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Also today, physical activity is tied to lower depression risk among older adults, high rates of prescription benzodiazepine observed in chronic liver disease, and rates of sexually transmitted infections are rising among U.S. teens who are sexually active.
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Also today, physical activity is tied to lower depression risk among older adults, high rates of prescription benzodiazepine observed in chronic liver disease, and rates of sexually transmitted infections are rising among U.S. teens who are sexually active.
Amazon Alexa
Apple Podcasts
Spotify
Also today, physical activity is tied to lower depression risk among older adults, high rates of prescription benzodiazepine observed in chronic liver disease, and rates of sexually transmitted infections are rising among U.S. teens who are sexually active.
Amazon Alexa
Apple Podcasts
Spotify
Can Probiotics Beat MRSA?
An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).
The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.
Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus (MRSA).
To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.
An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).
The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.
Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus (MRSA).
To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.
An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).
The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.
Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus (MRSA).
To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.
This month in the journal CHEST®
Editor’s picks
ORIGINAL RESEARCH
Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes.
By Dr. C. L. Ofstead, et al.
Lower Glucose Target Is Associated With Improved 30-Day Mortality in Cardiac and Cardiothoracic Patients.
By Dr. A. M. Hersh, et al.
Sarcoidosis Diagnostic Score: A Systematic Evaluation to Enhance the Diagnosis of Sarcoidosis.
By Dr. A. N. Bickett, et al.
EVIDENCE-BASED MEDICINE
Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report.
By Dr. G. Y. H. Lip, et al.
Editor’s picks
ORIGINAL RESEARCH
Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes.
By Dr. C. L. Ofstead, et al.
Lower Glucose Target Is Associated With Improved 30-Day Mortality in Cardiac and Cardiothoracic Patients.
By Dr. A. M. Hersh, et al.
Sarcoidosis Diagnostic Score: A Systematic Evaluation to Enhance the Diagnosis of Sarcoidosis.
By Dr. A. N. Bickett, et al.
EVIDENCE-BASED MEDICINE
Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report.
By Dr. G. Y. H. Lip, et al.
Editor’s picks
ORIGINAL RESEARCH
Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes.
By Dr. C. L. Ofstead, et al.
Lower Glucose Target Is Associated With Improved 30-Day Mortality in Cardiac and Cardiothoracic Patients.
By Dr. A. M. Hersh, et al.
Sarcoidosis Diagnostic Score: A Systematic Evaluation to Enhance the Diagnosis of Sarcoidosis.
By Dr. A. N. Bickett, et al.
EVIDENCE-BASED MEDICINE
Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report.
By Dr. G. Y. H. Lip, et al.
Financial burden of blood cancers in the U.S.
An analysis of more than 2,000 U.S. patients with blood cancers revealed an average healthcare cost of almost $157,000 in the first year after diagnosis.
Costs were highest for acute leukemia patients—almost triple the average for all blood cancers.
Out-of-pocket (OOP) costs were initially highest for acute leukemia patients. However, over time, OOP costs became highest for patients with multiple myeloma.
These results are included in a report commissioned by the Leukemia & Lymphoma Society and prepared by the actuarial firm Milliman.
The report is based on data from the Truven Health MarketScan commercial claims databases.
The cost figures are drawn from data for 2,332 patients, ages 18 to 64, who were diagnosed with blood cancer in 2014 and followed through 2016. This includes the following:
- 1,468 patients with lymphoma
- 286 with chronic leukemia
- 282 with multiple myeloma
- 148 with acute leukemia
- 148 with bone marrow disorders (myelodysplastic syndromes).
The average allowed spending—the amount paid by the payer and patient combined—in the first 12 months after diagnosis was:
- $156,845 overall
- $463,414 for acute leukemia
- $213,879 for multiple myeloma
- $133,744 for bone marrow disorders
- $130,545 for lymphoma
- $88,913 for chronic leukemia.
Differences in OOP costs were smaller, although OOP spending was 32% higher for acute leukemia patients than the overall average.
Average OOP costs—which include coinsurance, copay, and deductible—in the first 12 months after diagnosis were:
- $3,877 overall
- $5,147 for acute leukemia
- $4,849 for multiple myeloma
- $3,695 for lymphoma
- $3,480 for chronic leukemia
- $3,336 for bone marrow disorders.
Although OOP costs were initially highest for acute leukemia patients, over time, costs for multiple myeloma patients became the highest.
The average OOP costs in the month of diagnosis were $1,637 for acute leukemia patients and $1,210 for multiple myeloma patients.
The total accumulated OOP costs 3 years after diagnosis were $8,797 for acute leukemia and $9,127 for multiple myeloma. For the other blood cancers, the average 3-year accumulated OOP costs were under $7,800.
The Leukemia & Lymphoma Society received support from Pfizer, Genentech, and Amgen for this work.
An analysis of more than 2,000 U.S. patients with blood cancers revealed an average healthcare cost of almost $157,000 in the first year after diagnosis.
Costs were highest for acute leukemia patients—almost triple the average for all blood cancers.
Out-of-pocket (OOP) costs were initially highest for acute leukemia patients. However, over time, OOP costs became highest for patients with multiple myeloma.
These results are included in a report commissioned by the Leukemia & Lymphoma Society and prepared by the actuarial firm Milliman.
The report is based on data from the Truven Health MarketScan commercial claims databases.
