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Third trimester Tdap vaccination raises antibodies in newborns
Immunization of pregnant women with the Tdap vaccine during weeks 27-30 of pregnancy yielded the higher concentration of protective pertussis toxin antibodies in neonates, compared with neonates not exposed to the vaccine, based on data from more than 600 pregnancies.
The Centers for Disease Control and Prevention recommends Tdap vaccination for pregnant women between 27 and 35 weeks’ gestation, but “data on pertussis antibody concentrations following maternal Tdap immunization are limited because of small cohort size or differing immunization schedules,” wrote C. Mary Healy, MD, of Baylor College of Medicine, Houston and her colleagues.
In an observational study published in JAMA, the researchers reviewed data from 626 pregnancies and births at a single tertiary care center in Texas. The average age of the mothers was 30 years; 41% were white, 27% Hispanic, 26% black, 5% Asian, and 1% another ethnicity. Of these, 312 received the Tdap vaccine at an average gestation of 31 weeks, while 314 women were not immunized.
Overall, the geometric mean concentration (GMC) of neonatal umbilical cord pertussis toxin antibodies among infants exposed to Tdap was 47.3 IU/mL, compared with 12.9 IU/mL for unexposed infants, yielding a GMC ratio of 3.6 (P less than .001).
In addition, pertussis toxin antibody concentrations of 15 IU/mL or higher, 30 IU/mL or higher, and 40 IU/mL or higher were significantly more common in Tdap-exposed vs. Tdap-unexposed neonates (86% vs. 37%, 72% vs. 17%, 59% vs. 12%, respectively).
The GMC of pertussis toxin antibodies was highest when the vaccine was given during weeks 27-30, after which the GMC declined, the researchers noted.
The study was limited by several factors including the observational design, which does not support causes and effect analysis, the use of data from a single center, and the lack of pre- and postimmunization serum samples for comparison, and the absence of data on women immunized during the second trimester, the researchers wrote.
However, the results support data from previous studies, and were strengthened by the large study population. The findings suggest that “following U.S. immunization recommendations and in accordance with current understanding of the kinetics of placental transfer, optimal time to administer Tdap vaccine to maximize pertussis toxin antibodies at birth may be early in the third trimester, with the window of 27 through 30 weeks of gestation yielding the highest cord blood levels,” the researchers said.
The study was supported in part by the Centers for Disease Control and Prevention. Dr. Healy disclosed relationships with Sanofi Pasteur, Novartis Vaccines, Pfizer, and Novavax.
SOURCE: Healy C et al. JAMA. 2018 Oct 9;320(14):1464-70.
Immunization of pregnant women with the Tdap vaccine during weeks 27-30 of pregnancy yielded the higher concentration of protective pertussis toxin antibodies in neonates, compared with neonates not exposed to the vaccine, based on data from more than 600 pregnancies.
The Centers for Disease Control and Prevention recommends Tdap vaccination for pregnant women between 27 and 35 weeks’ gestation, but “data on pertussis antibody concentrations following maternal Tdap immunization are limited because of small cohort size or differing immunization schedules,” wrote C. Mary Healy, MD, of Baylor College of Medicine, Houston and her colleagues.
In an observational study published in JAMA, the researchers reviewed data from 626 pregnancies and births at a single tertiary care center in Texas. The average age of the mothers was 30 years; 41% were white, 27% Hispanic, 26% black, 5% Asian, and 1% another ethnicity. Of these, 312 received the Tdap vaccine at an average gestation of 31 weeks, while 314 women were not immunized.
Overall, the geometric mean concentration (GMC) of neonatal umbilical cord pertussis toxin antibodies among infants exposed to Tdap was 47.3 IU/mL, compared with 12.9 IU/mL for unexposed infants, yielding a GMC ratio of 3.6 (P less than .001).
In addition, pertussis toxin antibody concentrations of 15 IU/mL or higher, 30 IU/mL or higher, and 40 IU/mL or higher were significantly more common in Tdap-exposed vs. Tdap-unexposed neonates (86% vs. 37%, 72% vs. 17%, 59% vs. 12%, respectively).
The GMC of pertussis toxin antibodies was highest when the vaccine was given during weeks 27-30, after which the GMC declined, the researchers noted.
The study was limited by several factors including the observational design, which does not support causes and effect analysis, the use of data from a single center, and the lack of pre- and postimmunization serum samples for comparison, and the absence of data on women immunized during the second trimester, the researchers wrote.
However, the results support data from previous studies, and were strengthened by the large study population. The findings suggest that “following U.S. immunization recommendations and in accordance with current understanding of the kinetics of placental transfer, optimal time to administer Tdap vaccine to maximize pertussis toxin antibodies at birth may be early in the third trimester, with the window of 27 through 30 weeks of gestation yielding the highest cord blood levels,” the researchers said.
The study was supported in part by the Centers for Disease Control and Prevention. Dr. Healy disclosed relationships with Sanofi Pasteur, Novartis Vaccines, Pfizer, and Novavax.
SOURCE: Healy C et al. JAMA. 2018 Oct 9;320(14):1464-70.
Immunization of pregnant women with the Tdap vaccine during weeks 27-30 of pregnancy yielded the higher concentration of protective pertussis toxin antibodies in neonates, compared with neonates not exposed to the vaccine, based on data from more than 600 pregnancies.
The Centers for Disease Control and Prevention recommends Tdap vaccination for pregnant women between 27 and 35 weeks’ gestation, but “data on pertussis antibody concentrations following maternal Tdap immunization are limited because of small cohort size or differing immunization schedules,” wrote C. Mary Healy, MD, of Baylor College of Medicine, Houston and her colleagues.
In an observational study published in JAMA, the researchers reviewed data from 626 pregnancies and births at a single tertiary care center in Texas. The average age of the mothers was 30 years; 41% were white, 27% Hispanic, 26% black, 5% Asian, and 1% another ethnicity. Of these, 312 received the Tdap vaccine at an average gestation of 31 weeks, while 314 women were not immunized.
Overall, the geometric mean concentration (GMC) of neonatal umbilical cord pertussis toxin antibodies among infants exposed to Tdap was 47.3 IU/mL, compared with 12.9 IU/mL for unexposed infants, yielding a GMC ratio of 3.6 (P less than .001).
In addition, pertussis toxin antibody concentrations of 15 IU/mL or higher, 30 IU/mL or higher, and 40 IU/mL or higher were significantly more common in Tdap-exposed vs. Tdap-unexposed neonates (86% vs. 37%, 72% vs. 17%, 59% vs. 12%, respectively).
The GMC of pertussis toxin antibodies was highest when the vaccine was given during weeks 27-30, after which the GMC declined, the researchers noted.
The study was limited by several factors including the observational design, which does not support causes and effect analysis, the use of data from a single center, and the lack of pre- and postimmunization serum samples for comparison, and the absence of data on women immunized during the second trimester, the researchers wrote.
However, the results support data from previous studies, and were strengthened by the large study population. The findings suggest that “following U.S. immunization recommendations and in accordance with current understanding of the kinetics of placental transfer, optimal time to administer Tdap vaccine to maximize pertussis toxin antibodies at birth may be early in the third trimester, with the window of 27 through 30 weeks of gestation yielding the highest cord blood levels,” the researchers said.
The study was supported in part by the Centers for Disease Control and Prevention. Dr. Healy disclosed relationships with Sanofi Pasteur, Novartis Vaccines, Pfizer, and Novavax.
SOURCE: Healy C et al. JAMA. 2018 Oct 9;320(14):1464-70.
FROM JAMA
Key clinical point:
Major finding: The geometric mean concentration of neonatal cord pertussis toxin antibodies was 47.3 IU/mL among newborns exposed to Tdap, compared with 12.9 IU/mL among unexposed (P less than .001).
Study details: The data come from an observational study of 626 pregnancies.
Disclosures: The study was supported in part by the Centers for Disease Control and Prevention. Dr. Healy disclosed relationships with Sanofi Pasteur, Novartis Vaccines, Pfizer, and Novavax.
Source: Healy C et al. JAMA. 2018 Oct 9;320(14):1464-70.
Consider ART for younger endometriosis patients
but non-ART infertility treatment is less likely to succeed in the endometriosis population, according to data from approximately 1,800 women with infertility.
Moderate to severe endometriosis had a negative impact on the outcome of ART, but “the efficacy of non-ART treatment in patients with endometriosis remains elusive” wrote Wataru Isono of the University of Tokyo, and colleagues.
In a study published in the Journal of Obstetrics & Gynaecology Research, the investigators sought to determine the impact of endometriosis severity on the effectiveness of non-ART treatment. They calculated the cumulative live birth rates for women treated with ART and non-ART.
Overall, 49% of the 894 ART patients and 22% of the 1,358 non-ART patients gave birth after treatment. The birth rate remained more than twice as high among ART patients across all age groups, but declined among ART patients starting at 35 years of age and declined sharply as patients reached 40 years of age.
“The most important aspect of this study was that we determined the limitations of non-ART and sought to identify optimal management methods, as non-ART can be a more cost-effective treatment than ART in certain circumstances,” the researchers noted.
