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‘Fast food swamps’ linked to type 1 diabetes
Areas with a high density of fast food outlets are associated with a greater prevalence of type 1 diabetes but not type 2 diabetes, according to new research.
These findings come from an analysis of emergency claims data for 5 million adults and 1.6 million children in New York who visited an emergency department at least once during 2009-2013. Researchers also looked at sociodemographic data for the area from community surveys and used local authorities’ inspection data to characterize local restaurant and retail food environments.
But when the analysis was adjusted to account for a range of factors, including age, sex, ethnicity, household income, and employment rates, the association between fast food swamps and diabetes was significant for pediatric type 1 diabetes only.
“Given the rising prevalence of type 1 diabetes, there has been increasing belief that certain environmental influences are contributing sharply to these increases,” wrote David C. Lee, MD, New York University Langone Health, and his coauthors. “There is some emerging literature which suggests that pregnant women in adverse food environments may have a higher likelihood of gestational diabetes, which some believe may affect health outcomes in their offspring.”
The study also failed to find an influence of retail food swamps – areas with more bodegas or small convenience stores within a 1-mile radius – on the prevalence of either type 1 or type 2 diabetes, in either adults or children. When researchers extended this to a 2-mile radius, they did find a significantly higher prevalence of pediatric type 1 diabetes associated with retail food swamps but a significantly lower prevalence of adult type 1 diabetes.
“This result may suggest that the retail food environment does not have a strong association with local diabetes prevalence or may be due to how we measured the retail food environment,” they wrote.
In general, the study found that the prevalence of adult and pediatric type 1 diabetes was significantly lower in most black neighborhoods, while the prevalence of adult type 1 diabetes was significantly lower in most Hispanic neighborhoods. Higher-income neighborhoods showed a significantly higher prevalence of pediatric type 1 diabetes.
The prevalence of type 2 diabetes in adults was significantly higher in low-income neighborhoods and those with more elderly residents, while the highest rates of pediatric type 2 diabetes were found in black neighborhoods.
The authors commented that they were surprised that their data did not show a higher prevalence of adult type 2 diabetes in black neighborhoods.
“In our multivariate analysis, older age and lower income were the only demographic or socioeconomic factors associated with higher adult type 2 diabetes prevalence,” they wrote.
Their use of ED surveillance data may have skewed the findings toward individuals more likely to visit those departments, namely Medicaid patients. But they suggested this would be balanced by the fact that the analysis was based on small geographic areas.
“Overall, our results may suggest that the physical food environment may not play as strong a role in characterizing the risk of type 2 diabetes among children and that other factors such as genetics, health behaviors, environmental exposures, or family influences may play more important roles.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. No conflicts of interest were declared.
SOURCE: Lee DC et al. J Endocr Soc. 2018. Apr 17. doi: 10.1210/js.2018-00001.
Areas with a high density of fast food outlets are associated with a greater prevalence of type 1 diabetes but not type 2 diabetes, according to new research.
These findings come from an analysis of emergency claims data for 5 million adults and 1.6 million children in New York who visited an emergency department at least once during 2009-2013. Researchers also looked at sociodemographic data for the area from community surveys and used local authorities’ inspection data to characterize local restaurant and retail food environments.
But when the analysis was adjusted to account for a range of factors, including age, sex, ethnicity, household income, and employment rates, the association between fast food swamps and diabetes was significant for pediatric type 1 diabetes only.
“Given the rising prevalence of type 1 diabetes, there has been increasing belief that certain environmental influences are contributing sharply to these increases,” wrote David C. Lee, MD, New York University Langone Health, and his coauthors. “There is some emerging literature which suggests that pregnant women in adverse food environments may have a higher likelihood of gestational diabetes, which some believe may affect health outcomes in their offspring.”
The study also failed to find an influence of retail food swamps – areas with more bodegas or small convenience stores within a 1-mile radius – on the prevalence of either type 1 or type 2 diabetes, in either adults or children. When researchers extended this to a 2-mile radius, they did find a significantly higher prevalence of pediatric type 1 diabetes associated with retail food swamps but a significantly lower prevalence of adult type 1 diabetes.
“This result may suggest that the retail food environment does not have a strong association with local diabetes prevalence or may be due to how we measured the retail food environment,” they wrote.
In general, the study found that the prevalence of adult and pediatric type 1 diabetes was significantly lower in most black neighborhoods, while the prevalence of adult type 1 diabetes was significantly lower in most Hispanic neighborhoods. Higher-income neighborhoods showed a significantly higher prevalence of pediatric type 1 diabetes.
The prevalence of type 2 diabetes in adults was significantly higher in low-income neighborhoods and those with more elderly residents, while the highest rates of pediatric type 2 diabetes were found in black neighborhoods.
The authors commented that they were surprised that their data did not show a higher prevalence of adult type 2 diabetes in black neighborhoods.
“In our multivariate analysis, older age and lower income were the only demographic or socioeconomic factors associated with higher adult type 2 diabetes prevalence,” they wrote.
Their use of ED surveillance data may have skewed the findings toward individuals more likely to visit those departments, namely Medicaid patients. But they suggested this would be balanced by the fact that the analysis was based on small geographic areas.
“Overall, our results may suggest that the physical food environment may not play as strong a role in characterizing the risk of type 2 diabetes among children and that other factors such as genetics, health behaviors, environmental exposures, or family influences may play more important roles.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. No conflicts of interest were declared.
SOURCE: Lee DC et al. J Endocr Soc. 2018. Apr 17. doi: 10.1210/js.2018-00001.
Areas with a high density of fast food outlets are associated with a greater prevalence of type 1 diabetes but not type 2 diabetes, according to new research.
These findings come from an analysis of emergency claims data for 5 million adults and 1.6 million children in New York who visited an emergency department at least once during 2009-2013. Researchers also looked at sociodemographic data for the area from community surveys and used local authorities’ inspection data to characterize local restaurant and retail food environments.
But when the analysis was adjusted to account for a range of factors, including age, sex, ethnicity, household income, and employment rates, the association between fast food swamps and diabetes was significant for pediatric type 1 diabetes only.
“Given the rising prevalence of type 1 diabetes, there has been increasing belief that certain environmental influences are contributing sharply to these increases,” wrote David C. Lee, MD, New York University Langone Health, and his coauthors. “There is some emerging literature which suggests that pregnant women in adverse food environments may have a higher likelihood of gestational diabetes, which some believe may affect health outcomes in their offspring.”
The study also failed to find an influence of retail food swamps – areas with more bodegas or small convenience stores within a 1-mile radius – on the prevalence of either type 1 or type 2 diabetes, in either adults or children. When researchers extended this to a 2-mile radius, they did find a significantly higher prevalence of pediatric type 1 diabetes associated with retail food swamps but a significantly lower prevalence of adult type 1 diabetes.
“This result may suggest that the retail food environment does not have a strong association with local diabetes prevalence or may be due to how we measured the retail food environment,” they wrote.
In general, the study found that the prevalence of adult and pediatric type 1 diabetes was significantly lower in most black neighborhoods, while the prevalence of adult type 1 diabetes was significantly lower in most Hispanic neighborhoods. Higher-income neighborhoods showed a significantly higher prevalence of pediatric type 1 diabetes.
The prevalence of type 2 diabetes in adults was significantly higher in low-income neighborhoods and those with more elderly residents, while the highest rates of pediatric type 2 diabetes were found in black neighborhoods.
The authors commented that they were surprised that their data did not show a higher prevalence of adult type 2 diabetes in black neighborhoods.
“In our multivariate analysis, older age and lower income were the only demographic or socioeconomic factors associated with higher adult type 2 diabetes prevalence,” they wrote.
Their use of ED surveillance data may have skewed the findings toward individuals more likely to visit those departments, namely Medicaid patients. But they suggested this would be balanced by the fact that the analysis was based on small geographic areas.
“Overall, our results may suggest that the physical food environment may not play as strong a role in characterizing the risk of type 2 diabetes among children and that other factors such as genetics, health behaviors, environmental exposures, or family influences may play more important roles.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. No conflicts of interest were declared.
SOURCE: Lee DC et al. J Endocr Soc. 2018. Apr 17. doi: 10.1210/js.2018-00001.
FROM JOURNAL OF THE ENDOCRINE SOCIETY
Key clinical point: Neighborhoods with higher numbers of fast food restaurants are linked to a higher prevalence of type 1, not type 2, diabetes.
Major finding: Fast food swamps are associated with a higher prevalence of pediatric type 1 diabetes.
Study details: Retrospective analysis of emergency claims data for 5 million adults and 1.6 million children.
Disclosures: The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. No conflicts of interest were declared.
Source: Lee DC et al. J Endocr Soc. 2018. Apr 17. doi: 10.1210/js.2018-00001.
Mixed outcomes in analysis of NSAIDs and IBD exacerbation
The relationship between nonsteroidal anti-inflammatory drug (NSAID) use and exacerbations of inflammatory bowel disease (IBD) may not be as clear-cut as previously thought, according to the results of a systematic review and meta-analysis.
The report was published online in Alimentary Pharmacology and Therapeutics.
The researchers presented their analysis of 18 studies examining the association between acetaminophen, NSAIDs, and cyclo-oxygenase-2 (COX-2) inhibitors, and the risk of Crohn’s disease, ulcerative colitis flares, and IBD.
Five studies looked at the association between NSAIDS – such as naproxen and indomethacin – and the risk of Crohn’s disease exacerbation. While this showed a 42% increased risk of exacerbation with NSAID use, the authors noted that they saw substantial heterogeneity across the studies.
For example, two nonrandomized trials comparing NSAIDs and acetaminophen in patients with quiescent disease found NSAIDs were associated with frequent, early clinical relapse of IBD. But another study comparing patients with symptom flares and those in clinical remission found no difference between the two groups in the frequency of NSAID use.
Researchers also conducted a meta-analysis of studies involving acetaminophen, which found a statistically significant 56% increase in the risk of IBD exacerbation with acetaminophen. However, in the systematic review, there were two nonrandomized clinical trials which showed only one disease exacerbation in 46 patients with quiescent IBD, which was lower than the rate seen in the NSAID group.