The cost figures are drawn from data for 2,332 patients, ages 18 to 64, who were diagnosed with blood cancer in 2014 and followed through 2016. This includes the following:
- 1,468 patients with lymphoma
- 286 with chronic leukemia
- 282 with multiple myeloma
- 148 with acute leukemia
- 148 with bone marrow disorders (myelodysplastic syndromes).
The average allowed spending—the amount paid by the payer and patient combined—in the first 12 months after diagnosis was:
- $156,845 overall
- $463,414 for acute leukemia
- $213,879 for multiple myeloma
- $133,744 for bone marrow disorders
- $130,545 for lymphoma
- $88,913 for chronic leukemia.
Differences in OOP costs were smaller, although OOP spending was 32% higher for acute leukemia patients than the overall average.
Average OOP costs—which include coinsurance, copay, and deductible—in the first 12 months after diagnosis were:
- $3,877 overall
- $5,147 for acute leukemia
- $4,849 for multiple myeloma
- $3,695 for lymphoma
- $3,480 for chronic leukemia
- $3,336 for bone marrow disorders.
Although OOP costs were initially highest for acute leukemia patients, over time, costs for multiple myeloma patients became the highest.
The average OOP costs in the month of diagnosis were $1,637 for acute leukemia patients and $1,210 for multiple myeloma patients.
The total accumulated OOP costs 3 years after diagnosis were $8,797 for acute leukemia and $9,127 for multiple myeloma. For the other blood cancers, the average 3-year accumulated OOP costs were under $7,800.
The Leukemia & Lymphoma Society received support from Pfizer, Genentech, and Amgen for this work.
An analysis of more than 2,000 U.S. patients with blood cancers revealed an average healthcare cost of almost $157,000 in the first year after diagnosis.
Costs were highest for acute leukemia patients—almost triple the average for all blood cancers.
Out-of-pocket (OOP) costs were initially highest for acute leukemia patients. However, over time, OOP costs became highest for patients with multiple myeloma.
These results are included in a report commissioned by the Leukemia & Lymphoma Society and prepared by the actuarial firm Milliman.
The report is based on data from the Truven Health MarketScan commercial claims databases.
The cost figures are drawn from data for 2,332 patients, ages 18 to 64, who were diagnosed with blood cancer in 2014 and followed through 2016. This includes the following:
- 1,468 patients with lymphoma
- 286 with chronic leukemia
- 282 with multiple myeloma
- 148 with acute leukemia
- 148 with bone marrow disorders (myelodysplastic syndromes).
The average allowed spending—the amount paid by the payer and patient combined—in the first 12 months after diagnosis was:
- $156,845 overall
- $463,414 for acute leukemia
- $213,879 for multiple myeloma
- $133,744 for bone marrow disorders
- $130,545 for lymphoma
- $88,913 for chronic leukemia.
Differences in OOP costs were smaller, although OOP spending was 32% higher for acute leukemia patients than the overall average.
Average OOP costs—which include coinsurance, copay, and deductible—in the first 12 months after diagnosis were:
- $3,877 overall
- $5,147 for acute leukemia
- $4,849 for multiple myeloma
- $3,695 for lymphoma
- $3,480 for chronic leukemia
- $3,336 for bone marrow disorders.
Although OOP costs were initially highest for acute leukemia patients, over time, costs for multiple myeloma patients became the highest.
The average OOP costs in the month of diagnosis were $1,637 for acute leukemia patients and $1,210 for multiple myeloma patients.
The total accumulated OOP costs 3 years after diagnosis were $8,797 for acute leukemia and $9,127 for multiple myeloma. For the other blood cancers, the average 3-year accumulated OOP costs were under $7,800.
The Leukemia & Lymphoma Society received support from Pfizer, Genentech, and Amgen for this work.
Nearly half of infants don’t sleep through the night at 1 year
Just over half of infants get 8 hours of uninterrupted sleep at 12 months of age, an analysis of findings from a longitudinal birth cohort study showed.
It also found that whether an infant sleeps through night has no significant associated with any variations in mental or psychomotor development.
However, the rate of breastfeeding was significantly higher among infants who did not sleep through the night, investigators said in their report on the analysis, published in Pediatrics.
Being informed about the normal development of the sleep-wake cycle could be reassuring for parents, according to the authors, who said that new mothers tend to be “greatly surprised” by the sleep disturbance and exhaustion they experience.
“Keeping in mind the wide variability in the age when an infant starts to sleep through the night, expectations for early sleep consolidation could be moderated,” said Marie-Hélène Pennestri, PhD, of the Department of Educational and Counselling Psychology at McGill University, Montreal, and her coauthors.
Dr. Pennestri and colleagues reported on 388 mother-infant dyads in a longitudinal birth cohort study called Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN). Pregnant mothers were recruited from obstetric clinics in Canada. When their infants reached the age of 6 and 12 months, the mothers responded to questionnaires about sleep habits.
At 6 months, 62.4% of infants attained at least 6 hours of uninterrupted sleep, mothers reported, while 43.0% had reached 8 hours, the mothers reported. By 12 months of age, 72.1% of the infants attained 6 hours, and 56.6% attained 8 hours.
There were no associations between sleeping through the night and concurrent mental or psychomotor development, as measured by the Bayley Scales of Infant Development II at both 6 or 12 months of age, with P values greater than 0.05, investigators reported.
A similar lack of association between uninterrupted sleep and development or maternal mood was seen in a follow-up measurement at 36 months of age.