They then focused on 288 patients with advanced endometriosis, defined as stage III or IV according to the revised American Society for Reproductive Medicine score. Notably, the presence of moderate to severe endometriosis had a significant effect on the outcomes of non-ART patients in their 30s, but ART was effective in this age group in a multivariate analysis. The cumulative live birth rate in advanced endometriosis patients was significantly lower than in those without the condition who underwent non-ART treatment (10% vs. 25%). However, cumulative live birth rates after ART were not significantly different among advanced endometriosis patients, compared with patients without advanced endometriosis (45% vs. 51%).
The study was limited by several factors including the inability to analyze the varied types of infertility treatment, Dr. Isono and associates noted. However, “our results may provide infertility patients with accurate information regarding their expected probabilities of achieving a live birth and may help them select the optimal treatment based on their classification according to various risk factors,” they said.
The researchers had no financial conflicts to disclose. The study was supported by the Japan Society for the Promotion of Sciences; Grants-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture; the Japan Agency for Medical Research and Development; and the Ministry of Health, Labor and Welfare.
SOURCE: Isono W et al. J Obstet Gynaecol Res. 2018. doi: 10.1111/jog.13826.
but non-ART infertility treatment is less likely to succeed in the endometriosis population, according to data from approximately 1,800 women with infertility.
Moderate to severe endometriosis had a negative impact on the outcome of ART, but “the efficacy of non-ART treatment in patients with endometriosis remains elusive” wrote Wataru Isono of the University of Tokyo, and colleagues.
In a study published in the Journal of Obstetrics & Gynaecology Research, the investigators sought to determine the impact of endometriosis severity on the effectiveness of non-ART treatment. They calculated the cumulative live birth rates for women treated with ART and non-ART.
Overall, 49% of the 894 ART patients and 22% of the 1,358 non-ART patients gave birth after treatment. The birth rate remained more than twice as high among ART patients across all age groups, but declined among ART patients starting at 35 years of age and declined sharply as patients reached 40 years of age.
“The most important aspect of this study was that we determined the limitations of non-ART and sought to identify optimal management methods, as non-ART can be a more cost-effective treatment than ART in certain circumstances,” the researchers noted.
They then focused on 288 patients with advanced endometriosis, defined as stage III or IV according to the revised American Society for Reproductive Medicine score. Notably, the presence of moderate to severe endometriosis had a significant effect on the outcomes of non-ART patients in their 30s, but ART was effective in this age group in a multivariate analysis. The cumulative live birth rate in advanced endometriosis patients was significantly lower than in those without the condition who underwent non-ART treatment (10% vs. 25%). However, cumulative live birth rates after ART were not significantly different among advanced endometriosis patients, compared with patients without advanced endometriosis (45% vs. 51%).
The study was limited by several factors including the inability to analyze the varied types of infertility treatment, Dr. Isono and associates noted. However, “our results may provide infertility patients with accurate information regarding their expected probabilities of achieving a live birth and may help them select the optimal treatment based on their classification according to various risk factors,” they said.
The researchers had no financial conflicts to disclose. The study was supported by the Japan Society for the Promotion of Sciences; Grants-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture; the Japan Agency for Medical Research and Development; and the Ministry of Health, Labor and Welfare.
SOURCE: Isono W et al. J Obstet Gynaecol Res. 2018. doi: 10.1111/jog.13826.
but non-ART infertility treatment is less likely to succeed in the endometriosis population, according to data from approximately 1,800 women with infertility.
Moderate to severe endometriosis had a negative impact on the outcome of ART, but “the efficacy of non-ART treatment in patients with endometriosis remains elusive” wrote Wataru Isono of the University of Tokyo, and colleagues.
In a study published in the Journal of Obstetrics & Gynaecology Research, the investigators sought to determine the impact of endometriosis severity on the effectiveness of non-ART treatment. They calculated the cumulative live birth rates for women treated with ART and non-ART.
Overall, 49% of the 894 ART patients and 22% of the 1,358 non-ART patients gave birth after treatment. The birth rate remained more than twice as high among ART patients across all age groups, but declined among ART patients starting at 35 years of age and declined sharply as patients reached 40 years of age.
“The most important aspect of this study was that we determined the limitations of non-ART and sought to identify optimal management methods, as non-ART can be a more cost-effective treatment than ART in certain circumstances,” the researchers noted.
They then focused on 288 patients with advanced endometriosis, defined as stage III or IV according to the revised American Society for Reproductive Medicine score. Notably, the presence of moderate to severe endometriosis had a significant effect on the outcomes of non-ART patients in their 30s, but ART was effective in this age group in a multivariate analysis. The cumulative live birth rate in advanced endometriosis patients was significantly lower than in those without the condition who underwent non-ART treatment (10% vs. 25%). However, cumulative live birth rates after ART were not significantly different among advanced endometriosis patients, compared with patients without advanced endometriosis (45% vs. 51%).
The study was limited by several factors including the inability to analyze the varied types of infertility treatment, Dr. Isono and associates noted. However, “our results may provide infertility patients with accurate information regarding their expected probabilities of achieving a live birth and may help them select the optimal treatment based on their classification according to various risk factors,” they said.
The researchers had no financial conflicts to disclose. The study was supported by the Japan Society for the Promotion of Sciences; Grants-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture; the Japan Agency for Medical Research and Development; and the Ministry of Health, Labor and Welfare.
SOURCE: Isono W et al. J Obstet Gynaecol Res. 2018. doi: 10.1111/jog.13826.
FROM THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH
Key clinical point: ART was more effective than was non-ART against infertility in women with endometriosis, especially among younger women.
Major finding: The cumulative live birth rate in advanced endometriosis patients was significantly lower than in those without the condition who underwent non-ART treatment (10% vs. 25%).
Study details: A retrospective study of 1,864 infertile women in Japan, including 288 with advanced endometriosis.
Disclosures: The researchers had no financial conflicts to disclose. The study was supported by the Japan Society for the Promotion of Sciences; Grants-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture; the Japan Agency for Medical Research and Development; and the Ministry of Health, Labor and Welfare.
Source: Isono W et al. J Obstet Gynaecol Res. 2018. doi: 10.1111/jog.13826.
IL inhibitor options move psoriasis treatment forward
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Obesity in early childhood promotes obese adolescence
Most obese adolescents first became obese between the ages of 2 and 6 years, based on data from approximately 50,000 children in Germany.
Identifying periods of weight gain in childhood can help develop intervention and prevention strategies to reduce the risk of obesity in adolescence, wrote Mandy Geserick, MSc, of the University of Leipzig, Germany, and her colleagues in the New England Journal of Medicine.
To assess the timing of weight gain in early childhood, the researchers reviewed data from a German patient registry designed to monitor growth data. The study population included 51,505 children who had at least one visit to a pediatrician between birth and age 14 years and a second visit between age 15 and 19 years.
Overall, the probability of being overweight or obese in adolescence was 29% among children who gained more weight in the preschool years, between the ages of 2 and 6 years (defined as a change in body mass index [BMI] of 0.2 or more to less than 2.0), compared with 20% among children whose preschool weight remained stable (defined as a change in BMI of more than −0.2 to less than 0.2) – a relative risk of 1.43.
“A total of 83% of the children with obesity at the age of 4 were overweight or obese in adolescence, and only 17% returned to a normal weight,” they wrote. In addition, 44% of children who were born large for gestational age were overweight or obese in adolescence.
“A practical clinical implication of our study results would be surveillance for BMI acceleration, which should be recognized before 6 years of age, even in the absence of obesity,” the researchers wrote.
The study findings were limited by several factors including the variation in the number of visits, the lack of data on many children beyond the age of 14 years, and the lack of data on parental weight and perinatal risk factors associated with obesity, the researchers noted. However, the results were strengthened by the large, population-based design, and support the study hypothesis that obesity develops in early childhood and, once present, persists into adolescence.
“The specific dynamics and patterns of BMI in this early childhood period, rather than the absolute BMI, appear to be important factors in identifying children at risk for obesity later in life,” the researchers wrote. “It is therefore important for health care professionals, educational staff, and parents to become more sensitive to this critical time period.”
The study was supported by the German Research Council for the Clinical Research Center; the Federal Ministry of Education and Research; and the University of Leipzig, which was supported by the European Union, the European Regional Development Fund, and the Free State of Saxony within the framework of the excellence initiative. The CrescNet registry infrastructure was supported by grants from Hexal, Novo Nordisk, Merck Serono, Lilly Deutschland, Pfizer, and Ipsen Pharma. Dr. Geserick had no financial conflicts to report.
SOURCE: Geserick M et al. N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMoa1803527.
Most normal-weight children remained in the normal range throughout childhood, but the association between obesity by the age of 5 years and obese adolescence is a “new and important” finding, Michael S. Freemark, MD, wrote in an accompanying editorial (N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMe1811305).
Although body mass index (BMI) generally decreases by age 5-6 years before increasing through adolescence, data from previous studies have shown that “an early or exaggerated ‘adiposity rebound’ portends an increased risk of obesity in later childhood and adolescence,” he wrote.
