Pregnant women want genome guidance

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Almost all pregnant women would want information about serious treatable childhood-onset conditions from non-invasive prenatal whole-genome sequencing. Also today, a look at asthma, obesity, and the risk for severe sleep apnea in children, new questions about the role that antinuclear antibodies are playing in systemic lupus erythematosus, and the lifetime cost of tobacco is nearly $2 million per smoker.

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Almost all pregnant women would want information about serious treatable childhood-onset conditions from non-invasive prenatal whole-genome sequencing. Also today, a look at asthma, obesity, and the risk for severe sleep apnea in children, new questions about the role that antinuclear antibodies are playing in systemic lupus erythematosus, and the lifetime cost of tobacco is nearly $2 million per smoker.

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Almost all pregnant women would want information about serious treatable childhood-onset conditions from non-invasive prenatal whole-genome sequencing. Also today, a look at asthma, obesity, and the risk for severe sleep apnea in children, new questions about the role that antinuclear antibodies are playing in systemic lupus erythematosus, and the lifetime cost of tobacco is nearly $2 million per smoker.

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Interactive parenting, life skill intervention improves self-esteem in teen mothers

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Teen moms in a teen-tot clinic program who received added interactive parenting and life skill training had higher self-esteem and lower repeat pregnancy rates than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.

A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.

While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).

Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).

The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.

The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.

lfranki@mdedge.com

SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.

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Teen moms in a teen-tot clinic program who received added interactive parenting and life skill training had higher self-esteem and lower repeat pregnancy rates than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.

A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.

While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).

Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).

The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.

The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.

lfranki@mdedge.com

SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.

 

Teen moms in a teen-tot clinic program who received added interactive parenting and life skill training had higher self-esteem and lower repeat pregnancy rates than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.

A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.

While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).

Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).

The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.

The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.

lfranki@mdedge.com

SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.

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DAAs reduce mortality, cancer risk in HCV study

Best evidence to date of reduced complications
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Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.

copyright Eraxion/Thinkstock

Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).

There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.

Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.

Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.

 

 


“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.

Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.

In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.

There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.

“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.

However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.

Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.

SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1

Body

This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.

Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.

Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”

The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.

“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.

This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.

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Body

This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.

Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.

Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”

The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.

“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.

This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.

Body

This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.

Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.

Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”

The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.

“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.

This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.

Title
Best evidence to date of reduced complications
Best evidence to date of reduced complications

Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.

copyright Eraxion/Thinkstock

Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).

There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.

Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.

Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.

 

 


“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.

Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.

In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.

There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.

“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.

However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.

Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.

SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1

Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.

copyright Eraxion/Thinkstock

Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).

There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.

Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.

Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.

 

 


“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.

Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.

In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.

There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.

“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.

However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.

Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.

SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1

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Key clinical point: DAAs significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C.

Major finding: DAAs reduced risk of hepatocellular carcinoma (HR, 0.66; 95% confidence interval, 0.46-0.93) and all-cause mortality (HR, 0.48; 95% CI, 0.33-0.70).

Study details: A prospective study including about 10,000 adults with chronic HCV infection enrolled at 1 of 32 centers in France.

Disclosures: Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to the study pharma sponsors among others.

Source: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/20S0140-6736(18)32111-1.

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Watchful waiting up for low-risk prostate cancer

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Conservative management for low-risk localized prostate cancer is up recently, in line with clinical practice guideline changes, while in high-risk disease, use of radical prostatectomy has increased despite a lack of new high-level evidence supporting the approach, according to researchers.

Active surveillance or watchful waiting surpassed both radical prostatectomy and radiotherapy to become the most common management strategy in low-risk disease over the 2010-2015 time period, according to their analysis of a Surveillance, Epidemiology, and End Results (SEER) database.

Meanwhile, radical prostatectomy use declined in low-risk patients, but increased in those with higher-risk disease at the expense of radiotherapy, said authors of the analysis, led by Brandon A. Mahal, MD, and Paul L. Nguyen, MD, of Dana-Farber Cancer Institute, Boston.

“Although increasing use of active surveillance or watchful waiting for low-risk disease has been supported by high-level evidence and guidelines since 2010, shifting management patterns toward more radical prostatectomy in higher-risk disease and away from radiotherapy does not coincide with any new level 1 evidence or guideline changes,” Dr. Mahal, Dr. Nguyen, and coauthors said in JAMA.

