Whitney McKnight

WASHINGTON – Physicians have a role in combating early childhood obesity, but experts say the clinical setting is not ideal for effective treatment and prevention of this emerging epidemic.

“Pediatricians have high access to kids, parents, and guardians, and we are trusted sources of information for them,” Dr. Ian Paul, professor and chief of academic pediatrics at Penn State University Hershey Medical Center, said at an Institute of Medicine forum on early childhood obesity.

Emerging data underscore obesity’s complex societal components, which include an imbalance of diet and physical activity complicated by less tangible factors such as cultural attitudes, maternal habits, and socio-economic status. And then there is the question of the best way to reimburse physicians for applying the few proven long-term interventions they have.

“I think it’s one of those things where it takes a village,” Dr. Paul said in an interview. “You need multiple people going in the same direction. The pediatrician can give advice, and support what is happening, but it can’t just be the pediatrician by him- or herself.”

The U.S. Centers for Disease Control and Prevention says that pediatric obesity affects a third of the nation’s youth. But there are only vague policies and guidelines for how to intervene in the preschool years, a time when research now shows risk factors present can set the stage for obesity later in a child’s life. This all leaves pediatricians unsure of how to treat young patients who present with signs of overweight and obesity. To date, there are no proven clinical-based obesity interventions for birth to age 5 years, Dr. Paul said. “Pediatricians don’t always feel equipped to handle questions about obesity prevention and treatment,” compounded, by the fact that, “reimbursement for these services has been poor.”

However, through partnerships with community organizations and other clinicians, more effective models of care are emerging, particularly in minority and lower income communities where obesity rates are among the highest nationally (Contemp Clin Trials. 2013 Nov;36[3]:544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9), noted Dr. Paul.

“In poorer households, high rates of maternal stress and less access to resources such as time with a nutritionist or higher quality produce and other foods, are risk factors for obesity,” Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital in New York, said in an interview.

As part of their program, Dr. Messito, clinical associate professor of pediatrics at New York University, and her colleagues conducted a study of a family-based, early obesity intervention and prevention program with nutrition support groups as the central component.

The study involved 534 expectant mothers in their last trimester who were randomly assigned to receive either standard prenatal care followed by standard well-child care, or prenatal nutritional counseling, in addition to well-child visits coupled with continued nutritional counseling in a group setting, which they attend with their babies. The study group met regularly to learn how to make their own minimally processed baby foods, read and understand food labels, and offer peer support for any issues they might be encountering in raising their babies to eat healthfully.

Although many Hispanic families are affected by obesity, there is a need to teach and reinforce these skills in all families of young children affected by poverty, said Dr. Messito. “Middle and upper income people can also be affected by obesity, but they have the resources to deal with it, including education and nutritional support provided by insurance plans.”

The currently unpublished results of the study, based on 3 years of follow-up, are both statistically and clinically significant, said Dr. Messito. Only 6% of the families in the study group prematurely introduced complementary foods such as juices and solids compared with 17% in controls, according to Dr. Messito.

Exclusively breastfed babies in the control group totaled 34% compared with an impressive 46% in the study group, Dr. Messito said.

The potentially devastating consequences of resorting to quick-fixes such as cereal and juice at too young an age to sooth a fussy baby, is that at age 2 or 3 years, when it is still tricky to determine if they’ve exceeded the 95th percentile for their weight, these overfed babies can be on a trajectory that lasts long after they grow up. “If you are obese then, the odds are great you will be for life,” said Dr. Messito.

Much of the Starting Early study’s “plain language” materials, published in both English and Spanish, distributed to families as reinforcement to what they learn in their groups, was based on what is routinely provided by the federal Women, Infants, and Children (WIC) program, said Dr. Messito. “We see ourselves as collaborators with WIC and with primary care.”

This pleases Dr. Paul. “Pediatricians only have a limited amount of time for each visit, and an office setting is not very conducive to get in as in-depth a conversation as you would like, especially in well-child care. By meeting with several families at once, instead of delivering the same information five times, it can be done once in 100 minutes where everyone can be in on the discussion,” he said in an interview.

Partnering with others in the community not only adds another layer of support, it also takes the burden off the physician to do it all.

The NET-Works study (Now Everybody Together for Amazing and Healthful Kids), currently underway at the University of Minnesota, on the Twin Cities campus, includes the families of 500 preschoolers, followed for 3 years after being randomly assigned to standard care or an integrated model that features nutritional counseling, both at the primary care and community level, as well as a home-based intervention, and support from neighborhood and community resources to promote optimal healthful lifestyle habits, including diet and physical activity, and screen time limits. Results from the study are due in 2017.

“What I like about this study is that the pediatrician has a supporting, rather than leading, role in a community-wide effort to prevent and treat childhood obesity,” said Dr. Paul. “I think that’s the answer.”

Another model of community-based care, promoted by the CDC, leverages the time more than 60% of U.S. children spend in early education and care centers by linking various community resources with these early learning facilities to ensure that children learn to consume healthful foods and exercise.

Dr. Dianne Ward, professor of nutrition at the University of North Carolina, Chapel Hill, and a panelist at the IOM roundtable, noted that one hitch is that often the child care providers themselves are often unhealthy. “A number of studies show these women often have poor diets, stress, inactivity, and smoke, yet these are the same women we ask to be role models for our children and lead the healthy eating educational programs. It’s unclear whether their health status has a negative effect on the children.”

Dr. Paul’s own work with others such as Dr. Leann Birch, the William P. “Bill” Flatt Childhood Obesity Professor at the University of Georgia, Athens, focuses on home-based interventions delivered by nurses. By training parents and caregivers in what they call “responsive feeding,” their SLIM-Time study addresses how and why parents feed their children, rather than what they feed them, with the essential byproduct being greater capacity in both parents and children to self-soothe and exert self-control.

Similar to Dr. Messito’s work, SLIM-Time (Sleeping and Intake Methods Taught to Infants and Mothers Early in Life) “teaches people how to respond appropriately to a baby’s cues earlier in life. If you take a baby and give it a bottle, it will stop crying, whether or not [the baby is] hungry. Food should be used for hunger,” Dr. Paul said. “We teach parents to use food for hunger, not comfort.”

The results of the randomly controlled SLIM-Time study of 110 mother-infant dyads, published online in 2010, were that by teaching parents soothing and sleep strategies other than bottle feeding, and helping them to recognize satiety cues, as well as educating them on the appropriate time to introduce solid foods, study babies were encouraged to finish their bottles only half as often as were controls. At 1 year, study babies were in the 35th percentile for weight-for-length compared with 50% of controls. Babies in the test group also required fewer nighttime feedings than did controls at weeks 3, 4, 8, and 16 (P = .003) (Obesity. 2011 Feb; 19[2]: 353-61).

The results led Dr. Paul and his colleagues to create the similarly structured INSIGHT Study (Preventing Obesity Through Interventions During Infancy), the results of which are still in preparation, but preliminarily seem to reinforce SLIM-Time’s results, with 15% of controls being in the 95th or higher weight-per-length percentiles at 1 year compared with 5% of intervention group babies being in that range.

Dr. Birch stated during the IOM round table that the effects in each study group were similar, regardless of whether a child was fed formula or breast milk. “We still have a lot of data to analyze, but at this point, it looks like the effects aren’t limited to intense breastfeeding.” Breastfeeding has been found protective against obesity (Am J Epidemiol. 2005 Sept 1;162[5]:397-403. Epub 2005 Aug 2; Int J Obes Relat Metab Disord. 2004 Oct;28[10]:1247-56.)

Even though the literature for early childhood obesity intervention and prevention is nascent, it’s already evident that to see obesity primarily as a clinical issue is too limiting, according to Dr. Paul.

“This is the focus of my career, and I have state-of-the-art techniques. Yet, I still have plenty of obese patients of all ages in my care,” he said. How should he be reimbursed for treating these patients, particularly if some of them are already on the road to a lifetime of obesity, having been set upon it long before being diagnosed?

“I think a pediatrician should be responsible for delivering content and good advice, and addressing the health issues. That can be documented, and we can be scored on that” said Dr. Paul, but “it might be unfair to judge a pediatrician on the proportion of the number of children who are overweight or obese in his or her practice because there are so many factors that are going to be involved in that outcome.

“There is only so much we can do in the clinic.”

There were no conflicts of interest to report.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Physicians have a role in combating early childhood obesity, but experts say the clinical setting is not ideal for effective treatment and prevention of this emerging epidemic.

“Pediatricians have high access to kids, parents, and guardians, and we are trusted sources of information for them,” Dr. Ian Paul, professor and chief of academic pediatrics at Penn State University Hershey Medical Center, said at an Institute of Medicine forum on early childhood obesity.

Emerging data underscore obesity’s complex societal components, which include an imbalance of diet and physical activity complicated by less tangible factors such as cultural attitudes, maternal habits, and socio-economic status. And then there is the question of the best way to reimburse physicians for applying the few proven long-term interventions they have.

“I think it’s one of those things where it takes a village,” Dr. Paul said in an interview. “You need multiple people going in the same direction. The pediatrician can give advice, and support what is happening, but it can’t just be the pediatrician by him- or herself.”

The U.S. Centers for Disease Control and Prevention says that pediatric obesity affects a third of the nation’s youth. But there are only vague policies and guidelines for how to intervene in the preschool years, a time when research now shows risk factors present can set the stage for obesity later in a child’s life. This all leaves pediatricians unsure of how to treat young patients who present with signs of overweight and obesity. To date, there are no proven clinical-based obesity interventions for birth to age 5 years, Dr. Paul said. “Pediatricians don’t always feel equipped to handle questions about obesity prevention and treatment,” compounded, by the fact that, “reimbursement for these services has been poor.”

However, through partnerships with community organizations and other clinicians, more effective models of care are emerging, particularly in minority and lower income communities where obesity rates are among the highest nationally (Contemp Clin Trials. 2013 Nov;36[3]:544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9), noted Dr. Paul.

“In poorer households, high rates of maternal stress and less access to resources such as time with a nutritionist or higher quality produce and other foods, are risk factors for obesity,” Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital in New York, said in an interview.

As part of their program, Dr. Messito, clinical associate professor of pediatrics at New York University, and her colleagues conducted a study of a family-based, early obesity intervention and prevention program with nutrition support groups as the central component.

The study involved 534 expectant mothers in their last trimester who were randomly assigned to receive either standard prenatal care followed by standard well-child care, or prenatal nutritional counseling, in addition to well-child visits coupled with continued nutritional counseling in a group setting, which they attend with their babies. The study group met regularly to learn how to make their own minimally processed baby foods, read and understand food labels, and offer peer support for any issues they might be encountering in raising their babies to eat healthfully.

Although many Hispanic families are affected by obesity, there is a need to teach and reinforce these skills in all families of young children affected by poverty, said Dr. Messito. “Middle and upper income people can also be affected by obesity, but they have the resources to deal with it, including education and nutritional support provided by insurance plans.”

The currently unpublished results of the study, based on 3 years of follow-up, are both statistically and clinically significant, said Dr. Messito. Only 6% of the families in the study group prematurely introduced complementary foods such as juices and solids compared with 17% in controls, according to Dr. Messito.

Exclusively breastfed babies in the control group totaled 34% compared with an impressive 46% in the study group, Dr. Messito said.

The potentially devastating consequences of resorting to quick-fixes such as cereal and juice at too young an age to sooth a fussy baby, is that at age 2 or 3 years, when it is still tricky to determine if they’ve exceeded the 95th percentile for their weight, these overfed babies can be on a trajectory that lasts long after they grow up. “If you are obese then, the odds are great you will be for life,” said Dr. Messito.

Much of the Starting Early study’s “plain language” materials, published in both English and Spanish, distributed to families as reinforcement to what they learn in their groups, was based on what is routinely provided by the federal Women, Infants, and Children (WIC) program, said Dr. Messito. “We see ourselves as collaborators with WIC and with primary care.”

This pleases Dr. Paul. “Pediatricians only have a limited amount of time for each visit, and an office setting is not very conducive to get in as in-depth a conversation as you would like, especially in well-child care. By meeting with several families at once, instead of delivering the same information five times, it can be done once in 100 minutes where everyone can be in on the discussion,” he said in an interview.

Partnering with others in the community not only adds another layer of support, it also takes the burden off the physician to do it all.

The NET-Works study (Now Everybody Together for Amazing and Healthful Kids), currently underway at the University of Minnesota, on the Twin Cities campus, includes the families of 500 preschoolers, followed for 3 years after being randomly assigned to standard care or an integrated model that features nutritional counseling, both at the primary care and community level, as well as a home-based intervention, and support from neighborhood and community resources to promote optimal healthful lifestyle habits, including diet and physical activity, and screen time limits. Results from the study are due in 2017.

“What I like about this study is that the pediatrician has a supporting, rather than leading, role in a community-wide effort to prevent and treat childhood obesity,” said Dr. Paul. “I think that’s the answer.”

Another model of community-based care, promoted by the CDC, leverages the time more than 60% of U.S. children spend in early education and care centers by linking various community resources with these early learning facilities to ensure that children learn to consume healthful foods and exercise.