Sleeping through the night was likewise not associated with maternal mood, assessed using a depression scale with items that reflected symptom frequency in the previous week. “This is noteworthy because maternal sleep deprivation is often invoked to support the introduction of early behavioral interventions,” investigators said in a discussion of the results.
By contrast, sleeping through the night was linked to lower rates of breastfeeding as reported by mothers on retrospective questionnaires administered at both 6 and 12 months. At 12 months of age, 22.1% of infants sleeping through the night were breastfed, compared to 47.1% of infants not sleeping through the night (P less than 0.0001), Dr. Pennestri and colleagues reported.
However, that breastfeeding observation needs to be further investigated, according to the authors.
“The results of our study do not allow for the drawing of any causality between not sleeping through the night and breastfeeding,” they wrote.
Dr. Pennestri and coauthors said they had no financial relationships or potential conflicts of interest to disclose relevant to their report. They reported funding from the Ludmer Center for Neuroinformatics and Mental Health, Canadian Institutes of Health Research, and several other research institutions.
SOURCE: Pennestri MH, et al. Pediatrics. 2018;142(6):e20174330.
Multiple studies looking at whether sleep matters in infants and no clear consensus, the answer going forward may depend on the primary outcome evaluated, Jodi A. Mindell, PhD, and Melisa Moore, PhD
“The jury is still out,” Dr. Mindell and Dr. Moore wrote in an editorial discussing the present study, which like others before it have found no relationship or limited relationships between infant sleep and later development.
On the other hand, several studies have found that fragmented sleep is associated with negative outcomes with respect to development, the editorial authors said.
One reason for the lack of agreement between studies may be differences in measurement, as the studies to date have used a variety of different measures for both sleep and development, they said. Moreover, the age of infants varies across studies, as does their location, raising the possibility that cultural differences may account for the disparate results.
Beyond that, they added, there is no single primary sleep outcome that has been applied, with some studies looking at sleep duration, and others looking at sleep consolidation, longest stretch of sleep, or duration of night wakings.
What some of these studies may miss is that many other factors may influence development, including genetics, nutrition, parental education, and interaction between child and parent.
“Sleep may be a drop in the bucket for broad development but, instead, have a more significant impact on next-day functioning,” they said.
Thus, the editorialists propose that future studies evaluate function instead of development to assess the importance of infant sleep, as some studies to date have shown that sleep in infants is important for language learning and memory consolidation.
“Rather than investigate gross development, we propose that day-to-day functioning and skill development may be better indicators of the impact of sleep on development in early childhood,” they concluded.
Dr. Mindell, and Dr. Moore are with the Sleep Center, Children’s Hospital of Philadelphia. Their editorial appears in Pediatrics. Dr. Mindell reported she is a consultant for Johnson & Johnson Consumer. Dr. Moore reported no financial relationships relevant to the article.
Multiple studies looking at whether sleep matters in infants and no clear consensus, the answer going forward may depend on the primary outcome evaluated, Jodi A. Mindell, PhD, and Melisa Moore, PhD
“The jury is still out,” Dr. Mindell and Dr. Moore wrote in an editorial discussing the present study, which like others before it have found no relationship or limited relationships between infant sleep and later development.
On the other hand, several studies have found that fragmented sleep is associated with negative outcomes with respect to development, the editorial authors said.
One reason for the lack of agreement between studies may be differences in measurement, as the studies to date have used a variety of different measures for both sleep and development, they said. Moreover, the age of infants varies across studies, as does their location, raising the possibility that cultural differences may account for the disparate results.
Beyond that, they added, there is no single primary sleep outcome that has been applied, with some studies looking at sleep duration, and others looking at sleep consolidation, longest stretch of sleep, or duration of night wakings.
What some of these studies may miss is that many other factors may influence development, including genetics, nutrition, parental education, and interaction between child and parent.
“Sleep may be a drop in the bucket for broad development but, instead, have a more significant impact on next-day functioning,” they said.
Thus, the editorialists propose that future studies evaluate function instead of development to assess the importance of infant sleep, as some studies to date have shown that sleep in infants is important for language learning and memory consolidation.
“Rather than investigate gross development, we propose that day-to-day functioning and skill development may be better indicators of the impact of sleep on development in early childhood,” they concluded.
Dr. Mindell, and Dr. Moore are with the Sleep Center, Children’s Hospital of Philadelphia. Their editorial appears in Pediatrics. Dr. Mindell reported she is a consultant for Johnson & Johnson Consumer. Dr. Moore reported no financial relationships relevant to the article.
Multiple studies looking at whether sleep matters in infants and no clear consensus, the answer going forward may depend on the primary outcome evaluated, Jodi A. Mindell, PhD, and Melisa Moore, PhD
“The jury is still out,” Dr. Mindell and Dr. Moore wrote in an editorial discussing the present study, which like others before it have found no relationship or limited relationships between infant sleep and later development.
On the other hand, several studies have found that fragmented sleep is associated with negative outcomes with respect to development, the editorial authors said.
One reason for the lack of agreement between studies may be differences in measurement, as the studies to date have used a variety of different measures for both sleep and development, they said. Moreover, the age of infants varies across studies, as does their location, raising the possibility that cultural differences may account for the disparate results.
Beyond that, they added, there is no single primary sleep outcome that has been applied, with some studies looking at sleep duration, and others looking at sleep consolidation, longest stretch of sleep, or duration of night wakings.
