 25 of those on SSRIs, with an adjusted incidence rate ratio of 1.53. These were fractures in the upper and lower limbs.
Similar differences in fracture risk were not seen among the young adults in the study, of whom 32% were prescribed benzodiazepines and among whom fracture rates were low overall, 9 per 1,000 person-years in both medication groups.
Several SSRIs have been approved by the Food and Drug Administration to treat anxiety disorders in children, but benzodiazepines are used off label in youth. The drugs most commonly prescribed in the study were alprazolam and lorazepam, and 82% of the group in this study aged 6-17 years did not fill their prescriptions beyond 1 month.
In adults, benzodiazepine treatment has been shown to cause drowsiness, dizziness, and weakness, which can result in injury, and it also is associated with increased risk of car accidents, falls, and fractures. The higher fracture rate among children on benzodiazepine treatment seen in this study is similar to rates reported in studies of older adults, Dr. Bushnell and colleagues noted.
The researchers could not explain why the young adults in the study did not see a higher risk of fractures on benzodiazepines, compared with that among those taking SSRIs. They hypothesized that young adults are less active than children, with fewer opportunities for falls, and there were few fractures among the 18- to 24-year-old cohort in general.
David C. Rettew, MD, from the University of Vermont in Burlington, commented in an interview that, while there are plenty of reasons to be cautious about using benzodiazepines in youth, “fracture risk isn’t usually very prominent among them, so it is a nice reminder to have this on the radar screen.” Most clinicians, he said, already are quite wary of using benzodiazepines in children, which is suggested by the small proportion of children treated with them in this study.
“It seems quite possible that children and adolescents prescribed benzodiazepines are quite different clinically than the group prescribed SSRIs, despite the strong measures the study authors took to control for other variables between the two groups,” Dr. Rettew added. “I’d have to wonder if those clinical differences may be behind some of the fracture rate differences” seen in the study.
Dr. Bushnell and her colleagues acknowledged this among the study’s several limitations. “It is unclear how much unmeasured differences in psychiatric condition severity exist between youth initiating a benzodiazepine versus SSRI and how anxiety severity impacts fracture risk.” The researchers also noted that they could not measure use of the drugs beyond whether and when prescriptions were filled.
Dr. Bushnell and colleagues’ study was funded by the National Institute of Mental Health and by grants from the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, and the National Institutes of Health. One of its coauthors disclosed financial relationships with several pharmaceutical manufacturers. Dr. Rettew said he had no relevant financial disclosures
SOURCE: Bushnell GA et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2019-3478.
a new study found, which offers further argument for caution with this class of drugs in young patients.
In research published in Pediatrics, Greta A. Bushnell, PhD, of Columbia University in New York and colleagues, looked at private insurance claims data including prescription records from 120,715 children aged 6-17 years diagnosed with an anxiety disorder and from 179,768 young adults aged 18-24 years also diagnosed with anxiety.
The investigators compared fracture incidence within 3 months of treatment initiation between the group prescribed benzodiazepines for anxiety and the group prescribed SSRIs. Subjects prescribed both classes of drugs were excluded from the analysis.
Of patients aged 6-17 years, 11% were prescribed benzodiazepines, with the remainder receiving SSRIs. Children on benzodiazepines saw 33 fractures per 1,000 person-years, compared with 25 of those on SSRIs, with an adjusted incidence rate ratio of 1.53. These were fractures in the upper and lower limbs.
Similar differences in fracture risk were not seen among the young adults in the study, of whom 32% were prescribed benzodiazepines and among whom fracture rates were low overall, 9 per 1,000 person-years in both medication groups.
Several SSRIs have been approved by the Food and Drug Administration to treat anxiety disorders in children, but benzodiazepines are used off label in youth. The drugs most commonly prescribed in the study were alprazolam and lorazepam, and 82% of the group in this study aged 6-17 years did not fill their prescriptions beyond 1 month.
In adults, benzodiazepine treatment has been shown to cause drowsiness, dizziness, and weakness, which can result in injury, and it also is associated with increased risk of car accidents, falls, and fractures. The higher fracture rate among children on benzodiazepine treatment seen in this study is similar to rates reported in studies of older adults, Dr. Bushnell and colleagues noted.
The researchers could not explain why the young adults in the study did not see a higher risk of fractures on benzodiazepines, compared with that among those taking SSRIs. They hypothesized that young adults are less active than children, with fewer opportunities for falls, and there were few fractures among the 18- to 24-year-old cohort in general.
David C. Rettew, MD, from the University of Vermont in Burlington, commented in an interview that, while there are plenty of reasons to be cautious about using benzodiazepines in youth, “fracture risk isn’t usually very prominent among them, so it is a nice reminder to have this on the radar screen.” Most clinicians, he said, already are quite wary of using benzodiazepines in children, which is suggested by the small proportion of children treated with them in this study.
