Heidi Splete

Vaccination against Japanese encephalitis is recommended for persons moving to endemic areas, or who travel to these areas frequently or for long-term visits, according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Japanese encephalitis (JE) virus is a mosquito-borne flavivirus and those at risk for infection include travelers to countries where JE is endemic, as well as laboratory personnel who work with the virus.

The committee voted unanimously 15-0 in favor of the recommendations, which also advised vaccination for those whose travels in endemic areas are uncertain, but not for travelers with low-risk itineraries “such as shorter term travel limited to urban areas or travel that occurs outside of a well-defined JE virus transmission season.”

Susan Hills, MD, of the of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, presented data in support of the recommendations.

A second unanimous vote confirmed recommendations for a primary series schedule for JE vaccination for adults aged 18-65 years as “two doses of vaccine administered on days 0 and 7-28.”

The third vote, also a unanimous 15-0, updated recommendations for a JE booster dose. The new recommendation is that adults and children receive a booster dose (a third dose) at least a year after completion of the primary JE vaccine series “if ongoing exposure or re-exposure to JE virus is expected.”

The currently available Japanese encephalitis vaccine in the United States is an inactivated Vero cell culture-derived vaccine marketed as IXIARO that was approved in March 2009 for individuals aged 17 years and older and approved in May 2013 for children aged 2 months through 16 years.

The ACIP members had no financial conflicts to disclose.
 

Vaccination against Japanese encephalitis is recommended for persons moving to endemic areas, or who travel to these areas frequently or for long-term visits, according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Japanese encephalitis (JE) virus is a mosquito-borne flavivirus and those at risk for infection include travelers to countries where JE is endemic, as well as laboratory personnel who work with the virus.

The committee voted unanimously 15-0 in favor of the recommendations, which also advised vaccination for those whose travels in endemic areas are uncertain, but not for travelers with low-risk itineraries “such as shorter term travel limited to urban areas or travel that occurs outside of a well-defined JE virus transmission season.”

Susan Hills, MD, of the of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, presented data in support of the recommendations.

A second unanimous vote confirmed recommendations for a primary series schedule for JE vaccination for adults aged 18-65 years as “two doses of vaccine administered on days 0 and 7-28.”

The third vote, also a unanimous 15-0, updated recommendations for a JE booster dose. The new recommendation is that adults and children receive a booster dose (a third dose) at least a year after completion of the primary JE vaccine series “if ongoing exposure or re-exposure to JE virus is expected.”

The currently available Japanese encephalitis vaccine in the United States is an inactivated Vero cell culture-derived vaccine marketed as IXIARO that was approved in March 2009 for individuals aged 17 years and older and approved in May 2013 for children aged 2 months through 16 years.

The ACIP members had no financial conflicts to disclose.
 

Vaccination against Japanese encephalitis is recommended for persons moving to endemic areas, or who travel to these areas frequently or for long-term visits, according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Japanese encephalitis (JE) virus is a mosquito-borne flavivirus and those at risk for infection include travelers to countries where JE is endemic, as well as laboratory personnel who work with the virus.

The committee voted unanimously 15-0 in favor of the recommendations, which also advised vaccination for those whose travels in endemic areas are uncertain, but not for travelers with low-risk itineraries “such as shorter term travel limited to urban areas or travel that occurs outside of a well-defined JE virus transmission season.”

Susan Hills, MD, of the of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, presented data in support of the recommendations.

A second unanimous vote confirmed recommendations for a primary series schedule for JE vaccination for adults aged 18-65 years as “two doses of vaccine administered on days 0 and 7-28.”

The third vote, also a unanimous 15-0, updated recommendations for a JE booster dose. The new recommendation is that adults and children receive a booster dose (a third dose) at least a year after completion of the primary JE vaccine series “if ongoing exposure or re-exposure to JE virus is expected.”

The currently available Japanese encephalitis vaccine in the United States is an inactivated Vero cell culture-derived vaccine marketed as IXIARO that was approved in March 2009 for individuals aged 17 years and older and approved in May 2013 for children aged 2 months through 16 years.

The ACIP members had no financial conflicts to disclose.
 

A triple test was a significantly more effective predictor of preeclampsia than was either angiogenic placental growth factor (PlGF) alone or the antiangiogenic factor soluble fms-like tyrosine kinase-1(sFLT)/PlGF ratio, based on data from more than 15,000 pregnancies.

Jovanmandic/Getty Images

The use of either PlGF or sFLT/PlGF alone to predict preeclampsia fails to account for individual maternal risk factors or the measurement of blood pressure at presentation, wrote Anca Ciobanu, MD, of King’s College London, and her colleagues.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers reviewed data from 15,247 singleton pregnancies with live births of healthy babies and compared the preeclampsia detection rates of PlGF, sFLT/PlGF and a competing risks model that included a combination of maternal factors and median values of PlGF, sFLT, and mean arterial pressure (triple test). Preeclampsia developed in 2.1% of pregnancies.

Overall, the triple-test detection rate for delivery with preeclampsia was 10% higher than the sFLT/PlGF ratio and 20% higher than PlGF alone based on assessment at 2 weeks or less or 4 weeks or less before delivery. The negative predictive value was similar for the three tests.

At 2 weeks or less before delivery, the area under the receiver operating characteristic curves (AUROC) for preeclampsia was significantly higher for the combination model (0.975), compared with PlGF (0.900) or the sFLT/PlGF ratio (0.932), with P less than .0001 in each case. Similarly, at 4 weeks or less before delivery, the AUROC for preeclampsia was 0.907 for the triple test, 0.827 for PlGF alone, and 0.857 for the sFLT/PlGF ratio, with P less than .0001 in each case.

The competing risks model allows clinicians more flexibility to identify patients at increased risk by considering factors including maternal characteristics and variations from normal blood pressure, Dr. Ciobanu and her associates noted. Also, the combination model, “can form the basis of future research that would quantify and incorporate into the model, symptoms such as headache and epigastric pain, as well as proteinuria, creatinine, liver enzymes and platelets.”

The study findings were limited by several factors including the potential predictive value of screening for women with hypertensive symptoms attending specialist clinics, and whether mean arterial pressure would be an effective measure in patients seen at these clinics, the researchers noted. However, the results support the value of the competing risks model, which “provides a personalized risk for delivery with preeclampsia that could lead to personalized stratification of the intensity of monitoring and timing of delivery.”

The study was supported by a grant from the Fetal Medicine Foundation; Thermo Fisher Scientific provided the reagents and equipment. The researchers had no financial conflicts of interest.

SOURCE: Ciobanu A et al. Am J Obstet Gynecol. 2019 Feb 7. doi. org/10.1016/j.ajog.2019.01.235.

A triple test was a significantly more effective predictor of preeclampsia than was either angiogenic placental growth factor (PlGF) alone or the antiangiogenic factor soluble fms-like tyrosine kinase-1(sFLT)/PlGF ratio, based on data from more than 15,000 pregnancies.

Jovanmandic/Getty Images

The use of either PlGF or sFLT/PlGF alone to predict preeclampsia fails to account for individual maternal risk factors or the measurement of blood pressure at presentation, wrote Anca Ciobanu, MD, of King’s College London, and her colleagues.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers reviewed data from 15,247 singleton pregnancies with live births of healthy babies and compared the preeclampsia detection rates of PlGF, sFLT/PlGF and a competing risks model that included a combination of maternal factors and median values of PlGF, sFLT, and mean arterial pressure (triple test). Preeclampsia developed in 2.1% of pregnancies.

Overall, the triple-test detection rate for delivery with preeclampsia was 10% higher than the sFLT/PlGF ratio and 20% higher than PlGF alone based on assessment at 2 weeks or less or 4 weeks or less before delivery. The negative predictive value was similar for the three tests.