In this study, BMI increase between age 2 and 6 years was the strongest predictor of obesity in adolescence. Although the study was not designed to show causality, the results support the idea of a window of opportunity for intervention for children at increased risk for obesity, Dr. Freemark wrote. “The finding that the risk of adolescent obesity manifests by 3 to 5 years of age suggests that nutritional counseling should be considered when exaggerated weight gain persists or emerges after 2 years of age; it would be of value to test the efficacy of early dietary intervention in an appropriate trial.
“Counseling could be applied preemptively for families in which the parents are overweight, particularly if there is a history of maternal diabetes or smoking,” he added.
Dr. Freemark is affiliated with the division of pediatric endocrinology and diabetes at Duke University, Durham, N.C. He disclosed grants from Rhythm Pharmaceuticals, the American Heart Association, and the Humanitarian Innovation Fund and European Commission, as well as personal fees from Springer Publishing outside the submitted work.
Most normal-weight children remained in the normal range throughout childhood, but the association between obesity by the age of 5 years and obese adolescence is a “new and important” finding, Michael S. Freemark, MD, wrote in an accompanying editorial (N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMe1811305).
Although body mass index (BMI) generally decreases by age 5-6 years before increasing through adolescence, data from previous studies have shown that “an early or exaggerated ‘adiposity rebound’ portends an increased risk of obesity in later childhood and adolescence,” he wrote.
In this study, BMI increase between age 2 and 6 years was the strongest predictor of obesity in adolescence. Although the study was not designed to show causality, the results support the idea of a window of opportunity for intervention for children at increased risk for obesity, Dr. Freemark wrote. “The finding that the risk of adolescent obesity manifests by 3 to 5 years of age suggests that nutritional counseling should be considered when exaggerated weight gain persists or emerges after 2 years of age; it would be of value to test the efficacy of early dietary intervention in an appropriate trial.
“Counseling could be applied preemptively for families in which the parents are overweight, particularly if there is a history of maternal diabetes or smoking,” he added.
Dr. Freemark is affiliated with the division of pediatric endocrinology and diabetes at Duke University, Durham, N.C. He disclosed grants from Rhythm Pharmaceuticals, the American Heart Association, and the Humanitarian Innovation Fund and European Commission, as well as personal fees from Springer Publishing outside the submitted work.
Most normal-weight children remained in the normal range throughout childhood, but the association between obesity by the age of 5 years and obese adolescence is a “new and important” finding, Michael S. Freemark, MD, wrote in an accompanying editorial (N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMe1811305).
Although body mass index (BMI) generally decreases by age 5-6 years before increasing through adolescence, data from previous studies have shown that “an early or exaggerated ‘adiposity rebound’ portends an increased risk of obesity in later childhood and adolescence,” he wrote.
In this study, BMI increase between age 2 and 6 years was the strongest predictor of obesity in adolescence. Although the study was not designed to show causality, the results support the idea of a window of opportunity for intervention for children at increased risk for obesity, Dr. Freemark wrote. “The finding that the risk of adolescent obesity manifests by 3 to 5 years of age suggests that nutritional counseling should be considered when exaggerated weight gain persists or emerges after 2 years of age; it would be of value to test the efficacy of early dietary intervention in an appropriate trial.
“Counseling could be applied preemptively for families in which the parents are overweight, particularly if there is a history of maternal diabetes or smoking,” he added.
Dr. Freemark is affiliated with the division of pediatric endocrinology and diabetes at Duke University, Durham, N.C. He disclosed grants from Rhythm Pharmaceuticals, the American Heart Association, and the Humanitarian Innovation Fund and European Commission, as well as personal fees from Springer Publishing outside the submitted work.
Most obese adolescents first became obese between the ages of 2 and 6 years, based on data from approximately 50,000 children in Germany.
Identifying periods of weight gain in childhood can help develop intervention and prevention strategies to reduce the risk of obesity in adolescence, wrote Mandy Geserick, MSc, of the University of Leipzig, Germany, and her colleagues in the New England Journal of Medicine.
To assess the timing of weight gain in early childhood, the researchers reviewed data from a German patient registry designed to monitor growth data. The study population included 51,505 children who had at least one visit to a pediatrician between birth and age 14 years and a second visit between age 15 and 19 years.
Overall, the probability of being overweight or obese in adolescence was 29% among children who gained more weight in the preschool years, between the ages of 2 and 6 years (defined as a change in body mass index [BMI] of 0.2 or more to less than 2.0), compared with 20% among children whose preschool weight remained stable (defined as a change in BMI of more than −0.2 to less than 0.2) – a relative risk of 1.43.
“A total of 83% of the children with obesity at the age of 4 were overweight or obese in adolescence, and only 17% returned to a normal weight,” they wrote. In addition, 44% of children who were born large for gestational age were overweight or obese in adolescence.
“A practical clinical implication of our study results would be surveillance for BMI acceleration, which should be recognized before 6 years of age, even in the absence of obesity,” the researchers wrote.
The study findings were limited by several factors including the variation in the number of visits, the lack of data on many children beyond the age of 14 years, and the lack of data on parental weight and perinatal risk factors associated with obesity, the researchers noted. However, the results were strengthened by the large, population-based design, and support the study hypothesis that obesity develops in early childhood and, once present, persists into adolescence.
“The specific dynamics and patterns of BMI in this early childhood period, rather than the absolute BMI, appear to be important factors in identifying children at risk for obesity later in life,” the researchers wrote. “It is therefore important for health care professionals, educational staff, and parents to become more sensitive to this critical time period.”
The study was supported by the German Research Council for the Clinical Research Center; the Federal Ministry of Education and Research; and the University of Leipzig, which was supported by the European Union, the European Regional Development Fund, and the Free State of Saxony within the framework of the excellence initiative. The CrescNet registry infrastructure was supported by grants from Hexal, Novo Nordisk, Merck Serono, Lilly Deutschland, Pfizer, and Ipsen Pharma. Dr. Geserick had no financial conflicts to report.
SOURCE: Geserick M et al. N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMoa1803527.
Most obese adolescents first became obese between the ages of 2 and 6 years, based on data from approximately 50,000 children in Germany.
Identifying periods of weight gain in childhood can help develop intervention and prevention strategies to reduce the risk of obesity in adolescence, wrote Mandy Geserick, MSc, of the University of Leipzig, Germany, and her colleagues in the New England Journal of Medicine.
To assess the timing of weight gain in early childhood, the researchers reviewed data from a German patient registry designed to monitor growth data. The study population included 51,505 children who had at least one visit to a pediatrician between birth and age 14 years and a second visit between age 15 and 19 years.
Overall, the probability of being overweight or obese in adolescence was 29% among children who gained more weight in the preschool years, between the ages of 2 and 6 years (defined as a change in body mass index [BMI] of 0.2 or more to less than 2.0), compared with 20% among children whose preschool weight remained stable (defined as a change in BMI of more than −0.2 to less than 0.2) – a relative risk of 1.43.
“A total of 83% of the children with obesity at the age of 4 were overweight or obese in adolescence, and only 17% returned to a normal weight,” they wrote. In addition, 44% of children who were born large for gestational age were overweight or obese in adolescence.
“A practical clinical implication of our study results would be surveillance for BMI acceleration, which should be recognized before 6 years of age, even in the absence of obesity,” the researchers wrote.
The study findings were limited by several factors including the variation in the number of visits, the lack of data on many children beyond the age of 14 years, and the lack of data on parental weight and perinatal risk factors associated with obesity, the researchers noted. However, the results were strengthened by the large, population-based design, and support the study hypothesis that obesity develops in early childhood and, once present, persists into adolescence.
“The specific dynamics and patterns of BMI in this early childhood period, rather than the absolute BMI, appear to be important factors in identifying children at risk for obesity later in life,” the researchers wrote. “It is therefore important for health care professionals, educational staff, and parents to become more sensitive to this critical time period.”
The study was supported by the German Research Council for the Clinical Research Center; the Federal Ministry of Education and Research; and the University of Leipzig, which was supported by the European Union, the European Regional Development Fund, and the Free State of Saxony within the framework of the excellence initiative. The CrescNet registry infrastructure was supported by grants from Hexal, Novo Nordisk, Merck Serono, Lilly Deutschland, Pfizer, and Ipsen Pharma. Dr. Geserick had no financial conflicts to report.
SOURCE: Geserick M et al. N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMoa1803527.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Of children who were obese at age 4 years, 83% were overweight or obese in adolescence.
Study details: The data come from a retrospective study of 51,505 children in Germany.
Disclosures: The study was supported by the German Research Council for the Clinical Research Center; the Federal Ministry of Education and Research; and the University of Leipzig, which was supported by the European Union, the European Regional Development Fund, and the Free State of Saxony within the framework of the excellence initiative. The CrescNet registry infrastructure was supported by grants from Hexal, Novo Nordisk, Merck Serono, Lilly Deutschland, Pfizer, and Ipsen Pharma. Dr. Geserick had no financial conflicts to report.
Source: Geserick M et al. N Engl J Med. 2018 Oct 3. doi: 10.1056/NEJMoa1803527.