Given the heterogeneity seen across the studies, the authors conducted an analysis limited to studies that scored seven or above on the Newcastle-Ottowa Scale for assessing the quality of nonrandomized studies. In this analysis, the risk of Crohn’s disease exacerbations increased significantly with NSAID use (RR = 1.53; 95% confidence interval, 1.08-2.16) but they did not see an association between NSAID use and the risk of ulcerative colitis or other IBD exacerbations.
Similarly, when they restricted their analysis to studies with a low risk of bias, the researchers found there was an increased risk of Crohn’s disease exacerbations, but not ulcerative colitis, with NSAID use.
“American College of Gastroenterology guidelines for management of IBD recognise NSAIDs as potential triggers for disease exacerbation, highlighting the ongoing concern regarding the use of these medications in patients with established disease,” wrote Dr. Oluwatoba Moninuola of Harvard University T.H. Chan School of Public Health, and coauthors.
“Although, it’s well established that NSAIDs may cause de novo damage throughout the gastrointestinal tract, the precise mechanism through which NSAIDs promote IBD exacerbation remains largely unknown.”
They said previous research suggested COX-1 and COX-2 inhibitors may be responsible for the inhibition of intestinal prostaglandin synthesis.
The authors also noted that wide variations in the definition of disease exacerbation may have contributed to the heterogeneity of the studies included, and that there may have been confounding by the indication for acetaminophen and NSAID use.
“We recognise that IBD is a heterogeneous disease and therefore, there may be subgroups of patients particularly at risk of disease exacerbations with use of NSAIDs.”
One author was supported by the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases, and declared consulting and research funding from the pharmaceutical industry. No other conflicts of interest were declared.
SOURCE: Moninuola O et al. Aliment Pharmacol Ther. 2018 Apr 5. doi: 10.1111/apt.14606.
The relationship between nonsteroidal anti-inflammatory drug (NSAID) use and exacerbations of inflammatory bowel disease (IBD) may not be as clear-cut as previously thought, according to the results of a systematic review and meta-analysis.
The report was published online in Alimentary Pharmacology and Therapeutics.
The researchers presented their analysis of 18 studies examining the association between acetaminophen, NSAIDs, and cyclo-oxygenase-2 (COX-2) inhibitors, and the risk of Crohn’s disease, ulcerative colitis flares, and IBD.
Five studies looked at the association between NSAIDS – such as naproxen and indomethacin – and the risk of Crohn’s disease exacerbation. While this showed a 42% increased risk of exacerbation with NSAID use, the authors noted that they saw substantial heterogeneity across the studies.
For example, two nonrandomized trials comparing NSAIDs and acetaminophen in patients with quiescent disease found NSAIDs were associated with frequent, early clinical relapse of IBD. But another study comparing patients with symptom flares and those in clinical remission found no difference between the two groups in the frequency of NSAID use.
Researchers also conducted a meta-analysis of studies involving acetaminophen, which found a statistically significant 56% increase in the risk of IBD exacerbation with acetaminophen. However, in the systematic review, there were two nonrandomized clinical trials which showed only one disease exacerbation in 46 patients with quiescent IBD, which was lower than the rate seen in the NSAID group.
Given the heterogeneity seen across the studies, the authors conducted an analysis limited to studies that scored seven or above on the Newcastle-Ottowa Scale for assessing the quality of nonrandomized studies. In this analysis, the risk of Crohn’s disease exacerbations increased significantly with NSAID use (RR = 1.53; 95% confidence interval, 1.08-2.16) but they did not see an association between NSAID use and the risk of ulcerative colitis or other IBD exacerbations.
Similarly, when they restricted their analysis to studies with a low risk of bias, the researchers found there was an increased risk of Crohn’s disease exacerbations, but not ulcerative colitis, with NSAID use.
“American College of Gastroenterology guidelines for management of IBD recognise NSAIDs as potential triggers for disease exacerbation, highlighting the ongoing concern regarding the use of these medications in patients with established disease,” wrote Dr. Oluwatoba Moninuola of Harvard University T.H. Chan School of Public Health, and coauthors.
“Although, it’s well established that NSAIDs may cause de novo damage throughout the gastrointestinal tract, the precise mechanism through which NSAIDs promote IBD exacerbation remains largely unknown.”
They said previous research suggested COX-1 and COX-2 inhibitors may be responsible for the inhibition of intestinal prostaglandin synthesis.
The authors also noted that wide variations in the definition of disease exacerbation may have contributed to the heterogeneity of the studies included, and that there may have been confounding by the indication for acetaminophen and NSAID use.
“We recognise that IBD is a heterogeneous disease and therefore, there may be subgroups of patients particularly at risk of disease exacerbations with use of NSAIDs.”
One author was supported by the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases, and declared consulting and research funding from the pharmaceutical industry. No other conflicts of interest were declared.
SOURCE: Moninuola O et al. Aliment Pharmacol Ther. 2018 Apr 5. doi: 10.1111/apt.14606.
The relationship between nonsteroidal anti-inflammatory drug (NSAID) use and exacerbations of inflammatory bowel disease (IBD) may not be as clear-cut as previously thought, according to the results of a systematic review and meta-analysis.
The report was published online in Alimentary Pharmacology and Therapeutics.
The researchers presented their analysis of 18 studies examining the association between acetaminophen, NSAIDs, and cyclo-oxygenase-2 (COX-2) inhibitors, and the risk of Crohn’s disease, ulcerative colitis flares, and IBD.
Five studies looked at the association between NSAIDS – such as naproxen and indomethacin – and the risk of Crohn’s disease exacerbation. While this showed a 42% increased risk of exacerbation with NSAID use, the authors noted that they saw substantial heterogeneity across the studies.
For example, two nonrandomized trials comparing NSAIDs and acetaminophen in patients with quiescent disease found NSAIDs were associated with frequent, early clinical relapse of IBD. But another study comparing patients with symptom flares and those in clinical remission found no difference between the two groups in the frequency of NSAID use.
Researchers also conducted a meta-analysis of studies involving acetaminophen, which found a statistically significant 56% increase in the risk of IBD exacerbation with acetaminophen. However, in the systematic review, there were two nonrandomized clinical trials which showed only one disease exacerbation in 46 patients with quiescent IBD, which was lower than the rate seen in the NSAID group.
Given the heterogeneity seen across the studies, the authors conducted an analysis limited to studies that scored seven or above on the Newcastle-Ottowa Scale for assessing the quality of nonrandomized studies. In this analysis, the risk of Crohn’s disease exacerbations increased significantly with NSAID use (RR = 1.53; 95% confidence interval, 1.08-2.16) but they did not see an association between NSAID use and the risk of ulcerative colitis or other IBD exacerbations.
Similarly, when they restricted their analysis to studies with a low risk of bias, the researchers found there was an increased risk of Crohn’s disease exacerbations, but not ulcerative colitis, with NSAID use.
“American College of Gastroenterology guidelines for management of IBD recognise NSAIDs as potential triggers for disease exacerbation, highlighting the ongoing concern regarding the use of these medications in patients with established disease,” wrote Dr. Oluwatoba Moninuola of Harvard University T.H. Chan School of Public Health, and coauthors.
“Although, it’s well established that NSAIDs may cause de novo damage throughout the gastrointestinal tract, the precise mechanism through which NSAIDs promote IBD exacerbation remains largely unknown.”
They said previous research suggested COX-1 and COX-2 inhibitors may be responsible for the inhibition of intestinal prostaglandin synthesis.
The authors also noted that wide variations in the definition of disease exacerbation may have contributed to the heterogeneity of the studies included, and that there may have been confounding by the indication for acetaminophen and NSAID use.
“We recognise that IBD is a heterogeneous disease and therefore, there may be subgroups of patients particularly at risk of disease exacerbations with use of NSAIDs.”
One author was supported by the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases, and declared consulting and research funding from the pharmaceutical industry. No other conflicts of interest were declared.
SOURCE: Moninuola O et al. Aliment Pharmacol Ther. 2018 Apr 5. doi: 10.1111/apt.14606.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
Key clinical point: Nonsteroidal anti-inflammatory drugs may increase the risk of some inflammatory bowel diseases.
Major finding: NSAIDs are associated with a 42% increased risk of Crohn’s disease exacerbation.
Study details: Systematic review and meta-analysis of 18 studies.
Disclosures: One author was supported by the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases, and declared consulting and research funding from the pharmaceutical industry. No other conflicts of interest were declared.
Source: Moninuola O et al. Aliment Pharmacol Ther. 2018 Apr 5. doi: 10.1111/apt.14606.
Pot peaks in breast milk 1 hour after smoking
The levels of delta-9-tetrahydrocannabinol in breast milk peak around 1 hour after smoking, according to a pilot pharmacokinetic study.
Eight mothers who were either occasional or chronic cannabis smokers, and who exclusively breastfed their infants, were directed to smoke a preweighed, standardized amount of “Prezidential Kush” from a preselected Denver dispensary after initially discontinuing for 24 hours. Researchers collected breast milk samples from just before smoking, and at 20 minutes, 1 hour, 2 hours, and 4 hours after smoking, according to a paper published in the May issue of Obstetrics & Gynecology.
This translated to an estimated relative infant dose of 2.5% of the maternal dose, or 8 mcg per kilogram per day.
“It remains unclear what exposure to cannabis products during this critical neurobehavioral development period will mean for the infant,” wrote Teresa Baker, MD, of Texas Tech University Health Sciences Center, and her coauthors. “These questions will require an enormous effort to determine.”
Concentrations of delta-9-tetrahydrocannabinol metabolites 11-OH-delta-9-tetrahydrocannabinol and 11-Nor-9-carboxy-delta-9-tetrahydrocannabinol were too low to be detected.
The authors noted that these metabolites are known to be more water soluble and polar than delta-9-tetrahydrocannabinol itself, which may make it more difficult for them to enter the breast milk compartment.
Two of the participants had a low but measurable concentration of delta-9-tetrahydrocannabinol at zero time (the samples collected just before smoking), suggesting some residual accumulation of it from prior heavy use or use close to the start of breast milk collection.