At 2 weeks or less before delivery, the area under the receiver operating characteristic curves (AUROC) for preeclampsia was significantly higher for the combination model (0.975), compared with PlGF (0.900) or the sFLT/PlGF ratio (0.932), with P less than .0001 in each case. Similarly, at 4 weeks or less before delivery, the AUROC for preeclampsia was 0.907 for the triple test, 0.827 for PlGF alone, and 0.857 for the sFLT/PlGF ratio, with P less than .0001 in each case.

The competing risks model allows clinicians more flexibility to identify patients at increased risk by considering factors including maternal characteristics and variations from normal blood pressure, Dr. Ciobanu and her associates noted. Also, the combination model, “can form the basis of future research that would quantify and incorporate into the model, symptoms such as headache and epigastric pain, as well as proteinuria, creatinine, liver enzymes and platelets.”

The study findings were limited by several factors including the potential predictive value of screening for women with hypertensive symptoms attending specialist clinics, and whether mean arterial pressure would be an effective measure in patients seen at these clinics, the researchers noted. However, the results support the value of the competing risks model, which “provides a personalized risk for delivery with preeclampsia that could lead to personalized stratification of the intensity of monitoring and timing of delivery.”

The study was supported by a grant from the Fetal Medicine Foundation; Thermo Fisher Scientific provided the reagents and equipment. The researchers had no financial conflicts of interest.

SOURCE: Ciobanu A et al. Am J Obstet Gynecol. 2019 Feb 7. doi. org/10.1016/j.ajog.2019.01.235.

A triple test was a significantly more effective predictor of preeclampsia than was either angiogenic placental growth factor (PlGF) alone or the antiangiogenic factor soluble fms-like tyrosine kinase-1(sFLT)/PlGF ratio, based on data from more than 15,000 pregnancies.

Jovanmandic/Getty Images

The use of either PlGF or sFLT/PlGF alone to predict preeclampsia fails to account for individual maternal risk factors or the measurement of blood pressure at presentation, wrote Anca Ciobanu, MD, of King’s College London, and her colleagues.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers reviewed data from 15,247 singleton pregnancies with live births of healthy babies and compared the preeclampsia detection rates of PlGF, sFLT/PlGF and a competing risks model that included a combination of maternal factors and median values of PlGF, sFLT, and mean arterial pressure (triple test). Preeclampsia developed in 2.1% of pregnancies.

Overall, the triple-test detection rate for delivery with preeclampsia was 10% higher than the sFLT/PlGF ratio and 20% higher than PlGF alone based on assessment at 2 weeks or less or 4 weeks or less before delivery. The negative predictive value was similar for the three tests.

At 2 weeks or less before delivery, the area under the receiver operating characteristic curves (AUROC) for preeclampsia was significantly higher for the combination model (0.975), compared with PlGF (0.900) or the sFLT/PlGF ratio (0.932), with P less than .0001 in each case. Similarly, at 4 weeks or less before delivery, the AUROC for preeclampsia was 0.907 for the triple test, 0.827 for PlGF alone, and 0.857 for the sFLT/PlGF ratio, with P less than .0001 in each case.

The competing risks model allows clinicians more flexibility to identify patients at increased risk by considering factors including maternal characteristics and variations from normal blood pressure, Dr. Ciobanu and her associates noted. Also, the combination model, “can form the basis of future research that would quantify and incorporate into the model, symptoms such as headache and epigastric pain, as well as proteinuria, creatinine, liver enzymes and platelets.”

The study findings were limited by several factors including the potential predictive value of screening for women with hypertensive symptoms attending specialist clinics, and whether mean arterial pressure would be an effective measure in patients seen at these clinics, the researchers noted. However, the results support the value of the competing risks model, which “provides a personalized risk for delivery with preeclampsia that could lead to personalized stratification of the intensity of monitoring and timing of delivery.”

The study was supported by a grant from the Fetal Medicine Foundation; Thermo Fisher Scientific provided the reagents and equipment. The researchers had no financial conflicts of interest.

SOURCE: Ciobanu A et al. Am J Obstet Gynecol. 2019 Feb 7. doi. org/10.1016/j.ajog.2019.01.235.

Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.

SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.

Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.

SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.

Newly diagnosed ankylosing spondylitis (AS) patients are at increased risk for venous thromboembolism (VTE), especially during the first year after diagnosis, according to a population-based study of 7,190 cases.

SOURCE: Aviña-Zubieta JA et al. Ann Rheum Dis. 2019 Feb 8. doi: 10.1136/annrheumdis-2018-214388.

Pregnant and postpartum women who are at increased risk of developing perinatal depression should undergo a counseling intervention, according to a B recommendation from the U.S. Preventive Services Task Force.

monkeybusinessimages/Thinkstock

The Task Force determined that counseling interventions are effective in preventing perinatal depression, defined as a major or minor depressive episode during pregnancy or within the first year after delivery. The condition affects an estimated 12% of new mothers in the United States each year, according to lead author Susan J. Curry, PhD, of the University of Iowa, Iowa City, and her colleagues.

The recommendation, published in JAMA, applies to “pregnant persons and persons who are less than 1 year postpartum who do not have a current diagnosis of depression but are at increased risk of developing depression,” according to the authors (JAMA. 2019 Feb 12;321(6):580-7).

Risk factors for development of perinatal depression include:

• Past history of depression.
• Current depressive symptoms (that do not reach a diagnostic threshold).
• History of physical or sexual abuse.
• Unplanned or unwanted pregnancy.
• Stressful life events.
• Lack of social and financial support.
• Intimate partner violence.
• Pregestational or gestational diabetes.
• Complications during pregnancy.
• Adolescent parenthood.
• Low socioeconomic status.
• Lack of social support.

After reviewing the evidence, the USPSTF found a moderate net benefit for counseling interventions, particularly cognitive behavioral therapy and interpersonal therapy, for preventing perinatal depression in women at risk. Counseling sessions reviewed for this recommendation ranged from 4 to 20 meetings (median, 8 meetings).

The USPSTF found inadequate evidence to assess the harms and benefits of other noncounseling interventions, including pharmacologic therapy.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente, Portland, Ore., and her colleagues analyzed data from 50 studies including 22,385 individuals; 20 of these studies were randomized, controlled trials of counseling interventions (JAMA. 2019 Feb 12;321(6):588-601).

Overall, the likelihood of perinatal depression was significantly lower among women who received counseling, compared with controls, among more than 3,000 women in those studies (pooled risk ratio 0.61). Absolute risk differences for perinatal depression ranged from a 1% increased reduction in controls to a 32% increased reduction among women who received counseling. The effects were strongest for cognitive behavioral therapy and interpersonal therapy as interventions. No adverse events were reported in the counseling intervention studies.

In three studies of health system interventions, the researchers found a benefit for interventions vs. controls, but the difference was not statistically significant.

Trials of most other alternative interventions including infant sleep advice, birth-experience postpartum debriefing, omega-3 fatty acid supplementation, expressive writing, antidepressants, and yoga did not show statistical significance in benefit for reducing perinatal depression.

Only one of three randomized controlled trials of physical activity found a statistically significant group difference.

A trial of nortriptyline to prevent perinatal depression showed no benefit, compared with placebo. A sertraline study of found “a smaller percentage of participants taking sertraline had a depression recurrence, compared with those taking placebo,” the investigators wrote. In these two studies, women who took nortriptyline showed no adverse effects, and those in a trial involving sertraline reported significantly more dizziness and drowsiness compared with placebo patients.

The evidence review was limited by the small number of quality studies, especially studies of alternative interventions. More research is needed; however, the findings support data from similar reviews and support the potential for counseling to prevent perinatal depression, particularly in women at increased risk for perinatal depression, Dr. O’Connor and her associates said.