Zoledronate reduces fracture risk in elderly women with osteopenia
Intravenous zoledronate therapy given once every 18 months, with minimal use of calcium supplements, was associated with an increase in bone mass and significantly reduced the risk of vertebral and nonvertebral fractures in postmenopausal women, compared with a placebo, based on data from a 6-year trial of 2,000 ambulatory women aged 65 and older with osteopenia.
The findings were presented at the annual meeting of the American Society for Bone and Mineral Research and published simultaneously in the New England Journal of Medicine.
Bisphosphonates have been shown to prevent fractures in osteoporosis patients, but their effectiveness has not been well studied in patients with osteopenia alone, noted Ian R. Reid, MD, of the University of Auckland, New Zealand, and his colleagues. “Many patients at high risk for fracture do not have T scores of less than –2.5 but rather have osteopenia in combination with other risk factors such as age.”
The researchers randomized 2,000 women aged 65 years and older with osteopenia to receive four infusions of zoledronate or a saline placebo every 18 months. A dietary intake of 1 g of calcium per day was advised, but calcium supplements were not provided; 2% of the women took supplements. Those not taking vitamin D before the trial were given a single 2.5-mg dose of cholecalciferol and a monthly 1.25-mg dose during the trial. Trial participants were followed for 6 years.
Demographic characteristics were similar between the groups, and their T scores ranged from –1.0 to –2.5 at the total hip or femoral neck. The primary endpoint was the time to a first fragility fracture, defined as nonvertebral fractures and vertebral fractures confirmed by radiography.
Overall, 122 women in the zoledronate group experienced 131 fractures, and 190 women in the placebo group experienced 227 fractures (hazard ratio 0.63, P less than .001). Differences in bone mineral density between the two groups were observed by 3 years.
The number needed to treat to prevent a single fragility fracture was 10; the number needed to treat to prevent a symptomatic fracture was 20.
The findings were consistent with data on reduced fracture risk in osteoporosis patients treated with zoledronate. The study differed from other similar trials in its use of 18-month dosing intervals and low use of calcium supplements (2%), they noted.
The data were limited by the older age of the study individuals, so the results should not be extrapolated to younger women or individuals with normal bone mineral density, the researchers said. The results suggest that annual zoledronate dosing may be unnecessary, but further research is needed to explore longer dose intervals.
Dr. Reid disclosed grants from Health Research Council of New Zealand, nonfinancial support from Novartis during the study, and financial relationships with Amgen, Merck, Novartis, and Eli Lilly unrelated to the study.
SOURCE: Reid I et al. N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMoa1808082.
This trial reminds us that risk assessment and treatment decisions go well beyond bone mineral density and should focus particularly on age and a history of fractures.
Osteoporosis is defined as a T score below –2.5, but several longitudinal studies have shown that most fractures among postmenopausal women occur in those with osteopenia. Further, alendronate therapy did not reduce the risk of fractures among women with osteopenia which contributed to a treatment gap for women with osteopenic T scores but strong risk factors for an osteoporotic fracture.
In the current study, zoledronate was associated with a greater increase in bone mass and a lower fracture risk compared with placebo. Plus, zoledronate prevented fractures among women with an average T score of –1.27 at the total hip and –1.64 at the femoral neck. The positive data, coupled with the low number of adverse events over the 6-year study period, support the addition of zoledronate to the treatment options for osteoporosis. However, the average age of the patients in the current study was 3.5 years older than that of patients in previous alendronate studies. As a result, the findings should not be extrapolated to postmenopausal women under the age of 65 years with osteopenia.
Clifford J. Rosen, MD, is affiliated with the Maine Medical Center Research Institute, Scarborough, and serves as an associate editor at the New England Journal of Medicine. He made his remarks in an accompanying editorial (N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMe1812434). Dr. Rosen had no relevant financial conflicts to disclose.
This trial reminds us that risk assessment and treatment decisions go well beyond bone mineral density and should focus particularly on age and a history of fractures.
Osteoporosis is defined as a T score below –2.5, but several longitudinal studies have shown that most fractures among postmenopausal women occur in those with osteopenia. Further, alendronate therapy did not reduce the risk of fractures among women with osteopenia which contributed to a treatment gap for women with osteopenic T scores but strong risk factors for an osteoporotic fracture.
In the current study, zoledronate was associated with a greater increase in bone mass and a lower fracture risk compared with placebo. Plus, zoledronate prevented fractures among women with an average T score of –1.27 at the total hip and –1.64 at the femoral neck. The positive data, coupled with the low number of adverse events over the 6-year study period, support the addition of zoledronate to the treatment options for osteoporosis. However, the average age of the patients in the current study was 3.5 years older than that of patients in previous alendronate studies. As a result, the findings should not be extrapolated to postmenopausal women under the age of 65 years with osteopenia.
Clifford J. Rosen, MD, is affiliated with the Maine Medical Center Research Institute, Scarborough, and serves as an associate editor at the New England Journal of Medicine. He made his remarks in an accompanying editorial (N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMe1812434). Dr. Rosen had no relevant financial conflicts to disclose.
This trial reminds us that risk assessment and treatment decisions go well beyond bone mineral density and should focus particularly on age and a history of fractures.
Osteoporosis is defined as a T score below –2.5, but several longitudinal studies have shown that most fractures among postmenopausal women occur in those with osteopenia. Further, alendronate therapy did not reduce the risk of fractures among women with osteopenia which contributed to a treatment gap for women with osteopenic T scores but strong risk factors for an osteoporotic fracture.
In the current study, zoledronate was associated with a greater increase in bone mass and a lower fracture risk compared with placebo. Plus, zoledronate prevented fractures among women with an average T score of –1.27 at the total hip and –1.64 at the femoral neck. The positive data, coupled with the low number of adverse events over the 6-year study period, support the addition of zoledronate to the treatment options for osteoporosis. However, the average age of the patients in the current study was 3.5 years older than that of patients in previous alendronate studies. As a result, the findings should not be extrapolated to postmenopausal women under the age of 65 years with osteopenia.
Clifford J. Rosen, MD, is affiliated with the Maine Medical Center Research Institute, Scarborough, and serves as an associate editor at the New England Journal of Medicine. He made his remarks in an accompanying editorial (N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMe1812434). Dr. Rosen had no relevant financial conflicts to disclose.
Intravenous zoledronate therapy given once every 18 months, with minimal use of calcium supplements, was associated with an increase in bone mass and significantly reduced the risk of vertebral and nonvertebral fractures in postmenopausal women, compared with a placebo, based on data from a 6-year trial of 2,000 ambulatory women aged 65 and older with osteopenia.
The findings were presented at the annual meeting of the American Society for Bone and Mineral Research and published simultaneously in the New England Journal of Medicine.
Bisphosphonates have been shown to prevent fractures in osteoporosis patients, but their effectiveness has not been well studied in patients with osteopenia alone, noted Ian R. Reid, MD, of the University of Auckland, New Zealand, and his colleagues. “Many patients at high risk for fracture do not have T scores of less than –2.5 but rather have osteopenia in combination with other risk factors such as age.”
The researchers randomized 2,000 women aged 65 years and older with osteopenia to receive four infusions of zoledronate or a saline placebo every 18 months. A dietary intake of 1 g of calcium per day was advised, but calcium supplements were not provided; 2% of the women took supplements. Those not taking vitamin D before the trial were given a single 2.5-mg dose of cholecalciferol and a monthly 1.25-mg dose during the trial. Trial participants were followed for 6 years.
Demographic characteristics were similar between the groups, and their T scores ranged from –1.0 to –2.5 at the total hip or femoral neck. The primary endpoint was the time to a first fragility fracture, defined as nonvertebral fractures and vertebral fractures confirmed by radiography.
Overall, 122 women in the zoledronate group experienced 131 fractures, and 190 women in the placebo group experienced 227 fractures (hazard ratio 0.63, P less than .001). Differences in bone mineral density between the two groups were observed by 3 years.
The number needed to treat to prevent a single fragility fracture was 10; the number needed to treat to prevent a symptomatic fracture was 20.
The findings were consistent with data on reduced fracture risk in osteoporosis patients treated with zoledronate. The study differed from other similar trials in its use of 18-month dosing intervals and low use of calcium supplements (2%), they noted.
The data were limited by the older age of the study individuals, so the results should not be extrapolated to younger women or individuals with normal bone mineral density, the researchers said. The results suggest that annual zoledronate dosing may be unnecessary, but further research is needed to explore longer dose intervals.
Dr. Reid disclosed grants from Health Research Council of New Zealand, nonfinancial support from Novartis during the study, and financial relationships with Amgen, Merck, Novartis, and Eli Lilly unrelated to the study.
SOURCE: Reid I et al. N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMoa1808082.
Intravenous zoledronate therapy given once every 18 months, with minimal use of calcium supplements, was associated with an increase in bone mass and significantly reduced the risk of vertebral and nonvertebral fractures in postmenopausal women, compared with a placebo, based on data from a 6-year trial of 2,000 ambulatory women aged 65 and older with osteopenia.
The findings were presented at the annual meeting of the American Society for Bone and Mineral Research and published simultaneously in the New England Journal of Medicine.