“Although the transfer of delta-9-tetrahydrocannabinol into the plasma compartment is almost instantaneous, the transfer of delta-9-tetrahydrocannabinol into breast milk in our study appears to be slightly slower than the transfer into the plasma compartment,” the authors wrote.
The women in the study were all 2-5 months postpartum. The authors noted that in these women who were exclusively breastfeeding, the breast milk compartment, along with drug entry and exit, “remains fairly consistent.”
The researchers also noted that the lack of corresponding plasma samples was a major limitation of the study, but because of the nature of the study, anonymity was important.
No conflicts of interest were declared.
SOURCE: Baker T et al. Obstet Gynecol. 2018;131:783-8.
The levels of delta-9-tetrahydrocannabinol in breast milk peak around 1 hour after smoking, according to a pilot pharmacokinetic study.
Eight mothers who were either occasional or chronic cannabis smokers, and who exclusively breastfed their infants, were directed to smoke a preweighed, standardized amount of “Prezidential Kush” from a preselected Denver dispensary after initially discontinuing for 24 hours. Researchers collected breast milk samples from just before smoking, and at 20 minutes, 1 hour, 2 hours, and 4 hours after smoking, according to a paper published in the May issue of Obstetrics & Gynecology.
This translated to an estimated relative infant dose of 2.5% of the maternal dose, or 8 mcg per kilogram per day.
“It remains unclear what exposure to cannabis products during this critical neurobehavioral development period will mean for the infant,” wrote Teresa Baker, MD, of Texas Tech University Health Sciences Center, and her coauthors. “These questions will require an enormous effort to determine.”
Concentrations of delta-9-tetrahydrocannabinol metabolites 11-OH-delta-9-tetrahydrocannabinol and 11-Nor-9-carboxy-delta-9-tetrahydrocannabinol were too low to be detected.
The authors noted that these metabolites are known to be more water soluble and polar than delta-9-tetrahydrocannabinol itself, which may make it more difficult for them to enter the breast milk compartment.
Two of the participants had a low but measurable concentration of delta-9-tetrahydrocannabinol at zero time (the samples collected just before smoking), suggesting some residual accumulation of it from prior heavy use or use close to the start of breast milk collection.
“Although the transfer of delta-9-tetrahydrocannabinol into the plasma compartment is almost instantaneous, the transfer of delta-9-tetrahydrocannabinol into breast milk in our study appears to be slightly slower than the transfer into the plasma compartment,” the authors wrote.
The women in the study were all 2-5 months postpartum. The authors noted that in these women who were exclusively breastfeeding, the breast milk compartment, along with drug entry and exit, “remains fairly consistent.”
The researchers also noted that the lack of corresponding plasma samples was a major limitation of the study, but because of the nature of the study, anonymity was important.
No conflicts of interest were declared.
SOURCE: Baker T et al. Obstet Gynecol. 2018;131:783-8.
The levels of delta-9-tetrahydrocannabinol in breast milk peak around 1 hour after smoking, according to a pilot pharmacokinetic study.
Eight mothers who were either occasional or chronic cannabis smokers, and who exclusively breastfed their infants, were directed to smoke a preweighed, standardized amount of “Prezidential Kush” from a preselected Denver dispensary after initially discontinuing for 24 hours. Researchers collected breast milk samples from just before smoking, and at 20 minutes, 1 hour, 2 hours, and 4 hours after smoking, according to a paper published in the May issue of Obstetrics & Gynecology.
This translated to an estimated relative infant dose of 2.5% of the maternal dose, or 8 mcg per kilogram per day.
“It remains unclear what exposure to cannabis products during this critical neurobehavioral development period will mean for the infant,” wrote Teresa Baker, MD, of Texas Tech University Health Sciences Center, and her coauthors. “These questions will require an enormous effort to determine.”
Concentrations of delta-9-tetrahydrocannabinol metabolites 11-OH-delta-9-tetrahydrocannabinol and 11-Nor-9-carboxy-delta-9-tetrahydrocannabinol were too low to be detected.
The authors noted that these metabolites are known to be more water soluble and polar than delta-9-tetrahydrocannabinol itself, which may make it more difficult for them to enter the breast milk compartment.
Two of the participants had a low but measurable concentration of delta-9-tetrahydrocannabinol at zero time (the samples collected just before smoking), suggesting some residual accumulation of it from prior heavy use or use close to the start of breast milk collection.
“Although the transfer of delta-9-tetrahydrocannabinol into the plasma compartment is almost instantaneous, the transfer of delta-9-tetrahydrocannabinol into breast milk in our study appears to be slightly slower than the transfer into the plasma compartment,” the authors wrote.
The women in the study were all 2-5 months postpartum. The authors noted that in these women who were exclusively breastfeeding, the breast milk compartment, along with drug entry and exit, “remains fairly consistent.”
The researchers also noted that the lack of corresponding plasma samples was a major limitation of the study, but because of the nature of the study, anonymity was important.
No conflicts of interest were declared.
SOURCE: Baker T et al. Obstet Gynecol. 2018;131:783-8.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Cannabinoid levels peak in breast milk 1 hour after smoking.
Major finding: Breastfeeding infants ingest around 2.5% of the maternal dose in breast milk.
Study details: A pilot pharmacokinetic study in eight women.
Disclosures: No conflicts of interest were declared.
Source: Baker T et al. Obstet Gynecol. 2018;131:783-8.
Complication rates rise after decline in uterine fibroid morcellation
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
FROM JAMA SURGERY
Key clinical point: Major complications from uterine fibroid hysterectomies have increased with more open surgeries.
Major finding: The rate of 30-day complications after uterine fibroid hysterectomy has increased by 20%.
Study details: A retrospective cohort study of 75,487 women.
Disclosures: The study was supported by a grant from the National Center for Advancing Translational Sciences, a component of the National Institutes of Health, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
Source: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
Social support after Katrina may ease depressive, PTSD symptoms
The availability of social support after a traumatic event such as a natural disaster could help buffer the development of depressive and PTSD symptoms in individuals exposed to the event, according to research published April 5.
In the Journal of Traumatic Stress, researchers reported the results of a survey of 810 adults who were exposed to the third-deadliest hurricane in U.S. history – Hurricane Katrina – in August 2005. Of those adults, 259 were displaced by the hurricane and 546 were not displaced. All of the adults were residents of Mississippi before the hurricane. More than half of the participants were women (52.2%), most were white (73.5%), and their ages ranged from 18 to 91 years.
Interviewers who were supervised by doctoral level clinicians administered numerous self-report questionnaires 18-24 months after the hurricane. Among other measures, the interviews included the Composite International Interview for DSM-IV.
The researchers found a significant negative interaction between perceived social support received in the 2 months after the hurricane and depressive symptoms, both in displaced and nondisplaced individuals.
The study also showed that the number of Katrina-related traumatic events, and whether an individual had been displaced or not, were associated with depressive symptoms – even after accounting for potential confounders, such as the number of previous traumatic events, age, and minority status.
In addition, the study explored the interaction between the number of hurricane-related traumatic events, perceived social support received, and displacement status as predictors of each cluster of PTSD symptoms. Individuals who experienced greater numbers of hurricane-related traumatic events and were displaced by the event showed more reexperiencing, avoidance, and arousal symptoms. However, social support was associated with lower likelihood of all PTSD symptom clusters.
Nondisplaced individuals who experienced a greater number of hurricane-related traumatic events showed higher arousal and avoidance symptoms, but this was only significant in individuals who reported lower levels of social support.
“Unlike previous studies, by controlling for highly correlated variables: number of previous traumatic events experienced and disaster-related stressors,” wrote Adam P. McGuire, PhD, formerly of the University of Mississippi, Jackson, and now at the Veterans Integrated Service Network, and his coauthors.
The authors also commented on the “unexpected” finding that the significant buffering effect of social support was seen both in displaced and nondisplaced residents, “which suggests that perceived social support is linked to important cognitive and behavioral processes that reduce the likelihood of developing depressive symptoms [e.g., challenging negative beliefs about self], and those effects are not limited to nondisplaced disaster survivors.”
The study was supported by the National Institutes of Health and the Midwest Regional Postdoctoral Program in Eating Disorder Research. The authors had no conflicts of interest.
SOURCE: McGuire AP et al. J Trauma Stress. 2018 Apr 5. doi: 10.1002/jts.22270.
The availability of social support after a traumatic event such as a natural disaster could help buffer the development of depressive and PTSD symptoms in individuals exposed to the event, according to research published April 5.
In the Journal of Traumatic Stress, researchers reported the results of a survey of 810 adults who were exposed to the third-deadliest hurricane in U.S. history – Hurricane Katrina – in August 2005. Of those adults, 259 were displaced by the hurricane and 546 were not displaced. All of the adults were residents of Mississippi before the hurricane. More than half of the participants were women (52.2%), most were white (73.5%), and their ages ranged from 18 to 91 years.
Interviewers who were supervised by doctoral level clinicians administered numerous self-report questionnaires 18-24 months after the hurricane. Among other measures, the interviews included the Composite International Interview for DSM-IV.
The researchers found a significant negative interaction between perceived social support received in the 2 months after the hurricane and depressive symptoms, both in displaced and nondisplaced individuals.
The study also showed that the number of Katrina-related traumatic events, and whether an individual had been displaced or not, were associated with depressive symptoms – even after accounting for potential confounders, such as the number of previous traumatic events, age, and minority status.
In addition, the study explored the interaction between the number of hurricane-related traumatic events, perceived social support received, and displacement status as predictors of each cluster of PTSD symptoms. Individuals who experienced greater numbers of hurricane-related traumatic events and were displaced by the event showed more reexperiencing, avoidance, and arousal symptoms. However, social support was associated with lower likelihood of all PTSD symptom clusters.
Nondisplaced individuals who experienced a greater number of hurricane-related traumatic events showed higher arousal and avoidance symptoms, but this was only significant in individuals who reported lower levels of social support.