The USPSTF is supported by the Agency for Healthcare Research and Quality. Coauthor Dr. Michelle L. Henninger reported receiving grants from Pfizer IGLC (Independent Grants for Learning & Change) outside the submitted work. Coauthor Dr. Bradley N. Gaynes reported receiving personal fees from LivaNova and Johnson & Johnson outside the submitted work. The remaining researchers had no financial conflicts to disclose.

SOURCE: Curry SJ et al. JAMA. 2019;321(6):580-7; O’Connor E et al. JAMA. 2019;321(6):588-601.

Pregnant and postpartum women who are at increased risk of developing perinatal depression should undergo a counseling intervention, according to a B recommendation from the U.S. Preventive Services Task Force.

monkeybusinessimages/Thinkstock

The Task Force determined that counseling interventions are effective in preventing perinatal depression, defined as a major or minor depressive episode during pregnancy or within the first year after delivery. The condition affects an estimated 12% of new mothers in the United States each year, according to lead author Susan J. Curry, PhD, of the University of Iowa, Iowa City, and her colleagues.

The recommendation, published in JAMA, applies to “pregnant persons and persons who are less than 1 year postpartum who do not have a current diagnosis of depression but are at increased risk of developing depression,” according to the authors (JAMA. 2019 Feb 12;321(6):580-7).

Risk factors for development of perinatal depression include:

• Past history of depression.
• Current depressive symptoms (that do not reach a diagnostic threshold).
• History of physical or sexual abuse.
• Unplanned or unwanted pregnancy.
• Stressful life events.
• Lack of social and financial support.
• Intimate partner violence.
• Pregestational or gestational diabetes.
• Complications during pregnancy.
• Adolescent parenthood.
• Low socioeconomic status.
• Lack of social support.

After reviewing the evidence, the USPSTF found a moderate net benefit for counseling interventions, particularly cognitive behavioral therapy and interpersonal therapy, for preventing perinatal depression in women at risk. Counseling sessions reviewed for this recommendation ranged from 4 to 20 meetings (median, 8 meetings).

The USPSTF found inadequate evidence to assess the harms and benefits of other noncounseling interventions, including pharmacologic therapy.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente, Portland, Ore., and her colleagues analyzed data from 50 studies including 22,385 individuals; 20 of these studies were randomized, controlled trials of counseling interventions (JAMA. 2019 Feb 12;321(6):588-601).

Overall, the likelihood of perinatal depression was significantly lower among women who received counseling, compared with controls, among more than 3,000 women in those studies (pooled risk ratio 0.61). Absolute risk differences for perinatal depression ranged from a 1% increased reduction in controls to a 32% increased reduction among women who received counseling. The effects were strongest for cognitive behavioral therapy and interpersonal therapy as interventions. No adverse events were reported in the counseling intervention studies.

In three studies of health system interventions, the researchers found a benefit for interventions vs. controls, but the difference was not statistically significant.

Trials of most other alternative interventions including infant sleep advice, birth-experience postpartum debriefing, omega-3 fatty acid supplementation, expressive writing, antidepressants, and yoga did not show statistical significance in benefit for reducing perinatal depression.

Only one of three randomized controlled trials of physical activity found a statistically significant group difference.

A trial of nortriptyline to prevent perinatal depression showed no benefit, compared with placebo. A sertraline study of found “a smaller percentage of participants taking sertraline had a depression recurrence, compared with those taking placebo,” the investigators wrote. In these two studies, women who took nortriptyline showed no adverse effects, and those in a trial involving sertraline reported significantly more dizziness and drowsiness compared with placebo patients.

The evidence review was limited by the small number of quality studies, especially studies of alternative interventions. More research is needed; however, the findings support data from similar reviews and support the potential for counseling to prevent perinatal depression, particularly in women at increased risk for perinatal depression, Dr. O’Connor and her associates said.

The USPSTF is supported by the Agency for Healthcare Research and Quality. Coauthor Dr. Michelle L. Henninger reported receiving grants from Pfizer IGLC (Independent Grants for Learning & Change) outside the submitted work. Coauthor Dr. Bradley N. Gaynes reported receiving personal fees from LivaNova and Johnson & Johnson outside the submitted work. The remaining researchers had no financial conflicts to disclose.

SOURCE: Curry SJ et al. JAMA. 2019;321(6):580-7; O’Connor E et al. JAMA. 2019;321(6):588-601.

Pregnant and postpartum women who are at increased risk of developing perinatal depression should undergo a counseling intervention, according to a B recommendation from the U.S. Preventive Services Task Force.

monkeybusinessimages/Thinkstock

The Task Force determined that counseling interventions are effective in preventing perinatal depression, defined as a major or minor depressive episode during pregnancy or within the first year after delivery. The condition affects an estimated 12% of new mothers in the United States each year, according to lead author Susan J. Curry, PhD, of the University of Iowa, Iowa City, and her colleagues.

The recommendation, published in JAMA, applies to “pregnant persons and persons who are less than 1 year postpartum who do not have a current diagnosis of depression but are at increased risk of developing depression,” according to the authors (JAMA. 2019 Feb 12;321(6):580-7).

Risk factors for development of perinatal depression include:

• Past history of depression.
• Current depressive symptoms (that do not reach a diagnostic threshold).
• History of physical or sexual abuse.
• Unplanned or unwanted pregnancy.
• Stressful life events.
• Lack of social and financial support.
• Intimate partner violence.
• Pregestational or gestational diabetes.
• Complications during pregnancy.
• Adolescent parenthood.
• Low socioeconomic status.
• Lack of social support.

After reviewing the evidence, the USPSTF found a moderate net benefit for counseling interventions, particularly cognitive behavioral therapy and interpersonal therapy, for preventing perinatal depression in women at risk. Counseling sessions reviewed for this recommendation ranged from 4 to 20 meetings (median, 8 meetings).

The USPSTF found inadequate evidence to assess the harms and benefits of other noncounseling interventions, including pharmacologic therapy.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente, Portland, Ore., and her colleagues analyzed data from 50 studies including 22,385 individuals; 20 of these studies were randomized, controlled trials of counseling interventions (JAMA. 2019 Feb 12;321(6):588-601).

Overall, the likelihood of perinatal depression was significantly lower among women who received counseling, compared with controls, among more than 3,000 women in those studies (pooled risk ratio 0.61). Absolute risk differences for perinatal depression ranged from a 1% increased reduction in controls to a 32% increased reduction among women who received counseling. The effects were strongest for cognitive behavioral therapy and interpersonal therapy as interventions. No adverse events were reported in the counseling intervention studies.

In three studies of health system interventions, the researchers found a benefit for interventions vs. controls, but the difference was not statistically significant.

Trials of most other alternative interventions including infant sleep advice, birth-experience postpartum debriefing, omega-3 fatty acid supplementation, expressive writing, antidepressants, and yoga did not show statistical significance in benefit for reducing perinatal depression.

Only one of three randomized controlled trials of physical activity found a statistically significant group difference.

A trial of nortriptyline to prevent perinatal depression showed no benefit, compared with placebo. A sertraline study of found “a smaller percentage of participants taking sertraline had a depression recurrence, compared with those taking placebo,” the investigators wrote. In these two studies, women who took nortriptyline showed no adverse effects, and those in a trial involving sertraline reported significantly more dizziness and drowsiness compared with placebo patients.

The evidence review was limited by the small number of quality studies, especially studies of alternative interventions. More research is needed; however, the findings support data from similar reviews and support the potential for counseling to prevent perinatal depression, particularly in women at increased risk for perinatal depression, Dr. O’Connor and her associates said.