Bisphosphonates have been shown to prevent fractures in osteoporosis patients, but their effectiveness has not been well studied in patients with osteopenia alone, noted Ian R. Reid, MD, of the University of Auckland, New Zealand, and his colleagues. “Many patients at high risk for fracture do not have T scores of less than –2.5 but rather have osteopenia in combination with other risk factors such as age.”
The researchers randomized 2,000 women aged 65 years and older with osteopenia to receive four infusions of zoledronate or a saline placebo every 18 months. A dietary intake of 1 g of calcium per day was advised, but calcium supplements were not provided; 2% of the women took supplements. Those not taking vitamin D before the trial were given a single 2.5-mg dose of cholecalciferol and a monthly 1.25-mg dose during the trial. Trial participants were followed for 6 years.
Demographic characteristics were similar between the groups, and their T scores ranged from –1.0 to –2.5 at the total hip or femoral neck. The primary endpoint was the time to a first fragility fracture, defined as nonvertebral fractures and vertebral fractures confirmed by radiography.
Overall, 122 women in the zoledronate group experienced 131 fractures, and 190 women in the placebo group experienced 227 fractures (hazard ratio 0.63, P less than .001). Differences in bone mineral density between the two groups were observed by 3 years.
The number needed to treat to prevent a single fragility fracture was 10; the number needed to treat to prevent a symptomatic fracture was 20.
The findings were consistent with data on reduced fracture risk in osteoporosis patients treated with zoledronate. The study differed from other similar trials in its use of 18-month dosing intervals and low use of calcium supplements (2%), they noted.
The data were limited by the older age of the study individuals, so the results should not be extrapolated to younger women or individuals with normal bone mineral density, the researchers said. The results suggest that annual zoledronate dosing may be unnecessary, but further research is needed to explore longer dose intervals.
Dr. Reid disclosed grants from Health Research Council of New Zealand, nonfinancial support from Novartis during the study, and financial relationships with Amgen, Merck, Novartis, and Eli Lilly unrelated to the study.
SOURCE: Reid I et al. N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMoa1808082.
REPORTING FROM ASBMR
Key clinical point: Vertebral and nonvertebral fracture risk was significantly lower in osteopenic women who received zoledronate, compared with those who received a placebo.
Major finding: Fragility fractures occurred in 122 women in a zoledronate group and 190 women in a placebo group. The number needed to treat to prevent a single fragility fracture was 10; the number needed to treat to prevent a symptomatic fracture was 20.
Study details: A 6-year randomized, double-blind trial of 2,000 women aged 65 years and older with osteopenia.
Disclosures: The study was supported in part by grants from the Health Research Council of New Zealand; Novartis provided the medication. Dr. Reid disclosed grants from Health Research Council of New Zealand, nonfinancial support from Novartis during the study, and financial relationships with Amgen, Merck, Novartis, and Eli Lilly unrelated to the study.
Source: Reid I et al. N Engl J Med. 2018 Oct 1. doi: 10.1056/NEJMoa1808082.
Maximize well-woman visits for preventive services, counseling
A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.
“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.
Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.
The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.
“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.
Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.
The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.
“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.
“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”
Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.
The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.
The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.
“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.
Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.
The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.
“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.
Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.
The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.
“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.
“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”
Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.
The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.
The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
A well-woman visit with an ob.gyn. should include preventive services and counseling, according to an updated committee opinion from the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.
“A well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks,” according to the opinion, published in Obstetrics & Gynecology. The updated opinion coincides with the release of the new Well-Woman Chart from the Women’s Preventive Services Initiative.
Previous research suggests that many women prefer an ob.gyn. or other women’s health care specialist not only for reproductive health care but also for services such as cervical cancer screening, contraception, and treatment for sexually transmitted infections, the committee members wrote. Although surveys of ob.gyns. show that most provide some level of overall health and primary care, the screening and other clinical preventive services were not consistent.
The committee opinion consequently recommends that the “periodic well-woman care visit should include screening, evaluation and counseling, and immunizations based on age and risk factors.” However, the committee acknowledged that the interval for specific services varies among patients, as does the scope of services provided in different settings.
“Taking a comprehensive history (specifically obtaining detailed information on symptoms and past medical and gynecologic history) will inform if certain components of the physical examination, including breast or pelvic examination, are indicated at that visit and will inform shared decision making for these examinations,” committee members wrote. Topics that should be addressed during lifespan include sexual health (which may include contraception, prepregnancy counseling, sexually transmitted infections, and infertility), vulvovaginal symptoms, and bone health.
Not all components of a physical may be required at a well-woman visit, but ob.gyns. can play a key role by encouraging and facilitating healthy behaviors, counseling on preventive health strategies, and engaging women in shared decision-making. Screening for smoking, poor diet, and lack of physical activity are important. Ob.gyns. also can be part of the team-based care for women that may include physician assistants, nurse practitioners, and other medical professionals.
The most notable change from the previous opinion is that it coincides with the Women’s Preventive Services Initiative’s release of a Well-Woman Chart, which is designed to help ob.gyns. navigate the implementation of ACOG’s well-woman guidance, Christopher Zahn, MD, vice president of practice activities for ACOG, said in an interview.
“In tandem, these documents support ob.gyns. and other women’s health care providers’ efforts to make well-woman visits more personalized care that prioritizes shared decision-making over a woman’s lifetime,” he said. The opinion statement also includes the Women’s Preventive Services Initiative as a source of information for recommendations on well-woman care, and includes new guidance on the elements of a physical exam, including the pelvic exam.
“Ob.gyns. care for women over their lifetime, and increasingly this includes a lot of preventive care. The committee opinion details ACOG’s overall approach to well-women care and the role of the ob.gyn. as a provider of preventive services,” said Dr. Zahn. “The accompanying well-woman chart, targeted to providers, summarizes needed preventive services ensuring that time can be spent effectively and productively during each well-woman visit. By centering shared decision making and care tailored to each woman’s health care needs at every life stage, the well-woman visit is a fundamental part of the patient-provider relationship.”
Dr. Zahn noted that ongoing, high-quality research is essential to determine what strategies are most effective for women’s preventive care needs at every life stage. “Further research is also needed to identify screening strategies for women in certain higher risk groups and to reduce disparities in outcomes in certain populations of women. From cancer screening to new contraceptive methods, to managing symptoms of menopause, the more research we have to support our recommendations for these services, the more effectively we can care for women and help to keep them healthy for many, many years,” he emphasized.
The committee recommended additional resources for ob.gyns. and other health care providers, as well as for patients. The resources are available online at www.acog.org/More-Info/WellWoman.
The new opinion statement, which replaces the previous opinion issued in 2012, was developed by the ACOG Committee on Gynecologic Practice in collaboration with committee member Catherine Witkop, MD, MPH, of the Uniformed Health Sciences University in Bethesda, Md. The committee members had no relevant financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
ID experts urge widespread flu vaccination for 2018-2019 season
WASHINGTON – The flu vaccine may not be perfect, but it can reduce the severity of illness and curb the risk of spreading the disease to others, William Schaffner, MD, emphasized at a press conference held by the National Foundation for Infectious Diseases.
“Give the vaccine credit for softening the blow,” said Dr. Schaffner, medical director of NFID and a professor at Vanderbilt University in Nashville.
Dr. Schaffner and a panel of experts including U.S. Surgeon General Jerome M. Adams, MD, encouraged the public and the health care community to follow recommendation from the Centers for Disease Control & Prevention that everyone aged 6 months and older receive an influenza vaccine.
Dr. Schaffner shared recent data showing that complications from the flu don’t stop when the acute illness resolves. Acute influenza causes a whole-body inflammatory reaction, and consequently “there is an increased risk of heart attack and stroke during the 2-4 weeks of recovery from acute influenza,” he said. In addition, older adults who experience acute flu and are already frail may never regain their pre-flu level of function, as the flu can start a “domino effect of decline and disability.”
Despite last year’s severe flu season that included 180 deaths in children, vaccination remains the most effective protection against the flu, Dr. Adams said.
This year, between 163 million and 168 million doses of vaccine will be available in the United States. The vaccine is available in a range of settings including doctors’ offices, pharmacies, grocery stores, and workplaces, said Dr. Adams.
Flu vaccine choices this year include a return of the live-attenuated influenza vaccine (LAIV) given via nasal spray, along with the standard influenza vaccine that includes either three influenza viruses (trivalent, with two influenza A and one influenza B) or four influenza viruses (quadrivalent, with two influenza A and two influenza B). Other options are adjuvanted vaccine and high-dose vaccine for adults aged 65 years and older, and a cell-based and recombinant vaccine as alternatives to egg-based vaccines.
Dr. Adams emphasized the importance of healthy people getting vaccinated to protect the community. “All the people who died from the flu caught it from someone else,” he said.
The message to health care providers remains the same: Recommend the flu vaccine to patients at every opportunity, and lead by example and get vaccinated yourself, Dr. Adams said. He noted this year’s strategies to promote flu vaccination on social media, and encouraged clinicians to recommend the flu shot to their patients and to showcase their own shots via the #FightFlu hashtag.