The analysis included 164,760 men with a diagnosis of localized prostate cancer between 2010 and 2015 in the SEER Prostate Active Surveillance/Watchful Waiting database. Of that group, 12.7% were managed by active surveillance or watchful waiting, while 41.5% underwent radiotherapy and 45.8% had a radical prostatectomy.

For men with low-risk disease, active surveillance or watchful waiting increased from just 14.5% in 2010 to 42.1% in 2015, investigators found. Radical prostatectomy decreased from 47.4% to 31.3% over that 5-year period, while radiotherapy likewise decreased from 38.0% to 26.6% (P less than .001 for all three trends).

By contrast, in men with high-risk disease, use of radical prostatectomy increased from 38.0% to 42.8%, while radiotherapy decreased from 60.1% to 55.0% (P less than .001 for both trends), and use of active surveillance remained low and steady at 1.9% in 2010 to 2.2% in 2015.

Intermediate-risk disease saw a significant increase in active surveillance, from 5.8% to 9.6% over the time period, with commensurate decreases in both radical prostatectomy and radiotherapy, according to the report.

While low-risk prostate cancer was traditionally managed with radical prostatectomy, national clinical practice guidelines starting in 2010 began recommending conservative management with active surveillance or watchful waiting, researchers noted in their report.

These epidemiologic data don’t provide any insights on clinical outcomes related to the management changes, investigators acknowledged. They said further study is needed to determine the “downstream effects” of increased active surveillance or watchful waiting in low-risk prostate cancer.

Dr. Mahal reported no conflicts of interest, while Dr. Nguyen provided disclosures related to Ferring, Augmenix, Bayer, Janssen, Astellas, Dendreon, Genome DX, Blue Earth Diagnostics, Cota, Nanobiotix, Janssen, and Astellas. Coauthors had disclosures relate to Janssen, Blue Earth, and the National Institutes of Health.

SOURCE: Mahal BA et al. JAMA. 2019 Feb 11. doi: 10.1001/jama.2018.19941.

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Conservative management for low-risk localized prostate cancer is up recently, in line with clinical practice guideline changes, while in high-risk disease, use of radical prostatectomy has increased despite a lack of new high-level evidence supporting the approach, according to researchers.

Active surveillance or watchful waiting surpassed both radical prostatectomy and radiotherapy to become the most common management strategy in low-risk disease over the 2010-2015 time period, according to their analysis of a Surveillance, Epidemiology, and End Results (SEER) database.

Meanwhile, radical prostatectomy use declined in low-risk patients, but increased in those with higher-risk disease at the expense of radiotherapy, said authors of the analysis, led by Brandon A. Mahal, MD, and Paul L. Nguyen, MD, of Dana-Farber Cancer Institute, Boston.

“Although increasing use of active surveillance or watchful waiting for low-risk disease has been supported by high-level evidence and guidelines since 2010, shifting management patterns toward more radical prostatectomy in higher-risk disease and away from radiotherapy does not coincide with any new level 1 evidence or guideline changes,” Dr. Mahal, Dr. Nguyen, and coauthors said in JAMA.

The analysis included 164,760 men with a diagnosis of localized prostate cancer between 2010 and 2015 in the SEER Prostate Active Surveillance/Watchful Waiting database. Of that group, 12.7% were managed by active surveillance or watchful waiting, while 41.5% underwent radiotherapy and 45.8% had a radical prostatectomy.

For men with low-risk disease, active surveillance or watchful waiting increased from just 14.5% in 2010 to 42.1% in 2015, investigators found. Radical prostatectomy decreased from 47.4% to 31.3% over that 5-year period, while radiotherapy likewise decreased from 38.0% to 26.6% (P less than .001 for all three trends).

By contrast, in men with high-risk disease, use of radical prostatectomy increased from 38.0% to 42.8%, while radiotherapy decreased from 60.1% to 55.0% (P less than .001 for both trends), and use of active surveillance remained low and steady at 1.9% in 2010 to 2.2% in 2015.

Intermediate-risk disease saw a significant increase in active surveillance, from 5.8% to 9.6% over the time period, with commensurate decreases in both radical prostatectomy and radiotherapy, according to the report.

While low-risk prostate cancer was traditionally managed with radical prostatectomy, national clinical practice guidelines starting in 2010 began recommending conservative management with active surveillance or watchful waiting, researchers noted in their report.