The USPSTF is supported by the Agency for Healthcare Research and Quality. Coauthor Dr. Michelle L. Henninger reported receiving grants from Pfizer IGLC (Independent Grants for Learning & Change) outside the submitted work. Coauthor Dr. Bradley N. Gaynes reported receiving personal fees from LivaNova and Johnson & Johnson outside the submitted work. The remaining researchers had no financial conflicts to disclose.

SOURCE: Curry SJ et al. JAMA. 2019;321(6):580-7; O’Connor E et al. JAMA. 2019;321(6):588-601.

A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.

Courtesy CDC

E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*

In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.

“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.

The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.

“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.

 
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.

Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”

The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.

“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.

In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”

In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.

One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.

Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.

The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.

SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.

*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.

A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.

Courtesy CDC

E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*

In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.

“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.

The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.

“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.

 
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.

Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”

The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.

“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.

In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”

In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.

One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.

Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.

The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.

SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.

*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.

A significant increase during 2017-2018 in e-cigarette use among U.S. youths has erased recent progress in reducing overall tobacco product use in this age group, a study from the Centers for Disease Control and Prevention has found.

Courtesy CDC

E-cigarettes are driving the trend. About 4 million high school students in the United States reported using any tobacco product in the last 30 days, and 3 million of them reported using e-cigarettes, according to a Vital Signs document published by the CDC on Feb. 11 in its Morbidity and Mortality Weekly Report.*

In addition, many high school students who use e-cigarettes use them often; 28% reported using the products at least 20 times in the past 28 days, up from 20% in 2017.

“Any use of any tobacco product is unsafe for teens,” Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference to present the findings. Nicotine is highly addictive and can harm brain development in youth, including capacity for learning, memory, and attention, she said.

The rise in e-cigarette use corresponds with the rise in marketing and availability of e-cigarette devices such as JUUL, which dispense nicotine via liquid refill pods available in flavors including strawberry and cotton candy, said Brian King, MPH, PhD, deputy director for research translation at the CDC’s Office on Smoking and Health.

“The advertising will lead a horse to water, the flavors will make them drink, and the nicotine will keep them coming back for more,” said Dr. King.

 
No change was noted in the use of other tobacco products, including cigarettes, from 2017 to 2018, according to the report. However, conventional cigarettes remained the most common companion product to e-cigarettes for youth who use two or more tobacco products (two in five high school students and one in three middle school students in 2018). From a demographic standpoint, e-cigarette use was highest among males, whites, and high school students.

Tobacco use in teens is trending in the direction of wiping out the progress made in recent years to reduce exposure to youths. The report noted, “The prevalence of e-cigarette use by U.S. high school students had peaked in 2015 before declining by 29% during 2015-2016 (from 16% to 11.3%); this decline was the first ever recorded for e-cigarette use among youths in the NYTS since monitoring began, and it was subsequently sustained during 2016-2017). However, current e-cigarette use increased by 77.8% among high school students and 48.5% among middle school students during 2017-2018, erasing the progress in reducing e-cigarette use, as well as any tobacco product use, that had occurred in prior years.”

The CDC and the Food and Drug Administration are taking action to curb the rise in e-cigarette use in youth in particular by seeking regulations to make the products less accessible, raising prices, and banning most flavorings, said Dr. Schuchat.

“We have targeted companies engaged in kid friendly marketing,” said Mitch Zeller, JD, director of the Center for Tobacco Products for the FDA.

In a statement published simultaneously with the Vital Signs study, FDA Commissioner Scott Gottlieb, MD, emphasized the link between e-cigarette use in teens and the potential for future tobacco use. “The kids using e-cigarettes are children who rejected conventional cigarettes, but don’t see the same stigma associated with the use of e-cigarettes. But now, having become exposed to nicotine through e-cigs, they will be more likely to smoke.” Dr. Gottlieb declared, “I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We must stop the trends of youth e-cigarette use from continuing to build and will take whatever action is necessary to ensure these kids don’t become future smokers.” He reviewed steps taken in the past year by the FDA to counter tobacco use in teens but he warned of future actions that may need to be taken: “If these youth use trends continue, we’ll be forced to consider regulatory steps that could constrain or even foreclose the opportunities for currently addicted adult smokers to have the same level of access to these products that they now enjoy. I recognize that such a move could come with significant impacts to adult smokers.”

In the meantime, however, parents, teachers, community leaders, and health care providers are on the front lines and can make a difference in protecting youth and curbing nicotine use, Dr. King said.

One of the most important things clinicians can do is to ask young patients specifically about e-cigarette use, he emphasized. Learn and use the terminology the kids are using; ask, “Do you use JUUL?” If they are using these products, “make sure they know they are dangerous,” and can harm the developing brain, he said.

Although there are no currently approved medications to treat nicotine addiction in youth, research suggests that behavioral counseling, as well as reinforcement of the danger of nicotine from parents and other people of influence, can help, Dr. King said.

The Vital Signs report is based on data from the 2011-2018 National Youth Tobacco Survey, which assesses current use of cigarettes, cigars, smokeless tobacco, e-cigarettes, hookahs, pipe tobacco, and bidis among a nationally representative sample of middle and high school students in the United States. The findings were analyzed by the CDC, FDA, and the National Cancer Institute.

SOURCE: Gentzke AS et al. MMWR 2019 Feb 11. doi: 10.15585/mmwr.mm6806e1.

*Correction 2/13/2019 An earlier version of this article misstated the number of students using e-cigarettes as a proportion of all teen tobacco users.

Treatment with biologic therapy significantly improves coronary plaque profiles in patients with severe psoriasis, based on data from 121 adult patients who completed a year of follow-up.

A previous study showed a reduced rate of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death among individuals treated with biologic therapies, wrote Youssef A. Elnabawi, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and his colleagues.

Psoriasis “provides a reliable model to study inflammatory atherogenesis and the longitudinal impact of modulating specific cytokines on vascular behavior, while treating the primary skin disease with [Food and Drug Administration]–approved biologic therapies,” the researchers said.

In a study published in Cardiovascular Research, patients given biologics showed a 5% reduction in total coronary plaque burden after 1 year, as well as a 64% improvement in Psoriasis Area Severity Index scores. In addition, the decrease in noncalcified plaque burden in the biologics group was significantly greater, compared with the nonbiologics group (P =.03), and remained significant after controlling for standard cardiovascular risk factors.

When broken down by biologic, “we observed the greatest percent reduction of noncalcified plaque burden in patients on [anti-interleukin (IL)–17] therapy with a reduction in necrotic core suggesting a potential role for IL-17 in atherosclerotic pathways,” Dr. Elnabawi and his colleagues wrote.

The researchers also noted improvement in high-sensitivity C-reactive protein levels in the biologics group after 1 year (from 2.0 mg/dL to 1.4 mg/dL), but no change in the nonbiologics group.

The study population included patients naive to biologic or systemic psoriasis therapies who were assessed via clinical and laboratory data and coronary computed tomography angiography at baseline and after 1 year. A total of 89 participants with moderate to severe psoriasis received biologics, including adalimumab, etanercept, ustekinumab, secukinumab, and ixekizumab; 32 psoriasis patients received no biologics and served as a reference group. The average age of the patients was 50 years, and 58% were male. At baseline, patients had low cardiovascular risk based on Framingham scores, and moderate to severe skin disease.

The findings were limited by several factors, including the observational nature of the study, small study population, and the open-label use of biologics, as well as the use of coronary indices, rather than actual cardiovascular events, to assess cardiovascular disease risk, the researchers noted.

However, the results, combined with results from previous studies in animal models, “support further investigation of IL-17 blockade on coronary disease in humans,” they said.