“Unlike previous studies, by controlling for highly correlated variables: number of previous traumatic events experienced and disaster-related stressors,” wrote Adam P. McGuire, PhD, formerly of the University of Mississippi, Jackson, and now at the Veterans Integrated Service Network, and his coauthors.
The authors also commented on the “unexpected” finding that the significant buffering effect of social support was seen both in displaced and nondisplaced residents, “which suggests that perceived social support is linked to important cognitive and behavioral processes that reduce the likelihood of developing depressive symptoms [e.g., challenging negative beliefs about self], and those effects are not limited to nondisplaced disaster survivors.”
The study was supported by the National Institutes of Health and the Midwest Regional Postdoctoral Program in Eating Disorder Research. The authors had no conflicts of interest.
SOURCE: McGuire AP et al. J Trauma Stress. 2018 Apr 5. doi: 10.1002/jts.22270.
The availability of social support after a traumatic event such as a natural disaster could help buffer the development of depressive and PTSD symptoms in individuals exposed to the event, according to research published April 5.
In the Journal of Traumatic Stress, researchers reported the results of a survey of 810 adults who were exposed to the third-deadliest hurricane in U.S. history – Hurricane Katrina – in August 2005. Of those adults, 259 were displaced by the hurricane and 546 were not displaced. All of the adults were residents of Mississippi before the hurricane. More than half of the participants were women (52.2%), most were white (73.5%), and their ages ranged from 18 to 91 years.
Interviewers who were supervised by doctoral level clinicians administered numerous self-report questionnaires 18-24 months after the hurricane. Among other measures, the interviews included the Composite International Interview for DSM-IV.
The researchers found a significant negative interaction between perceived social support received in the 2 months after the hurricane and depressive symptoms, both in displaced and nondisplaced individuals.
The study also showed that the number of Katrina-related traumatic events, and whether an individual had been displaced or not, were associated with depressive symptoms – even after accounting for potential confounders, such as the number of previous traumatic events, age, and minority status.
In addition, the study explored the interaction between the number of hurricane-related traumatic events, perceived social support received, and displacement status as predictors of each cluster of PTSD symptoms. Individuals who experienced greater numbers of hurricane-related traumatic events and were displaced by the event showed more reexperiencing, avoidance, and arousal symptoms. However, social support was associated with lower likelihood of all PTSD symptom clusters.
Nondisplaced individuals who experienced a greater number of hurricane-related traumatic events showed higher arousal and avoidance symptoms, but this was only significant in individuals who reported lower levels of social support.
“Unlike previous studies, by controlling for highly correlated variables: number of previous traumatic events experienced and disaster-related stressors,” wrote Adam P. McGuire, PhD, formerly of the University of Mississippi, Jackson, and now at the Veterans Integrated Service Network, and his coauthors.
The authors also commented on the “unexpected” finding that the significant buffering effect of social support was seen both in displaced and nondisplaced residents, “which suggests that perceived social support is linked to important cognitive and behavioral processes that reduce the likelihood of developing depressive symptoms [e.g., challenging negative beliefs about self], and those effects are not limited to nondisplaced disaster survivors.”
The study was supported by the National Institutes of Health and the Midwest Regional Postdoctoral Program in Eating Disorder Research. The authors had no conflicts of interest.
SOURCE: McGuire AP et al. J Trauma Stress. 2018 Apr 5. doi: 10.1002/jts.22270.
FROM THE JOURNAL OF TRAUMATIC STRESS
Key clinical point: Social support can reduce the impact of traumatic events such as hurricanes.
Major finding: Perceived social support was associated with reduced depressive symptoms.
Study details: A survey of 810 adults who were exposed to Hurricane Katrina while living in Mississippi.
Disclosures: The study was supported by the National Institutes of Health and the Midwest Regional Postdoctoral Program in Eating Disorder Research. The presenters had no conflicts of interest.
Source: McGuire AP et al. J Trauma Stress. 2018 Apr 5. doi: 10.1002/jts.22270.
Reassurance for women taking certolizumab during pregnancy
according to results of a new study.
Megan E.B. Clowse, MD, of Duke University Medical Center, Durham, N.C., and her coauthors reported on a prospective and retrospective analysis of data from 528 pregnancies – including 10 twin pregnancies – in which the mother was exposed to the anti–tumor necrosis factor (anti-TNF) drug certolizumab during pregnancy.
There were 459 (85.3%) live births, 47 (8.7%) miscarriages, 27 (5%) elective abortions, and five (0.9%) stillbirths, figures that are similar to those seen in the general population. Among the singleton births, 11.7% were low birth weight, which the authors noted was slightly higher than the frequency observed in the general population but was in line with previous reports with TNF inhibitors.
Two cases of neonatal death were reported. One occurred in one member of a female twin pair, born at 25 weeks, who succumbed to brain damage and pneumoperitoneum. The other was also in female twins, born at 27 weeks, in which one of the pair was born with a heart defect and died during surgery for an unspecified infection of the intestines, the authors reported in Arthritis & Rheumatology.
The study noted eight (1.7%) reports of congenital malformations in the infants born alive, including accessory auricle, polydactyly, hydronephrosis, cerebral ventricle dilatation, and congenital heart disease.
Four cases were in infants whose mothers had rheumatoid arthritis, one in an infant whose mother had ankylosing spondylitis, and three in infants whose mothers had Crohn’s disease (CD).
In five cases, the women were exposed to certolizumab at least in the first trimester, in four they were exposed at least in the second trimester, and in five cases, the women were exposed at least during the third trimester of pregnancy.
“The teratologist review concluded no temporal association with CZP [certolizumab] exposure for the case of hydronephrosis, owing to evidence of anomalies on ultrasound prior to initiation of medication (during the third trimester); the possibility of an association could not be ruled out for the cases of anal fistula, accessory auricle, vesicoureteric reflux, talipes, and congenital heart disease,” the researchers wrote.
Twenty-two women (4.2%) had serious infections during pregnancy, which was in line with the frequency of serious infections reported in patients taking certolizumab.
Among the live births, nearly half (44.5%) reported certolizumab exposure during all three trimesters, 81.2% reported exposure at least during the first trimester, and 29.2% were exposed during the first trimester only.
“More women with rheumatic diseases than CD had first-trimester–only or first- and second-trimester exposure to CZP, reflecting the differing clinical practice between CD and rheumatic diseases,” the authors wrote. “Spontaneous disease improvement in women with IBD [inflammatory bowel disease] during pregnancy is less likely, compared to RA and other rheumatic diseases, and many patients may require treatment throughout pregnancy; thus, potentially reducing the risk of adverse outcomes, such as spontaneous miscarriage, premature birth, low birth weight, small gestational age.”
The authors commented that, despite increasing evidence of the safety of TNF inhibitors during pregnancy – recent systematic reviews and meta-analyses have found no link to adverse outcomes with anti-TNF exposure during the first trimester – patients and physicians still have had concerns about their use.
“This analysis of prospective pregnancy reports from the UCB Pharma safety database represents the largest published cohort of pregnant women exposed to an anti-TNF for the management of chronic inflammatory diseases,” the authors wrote. “It addresses the need for new and detailed studies on the impact of drug exposure during pregnancy and supports the conclusion that CZP exposure in utero does not appear to increase the risk of major congenital malformations or fetal loss.”
However, they acknowledged the lack of an untreated control group and said this meant a formal statistical analysis was not possible. They also noted that outcomes data were not available for about one-third of the entire cohort of 1,137 women whose pregnancies were exposed to certolizumab.
“However, these data are reassuring for women of childbearing age affected by chronic inflammatory diseases who need an anti-TNF to control their condition and wish to become or are pregnant during CZP treatment,” they wrote.
The study was funded by UCB Pharma. One author was a contractor for, and three were employees of, UCB Pharma. Six authors declared grants, consulting fees, and other remuneration from pharmaceutical companies, including UCB Pharma.
SOURCE: Clowse MEB et al. Arthritis & Rheumatology. 2018 Apr 5. doi: 10.1002/art.40508.
according to results of a new study.
Megan E.B. Clowse, MD, of Duke University Medical Center, Durham, N.C., and her coauthors reported on a prospective and retrospective analysis of data from 528 pregnancies – including 10 twin pregnancies – in which the mother was exposed to the anti–tumor necrosis factor (anti-TNF) drug certolizumab during pregnancy.
There were 459 (85.3%) live births, 47 (8.7%) miscarriages, 27 (5%) elective abortions, and five (0.9%) stillbirths, figures that are similar to those seen in the general population. Among the singleton births, 11.7% were low birth weight, which the authors noted was slightly higher than the frequency observed in the general population but was in line with previous reports with TNF inhibitors.
Two cases of neonatal death were reported. One occurred in one member of a female twin pair, born at 25 weeks, who succumbed to brain damage and pneumoperitoneum. The other was also in female twins, born at 27 weeks, in which one of the pair was born with a heart defect and died during surgery for an unspecified infection of the intestines, the authors reported in Arthritis & Rheumatology.
The study noted eight (1.7%) reports of congenital malformations in the infants born alive, including accessory auricle, polydactyly, hydronephrosis, cerebral ventricle dilatation, and congenital heart disease.
Four cases were in infants whose mothers had rheumatoid arthritis, one in an infant whose mother had ankylosing spondylitis, and three in infants whose mothers had Crohn’s disease (CD).
In five cases, the women were exposed to certolizumab at least in the first trimester, in four they were exposed at least in the second trimester, and in five cases, the women were exposed at least during the third trimester of pregnancy.
“The teratologist review concluded no temporal association with CZP [certolizumab] exposure for the case of hydronephrosis, owing to evidence of anomalies on ultrasound prior to initiation of medication (during the third trimester); the possibility of an association could not be ruled out for the cases of anal fistula, accessory auricle, vesicoureteric reflux, talipes, and congenital heart disease,” the researchers wrote.
Twenty-two women (4.2%) had serious infections during pregnancy, which was in line with the frequency of serious infections reported in patients taking certolizumab.
Among the live births, nearly half (44.5%) reported certolizumab exposure during all three trimesters, 81.2% reported exposure at least during the first trimester, and 29.2% were exposed during the first trimester only.