“It seems quite possible that children and adolescents prescribed benzodiazepines are quite different clinically than the group prescribed SSRIs, despite the strong measures the study authors took to control for other variables between the two groups,” Dr. Rettew added. “I’d have to wonder if those clinical differences may be behind some of the fracture rate differences” seen in the study.
Dr. Bushnell and her colleagues acknowledged this among the study’s several limitations. “It is unclear how much unmeasured differences in psychiatric condition severity exist between youth initiating a benzodiazepine versus SSRI and how anxiety severity impacts fracture risk.” The researchers also noted that they could not measure use of the drugs beyond whether and when prescriptions were filled.
Dr. Bushnell and colleagues’ study was funded by the National Institute of Mental Health and by grants from the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, and the National Institutes of Health. One of its coauthors disclosed financial relationships with several pharmaceutical manufacturers. Dr. Rettew said he had no relevant financial disclosures
SOURCE: Bushnell GA et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2019-3478.
FROM PEDIATRICS
Key clinical point: Children aged 6-17 years prescribed sedatives for anxiety saw a higher risk of fractures, compared with those on SSRIs.
Major finding: Children prescribed benzodiazepines for anxiety had 33 fractures per 1,000 person-years versus 25 among children prescribed SSRIs (adjusted incidence rate ratio, 1.53).
Study details: A retrospective cohort study using commercial insurance claims data from 120,715 children aged 6-17 years and 179,768 young adults ages 18-24 years from 2007 through 2016, all with anxiety diagnoses and prescribed either benzodiazepines or SSRIs.
Disclosures: Dr. Bushnell and colleagues’ study was funded by the National Institute of Mental Health, and grants from the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, and the National Institutes of Health. One of its coauthors disclosed financial relationships with several pharmaceutical manufacturers.
Source: Bushnell GA et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2019-3478.
COVID-19 complicates prescribing for children with inflammatory skin disease
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
designed to offer guidance to specialists and nonspecialists faced with tough choices about risks.
Some 87% reported that they were reducing the frequency of lab monitoring for some medications, while more than half said they had reached out to patients and their families to discuss the implications of continuing or stopping a drug.
Virtually all – 97% – said that the COVID-19 crisis had affected their decision to initiate immunosuppressive medications, with 84% saying the decision depended on a patient’s risk factors for contracting COVID-19 infection, and also the potential consequences of infection while treated, compared with the risks of not optimally treating the skin condition.
To develop a consensus-based guidance for clinicians, published online April 22 in Pediatric Dermatology, Kelly Cordoro, MD, professor of dermatology at the University of California, San Francisco, assembled a task force of pediatric dermatologists at academic institutions (the Pediatric Dermatology COVID-19 Response Task Force). Together with Sean Reynolds, MD, a pediatric dermatology fellow at UCSF and colleagues, they issued a survey to the 37 members of the task force with questions on how the pandemic has affected their prescribing decisions and certain therapies specifically. All the recipients responded.
The dermatologists were asked about conventional systemic and biologic medications. Most felt confident in continuing biologics, with 78% saying they would keep patients with no signs of COVID-19 exposure or infection on tumor necrosis factor (TNF) inhibitors. More than 90% of respondents said they would continue patients on dupilumab, as well as anti–interleukin (IL)–17, anti–IL-12/23, and anti–IL-23 therapies.
Responses varied more on approaches to the nonbiologic treatments. Fewer than half (46%) said they would continue patients without apparent COVID-19 exposure on systemic steroids, with another 46% saying it depended on the clinical context.
For other systemic therapies, respondents were more likely to want to continue their patients with no signs or symptoms of COVID-19 on methotrexate and apremilast (78% and 83%, respectively) than others (mycophenolate mofetil, azathioprine, cyclosporine, and JAK inhibitors), which saw between 50% and 60% support in the survey.
Patients on any immunosuppressive medications with likely exposure to COVID-19 or who test positive for the virus should be temporarily taken off their medications, the majority concurred. Exceptions were for systemic steroids, which must be tapered. And a significant minority of the dermatologists said that they would continue apremilast or dupilumab (24% and 16%, respectively) in the event of a confirmed COVID-19 infection.
In an interview, Dr. Cordoro commented that, even in normal times, most systemic or biological immunosuppressive treatments are used off-label by pediatric dermatologists. “There’s no way this could have been an evidence-based document, as we didn’t have the data to drive this. Many of the medications have been tested in children but not necessarily for dermatologic indications; some are chemotherapy agents or drugs used in rheumatologic diseases.”
The COVID-19 pandemic complicated an already difficult decision-making process, she said.