What some of these studies may miss is that many other factors may influence development, including genetics, nutrition, parental education, and interaction between child and parent.
“Sleep may be a drop in the bucket for broad development but, instead, have a more significant impact on next-day functioning,” they said.
Thus, the editorialists propose that future studies evaluate function instead of development to assess the importance of infant sleep, as some studies to date have shown that sleep in infants is important for language learning and memory consolidation.
“Rather than investigate gross development, we propose that day-to-day functioning and skill development may be better indicators of the impact of sleep on development in early childhood,” they concluded.
Dr. Mindell, and Dr. Moore are with the Sleep Center, Children’s Hospital of Philadelphia. Their editorial appears in Pediatrics. Dr. Mindell reported she is a consultant for Johnson & Johnson Consumer. Dr. Moore reported no financial relationships relevant to the article.
Just over half of infants get 8 hours of uninterrupted sleep at 12 months of age, an analysis of findings from a longitudinal birth cohort study showed.
It also found that whether an infant sleeps through night has no significant associated with any variations in mental or psychomotor development.
However, the rate of breastfeeding was significantly higher among infants who did not sleep through the night, investigators said in their report on the analysis, published in Pediatrics.
Being informed about the normal development of the sleep-wake cycle could be reassuring for parents, according to the authors, who said that new mothers tend to be “greatly surprised” by the sleep disturbance and exhaustion they experience.
“Keeping in mind the wide variability in the age when an infant starts to sleep through the night, expectations for early sleep consolidation could be moderated,” said Marie-Hélène Pennestri, PhD, of the Department of Educational and Counselling Psychology at McGill University, Montreal, and her coauthors.
Dr. Pennestri and colleagues reported on 388 mother-infant dyads in a longitudinal birth cohort study called Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN). Pregnant mothers were recruited from obstetric clinics in Canada. When their infants reached the age of 6 and 12 months, the mothers responded to questionnaires about sleep habits.
At 6 months, 62.4% of infants attained at least 6 hours of uninterrupted sleep, mothers reported, while 43.0% had reached 8 hours, the mothers reported. By 12 months of age, 72.1% of the infants attained 6 hours, and 56.6% attained 8 hours.
There were no associations between sleeping through the night and concurrent mental or psychomotor development, as measured by the Bayley Scales of Infant Development II at both 6 or 12 months of age, with P values greater than 0.05, investigators reported.
A similar lack of association between uninterrupted sleep and development or maternal mood was seen in a follow-up measurement at 36 months of age.
Sleeping through the night was likewise not associated with maternal mood, assessed using a depression scale with items that reflected symptom frequency in the previous week. “This is noteworthy because maternal sleep deprivation is often invoked to support the introduction of early behavioral interventions,” investigators said in a discussion of the results.
By contrast, sleeping through the night was linked to lower rates of breastfeeding as reported by mothers on retrospective questionnaires administered at both 6 and 12 months. At 12 months of age, 22.1% of infants sleeping through the night were breastfed, compared to 47.1% of infants not sleeping through the night (P less than 0.0001), Dr. Pennestri and colleagues reported.
However, that breastfeeding observation needs to be further investigated, according to the authors.
“The results of our study do not allow for the drawing of any causality between not sleeping through the night and breastfeeding,” they wrote.
Dr. Pennestri and coauthors said they had no financial relationships or potential conflicts of interest to disclose relevant to their report. They reported funding from the Ludmer Center for Neuroinformatics and Mental Health, Canadian Institutes of Health Research, and several other research institutions.
SOURCE: Pennestri MH, et al. Pediatrics. 2018;142(6):e20174330.
Just over half of infants get 8 hours of uninterrupted sleep at 12 months of age, an analysis of findings from a longitudinal birth cohort study showed.
It also found that whether an infant sleeps through night has no significant associated with any variations in mental or psychomotor development.
However, the rate of breastfeeding was significantly higher among infants who did not sleep through the night, investigators said in their report on the analysis, published in Pediatrics.
Being informed about the normal development of the sleep-wake cycle could be reassuring for parents, according to the authors, who said that new mothers tend to be “greatly surprised” by the sleep disturbance and exhaustion they experience.
“Keeping in mind the wide variability in the age when an infant starts to sleep through the night, expectations for early sleep consolidation could be moderated,” said Marie-Hélène Pennestri, PhD, of the Department of Educational and Counselling Psychology at McGill University, Montreal, and her coauthors.
Dr. Pennestri and colleagues reported on 388 mother-infant dyads in a longitudinal birth cohort study called Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN). Pregnant mothers were recruited from obstetric clinics in Canada. When their infants reached the age of 6 and 12 months, the mothers responded to questionnaires about sleep habits.
At 6 months, 62.4% of infants attained at least 6 hours of uninterrupted sleep, mothers reported, while 43.0% had reached 8 hours, the mothers reported. By 12 months of age, 72.1% of the infants attained 6 hours, and 56.6% attained 8 hours.
There were no associations between sleeping through the night and concurrent mental or psychomotor development, as measured by the Bayley Scales of Infant Development II at both 6 or 12 months of age, with P values greater than 0.05, investigators reported.
A similar lack of association between uninterrupted sleep and development or maternal mood was seen in a follow-up measurement at 36 months of age.