Dr. Dianne Ward, professor of nutrition at the University of North Carolina, Chapel Hill, and a panelist at the IOM roundtable, noted that one hitch is that often the child care providers themselves are often unhealthy. “A number of studies show these women often have poor diets, stress, inactivity, and smoke, yet these are the same women we ask to be role models for our children and lead the healthy eating educational programs. It’s unclear whether their health status has a negative effect on the children.”

Dr. Paul’s own work with others such as Dr. Leann Birch, the William P. “Bill” Flatt Childhood Obesity Professor at the University of Georgia, Athens, focuses on home-based interventions delivered by nurses. By training parents and caregivers in what they call “responsive feeding,” their SLIM-Time study addresses how and why parents feed their children, rather than what they feed them, with the essential byproduct being greater capacity in both parents and children to self-soothe and exert self-control.

Similar to Dr. Messito’s work, SLIM-Time (Sleeping and Intake Methods Taught to Infants and Mothers Early in Life) “teaches people how to respond appropriately to a baby’s cues earlier in life. If you take a baby and give it a bottle, it will stop crying, whether or not [the baby is] hungry. Food should be used for hunger,” Dr. Paul said. “We teach parents to use food for hunger, not comfort.”

The results of the randomly controlled SLIM-Time study of 110 mother-infant dyads, published online in 2010, were that by teaching parents soothing and sleep strategies other than bottle feeding, and helping them to recognize satiety cues, as well as educating them on the appropriate time to introduce solid foods, study babies were encouraged to finish their bottles only half as often as were controls. At 1 year, study babies were in the 35th percentile for weight-for-length compared with 50% of controls. Babies in the test group also required fewer nighttime feedings than did controls at weeks 3, 4, 8, and 16 (P = .003) (Obesity. 2011 Feb; 19[2]: 353-61).

The results led Dr. Paul and his colleagues to create the similarly structured INSIGHT Study (Preventing Obesity Through Interventions During Infancy), the results of which are still in preparation, but preliminarily seem to reinforce SLIM-Time’s results, with 15% of controls being in the 95th or higher weight-per-length percentiles at 1 year compared with 5% of intervention group babies being in that range.

Dr. Birch stated during the IOM round table that the effects in each study group were similar, regardless of whether a child was fed formula or breast milk. “We still have a lot of data to analyze, but at this point, it looks like the effects aren’t limited to intense breastfeeding.” Breastfeeding has been found protective against obesity (Am J Epidemiol. 2005 Sept 1;162[5]:397-403. Epub 2005 Aug 2; Int J Obes Relat Metab Disord. 2004 Oct;28[10]:1247-56.)

Even though the literature for early childhood obesity intervention and prevention is nascent, it’s already evident that to see obesity primarily as a clinical issue is too limiting, according to Dr. Paul.

“This is the focus of my career, and I have state-of-the-art techniques. Yet, I still have plenty of obese patients of all ages in my care,” he said. How should he be reimbursed for treating these patients, particularly if some of them are already on the road to a lifetime of obesity, having been set upon it long before being diagnosed?

“I think a pediatrician should be responsible for delivering content and good advice, and addressing the health issues. That can be documented, and we can be scored on that” said Dr. Paul, but “it might be unfair to judge a pediatrician on the proportion of the number of children who are overweight or obese in his or her practice because there are so many factors that are going to be involved in that outcome.

“There is only so much we can do in the clinic.”

There were no conflicts of interest to report.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Physicians have a role in combating early childhood obesity, but experts say the clinical setting is not ideal for effective treatment and prevention of this emerging epidemic.

“Pediatricians have high access to kids, parents, and guardians, and we are trusted sources of information for them,” Dr. Ian Paul, professor and chief of academic pediatrics at Penn State University Hershey Medical Center, said at an Institute of Medicine forum on early childhood obesity.

Emerging data underscore obesity’s complex societal components, which include an imbalance of diet and physical activity complicated by less tangible factors such as cultural attitudes, maternal habits, and socio-economic status. And then there is the question of the best way to reimburse physicians for applying the few proven long-term interventions they have.

“I think it’s one of those things where it takes a village,” Dr. Paul said in an interview. “You need multiple people going in the same direction. The pediatrician can give advice, and support what is happening, but it can’t just be the pediatrician by him- or herself.”

The U.S. Centers for Disease Control and Prevention says that pediatric obesity affects a third of the nation’s youth. But there are only vague policies and guidelines for how to intervene in the preschool years, a time when research now shows risk factors present can set the stage for obesity later in a child’s life. This all leaves pediatricians unsure of how to treat young patients who present with signs of overweight and obesity. To date, there are no proven clinical-based obesity interventions for birth to age 5 years, Dr. Paul said. “Pediatricians don’t always feel equipped to handle questions about obesity prevention and treatment,” compounded, by the fact that, “reimbursement for these services has been poor.”

However, through partnerships with community organizations and other clinicians, more effective models of care are emerging, particularly in minority and lower income communities where obesity rates are among the highest nationally (Contemp Clin Trials. 2013 Nov;36[3]:544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9), noted Dr. Paul.

“In poorer households, high rates of maternal stress and less access to resources such as time with a nutritionist or higher quality produce and other foods, are risk factors for obesity,” Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital in New York, said in an interview.

As part of their program, Dr. Messito, clinical associate professor of pediatrics at New York University, and her colleagues conducted a study of a family-based, early obesity intervention and prevention program with nutrition support groups as the central component.

The study involved 534 expectant mothers in their last trimester who were randomly assigned to receive either standard prenatal care followed by standard well-child care, or prenatal nutritional counseling, in addition to well-child visits coupled with continued nutritional counseling in a group setting, which they attend with their babies. The study group met regularly to learn how to make their own minimally processed baby foods, read and understand food labels, and offer peer support for any issues they might be encountering in raising their babies to eat healthfully.

Although many Hispanic families are affected by obesity, there is a need to teach and reinforce these skills in all families of young children affected by poverty, said Dr. Messito. “Middle and upper income people can also be affected by obesity, but they have the resources to deal with it, including education and nutritional support provided by insurance plans.”

The currently unpublished results of the study, based on 3 years of follow-up, are both statistically and clinically significant, said Dr. Messito. Only 6% of the families in the study group prematurely introduced complementary foods such as juices and solids compared with 17% in controls, according to Dr. Messito.

Exclusively breastfed babies in the control group totaled 34% compared with an impressive 46% in the study group, Dr. Messito said.

The potentially devastating consequences of resorting to quick-fixes such as cereal and juice at too young an age to sooth a fussy baby, is that at age 2 or 3 years, when it is still tricky to determine if they’ve exceeded the 95th percentile for their weight, these overfed babies can be on a trajectory that lasts long after they grow up. “If you are obese then, the odds are great you will be for life,” said Dr. Messito.

Much of the Starting Early study’s “plain language” materials, published in both English and Spanish, distributed to families as reinforcement to what they learn in their groups, was based on what is routinely provided by the federal Women, Infants, and Children (WIC) program, said Dr. Messito. “We see ourselves as collaborators with WIC and with primary care.”

This pleases Dr. Paul. “Pediatricians only have a limited amount of time for each visit, and an office setting is not very conducive to get in as in-depth a conversation as you would like, especially in well-child care. By meeting with several families at once, instead of delivering the same information five times, it can be done once in 100 minutes where everyone can be in on the discussion,” he said in an interview.

Partnering with others in the community not only adds another layer of support, it also takes the burden off the physician to do it all.

The NET-Works study (Now Everybody Together for Amazing and Healthful Kids), currently underway at the University of Minnesota, on the Twin Cities campus, includes the families of 500 preschoolers, followed for 3 years after being randomly assigned to standard care or an integrated model that features nutritional counseling, both at the primary care and community level, as well as a home-based intervention, and support from neighborhood and community resources to promote optimal healthful lifestyle habits, including diet and physical activity, and screen time limits. Results from the study are due in 2017.

“What I like about this study is that the pediatrician has a supporting, rather than leading, role in a community-wide effort to prevent and treat childhood obesity,” said Dr. Paul. “I think that’s the answer.”

Another model of community-based care, promoted by the CDC, leverages the time more than 60% of U.S. children spend in early education and care centers by linking various community resources with these early learning facilities to ensure that children learn to consume healthful foods and exercise.

Dr. Dianne Ward, professor of nutrition at the University of North Carolina, Chapel Hill, and a panelist at the IOM roundtable, noted that one hitch is that often the child care providers themselves are often unhealthy. “A number of studies show these women often have poor diets, stress, inactivity, and smoke, yet these are the same women we ask to be role models for our children and lead the healthy eating educational programs. It’s unclear whether their health status has a negative effect on the children.”

Dr. Paul’s own work with others such as Dr. Leann Birch, the William P. “Bill” Flatt Childhood Obesity Professor at the University of Georgia, Athens, focuses on home-based interventions delivered by nurses. By training parents and caregivers in what they call “responsive feeding,” their SLIM-Time study addresses how and why parents feed their children, rather than what they feed them, with the essential byproduct being greater capacity in both parents and children to self-soothe and exert self-control.

Similar to Dr. Messito’s work, SLIM-Time (Sleeping and Intake Methods Taught to Infants and Mothers Early in Life) “teaches people how to respond appropriately to a baby’s cues earlier in life. If you take a baby and give it a bottle, it will stop crying, whether or not [the baby is] hungry. Food should be used for hunger,” Dr. Paul said. “We teach parents to use food for hunger, not comfort.”

The results of the randomly controlled SLIM-Time study of 110 mother-infant dyads, published online in 2010, were that by teaching parents soothing and sleep strategies other than bottle feeding, and helping them to recognize satiety cues, as well as educating them on the appropriate time to introduce solid foods, study babies were encouraged to finish their bottles only half as often as were controls. At 1 year, study babies were in the 35th percentile for weight-for-length compared with 50% of controls. Babies in the test group also required fewer nighttime feedings than did controls at weeks 3, 4, 8, and 16 (P = .003) (Obesity. 2011 Feb; 19[2]: 353-61).

The results led Dr. Paul and his colleagues to create the similarly structured INSIGHT Study (Preventing Obesity Through Interventions During Infancy), the results of which are still in preparation, but preliminarily seem to reinforce SLIM-Time’s results, with 15% of controls being in the 95th or higher weight-per-length percentiles at 1 year compared with 5% of intervention group babies being in that range.

Dr. Birch stated during the IOM round table that the effects in each study group were similar, regardless of whether a child was fed formula or breast milk. “We still have a lot of data to analyze, but at this point, it looks like the effects aren’t limited to intense breastfeeding.” Breastfeeding has been found protective against obesity (Am J Epidemiol. 2005 Sept 1;162[5]:397-403. Epub 2005 Aug 2; Int J Obes Relat Metab Disord. 2004 Oct;28[10]:1247-56.)

Even though the literature for early childhood obesity intervention and prevention is nascent, it’s already evident that to see obesity primarily as a clinical issue is too limiting, according to Dr. Paul.

“This is the focus of my career, and I have state-of-the-art techniques. Yet, I still have plenty of obese patients of all ages in my care,” he said. How should he be reimbursed for treating these patients, particularly if some of them are already on the road to a lifetime of obesity, having been set upon it long before being diagnosed?

“I think a pediatrician should be responsible for delivering content and good advice, and addressing the health issues. That can be documented, and we can be scored on that” said Dr. Paul, but “it might be unfair to judge a pediatrician on the proportion of the number of children who are overweight or obese in his or her practice because there are so many factors that are going to be involved in that outcome.

“There is only so much we can do in the clinic.”

There were no conflicts of interest to report.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Childhood obesity is soaring in the United States, especially among Hispanic and African-American children. At the heart of this “epidemic” are dietary and behavioral factors that are linked to stress and poverty rather than race and ethnicity, and the risks may even begin prenatally, according to experts attending an Institute of Medicine forum on early childhood obesity.

Based on data from the 2009-2010 NHANES (National Health and Nutrition Examination Survey), over 8% of children aged 2-5 years in the United States are obese; based on ethnicity, 18% of Hispanic boys and 15% of Hispanic girls in this age group are obese. Nearly 18% of U.S. children aged 6-11 years are obese; nearly 29% of Hispanic boys and 26% of non-Hispanic black girls in this age group are obese.

“If we’re looking for reasons why black and Hispanic children have these disparities ... then we’re looking at what happens in their early years and during pregnancy,” Dr. Elsie Taveras, chief of general academic pediatrics at Massachusetts General Hospital, Boston, said at the IOM meeting.

Chief among the culprits responsible for the “metabolic programming of risk” is the mother’s pregestational weight, according to Dr. Lisa Bodnar, associate professor of endocrinology at the University of Pittsburgh. “Children may already be programmed to become obese as a result of their intrauterine exposure to an obesogenic environment.”