The study was supported by the National Heart, Lung, and Blood Institute, with additional support from the National Institutes of Health Medical Research Scholars Program, the Doris Duke Charitable Foundation, the American Association for Dental Research, the Colgate-Palmolive Company, Genentech, Elsevier, and other private donors. Dr. Elnabawi had no financial conflicts to disclose.

SOURCE: Elnabawi YA et al. Cardiovasc Res. 2019. doi: 10.1093/cvr/cvz009.

Treatment with biologic therapy significantly improves coronary plaque profiles in patients with severe psoriasis, based on data from 121 adult patients who completed a year of follow-up.

A previous study showed a reduced rate of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death among individuals treated with biologic therapies, wrote Youssef A. Elnabawi, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and his colleagues.

Psoriasis “provides a reliable model to study inflammatory atherogenesis and the longitudinal impact of modulating specific cytokines on vascular behavior, while treating the primary skin disease with [Food and Drug Administration]–approved biologic therapies,” the researchers said.

In a study published in Cardiovascular Research, patients given biologics showed a 5% reduction in total coronary plaque burden after 1 year, as well as a 64% improvement in Psoriasis Area Severity Index scores. In addition, the decrease in noncalcified plaque burden in the biologics group was significantly greater, compared with the nonbiologics group (P =.03), and remained significant after controlling for standard cardiovascular risk factors.

When broken down by biologic, “we observed the greatest percent reduction of noncalcified plaque burden in patients on [anti-interleukin (IL)–17] therapy with a reduction in necrotic core suggesting a potential role for IL-17 in atherosclerotic pathways,” Dr. Elnabawi and his colleagues wrote.

The researchers also noted improvement in high-sensitivity C-reactive protein levels in the biologics group after 1 year (from 2.0 mg/dL to 1.4 mg/dL), but no change in the nonbiologics group.

The study population included patients naive to biologic or systemic psoriasis therapies who were assessed via clinical and laboratory data and coronary computed tomography angiography at baseline and after 1 year. A total of 89 participants with moderate to severe psoriasis received biologics, including adalimumab, etanercept, ustekinumab, secukinumab, and ixekizumab; 32 psoriasis patients received no biologics and served as a reference group. The average age of the patients was 50 years, and 58% were male. At baseline, patients had low cardiovascular risk based on Framingham scores, and moderate to severe skin disease.

The findings were limited by several factors, including the observational nature of the study, small study population, and the open-label use of biologics, as well as the use of coronary indices, rather than actual cardiovascular events, to assess cardiovascular disease risk, the researchers noted.

However, the results, combined with results from previous studies in animal models, “support further investigation of IL-17 blockade on coronary disease in humans,” they said.

The study was supported by the National Heart, Lung, and Blood Institute, with additional support from the National Institutes of Health Medical Research Scholars Program, the Doris Duke Charitable Foundation, the American Association for Dental Research, the Colgate-Palmolive Company, Genentech, Elsevier, and other private donors. Dr. Elnabawi had no financial conflicts to disclose.

SOURCE: Elnabawi YA et al. Cardiovasc Res. 2019. doi: 10.1093/cvr/cvz009.

Treatment with biologic therapy significantly improves coronary plaque profiles in patients with severe psoriasis, based on data from 121 adult patients who completed a year of follow-up.

A previous study showed a reduced rate of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death among individuals treated with biologic therapies, wrote Youssef A. Elnabawi, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and his colleagues.

Psoriasis “provides a reliable model to study inflammatory atherogenesis and the longitudinal impact of modulating specific cytokines on vascular behavior, while treating the primary skin disease with [Food and Drug Administration]–approved biologic therapies,” the researchers said.

In a study published in Cardiovascular Research, patients given biologics showed a 5% reduction in total coronary plaque burden after 1 year, as well as a 64% improvement in Psoriasis Area Severity Index scores. In addition, the decrease in noncalcified plaque burden in the biologics group was significantly greater, compared with the nonbiologics group (P =.03), and remained significant after controlling for standard cardiovascular risk factors.

When broken down by biologic, “we observed the greatest percent reduction of noncalcified plaque burden in patients on [anti-interleukin (IL)–17] therapy with a reduction in necrotic core suggesting a potential role for IL-17 in atherosclerotic pathways,” Dr. Elnabawi and his colleagues wrote.

The researchers also noted improvement in high-sensitivity C-reactive protein levels in the biologics group after 1 year (from 2.0 mg/dL to 1.4 mg/dL), but no change in the nonbiologics group.

The study population included patients naive to biologic or systemic psoriasis therapies who were assessed via clinical and laboratory data and coronary computed tomography angiography at baseline and after 1 year. A total of 89 participants with moderate to severe psoriasis received biologics, including adalimumab, etanercept, ustekinumab, secukinumab, and ixekizumab; 32 psoriasis patients received no biologics and served as a reference group. The average age of the patients was 50 years, and 58% were male. At baseline, patients had low cardiovascular risk based on Framingham scores, and moderate to severe skin disease.

The findings were limited by several factors, including the observational nature of the study, small study population, and the open-label use of biologics, as well as the use of coronary indices, rather than actual cardiovascular events, to assess cardiovascular disease risk, the researchers noted.

However, the results, combined with results from previous studies in animal models, “support further investigation of IL-17 blockade on coronary disease in humans,” they said.

The study was supported by the National Heart, Lung, and Blood Institute, with additional support from the National Institutes of Health Medical Research Scholars Program, the Doris Duke Charitable Foundation, the American Association for Dental Research, the Colgate-Palmolive Company, Genentech, Elsevier, and other private donors. Dr. Elnabawi had no financial conflicts to disclose.

SOURCE: Elnabawi YA et al. Cardiovasc Res. 2019. doi: 10.1093/cvr/cvz009.

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

pdnews@mdedge.com

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

pdnews@mdedge.com

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

Mild aerobic exercise significantly shortened recovery time from sports-related concussion in adolescent athletes, compared with a stretching program in a randomized trial of 103 participants.

YanLev/ThinkStock

Sports-related concussion (SRC) remains a major public health problem with no effective treatment, wrote John J. Leddy, MD, of the State University of New York at Buffalo, and his colleagues.

Exercise tolerance after SRC has not been well studied. However, given the demonstrated benefits of aerobic exercise training on autonomic nervous system regulation, cerebral blood flow regulation, cardiovascular physiology, and brain neuroplasticity, the researchers hypothesized that exercise at a level that does not exacerbate symptoms might facilitate recovery in concussion patients.

In a study published in JAMA Pediatrics, the researchers randomized 103 adolescent athletes aged 13-18 years to a program of subsymptom aerobic exercise or a placebo stretching program. The participants were enrolled in the study within 10 days of an SRC, and were followed for 30 days or until recovery.

Athletes in the aerobic exercise group recovered in a median of 13 days, compared with 17 days for those in the stretching group (P = .009). Recovery was defined as “symptom resolution to normal,” based on normal physical and neurological examinations, “further confirmed by demonstration of the ability to exercise to exhaustion without exacerbation of symptoms” according to the Buffalo Concussion Treadmill Test, the researchers wrote.

No demographic differences or difference in previous concussions, time from injury until treatment, initial symptom severity score, initial exercise treadmill test, or physical exam were noted between the groups.

The average age of the participants was 15 years, 47% were female. The athletes performed the aerobic exercise or stretching programs approximately 20 minutes per day, and reported their daily symptoms and compliance via a website. The aerobic exercise consisted of walking or jogging on a treadmill or outdoors, or riding a stationary bike while wearing a heart rate monitor to maintain a target heart rate. The target heart rate was calculated as 80% of the heart rate at symptom exacerbation during the Buffalo Concussion Treadmill Test at each participant’s initial visit.

No adverse events related to the exercise intervention were reported, which supports the safety of subsymptom threshhold exercise, in the study population, Dr. Leddy and his associates noted.