These epidemiologic data don’t provide any insights on clinical outcomes related to the management changes, investigators acknowledged. They said further study is needed to determine the “downstream effects” of increased active surveillance or watchful waiting in low-risk prostate cancer.

Dr. Mahal reported no conflicts of interest, while Dr. Nguyen provided disclosures related to Ferring, Augmenix, Bayer, Janssen, Astellas, Dendreon, Genome DX, Blue Earth Diagnostics, Cota, Nanobiotix, Janssen, and Astellas. Coauthors had disclosures relate to Janssen, Blue Earth, and the National Institutes of Health.

SOURCE: Mahal BA et al. JAMA. 2019 Feb 11. doi: 10.1001/jama.2018.19941.

 

Conservative management for low-risk localized prostate cancer is up recently, in line with clinical practice guideline changes, while in high-risk disease, use of radical prostatectomy has increased despite a lack of new high-level evidence supporting the approach, according to researchers.

Active surveillance or watchful waiting surpassed both radical prostatectomy and radiotherapy to become the most common management strategy in low-risk disease over the 2010-2015 time period, according to their analysis of a Surveillance, Epidemiology, and End Results (SEER) database.

Meanwhile, radical prostatectomy use declined in low-risk patients, but increased in those with higher-risk disease at the expense of radiotherapy, said authors of the analysis, led by Brandon A. Mahal, MD, and Paul L. Nguyen, MD, of Dana-Farber Cancer Institute, Boston.

“Although increasing use of active surveillance or watchful waiting for low-risk disease has been supported by high-level evidence and guidelines since 2010, shifting management patterns toward more radical prostatectomy in higher-risk disease and away from radiotherapy does not coincide with any new level 1 evidence or guideline changes,” Dr. Mahal, Dr. Nguyen, and coauthors said in JAMA.

The analysis included 164,760 men with a diagnosis of localized prostate cancer between 2010 and 2015 in the SEER Prostate Active Surveillance/Watchful Waiting database. Of that group, 12.7% were managed by active surveillance or watchful waiting, while 41.5% underwent radiotherapy and 45.8% had a radical prostatectomy.

For men with low-risk disease, active surveillance or watchful waiting increased from just 14.5% in 2010 to 42.1% in 2015, investigators found. Radical prostatectomy decreased from 47.4% to 31.3% over that 5-year period, while radiotherapy likewise decreased from 38.0% to 26.6% (P less than .001 for all three trends).

By contrast, in men with high-risk disease, use of radical prostatectomy increased from 38.0% to 42.8%, while radiotherapy decreased from 60.1% to 55.0% (P less than .001 for both trends), and use of active surveillance remained low and steady at 1.9% in 2010 to 2.2% in 2015.

Intermediate-risk disease saw a significant increase in active surveillance, from 5.8% to 9.6% over the time period, with commensurate decreases in both radical prostatectomy and radiotherapy, according to the report.

While low-risk prostate cancer was traditionally managed with radical prostatectomy, national clinical practice guidelines starting in 2010 began recommending conservative management with active surveillance or watchful waiting, researchers noted in their report.

These epidemiologic data don’t provide any insights on clinical outcomes related to the management changes, investigators acknowledged. They said further study is needed to determine the “downstream effects” of increased active surveillance or watchful waiting in low-risk prostate cancer.

Dr. Mahal reported no conflicts of interest, while Dr. Nguyen provided disclosures related to Ferring, Augmenix, Bayer, Janssen, Astellas, Dendreon, Genome DX, Blue Earth Diagnostics, Cota, Nanobiotix, Janssen, and Astellas. Coauthors had disclosures relate to Janssen, Blue Earth, and the National Institutes of Health.

SOURCE: Mahal BA et al. JAMA. 2019 Feb 11. doi: 10.1001/jama.2018.19941.

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Key clinical point: Conservative management for low-risk localized prostate cancer is up, in line with guidelines, while radical prostatectomy use has increased in high-risk disease despite a lack of new high-level evidence to support that approach.

Major finding: In men with low-risk disease, active surveillance or watchful waiting increased from 14.5% in 2010 to 42.1% in 2015, while in high-risk disease, radical prostatectomy increased from 38.0% to 42.8%

Study details: Analysis including 164,760 men with a diagnosis of localized prostate cancer between 2010 and 2015 in the SEER Prostate Active Surveillance/Watchful Waiting database.