The researchers cautioned against attempting to make decisions about medications based on data on other infections from clinical trials. “Infection data from standard infections that were identified and watched for in clinical trials really still has no bearing on COVID-19 because it’s such a different virus,” Dr. Cordoro said.
And while some immunosuppressive medications could potentially attenuate a SARS-CoV-2–induced cytokine storm, “we certainly don’t assume this is necessarily going to help.”
The authors advised that physicians anxious about initiating an immunosuppressive treatment should take into consideration whether early intervention could “prevent permanent physical impairment or disfigurement” in diseases such as erythrodermic pustular psoriasis or rapidly progressive linear morphea.
Other diseases, such as atopic dermatitis, “may be acceptably, though not optimally, managed with topical and other home-based therapeutic options” during the pandemic, they wrote.
Dr. Cordoro commented that, given how fast new findings are emerging from the pandemic, the guidance on medications could change. “We will know so much more 3 months from now,” she said. And while there are no formal plans to reissue the survey, “we’re maintaining communication and will have some kind of follow up” with the academic dermatologists.
“If we recognize any signals that are counter to what we say in this work we will immediately let people know,” she said.
The researchers received no outside funding for their study. Of the study’s 24 coauthors, nine disclosed financial relationships with industry.
SOURCE: Add the first auSOURCE: Reynolds et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14202.
FROM PEDIATRIC DERMATOLOGY
Vitamin D intake among U.S. infants has not improved, despite guidance
with breastfed infants less likely to have adequate levels than formula-fed infants, according to results of a study.
The American Association of Pediatrics has recommended since 2008 that breastfeeding babies under 1 year of age receive 400 IU of vitamin D supplementation daily, usually in the form of drops, to prevent rickets. For formula-fed infants, the AAP recommends that infants be fed one liter of formula daily, as formulas must contain 400 IU of vitamin D per liter.
A study looking at caregiver-reported dietary data through 2012 suggested that the guideline was having little impact, with only 27% of U.S. infants considered to be getting adequate vitamin D. The same researchers have now updated those findings with data through 2016 to report virtually no improvement over time. For their research, published in Pediatrics, Alan E. Simon, MD, of the National Institutes of Health in Rockville, Md., and Katherine A. Ahrens, PhD, of the University of Southern Maine in Portland, analyzed data for 1,435 infants aged 0-11 months. All data were recorded during 2009-2016 as part of the ongoing National Health and Nutrition Examination Survey (NHANES).
Overall, 27% of infants in the study were considered likely to meet the guidelines. Among nonbreastfeeding infants, 31% were deemed to have adequate levels, compared with 21% of breastfeeding infants (P less than .01).
Parents’ income and education affected infants’ likelihood of meeting guidelines. Breastfeeding infants in families with incomes above 400% of the federal poverty level were twice as likely to meet guidelines (31% vs. 14%-16% for lower income brackets, P less than .05). Babies from families whose head of household had a college degree had a 26% likelihood of having enough vitamin D, compared with less than 11% of those in whose parents had less than a high school education (P less than .05). Babies from families with private insurance also had a better chance of meeting guidelines, compared with those with public insurance (24% vs. 13%; P less than .05).
Ethnicity was seen as affecting vitamin D intake only insofar as some groups had more formula use than breastfeeding. The only ethnic or racial subgroup in the study that saw more than 40% of infants likely to meet guidelines was nonbreastfeeding infants of Asian, American Indian, Native Hawaiian or Pacific Islander, or multiracial parentage, with 46% considered to have adequate vitamin D levels. This group makes up 6% of the infant population in the United States.
“Reasons for low rates of meeting guidelines in the United States and little improvement over time are not fully known,” Dr. Simon and Dr. Ahrens wrote in their analysis. “One factor may be that the impact of low vitamin D in infancy is not highly visible to physicians because rickets is an uncommon diagnosis in the United States.” They noted that recent studies from Canada, where public health officials have done more to promote supplementation, have shown rates of adequate vitamin D in breastfeeding babies to be as high as 90%.
The researchers listed among limitations of their study the fact that the data source, NHANES, captured nutrition information only for the previous 24 hours; that it relied on parental report, and did not confirm serum levels of vitamin D; and that it was possible that cow’s milk – which is not recommended before age 1 but frequently given to older infants anyway – could be a hidden source of vitamin D that was not taken into consideration.
In an editorial comment, Jaspreet Loyal, MD, and Annette Cameron, MD, of Yale University in New Haven, Conn., faulted “a combination of inconsistent prescribing by clinicians and poor adherence to the use of a supplement by parents of infants … further complicated by a lack of awareness of the consequences of vitamin D deficiency in infants among the public” for the low adherence to guidelines in the United States, compared with other countries.