Vaccination among health care personnel last year was approximately 78%, which is a plateau over the past several years (MMWR 2018; 67:1050-54).
Be prepared to offer antivirals to patients as appropriate, and to promote the pneumococcal vaccine to eligible older adults as well, to protect not only themselves, but their contacts and the community, Dr. Adams emphasized. Currently approved antiviral drugs recommended for the 2018-2019 flu season: oseltamivir, zanamivir, and peramivir.
Wendy Sue Swanson, MD, of Seattle Children’s Hospital, stressed the importance of flu vaccination for all children, given their ability to spread viral infections. She noted a concerning 2% drop in vaccinations for children aged 6 months to 4 years, although vaccination coverage in this group was highest among children overall, at approximately 68% last season.
Last year, approximately 80% of the child deaths from flu occurred in unvaccinated children, but the vaccine has been shown to reduce the likelihood of hospitalization or death even if a child does become ill, Dr. Swanson said.
Laura E. Riley, MD, of Weill Cornell Medical Center, noted that vaccination of pregnant women has plateaued in recent years, and was 49% last year. “Our goal is 80% plus,” she said. Data show that pregnant women who received flu vaccination were 40% less likely to be hospitalized for the flu, she noted. The American College of Obstetricians and Gynecologists recommends flu vaccination as safe during any trimester, and valuable to both mothers and newborns because it provides protective antibodies during the first 6 months of life before babies can receive their own vaccinations, Dr. Riley said.
More information about this year’s flu season is available from the CDC and NFID.
WASHINGTON – The flu vaccine may not be perfect, but it can reduce the severity of illness and curb the risk of spreading the disease to others, William Schaffner, MD, emphasized at a press conference held by the National Foundation for Infectious Diseases.
“Give the vaccine credit for softening the blow,” said Dr. Schaffner, medical director of NFID and a professor at Vanderbilt University in Nashville.
Dr. Schaffner and a panel of experts including U.S. Surgeon General Jerome M. Adams, MD, encouraged the public and the health care community to follow recommendation from the Centers for Disease Control & Prevention that everyone aged 6 months and older receive an influenza vaccine.
Dr. Schaffner shared recent data showing that complications from the flu don’t stop when the acute illness resolves. Acute influenza causes a whole-body inflammatory reaction, and consequently “there is an increased risk of heart attack and stroke during the 2-4 weeks of recovery from acute influenza,” he said. In addition, older adults who experience acute flu and are already frail may never regain their pre-flu level of function, as the flu can start a “domino effect of decline and disability.”
Despite last year’s severe flu season that included 180 deaths in children, vaccination remains the most effective protection against the flu, Dr. Adams said.
This year, between 163 million and 168 million doses of vaccine will be available in the United States. The vaccine is available in a range of settings including doctors’ offices, pharmacies, grocery stores, and workplaces, said Dr. Adams.
Flu vaccine choices this year include a return of the live-attenuated influenza vaccine (LAIV) given via nasal spray, along with the standard influenza vaccine that includes either three influenza viruses (trivalent, with two influenza A and one influenza B) or four influenza viruses (quadrivalent, with two influenza A and two influenza B). Other options are adjuvanted vaccine and high-dose vaccine for adults aged 65 years and older, and a cell-based and recombinant vaccine as alternatives to egg-based vaccines.
Dr. Adams emphasized the importance of healthy people getting vaccinated to protect the community. “All the people who died from the flu caught it from someone else,” he said.
The message to health care providers remains the same: Recommend the flu vaccine to patients at every opportunity, and lead by example and get vaccinated yourself, Dr. Adams said. He noted this year’s strategies to promote flu vaccination on social media, and encouraged clinicians to recommend the flu shot to their patients and to showcase their own shots via the #FightFlu hashtag.
Vaccination among health care personnel last year was approximately 78%, which is a plateau over the past several years (MMWR 2018; 67:1050-54).
Be prepared to offer antivirals to patients as appropriate, and to promote the pneumococcal vaccine to eligible older adults as well, to protect not only themselves, but their contacts and the community, Dr. Adams emphasized. Currently approved antiviral drugs recommended for the 2018-2019 flu season: oseltamivir, zanamivir, and peramivir.
Wendy Sue Swanson, MD, of Seattle Children’s Hospital, stressed the importance of flu vaccination for all children, given their ability to spread viral infections. She noted a concerning 2% drop in vaccinations for children aged 6 months to 4 years, although vaccination coverage in this group was highest among children overall, at approximately 68% last season.
Last year, approximately 80% of the child deaths from flu occurred in unvaccinated children, but the vaccine has been shown to reduce the likelihood of hospitalization or death even if a child does become ill, Dr. Swanson said.
Laura E. Riley, MD, of Weill Cornell Medical Center, noted that vaccination of pregnant women has plateaued in recent years, and was 49% last year. “Our goal is 80% plus,” she said. Data show that pregnant women who received flu vaccination were 40% less likely to be hospitalized for the flu, she noted. The American College of Obstetricians and Gynecologists recommends flu vaccination as safe during any trimester, and valuable to both mothers and newborns because it provides protective antibodies during the first 6 months of life before babies can receive their own vaccinations, Dr. Riley said.
More information about this year’s flu season is available from the CDC and NFID.
WASHINGTON – The flu vaccine may not be perfect, but it can reduce the severity of illness and curb the risk of spreading the disease to others, William Schaffner, MD, emphasized at a press conference held by the National Foundation for Infectious Diseases.
“Give the vaccine credit for softening the blow,” said Dr. Schaffner, medical director of NFID and a professor at Vanderbilt University in Nashville.
Dr. Schaffner and a panel of experts including U.S. Surgeon General Jerome M. Adams, MD, encouraged the public and the health care community to follow recommendation from the Centers for Disease Control & Prevention that everyone aged 6 months and older receive an influenza vaccine.
Dr. Schaffner shared recent data showing that complications from the flu don’t stop when the acute illness resolves. Acute influenza causes a whole-body inflammatory reaction, and consequently “there is an increased risk of heart attack and stroke during the 2-4 weeks of recovery from acute influenza,” he said. In addition, older adults who experience acute flu and are already frail may never regain their pre-flu level of function, as the flu can start a “domino effect of decline and disability.”
Despite last year’s severe flu season that included 180 deaths in children, vaccination remains the most effective protection against the flu, Dr. Adams said.
This year, between 163 million and 168 million doses of vaccine will be available in the United States. The vaccine is available in a range of settings including doctors’ offices, pharmacies, grocery stores, and workplaces, said Dr. Adams.
Flu vaccine choices this year include a return of the live-attenuated influenza vaccine (LAIV) given via nasal spray, along with the standard influenza vaccine that includes either three influenza viruses (trivalent, with two influenza A and one influenza B) or four influenza viruses (quadrivalent, with two influenza A and two influenza B). Other options are adjuvanted vaccine and high-dose vaccine for adults aged 65 years and older, and a cell-based and recombinant vaccine as alternatives to egg-based vaccines.
Dr. Adams emphasized the importance of healthy people getting vaccinated to protect the community. “All the people who died from the flu caught it from someone else,” he said.
The message to health care providers remains the same: Recommend the flu vaccine to patients at every opportunity, and lead by example and get vaccinated yourself, Dr. Adams said. He noted this year’s strategies to promote flu vaccination on social media, and encouraged clinicians to recommend the flu shot to their patients and to showcase their own shots via the #FightFlu hashtag.
Vaccination among health care personnel last year was approximately 78%, which is a plateau over the past several years (MMWR 2018; 67:1050-54).
Be prepared to offer antivirals to patients as appropriate, and to promote the pneumococcal vaccine to eligible older adults as well, to protect not only themselves, but their contacts and the community, Dr. Adams emphasized. Currently approved antiviral drugs recommended for the 2018-2019 flu season: oseltamivir, zanamivir, and peramivir.
Wendy Sue Swanson, MD, of Seattle Children’s Hospital, stressed the importance of flu vaccination for all children, given their ability to spread viral infections. She noted a concerning 2% drop in vaccinations for children aged 6 months to 4 years, although vaccination coverage in this group was highest among children overall, at approximately 68% last season.
Last year, approximately 80% of the child deaths from flu occurred in unvaccinated children, but the vaccine has been shown to reduce the likelihood of hospitalization or death even if a child does become ill, Dr. Swanson said.
Laura E. Riley, MD, of Weill Cornell Medical Center, noted that vaccination of pregnant women has plateaued in recent years, and was 49% last year. “Our goal is 80% plus,” she said. Data show that pregnant women who received flu vaccination were 40% less likely to be hospitalized for the flu, she noted. The American College of Obstetricians and Gynecologists recommends flu vaccination as safe during any trimester, and valuable to both mothers and newborns because it provides protective antibodies during the first 6 months of life before babies can receive their own vaccinations, Dr. Riley said.
More information about this year’s flu season is available from the CDC and NFID.
FROM AN NFID PRESS CONFERENCE
Gestational weight outside guidelines adversely affects mothers, babies
Gestational weight gain above or below the level recommended by the Institute of Medicine (IOM) guidelines resulted in significantly worse outcomes for mothers and babies, according to data from nearly 30,000 women.