Disclosures: Study authors reported disclosures related to Ferring, Augmenix, Bayer, Janssen, Astellas, Dendreon, Genome DX, Blue Earth Diagnostics, Cota, Nanobiotix, Janssen, Astellas, and the National Institutes of Health.

Source: Mahal BA et al. JAMA. 2019 Feb 11. doi: 10.1001/jama.2018.19941.

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Quick Byte: Needle-free injections

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A start-up operating out of MIT in Cambridge, Mass., called Portal Instruments has developed a needleless injection system.

The device, called PRIME, delivers medication into the bloodstream in a high-pressure stream that travels at Mach 0.7 – the speed of a jet. The makers signed a commercial deal in December 2017, and the device is expected to be available soon.

Reference

1. Kerrigan S. The 16 Most Remarkable Healthcare Innovations, Events, and Discoveries of 2018 For World Health Day. https://interestingengineering.com/the-16-most-remarkable-healthcare-innovations-events-and-discoveries-of-2018-for-world-health-day. April 7, 2018. Accessed June 4, 2018.

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A start-up operating out of MIT in Cambridge, Mass., called Portal Instruments has developed a needleless injection system.

The device, called PRIME, delivers medication into the bloodstream in a high-pressure stream that travels at Mach 0.7 – the speed of a jet. The makers signed a commercial deal in December 2017, and the device is expected to be available soon.

Reference

1. Kerrigan S. The 16 Most Remarkable Healthcare Innovations, Events, and Discoveries of 2018 For World Health Day. https://interestingengineering.com/the-16-most-remarkable-healthcare-innovations-events-and-discoveries-of-2018-for-world-health-day. April 7, 2018. Accessed June 4, 2018.

 

A start-up operating out of MIT in Cambridge, Mass., called Portal Instruments has developed a needleless injection system.

The device, called PRIME, delivers medication into the bloodstream in a high-pressure stream that travels at Mach 0.7 – the speed of a jet. The makers signed a commercial deal in December 2017, and the device is expected to be available soon.

Reference

1. Kerrigan S. The 16 Most Remarkable Healthcare Innovations, Events, and Discoveries of 2018 For World Health Day. https://interestingengineering.com/the-16-most-remarkable-healthcare-innovations-events-and-discoveries-of-2018-for-world-health-day. April 7, 2018. Accessed June 4, 2018.

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United States now over 100 measles cases for the year

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Through the first full week of February 2019, there were 101 confirmed cases of measles in 10 states, according to the Centers for Disease Control and Prevention.

Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.



The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.

“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.



In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.

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Through the first full week of February 2019, there were 101 confirmed cases of measles in 10 states, according to the Centers for Disease Control and Prevention.

Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.



The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.

“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.



In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.

 

Through the first full week of February 2019, there were 101 confirmed cases of measles in 10 states, according to the Centers for Disease Control and Prevention.

Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.



The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.

“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.



In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.

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E-cig use reverses progress in reducing tobacco use in teens

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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
Nearly 5 million middle school and high school students in the United States, approximately 27% of high school students and 7% of middle school students, used tobacco products, including e-cigarettes, in 2018, according to study findings.

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.

 

 


Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.

 
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.

 

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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
Nearly 5 million middle school and high school students in the United States, approximately 27% of high school students and 7% of middle school students, used tobacco products, including e-cigarettes, in 2018, according to study findings.

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.

 

 


Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.

 
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
Nearly 5 million middle school and high school students in the United States, approximately 27% of high school students and 7% of middle school students, used tobacco products, including e-cigarettes, in 2018, according to study findings.

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.

 

 


Approximately 27.1% of high school students and 7.2% of middle school students used a tobacco product in 2018, a significant increase from 2017 data, and with a major increase in e-cigarette use.

 
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.

 

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EC approves dasatinib plus chemo for kids with Ph+ ALL

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The European Commission has approved dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed, Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

Dasatinib will be available in tablet form and as a powder for oral suspension, Bristol-Myers Squib said in a press release.

The approval was based on an event-free survival rate of 65.5% (95% confidence interval, 57.7-73.7) and an overall survival rate of 91.5% (95% CI, 84.2-95.5) in a phase 2 trial that evaluated the addition of dasatinib to a chemotherapy regimen modeled on a Berlin-Frankfurt-Münster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.