“More women with rheumatic diseases than CD had first-trimester–only or first- and second-trimester exposure to CZP, reflecting the differing clinical practice between CD and rheumatic diseases,” the authors wrote. “Spontaneous disease improvement in women with IBD [inflammatory bowel disease] during pregnancy is less likely, compared to RA and other rheumatic diseases, and many patients may require treatment throughout pregnancy; thus, potentially reducing the risk of adverse outcomes, such as spontaneous miscarriage, premature birth, low birth weight, small gestational age.”
The authors commented that, despite increasing evidence of the safety of TNF inhibitors during pregnancy – recent systematic reviews and meta-analyses have found no link to adverse outcomes with anti-TNF exposure during the first trimester – patients and physicians still have had concerns about their use.
“This analysis of prospective pregnancy reports from the UCB Pharma safety database represents the largest published cohort of pregnant women exposed to an anti-TNF for the management of chronic inflammatory diseases,” the authors wrote. “It addresses the need for new and detailed studies on the impact of drug exposure during pregnancy and supports the conclusion that CZP exposure in utero does not appear to increase the risk of major congenital malformations or fetal loss.”
However, they acknowledged the lack of an untreated control group and said this meant a formal statistical analysis was not possible. They also noted that outcomes data were not available for about one-third of the entire cohort of 1,137 women whose pregnancies were exposed to certolizumab.
“However, these data are reassuring for women of childbearing age affected by chronic inflammatory diseases who need an anti-TNF to control their condition and wish to become or are pregnant during CZP treatment,” they wrote.
The study was funded by UCB Pharma. One author was a contractor for, and three were employees of, UCB Pharma. Six authors declared grants, consulting fees, and other remuneration from pharmaceutical companies, including UCB Pharma.
SOURCE: Clowse MEB et al. Arthritis & Rheumatology. 2018 Apr 5. doi: 10.1002/art.40508.
according to results of a new study.
Megan E.B. Clowse, MD, of Duke University Medical Center, Durham, N.C., and her coauthors reported on a prospective and retrospective analysis of data from 528 pregnancies – including 10 twin pregnancies – in which the mother was exposed to the anti–tumor necrosis factor (anti-TNF) drug certolizumab during pregnancy.
There were 459 (85.3%) live births, 47 (8.7%) miscarriages, 27 (5%) elective abortions, and five (0.9%) stillbirths, figures that are similar to those seen in the general population. Among the singleton births, 11.7% were low birth weight, which the authors noted was slightly higher than the frequency observed in the general population but was in line with previous reports with TNF inhibitors.
Two cases of neonatal death were reported. One occurred in one member of a female twin pair, born at 25 weeks, who succumbed to brain damage and pneumoperitoneum. The other was also in female twins, born at 27 weeks, in which one of the pair was born with a heart defect and died during surgery for an unspecified infection of the intestines, the authors reported in Arthritis & Rheumatology.
The study noted eight (1.7%) reports of congenital malformations in the infants born alive, including accessory auricle, polydactyly, hydronephrosis, cerebral ventricle dilatation, and congenital heart disease.
Four cases were in infants whose mothers had rheumatoid arthritis, one in an infant whose mother had ankylosing spondylitis, and three in infants whose mothers had Crohn’s disease (CD).
In five cases, the women were exposed to certolizumab at least in the first trimester, in four they were exposed at least in the second trimester, and in five cases, the women were exposed at least during the third trimester of pregnancy.
“The teratologist review concluded no temporal association with CZP [certolizumab] exposure for the case of hydronephrosis, owing to evidence of anomalies on ultrasound prior to initiation of medication (during the third trimester); the possibility of an association could not be ruled out for the cases of anal fistula, accessory auricle, vesicoureteric reflux, talipes, and congenital heart disease,” the researchers wrote.
Twenty-two women (4.2%) had serious infections during pregnancy, which was in line with the frequency of serious infections reported in patients taking certolizumab.
Among the live births, nearly half (44.5%) reported certolizumab exposure during all three trimesters, 81.2% reported exposure at least during the first trimester, and 29.2% were exposed during the first trimester only.
“More women with rheumatic diseases than CD had first-trimester–only or first- and second-trimester exposure to CZP, reflecting the differing clinical practice between CD and rheumatic diseases,” the authors wrote. “Spontaneous disease improvement in women with IBD [inflammatory bowel disease] during pregnancy is less likely, compared to RA and other rheumatic diseases, and many patients may require treatment throughout pregnancy; thus, potentially reducing the risk of adverse outcomes, such as spontaneous miscarriage, premature birth, low birth weight, small gestational age.”
The authors commented that, despite increasing evidence of the safety of TNF inhibitors during pregnancy – recent systematic reviews and meta-analyses have found no link to adverse outcomes with anti-TNF exposure during the first trimester – patients and physicians still have had concerns about their use.
“This analysis of prospective pregnancy reports from the UCB Pharma safety database represents the largest published cohort of pregnant women exposed to an anti-TNF for the management of chronic inflammatory diseases,” the authors wrote. “It addresses the need for new and detailed studies on the impact of drug exposure during pregnancy and supports the conclusion that CZP exposure in utero does not appear to increase the risk of major congenital malformations or fetal loss.”
However, they acknowledged the lack of an untreated control group and said this meant a formal statistical analysis was not possible. They also noted that outcomes data were not available for about one-third of the entire cohort of 1,137 women whose pregnancies were exposed to certolizumab.
“However, these data are reassuring for women of childbearing age affected by chronic inflammatory diseases who need an anti-TNF to control their condition and wish to become or are pregnant during CZP treatment,” they wrote.
The study was funded by UCB Pharma. One author was a contractor for, and three were employees of, UCB Pharma. Six authors declared grants, consulting fees, and other remuneration from pharmaceutical companies, including UCB Pharma.
SOURCE: Clowse MEB et al. Arthritis & Rheumatology. 2018 Apr 5. doi: 10.1002/art.40508.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point: Certolizumab use during pregnancy does not appear to increase the risk of congenital malformations.
Major finding: The incidence of fetal death and congenital malformations in certolizumab-exposed pregnancies is similar to that in the general population.
Study details: A prospective and retrospective analysis of data from 528 certolizumab-exposed pregnancies.
Disclosures: The study was funded by UCB Pharma. One author was a contractor for UCB Pharma, and three were employees of, UCB Pharma. Six authors declared grants, consulting fees, and other remuneration from pharmaceutical companies, including UCB Pharma.
Source: Clowse MEB et al. Arthritis & Rheumatology. 2018 Apr 5. doi: 10.1002/art.40508
Consanguineous parentage raises risk of mood disorders, psychoses in offspring
Children of consanguineous parents are three times more likely to be prescribed medications for common mood disorders than the children of nonrelated parents, according to a study published April 4.
In JAMA Psychiatry, researchers reported the results of a retrospective populationwide cohort study involving 363,960 individuals born in Northern Ireland between 1971 and 1986; 609 (0.2%) of whom were born to parents who were either first or second cousins.
The analysis showed a clear relationship between the degree of consanguinity and the likelihood of being prescribed psychotropic medications. After adjusting for known mental health risk factors, including birth weight, children of parents who were first cousins had threefold higher odds of being prescribed antidepressant or anxiolytic medicines (odds ratio, 3.01; 95% confidence interval, 1.24-7.31) and a twofold higher odds of receiving antipsychotics (OR, 2.13; 95% CI, 1.29-3.51), compared with the children of nonconsanguineous parents.
“The results illustrate a clear increasing, stepwise association between level of consanguinity and mental ill health, suggesting a quasi–dose-response association, supporting a causal association between consanguineous parents and mental health of progeny,” wrote Aideen Maguire, PhD, and colleagues from Queen’s University Belfast (Northern Ireland).
Overall, , and 8.5% received antipsychotic medications, compared with one-quarter (26%) and 2.7% of nonrelated offspring.
Children of parents who were second cousins had an elevated but not statistically significant risk of receiving psychotropic medications (OR, 1.31; 95% CI, 0.63-2.71). None of these associations were affected by whether the births were singleton or multiple births.
“Despite the recent debate around the physical genetic risk of consanguineous parents, more research is required on the psychological effects of consanguineous parents on progeny,” the authors wrote.
The analysis also showed that participants aged 38-41 years were 15% more likely to receive antipsychotic medication, compared with those aged 26-29 years. The odds also were higher among fourth-born progeny, compared with first-born children, and in those from rural as opposed to urban areas.
Researchers also looked at whether deprivation or living in rural areas was associated with a higher likelihood of consanguineous pairings but found no such interactions. The incidence of consanguineous marriages found in the study was consistent with previous estimates in this population.
The authors suggested several possible explanations as to the association between consanguineous parents and mood disorders. The first was that psychiatric disorders are known to be heritable, suggesting that inherited genetic variants play a major role.
“As a form of assortative mating, consanguinity increases polygenic loading and thus is likely associated with a higher risk of mental disorder in progeny,” the authors wrote.
They also speculated that having consanguineous parents is associated with social stigma, particularly in Western societies where these partnerships are taboo. Offspring in these societies may experience discrimination that can affect mental health outcomes. However, they also noted that the children in the cohort might not have known about their parents’ consanguineous status.
“This study demonstrates the ability of populationwide data linkage to explore hard-to-reach populations, and we call on other countries with similar large-scale administrative data sources to use their data to explore the effects of consanguinity on offspring.”
The study was funded by the Centre of Excellence for Public Health Northern Ireland, with additional assistance from the Honest Broker Service. No conflicts of interest were declared.
SOURCE: Maguire A et al. JAMA Psychiatry. 2018 Apr 4. doi: 10.1001/jamapsychiatry.2018.0133.
While Charles Darwin – himself the product of a consanguineous marriage – found no evidence of a higher prevalence of consanguineous parentage among the inmates of asylums in England, there is known to be a higher risk of recessively inherited single-gene disorders among the offspring of consanguineous couples. However, until now, it was not known whether this also included an elevated risk of psychiatric disorders.
The findings of this study should stimulate further research efforts toward a greater understanding of the genetic contribution to common complex psychiatric conditions. The increase in whole-genome sequencing could provide entire genomes to help guide genetic counseling, not only for medical but also psychiatric conditions.