Also, the editorialists noted, the dropper used to administer liquid supplements has been associated with “inconsistent precision” and concerns about infants gagging on the liquid. More research is needed to better understand “prescribing patterns, barriers to adherence by parents of infants, and alternate strategies for vitamin D supplementation to inform novel public health programs in the United States,” they wrote.
The National Institutes of Health funded the study, and Dr. Ahrens is supported by a faculty development grant from the Maine Economic Improvement Fund. The researchers declared no conflicts of interest. Dr. Loyal and Dr. Cameron disclosed no funding and no relevant financial disclosures.
SOURCE: Simon AE and Ahrens KA. Pediatrics 2020 May. doi: 10.1542/peds.2019-3574; Loyal J and Cameron A. Pediatrics. 2020 May. doi: 10.1542/peds.2020-0504.
with breastfed infants less likely to have adequate levels than formula-fed infants, according to results of a study.
The American Association of Pediatrics has recommended since 2008 that breastfeeding babies under 1 year of age receive 400 IU of vitamin D supplementation daily, usually in the form of drops, to prevent rickets. For formula-fed infants, the AAP recommends that infants be fed one liter of formula daily, as formulas must contain 400 IU of vitamin D per liter.
A study looking at caregiver-reported dietary data through 2012 suggested that the guideline was having little impact, with only 27% of U.S. infants considered to be getting adequate vitamin D. The same researchers have now updated those findings with data through 2016 to report virtually no improvement over time. For their research, published in Pediatrics, Alan E. Simon, MD, of the National Institutes of Health in Rockville, Md., and Katherine A. Ahrens, PhD, of the University of Southern Maine in Portland, analyzed data for 1,435 infants aged 0-11 months. All data were recorded during 2009-2016 as part of the ongoing National Health and Nutrition Examination Survey (NHANES).
Overall, 27% of infants in the study were considered likely to meet the guidelines. Among nonbreastfeeding infants, 31% were deemed to have adequate levels, compared with 21% of breastfeeding infants (P less than .01).
Parents’ income and education affected infants’ likelihood of meeting guidelines. Breastfeeding infants in families with incomes above 400% of the federal poverty level were twice as likely to meet guidelines (31% vs. 14%-16% for lower income brackets, P less than .05). Babies from families whose head of household had a college degree had a 26% likelihood of having enough vitamin D, compared with less than 11% of those in whose parents had less than a high school education (P less than .05). Babies from families with private insurance also had a better chance of meeting guidelines, compared with those with public insurance (24% vs. 13%; P less than .05).
Ethnicity was seen as affecting vitamin D intake only insofar as some groups had more formula use than breastfeeding. The only ethnic or racial subgroup in the study that saw more than 40% of infants likely to meet guidelines was nonbreastfeeding infants of Asian, American Indian, Native Hawaiian or Pacific Islander, or multiracial parentage, with 46% considered to have adequate vitamin D levels. This group makes up 6% of the infant population in the United States.
“Reasons for low rates of meeting guidelines in the United States and little improvement over time are not fully known,” Dr. Simon and Dr. Ahrens wrote in their analysis. “One factor may be that the impact of low vitamin D in infancy is not highly visible to physicians because rickets is an uncommon diagnosis in the United States.” They noted that recent studies from Canada, where public health officials have done more to promote supplementation, have shown rates of adequate vitamin D in breastfeeding babies to be as high as 90%.
The researchers listed among limitations of their study the fact that the data source, NHANES, captured nutrition information only for the previous 24 hours; that it relied on parental report, and did not confirm serum levels of vitamin D; and that it was possible that cow’s milk – which is not recommended before age 1 but frequently given to older infants anyway – could be a hidden source of vitamin D that was not taken into consideration.
In an editorial comment, Jaspreet Loyal, MD, and Annette Cameron, MD, of Yale University in New Haven, Conn., faulted “a combination of inconsistent prescribing by clinicians and poor adherence to the use of a supplement by parents of infants … further complicated by a lack of awareness of the consequences of vitamin D deficiency in infants among the public” for the low adherence to guidelines in the United States, compared with other countries.
Also, the editorialists noted, the dropper used to administer liquid supplements has been associated with “inconsistent precision” and concerns about infants gagging on the liquid. More research is needed to better understand “prescribing patterns, barriers to adherence by parents of infants, and alternate strategies for vitamin D supplementation to inform novel public health programs in the United States,” they wrote.
The National Institutes of Health funded the study, and Dr. Ahrens is supported by a faculty development grant from the Maine Economic Improvement Fund. The researchers declared no conflicts of interest. Dr. Loyal and Dr. Cameron disclosed no funding and no relevant financial disclosures.
SOURCE: Simon AE and Ahrens KA. Pediatrics 2020 May. doi: 10.1542/peds.2019-3574; Loyal J and Cameron A. Pediatrics. 2020 May. doi: 10.1542/peds.2020-0504.
with breastfed infants less likely to have adequate levels than formula-fed infants, according to results of a study.