Sleeping through the night was likewise not associated with maternal mood, assessed using a depression scale with items that reflected symptom frequency in the previous week. “This is noteworthy because maternal sleep deprivation is often invoked to support the introduction of early behavioral interventions,” investigators said in a discussion of the results.
By contrast, sleeping through the night was linked to lower rates of breastfeeding as reported by mothers on retrospective questionnaires administered at both 6 and 12 months. At 12 months of age, 22.1% of infants sleeping through the night were breastfed, compared to 47.1% of infants not sleeping through the night (P less than 0.0001), Dr. Pennestri and colleagues reported.
However, that breastfeeding observation needs to be further investigated, according to the authors.
“The results of our study do not allow for the drawing of any causality between not sleeping through the night and breastfeeding,” they wrote.
Dr. Pennestri and coauthors said they had no financial relationships or potential conflicts of interest to disclose relevant to their report. They reported funding from the Ludmer Center for Neuroinformatics and Mental Health, Canadian Institutes of Health Research, and several other research institutions.
SOURCE: Pennestri MH, et al. Pediatrics. 2018;142(6):e20174330.
FROM PEDIATRICS
Key clinical point: Sleeping through the night in infancy was not significantly associated with any variations in development or maternal mood.
Major finding: There were no associations between 6 or 8 hours of uninterrupted sleep and concurrent mental or psychomotor development or reported depressive symptoms.
Study details: An analysis of 388 mother-infant dyads in a longitudinal birth cohort study.
Disclosures: Authors said they had no financial relationships or potential conflicts of interest to disclose.
Source: Pennestri MH, et al. Pediatrics. 2018;142(6):e20174330.
The Unintended Off-road Experience
ANSWER
A moderate amount of soft-tissue swelling is evident. There is also a fracture of the distal radius and an avulsion fracture of the triquetrum. The latter is the second most commonly fractured carpal bone after the scaphoid. Triquetral fractures usually result from a hyperflexion injury.
The patient’s wrist was immobilized in a splint, and referral to a hand surgeon was coordinated.
ANSWER
A moderate amount of soft-tissue swelling is evident. There is also a fracture of the distal radius and an avulsion fracture of the triquetrum. The latter is the second most commonly fractured carpal bone after the scaphoid. Triquetral fractures usually result from a hyperflexion injury.
The patient’s wrist was immobilized in a splint, and referral to a hand surgeon was coordinated.
ANSWER
A moderate amount of soft-tissue swelling is evident. There is also a fracture of the distal radius and an avulsion fracture of the triquetrum. The latter is the second most commonly fractured carpal bone after the scaphoid. Triquetral fractures usually result from a hyperflexion injury.
The patient’s wrist was immobilized in a splint, and referral to a hand surgeon was coordinated.
A 70-year-old woman is brought to the emergency department by EMS after being involved in a motor vehicle collision. She was a restrained driver in a vehicle that was hit by a tractor-trailer, causing her vehicle to go off the road and hit the guardrail. She does not recall if the airbag deployed, and she believes she momentarily lost consciousness. She is complaining of pain in the head and the right wrist.
Her medical history is significant for mild (controlled) hypertension. Primary survey reveals an elderly female who is awake, alert, and oriented and in mild distress. Her vital signs are stable.
The patient has a small laceration on her face. Her right wrist is moderately swollen, and she has decreased range of motion. There is also moderate tenderness to palpation. Pulses are good, as is capillary refill time in the fingernail bed.
Radiograph of the right wrist is obtained (oblique view shown). What is your impression?
PIONEER-HF secures place for sacubitril/valsartan in this heart failure doc’s practice
CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.
That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.
, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.
Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”
To find out why, watch the complete interview.
CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.
That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.
, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.
Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”
To find out why, watch the complete interview.
CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.
That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.
, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.
Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”
To find out why, watch the complete interview.
REPORTING FROM AHA 2018
Revised U.S. cholesterol guidelines promote personalized risk assessment
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Vitamin D, fish oil circling the drain for primary prevention
CHICAGO – In what will surely come as a major disappointment to many millions of nutritional supplement enthusiasts, the daily use of vitamin D3 and/or omega-3 fatty acid capsules for a median of 5.3 years did not result in a lower incidence of invasive cancers or cardiovascular events than placebo in nearly 26,000 average-risk Americans who participated in the VITAL trial, JoAnn E. Manson, MD, reported at the American Heart Association scientific sessions.
VITAL (the Vitamin D and Omega-3 Trial) featured a 2x2 factorial design in which 25,871 subjects, including 5,016 black participants, were randomized in double-blind fashion to either vitamin D3, also known as cholecalciferol, at 2,000 IU/day and/or 1 g/day of omega-3 fatty acid, or placebo. The men had to be at least 50 years old, the women 55, and none had a baseline history of cardiovascular disease or invasive cancer. Their mean age was 67. Study pill adherence exceeded 83% over the course of 5.3 years.
This major study, funded by the National Institutes of Health, was designed to answer the question of whether two relatively inexpensive supplements with plausible mechanisms of potential benefit could be harnessed as effective agents for primary prevention of the two leading causes of death in the United States.
The simple answer turned out to be no. Invasive cancer of any type occurred in 793 patients in the vitamin D group and 824 placebo-treated controls, for a nonsignificant hazard ratio of 0.96. Major cardiovascular events – a composite of MI, stroke, or cardiovascular mortality – occurred in 396 and 409 patients, respectively, for a hazard ratio of 0.97.