A 2013 report from the Centers for Disease Control and Prevention found that about 1 in 5 women aged 20 years and older who delivered a live-born infant in 2009 were obese prior to becoming pregnant. The prevalence of obesity was highest among women who were 35 years of age and older (24%); were black, non-Hispanic (32%); had a high school education (28%); and reported Medicaid as their source of insurance coverage before pregnancy (30%). The prevalence of obesity was lowest among women who were 20-34 years of age (22%); were of “other” race/ethnicity (13%); had more than a high school education (20%); and who reported having private insurance coverage before pregnancy (20%), according to the report.

Studies have established that pre-pregnancy body mass index is highly correlated with rates of childhood obesity, but Dr. Bodnar believes the most elegant study, published in Pediatrics in 2004, links the birth records of 8,500 children born to low-income mothers in Ohio with corresponding Women, Infants, and Children data for their children’s respective weights and heights at ages 2, 3, and 4 years. Mothers with pre-pregnancy BMIs in the obese and severely obese ranges had a 3-4 times greater probability that their children had similar BMIs.

More recent U.S. data show that nearly half of all expectant mothers with normal pregravid weights also gain more weight prenatally than the IOM-recommended amounts. The tendency is even more prevalent in those with BMIs in the overweight and obese ranges: 70% of women with pre-gestational BMIs between 25 and 29.9, and 65% of those with BMIs of 30 and over gain too much weight. A 2013 meta-analysis published in JAMA correlated these weight gain patterns with a 90% increased risk of children being obese before the age of 5 years, and a 40% overall lifetime increased risk of obesity.

Stress and sociodemographic factors also can contribute to overeating and unhealthy eating, Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital, New York, said in an interview. “High stress can lead to eating higher levels of sugary and processed food.” In lower socioeconomic neighborhoods, processed and fast foods can also be more affordable and more readily available, she added.

At least one study (Sleep Med Rev. 2012 Jun;16[3]:203-11) has established a link between later bedtimes and obesity.

This generation of children sleeps nearly a half hour less per night than did their parents, Dr. Taveras said, and the culprits include later bedtimes, the intake of caffeinated and sugary beverages, and electronic intrusions. A television left on in the room where the child sleeps can make the child dependent upon external means rather than self regulation for putting themselves to sleep, according to Dr. Taveras’ research, published in Pediatrics.

Dr. Taveras also lead a 7-year prospective prebirth cohort study (JAMA Pediatr. 2013 Aug 1;167[8]:731-8) of 1,116 mother and child dyads. In that study, the higher levels of obesity in racial and ethnic minority children were linked to modifiable risk factors. Black and Hispanic 2-year-olds were twice as likely as white ones to have had a cola or other sweetened or caffeinated drink prior to bedtime. By age 4 years, 6.4% of white children, 53% of black children, and 61% of Hispanic children in the study fell to sleep with a television on.

“Dietary patterns in the U.S. are poor, start early, and persist,” Dr. Jose M. Saavedra, chief medical officer for the nutrition division of Nestle USA, said at the meeting. Recently published data in Journal of Obesity (doi: 10.1155/2012/123023) indicate that children who consume sugar-sweetened beverages during infancy are twice as likely to consume them at age 6 years. Similarly, children who do not consume fruits and vegetables daily in infancy were also found to consume them infrequently at the age of 6.

“The patterns start much earlier than what we’ve been paying attention to,” said Dr. Saavedra. He thinks that the window of behavioral plasticity is widest at age 20 months, and urged his peers to find ways to help parents to establish good habits in their children during that time.

Discussing healthy behaviors with parents can help, and may elicit some parental behaviors that can be corrected. During the question and answer session at the meeting, for example, an audience member shared an anecdote about a mother who would only serve her children soda because she’d come from an island nation where the water supply was often unsafe.

Others noted that parents and grandparents who have grown up under conditions of food scarcity can view a “chubby” baby as a healthy baby. Mothers also can feel pressured into overfeeding infants, beginning with supplementing formula.

Also, food is often used as a quick and easy reward, Dr. Messito said. When money is tight, a cookie is an inexpensive treat.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Childhood obesity is soaring in the United States, especially among Hispanic and African-American children. At the heart of this “epidemic” are dietary and behavioral factors that are linked to stress and poverty rather than race and ethnicity, and the risks may even begin prenatally, according to experts attending an Institute of Medicine forum on early childhood obesity.

Based on data from the 2009-2010 NHANES (National Health and Nutrition Examination Survey), over 8% of children aged 2-5 years in the United States are obese; based on ethnicity, 18% of Hispanic boys and 15% of Hispanic girls in this age group are obese. Nearly 18% of U.S. children aged 6-11 years are obese; nearly 29% of Hispanic boys and 26% of non-Hispanic black girls in this age group are obese.

“If we’re looking for reasons why black and Hispanic children have these disparities ... then we’re looking at what happens in their early years and during pregnancy,” Dr. Elsie Taveras, chief of general academic pediatrics at Massachusetts General Hospital, Boston, said at the IOM meeting.

Chief among the culprits responsible for the “metabolic programming of risk” is the mother’s pregestational weight, according to Dr. Lisa Bodnar, associate professor of endocrinology at the University of Pittsburgh. “Children may already be programmed to become obese as a result of their intrauterine exposure to an obesogenic environment.”

A 2013 report from the Centers for Disease Control and Prevention found that about 1 in 5 women aged 20 years and older who delivered a live-born infant in 2009 were obese prior to becoming pregnant. The prevalence of obesity was highest among women who were 35 years of age and older (24%); were black, non-Hispanic (32%); had a high school education (28%); and reported Medicaid as their source of insurance coverage before pregnancy (30%). The prevalence of obesity was lowest among women who were 20-34 years of age (22%); were of “other” race/ethnicity (13%); had more than a high school education (20%); and who reported having private insurance coverage before pregnancy (20%), according to the report.

Studies have established that pre-pregnancy body mass index is highly correlated with rates of childhood obesity, but Dr. Bodnar believes the most elegant study, published in Pediatrics in 2004, links the birth records of 8,500 children born to low-income mothers in Ohio with corresponding Women, Infants, and Children data for their children’s respective weights and heights at ages 2, 3, and 4 years. Mothers with pre-pregnancy BMIs in the obese and severely obese ranges had a 3-4 times greater probability that their children had similar BMIs.

More recent U.S. data show that nearly half of all expectant mothers with normal pregravid weights also gain more weight prenatally than the IOM-recommended amounts. The tendency is even more prevalent in those with BMIs in the overweight and obese ranges: 70% of women with pre-gestational BMIs between 25 and 29.9, and 65% of those with BMIs of 30 and over gain too much weight. A 2013 meta-analysis published in JAMA correlated these weight gain patterns with a 90% increased risk of children being obese before the age of 5 years, and a 40% overall lifetime increased risk of obesity.

Stress and sociodemographic factors also can contribute to overeating and unhealthy eating, Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital, New York, said in an interview. “High stress can lead to eating higher levels of sugary and processed food.” In lower socioeconomic neighborhoods, processed and fast foods can also be more affordable and more readily available, she added.

At least one study (Sleep Med Rev. 2012 Jun;16[3]:203-11) has established a link between later bedtimes and obesity.

This generation of children sleeps nearly a half hour less per night than did their parents, Dr. Taveras said, and the culprits include later bedtimes, the intake of caffeinated and sugary beverages, and electronic intrusions. A television left on in the room where the child sleeps can make the child dependent upon external means rather than self regulation for putting themselves to sleep, according to Dr. Taveras’ research, published in Pediatrics.

Dr. Taveras also lead a 7-year prospective prebirth cohort study (JAMA Pediatr. 2013 Aug 1;167[8]:731-8) of 1,116 mother and child dyads. In that study, the higher levels of obesity in racial and ethnic minority children were linked to modifiable risk factors. Black and Hispanic 2-year-olds were twice as likely as white ones to have had a cola or other sweetened or caffeinated drink prior to bedtime. By age 4 years, 6.4% of white children, 53% of black children, and 61% of Hispanic children in the study fell to sleep with a television on.

“Dietary patterns in the U.S. are poor, start early, and persist,” Dr. Jose M. Saavedra, chief medical officer for the nutrition division of Nestle USA, said at the meeting. Recently published data in Journal of Obesity (doi: 10.1155/2012/123023) indicate that children who consume sugar-sweetened beverages during infancy are twice as likely to consume them at age 6 years. Similarly, children who do not consume fruits and vegetables daily in infancy were also found to consume them infrequently at the age of 6.

“The patterns start much earlier than what we’ve been paying attention to,” said Dr. Saavedra. He thinks that the window of behavioral plasticity is widest at age 20 months, and urged his peers to find ways to help parents to establish good habits in their children during that time.

Discussing healthy behaviors with parents can help, and may elicit some parental behaviors that can be corrected. During the question and answer session at the meeting, for example, an audience member shared an anecdote about a mother who would only serve her children soda because she’d come from an island nation where the water supply was often unsafe.

Others noted that parents and grandparents who have grown up under conditions of food scarcity can view a “chubby” baby as a healthy baby. Mothers also can feel pressured into overfeeding infants, beginning with supplementing formula.

Also, food is often used as a quick and easy reward, Dr. Messito said. When money is tight, a cookie is an inexpensive treat.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Childhood obesity is soaring in the United States, especially among Hispanic and African-American children. At the heart of this “epidemic” are dietary and behavioral factors that are linked to stress and poverty rather than race and ethnicity, and the risks may even begin prenatally, according to experts attending an Institute of Medicine forum on early childhood obesity.

Based on data from the 2009-2010 NHANES (National Health and Nutrition Examination Survey), over 8% of children aged 2-5 years in the United States are obese; based on ethnicity, 18% of Hispanic boys and 15% of Hispanic girls in this age group are obese. Nearly 18% of U.S. children aged 6-11 years are obese; nearly 29% of Hispanic boys and 26% of non-Hispanic black girls in this age group are obese.

“If we’re looking for reasons why black and Hispanic children have these disparities ... then we’re looking at what happens in their early years and during pregnancy,” Dr. Elsie Taveras, chief of general academic pediatrics at Massachusetts General Hospital, Boston, said at the IOM meeting.

Chief among the culprits responsible for the “metabolic programming of risk” is the mother’s pregestational weight, according to Dr. Lisa Bodnar, associate professor of endocrinology at the University of Pittsburgh. “Children may already be programmed to become obese as a result of their intrauterine exposure to an obesogenic environment.”

A 2013 report from the Centers for Disease Control and Prevention found that about 1 in 5 women aged 20 years and older who delivered a live-born infant in 2009 were obese prior to becoming pregnant. The prevalence of obesity was highest among women who were 35 years of age and older (24%); were black, non-Hispanic (32%); had a high school education (28%); and reported Medicaid as their source of insurance coverage before pregnancy (30%). The prevalence of obesity was lowest among women who were 20-34 years of age (22%); were of “other” race/ethnicity (13%); had more than a high school education (20%); and who reported having private insurance coverage before pregnancy (20%), according to the report.

Studies have established that pre-pregnancy body mass index is highly correlated with rates of childhood obesity, but Dr. Bodnar believes the most elegant study, published in Pediatrics in 2004, links the birth records of 8,500 children born to low-income mothers in Ohio with corresponding Women, Infants, and Children data for their children’s respective weights and heights at ages 2, 3, and 4 years. Mothers with pre-pregnancy BMIs in the obese and severely obese ranges had a 3-4 times greater probability that their children had similar BMIs.

More recent U.S. data show that nearly half of all expectant mothers with normal pregravid weights also gain more weight prenatally than the IOM-recommended amounts. The tendency is even more prevalent in those with BMIs in the overweight and obese ranges: 70% of women with pre-gestational BMIs between 25 and 29.9, and 65% of those with BMIs of 30 and over gain too much weight. A 2013 meta-analysis published in JAMA correlated these weight gain patterns with a 90% increased risk of children being obese before the age of 5 years, and a 40% overall lifetime increased risk of obesity.

Stress and sociodemographic factors also can contribute to overeating and unhealthy eating, Dr. Mary Jo Messito, director of the Starting Early Child Obesity Prevention Program at Bellevue Hospital, New York, said in an interview. “High stress can lead to eating higher levels of sugary and processed food.” In lower socioeconomic neighborhoods, processed and fast foods can also be more affordable and more readily available, she added.

At least one study (Sleep Med Rev. 2012 Jun;16[3]:203-11) has established a link between later bedtimes and obesity.

This generation of children sleeps nearly a half hour less per night than did their parents, Dr. Taveras said, and the culprits include later bedtimes, the intake of caffeinated and sugary beverages, and electronic intrusions. A television left on in the room where the child sleeps can make the child dependent upon external means rather than self regulation for putting themselves to sleep, according to Dr. Taveras’ research, published in Pediatrics.

Dr. Taveras also lead a 7-year prospective prebirth cohort study (JAMA Pediatr. 2013 Aug 1;167[8]:731-8) of 1,116 mother and child dyads. In that study, the higher levels of obesity in racial and ethnic minority children were linked to modifiable risk factors. Black and Hispanic 2-year-olds were twice as likely as white ones to have had a cola or other sweetened or caffeinated drink prior to bedtime. By age 4 years, 6.4% of white children, 53% of black children, and 61% of Hispanic children in the study fell to sleep with a television on.