The American Association of Pediatrics has recommended since 2008 that breastfeeding babies under 1 year of age receive 400 IU of vitamin D supplementation daily, usually in the form of drops, to prevent rickets. For formula-fed infants, the AAP recommends that infants be fed one liter of formula daily, as formulas must contain 400 IU of vitamin D per liter.
A study looking at caregiver-reported dietary data through 2012 suggested that the guideline was having little impact, with only 27% of U.S. infants considered to be getting adequate vitamin D. The same researchers have now updated those findings with data through 2016 to report virtually no improvement over time. For their research, published in Pediatrics, Alan E. Simon, MD, of the National Institutes of Health in Rockville, Md., and Katherine A. Ahrens, PhD, of the University of Southern Maine in Portland, analyzed data for 1,435 infants aged 0-11 months. All data were recorded during 2009-2016 as part of the ongoing National Health and Nutrition Examination Survey (NHANES).
Overall, 27% of infants in the study were considered likely to meet the guidelines. Among nonbreastfeeding infants, 31% were deemed to have adequate levels, compared with 21% of breastfeeding infants (P less than .01).
Parents’ income and education affected infants’ likelihood of meeting guidelines. Breastfeeding infants in families with incomes above 400% of the federal poverty level were twice as likely to meet guidelines (31% vs. 14%-16% for lower income brackets, P less than .05). Babies from families whose head of household had a college degree had a 26% likelihood of having enough vitamin D, compared with less than 11% of those in whose parents had less than a high school education (P less than .05). Babies from families with private insurance also had a better chance of meeting guidelines, compared with those with public insurance (24% vs. 13%; P less than .05).
Ethnicity was seen as affecting vitamin D intake only insofar as some groups had more formula use than breastfeeding. The only ethnic or racial subgroup in the study that saw more than 40% of infants likely to meet guidelines was nonbreastfeeding infants of Asian, American Indian, Native Hawaiian or Pacific Islander, or multiracial parentage, with 46% considered to have adequate vitamin D levels. This group makes up 6% of the infant population in the United States.
“Reasons for low rates of meeting guidelines in the United States and little improvement over time are not fully known,” Dr. Simon and Dr. Ahrens wrote in their analysis. “One factor may be that the impact of low vitamin D in infancy is not highly visible to physicians because rickets is an uncommon diagnosis in the United States.” They noted that recent studies from Canada, where public health officials have done more to promote supplementation, have shown rates of adequate vitamin D in breastfeeding babies to be as high as 90%.
The researchers listed among limitations of their study the fact that the data source, NHANES, captured nutrition information only for the previous 24 hours; that it relied on parental report, and did not confirm serum levels of vitamin D; and that it was possible that cow’s milk – which is not recommended before age 1 but frequently given to older infants anyway – could be a hidden source of vitamin D that was not taken into consideration.
In an editorial comment, Jaspreet Loyal, MD, and Annette Cameron, MD, of Yale University in New Haven, Conn., faulted “a combination of inconsistent prescribing by clinicians and poor adherence to the use of a supplement by parents of infants … further complicated by a lack of awareness of the consequences of vitamin D deficiency in infants among the public” for the low adherence to guidelines in the United States, compared with other countries.
Also, the editorialists noted, the dropper used to administer liquid supplements has been associated with “inconsistent precision” and concerns about infants gagging on the liquid. More research is needed to better understand “prescribing patterns, barriers to adherence by parents of infants, and alternate strategies for vitamin D supplementation to inform novel public health programs in the United States,” they wrote.
The National Institutes of Health funded the study, and Dr. Ahrens is supported by a faculty development grant from the Maine Economic Improvement Fund. The researchers declared no conflicts of interest. Dr. Loyal and Dr. Cameron disclosed no funding and no relevant financial disclosures.
SOURCE: Simon AE and Ahrens KA. Pediatrics 2020 May. doi: 10.1542/peds.2019-3574; Loyal J and Cameron A. Pediatrics. 2020 May. doi: 10.1542/peds.2020-0504.
FROM PEDIATRICS
Distracted driving laws reduce teen driver deaths
While car crashes are still the leading cause of death among adolescents in the United States, the expansion of state laws restricting cell phone use or texting while driving has pushed down death rates for teen drivers, a study has found.
However, the researchers wrote that the type of law and the manner of enforcement bear on how much teen road deaths are reduced.
In an article published in Pediatrics, Michael R. Flaherty, DO, of Harvard Medical School and Massachusetts General Hospital in Boston, and colleagues used data from the Fatality Analysis Reporting System, a national database of motor vehicle deaths in the United States, to identify 38,215 fatal crashes nationwide involving teen drivers from 2007 to 2017.