Patients treated in the study (n = 106) were all aged younger than 18 years and received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to 24 months, in combination with chemotherapy. About 77 % of patients (n = 82) received tablets exclusively; 23% of patients (n = 24) received the powder for oral suspension at least once.

Hematologic adverse events included grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%), and bacteremia (24.5%). Nonhematologic, noninfectious grade 3 or 4 adverse events attributed to dasatinib and reported in more than 10% of patients included elevated ALT (21.7%) and AST (10.4%). Additional grade 3 or 4 adverse events attributed to dasatinib were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported, the company said in the press release.

Dasatinib is already approved by the European Commission to treat children with Ph+ chronic myeloid leukemia in the chronic phase, which includes newly diagnosed patients and those with resistance or intolerance to imatinib.

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The European Commission has approved dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed, Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

Dasatinib will be available in tablet form and as a powder for oral suspension, Bristol-Myers Squib said in a press release.

The approval was based on an event-free survival rate of 65.5% (95% confidence interval, 57.7-73.7) and an overall survival rate of 91.5% (95% CI, 84.2-95.5) in a phase 2 trial that evaluated the addition of dasatinib to a chemotherapy regimen modeled on a Berlin-Frankfurt-Münster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.

Patients treated in the study (n = 106) were all aged younger than 18 years and received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to 24 months, in combination with chemotherapy. About 77 % of patients (n = 82) received tablets exclusively; 23% of patients (n = 24) received the powder for oral suspension at least once.

Hematologic adverse events included grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%), and bacteremia (24.5%). Nonhematologic, noninfectious grade 3 or 4 adverse events attributed to dasatinib and reported in more than 10% of patients included elevated ALT (21.7%) and AST (10.4%). Additional grade 3 or 4 adverse events attributed to dasatinib were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported, the company said in the press release.

Dasatinib is already approved by the European Commission to treat children with Ph+ chronic myeloid leukemia in the chronic phase, which includes newly diagnosed patients and those with resistance or intolerance to imatinib.

 

The European Commission has approved dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed, Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

Dasatinib will be available in tablet form and as a powder for oral suspension, Bristol-Myers Squib said in a press release.

The approval was based on an event-free survival rate of 65.5% (95% confidence interval, 57.7-73.7) and an overall survival rate of 91.5% (95% CI, 84.2-95.5) in a phase 2 trial that evaluated the addition of dasatinib to a chemotherapy regimen modeled on a Berlin-Frankfurt-Münster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.

Patients treated in the study (n = 106) were all aged younger than 18 years and received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to 24 months, in combination with chemotherapy. About 77 % of patients (n = 82) received tablets exclusively; 23% of patients (n = 24) received the powder for oral suspension at least once.

Hematologic adverse events included grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%), and bacteremia (24.5%). Nonhematologic, noninfectious grade 3 or 4 adverse events attributed to dasatinib and reported in more than 10% of patients included elevated ALT (21.7%) and AST (10.4%). Additional grade 3 or 4 adverse events attributed to dasatinib were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%), and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported, the company said in the press release.

Dasatinib is already approved by the European Commission to treat children with Ph+ chronic myeloid leukemia in the chronic phase, which includes newly diagnosed patients and those with resistance or intolerance to imatinib.

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Treatment missing for U.S. children with mental illness

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More than 16% of American children have a mental health disorder, and almost half did not receive treatment from a mental health professional in 2016, according to data from a national survey of parents.

Among the estimated 7.7 million children with a treatable mental illness, 49.4% did not receive needed treatment from a psychiatrist, psychologist, psychiatric nurse, or clinical social worker in the previous 12 months, Daniel G. Whitney, PhD, and Mark D. Peterson, PhD, of the University of Michigan, Ann Arbor, wrote in JAMA Pediatrics.

State-level data from the National Survey of Children’s Health show considerable variation from the national average. North Carolina had the highest prevalence of nontreatment at 72.2% and Washington, D.C., had the lowest rate at 29.5%. The prevalence of at least one mental health disorder was highest in Maine (27.2%) and lowest in Hawaii (7.6%), the investigators reported.



Four states – Alabama, Mississippi, Oklahoma, and Utah – were in the top quartile for both mental health disorder prevalence and prevalence of children with a disorder who did not receive treatment, they noted.