“Dietary patterns in the U.S. are poor, start early, and persist,” Dr. Jose M. Saavedra, chief medical officer for the nutrition division of Nestle USA, said at the meeting. Recently published data in Journal of Obesity (doi: 10.1155/2012/123023) indicate that children who consume sugar-sweetened beverages during infancy are twice as likely to consume them at age 6 years. Similarly, children who do not consume fruits and vegetables daily in infancy were also found to consume them infrequently at the age of 6.

“The patterns start much earlier than what we’ve been paying attention to,” said Dr. Saavedra. He thinks that the window of behavioral plasticity is widest at age 20 months, and urged his peers to find ways to help parents to establish good habits in their children during that time.

Discussing healthy behaviors with parents can help, and may elicit some parental behaviors that can be corrected. During the question and answer session at the meeting, for example, an audience member shared an anecdote about a mother who would only serve her children soda because she’d come from an island nation where the water supply was often unsafe.

Others noted that parents and grandparents who have grown up under conditions of food scarcity can view a “chubby” baby as a healthy baby. Mothers also can feel pressured into overfeeding infants, beginning with supplementing formula.

Also, food is often used as a quick and easy reward, Dr. Messito said. When money is tight, a cookie is an inexpensive treat.

[email protected]

On Twitter @whitneymcknight

The first-ever report on substance use and addiction to be commissioned by a U.S. surgeon general is expected later this year, the Obama administration has announced.

The report is intended to be a comprehensive examination of the effects of drugs and alcohol on health and will include perspectives on the continuum of addiction care, as well as explore the epidemiologic, etiologic, and neurobiologic factors that contribute to substance use and addiction.

U.S. Surgeon General Vivek H. Murthy last year announced his intention to commission the report at a rally held in Washington to draw attention to the number of Americans affected by addiction. “We’re going to look at the best science on everything, from heroin and marijuana, to alcohol and prescription opioids,” Dr. Murthy said at the Unite to Face Addiction campaign last October. “We’ll use this report to find a way forward, together ... because we know that we need a comprehensive approach. And we’re going to launch a national campaign to tackle the prescription drug crisis, because we know that someone dies from an opioid overdose every 24 minutes in this country.”

Data from the 2014 National Survey on Drug Use and Health showed that 21.5 million Americans aged 12 years or older met DSM-IV criteria for alcohol or illicit drug dependence or abuse. Meanwhile, despite expansions in health coverage because of the Affordable Care Act and greater attention to mental health parity, only 2.3 million people received treatment in the past year, the Department of Health & Human Services said Dec. 31, in a Federal Register notice confirming plans to issue the report.

[email protected]

On Twitter @whitneymcknight

The first-ever report on substance use and addiction to be commissioned by a U.S. surgeon general is expected later this year, the Obama administration has announced.

The report is intended to be a comprehensive examination of the effects of drugs and alcohol on health and will include perspectives on the continuum of addiction care, as well as explore the epidemiologic, etiologic, and neurobiologic factors that contribute to substance use and addiction.

U.S. Surgeon General Vivek H. Murthy last year announced his intention to commission the report at a rally held in Washington to draw attention to the number of Americans affected by addiction. “We’re going to look at the best science on everything, from heroin and marijuana, to alcohol and prescription opioids,” Dr. Murthy said at the Unite to Face Addiction campaign last October. “We’ll use this report to find a way forward, together ... because we know that we need a comprehensive approach. And we’re going to launch a national campaign to tackle the prescription drug crisis, because we know that someone dies from an opioid overdose every 24 minutes in this country.”

Data from the 2014 National Survey on Drug Use and Health showed that 21.5 million Americans aged 12 years or older met DSM-IV criteria for alcohol or illicit drug dependence or abuse. Meanwhile, despite expansions in health coverage because of the Affordable Care Act and greater attention to mental health parity, only 2.3 million people received treatment in the past year, the Department of Health & Human Services said Dec. 31, in a Federal Register notice confirming plans to issue the report.

[email protected]

On Twitter @whitneymcknight

The first-ever report on substance use and addiction to be commissioned by a U.S. surgeon general is expected later this year, the Obama administration has announced.

The report is intended to be a comprehensive examination of the effects of drugs and alcohol on health and will include perspectives on the continuum of addiction care, as well as explore the epidemiologic, etiologic, and neurobiologic factors that contribute to substance use and addiction.

U.S. Surgeon General Vivek H. Murthy last year announced his intention to commission the report at a rally held in Washington to draw attention to the number of Americans affected by addiction. “We’re going to look at the best science on everything, from heroin and marijuana, to alcohol and prescription opioids,” Dr. Murthy said at the Unite to Face Addiction campaign last October. “We’ll use this report to find a way forward, together ... because we know that we need a comprehensive approach. And we’re going to launch a national campaign to tackle the prescription drug crisis, because we know that someone dies from an opioid overdose every 24 minutes in this country.”

Data from the 2014 National Survey on Drug Use and Health showed that 21.5 million Americans aged 12 years or older met DSM-IV criteria for alcohol or illicit drug dependence or abuse. Meanwhile, despite expansions in health coverage because of the Affordable Care Act and greater attention to mental health parity, only 2.3 million people received treatment in the past year, the Department of Health & Human Services said Dec. 31, in a Federal Register notice confirming plans to issue the report.

[email protected]

On Twitter @whitneymcknight

Now that data indicate 7 out of 10 American youth are routinely exposed to electronic cigarette imagery, the Centers for Disease Control and Prevention are calling for restrictions on how e-cigarettes are marketed to teens.

“The same advertising tactics the tobacco industry used years ago to get kids addicted to nicotine are now being used to entice a new generation of young people to use e-cigarettes,” CDC director Dr. Thomas R. Frieden said in a media briefing. “I hope all can agree that kids should not use e-cigarettes.”

librakv/Thinkstock.com

Data from the 2014 National Youth Tobacco Use Survey of 22,007 students in grades 6-12 indicated that 18.3 million youth take in imagery depicting e-cigarette use as desirable. Over half of all respondents reported retail establishments were responsible for their exposure to e-cigarette marketing. Nearly 40% said they were exposed to e-cigarette ads online, with more than a third saying they saw such advertising on television and in movies. A quarter reported seeing e-cigarette ads in print media (MMWR. 2016 Jan 5; 64[Early Release]:1-6).

E-cigarettes deliver nicotine and other additives to users in aerosol form by way of a battery-powered device. Tobacco use in teens has been implicated in thwarting healthy brain development, and to the development of lifelong addictions.

Marketing the electronic nicotine delivery devices to young Americans as expressions of “independence, rebellion, and sex” is no different from the tobacco industry’s past tactics for addicting youth to regular tobacco products, according to a CDC statement. In 2014, the CDC reported e-cigarettes had surpassed conventional cigarette use by U.S. teens, rising from 1.5% to 13.4% in high schoolers and from 0.6% to 3.9% in middle school-aged students between 2011 and 2014. Concurrently, industry spending on e-cigarette marketing exploded from $6.4 million to $115 million, according to a CDC statement.

Fearing a reversal of the progress made over the years in curbing tobacco use among teens, the CDC is calling for tighter controls on how e-cigarettes are sold. Among its suggested strategies are limiting the sale of nicotine-based products only to facilities where youth are not permitted; creating “tobacco-sales-free” zones around schools; banning online sales of e-cigarettes; and requiring age verification for the purchase and delivery acceptance of e-cigarettes or before customers can enter e-cigarette vendors’ websites.

The CDC also is calling upon health care providers to counsel younger patients about the dangers of tobacco use, including e-cigarettes, to encourage those who use such products to quit, and to offer assistance with quitting.

[email protected]

On Twitter @whitneymcknight

Now that data indicate 7 out of 10 American youth are routinely exposed to electronic cigarette imagery, the Centers for Disease Control and Prevention are calling for restrictions on how e-cigarettes are marketed to teens.

“The same advertising tactics the tobacco industry used years ago to get kids addicted to nicotine are now being used to entice a new generation of young people to use e-cigarettes,” CDC director Dr. Thomas R. Frieden said in a media briefing. “I hope all can agree that kids should not use e-cigarettes.”

librakv/Thinkstock.com

Data from the 2014 National Youth Tobacco Use Survey of 22,007 students in grades 6-12 indicated that 18.3 million youth take in imagery depicting e-cigarette use as desirable. Over half of all respondents reported retail establishments were responsible for their exposure to e-cigarette marketing. Nearly 40% said they were exposed to e-cigarette ads online, with more than a third saying they saw such advertising on television and in movies. A quarter reported seeing e-cigarette ads in print media (MMWR. 2016 Jan 5; 64[Early Release]:1-6).

E-cigarettes deliver nicotine and other additives to users in aerosol form by way of a battery-powered device. Tobacco use in teens has been implicated in thwarting healthy brain development, and to the development of lifelong addictions.

Marketing the electronic nicotine delivery devices to young Americans as expressions of “independence, rebellion, and sex” is no different from the tobacco industry’s past tactics for addicting youth to regular tobacco products, according to a CDC statement. In 2014, the CDC reported e-cigarettes had surpassed conventional cigarette use by U.S. teens, rising from 1.5% to 13.4% in high schoolers and from 0.6% to 3.9% in middle school-aged students between 2011 and 2014. Concurrently, industry spending on e-cigarette marketing exploded from $6.4 million to $115 million, according to a CDC statement.

Fearing a reversal of the progress made over the years in curbing tobacco use among teens, the CDC is calling for tighter controls on how e-cigarettes are sold. Among its suggested strategies are limiting the sale of nicotine-based products only to facilities where youth are not permitted; creating “tobacco-sales-free” zones around schools; banning online sales of e-cigarettes; and requiring age verification for the purchase and delivery acceptance of e-cigarettes or before customers can enter e-cigarette vendors’ websites.

The CDC also is calling upon health care providers to counsel younger patients about the dangers of tobacco use, including e-cigarettes, to encourage those who use such products to quit, and to offer assistance with quitting.

[email protected]

On Twitter @whitneymcknight

Now that data indicate 7 out of 10 American youth are routinely exposed to electronic cigarette imagery, the Centers for Disease Control and Prevention are calling for restrictions on how e-cigarettes are marketed to teens.

“The same advertising tactics the tobacco industry used years ago to get kids addicted to nicotine are now being used to entice a new generation of young people to use e-cigarettes,” CDC director Dr. Thomas R. Frieden said in a media briefing. “I hope all can agree that kids should not use e-cigarettes.”

librakv/Thinkstock.com

Data from the 2014 National Youth Tobacco Use Survey of 22,007 students in grades 6-12 indicated that 18.3 million youth take in imagery depicting e-cigarette use as desirable. Over half of all respondents reported retail establishments were responsible for their exposure to e-cigarette marketing. Nearly 40% said they were exposed to e-cigarette ads online, with more than a third saying they saw such advertising on television and in movies. A quarter reported seeing e-cigarette ads in print media (MMWR. 2016 Jan 5; 64[Early Release]:1-6).

E-cigarettes deliver nicotine and other additives to users in aerosol form by way of a battery-powered device. Tobacco use in teens has been implicated in thwarting healthy brain development, and to the development of lifelong addictions.

Marketing the electronic nicotine delivery devices to young Americans as expressions of “independence, rebellion, and sex” is no different from the tobacco industry’s past tactics for addicting youth to regular tobacco products, according to a CDC statement. In 2014, the CDC reported e-cigarettes had surpassed conventional cigarette use by U.S. teens, rising from 1.5% to 13.4% in high schoolers and from 0.6% to 3.9% in middle school-aged students between 2011 and 2014. Concurrently, industry spending on e-cigarette marketing exploded from $6.4 million to $115 million, according to a CDC statement.

Fearing a reversal of the progress made over the years in curbing tobacco use among teens, the CDC is calling for tighter controls on how e-cigarettes are sold. Among its suggested strategies are limiting the sale of nicotine-based products only to facilities where youth are not permitted; creating “tobacco-sales-free” zones around schools; banning online sales of e-cigarettes; and requiring age verification for the purchase and delivery acceptance of e-cigarettes or before customers can enter e-cigarette vendors’ websites.

The CDC also is calling upon health care providers to counsel younger patients about the dangers of tobacco use, including e-cigarettes, to encourage those who use such products to quit, and to offer assistance with quitting.

[email protected]

On Twitter @whitneymcknight

ORLANDO – A range of novel therapies are set to come online for the treatment of inflammatory bowel disease (IBD), but they will miss the mark when it comes to meeting the need for better, longer-lasting outcomes, according to one expert.

“We’re positioning our therapies all wrong,” Dr. Stephen Hanauer said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

“In psoriasis, patients are immediately given effective treatment with ustekinumab, but in IBD, we have to wait for patients to fail multiple therapies before they are given an effective one,” said Dr. Hanauer, who is the Clifford Joseph Barborka Professor of Medicine in the division of gastroenterology and hepatology at Northwestern University, Chicago. The result, he said, is that after first-line therapies in IBD have been used to diminishing effect, patients typically have waited up to between 6 and 10 years before they are given the treatment that works best for them. By then, when a patient likely has experienced penetrating disease and fistulas, even the most effective therapy has less than a 50% chance of working well.