Similarly, invasive cancer was diagnosed in 820 subjects in the omega-3 fatty acid group and 797 controls, while major cardiovascular events occurred in 386 patients taking fish oil and 419 on placebo. Again, the between-group differences were nonsignificant, noted Dr. Manson, chief of the division of preventive medicine and Brigham and Women’s Hospital and professor of medicine and women’s health at Harvard Medical School, Boston.
Buried within this vast data set were a few intriguing bright spots. For example, the prespecified secondary endpoint of total MIs was significantly reduced by 28% in patients using omega-3 fatty acid compared with placebo. In nonprespecified exploratory analyses, the risk of PCI was decreased by 22% in the omega-3 fatty acid group and total coronary heart disease events - a composite of MI, revascularization, or death due to coronary heart disease – was reduced by 17%. In black subjects, the use of omega-3 fatty acids reduced the risk of MIs by 77%.
Dietary fish consumption interacted with the effects of omega-3 supplementation. Subjects in the omega-3 group who ate less than the median 1.5 servings of fish per week had a statistically significant 19% relative risk reduction in major cardiovascular events and 40% fewer MIs than with placebo. In contrast, subjects who ate 1.5 or more fish servings derived no benefit from omega-3 supplements.
The most noteworthy finding in the vitamin D group was that, after excluding the first 2 years of follow-up, they had a 25% reduction in cancer mortality compared with controls.
However, Dr. Manson cautioned that these subgroup analyses should be interpreted with caution.
Discussant Jane Armitage, MD, went further, emphasizing that the primary study endpoints of invasive cancer and major cardiovascular events were negative for both vitamin D and fish oil.
“To drill down into the secondary endpoints is of some concern because I think there is often the risk of getting spurious results,” said Dr. Armitage, professor of clinical trials and epidemiology at the University of Oxford (England).
“I think the primary result that universal supplementation with vitamin D in a primary prevention population has not been shown to be beneficial is a robust result, and these other results need to be seen as hypothesis-generating,” according to Dr. Armitage.
She added that she thinks the VITAL trial is practice-changing.
“I think the general recommendation to take vitamin D is not supported by this paper,” she said.
The same holds true for omega-3 fatty acid supplementation based on the VITAL results, Dr. Armitage continued. She noted that the VITAL findings are consistent with a recent meta-analysis of 10 large trials of omega-3 which found no benefit in nearly 78,000 high-cardiovascular-risk subjects (JAMA Cardiol. 2018 Mar 1;3[3]:225-234).
VITAL vs. REDUCE-IT
The negative results in VITAL stood in sharp contrast to the findings of the REDUCE-IT trial, presented at the same late-breaker session by Deepak Bhatt, MD, of Harvard Medical School. In REDUCE-IT, icosapent ethyl, another fish-derived product, reduced major cardiovascular events by 25% in a study of more than 8,000 high-cardiovascular-risk patients with elevated triglycerides.
Why the difference in outcomes? Among the proposed explanations were that participants in VITAL got 1 g/day of omega-3 while those in REDUCE-IT got a much higher dose of 4 g/day of iscosapent ethyl, the REDUCE-IT population was at much higher cardiovascular risk, and icosapent ethyl has a mechanism of action that’s distinct from that of conventional fish oil products.
Dr. Manson said numerous ancillary studies from VITAL are underway and will begin appearing soon. These will look at the impact of vitamin D and fish oil supplementation on cognitive function, hypertension, atrial fibrillation, autoimmune disorders, bone health, depression, kidney disease, and other issues.
Simultaneously with her presentation at the AHA scientific sessions, the VITAL results were published online (N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa1809944 and 10.1056/NEJMoa1811403).
The study was sponsored by the National Institutes of Health. The presenter reported having no financial conflicts.
SOURCE: Manson JE. AHA Abstr. #19539
CHICAGO – In what will surely come as a major disappointment to many millions of nutritional supplement enthusiasts, the daily use of vitamin D3 and/or omega-3 fatty acid capsules for a median of 5.3 years did not result in a lower incidence of invasive cancers or cardiovascular events than placebo in nearly 26,000 average-risk Americans who participated in the VITAL trial, JoAnn E. Manson, MD, reported at the American Heart Association scientific sessions.
VITAL (the Vitamin D and Omega-3 Trial) featured a 2x2 factorial design in which 25,871 subjects, including 5,016 black participants, were randomized in double-blind fashion to either vitamin D3, also known as cholecalciferol, at 2,000 IU/day and/or 1 g/day of omega-3 fatty acid, or placebo. The men had to be at least 50 years old, the women 55, and none had a baseline history of cardiovascular disease or invasive cancer. Their mean age was 67. Study pill adherence exceeded 83% over the course of 5.3 years.
This major study, funded by the National Institutes of Health, was designed to answer the question of whether two relatively inexpensive supplements with plausible mechanisms of potential benefit could be harnessed as effective agents for primary prevention of the two leading causes of death in the United States.
The simple answer turned out to be no. Invasive cancer of any type occurred in 793 patients in the vitamin D group and 824 placebo-treated controls, for a nonsignificant hazard ratio of 0.96. Major cardiovascular events – a composite of MI, stroke, or cardiovascular mortality – occurred in 396 and 409 patients, respectively, for a hazard ratio of 0.97.