The researchers also found lower rates of persistent symptoms at 1 month in the exercise group, compared with the stretching group (two participants vs. seven participants), but this difference was not statistically significant.

The study findings were limited by several factors, including the unblinded design and failure to address the mechanism of action for the effects of exercise. In addition, the results are not generalizable to younger children or other demographic groups, including those with concussions from causes other than sports and adults with heart conditions, the researchers noted.

However, “the results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed subsymptom threshold aerobic exercise, after the first 48 hours following SRC can safely and significantly speed recovery,” Dr. Leddy and his associates concluded.

The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
 

pdnews@mdedge.com

SOURCE: Leddy JJ et al. JAMA Pediatr. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.4397.

The American Society of Clinical Oncology (ASCO) named “Progress in Treating Rare Cancers” as the Advance of the Year for 2018, citing five major studies as examples of significant breakthroughs.

In an ASCO Special Article published in the Journal of Clinical Oncology, Sumanta K. Pal, MD, of City of Hope Comprehensive Cancer Center, Duarte, Calif., and colleagues, identified five studies that notably advanced cancer research.

Each study “reflects the impressive gains we have made in understanding these so-called orphan diseases and in tailoring treatments to target their unique characteristics,” wrote ASCO president Monica M. Bertagnolli, MD, in an introduction to the report.

One of the significant advances included use of a new combination of targeted therapies for a rare thyroid cancer that elicited responses in more than two-thirds of patients. A second study showed sorafenib improving progression-free survival for patients with desmoid tumors. In addition, patients with advanced midgut neuroendocrine tumors had a 79% lower risk of disease progression or death when treated with a new therapy of targeted radiation to tumor cells, lutetium-177 (177Lu)–Dotatate, compared with standard therapy; and trastuzumab, a standard treatment for human epidermal growth factor receptor 2 (HER2)–positive breast cancer, expanded its reach and significantly slowed progression of HER2-positive uterine serous carcinoma, the authors wrote. Finally, the “first promising therapy – the colony-stimulating factor-1 (CSF-1) inhibitor pexidartinib – for a rare cancer of the joints known as tenosynovial giant cell tumor, showed an overall response rate of 39.3% in patients taking pexidartinib versus 0% in patients taking a placebo,” they said.

For the first time, the ASCO progress report included a list of priorities to guide future research efforts, stated as follows:

• Identify strategies that better predict response to immunotherapies.
• Better define the patient populations that benefit from postoperative (adjuvant) therapy.
• Translate innovations in cellular therapies to solid tumors.
• Increase precision medicine research and treatment approaches in pediatric cancers.
• Optimize care for older adults with cancer.
• Increase equitable access to cancer clinical trials.
• Reduce the long-term consequences of cancer treatment.
• Reduce obesity and its impact on cancer incidence and outcomes.
• Identify strategies to detect and treat premalignant lesions.

“These priority areas, listed in no particular order, address an unmet need or help fill a knowledge gap in areas critical to improving patient care and outcomes,” the authors wrote.

The report acknowledged the value of federally funded research and the importance of ongoing federal investment in cancer research.

Dr. Pal disclosed relationships with Pfizer, Novartis, Aveo, Myriad Pharmaceuticals, Genentech, Exelixis, Bristol-Myers Squibb, Astellas Pharma, Ipsen, Eisai, and Medivation. Coauthors disclosed relationships with these and other companies.

SOURCE: Pal SK et al. J Clin Oncol. 2019 Jan 31. doi: 10.1200/JCO.18.02037.

The American Society of Clinical Oncology (ASCO) named “Progress in Treating Rare Cancers” as the Advance of the Year for 2018, citing five major studies as examples of significant breakthroughs.

In an ASCO Special Article published in the Journal of Clinical Oncology, Sumanta K. Pal, MD, of City of Hope Comprehensive Cancer Center, Duarte, Calif., and colleagues, identified five studies that notably advanced cancer research.

Each study “reflects the impressive gains we have made in understanding these so-called orphan diseases and in tailoring treatments to target their unique characteristics,” wrote ASCO president Monica M. Bertagnolli, MD, in an introduction to the report.

One of the significant advances included use of a new combination of targeted therapies for a rare thyroid cancer that elicited responses in more than two-thirds of patients. A second study showed sorafenib improving progression-free survival for patients with desmoid tumors. In addition, patients with advanced midgut neuroendocrine tumors had a 79% lower risk of disease progression or death when treated with a new therapy of targeted radiation to tumor cells, lutetium-177 (177Lu)–Dotatate, compared with standard therapy; and trastuzumab, a standard treatment for human epidermal growth factor receptor 2 (HER2)–positive breast cancer, expanded its reach and significantly slowed progression of HER2-positive uterine serous carcinoma, the authors wrote. Finally, the “first promising therapy – the colony-stimulating factor-1 (CSF-1) inhibitor pexidartinib – for a rare cancer of the joints known as tenosynovial giant cell tumor, showed an overall response rate of 39.3% in patients taking pexidartinib versus 0% in patients taking a placebo,” they said.

For the first time, the ASCO progress report included a list of priorities to guide future research efforts, stated as follows:

• Identify strategies that better predict response to immunotherapies.
• Better define the patient populations that benefit from postoperative (adjuvant) therapy.
• Translate innovations in cellular therapies to solid tumors.
• Increase precision medicine research and treatment approaches in pediatric cancers.
• Optimize care for older adults with cancer.
• Increase equitable access to cancer clinical trials.
• Reduce the long-term consequences of cancer treatment.
• Reduce obesity and its impact on cancer incidence and outcomes.
• Identify strategies to detect and treat premalignant lesions.

“These priority areas, listed in no particular order, address an unmet need or help fill a knowledge gap in areas critical to improving patient care and outcomes,” the authors wrote.

The report acknowledged the value of federally funded research and the importance of ongoing federal investment in cancer research.

Dr. Pal disclosed relationships with Pfizer, Novartis, Aveo, Myriad Pharmaceuticals, Genentech, Exelixis, Bristol-Myers Squibb, Astellas Pharma, Ipsen, Eisai, and Medivation. Coauthors disclosed relationships with these and other companies.

SOURCE: Pal SK et al. J Clin Oncol. 2019 Jan 31. doi: 10.1200/JCO.18.02037.

The American Society of Clinical Oncology (ASCO) named “Progress in Treating Rare Cancers” as the Advance of the Year for 2018, citing five major studies as examples of significant breakthroughs.

In an ASCO Special Article published in the Journal of Clinical Oncology, Sumanta K. Pal, MD, of City of Hope Comprehensive Cancer Center, Duarte, Calif., and colleagues, identified five studies that notably advanced cancer research.

Each study “reflects the impressive gains we have made in understanding these so-called orphan diseases and in tailoring treatments to target their unique characteristics,” wrote ASCO president Monica M. Bertagnolli, MD, in an introduction to the report.

One of the significant advances included use of a new combination of targeted therapies for a rare thyroid cancer that elicited responses in more than two-thirds of patients. A second study showed sorafenib improving progression-free survival for patients with desmoid tumors. In addition, patients with advanced midgut neuroendocrine tumors had a 79% lower risk of disease progression or death when treated with a new therapy of targeted radiation to tumor cells, lutetium-177 (177Lu)–Dotatate, compared with standard therapy; and trastuzumab, a standard treatment for human epidermal growth factor receptor 2 (HER2)–positive breast cancer, expanded its reach and significantly slowed progression of HER2-positive uterine serous carcinoma, the authors wrote. Finally, the “first promising therapy – the colony-stimulating factor-1 (CSF-1) inhibitor pexidartinib – for a rare cancer of the joints known as tenosynovial giant cell tumor, showed an overall response rate of 39.3% in patients taking pexidartinib versus 0% in patients taking a placebo,” they said.