This upside down state of affairs in the field is due to a combination of factors. Since the 1998 introduction to the U.S. market of infliximab for treating Crohn’s disease, much has been learned about the characteristics of IBD, including that it is a chronic, progressive condition with a higher burden of inflammation than is necessarily indicated by clinical symptoms.

But at the time infliximab was introduced, it was viewed not as a first-line treatment that could prevent further disease, but as a last ditch effort to halt an already rampant disease state that typically had its roots of destruction well planted long before the patient presented clinically, according to Dr. Hanauer.

In the last 2 decades, however, numerous studies have shown that earlier intervention with biologics results in higher treatment response rates and less structural trauma. []

In addition, data indicate that administering the correct choice of anti–tumor necrosis factor (TNF) agent in biologic-naive patients will yield as much as a 20% greater response rate, which could lead to lower costs. “Long-term pharmacoeconomic data are needed to include not only direct costs of care, but also indirect costs that capture lost income, productivity, [and] disability,” Dr. Hanauer said in an interview.

As it stands now, even vedolizumab, indicated in 2014 for use in both Crohn’s disease and ulcerative colitis, is kept for an even later stage of disease in the standard algorithm, coming behind not only “severe stage of disease” but placed after a patient has failed other anti-TNF treatment.

Biologics are far safer than the corticosteroids, which precede them in the typical treatment algorithm, but because cost is king, according Dr. Hanauer, “it’s the cost that drives our later-stage intervention … if anti-TNFs cost a dollar, we’d use them in everything.”

“We would see more impact if we move these therapies earlier into treatment,” he said. “Now we give the patients least likely to respond to these treatments, the [costliest] therapies,” Dr. Hanauer said during his presentation.

Meanwhile, the several novel IBD therapies in development are primarily being tested for late-stage disease. Changing the criteria for inclusion in such clinical trials could mean future treatment is more cost effective. “Study sponsors could go after ‘earlier’ indications in the mild to moderate range,” he said in the interview.

To improve the treatment algorithms already in use, Dr. Hanauer said clinicians should learn more about the pharmacokinetics and pharmacodynamics of their armamentarium, something he said most clinical trials tend to ignore. “Most [IBD] drugs were developed for rheumatoid arthritis where these kinds of considerations are not as important since they have many more ‘tools’ [to choose from] in rheumatology. In IBD, we have had to make the best of our limited tools. Industry would prefer to keep things simple, but it isn’t.”

Also availing themselves of therapeutic drug monitoring would help clinicians ensure that patients have high enough blood levels of their treatment at the time they complete induction therapy, making the management phase easier, Dr. Hanauer said.

Redefining disease severity will mean that new treatments will have more efficacy, and can lead to more opportunities for novel treatments to work. Until then, leaving biologics to be the agent of last resort means, according to Dr. Hanauer, there are more patients “who have none of the benefit and all of the risk.”

Dr. Hanauer reported several relevant financial disclosures, including AbbVie, Actavis, Hospira, Janssen, Novo Nordisk, and Pfizer.

Potential new inflammatory bowel disease treatments

Adhesion molecule–based therapies
• PF-00547659 (Pfizer), an anti-MAdCam S1P1 agonist; an oral agent; for ulcerative colitis
• Ozanimod (Celgene); for ulcerative colitis; now in phase III
• Etrolizumab (Hoffmann-La Roche); for Crohn’s disease; now in phase III

Biologics for IL-12/23 pathways
MEDI2070 (MedImmune/Amgen), an anti-p19 antibody; targets IL-23 for Crohn’s disease

Agents for the JAK-STAT pathway
• Mongersen (Celgene), an oral SMAD7 antisense oligonucleotide; for Crohn’s disease; in phase III
• Tofacitinib (Pfizer)

Sources: Dr. Brian Feagan, University of Western Ontario; Dr. Bruce Sands, Mount Sinai School of Medicine; Dr. Bill Sandborn, University of California, San Diego

[email protected]

On Twitter @whitneymcknight

ORLANDO – A range of novel therapies are set to come online for the treatment of inflammatory bowel disease (IBD), but they will miss the mark when it comes to meeting the need for better, longer-lasting outcomes, according to one expert.

“We’re positioning our therapies all wrong,” Dr. Stephen Hanauer said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

“In psoriasis, patients are immediately given effective treatment with ustekinumab, but in IBD, we have to wait for patients to fail multiple therapies before they are given an effective one,” said Dr. Hanauer, who is the Clifford Joseph Barborka Professor of Medicine in the division of gastroenterology and hepatology at Northwestern University, Chicago. The result, he said, is that after first-line therapies in IBD have been used to diminishing effect, patients typically have waited up to between 6 and 10 years before they are given the treatment that works best for them. By then, when a patient likely has experienced penetrating disease and fistulas, even the most effective therapy has less than a 50% chance of working well.

This upside down state of affairs in the field is due to a combination of factors. Since the 1998 introduction to the U.S. market of infliximab for treating Crohn’s disease, much has been learned about the characteristics of IBD, including that it is a chronic, progressive condition with a higher burden of inflammation than is necessarily indicated by clinical symptoms.

But at the time infliximab was introduced, it was viewed not as a first-line treatment that could prevent further disease, but as a last ditch effort to halt an already rampant disease state that typically had its roots of destruction well planted long before the patient presented clinically, according to Dr. Hanauer.

In the last 2 decades, however, numerous studies have shown that earlier intervention with biologics results in higher treatment response rates and less structural trauma. []

In addition, data indicate that administering the correct choice of anti–tumor necrosis factor (TNF) agent in biologic-naive patients will yield as much as a 20% greater response rate, which could lead to lower costs. “Long-term pharmacoeconomic data are needed to include not only direct costs of care, but also indirect costs that capture lost income, productivity, [and] disability,” Dr. Hanauer said in an interview.

As it stands now, even vedolizumab, indicated in 2014 for use in both Crohn’s disease and ulcerative colitis, is kept for an even later stage of disease in the standard algorithm, coming behind not only “severe stage of disease” but placed after a patient has failed other anti-TNF treatment.

Biologics are far safer than the corticosteroids, which precede them in the typical treatment algorithm, but because cost is king, according Dr. Hanauer, “it’s the cost that drives our later-stage intervention … if anti-TNFs cost a dollar, we’d use them in everything.”

“We would see more impact if we move these therapies earlier into treatment,” he said. “Now we give the patients least likely to respond to these treatments, the [costliest] therapies,” Dr. Hanauer said during his presentation.

Meanwhile, the several novel IBD therapies in development are primarily being tested for late-stage disease. Changing the criteria for inclusion in such clinical trials could mean future treatment is more cost effective. “Study sponsors could go after ‘earlier’ indications in the mild to moderate range,” he said in the interview.

To improve the treatment algorithms already in use, Dr. Hanauer said clinicians should learn more about the pharmacokinetics and pharmacodynamics of their armamentarium, something he said most clinical trials tend to ignore. “Most [IBD] drugs were developed for rheumatoid arthritis where these kinds of considerations are not as important since they have many more ‘tools’ [to choose from] in rheumatology. In IBD, we have had to make the best of our limited tools. Industry would prefer to keep things simple, but it isn’t.”

Also availing themselves of therapeutic drug monitoring would help clinicians ensure that patients have high enough blood levels of their treatment at the time they complete induction therapy, making the management phase easier, Dr. Hanauer said.

Redefining disease severity will mean that new treatments will have more efficacy, and can lead to more opportunities for novel treatments to work. Until then, leaving biologics to be the agent of last resort means, according to Dr. Hanauer, there are more patients “who have none of the benefit and all of the risk.”

Dr. Hanauer reported several relevant financial disclosures, including AbbVie, Actavis, Hospira, Janssen, Novo Nordisk, and Pfizer.

Potential new inflammatory bowel disease treatments

Adhesion molecule–based therapies
• PF-00547659 (Pfizer), an anti-MAdCam S1P1 agonist; an oral agent; for ulcerative colitis
• Ozanimod (Celgene); for ulcerative colitis; now in phase III
• Etrolizumab (Hoffmann-La Roche); for Crohn’s disease; now in phase III

Biologics for IL-12/23 pathways
MEDI2070 (MedImmune/Amgen), an anti-p19 antibody; targets IL-23 for Crohn’s disease

Agents for the JAK-STAT pathway
• Mongersen (Celgene), an oral SMAD7 antisense oligonucleotide; for Crohn’s disease; in phase III
• Tofacitinib (Pfizer)

Sources: Dr. Brian Feagan, University of Western Ontario; Dr. Bruce Sands, Mount Sinai School of Medicine; Dr. Bill Sandborn, University of California, San Diego

[email protected]

On Twitter @whitneymcknight

ORLANDO – A range of novel therapies are set to come online for the treatment of inflammatory bowel disease (IBD), but they will miss the mark when it comes to meeting the need for better, longer-lasting outcomes, according to one expert.

“We’re positioning our therapies all wrong,” Dr. Stephen Hanauer said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

“In psoriasis, patients are immediately given effective treatment with ustekinumab, but in IBD, we have to wait for patients to fail multiple therapies before they are given an effective one,” said Dr. Hanauer, who is the Clifford Joseph Barborka Professor of Medicine in the division of gastroenterology and hepatology at Northwestern University, Chicago. The result, he said, is that after first-line therapies in IBD have been used to diminishing effect, patients typically have waited up to between 6 and 10 years before they are given the treatment that works best for them. By then, when a patient likely has experienced penetrating disease and fistulas, even the most effective therapy has less than a 50% chance of working well.

This upside down state of affairs in the field is due to a combination of factors. Since the 1998 introduction to the U.S. market of infliximab for treating Crohn’s disease, much has been learned about the characteristics of IBD, including that it is a chronic, progressive condition with a higher burden of inflammation than is necessarily indicated by clinical symptoms.

But at the time infliximab was introduced, it was viewed not as a first-line treatment that could prevent further disease, but as a last ditch effort to halt an already rampant disease state that typically had its roots of destruction well planted long before the patient presented clinically, according to Dr. Hanauer.

In the last 2 decades, however, numerous studies have shown that earlier intervention with biologics results in higher treatment response rates and less structural trauma. []

In addition, data indicate that administering the correct choice of anti–tumor necrosis factor (TNF) agent in biologic-naive patients will yield as much as a 20% greater response rate, which could lead to lower costs. “Long-term pharmacoeconomic data are needed to include not only direct costs of care, but also indirect costs that capture lost income, productivity, [and] disability,” Dr. Hanauer said in an interview.

As it stands now, even vedolizumab, indicated in 2014 for use in both Crohn’s disease and ulcerative colitis, is kept for an even later stage of disease in the standard algorithm, coming behind not only “severe stage of disease” but placed after a patient has failed other anti-TNF treatment.

Biologics are far safer than the corticosteroids, which precede them in the typical treatment algorithm, but because cost is king, according Dr. Hanauer, “it’s the cost that drives our later-stage intervention … if anti-TNFs cost a dollar, we’d use them in everything.”

“We would see more impact if we move these therapies earlier into treatment,” he said. “Now we give the patients least likely to respond to these treatments, the [costliest] therapies,” Dr. Hanauer said during his presentation.

Meanwhile, the several novel IBD therapies in development are primarily being tested for late-stage disease. Changing the criteria for inclusion in such clinical trials could mean future treatment is more cost effective. “Study sponsors could go after ‘earlier’ indications in the mild to moderate range,” he said in the interview.

To improve the treatment algorithms already in use, Dr. Hanauer said clinicians should learn more about the pharmacokinetics and pharmacodynamics of their armamentarium, something he said most clinical trials tend to ignore. “Most [IBD] drugs were developed for rheumatoid arthritis where these kinds of considerations are not as important since they have many more ‘tools’ [to choose from] in rheumatology. In IBD, we have had to make the best of our limited tools. Industry would prefer to keep things simple, but it isn’t.”

Also availing themselves of therapeutic drug monitoring would help clinicians ensure that patients have high enough blood levels of their treatment at the time they complete induction therapy, making the management phase easier, Dr. Hanauer said.

Redefining disease severity will mean that new treatments will have more efficacy, and can lead to more opportunities for novel treatments to work. Until then, leaving biologics to be the agent of last resort means, according to Dr. Hanauer, there are more patients “who have none of the benefit and all of the risk.”

Dr. Hanauer reported several relevant financial disclosures, including AbbVie, Actavis, Hospira, Janssen, Novo Nordisk, and Pfizer.

Potential new inflammatory bowel disease treatments

Adhesion molecule–based therapies
• PF-00547659 (Pfizer), an anti-MAdCam S1P1 agonist; an oral agent; for ulcerative colitis
• Ozanimod (Celgene); for ulcerative colitis; now in phase III
• Etrolizumab (Hoffmann-La Roche); for Crohn’s disease; now in phase III

Biologics for IL-12/23 pathways
MEDI2070 (MedImmune/Amgen), an anti-p19 antibody; targets IL-23 for Crohn’s disease

Agents for the JAK-STAT pathway
• Mongersen (Celgene), an oral SMAD7 antisense oligonucleotide; for Crohn’s disease; in phase III
• Tofacitinib (Pfizer)

Sources: Dr. Brian Feagan, University of Western Ontario; Dr. Bruce Sands, Mount Sinai School of Medicine; Dr. Bill Sandborn, University of California, San Diego

[email protected]

On Twitter @whitneymcknight

Diet and exercise, either in combination or alone, improved exercise capacity in older obese patients with clinically stable heart failure with preserved ejection fraction in a controlled trial reported Jan. 5 in JAMA.