“State-level practices and policies play a role in health care needs and use, which may help to explain the state variability observed in this study. Nevertheless, initiatives that assist systems of care coordination have demonstrated a reduction of mental health–related burdens across multiple domains,” Dr. Whitney and Dr. Peterson wrote.

SOURCE: Whitney DG et al. JAMA Pediatr. 2019 Feb 11. doi: 10.1001/jamapediatrics.2018.5399.

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More than 16% of American children have a mental health disorder, and almost half did not receive treatment from a mental health professional in 2016, according to data from a national survey of parents.

Among the estimated 7.7 million children with a treatable mental illness, 49.4% did not receive needed treatment from a psychiatrist, psychologist, psychiatric nurse, or clinical social worker in the previous 12 months, Daniel G. Whitney, PhD, and Mark D. Peterson, PhD, of the University of Michigan, Ann Arbor, wrote in JAMA Pediatrics.

State-level data from the National Survey of Children’s Health show considerable variation from the national average. North Carolina had the highest prevalence of nontreatment at 72.2% and Washington, D.C., had the lowest rate at 29.5%. The prevalence of at least one mental health disorder was highest in Maine (27.2%) and lowest in Hawaii (7.6%), the investigators reported.



Four states – Alabama, Mississippi, Oklahoma, and Utah – were in the top quartile for both mental health disorder prevalence and prevalence of children with a disorder who did not receive treatment, they noted.

“State-level practices and policies play a role in health care needs and use, which may help to explain the state variability observed in this study. Nevertheless, initiatives that assist systems of care coordination have demonstrated a reduction of mental health–related burdens across multiple domains,” Dr. Whitney and Dr. Peterson wrote.

SOURCE: Whitney DG et al. JAMA Pediatr. 2019 Feb 11. doi: 10.1001/jamapediatrics.2018.5399.

 

More than 16% of American children have a mental health disorder, and almost half did not receive treatment from a mental health professional in 2016, according to data from a national survey of parents.

Among the estimated 7.7 million children with a treatable mental illness, 49.4% did not receive needed treatment from a psychiatrist, psychologist, psychiatric nurse, or clinical social worker in the previous 12 months, Daniel G. Whitney, PhD, and Mark D. Peterson, PhD, of the University of Michigan, Ann Arbor, wrote in JAMA Pediatrics.

State-level data from the National Survey of Children’s Health show considerable variation from the national average. North Carolina had the highest prevalence of nontreatment at 72.2% and Washington, D.C., had the lowest rate at 29.5%. The prevalence of at least one mental health disorder was highest in Maine (27.2%) and lowest in Hawaii (7.6%), the investigators reported.



Four states – Alabama, Mississippi, Oklahoma, and Utah – were in the top quartile for both mental health disorder prevalence and prevalence of children with a disorder who did not receive treatment, they noted.

“State-level practices and policies play a role in health care needs and use, which may help to explain the state variability observed in this study. Nevertheless, initiatives that assist systems of care coordination have demonstrated a reduction of mental health–related burdens across multiple domains,” Dr. Whitney and Dr. Peterson wrote.

SOURCE: Whitney DG et al. JAMA Pediatr. 2019 Feb 11. doi: 10.1001/jamapediatrics.2018.5399.

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Herpes zoster could pose special threat to younger IBD patients

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– Herpes zoster infection could pose a special risk for younger patients with inflammatory bowel disease who are on immunosuppressant or biologic therapies, a new study suggests.

Dr. Marie L. Borum

About 3% of inflammatory bowel disease (IBD) patients developed herpes zoster (HZ) over a 5-year period at a single center, researchers found, and their average age was 37 years. The mean national age of HZ diagnosis is 59 years, and the latest guidelines from the Centers for Disease Control and Prevention do not recommend that people get vaccinated against HZ, or shingles, until age 50.

“Increased efforts should be made to administer herpes zoster vaccine in all eligible IBD patients, and there should be additional research focused on determining whether IBD patients under 50 years old, especially those on immunosuppressants or biologic therapy, would benefit from herpes zoster vaccination,” said gastroenterologist and study coauthor Marie L. Borum, MD, MPH, of George Washington University, Washington. She spoke in an interview before presenting the study findings at the the Crohn’s & Colitis Congress – a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Borum and her associates launched the study, published in Inflammatory Bowel Diseases, after noticing an increase in HZ cases among patients with IBD. The authors retrospectively analyzed the medical charts of all patients with IBD who were treated at a single center from 2012 to 2017 (n = 393; 55% female; average age, 44 years). Nearly all had ulcerative colitis (71%) or Crohn’s disease (24%).