For the first time, the ASCO progress report included a list of priorities to guide future research efforts, stated as follows:

• Identify strategies that better predict response to immunotherapies.
• Better define the patient populations that benefit from postoperative (adjuvant) therapy.
• Translate innovations in cellular therapies to solid tumors.
• Increase precision medicine research and treatment approaches in pediatric cancers.
• Optimize care for older adults with cancer.
• Increase equitable access to cancer clinical trials.
• Reduce the long-term consequences of cancer treatment.
• Reduce obesity and its impact on cancer incidence and outcomes.
• Identify strategies to detect and treat premalignant lesions.

“These priority areas, listed in no particular order, address an unmet need or help fill a knowledge gap in areas critical to improving patient care and outcomes,” the authors wrote.

The report acknowledged the value of federally funded research and the importance of ongoing federal investment in cancer research.

Dr. Pal disclosed relationships with Pfizer, Novartis, Aveo, Myriad Pharmaceuticals, Genentech, Exelixis, Bristol-Myers Squibb, Astellas Pharma, Ipsen, Eisai, and Medivation. Coauthors disclosed relationships with these and other companies.

SOURCE: Pal SK et al. J Clin Oncol. 2019 Jan 31. doi: 10.1200/JCO.18.02037.

Promoting school attendance can have positive effects on children’s health, according to a new policy statement from the American Academy of Pediatrics’ Council on School Health.

School absence can affect not only children’s academic achievement but also their health, and the AAP advises health care providers to promote regular school attendance as preventive medicine, wrote Mandy Allison, MD, of the University of Colorado and Children’s Hospital Colorado, both in Aurora, and Elliott Attisha, DO, FAAP, of the Detroit Public Schools Community District.

In the statement, published in Pediatrics, the authors detailed factors associated with chronic absenteeism and provided guidelines for how clinicians can help reduce and prevent the problem. “Regardless of whether absences are unexcused or excused, chronic absenteeism typically results in poor academic outcomes and is linked to poor health outcomes,” they noted.

Factors linked with chronic absenteeism, defined by the U.S. Department of Education as missing 15 or more days of school in a year, include socioeconomic factors such as poverty, domestic violence, and foster care, as well as poorly controlled health conditions, such as asthma and diabetes. Approximately 13% of all students meet criteria for chronic absenteeism, the researchers noted.

Chronic absenteeism has been linked to an increased risk of unhealthy behaviors, including mental health problems in teens and poor health in adulthood, and students who miss school often struggle academically and may be more likely to drop out, they noted.

The AAP statement emphasizes school strategies to improve attendance, including education on hand washing and other infection prevention measures, use of school-based flu vaccination programs, availability of school nurses and counselors, and other school-based health and nutrition services.

The policy statement encourages pediatricians and other health care providers to promote school attendance in the office setting and the community.

The AAP encourages pediatricians and their colleagues caring for children to promote school attendance. In the office setting, the AAP recommends the clinicians stress the importance of school attendance, ask whether children have been absent from school and how often, encourage families to share any health concerns with the school nurse, and provide firm and specific guidance on when children should go to school or stay home. The AAP also recommends encouraging well children to return to school after routine appointments rather than miss a whole day and documenting medical needs for an Individualized Education Program or 504 Plan to maximize learning and promote attendance.

For students who are chronically absent from school (missing 2-3 days/month), the AAP encourages clinicians to identify physical health issues and psychosocial factors that may be contributing to absenteeism and to communicate with school health providers. In rare cases, out-of-school educational services may be justified, but with an established time line for returning to school, according to the statement.

In addition, the AAP encourages clinicians to advocate in the community in support of school attendance by sharing relevant data on chronic absences, working with community leaders to send a consistent message about the value of school attendance, and serving as a school physician or on a school board or wellness committee to promote attendance.

The full statement is available online and includes links to parent handouts, a waiting room video, and a mobile-friendly website for preteens, teens, and parents.

The researchers had no financial conflicts to disclose.

SOURCE: Allison MA et al. Pediatrics. 2019. doi: 10.1542/peds.2018-3648.

Promoting school attendance can have positive effects on children’s health, according to a new policy statement from the American Academy of Pediatrics’ Council on School Health.

School absence can affect not only children’s academic achievement but also their health, and the AAP advises health care providers to promote regular school attendance as preventive medicine, wrote Mandy Allison, MD, of the University of Colorado and Children’s Hospital Colorado, both in Aurora, and Elliott Attisha, DO, FAAP, of the Detroit Public Schools Community District.

In the statement, published in Pediatrics, the authors detailed factors associated with chronic absenteeism and provided guidelines for how clinicians can help reduce and prevent the problem. “Regardless of whether absences are unexcused or excused, chronic absenteeism typically results in poor academic outcomes and is linked to poor health outcomes,” they noted.

Factors linked with chronic absenteeism, defined by the U.S. Department of Education as missing 15 or more days of school in a year, include socioeconomic factors such as poverty, domestic violence, and foster care, as well as poorly controlled health conditions, such as asthma and diabetes. Approximately 13% of all students meet criteria for chronic absenteeism, the researchers noted.

Chronic absenteeism has been linked to an increased risk of unhealthy behaviors, including mental health problems in teens and poor health in adulthood, and students who miss school often struggle academically and may be more likely to drop out, they noted.

The AAP statement emphasizes school strategies to improve attendance, including education on hand washing and other infection prevention measures, use of school-based flu vaccination programs, availability of school nurses and counselors, and other school-based health and nutrition services.

The policy statement encourages pediatricians and other health care providers to promote school attendance in the office setting and the community.

The AAP encourages pediatricians and their colleagues caring for children to promote school attendance. In the office setting, the AAP recommends the clinicians stress the importance of school attendance, ask whether children have been absent from school and how often, encourage families to share any health concerns with the school nurse, and provide firm and specific guidance on when children should go to school or stay home. The AAP also recommends encouraging well children to return to school after routine appointments rather than miss a whole day and documenting medical needs for an Individualized Education Program or 504 Plan to maximize learning and promote attendance.

For students who are chronically absent from school (missing 2-3 days/month), the AAP encourages clinicians to identify physical health issues and psychosocial factors that may be contributing to absenteeism and to communicate with school health providers. In rare cases, out-of-school educational services may be justified, but with an established time line for returning to school, according to the statement.

In addition, the AAP encourages clinicians to advocate in the community in support of school attendance by sharing relevant data on chronic absences, working with community leaders to send a consistent message about the value of school attendance, and serving as a school physician or on a school board or wellness committee to promote attendance.

The full statement is available online and includes links to parent handouts, a waiting room video, and a mobile-friendly website for preteens, teens, and parents.

The researchers had no financial conflicts to disclose.

SOURCE: Allison MA et al. Pediatrics. 2019. doi: 10.1542/peds.2018-3648.

Promoting school attendance can have positive effects on children’s health, according to a new policy statement from the American Academy of Pediatrics’ Council on School Health.

School absence can affect not only children’s academic achievement but also their health, and the AAP advises health care providers to promote regular school attendance as preventive medicine, wrote Mandy Allison, MD, of the University of Colorado and Children’s Hospital Colorado, both in Aurora, and Elliott Attisha, DO, FAAP, of the Detroit Public Schools Community District.

In the statement, published in Pediatrics, the authors detailed factors associated with chronic absenteeism and provided guidelines for how clinicians can help reduce and prevent the problem. “Regardless of whether absences are unexcused or excused, chronic absenteeism typically results in poor academic outcomes and is linked to poor health outcomes,” they noted.

Factors linked with chronic absenteeism, defined by the U.S. Department of Education as missing 15 or more days of school in a year, include socioeconomic factors such as poverty, domestic violence, and foster care, as well as poorly controlled health conditions, such as asthma and diabetes. Approximately 13% of all students meet criteria for chronic absenteeism, the researchers noted.