The study also should raise awareness about the difficulties and challenges associated with determining consanguinity, amid the potential stigma associated with cousin marriage.
Alison Shaw, DPhil, is affiliated with the department of social anthropology at the University of Oxford (England). These comments are taken from an accompanying editorial (JAMA Psychiatry 2018. Apr 4. doi: 10.1001/jamapsychiatry.2018.0513). No conflicts of interest were declared.
While Charles Darwin – himself the product of a consanguineous marriage – found no evidence of a higher prevalence of consanguineous parentage among the inmates of asylums in England, there is known to be a higher risk of recessively inherited single-gene disorders among the offspring of consanguineous couples. However, until now, it was not known whether this also included an elevated risk of psychiatric disorders.
The findings of this study should stimulate further research efforts toward a greater understanding of the genetic contribution to common complex psychiatric conditions. The increase in whole-genome sequencing could provide entire genomes to help guide genetic counseling, not only for medical but also psychiatric conditions.
The study also should raise awareness about the difficulties and challenges associated with determining consanguinity, amid the potential stigma associated with cousin marriage.
Alison Shaw, DPhil, is affiliated with the department of social anthropology at the University of Oxford (England). These comments are taken from an accompanying editorial (JAMA Psychiatry 2018. Apr 4. doi: 10.1001/jamapsychiatry.2018.0513). No conflicts of interest were declared.
While Charles Darwin – himself the product of a consanguineous marriage – found no evidence of a higher prevalence of consanguineous parentage among the inmates of asylums in England, there is known to be a higher risk of recessively inherited single-gene disorders among the offspring of consanguineous couples. However, until now, it was not known whether this also included an elevated risk of psychiatric disorders.
The findings of this study should stimulate further research efforts toward a greater understanding of the genetic contribution to common complex psychiatric conditions. The increase in whole-genome sequencing could provide entire genomes to help guide genetic counseling, not only for medical but also psychiatric conditions.
The study also should raise awareness about the difficulties and challenges associated with determining consanguinity, amid the potential stigma associated with cousin marriage.
Alison Shaw, DPhil, is affiliated with the department of social anthropology at the University of Oxford (England). These comments are taken from an accompanying editorial (JAMA Psychiatry 2018. Apr 4. doi: 10.1001/jamapsychiatry.2018.0513). No conflicts of interest were declared.
Children of consanguineous parents are three times more likely to be prescribed medications for common mood disorders than the children of nonrelated parents, according to a study published April 4.
In JAMA Psychiatry, researchers reported the results of a retrospective populationwide cohort study involving 363,960 individuals born in Northern Ireland between 1971 and 1986; 609 (0.2%) of whom were born to parents who were either first or second cousins.
The analysis showed a clear relationship between the degree of consanguinity and the likelihood of being prescribed psychotropic medications. After adjusting for known mental health risk factors, including birth weight, children of parents who were first cousins had threefold higher odds of being prescribed antidepressant or anxiolytic medicines (odds ratio, 3.01; 95% confidence interval, 1.24-7.31) and a twofold higher odds of receiving antipsychotics (OR, 2.13; 95% CI, 1.29-3.51), compared with the children of nonconsanguineous parents.
“The results illustrate a clear increasing, stepwise association between level of consanguinity and mental ill health, suggesting a quasi–dose-response association, supporting a causal association between consanguineous parents and mental health of progeny,” wrote Aideen Maguire, PhD, and colleagues from Queen’s University Belfast (Northern Ireland).
Overall, , and 8.5% received antipsychotic medications, compared with one-quarter (26%) and 2.7% of nonrelated offspring.
Children of parents who were second cousins had an elevated but not statistically significant risk of receiving psychotropic medications (OR, 1.31; 95% CI, 0.63-2.71). None of these associations were affected by whether the births were singleton or multiple births.
“Despite the recent debate around the physical genetic risk of consanguineous parents, more research is required on the psychological effects of consanguineous parents on progeny,” the authors wrote.
The analysis also showed that participants aged 38-41 years were 15% more likely to receive antipsychotic medication, compared with those aged 26-29 years. The odds also were higher among fourth-born progeny, compared with first-born children, and in those from rural as opposed to urban areas.
Researchers also looked at whether deprivation or living in rural areas was associated with a higher likelihood of consanguineous pairings but found no such interactions. The incidence of consanguineous marriages found in the study was consistent with previous estimates in this population.
The authors suggested several possible explanations as to the association between consanguineous parents and mood disorders. The first was that psychiatric disorders are known to be heritable, suggesting that inherited genetic variants play a major role.
“As a form of assortative mating, consanguinity increases polygenic loading and thus is likely associated with a higher risk of mental disorder in progeny,” the authors wrote.
They also speculated that having consanguineous parents is associated with social stigma, particularly in Western societies where these partnerships are taboo. Offspring in these societies may experience discrimination that can affect mental health outcomes. However, they also noted that the children in the cohort might not have known about their parents’ consanguineous status.
“This study demonstrates the ability of populationwide data linkage to explore hard-to-reach populations, and we call on other countries with similar large-scale administrative data sources to use their data to explore the effects of consanguinity on offspring.”
The study was funded by the Centre of Excellence for Public Health Northern Ireland, with additional assistance from the Honest Broker Service. No conflicts of interest were declared.
SOURCE: Maguire A et al. JAMA Psychiatry. 2018 Apr 4. doi: 10.1001/jamapsychiatry.2018.0133.
Children of consanguineous parents are three times more likely to be prescribed medications for common mood disorders than the children of nonrelated parents, according to a study published April 4.
In JAMA Psychiatry, researchers reported the results of a retrospective populationwide cohort study involving 363,960 individuals born in Northern Ireland between 1971 and 1986; 609 (0.2%) of whom were born to parents who were either first or second cousins.
The analysis showed a clear relationship between the degree of consanguinity and the likelihood of being prescribed psychotropic medications. After adjusting for known mental health risk factors, including birth weight, children of parents who were first cousins had threefold higher odds of being prescribed antidepressant or anxiolytic medicines (odds ratio, 3.01; 95% confidence interval, 1.24-7.31) and a twofold higher odds of receiving antipsychotics (OR, 2.13; 95% CI, 1.29-3.51), compared with the children of nonconsanguineous parents.
“The results illustrate a clear increasing, stepwise association between level of consanguinity and mental ill health, suggesting a quasi–dose-response association, supporting a causal association between consanguineous parents and mental health of progeny,” wrote Aideen Maguire, PhD, and colleagues from Queen’s University Belfast (Northern Ireland).
Overall, , and 8.5% received antipsychotic medications, compared with one-quarter (26%) and 2.7% of nonrelated offspring.
Children of parents who were second cousins had an elevated but not statistically significant risk of receiving psychotropic medications (OR, 1.31; 95% CI, 0.63-2.71). None of these associations were affected by whether the births were singleton or multiple births.
“Despite the recent debate around the physical genetic risk of consanguineous parents, more research is required on the psychological effects of consanguineous parents on progeny,” the authors wrote.
The analysis also showed that participants aged 38-41 years were 15% more likely to receive antipsychotic medication, compared with those aged 26-29 years. The odds also were higher among fourth-born progeny, compared with first-born children, and in those from rural as opposed to urban areas.
Researchers also looked at whether deprivation or living in rural areas was associated with a higher likelihood of consanguineous pairings but found no such interactions. The incidence of consanguineous marriages found in the study was consistent with previous estimates in this population.
The authors suggested several possible explanations as to the association between consanguineous parents and mood disorders. The first was that psychiatric disorders are known to be heritable, suggesting that inherited genetic variants play a major role.
“As a form of assortative mating, consanguinity increases polygenic loading and thus is likely associated with a higher risk of mental disorder in progeny,” the authors wrote.
They also speculated that having consanguineous parents is associated with social stigma, particularly in Western societies where these partnerships are taboo. Offspring in these societies may experience discrimination that can affect mental health outcomes. However, they also noted that the children in the cohort might not have known about their parents’ consanguineous status.
“This study demonstrates the ability of populationwide data linkage to explore hard-to-reach populations, and we call on other countries with similar large-scale administrative data sources to use their data to explore the effects of consanguinity on offspring.”
The study was funded by the Centre of Excellence for Public Health Northern Ireland, with additional assistance from the Honest Broker Service. No conflicts of interest were declared.
SOURCE: Maguire A et al. JAMA Psychiatry. 2018 Apr 4. doi: 10.1001/jamapsychiatry.2018.0133.
FROM JAMA PSYCHIATRY
Key clinical point: Children of consanguineous parents are at significantly greater risk of mood disorders.
Major finding: Children of first-cousin parents have a threefold greater risk of mood disorders.
Study details: A retrospective populationwide cohort study involving 363,960 individuals.
Disclosures: The study was funded by the Centre of Excellence for Public Health Northern Ireland, with additional assistance from the Honest Broker Service. No conflicts of interest were declared.
Source: Maguire A et al. JAMA Psychiatry. doi: 10.1001/jamapsychiatry.2018.0133.
Wound protectors lower risk of surgical site infections
particularly dual-ring devices, new research suggests.
A meta-analysis of 12 randomized, controlled trials with 3,029 participants found that the use of wound protectors during surgery was associated with 34% lower odds of surgical site infection (95% confidence interval, 0.45–0.90; P less than .01).
The study, published in the March edition of Surgical Endoscopy, also showed that dual-ring wound protectors were associated with a highly significant 69% reduction in the odds of surgical site infections (95% CI, 0.18-0.52; P less than .0001), while the benefits of single-ring wound protectors did not reach statistical significance (OR, 0.84; 95% CI, 0.67–1.04; P = .11).
Wound protectors – also known as wound guards or wound retractors – are intended to prevent the edges of a surgical wound from coming into contact with the contaminated surgical field.
The single-ring model consists of a plastic ring that sits within the wound and a protective drape that extends out from it. In the dual-ring model, one ring sits inside the wound and the other outside the wound, with the two rings joined by the protective plastic.