Over the 5-year period, 11 patients – 5 with ulcerative colitis, 5 with Crohn’s disease, and 1 patient with unspecified colitis – were diagnosed with HZ. All were taking immunosuppressant or biologic medications, and none had been vaccinated against HZ.

The difference in the average age of diagnosis of the infected patients versus the national mean age (37 years vs. 59 years) was statistically significant (P less than .0001).

The IBD patients with HZ often had postherpetic neuralgia, Dr. Borum said.

Previous studies also have linked IBD to higher rates of HZ. A 2018 retrospective study of veterans found that “the incidence rates of herpes zoster in all age groups and all IBD medication subgroups were substantially higher than that in the oldest group of patients without IBD [older than 60 years]” (Clin Gastroenterol Hepatol. 2018 Dec;16[12]:1919-27).

In 2017, researchers at the University of Wisconsin–Madison received a grant to study immunity to the varicella zoster virus in patients with IBD. A university press release said the results “could support recommendations for universal herpes zoster immunization for all IBD patients above the age of 40.”

Why might IBD boost the risk of HZ? “Individuals with IBD may have an increased risk of developing more episodes of herpes zoster due to immune dysregulation,” Dr. Borum said. “Those on immunosuppressants or biologic therapies have greater risk of more frequent and severe complications. It has been speculated that Janus kinase inhibitors may be associated with an increased risk for developing HZ.”

Dr. Borum noted that the study is limited by its size and single-center design. “However, it supports the recommendations that additional research is needed to fully understand the potential impact of HZ on IBD patients.”

The study authors reported no relevant disclosures.

SOURCE: Borum ML et al. Inflamm Bowel Dis. 2019 Feb 7. doi: 10.1093/ibd/izy393.073.

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– Herpes zoster infection could pose a special risk for younger patients with inflammatory bowel disease who are on immunosuppressant or biologic therapies, a new study suggests.

Dr. Marie L. Borum

About 3% of inflammatory bowel disease (IBD) patients developed herpes zoster (HZ) over a 5-year period at a single center, researchers found, and their average age was 37 years. The mean national age of HZ diagnosis is 59 years, and the latest guidelines from the Centers for Disease Control and Prevention do not recommend that people get vaccinated against HZ, or shingles, until age 50.

“Increased efforts should be made to administer herpes zoster vaccine in all eligible IBD patients, and there should be additional research focused on determining whether IBD patients under 50 years old, especially those on immunosuppressants or biologic therapy, would benefit from herpes zoster vaccination,” said gastroenterologist and study coauthor Marie L. Borum, MD, MPH, of George Washington University, Washington. She spoke in an interview before presenting the study findings at the the Crohn’s & Colitis Congress – a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Borum and her associates launched the study, published in Inflammatory Bowel Diseases, after noticing an increase in HZ cases among patients with IBD. The authors retrospectively analyzed the medical charts of all patients with IBD who were treated at a single center from 2012 to 2017 (n = 393; 55% female; average age, 44 years). Nearly all had ulcerative colitis (71%) or Crohn’s disease (24%).

Over the 5-year period, 11 patients – 5 with ulcerative colitis, 5 with Crohn’s disease, and 1 patient with unspecified colitis – were diagnosed with HZ. All were taking immunosuppressant or biologic medications, and none had been vaccinated against HZ.

The difference in the average age of diagnosis of the infected patients versus the national mean age (37 years vs. 59 years) was statistically significant (P less than .0001).

The IBD patients with HZ often had postherpetic neuralgia, Dr. Borum said.

Previous studies also have linked IBD to higher rates of HZ. A 2018 retrospective study of veterans found that “the incidence rates of herpes zoster in all age groups and all IBD medication subgroups were substantially higher than that in the oldest group of patients without IBD [older than 60 years]” (Clin Gastroenterol Hepatol. 2018 Dec;16[12]:1919-27).

In 2017, researchers at the University of Wisconsin–Madison received a grant to study immunity to the varicella zoster virus in patients with IBD. A university press release said the results “could support recommendations for universal herpes zoster immunization for all IBD patients above the age of 40.”