In a controlled trial of 100 obese persons aged 60 years or over, 81 of whom were women, all with stable but chronic HFpEF, participants were randomly assigned to a diet intervention, exercise, both, or to a control group that did not modify behavior. The diet and exercise combination arm had double the increased oxygen intake capacity (VO₂) when compared with the other test arms. The groups assigned to either diet or exercise saw virtually the same increase in their peak VO₂ compared with controls, although, across the study, there were no statistically significant changes in quality-of-life scores as measured by the Minnesota Living with Heart Failure Questionnaire.

The trial was the first to explore a nonpharmaceutical approach to improving this cohort’s capacity to exercise, as well as its overall heart function and reduced symptoms of HFpEF.

The results are “intriguing, and worthy of further investigation in a community population with longer follow-up,” Dr. Nanette K. Wenger, professor of medicine in cardiology at Emory University, Atlanta, wrote in an accompanying editorial (JAMA. 2016;315[1]:31-3. doi: 10.1001/jama.2015.17347).

Despite HFpEF being the most common form of heart failure in the United States, primarily affecting older women, there are no treatment guidelines specifically for its management. Exercise intolerance, typically with exertional dyspnea leading to a reduced quality of life, is HFpEF’s primary symptom. Because of the so-called heart failure “obesity paradox” that indicates persons who are slightly overweight or obese have less mortality from heart failure than do their average or underweight counterparts, diet is a controversial aspect of treating HFpEF (Circ Heart Fail. 2011 May;4[3]:324-31).

Although the condition is nearly always associated with being overweight or obese, the 2013 American Heart Association/American College of Cardiology Guideline for the Management of Heart Failure does not include dietary recommendations for weight loss as a HFpEF management strategy, but it does recommend treating the condition by way of lowering hypertension pharmaceutically.

“Diet to achieve weight loss could be an important new strategy to help patients with HFpEF, particularly those afflicted with severe exercise intolerance,” said the study’s lead author, Dr. Dalane W. Kitzman, professor of internal medicine in cardiology and geriatrics at Wake Forest University, Winston-Salem, N.C.

The study’s focus on diet alone and in combination with exercise for the sake of impacting peak oxygen intake was to help clarify the role of diet in heart failure. In the non-HFpEF older, obese population, restricting calories has been shown to improve left ventricular function and exercise capacity, lower inflammation markers, and improve skeletal muscular function.

Over the course of the study’s 20 weeks, the group that was assigned a hypocaloric dietary intervention had an increase in its peak oxygen consumption, the study’s primary endpoint, of 1.3 mL/kg per min. The exercise-only group increased by 1.2 mL/kg per min. Meanwhile, the group assigned to a reduced-calorie diet and exercise increased by 2.5 mL/kg per min (JAMA. 2016;315[1]:36-46. doi: 10.1001/jama.2015.17346). The accepted clinically meaningful increase in peak oxygen consumption is 1.0 mL/kg per min.

Diet and exercise together also produced the most significant weight loss, with the combination group dropping an average of 22 pounds while the diet-alone group lost an average of 15 pounds. The exercise-only group lost an average of 6.5 pounds. Exercise for the groups assigned to it consisted of 1-hour supervised sessions, three times weekly.

As for why there was no notable improvement in quality of life, the other endpoint of the study, Dr. Wenger theorized in her editorial that “patients with HFpEF test their newly acquired activity tolerance to the precipitation of exertional dyspnea, [in other words], they remain symptomatic.”

Dr. Kitzman and his colleagues, however, wrote that upward trends in two other quality-of-life measures – the Kansas City Cardiomyopathy Questionnaire score and the Rand SF-36 – showed a possible effect on quality of life.

The overall findings indicate that intentional weight loss via calorie restriction is “feasible, appeared safe, and significantly improved the coprimary outcome of exercise capacity,” according to the authors.

Also in this study, the change in peak VO₂ levels positively correlated with the change in the percentage of lean body mass (P = .003) and the change in the ratio between thigh muscle and intermuscular fat. This seemed to equal an increase in leg muscle and leg muscle quality.

Because higher levels of adipose tissue are associated with inflammation, hypertension, insulin resistance, and dyslipidemia, the study authors theorized that, as the body mass ratios of study participants improved, their bodies became more efficient at extracting oxygen from the blood, and thus could better sustain physical activity.

Although there were few adverse events observed in the study, including acute shortness of breath in a member of the exercise-only group, Dr. Kitzman said in a JAMA podcast that, of some concern was that a third of the body mass lost by participants was muscle tissue. “That’s important because persons with heart failure have less-than-normal amounts of muscle tissue as part of their heart failure syndrome and as part of growing old. It could have adverse long-term consequences,” he said.

Dr. Kitzman said in an interview that he and his colleagues have decided next to focus on resistance training’s impact on VO₂, after this study showed that overall muscle mass decreased mildly with diet, even with aerobic exercise. The new study will seek to establish a correlation between improved retention of skeletal muscle, strength, and overall function and resistance training combined with diet and aerobic exercise in HFpEF.

“We chose resistance training because it is known to increase skeletal muscle mass. On the other hand, resistance training can temporarily increase blood pressure and left ventricular afterload, which are already increased in HFpEF,” he said.

The net effect is that, at least for now, “resistance training in HFpEF should be formally tested before applying to patients,” Dr. Kitzman noted. The same is true, he added, for recommending dietary restrictions in HFpEF patients.

[email protected]

On Twitter @whitneymcknight

Diet and exercise, either in combination or alone, improved exercise capacity in older obese patients with clinically stable heart failure with preserved ejection fraction in a controlled trial reported Jan. 5 in JAMA.

In a controlled trial of 100 obese persons aged 60 years or over, 81 of whom were women, all with stable but chronic HFpEF, participants were randomly assigned to a diet intervention, exercise, both, or to a control group that did not modify behavior. The diet and exercise combination arm had double the increased oxygen intake capacity (VO₂) when compared with the other test arms. The groups assigned to either diet or exercise saw virtually the same increase in their peak VO₂ compared with controls, although, across the study, there were no statistically significant changes in quality-of-life scores as measured by the Minnesota Living with Heart Failure Questionnaire.

The trial was the first to explore a nonpharmaceutical approach to improving this cohort’s capacity to exercise, as well as its overall heart function and reduced symptoms of HFpEF.

The results are “intriguing, and worthy of further investigation in a community population with longer follow-up,” Dr. Nanette K. Wenger, professor of medicine in cardiology at Emory University, Atlanta, wrote in an accompanying editorial (JAMA. 2016;315[1]:31-3. doi: 10.1001/jama.2015.17347).

Despite HFpEF being the most common form of heart failure in the United States, primarily affecting older women, there are no treatment guidelines specifically for its management. Exercise intolerance, typically with exertional dyspnea leading to a reduced quality of life, is HFpEF’s primary symptom. Because of the so-called heart failure “obesity paradox” that indicates persons who are slightly overweight or obese have less mortality from heart failure than do their average or underweight counterparts, diet is a controversial aspect of treating HFpEF (Circ Heart Fail. 2011 May;4[3]:324-31).

Although the condition is nearly always associated with being overweight or obese, the 2013 American Heart Association/American College of Cardiology Guideline for the Management of Heart Failure does not include dietary recommendations for weight loss as a HFpEF management strategy, but it does recommend treating the condition by way of lowering hypertension pharmaceutically.

“Diet to achieve weight loss could be an important new strategy to help patients with HFpEF, particularly those afflicted with severe exercise intolerance,” said the study’s lead author, Dr. Dalane W. Kitzman, professor of internal medicine in cardiology and geriatrics at Wake Forest University, Winston-Salem, N.C.

The study’s focus on diet alone and in combination with exercise for the sake of impacting peak oxygen intake was to help clarify the role of diet in heart failure. In the non-HFpEF older, obese population, restricting calories has been shown to improve left ventricular function and exercise capacity, lower inflammation markers, and improve skeletal muscular function.

Over the course of the study’s 20 weeks, the group that was assigned a hypocaloric dietary intervention had an increase in its peak oxygen consumption, the study’s primary endpoint, of 1.3 mL/kg per min. The exercise-only group increased by 1.2 mL/kg per min. Meanwhile, the group assigned to a reduced-calorie diet and exercise increased by 2.5 mL/kg per min (JAMA. 2016;315[1]:36-46. doi: 10.1001/jama.2015.17346). The accepted clinically meaningful increase in peak oxygen consumption is 1.0 mL/kg per min.

Diet and exercise together also produced the most significant weight loss, with the combination group dropping an average of 22 pounds while the diet-alone group lost an average of 15 pounds. The exercise-only group lost an average of 6.5 pounds. Exercise for the groups assigned to it consisted of 1-hour supervised sessions, three times weekly.

As for why there was no notable improvement in quality of life, the other endpoint of the study, Dr. Wenger theorized in her editorial that “patients with HFpEF test their newly acquired activity tolerance to the precipitation of exertional dyspnea, [in other words], they remain symptomatic.”

Dr. Kitzman and his colleagues, however, wrote that upward trends in two other quality-of-life measures – the Kansas City Cardiomyopathy Questionnaire score and the Rand SF-36 – showed a possible effect on quality of life.

The overall findings indicate that intentional weight loss via calorie restriction is “feasible, appeared safe, and significantly improved the coprimary outcome of exercise capacity,” according to the authors.

Also in this study, the change in peak VO₂ levels positively correlated with the change in the percentage of lean body mass (P = .003) and the change in the ratio between thigh muscle and intermuscular fat. This seemed to equal an increase in leg muscle and leg muscle quality.

Because higher levels of adipose tissue are associated with inflammation, hypertension, insulin resistance, and dyslipidemia, the study authors theorized that, as the body mass ratios of study participants improved, their bodies became more efficient at extracting oxygen from the blood, and thus could better sustain physical activity.

Although there were few adverse events observed in the study, including acute shortness of breath in a member of the exercise-only group, Dr. Kitzman said in a JAMA podcast that, of some concern was that a third of the body mass lost by participants was muscle tissue. “That’s important because persons with heart failure have less-than-normal amounts of muscle tissue as part of their heart failure syndrome and as part of growing old. It could have adverse long-term consequences,” he said.

Dr. Kitzman said in an interview that he and his colleagues have decided next to focus on resistance training’s impact on VO₂, after this study showed that overall muscle mass decreased mildly with diet, even with aerobic exercise. The new study will seek to establish a correlation between improved retention of skeletal muscle, strength, and overall function and resistance training combined with diet and aerobic exercise in HFpEF.

“We chose resistance training because it is known to increase skeletal muscle mass. On the other hand, resistance training can temporarily increase blood pressure and left ventricular afterload, which are already increased in HFpEF,” he said.

The net effect is that, at least for now, “resistance training in HFpEF should be formally tested before applying to patients,” Dr. Kitzman noted. The same is true, he added, for recommending dietary restrictions in HFpEF patients.

[email protected]

On Twitter @whitneymcknight

Diet and exercise, either in combination or alone, improved exercise capacity in older obese patients with clinically stable heart failure with preserved ejection fraction in a controlled trial reported Jan. 5 in JAMA.

In a controlled trial of 100 obese persons aged 60 years or over, 81 of whom were women, all with stable but chronic HFpEF, participants were randomly assigned to a diet intervention, exercise, both, or to a control group that did not modify behavior. The diet and exercise combination arm had double the increased oxygen intake capacity (VO₂) when compared with the other test arms. The groups assigned to either diet or exercise saw virtually the same increase in their peak VO₂ compared with controls, although, across the study, there were no statistically significant changes in quality-of-life scores as measured by the Minnesota Living with Heart Failure Questionnaire.

The trial was the first to explore a nonpharmaceutical approach to improving this cohort’s capacity to exercise, as well as its overall heart function and reduced symptoms of HFpEF.

The results are “intriguing, and worthy of further investigation in a community population with longer follow-up,” Dr. Nanette K. Wenger, professor of medicine in cardiology at Emory University, Atlanta, wrote in an accompanying editorial (JAMA. 2016;315[1]:31-3. doi: 10.1001/jama.2015.17347).

Despite HFpEF being the most common form of heart failure in the United States, primarily affecting older women, there are no treatment guidelines specifically for its management. Exercise intolerance, typically with exertional dyspnea leading to a reduced quality of life, is HFpEF’s primary symptom. Because of the so-called heart failure “obesity paradox” that indicates persons who are slightly overweight or obese have less mortality from heart failure than do their average or underweight counterparts, diet is a controversial aspect of treating HFpEF (Circ Heart Fail. 2011 May;4[3]:324-31).