During that same time period, in which a majority of states began to adopt some form of “distracted driving” legislation prohibiting texting or all handheld cell phone use, fatal crashes involving 16- to 19-year-old drivers decreased from 30 in 100,000 persons to 19 in 100,000.
Under primarily enforced laws – those that make texting an offense for which police can stop and cite a driver – 16- to 19-year-old drivers saw a 29% lower driver fatality rate, compared with those living in states with no texting laws (adjusted incidence rate ratio, 0.71; 95% confidence interval, 0.67-0.76).
Under secondarily enforced bans, deaths of drivers aged 16-19 were reduced 15%, compared with no restrictions (aIRR, 0.85; 95% CI, 0.77-0.95).
Importantly, state laws limiting texting and cell phone use had to apply to drivers of all ages to be protective, the investigators found. Laws banning cell phone use only among novice drivers, which have been adopted in many states, were not seen lowering teen driver fatality rates. At the time of this study in 2017, “40 states had primary enforcement texting bans, 6 states had secondary enforcement texting bans, 34 states banned all cellphone use for novice drivers, and 12 banned handheld cellphones for all drivers, they reported.
Dr. Flaherty and colleagues noted that their study was the first to look in detail at the effects of anti–distracted driving laws on teen drivers specifically. They noted among the study’s limitations that the database used did not capture nonfatal accidents, and that the findings could not be adjusted for social or technological changes such as alcohol use trends among teens or safety improvements to cars.
In an accompanying editorial, Catherine C. McDonald, PhD, RN, and M. Kit Delgado, MD, of the University of Pennsylvania, Philadelphia, along with Mark R. Zonfrillo, MD, of Brown University, Providence, R.I., wrote that the findings show “reducing adolescent [crash] fatalities is not just about targeting laws to the adolescent drivers who are at elevated crash risk but also the other drivers who share the road with them.”
“The basic concepts related to eyes on the road, hands on the wheel, and mind on the task of driving are fundamental to driver safety. There is no one cause to pinpoint for adolescent motor vehicle crashes because there are multiple contributing factors, including inexperience, maturational development, and risk-taking.” they wrote.
Noting that nearly half of high school–aged drivers acknowledge texting while driving, the editorialists argued that most states still had room to “refine existing laws or implement new laws” to help reduce fatalities associated with adolescent drivers. “In the meantime, other technological and behavioral approaches may be needed to encourage adolescent drivers to act in their own and society’s best interests and comply with the law.”
Dr. Flaherty and colleagues declared no external funding for their study or financial conflicts of interest. Dr. McDonald, Dr. Delgado, and Dr. Zonfrillo declared funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development related to their editorial and no relevant financial disclosures.
SOURCE: Flaherty M et al. Pediatrics. 2020;145(6):e20193621; McDonald CC et al. Pediatrics. 2020;145(6):e20200419.
While car crashes are still the leading cause of death among adolescents in the United States, the expansion of state laws restricting cell phone use or texting while driving has pushed down death rates for teen drivers, a study has found.
However, the researchers wrote that the type of law and the manner of enforcement bear on how much teen road deaths are reduced.
In an article published in Pediatrics, Michael R. Flaherty, DO, of Harvard Medical School and Massachusetts General Hospital in Boston, and colleagues used data from the Fatality Analysis Reporting System, a national database of motor vehicle deaths in the United States, to identify 38,215 fatal crashes nationwide involving teen drivers from 2007 to 2017.
During that same time period, in which a majority of states began to adopt some form of “distracted driving” legislation prohibiting texting or all handheld cell phone use, fatal crashes involving 16- to 19-year-old drivers decreased from 30 in 100,000 persons to 19 in 100,000.
Under primarily enforced laws – those that make texting an offense for which police can stop and cite a driver – 16- to 19-year-old drivers saw a 29% lower driver fatality rate, compared with those living in states with no texting laws (adjusted incidence rate ratio, 0.71; 95% confidence interval, 0.67-0.76).
Under secondarily enforced bans, deaths of drivers aged 16-19 were reduced 15%, compared with no restrictions (aIRR, 0.85; 95% CI, 0.77-0.95).
Importantly, state laws limiting texting and cell phone use had to apply to drivers of all ages to be protective, the investigators found. Laws banning cell phone use only among novice drivers, which have been adopted in many states, were not seen lowering teen driver fatality rates. At the time of this study in 2017, “40 states had primary enforcement texting bans, 6 states had secondary enforcement texting bans, 34 states banned all cellphone use for novice drivers, and 12 banned handheld cellphones for all drivers, they reported.
Dr. Flaherty and colleagues noted that their study was the first to look in detail at the effects of anti–distracted driving laws on teen drivers specifically. They noted among the study’s limitations that the database used did not capture nonfatal accidents, and that the findings could not be adjusted for social or technological changes such as alcohol use trends among teens or safety improvements to cars.