Why might IBD boost the risk of HZ? “Individuals with IBD may have an increased risk of developing more episodes of herpes zoster due to immune dysregulation,” Dr. Borum said. “Those on immunosuppressants or biologic therapies have greater risk of more frequent and severe complications. It has been speculated that Janus kinase inhibitors may be associated with an increased risk for developing HZ.”

Dr. Borum noted that the study is limited by its size and single-center design. “However, it supports the recommendations that additional research is needed to fully understand the potential impact of HZ on IBD patients.”

The study authors reported no relevant disclosures.

SOURCE: Borum ML et al. Inflamm Bowel Dis. 2019 Feb 7. doi: 10.1093/ibd/izy393.073.

– Herpes zoster infection could pose a special risk for younger patients with inflammatory bowel disease who are on immunosuppressant or biologic therapies, a new study suggests.

Dr. Marie L. Borum

About 3% of inflammatory bowel disease (IBD) patients developed herpes zoster (HZ) over a 5-year period at a single center, researchers found, and their average age was 37 years. The mean national age of HZ diagnosis is 59 years, and the latest guidelines from the Centers for Disease Control and Prevention do not recommend that people get vaccinated against HZ, or shingles, until age 50.

“Increased efforts should be made to administer herpes zoster vaccine in all eligible IBD patients, and there should be additional research focused on determining whether IBD patients under 50 years old, especially those on immunosuppressants or biologic therapy, would benefit from herpes zoster vaccination,” said gastroenterologist and study coauthor Marie L. Borum, MD, MPH, of George Washington University, Washington. She spoke in an interview before presenting the study findings at the the Crohn’s & Colitis Congress – a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Borum and her associates launched the study, published in Inflammatory Bowel Diseases, after noticing an increase in HZ cases among patients with IBD. The authors retrospectively analyzed the medical charts of all patients with IBD who were treated at a single center from 2012 to 2017 (n = 393; 55% female; average age, 44 years). Nearly all had ulcerative colitis (71%) or Crohn’s disease (24%).

Over the 5-year period, 11 patients – 5 with ulcerative colitis, 5 with Crohn’s disease, and 1 patient with unspecified colitis – were diagnosed with HZ. All were taking immunosuppressant or biologic medications, and none had been vaccinated against HZ.

The difference in the average age of diagnosis of the infected patients versus the national mean age (37 years vs. 59 years) was statistically significant (P less than .0001).

The IBD patients with HZ often had postherpetic neuralgia, Dr. Borum said.

Previous studies also have linked IBD to higher rates of HZ. A 2018 retrospective study of veterans found that “the incidence rates of herpes zoster in all age groups and all IBD medication subgroups were substantially higher than that in the oldest group of patients without IBD [older than 60 years]” (Clin Gastroenterol Hepatol. 2018 Dec;16[12]:1919-27).

In 2017, researchers at the University of Wisconsin–Madison received a grant to study immunity to the varicella zoster virus in patients with IBD. A university press release said the results “could support recommendations for universal herpes zoster immunization for all IBD patients above the age of 40.”

Why might IBD boost the risk of HZ? “Individuals with IBD may have an increased risk of developing more episodes of herpes zoster due to immune dysregulation,” Dr. Borum said. “Those on immunosuppressants or biologic therapies have greater risk of more frequent and severe complications. It has been speculated that Janus kinase inhibitors may be associated with an increased risk for developing HZ.”

Dr. Borum noted that the study is limited by its size and single-center design. “However, it supports the recommendations that additional research is needed to fully understand the potential impact of HZ on IBD patients.”

The study authors reported no relevant disclosures.

SOURCE: Borum ML et al. Inflamm Bowel Dis. 2019 Feb 7. doi: 10.1093/ibd/izy393.073.

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Key clinical point: Younger patients with inflammatory bowel disease may face a higher risk of infection with herpes zoster.

Major finding: About 3% of patients with inflammatory bowel disease were diagnosed with herpes zoster infection, and their average age was 37 years.

Study details: A retrospective 5-year chart review of 393 patients with inflammatory bowel disease.

Disclosures: The authors reported no relevant disclosures.

Source: Borum ML et al. Inflamm Bowel Dis. 2019 Feb 7. doi: 10.1093/ibd/izy393.073.

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