Previous studies of the relationship between gestational weight gain and maternal and neonatal outcomes have been limited by “small sample sizes, single sites, restricted reporting of outcomes, and a lack of racial-ethnic diversity,” Michelle A. Kominiarek, MD, of Northwestern University in Chicago and her colleagues wrote . To determine the effects of gestational weight gain on a large and more diverse population, the researchers conducted a secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network’s Assessment of Perinatal Excellence study. The findings were published in Obstetrics & Gynecology.
Gestational weight gain above the amount recommended by IOM guidelines was significantly associated with adverse outcomes in neonates, including macrosomia (adjusted odds ratio, 2.66), shoulder dystocia (aOR, 1.74), and neonatal hypoglycemia (aOR, 1.60).
In further multivariate analysis, adverse maternal outcomes associated with gestational weight gain above that recommended by the guidelines included hypertensive diseases of pregnancy for any parity (aOR, 1.84) and increased risk of cesarean delivery in nulliparous and multiparous women (aORs, 1.44 and 1.26, respectively).
Gestational weight gain below the recommended amount was associated with both spontaneous (aOR, 1.50) and indicated (aOR, 1.34) preterm birth. Weight gain above the guidelines was associated with a greater risk of indicated preterm birth only (aOR, 1.24).
The study population included 29,861 women at 25 hospitals over a 3-year period. Of these, 51% had gestational weight gains above the amount recommended by the IOM guidelines and 21% had gestational weight gains below it. The researchers calculated gestational weight gain by subtracting prepregnancy weight from delivery weight or, if prepregnancy weight was not available, by subtracting weight at the first prenatal visit at 13 weeks of gestation or earlier from delivery weight.
The study findings were limited by the use of self-reported prepregnancy weight and the possible effects of changes to the guidelines with respect to obese patients, the researchers said. However, the results support those from previous studies, and the “noted strengths include analysis of 29,861 women representative of the United States with rigorous ascertainment of outcomes and calculation of gestational weight gain to account for the wide range of gestational ages at delivery,” Dr. Kominiarek and her associates wrote.
Overall, the data support efforts to educate women on health behaviors and how gestational weight gain affects them and their infants, and additional research is needed to help women meet their goals for appropriate gestational weight, the researchers concluded.
SOURCE: Kominiarek MA et al. Obstet Gynecol. 2018 Oct;132(4):875-81.
“We are struggling with an obesity epidemic in this country, and pregnancy accounts for a risk time for women to gain excessive weight,” Martina L. Badell, MD, said in an interview. “This is a very well-designed large study which attempted to systematically evaluate the adverse perinatal outcomes associated with inappropriate weight gain in pregnancy across a diverse group of women.”
She emphasized that “the take home message is the importance of counseling regarding weight gain in pregnancy and monitoring it closely in real time as the associated risks are significant and potentially avoidable. The first step to solving a problem is adequately quantifying it, and this study does just that. The next step is giving this information to pregnant women along with making weight gain a part of the discussion prior to pregnancy and at every prenatal visit.”
Dr. Badell added, “Ideally, the weight gain for an individual pregnant women would be tracked and discussed with her during each prenatal visit. If she is below or above the recommendations, the risks associated with this could be discussed along with strategies to get/stay on track. In an ideal world, women struggling with weight gain goals in pregnancy would have access to a dietitian. However, in reality, ob.gyn. offices will likely need to come up with patient education handouts or staff education.”
Another useful avenue for research would be assessing the effects of patient education, Dr. Badell said. “The next best step would be implementing a study to assess if education of women during pregnancy about their individual weight gain at each visit and discussion regarding perinatal risks affects ultimate weight gain and reduces risks. Additionally, education could begin in the preconception phase as this knowledge is likely important even prior to pregnancy. Finally, studies are needed on interventions such as working with dietitians or patient education classes once a woman has been identified as not being within weight gain goals to evaluate if these can alter weight gain and improve outcomes.”
Dr. Badell is a maternal-fetal medicine specialist in the department of gynecology and obstetrics at Emory University, Atlanta. She was asked to comment on the findings of Kominiarek MA et al. Dr. Badell had no relevant financial conflicts to disclose.
“We are struggling with an obesity epidemic in this country, and pregnancy accounts for a risk time for women to gain excessive weight,” Martina L. Badell, MD, said in an interview. “This is a very well-designed large study which attempted to systematically evaluate the adverse perinatal outcomes associated with inappropriate weight gain in pregnancy across a diverse group of women.”
She emphasized that “the take home message is the importance of counseling regarding weight gain in pregnancy and monitoring it closely in real time as the associated risks are significant and potentially avoidable. The first step to solving a problem is adequately quantifying it, and this study does just that. The next step is giving this information to pregnant women along with making weight gain a part of the discussion prior to pregnancy and at every prenatal visit.”
Dr. Badell added, “Ideally, the weight gain for an individual pregnant women would be tracked and discussed with her during each prenatal visit. If she is below or above the recommendations, the risks associated with this could be discussed along with strategies to get/stay on track. In an ideal world, women struggling with weight gain goals in pregnancy would have access to a dietitian. However, in reality, ob.gyn. offices will likely need to come up with patient education handouts or staff education.”
Another useful avenue for research would be assessing the effects of patient education, Dr. Badell said. “The next best step would be implementing a study to assess if education of women during pregnancy about their individual weight gain at each visit and discussion regarding perinatal risks affects ultimate weight gain and reduces risks. Additionally, education could begin in the preconception phase as this knowledge is likely important even prior to pregnancy. Finally, studies are needed on interventions such as working with dietitians or patient education classes once a woman has been identified as not being within weight gain goals to evaluate if these can alter weight gain and improve outcomes.”
Dr. Badell is a maternal-fetal medicine specialist in the department of gynecology and obstetrics at Emory University, Atlanta. She was asked to comment on the findings of Kominiarek MA et al. Dr. Badell had no relevant financial conflicts to disclose.
“We are struggling with an obesity epidemic in this country, and pregnancy accounts for a risk time for women to gain excessive weight,” Martina L. Badell, MD, said in an interview. “This is a very well-designed large study which attempted to systematically evaluate the adverse perinatal outcomes associated with inappropriate weight gain in pregnancy across a diverse group of women.”
She emphasized that “the take home message is the importance of counseling regarding weight gain in pregnancy and monitoring it closely in real time as the associated risks are significant and potentially avoidable. The first step to solving a problem is adequately quantifying it, and this study does just that. The next step is giving this information to pregnant women along with making weight gain a part of the discussion prior to pregnancy and at every prenatal visit.”
Dr. Badell added, “Ideally, the weight gain for an individual pregnant women would be tracked and discussed with her during each prenatal visit. If she is below or above the recommendations, the risks associated with this could be discussed along with strategies to get/stay on track. In an ideal world, women struggling with weight gain goals in pregnancy would have access to a dietitian. However, in reality, ob.gyn. offices will likely need to come up with patient education handouts or staff education.”
Another useful avenue for research would be assessing the effects of patient education, Dr. Badell said. “The next best step would be implementing a study to assess if education of women during pregnancy about their individual weight gain at each visit and discussion regarding perinatal risks affects ultimate weight gain and reduces risks. Additionally, education could begin in the preconception phase as this knowledge is likely important even prior to pregnancy. Finally, studies are needed on interventions such as working with dietitians or patient education classes once a woman has been identified as not being within weight gain goals to evaluate if these can alter weight gain and improve outcomes.”
Dr. Badell is a maternal-fetal medicine specialist in the department of gynecology and obstetrics at Emory University, Atlanta. She was asked to comment on the findings of Kominiarek MA et al. Dr. Badell had no relevant financial conflicts to disclose.
Gestational weight gain above or below the level recommended by the Institute of Medicine (IOM) guidelines resulted in significantly worse outcomes for mothers and babies, according to data from nearly 30,000 women.
Previous studies of the relationship between gestational weight gain and maternal and neonatal outcomes have been limited by “small sample sizes, single sites, restricted reporting of outcomes, and a lack of racial-ethnic diversity,” Michelle A. Kominiarek, MD, of Northwestern University in Chicago and her colleagues wrote . To determine the effects of gestational weight gain on a large and more diverse population, the researchers conducted a secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network’s Assessment of Perinatal Excellence study. The findings were published in Obstetrics & Gynecology.
Gestational weight gain above the amount recommended by IOM guidelines was significantly associated with adverse outcomes in neonates, including macrosomia (adjusted odds ratio, 2.66), shoulder dystocia (aOR, 1.74), and neonatal hypoglycemia (aOR, 1.60).
In further multivariate analysis, adverse maternal outcomes associated with gestational weight gain above that recommended by the guidelines included hypertensive diseases of pregnancy for any parity (aOR, 1.84) and increased risk of cesarean delivery in nulliparous and multiparous women (aORs, 1.44 and 1.26, respectively).
Gestational weight gain below the recommended amount was associated with both spontaneous (aOR, 1.50) and indicated (aOR, 1.34) preterm birth. Weight gain above the guidelines was associated with a greater risk of indicated preterm birth only (aOR, 1.24).