Although the condition is nearly always associated with being overweight or obese, the 2013 American Heart Association/American College of Cardiology Guideline for the Management of Heart Failure does not include dietary recommendations for weight loss as a HFpEF management strategy, but it does recommend treating the condition by way of lowering hypertension pharmaceutically.

“Diet to achieve weight loss could be an important new strategy to help patients with HFpEF, particularly those afflicted with severe exercise intolerance,” said the study’s lead author, Dr. Dalane W. Kitzman, professor of internal medicine in cardiology and geriatrics at Wake Forest University, Winston-Salem, N.C.

The study’s focus on diet alone and in combination with exercise for the sake of impacting peak oxygen intake was to help clarify the role of diet in heart failure. In the non-HFpEF older, obese population, restricting calories has been shown to improve left ventricular function and exercise capacity, lower inflammation markers, and improve skeletal muscular function.

Over the course of the study’s 20 weeks, the group that was assigned a hypocaloric dietary intervention had an increase in its peak oxygen consumption, the study’s primary endpoint, of 1.3 mL/kg per min. The exercise-only group increased by 1.2 mL/kg per min. Meanwhile, the group assigned to a reduced-calorie diet and exercise increased by 2.5 mL/kg per min (JAMA. 2016;315[1]:36-46. doi: 10.1001/jama.2015.17346). The accepted clinically meaningful increase in peak oxygen consumption is 1.0 mL/kg per min.

Diet and exercise together also produced the most significant weight loss, with the combination group dropping an average of 22 pounds while the diet-alone group lost an average of 15 pounds. The exercise-only group lost an average of 6.5 pounds. Exercise for the groups assigned to it consisted of 1-hour supervised sessions, three times weekly.

As for why there was no notable improvement in quality of life, the other endpoint of the study, Dr. Wenger theorized in her editorial that “patients with HFpEF test their newly acquired activity tolerance to the precipitation of exertional dyspnea, [in other words], they remain symptomatic.”

Dr. Kitzman and his colleagues, however, wrote that upward trends in two other quality-of-life measures – the Kansas City Cardiomyopathy Questionnaire score and the Rand SF-36 – showed a possible effect on quality of life.

The overall findings indicate that intentional weight loss via calorie restriction is “feasible, appeared safe, and significantly improved the coprimary outcome of exercise capacity,” according to the authors.

Also in this study, the change in peak VO₂ levels positively correlated with the change in the percentage of lean body mass (P = .003) and the change in the ratio between thigh muscle and intermuscular fat. This seemed to equal an increase in leg muscle and leg muscle quality.

Because higher levels of adipose tissue are associated with inflammation, hypertension, insulin resistance, and dyslipidemia, the study authors theorized that, as the body mass ratios of study participants improved, their bodies became more efficient at extracting oxygen from the blood, and thus could better sustain physical activity.

Although there were few adverse events observed in the study, including acute shortness of breath in a member of the exercise-only group, Dr. Kitzman said in a JAMA podcast that, of some concern was that a third of the body mass lost by participants was muscle tissue. “That’s important because persons with heart failure have less-than-normal amounts of muscle tissue as part of their heart failure syndrome and as part of growing old. It could have adverse long-term consequences,” he said.

Dr. Kitzman said in an interview that he and his colleagues have decided next to focus on resistance training’s impact on VO₂, after this study showed that overall muscle mass decreased mildly with diet, even with aerobic exercise. The new study will seek to establish a correlation between improved retention of skeletal muscle, strength, and overall function and resistance training combined with diet and aerobic exercise in HFpEF.

“We chose resistance training because it is known to increase skeletal muscle mass. On the other hand, resistance training can temporarily increase blood pressure and left ventricular afterload, which are already increased in HFpEF,” he said.

The net effect is that, at least for now, “resistance training in HFpEF should be formally tested before applying to patients,” Dr. Kitzman noted. The same is true, he added, for recommending dietary restrictions in HFpEF patients.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You think in terms of inflammation, but your inflammatory bowel disease patients tend to think in terms of clinical symptoms, often unilaterally changing their diets according to how they “feel,” rather than in relation to their disease activity, despite your reassurances that diet is not causal to their disease state.

“The data on IBD and diet are awfully thin,” Dr. Peter D.R. Higgins, who directs the IBD program at the University of Michigan, Ann Arbor, said at a conference on inflammatory bowel diseases. The result of this data dearth is that clinicians “have a credibility gap when it comes to diet and IBD,” he said.

Although diet can be manipulated to reduce antigens, toxins, and other aggravating elements, as well as to alter gut bacteria composition, gas, and fluid retention – all possible, even “sensible” mechanisms for some symptoms, according to Dr. Higgins – there still is not enough evidence to link them to disease activity.

Any studies that show a modicum of relationship between diet and IBD currently are still bench science. Of the 11 clinical, randomized, controlled trials Dr. Higgins said he reviewed, none were positive studies. “Zero.”

That goes for exclusive enteral nutrition, too. “There are zero prospective randomized, controlled trials for mucosal healing endpoints for EEN. None,” said Dr. Higgins.

To accrue such data is difficult for many reasons, Dr. Higgins said, especially because extremely large sample sizes are needed, a Herculean feat since so many IBD patients have very decided opinions about diet and would balk at being randomly assigned to certain test groups, and because to blind them as to what they were eating would be difficult. “You need a convincing sham diet that is identical to the intervention diet in every way.” He said there are similar concerns for testing nutriceuticals.

Meanwhile, patients desperate to assuage symptoms such as bloating and abdominal pressure thus go rogue, severely restricting their diets, spending money on alternative therapies, and even discontinuing their prescribed anti-inflammatories per the counsel of so-called Internet gurus whose primary directive is, according to Dr. Higgins, “to denigrate Western medicine.

Very often, IBD patients will develop food avoidances, usually dairy, gluten, fiber, nuts, and some meats, Dr. Higgins said, citing a poster presented at the meeting. Patients with Crohn’s disease or ulcerative colitis reported that they believed certain foods exacerbated their symptoms, so they cut them from their diets. Over time, this leads to malnutrition, including a depletion of micronutrients, he noted.

One study showed that 7% of inpatients with IBD met criteria for severe protein and calorie malnutrition, which was associated with more than triple mortality rates for this cohort, as well as double the length of stays and at twice the cost.

“Patients who choose to do this make their outcomes a lot worse,” Dr. Higgins said. “We really need to prevent [patients from inflicting] self-harm.”

The way forward is to engage patients on diet, and keep them talking.

“Reassure them that you are paying attention to their nutrition, and test them regularly for low iron, low vitamin D, and vitamin B₁₂. Reassure them when [the levels] are normal, and supplement them when deficient,” Dr. Higgins said.

There’s just not enough evidence for offering more treatment than that, aside from patients making sure to meet their protein and caloric needs, according to Dr. Higgins. For patients on methotrexate or sulfasalazine, “you could also recommend folate,” he said.

To facilitate conversations about diet and IBD with patients, Dr. Higgins said he does rely on one “terrible study” that had no controls, no randomization, and only retrospective patient assessment of symptoms, but which correlated a low FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet with lower rates of abdominal pain, bloating, gas, and diarrhea in half of the 52 Crohn’s and 20 ulcerative colitis patients who participated. There was no change in levels of inflammation, however.

“It’s basically a case series, but at least there is no evidence of harm, and it allows me to regain credibility and recapture the patient from the [online] Rasputins,” Dr. Higgins said.

He offered this strategy: Engage patients by talking about and treating their IBD symptoms, so you can get them to work with you when you have concerns around any disease activity. If you think a patient would benefit from a low FODMAP diet, try it. Typical candidates for this approach, he said, are those who have a small intestine bacterial overgrowth response to antibiotics, and those with a history of abdominal pain, distension, extreme amounts of gas, strictures, adhesions, slow motility, and those lacking an ileocecal valve.

If a patient experiences a flare, restricting the diet does make sense in terms of reducing discomfort, Dr. Higgins said, but these patients run the risk of “dehydration, and rapid and significant malnutrition” if they continue to restrict their diets once the flare has quieted.

To lessen symptoms during a flare, patients can be counseled to eat smaller quantities of food, to eat bland food, and to steer clear of caffeine and alcohol, the former making motility worse, and the latter increasing dehydration.

Patients seeking to alleviate symptoms can benefit from “low residue” diets that are low in fiber. Overall, stress the importance of protein and caloric intake, even recommending that patients take liquid calorie supplements if necessary, particularly when sick.

To deepen and continue this kind of patient interaction in your clinic, Dr. Higgins said it is increasingly possible to find a balance between patient volume and interest in this model, registered dietitians – preferably those who can see patients on site, and third-party payers who will cover these services.

The meeting was sponsored by the Crohn’s & Colitis Foundation of America. Dr. Higgins has numerous financial relationships with pharmaceutical companies, including Abbott, Buhlman, Centocor, Millenium, and Pfizer.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You think in terms of inflammation, but your inflammatory bowel disease patients tend to think in terms of clinical symptoms, often unilaterally changing their diets according to how they “feel,” rather than in relation to their disease activity, despite your reassurances that diet is not causal to their disease state.

“The data on IBD and diet are awfully thin,” Dr. Peter D.R. Higgins, who directs the IBD program at the University of Michigan, Ann Arbor, said at a conference on inflammatory bowel diseases. The result of this data dearth is that clinicians “have a credibility gap when it comes to diet and IBD,” he said.

Although diet can be manipulated to reduce antigens, toxins, and other aggravating elements, as well as to alter gut bacteria composition, gas, and fluid retention – all possible, even “sensible” mechanisms for some symptoms, according to Dr. Higgins – there still is not enough evidence to link them to disease activity.

Any studies that show a modicum of relationship between diet and IBD currently are still bench science. Of the 11 clinical, randomized, controlled trials Dr. Higgins said he reviewed, none were positive studies. “Zero.”

That goes for exclusive enteral nutrition, too. “There are zero prospective randomized, controlled trials for mucosal healing endpoints for EEN. None,” said Dr. Higgins.

To accrue such data is difficult for many reasons, Dr. Higgins said, especially because extremely large sample sizes are needed, a Herculean feat since so many IBD patients have very decided opinions about diet and would balk at being randomly assigned to certain test groups, and because to blind them as to what they were eating would be difficult. “You need a convincing sham diet that is identical to the intervention diet in every way.” He said there are similar concerns for testing nutriceuticals.

Meanwhile, patients desperate to assuage symptoms such as bloating and abdominal pressure thus go rogue, severely restricting their diets, spending money on alternative therapies, and even discontinuing their prescribed anti-inflammatories per the counsel of so-called Internet gurus whose primary directive is, according to Dr. Higgins, “to denigrate Western medicine.

Very often, IBD patients will develop food avoidances, usually dairy, gluten, fiber, nuts, and some meats, Dr. Higgins said, citing a poster presented at the meeting. Patients with Crohn’s disease or ulcerative colitis reported that they believed certain foods exacerbated their symptoms, so they cut them from their diets. Over time, this leads to malnutrition, including a depletion of micronutrients, he noted.

One study showed that 7% of inpatients with IBD met criteria for severe protein and calorie malnutrition, which was associated with more than triple mortality rates for this cohort, as well as double the length of stays and at twice the cost.

“Patients who choose to do this make their outcomes a lot worse,” Dr. Higgins said. “We really need to prevent [patients from inflicting] self-harm.”

The way forward is to engage patients on diet, and keep them talking.

“Reassure them that you are paying attention to their nutrition, and test them regularly for low iron, low vitamin D, and vitamin B₁₂. Reassure them when [the levels] are normal, and supplement them when deficient,” Dr. Higgins said.

There’s just not enough evidence for offering more treatment than that, aside from patients making sure to meet their protein and caloric needs, according to Dr. Higgins. For patients on methotrexate or sulfasalazine, “you could also recommend folate,” he said.

To facilitate conversations about diet and IBD with patients, Dr. Higgins said he does rely on one “terrible study” that had no controls, no randomization, and only retrospective patient assessment of symptoms, but which correlated a low FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet with lower rates of abdominal pain, bloating, gas, and diarrhea in half of the 52 Crohn’s and 20 ulcerative colitis patients who participated. There was no change in levels of inflammation, however.

“It’s basically a case series, but at least there is no evidence of harm, and it allows me to regain credibility and recapture the patient from the [online] Rasputins,” Dr. Higgins said.

He offered this strategy: Engage patients by talking about and treating their IBD symptoms, so you can get them to work with you when you have concerns around any disease activity. If you think a patient would benefit from a low FODMAP diet, try it. Typical candidates for this approach, he said, are those who have a small intestine bacterial overgrowth response to antibiotics, and those with a history of abdominal pain, distension, extreme amounts of gas, strictures, adhesions, slow motility, and those lacking an ileocecal valve.

If a patient experiences a flare, restricting the diet does make sense in terms of reducing discomfort, Dr. Higgins said, but these patients run the risk of “dehydration, and rapid and significant malnutrition” if they continue to restrict their diets once the flare has quieted.