Similarly, invasive cancer was diagnosed in 820 subjects in the omega-3 fatty acid group and 797 controls, while major cardiovascular events occurred in 386 patients taking fish oil and 419 on placebo. Again, the between-group differences were nonsignificant, noted Dr. Manson, chief of the division of preventive medicine and Brigham and Women’s Hospital and professor of medicine and women’s health at Harvard Medical School, Boston.
Buried within this vast data set were a few intriguing bright spots. For example, the prespecified secondary endpoint of total MIs was significantly reduced by 28% in patients using omega-3 fatty acid compared with placebo. In nonprespecified exploratory analyses, the risk of PCI was decreased by 22% in the omega-3 fatty acid group and total coronary heart disease events - a composite of MI, revascularization, or death due to coronary heart disease – was reduced by 17%. In black subjects, the use of omega-3 fatty acids reduced the risk of MIs by 77%.
Dietary fish consumption interacted with the effects of omega-3 supplementation. Subjects in the omega-3 group who ate less than the median 1.5 servings of fish per week had a statistically significant 19% relative risk reduction in major cardiovascular events and 40% fewer MIs than with placebo. In contrast, subjects who ate 1.5 or more fish servings derived no benefit from omega-3 supplements.
The most noteworthy finding in the vitamin D group was that, after excluding the first 2 years of follow-up, they had a 25% reduction in cancer mortality compared with controls.
However, Dr. Manson cautioned that these subgroup analyses should be interpreted with caution.
Discussant Jane Armitage, MD, went further, emphasizing that the primary study endpoints of invasive cancer and major cardiovascular events were negative for both vitamin D and fish oil.
“To drill down into the secondary endpoints is of some concern because I think there is often the risk of getting spurious results,” said Dr. Armitage, professor of clinical trials and epidemiology at the University of Oxford (England).
“I think the primary result that universal supplementation with vitamin D in a primary prevention population has not been shown to be beneficial is a robust result, and these other results need to be seen as hypothesis-generating,” according to Dr. Armitage.
She added that she thinks the VITAL trial is practice-changing.
“I think the general recommendation to take vitamin D is not supported by this paper,” she said.
The same holds true for omega-3 fatty acid supplementation based on the VITAL results, Dr. Armitage continued. She noted that the VITAL findings are consistent with a recent meta-analysis of 10 large trials of omega-3 which found no benefit in nearly 78,000 high-cardiovascular-risk subjects (JAMA Cardiol. 2018 Mar 1;3[3]:225-234).
VITAL vs. REDUCE-IT
The negative results in VITAL stood in sharp contrast to the findings of the REDUCE-IT trial, presented at the same late-breaker session by Deepak Bhatt, MD, of Harvard Medical School. In REDUCE-IT, icosapent ethyl, another fish-derived product, reduced major cardiovascular events by 25% in a study of more than 8,000 high-cardiovascular-risk patients with elevated triglycerides.
Why the difference in outcomes? Among the proposed explanations were that participants in VITAL got 1 g/day of omega-3 while those in REDUCE-IT got a much higher dose of 4 g/day of iscosapent ethyl, the REDUCE-IT population was at much higher cardiovascular risk, and icosapent ethyl has a mechanism of action that’s distinct from that of conventional fish oil products.
Dr. Manson said numerous ancillary studies from VITAL are underway and will begin appearing soon. These will look at the impact of vitamin D and fish oil supplementation on cognitive function, hypertension, atrial fibrillation, autoimmune disorders, bone health, depression, kidney disease, and other issues.
Simultaneously with her presentation at the AHA scientific sessions, the VITAL results were published online (N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa1809944 and 10.1056/NEJMoa1811403).
The study was sponsored by the National Institutes of Health. The presenter reported having no financial conflicts.
SOURCE: Manson JE. AHA Abstr. #19539
CHICAGO – In what will surely come as a major disappointment to many millions of nutritional supplement enthusiasts, the daily use of vitamin D3 and/or omega-3 fatty acid capsules for a median of 5.3 years did not result in a lower incidence of invasive cancers or cardiovascular events than placebo in nearly 26,000 average-risk Americans who participated in the VITAL trial, JoAnn E. Manson, MD, reported at the American Heart Association scientific sessions.
VITAL (the Vitamin D and Omega-3 Trial) featured a 2x2 factorial design in which 25,871 subjects, including 5,016 black participants, were randomized in double-blind fashion to either vitamin D3, also known as cholecalciferol, at 2,000 IU/day and/or 1 g/day of omega-3 fatty acid, or placebo. The men had to be at least 50 years old, the women 55, and none had a baseline history of cardiovascular disease or invasive cancer. Their mean age was 67. Study pill adherence exceeded 83% over the course of 5.3 years.
This major study, funded by the National Institutes of Health, was designed to answer the question of whether two relatively inexpensive supplements with plausible mechanisms of potential benefit could be harnessed as effective agents for primary prevention of the two leading causes of death in the United States.
The simple answer turned out to be no. Invasive cancer of any type occurred in 793 patients in the vitamin D group and 824 placebo-treated controls, for a nonsignificant hazard ratio of 0.96. Major cardiovascular events – a composite of MI, stroke, or cardiovascular mortality – occurred in 396 and 409 patients, respectively, for a hazard ratio of 0.97.
Similarly, invasive cancer was diagnosed in 820 subjects in the omega-3 fatty acid group and 797 controls, while major cardiovascular events occurred in 386 patients taking fish oil and 419 on placebo. Again, the between-group differences were nonsignificant, noted Dr. Manson, chief of the division of preventive medicine and Brigham and Women’s Hospital and professor of medicine and women’s health at Harvard Medical School, Boston.