The study population included 29,861 women at 25 hospitals over a 3-year period. Of these, 51% had gestational weight gains above the amount recommended by the IOM guidelines and 21% had gestational weight gains below it. The researchers calculated gestational weight gain by subtracting prepregnancy weight from delivery weight or, if prepregnancy weight was not available, by subtracting weight at the first prenatal visit at 13 weeks of gestation or earlier from delivery weight.
The study findings were limited by the use of self-reported prepregnancy weight and the possible effects of changes to the guidelines with respect to obese patients, the researchers said. However, the results support those from previous studies, and the “noted strengths include analysis of 29,861 women representative of the United States with rigorous ascertainment of outcomes and calculation of gestational weight gain to account for the wide range of gestational ages at delivery,” Dr. Kominiarek and her associates wrote.
Overall, the data support efforts to educate women on health behaviors and how gestational weight gain affects them and their infants, and additional research is needed to help women meet their goals for appropriate gestational weight, the researchers concluded.
SOURCE: Kominiarek MA et al. Obstet Gynecol. 2018 Oct;132(4):875-81.
Gestational weight gain above or below the level recommended by the Institute of Medicine (IOM) guidelines resulted in significantly worse outcomes for mothers and babies, according to data from nearly 30,000 women.
Previous studies of the relationship between gestational weight gain and maternal and neonatal outcomes have been limited by “small sample sizes, single sites, restricted reporting of outcomes, and a lack of racial-ethnic diversity,” Michelle A. Kominiarek, MD, of Northwestern University in Chicago and her colleagues wrote . To determine the effects of gestational weight gain on a large and more diverse population, the researchers conducted a secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network’s Assessment of Perinatal Excellence study. The findings were published in Obstetrics & Gynecology.
Gestational weight gain above the amount recommended by IOM guidelines was significantly associated with adverse outcomes in neonates, including macrosomia (adjusted odds ratio, 2.66), shoulder dystocia (aOR, 1.74), and neonatal hypoglycemia (aOR, 1.60).
In further multivariate analysis, adverse maternal outcomes associated with gestational weight gain above that recommended by the guidelines included hypertensive diseases of pregnancy for any parity (aOR, 1.84) and increased risk of cesarean delivery in nulliparous and multiparous women (aORs, 1.44 and 1.26, respectively).
Gestational weight gain below the recommended amount was associated with both spontaneous (aOR, 1.50) and indicated (aOR, 1.34) preterm birth. Weight gain above the guidelines was associated with a greater risk of indicated preterm birth only (aOR, 1.24).
The study population included 29,861 women at 25 hospitals over a 3-year period. Of these, 51% had gestational weight gains above the amount recommended by the IOM guidelines and 21% had gestational weight gains below it. The researchers calculated gestational weight gain by subtracting prepregnancy weight from delivery weight or, if prepregnancy weight was not available, by subtracting weight at the first prenatal visit at 13 weeks of gestation or earlier from delivery weight.
The study findings were limited by the use of self-reported prepregnancy weight and the possible effects of changes to the guidelines with respect to obese patients, the researchers said. However, the results support those from previous studies, and the “noted strengths include analysis of 29,861 women representative of the United States with rigorous ascertainment of outcomes and calculation of gestational weight gain to account for the wide range of gestational ages at delivery,” Dr. Kominiarek and her associates wrote.
Overall, the data support efforts to educate women on health behaviors and how gestational weight gain affects them and their infants, and additional research is needed to help women meet their goals for appropriate gestational weight, the researchers concluded.
SOURCE: Kominiarek MA et al. Obstet Gynecol. 2018 Oct;132(4):875-81.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Gestational weight gain or loss is a significant risk factor for adverse maternal and neonatal outcomes.
Major finding: Gestational weight gain above the recommended amount was significantly associated with adverse outcomes in neonates, including macrosomia (adjusted odds ratio, 2.66), shoulder dystocia (aOR, 1.74), and neonatal hypoglycemia (aOR, 1.60).
Study details: The data came from 29,861 women who delivered at 25 hospitals across the United States on randomly selected days during a 3-year period.
Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by various grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Research Resources.
Source: Kominiarek MA et al. Obstet Gynecol. 2018 Oct;132(4):875-81.
FDA review supports Nuplazid’s safety
Pimavanserin (Nuplazid) remains an acceptable treatment for the hallucinations and delusions associated with Parkinson’s disease, according to a statement issued by the Food and Drug Administration after the agency conducted a postmarketing review of deaths and serious adverse events associated with the drug.
“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings” associated with the drug, according to the Sept. 20 statement.
However, the FDA researchers identified prescribing patterns that might increase the risk of serious adverse events, such as the concomitant use of pimavanserin and other antipsychotic drugs or drugs that can cause QT prolongation. The QT prolongation risk is listed on the drug label, which also includes a Boxed Warning about increased mortality risk in elderly patients.
The FDA statement reminds clinicians to know the risks described in the label and to be aware that no other antipsychotics are currently approved for psychosis in Parkinson’s patients.
The review was prompted by the number of reports of serious adverse events and deaths associated with pimavanserin, based on data obtained from multiple sources including the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports, and data from published medical literature.
When conducting the review, the FDA considered several factors, including the fact that Parkinson’s disease patients have higher mortality in general because of older age, advanced disease, and other medical comorbidities. In addition, pimavanserin adverse events and deaths are more likely to be reported because the drug is distributed mainly through a patient-support program and specialty pharmacy. The FDA also found no pattern suggestive of a drug effect on causes of death in patients whose deaths were reported through FAERS.
“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” according to the FDA statement.
Pimavanserin (Nuplazid) remains an acceptable treatment for the hallucinations and delusions associated with Parkinson’s disease, according to a statement issued by the Food and Drug Administration after the agency conducted a postmarketing review of deaths and serious adverse events associated with the drug.
“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings” associated with the drug, according to the Sept. 20 statement.
However, the FDA researchers identified prescribing patterns that might increase the risk of serious adverse events, such as the concomitant use of pimavanserin and other antipsychotic drugs or drugs that can cause QT prolongation. The QT prolongation risk is listed on the drug label, which also includes a Boxed Warning about increased mortality risk in elderly patients.
The FDA statement reminds clinicians to know the risks described in the label and to be aware that no other antipsychotics are currently approved for psychosis in Parkinson’s patients.
The review was prompted by the number of reports of serious adverse events and deaths associated with pimavanserin, based on data obtained from multiple sources including the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports, and data from published medical literature.
When conducting the review, the FDA considered several factors, including the fact that Parkinson’s disease patients have higher mortality in general because of older age, advanced disease, and other medical comorbidities. In addition, pimavanserin adverse events and deaths are more likely to be reported because the drug is distributed mainly through a patient-support program and specialty pharmacy. The FDA also found no pattern suggestive of a drug effect on causes of death in patients whose deaths were reported through FAERS.
“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” according to the FDA statement.
Pimavanserin (Nuplazid) remains an acceptable treatment for the hallucinations and delusions associated with Parkinson’s disease, according to a statement issued by the Food and Drug Administration after the agency conducted a postmarketing review of deaths and serious adverse events associated with the drug.
“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings” associated with the drug, according to the Sept. 20 statement.
However, the FDA researchers identified prescribing patterns that might increase the risk of serious adverse events, such as the concomitant use of pimavanserin and other antipsychotic drugs or drugs that can cause QT prolongation. The QT prolongation risk is listed on the drug label, which also includes a Boxed Warning about increased mortality risk in elderly patients.
The FDA statement reminds clinicians to know the risks described in the label and to be aware that no other antipsychotics are currently approved for psychosis in Parkinson’s patients.
The review was prompted by the number of reports of serious adverse events and deaths associated with pimavanserin, based on data obtained from multiple sources including the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports, and data from published medical literature.
When conducting the review, the FDA considered several factors, including the fact that Parkinson’s disease patients have higher mortality in general because of older age, advanced disease, and other medical comorbidities. In addition, pimavanserin adverse events and deaths are more likely to be reported because the drug is distributed mainly through a patient-support program and specialty pharmacy. The FDA also found no pattern suggestive of a drug effect on causes of death in patients whose deaths were reported through FAERS.
“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” according to the FDA statement.
Opioid use predicts longer sleep latency in chronic pain patients
Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.
“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.
To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.
The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.
The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.
The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.
Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.
Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.
The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.
The researchers had no financial conflicts to disclose.
SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.
Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.
“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.
To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.
The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.
The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.
The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.
Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.
Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.
The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.
The researchers had no financial conflicts to disclose.
SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.
Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.
“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.
To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.
The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.
The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.
The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.
Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.
Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.
The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.
The researchers had no financial conflicts to disclose.
SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.
FROM SLEEP MEDICINE
Key clinical point: Adults taking opioids for chronic pain reported more difficulty falling asleep, compared with those who didn’t use opioids.
Major finding: Approximately one-third of adults with chronic pain reported using an opioid.
Study details: The data come from 144 adults who reported both insomnia and fibromyalgia.
Disclosures: The researchers had no financial conflicts to disclose.
Source: Miller M et al. Sleep Medicine. 2018. doi: 10.1016/j.sleep.2018.08.015.