In an accompanying editorial, Catherine C. McDonald, PhD, RN, and M. Kit Delgado, MD, of the University of Pennsylvania, Philadelphia, along with Mark R. Zonfrillo, MD, of Brown University, Providence, R.I., wrote that the findings show “reducing adolescent [crash] fatalities is not just about targeting laws to the adolescent drivers who are at elevated crash risk but also the other drivers who share the road with them.”
“The basic concepts related to eyes on the road, hands on the wheel, and mind on the task of driving are fundamental to driver safety. There is no one cause to pinpoint for adolescent motor vehicle crashes because there are multiple contributing factors, including inexperience, maturational development, and risk-taking.” they wrote.
Noting that nearly half of high school–aged drivers acknowledge texting while driving, the editorialists argued that most states still had room to “refine existing laws or implement new laws” to help reduce fatalities associated with adolescent drivers. “In the meantime, other technological and behavioral approaches may be needed to encourage adolescent drivers to act in their own and society’s best interests and comply with the law.”
Dr. Flaherty and colleagues declared no external funding for their study or financial conflicts of interest. Dr. McDonald, Dr. Delgado, and Dr. Zonfrillo declared funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development related to their editorial and no relevant financial disclosures.
SOURCE: Flaherty M et al. Pediatrics. 2020;145(6):e20193621; McDonald CC et al. Pediatrics. 2020;145(6):e20200419.
While car crashes are still the leading cause of death among adolescents in the United States, the expansion of state laws restricting cell phone use or texting while driving has pushed down death rates for teen drivers, a study has found.
However, the researchers wrote that the type of law and the manner of enforcement bear on how much teen road deaths are reduced.
In an article published in Pediatrics, Michael R. Flaherty, DO, of Harvard Medical School and Massachusetts General Hospital in Boston, and colleagues used data from the Fatality Analysis Reporting System, a national database of motor vehicle deaths in the United States, to identify 38,215 fatal crashes nationwide involving teen drivers from 2007 to 2017.
During that same time period, in which a majority of states began to adopt some form of “distracted driving” legislation prohibiting texting or all handheld cell phone use, fatal crashes involving 16- to 19-year-old drivers decreased from 30 in 100,000 persons to 19 in 100,000.
Under primarily enforced laws – those that make texting an offense for which police can stop and cite a driver – 16- to 19-year-old drivers saw a 29% lower driver fatality rate, compared with those living in states with no texting laws (adjusted incidence rate ratio, 0.71; 95% confidence interval, 0.67-0.76).
Under secondarily enforced bans, deaths of drivers aged 16-19 were reduced 15%, compared with no restrictions (aIRR, 0.85; 95% CI, 0.77-0.95).
Importantly, state laws limiting texting and cell phone use had to apply to drivers of all ages to be protective, the investigators found. Laws banning cell phone use only among novice drivers, which have been adopted in many states, were not seen lowering teen driver fatality rates. At the time of this study in 2017, “40 states had primary enforcement texting bans, 6 states had secondary enforcement texting bans, 34 states banned all cellphone use for novice drivers, and 12 banned handheld cellphones for all drivers, they reported.
Dr. Flaherty and colleagues noted that their study was the first to look in detail at the effects of anti–distracted driving laws on teen drivers specifically. They noted among the study’s limitations that the database used did not capture nonfatal accidents, and that the findings could not be adjusted for social or technological changes such as alcohol use trends among teens or safety improvements to cars.
In an accompanying editorial, Catherine C. McDonald, PhD, RN, and M. Kit Delgado, MD, of the University of Pennsylvania, Philadelphia, along with Mark R. Zonfrillo, MD, of Brown University, Providence, R.I., wrote that the findings show “reducing adolescent [crash] fatalities is not just about targeting laws to the adolescent drivers who are at elevated crash risk but also the other drivers who share the road with them.”
“The basic concepts related to eyes on the road, hands on the wheel, and mind on the task of driving are fundamental to driver safety. There is no one cause to pinpoint for adolescent motor vehicle crashes because there are multiple contributing factors, including inexperience, maturational development, and risk-taking.” they wrote.
Noting that nearly half of high school–aged drivers acknowledge texting while driving, the editorialists argued that most states still had room to “refine existing laws or implement new laws” to help reduce fatalities associated with adolescent drivers. “In the meantime, other technological and behavioral approaches may be needed to encourage adolescent drivers to act in their own and society’s best interests and comply with the law.”
Dr. Flaherty and colleagues declared no external funding for their study or financial conflicts of interest. Dr. McDonald, Dr. Delgado, and Dr. Zonfrillo declared funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development related to their editorial and no relevant financial disclosures.