Of the 12 studies included in the meta-analysis, 5 involved colorectal surgery only, 5 included both colorectal and other gastrointestinal surgery, and 2 studies focused on appendectomies. All but one study involved open surgery.
“Our study is more specific in the interventions included in that we included lower gastrointestinal surgery only, which is a population that would likely benefit the most from the intervention due to the high incidence of SSIs in bowel surgery, compared to other abdominal surgeries,” wrote Lisa Zhang, MD, a general surgery resident at the department of surgery at Kingston (Ont.) General Hospital and her coauthors.
There was no difference in the effect of wound protectors based on the target organ for surgery, even with a high number of patients in one of the appendectomy trials, which the authors were concerned may have skewed the results.
Overall, the authors rated the evidence to be of moderate quality, but several studies had a high risk of bias.
The authors said that one barrier to routine use of these devices was cost. However, given that surgical site infections are estimated to cost around $3.5 billion to $10 billion annually in health care expenditures, they argued that “the use of dual-ring wound edge protectors should be considered in open lower gastrointestinal surgery, including open appendectomies.”
No funding sources or conflicts of interest were declared.
SOURCE: Zhang L et al. Surg Endosc. 2018;32:1111–22.
particularly dual-ring devices, new research suggests.
A meta-analysis of 12 randomized, controlled trials with 3,029 participants found that the use of wound protectors during surgery was associated with 34% lower odds of surgical site infection (95% confidence interval, 0.45–0.90; P less than .01).
The study, published in the March edition of Surgical Endoscopy, also showed that dual-ring wound protectors were associated with a highly significant 69% reduction in the odds of surgical site infections (95% CI, 0.18-0.52; P less than .0001), while the benefits of single-ring wound protectors did not reach statistical significance (OR, 0.84; 95% CI, 0.67–1.04; P = .11).
Wound protectors – also known as wound guards or wound retractors – are intended to prevent the edges of a surgical wound from coming into contact with the contaminated surgical field.
The single-ring model consists of a plastic ring that sits within the wound and a protective drape that extends out from it. In the dual-ring model, one ring sits inside the wound and the other outside the wound, with the two rings joined by the protective plastic.
Of the 12 studies included in the meta-analysis, 5 involved colorectal surgery only, 5 included both colorectal and other gastrointestinal surgery, and 2 studies focused on appendectomies. All but one study involved open surgery.
“Our study is more specific in the interventions included in that we included lower gastrointestinal surgery only, which is a population that would likely benefit the most from the intervention due to the high incidence of SSIs in bowel surgery, compared to other abdominal surgeries,” wrote Lisa Zhang, MD, a general surgery resident at the department of surgery at Kingston (Ont.) General Hospital and her coauthors.
There was no difference in the effect of wound protectors based on the target organ for surgery, even with a high number of patients in one of the appendectomy trials, which the authors were concerned may have skewed the results.
Overall, the authors rated the evidence to be of moderate quality, but several studies had a high risk of bias.
The authors said that one barrier to routine use of these devices was cost. However, given that surgical site infections are estimated to cost around $3.5 billion to $10 billion annually in health care expenditures, they argued that “the use of dual-ring wound edge protectors should be considered in open lower gastrointestinal surgery, including open appendectomies.”
No funding sources or conflicts of interest were declared.
SOURCE: Zhang L et al. Surg Endosc. 2018;32:1111–22.
particularly dual-ring devices, new research suggests.
A meta-analysis of 12 randomized, controlled trials with 3,029 participants found that the use of wound protectors during surgery was associated with 34% lower odds of surgical site infection (95% confidence interval, 0.45–0.90; P less than .01).
The study, published in the March edition of Surgical Endoscopy, also showed that dual-ring wound protectors were associated with a highly significant 69% reduction in the odds of surgical site infections (95% CI, 0.18-0.52; P less than .0001), while the benefits of single-ring wound protectors did not reach statistical significance (OR, 0.84; 95% CI, 0.67–1.04; P = .11).
Wound protectors – also known as wound guards or wound retractors – are intended to prevent the edges of a surgical wound from coming into contact with the contaminated surgical field.
The single-ring model consists of a plastic ring that sits within the wound and a protective drape that extends out from it. In the dual-ring model, one ring sits inside the wound and the other outside the wound, with the two rings joined by the protective plastic.
Of the 12 studies included in the meta-analysis, 5 involved colorectal surgery only, 5 included both colorectal and other gastrointestinal surgery, and 2 studies focused on appendectomies. All but one study involved open surgery.
“Our study is more specific in the interventions included in that we included lower gastrointestinal surgery only, which is a population that would likely benefit the most from the intervention due to the high incidence of SSIs in bowel surgery, compared to other abdominal surgeries,” wrote Lisa Zhang, MD, a general surgery resident at the department of surgery at Kingston (Ont.) General Hospital and her coauthors.
There was no difference in the effect of wound protectors based on the target organ for surgery, even with a high number of patients in one of the appendectomy trials, which the authors were concerned may have skewed the results.
Overall, the authors rated the evidence to be of moderate quality, but several studies had a high risk of bias.
The authors said that one barrier to routine use of these devices was cost. However, given that surgical site infections are estimated to cost around $3.5 billion to $10 billion annually in health care expenditures, they argued that “the use of dual-ring wound edge protectors should be considered in open lower gastrointestinal surgery, including open appendectomies.”
No funding sources or conflicts of interest were declared.
SOURCE: Zhang L et al. Surg Endosc. 2018;32:1111–22.
FROM SURGICAL ENDOSCOPY
Key clinical point: Dual-ring wound protectors significantly decrease the risk of gastrointestinal surgical site infections.
Major finding: Dual-ring wound protectors were associated with a 69% reduction in the odds of surgical site infections.
Study details: A meta-analysis of 12 randomized, controlled trials.
Disclosures: No funding source or conflicts of interest were declared.
Source: Zhang L et al. Surg Endosc. 2018;32:1111–22.
PPIs, H2RAs in infants raise later allergy risk
Children prescribed histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs), or antibiotics during the first 6 months of life may be at greater risk of developing allergic disease, research suggests.
A retrospective cohort study looked at the incidence of subsequent allergic disease in 792,130 children, 7.6% of whom were prescribed an H2RA, 1.7% were prescribed a PPI, and 16.6% were prescribed an antibiotic during the first 6 months of life.
Children who were prescribed a H2RA or a PPI had a greater than twofold higher incidence of food allergy (adjusted hazard ratios 2.18 and 2.59, respectively), reported Edward Mitre, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his coauthors, reported in the April 2 online edition of JAMA Pediatrics.
In particular, the use of acid-suppressing medications was associated with a 2.4-fold increase in the risk of being diagnosed with cow’s milk allergy, while the risk of egg allergy was 74% higher in children prescribed an H2RA and 35% higher in children prescribed a PPI. In children prescribed an H2RA, the risk of peanut allergy was 21% higher, and in children prescribed a PPI, it was 27% higher.
There also was a dose-dependent interaction between the duration of medication and risk of food allergy. Children who were prescribed more than 60 days of PPIs had a 52% higher risk than did those who were prescribed 1-60 days, and a similar but slightly lower increased risk was seen in those prescribed more than 60 days of H2RAs (hazard ratio, 1.32).
Acid-suppressing medication use also was associated with an increased risk of nonfood allergies, in particular medication allergy (adjusted HR, 1.70 for H2RAs and 1.84 for PPIs), allergic rhinitis (aHR, 1.50 for H2RAs and 1.44 for PPIs), anaphylaxis (aHR, 1.51 for H2RAs and 1.45 for PPIs).
Infants prescribed acid-suppressing medication also showed higher rates of asthma, allergic conjunctivitis, and urticaria during childhood.
The use of antibiotics in the first 6 months of life was associated with a 14% higher incidence of food allergy but with a 24% higher risk of cow’s milk allergy and egg allergy. Children prescribed antibiotics also had a twofold greater risk of asthma, a 51% higher risk of anaphylaxis, 42% higher risk of allergic conjunctivitis, and a 34% higher risk of medication allergy.
“This study adds to the mounting evidence that agents that disrupt the normal intestinal microbiome during infancy may increase the development of allergic disease,” said Dr. Mitre and his coauthors. “Thus, this study provides further impetus that antibiotics and acid-suppressive medications should be used during infancy only in situations of clear clinical benefit.”
No funding source or conflicts of interest were declared.
SOURCE: Mitre E et al. JAMA Pediatrics. 2018 Apr 2. doi: 10.1001/jamapediatrics.2018.0315.
Children prescribed histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs), or antibiotics during the first 6 months of life may be at greater risk of developing allergic disease, research suggests.
A retrospective cohort study looked at the incidence of subsequent allergic disease in 792,130 children, 7.6% of whom were prescribed an H2RA, 1.7% were prescribed a PPI, and 16.6% were prescribed an antibiotic during the first 6 months of life.
Children who were prescribed a H2RA or a PPI had a greater than twofold higher incidence of food allergy (adjusted hazard ratios 2.18 and 2.59, respectively), reported Edward Mitre, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his coauthors, reported in the April 2 online edition of JAMA Pediatrics.
In particular, the use of acid-suppressing medications was associated with a 2.4-fold increase in the risk of being diagnosed with cow’s milk allergy, while the risk of egg allergy was 74% higher in children prescribed an H2RA and 35% higher in children prescribed a PPI. In children prescribed an H2RA, the risk of peanut allergy was 21% higher, and in children prescribed a PPI, it was 27% higher.
There also was a dose-dependent interaction between the duration of medication and risk of food allergy. Children who were prescribed more than 60 days of PPIs had a 52% higher risk than did those who were prescribed 1-60 days, and a similar but slightly lower increased risk was seen in those prescribed more than 60 days of H2RAs (hazard ratio, 1.32).
Acid-suppressing medication use also was associated with an increased risk of nonfood allergies, in particular medication allergy (adjusted HR, 1.70 for H2RAs and 1.84 for PPIs), allergic rhinitis (aHR, 1.50 for H2RAs and 1.44 for PPIs), anaphylaxis (aHR, 1.51 for H2RAs and 1.45 for PPIs).