Chronic absenteeism has been linked to an increased risk of unhealthy behaviors, including mental health problems in teens and poor health in adulthood, and students who miss school often struggle academically and may be more likely to drop out, they noted.

The AAP statement emphasizes school strategies to improve attendance, including education on hand washing and other infection prevention measures, use of school-based flu vaccination programs, availability of school nurses and counselors, and other school-based health and nutrition services.

The policy statement encourages pediatricians and other health care providers to promote school attendance in the office setting and the community.

The AAP encourages pediatricians and their colleagues caring for children to promote school attendance. In the office setting, the AAP recommends the clinicians stress the importance of school attendance, ask whether children have been absent from school and how often, encourage families to share any health concerns with the school nurse, and provide firm and specific guidance on when children should go to school or stay home. The AAP also recommends encouraging well children to return to school after routine appointments rather than miss a whole day and documenting medical needs for an Individualized Education Program or 504 Plan to maximize learning and promote attendance.

For students who are chronically absent from school (missing 2-3 days/month), the AAP encourages clinicians to identify physical health issues and psychosocial factors that may be contributing to absenteeism and to communicate with school health providers. In rare cases, out-of-school educational services may be justified, but with an established time line for returning to school, according to the statement.

In addition, the AAP encourages clinicians to advocate in the community in support of school attendance by sharing relevant data on chronic absences, working with community leaders to send a consistent message about the value of school attendance, and serving as a school physician or on a school board or wellness committee to promote attendance.

The full statement is available online and includes links to parent handouts, a waiting room video, and a mobile-friendly website for preteens, teens, and parents.

The researchers had no financial conflicts to disclose.

SOURCE: Allison MA et al. Pediatrics. 2019. doi: 10.1542/peds.2018-3648.

Aspirin use is associated with a reduced risk of cardiovascular events among adults without cardiovascular disease, but this protection comes with a similarly increased risk for bleeding, according to data from a meta-analysis that included more than 1 million participant-years of follow-up.

©David Sucsy/iStockphoto

“The uncertain role of aspirin in primary prevention of cardiovascular events is reflected in contrasting recommendations offered by guideline bodies,” and has led to a decline in prescribing aspirin for primary prevention of such events, wrote Sean L. Zheng, MRCP, of Imperial College London (England) and his colleagues.

In a systematic review and meta-analysis published in JAMA, the researchers examined 13 randomized trials altogether including 164,225 participants and 1,050,511 participant-years of follow-up.

Overall, aspirin use significantly reduced a composite of cardiovascular outcomes, compared with no aspirin (hazard ratio, 0.89). The composite outcome included cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke, and it occurred in 57.1 per 10,000 participant-years in aspirin users versus 61.4 per 10,000 participant-years among individuals who did not use aspirin. The absolute risk reduction was 0.38%.

The median age of the study participants was 62 years, and roughly half (47%) were male.

However, the risk of major bleeding events was significantly higher among aspirin users, compared with nonusers (23.1 per 10,000 participant-years and 16.4 per 10,000 participant-years, respectively), with a HR of 1.43 and an absolute risk increase of 0.47%.

Aspirin use was not associated with several secondary outcomes, including reductions in all-cause mortality or cardiovascular mortality, compared with no aspirin, but it was associated with a reduced risk specifically of myocardial infarction and ischemic stroke. Few deaths related to bleeding were reported.

The number needed to treat (265) and the number needed to harm (210) were similar, which emphasizes the need for an individual approach to treatment, the researchers noted.

“Consequently, the decision to use aspirin for primary prevention may need to be made on an individual basis, accounting for the patient’s risk of bleeding and their views on the balance of risk vs. benefit,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Zheng SL et al. JAMA. 2019;321(3):277-87.

Aspirin use is associated with a reduced risk of cardiovascular events among adults without cardiovascular disease, but this protection comes with a similarly increased risk for bleeding, according to data from a meta-analysis that included more than 1 million participant-years of follow-up.

©David Sucsy/iStockphoto

“The uncertain role of aspirin in primary prevention of cardiovascular events is reflected in contrasting recommendations offered by guideline bodies,” and has led to a decline in prescribing aspirin for primary prevention of such events, wrote Sean L. Zheng, MRCP, of Imperial College London (England) and his colleagues.

In a systematic review and meta-analysis published in JAMA, the researchers examined 13 randomized trials altogether including 164,225 participants and 1,050,511 participant-years of follow-up.

Overall, aspirin use significantly reduced a composite of cardiovascular outcomes, compared with no aspirin (hazard ratio, 0.89). The composite outcome included cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke, and it occurred in 57.1 per 10,000 participant-years in aspirin users versus 61.4 per 10,000 participant-years among individuals who did not use aspirin. The absolute risk reduction was 0.38%.

The median age of the study participants was 62 years, and roughly half (47%) were male.

However, the risk of major bleeding events was significantly higher among aspirin users, compared with nonusers (23.1 per 10,000 participant-years and 16.4 per 10,000 participant-years, respectively), with a HR of 1.43 and an absolute risk increase of 0.47%.

Aspirin use was not associated with several secondary outcomes, including reductions in all-cause mortality or cardiovascular mortality, compared with no aspirin, but it was associated with a reduced risk specifically of myocardial infarction and ischemic stroke. Few deaths related to bleeding were reported.

The number needed to treat (265) and the number needed to harm (210) were similar, which emphasizes the need for an individual approach to treatment, the researchers noted.

“Consequently, the decision to use aspirin for primary prevention may need to be made on an individual basis, accounting for the patient’s risk of bleeding and their views on the balance of risk vs. benefit,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Zheng SL et al. JAMA. 2019;321(3):277-87.

Aspirin use is associated with a reduced risk of cardiovascular events among adults without cardiovascular disease, but this protection comes with a similarly increased risk for bleeding, according to data from a meta-analysis that included more than 1 million participant-years of follow-up.

©David Sucsy/iStockphoto

“The uncertain role of aspirin in primary prevention of cardiovascular events is reflected in contrasting recommendations offered by guideline bodies,” and has led to a decline in prescribing aspirin for primary prevention of such events, wrote Sean L. Zheng, MRCP, of Imperial College London (England) and his colleagues.

In a systematic review and meta-analysis published in JAMA, the researchers examined 13 randomized trials altogether including 164,225 participants and 1,050,511 participant-years of follow-up.

Overall, aspirin use significantly reduced a composite of cardiovascular outcomes, compared with no aspirin (hazard ratio, 0.89). The composite outcome included cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke, and it occurred in 57.1 per 10,000 participant-years in aspirin users versus 61.4 per 10,000 participant-years among individuals who did not use aspirin. The absolute risk reduction was 0.38%.

The median age of the study participants was 62 years, and roughly half (47%) were male.

However, the risk of major bleeding events was significantly higher among aspirin users, compared with nonusers (23.1 per 10,000 participant-years and 16.4 per 10,000 participant-years, respectively), with a HR of 1.43 and an absolute risk increase of 0.47%.

Aspirin use was not associated with several secondary outcomes, including reductions in all-cause mortality or cardiovascular mortality, compared with no aspirin, but it was associated with a reduced risk specifically of myocardial infarction and ischemic stroke. Few deaths related to bleeding were reported.

The number needed to treat (265) and the number needed to harm (210) were similar, which emphasizes the need for an individual approach to treatment, the researchers noted.

“Consequently, the decision to use aspirin for primary prevention may need to be made on an individual basis, accounting for the patient’s risk of bleeding and their views on the balance of risk vs. benefit,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Zheng SL et al. JAMA. 2019;321(3):277-87.