Buried within this vast data set were a few intriguing bright spots. For example, the prespecified secondary endpoint of total MIs was significantly reduced by 28% in patients using omega-3 fatty acid compared with placebo. In nonprespecified exploratory analyses, the risk of PCI was decreased by 22% in the omega-3 fatty acid group and total coronary heart disease events - a composite of MI, revascularization, or death due to coronary heart disease – was reduced by 17%. In black subjects, the use of omega-3 fatty acids reduced the risk of MIs by 77%.
Dietary fish consumption interacted with the effects of omega-3 supplementation. Subjects in the omega-3 group who ate less than the median 1.5 servings of fish per week had a statistically significant 19% relative risk reduction in major cardiovascular events and 40% fewer MIs than with placebo. In contrast, subjects who ate 1.5 or more fish servings derived no benefit from omega-3 supplements.
The most noteworthy finding in the vitamin D group was that, after excluding the first 2 years of follow-up, they had a 25% reduction in cancer mortality compared with controls.
However, Dr. Manson cautioned that these subgroup analyses should be interpreted with caution.
Discussant Jane Armitage, MD, went further, emphasizing that the primary study endpoints of invasive cancer and major cardiovascular events were negative for both vitamin D and fish oil.
“To drill down into the secondary endpoints is of some concern because I think there is often the risk of getting spurious results,” said Dr. Armitage, professor of clinical trials and epidemiology at the University of Oxford (England).
“I think the primary result that universal supplementation with vitamin D in a primary prevention population has not been shown to be beneficial is a robust result, and these other results need to be seen as hypothesis-generating,” according to Dr. Armitage.
She added that she thinks the VITAL trial is practice-changing.
“I think the general recommendation to take vitamin D is not supported by this paper,” she said.
The same holds true for omega-3 fatty acid supplementation based on the VITAL results, Dr. Armitage continued. She noted that the VITAL findings are consistent with a recent meta-analysis of 10 large trials of omega-3 which found no benefit in nearly 78,000 high-cardiovascular-risk subjects (JAMA Cardiol. 2018 Mar 1;3[3]:225-234).
VITAL vs. REDUCE-IT
The negative results in VITAL stood in sharp contrast to the findings of the REDUCE-IT trial, presented at the same late-breaker session by Deepak Bhatt, MD, of Harvard Medical School. In REDUCE-IT, icosapent ethyl, another fish-derived product, reduced major cardiovascular events by 25% in a study of more than 8,000 high-cardiovascular-risk patients with elevated triglycerides.
Why the difference in outcomes? Among the proposed explanations were that participants in VITAL got 1 g/day of omega-3 while those in REDUCE-IT got a much higher dose of 4 g/day of iscosapent ethyl, the REDUCE-IT population was at much higher cardiovascular risk, and icosapent ethyl has a mechanism of action that’s distinct from that of conventional fish oil products.
Dr. Manson said numerous ancillary studies from VITAL are underway and will begin appearing soon. These will look at the impact of vitamin D and fish oil supplementation on cognitive function, hypertension, atrial fibrillation, autoimmune disorders, bone health, depression, kidney disease, and other issues.
Simultaneously with her presentation at the AHA scientific sessions, the VITAL results were published online (N Engl J Med. 2018 Nov 10; doi: 10.1056/NEJMoa1809944 and 10.1056/NEJMoa1811403).
The study was sponsored by the National Institutes of Health. The presenter reported having no financial conflicts.
SOURCE: Manson JE. AHA Abstr. #19539
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The primary cancer and cardiovascular outcomes were unaffected by either supplement in the VITAL study.
Study details: VITAL was a randomized, double-blind trial in which nearly 26,000 middle-age or older Americans at average cardiovascular risk were assigned to vitamin D3, omega-3 fatty acid, and placebo in a 2x2 factorial design and followed prospectively for a median of 5.3 years.
Disclosures: The study was sponsored by the National Institutes of Health. The presenter reported having no financial conflicts.
Source: Manson JE. AHA 2018 Abst. #19539.
New private online community for SVS members
The Society for Vascular Surgery is creating a private online community, SVSConnect, with a number of resources for SVS members and their peers. This new collaborative online community will let members connect and engage with, and learn from, fellow members and peers on an infinite number of topics. It is expected to launch by late 2018. Users will enjoy a member directory search, forums, mentor match programs and resource sharing. More information will be communicated to members soon via Pulse newsletters, emails and the SVS Website.
The Society for Vascular Surgery is creating a private online community, SVSConnect, with a number of resources for SVS members and their peers. This new collaborative online community will let members connect and engage with, and learn from, fellow members and peers on an infinite number of topics. It is expected to launch by late 2018. Users will enjoy a member directory search, forums, mentor match programs and resource sharing. More information will be communicated to members soon via Pulse newsletters, emails and the SVS Website.
The Society for Vascular Surgery is creating a private online community, SVSConnect, with a number of resources for SVS members and their peers. This new collaborative online community will let members connect and engage with, and learn from, fellow members and peers on an infinite number of topics. It is expected to launch by late 2018. Users will enjoy a member directory search, forums, mentor match programs and resource sharing. More information will be communicated to members soon via Pulse newsletters, emails and the SVS Website.