Infants prescribed acid-suppressing medication also showed higher rates of asthma, allergic conjunctivitis, and urticaria during childhood.
The use of antibiotics in the first 6 months of life was associated with a 14% higher incidence of food allergy but with a 24% higher risk of cow’s milk allergy and egg allergy. Children prescribed antibiotics also had a twofold greater risk of asthma, a 51% higher risk of anaphylaxis, 42% higher risk of allergic conjunctivitis, and a 34% higher risk of medication allergy.
“This study adds to the mounting evidence that agents that disrupt the normal intestinal microbiome during infancy may increase the development of allergic disease,” said Dr. Mitre and his coauthors. “Thus, this study provides further impetus that antibiotics and acid-suppressive medications should be used during infancy only in situations of clear clinical benefit.”
No funding source or conflicts of interest were declared.
SOURCE: Mitre E et al. JAMA Pediatrics. 2018 Apr 2. doi: 10.1001/jamapediatrics.2018.0315.
Children prescribed histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs), or antibiotics during the first 6 months of life may be at greater risk of developing allergic disease, research suggests.
A retrospective cohort study looked at the incidence of subsequent allergic disease in 792,130 children, 7.6% of whom were prescribed an H2RA, 1.7% were prescribed a PPI, and 16.6% were prescribed an antibiotic during the first 6 months of life.
Children who were prescribed a H2RA or a PPI had a greater than twofold higher incidence of food allergy (adjusted hazard ratios 2.18 and 2.59, respectively), reported Edward Mitre, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his coauthors, reported in the April 2 online edition of JAMA Pediatrics.
In particular, the use of acid-suppressing medications was associated with a 2.4-fold increase in the risk of being diagnosed with cow’s milk allergy, while the risk of egg allergy was 74% higher in children prescribed an H2RA and 35% higher in children prescribed a PPI. In children prescribed an H2RA, the risk of peanut allergy was 21% higher, and in children prescribed a PPI, it was 27% higher.
There also was a dose-dependent interaction between the duration of medication and risk of food allergy. Children who were prescribed more than 60 days of PPIs had a 52% higher risk than did those who were prescribed 1-60 days, and a similar but slightly lower increased risk was seen in those prescribed more than 60 days of H2RAs (hazard ratio, 1.32).
Acid-suppressing medication use also was associated with an increased risk of nonfood allergies, in particular medication allergy (adjusted HR, 1.70 for H2RAs and 1.84 for PPIs), allergic rhinitis (aHR, 1.50 for H2RAs and 1.44 for PPIs), anaphylaxis (aHR, 1.51 for H2RAs and 1.45 for PPIs).
Infants prescribed acid-suppressing medication also showed higher rates of asthma, allergic conjunctivitis, and urticaria during childhood.
The use of antibiotics in the first 6 months of life was associated with a 14% higher incidence of food allergy but with a 24% higher risk of cow’s milk allergy and egg allergy. Children prescribed antibiotics also had a twofold greater risk of asthma, a 51% higher risk of anaphylaxis, 42% higher risk of allergic conjunctivitis, and a 34% higher risk of medication allergy.
“This study adds to the mounting evidence that agents that disrupt the normal intestinal microbiome during infancy may increase the development of allergic disease,” said Dr. Mitre and his coauthors. “Thus, this study provides further impetus that antibiotics and acid-suppressive medications should be used during infancy only in situations of clear clinical benefit.”
No funding source or conflicts of interest were declared.
SOURCE: Mitre E et al. JAMA Pediatrics. 2018 Apr 2. doi: 10.1001/jamapediatrics.2018.0315.
FROM JAMA PEDIATRICS
Key clinical point:
Major finding: Children prescribed acid-suppressing medications before 6 months had a greater than twofold higher incidence of food allergy.
Study details: A retrospective cohort study in 792,130 children between Oct. 1, 2001, and Sept. 30, 2013.
Disclosures: No funding source or conflicts of interest were declared.
Source: Mitre E et al. JAMA Pediatrics. 2018 Apr 2. doi: 10.1001/jamapediatrics.2018.0315.
Higher preconception blood pressure linked to pregnancy loss
High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.
Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).
although the authors noted that group sizes were small.
Overall, one-quarter of the women enrolled in the study met the criteria for hypertension stage I, and 4.3% met the criteria for hypertension stage II.
“Screening and lifestyle interventions targeting maintenance of healthy blood pressure levels among reproductive-aged women may have additional important short-term benefits on reproductive health,” wrote Carrie J. Nobles, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and coauthors.
The authors also saw an impact of early pregnancy blood pressure on pregnancy loss, with an 18% greater risk of loss with each 10–mm Hg increase in mean arterial pressure.
Higher blood pressure during preconception was also associated with a decrease in the chance of live birth, but this association disappeared after adjusting for other confounders.
The study also examined the relationship between preconception blood pressure and the probability of conception. While the unadjusted models suggested 10% lower odds of fecundability, adjusting for all covariates except for BMI found similar effect estimates.
“We observed no clear associations of preconception blood pressure with fecundability after adjustment for BMI, suggesting that pathways related to BMI, which is strongly related to fecundability, may explain the marginal association of blood pressure with fecundability,” the authors wrote.
There was also some evidence that aspirin may influence the association between higher preconception blood pressure and pregnancy loss, as this association was marginally stronger in the placebo group than in the group randomized to low-dose aspirin.
“Pregnancy loss and other adverse reproductive outcomes may serve as sensitive markers of early-stage progression toward cardiometabolic disease in young adults,” Dr. Noble and coauthors wrote. “Further elucidating the cardiometabolic risk factors for pregnancy loss may help identify early intervention strategies, such as regular physical activity and following a DASH-type (Dietary Approaches to Stop Hypertension) diet.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. No conflicts of interest were declared.
SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.
High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.
Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).
although the authors noted that group sizes were small.
Overall, one-quarter of the women enrolled in the study met the criteria for hypertension stage I, and 4.3% met the criteria for hypertension stage II.
“Screening and lifestyle interventions targeting maintenance of healthy blood pressure levels among reproductive-aged women may have additional important short-term benefits on reproductive health,” wrote Carrie J. Nobles, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and coauthors.
The authors also saw an impact of early pregnancy blood pressure on pregnancy loss, with an 18% greater risk of loss with each 10–mm Hg increase in mean arterial pressure.
Higher blood pressure during preconception was also associated with a decrease in the chance of live birth, but this association disappeared after adjusting for other confounders.
The study also examined the relationship between preconception blood pressure and the probability of conception. While the unadjusted models suggested 10% lower odds of fecundability, adjusting for all covariates except for BMI found similar effect estimates.
“We observed no clear associations of preconception blood pressure with fecundability after adjustment for BMI, suggesting that pathways related to BMI, which is strongly related to fecundability, may explain the marginal association of blood pressure with fecundability,” the authors wrote.
There was also some evidence that aspirin may influence the association between higher preconception blood pressure and pregnancy loss, as this association was marginally stronger in the placebo group than in the group randomized to low-dose aspirin.
“Pregnancy loss and other adverse reproductive outcomes may serve as sensitive markers of early-stage progression toward cardiometabolic disease in young adults,” Dr. Noble and coauthors wrote. “Further elucidating the cardiometabolic risk factors for pregnancy loss may help identify early intervention strategies, such as regular physical activity and following a DASH-type (Dietary Approaches to Stop Hypertension) diet.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. No conflicts of interest were declared.
SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.
High preconception blood pressure is associated with a greater risk of pregnancy loss, according to analysis of data from a randomized clinical trial of aspirin and pregnancy outcomes.
Researchers in the EAGeR (Effects of Aspirin on Gestational and Reproduction) trial analyzed data from 1,228 women attempting pregnancy with a history of pregnancy loss. After researchers adjusted for treatment assignment, body mass index (BMI), race, marital status, smoking, parity, and time from last pregnancy loss, an increase in all blood pressure measures was associated with a 17% increase in the risk of pregnancy loss (Hypertension. doi: 10.1161/hypertensionaha.117.10705).
although the authors noted that group sizes were small.
Overall, one-quarter of the women enrolled in the study met the criteria for hypertension stage I, and 4.3% met the criteria for hypertension stage II.
“Screening and lifestyle interventions targeting maintenance of healthy blood pressure levels among reproductive-aged women may have additional important short-term benefits on reproductive health,” wrote Carrie J. Nobles, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and coauthors.
The authors also saw an impact of early pregnancy blood pressure on pregnancy loss, with an 18% greater risk of loss with each 10–mm Hg increase in mean arterial pressure.
Higher blood pressure during preconception was also associated with a decrease in the chance of live birth, but this association disappeared after adjusting for other confounders.
The study also examined the relationship between preconception blood pressure and the probability of conception. While the unadjusted models suggested 10% lower odds of fecundability, adjusting for all covariates except for BMI found similar effect estimates.
“We observed no clear associations of preconception blood pressure with fecundability after adjustment for BMI, suggesting that pathways related to BMI, which is strongly related to fecundability, may explain the marginal association of blood pressure with fecundability,” the authors wrote.
There was also some evidence that aspirin may influence the association between higher preconception blood pressure and pregnancy loss, as this association was marginally stronger in the placebo group than in the group randomized to low-dose aspirin.
“Pregnancy loss and other adverse reproductive outcomes may serve as sensitive markers of early-stage progression toward cardiometabolic disease in young adults,” Dr. Noble and coauthors wrote. “Further elucidating the cardiometabolic risk factors for pregnancy loss may help identify early intervention strategies, such as regular physical activity and following a DASH-type (Dietary Approaches to Stop Hypertension) diet.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. No conflicts of interest were declared.
SOURCE: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.
FROM HYPERTENSION
Key clinical point: Maintaining normal blood pressure is even more important for women who previously have miscarried.
Major finding: Higher preconception blood pressure was associated with a 17% increase in the risk of pregnancy loss.
Study details: Analysis of data from a randomized clinical trial in 1,228 women.
Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. No conflicts of interest were declared.
Source: Nobles CJ et al. Hypertension. 2018 Apr 2;71. doi: 10.1161/hypertensionaha.117.10705.