SOURCE: Flaherty M et al. Pediatrics. 2020;145(6):e20193621; McDonald CC et al. Pediatrics. 2020;145(6):e20200419.
FROM PEDIATRICS
L-thyroxine no help for older patients with symptomatic SCH
A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.
The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.
But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.
For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.
Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.
At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.
Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).
Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.
The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.
In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”
The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.
The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.
SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.
A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.
The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.
But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.
For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.
Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.
At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.
Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).
Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.
The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.
In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”
The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.
The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.
SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.
A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.
The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.
But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.
For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.
Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.
At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.
Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).
Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.
The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.
In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”
The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.
The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.
SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.
FROM ANNALS OF INTERNAL MEDICINE
Starting school later in the morning improves adolescents’ sleep
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
according to results from a cohort study.
For their research published in JAMA Pediatrics, Rachel Widome, PhD, of the University of Minnesota, Minneapolis, and colleagues followed a cohort of students at five public high schools in suburban and rural Minneapolis, randomly selecting 455 (225 girls; mean age, 15 years) for wrist actigraphy to track sleep and activity.
The students were followed up over 2 years, from 2016 to 2018. Sleep and activity were monitored at baseline, at year 1, and at year 2. Baseline monitoring lasted a month, and each follow-up monitoring period lasted over 2 months.
Although all the high schools in the study had early start times when the study began, two moved within the first year to delay their starting times to after 8:30 a.m., after a decision by the local school district. The other three schools retained start times of 7:30 a.m. This allowed investigators to compare students’ sleep patterns between start times for an extended period.
Dr. Widome and colleagues found significant improvements in sleep at 1 year that did not attenuate in the second year. At the end of year 2, students in the delayed-start schools slept 43 minutes more on weeknights than their early-starting peers (95% confidence interval, 25-61, P < .001.) The investigators did not see significant between-group differences in weeknight bedtimes. On weekends, students in the delayed-start group slept a mean 34 minutes less at year 2 (95% CI, –65 to –3, P = .03) than their peers in the early groups.
The researchers described the study’s design, a natural experiment with long follow-up and objectively measured sleep data, as its key strength. “No previous studies have been performed of sufficient quality to conclude that later start times cause students to get more sleep and that this effect can be sustained,” they concluded.
In an editorial comment, Erika R. Cheng, PhD, and Aaron E. Carroll, MD, of Indiana University, Indianapolis, wrote that the study provides strong evidence that delaying early school start times “would help adolescents get the sleep they need to thrive,” and belies the commonly held argument that delayed school times would merely lead to them staying awake later on school nights.
Adolescents “experience natural circadian and physiological brain changes that shift their sleep preference to go to bed and wake up later than adults or younger children,” Dr. Cheng and Dr. Carroll noted, with 12th graders’ bedtimes typically after 11 p.m. on weekdays. Regardless, “more than 40% of high schools in the United States start before 8 a.m., and more than 20% of middle schools start at 7:45 a.m. or earlier.”
Dr. Cheng and Dr. Carroll cautioned that the population in this study comprised “relatively affluent students and schools,” and that there were “socioeconomic and racial differences in student characteristics between schools that did and did not adopt the later start times.” For instance, they noted, nearly 90% of students in the delayed-start schools reported having at least one college-educated parent, while in the comparison schools fewer than 75% did. Unmeasured characteristics associated with parent education may have “influenced the school district’s decision to delay schools’ start times and had an effect on student sleep duration.”
Dr. Widome and colleagues’ study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the authors received support from a grant from the Minnesota Population Center. One coauthor acknowledged receiving a consulting fee from Jazz Pharmaceuticals. Dr. Cheng and Dr. Carroll disclosed no relevant conflicts of interest.
SOURCES: Widome R et al. JAMA Pedatr. 2020 Apr 27. doi: 10.1001/jamapediatrics.2020.0344; Cheng ER, Carroll AE. JAMA Pediatr. 2020 Apr 27. oi: 10.1001/jamapediatrics.2020.0351.
FROM JAMA PEDIATRICS
Parents would avoid cognitive effects in children over better chance of cancer cure
Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.
While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.
In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.
Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).
Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.
The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.
“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”
In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.
But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”
Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.
SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.
Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.
While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.
In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.
Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).
Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.
The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.
“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”
In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.
But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”
Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.
SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.
Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.
While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.
In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.
Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).
Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.
The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.
“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”
In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.
But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”
Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.
SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.
FROM PEDIATRICS
Treatment for RA, SpA may not affect COVID-19 severity
Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.
Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.
In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).
Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.
Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.
“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”
The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”
Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.
“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.
Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.
SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.
Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.
Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.
In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).
Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.
Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.
“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”
The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”
Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.
“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.
Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.
SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.
Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.
Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.
In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).
Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.
Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.
“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”
The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”
Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.
“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.
Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.
SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.
FROM ANNALS OF THE RHEUMATIC DISEASES