To lessen symptoms during a flare, patients can be counseled to eat smaller quantities of food, to eat bland food, and to steer clear of caffeine and alcohol, the former making motility worse, and the latter increasing dehydration.

Patients seeking to alleviate symptoms can benefit from “low residue” diets that are low in fiber. Overall, stress the importance of protein and caloric intake, even recommending that patients take liquid calorie supplements if necessary, particularly when sick.

To deepen and continue this kind of patient interaction in your clinic, Dr. Higgins said it is increasingly possible to find a balance between patient volume and interest in this model, registered dietitians – preferably those who can see patients on site, and third-party payers who will cover these services.

The meeting was sponsored by the Crohn’s & Colitis Foundation of America. Dr. Higgins has numerous financial relationships with pharmaceutical companies, including Abbott, Buhlman, Centocor, Millenium, and Pfizer.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You think in terms of inflammation, but your inflammatory bowel disease patients tend to think in terms of clinical symptoms, often unilaterally changing their diets according to how they “feel,” rather than in relation to their disease activity, despite your reassurances that diet is not causal to their disease state.

“The data on IBD and diet are awfully thin,” Dr. Peter D.R. Higgins, who directs the IBD program at the University of Michigan, Ann Arbor, said at a conference on inflammatory bowel diseases. The result of this data dearth is that clinicians “have a credibility gap when it comes to diet and IBD,” he said.

Although diet can be manipulated to reduce antigens, toxins, and other aggravating elements, as well as to alter gut bacteria composition, gas, and fluid retention – all possible, even “sensible” mechanisms for some symptoms, according to Dr. Higgins – there still is not enough evidence to link them to disease activity.

Any studies that show a modicum of relationship between diet and IBD currently are still bench science. Of the 11 clinical, randomized, controlled trials Dr. Higgins said he reviewed, none were positive studies. “Zero.”

That goes for exclusive enteral nutrition, too. “There are zero prospective randomized, controlled trials for mucosal healing endpoints for EEN. None,” said Dr. Higgins.

To accrue such data is difficult for many reasons, Dr. Higgins said, especially because extremely large sample sizes are needed, a Herculean feat since so many IBD patients have very decided opinions about diet and would balk at being randomly assigned to certain test groups, and because to blind them as to what they were eating would be difficult. “You need a convincing sham diet that is identical to the intervention diet in every way.” He said there are similar concerns for testing nutriceuticals.

Meanwhile, patients desperate to assuage symptoms such as bloating and abdominal pressure thus go rogue, severely restricting their diets, spending money on alternative therapies, and even discontinuing their prescribed anti-inflammatories per the counsel of so-called Internet gurus whose primary directive is, according to Dr. Higgins, “to denigrate Western medicine.

Very often, IBD patients will develop food avoidances, usually dairy, gluten, fiber, nuts, and some meats, Dr. Higgins said, citing a poster presented at the meeting. Patients with Crohn’s disease or ulcerative colitis reported that they believed certain foods exacerbated their symptoms, so they cut them from their diets. Over time, this leads to malnutrition, including a depletion of micronutrients, he noted.

One study showed that 7% of inpatients with IBD met criteria for severe protein and calorie malnutrition, which was associated with more than triple mortality rates for this cohort, as well as double the length of stays and at twice the cost.

“Patients who choose to do this make their outcomes a lot worse,” Dr. Higgins said. “We really need to prevent [patients from inflicting] self-harm.”

The way forward is to engage patients on diet, and keep them talking.

“Reassure them that you are paying attention to their nutrition, and test them regularly for low iron, low vitamin D, and vitamin B₁₂. Reassure them when [the levels] are normal, and supplement them when deficient,” Dr. Higgins said.

There’s just not enough evidence for offering more treatment than that, aside from patients making sure to meet their protein and caloric needs, according to Dr. Higgins. For patients on methotrexate or sulfasalazine, “you could also recommend folate,” he said.

To facilitate conversations about diet and IBD with patients, Dr. Higgins said he does rely on one “terrible study” that had no controls, no randomization, and only retrospective patient assessment of symptoms, but which correlated a low FODMAP (fermentable oligo-, di-, monosaccharides and polyols) diet with lower rates of abdominal pain, bloating, gas, and diarrhea in half of the 52 Crohn’s and 20 ulcerative colitis patients who participated. There was no change in levels of inflammation, however.

“It’s basically a case series, but at least there is no evidence of harm, and it allows me to regain credibility and recapture the patient from the [online] Rasputins,” Dr. Higgins said.

He offered this strategy: Engage patients by talking about and treating their IBD symptoms, so you can get them to work with you when you have concerns around any disease activity. If you think a patient would benefit from a low FODMAP diet, try it. Typical candidates for this approach, he said, are those who have a small intestine bacterial overgrowth response to antibiotics, and those with a history of abdominal pain, distension, extreme amounts of gas, strictures, adhesions, slow motility, and those lacking an ileocecal valve.

If a patient experiences a flare, restricting the diet does make sense in terms of reducing discomfort, Dr. Higgins said, but these patients run the risk of “dehydration, and rapid and significant malnutrition” if they continue to restrict their diets once the flare has quieted.

To lessen symptoms during a flare, patients can be counseled to eat smaller quantities of food, to eat bland food, and to steer clear of caffeine and alcohol, the former making motility worse, and the latter increasing dehydration.

Patients seeking to alleviate symptoms can benefit from “low residue” diets that are low in fiber. Overall, stress the importance of protein and caloric intake, even recommending that patients take liquid calorie supplements if necessary, particularly when sick.

To deepen and continue this kind of patient interaction in your clinic, Dr. Higgins said it is increasingly possible to find a balance between patient volume and interest in this model, registered dietitians – preferably those who can see patients on site, and third-party payers who will cover these services.

The meeting was sponsored by the Crohn’s & Colitis Foundation of America. Dr. Higgins has numerous financial relationships with pharmaceutical companies, including Abbott, Buhlman, Centocor, Millenium, and Pfizer.

[email protected]

On Twitter @whitneymcknight

ORLANDO – To delay or prevent recurrence of Crohn’s disease in patients after they’ve undergone ileocolonic resectioning, the ultimate question is where the “sweet spot” is for timing biologic therapy.

“In 2016, symptoms will still guide treatment,” said Dr. Miguel D. Regueiro, professor of medicine at the University of Pittsburgh and clinical medical director of the University’s IBD Center, during the clinical track of this year’s annual Advances in Inflammatory Bowel Diseases meeting, sponsored by the Crohn’s and Colitis Foundation of America. But when it comes to the exact timing of administering anti–tumor necrosis factor (TNF) agents, clinicians should look to risk factors for recurrence.

Whitney McKnight/Frontline Medical News

The notion that immediate treatment with a biologic after surgical resectioning is best is supported by phase III data from the international, multicenter PREVENT trial, for which Dr. Regueiro was principal investigator. It demonstrated that at week 79 and week 104, immediate treatment with the biologic infliximab 5 mg/kg every 8 weeks postsurgery in patients with high risk for recurrence (smokers, those with penetrating or fistulizing disease, or a history of resectioning) resulted in lower but not statistically significant rates of the composite endpoint of clinical recurrence and endoscopic scores greater than 2, when compared with placebo (P = .097 at 76 weeks and P = .098 at 104 weeks).

Dr. Regueiro noted in an interview that often, even though endoscopic recurrence scores might be high, following surgery, patients are in clinical remission and so do not report any symptoms. He noted that when only endoscopic outcomes prior to or at week 76 in the PREVENT trial were analyzed as the secondary endpoint, there was a statistically significant difference when compared with placebo: The 147 randomly assigned study arm participants had a recurrence rate of 22.4% vs. 51.3% in 150 controls (P less than .001). Further, Rutgeerts scores equal or greater than i-3 occurred in 83.1% of participants in the placebo group, compared with 28.4% in the infliximab group at week 76.

“The take-home message is that surgery induces a deep remission where patient’s ‘feel well’ and by using a clinical symptom score we do not detect recurrence, probably for years,” Dr. Regueiro said in the interview.

What about waiting to offer treatment?

Results from the POCER trial, also conducted internationally at a number of centers, support this approach.

In the trial, 174 postoperative patients at high risk for recurrence were randomly assigned in a 2:1 ratio to either standard care – colonoscopy at 18 months – or to receive a colonoscopy at 6 months, followed by medication if there was an endoscopic recurrence of i-2 or greater.

Both study arms were given metronidazole 400 mg twice a day for 3 months. If patients were intolerant, the dose was reduced to 200 mg twice daily or was stopped altogether. If they were high risk but medication naive, patients were given azathioprine 2 mg/kg or 6-mercaptopurine 1.5 mg/kg once daily, beginning within 1 month after surgery. Patients intolerant to this regime were administered adalimumab 160/80/40 mg accordingly, every other week.

At 18 months, those patients who’d been observed endoscopically at 6 months and given medication if necessary had a 49% rate of recurrence compared with 67% in the group given standard care, a statistically significant difference.

However, when Dr. Regueiro, who was not directly involved with the POCER trial, conducted an informal review of the data, he found that patients who’d been on thiopurines had an endoscopic recurrence rate at 6 months of 45% vs. the 21% rate in the adalimumab patients. “This means that waiting on anti-TNF and giving thiopurine meant nearly half the patients had recurrence in 6 months, compared with anti-TNF treated patients.”

So then, when should biologics enter the treatment picture?

Again, look to the risk profile, said Dr. Regueiro. Patients who are 30 years of age or younger, have ileocolonic disease, smoke, have penetrating disease, or have already had two or more surgeries or had a short duration between time of diagnosis and surgery are considered at high risk for return of the disease.

In his own practice, Dr. Regueiro said he puts all but the low-risk patients on some form of immediate postoperative medication. Patients at moderate risk, such as those who have had a resection within 10 years of diagnosis, receive 6-mercaptopurine or azathioprine plus metronidazole (if tolerated) and are given colonoscopy at 6-12 months postoperatively. If there is a recurrence at that point, then he will start the patient on an anti-TNF. If not, then he sees them again in 1-3 years for a colonoscopy. Dr. Regueiro treats patients at high risk for recurrence more frequently with combination therapies, immediately setting them on a regimen of anti-TNF plus immunosuppressive therapy followed by a 6-12 month postoperative colonoscopy after which he adjusts treatment if there is active disease, including increasing the dose of the biologic or switching to another one.

But just what length of time actually constitutes “immediately after surgery?” In the PREVENT trial, clinicians had up to 45 days to begin therapy, although Dr. Regueiro said he prefers to start between 2 and 4 weeks postsurgery, a number with which panel moderator Dr. David T. Rubin, codirector of the University of Chicago Digestive Diseases Center, agreed.

While these study results help pinpoint the range for when to use biologics, Dr. Regueiro said in the interview, “Future study is need to determine the ‘tipping point’ where postoperative Crohn’s disease recurrence results in significant bowel damage and renders medications ineffective. Finding the ‘biologic sweet spot’ of when to start aggressive therapy versus a ‘wait and watch’ approach remains the question.”

Dr. Regueiro disclosed he is a consultant for AbbVie, Janssen, UCB, Pfizer, and Takeda.

[email protected]

On Twitter @whitneymcknight

ORLANDO – To delay or prevent recurrence of Crohn’s disease in patients after they’ve undergone ileocolonic resectioning, the ultimate question is where the “sweet spot” is for timing biologic therapy.

“In 2016, symptoms will still guide treatment,” said Dr. Miguel D. Regueiro, professor of medicine at the University of Pittsburgh and clinical medical director of the University’s IBD Center, during the clinical track of this year’s annual Advances in Inflammatory Bowel Diseases meeting, sponsored by the Crohn’s and Colitis Foundation of America. But when it comes to the exact timing of administering anti–tumor necrosis factor (TNF) agents, clinicians should look to risk factors for recurrence.

Whitney McKnight/Frontline Medical News

The notion that immediate treatment with a biologic after surgical resectioning is best is supported by phase III data from the international, multicenter PREVENT trial, for which Dr. Regueiro was principal investigator. It demonstrated that at week 79 and week 104, immediate treatment with the biologic infliximab 5 mg/kg every 8 weeks postsurgery in patients with high risk for recurrence (smokers, those with penetrating or fistulizing disease, or a history of resectioning) resulted in lower but not statistically significant rates of the composite endpoint of clinical recurrence and endoscopic scores greater than 2, when compared with placebo (P = .097 at 76 weeks and P = .098 at 104 weeks).

Dr. Regueiro noted in an interview that often, even though endoscopic recurrence scores might be high, following surgery, patients are in clinical remission and so do not report any symptoms. He noted that when only endoscopic outcomes prior to or at week 76 in the PREVENT trial were analyzed as the secondary endpoint, there was a statistically significant difference when compared with placebo: The 147 randomly assigned study arm participants had a recurrence rate of 22.4% vs. 51.3% in 150 controls (P less than .001). Further, Rutgeerts scores equal or greater than i-3 occurred in 83.1% of participants in the placebo group, compared with 28.4% in the infliximab group at week 76.

“The take-home message is that surgery induces a deep remission where patient’s ‘feel well’ and by using a clinical symptom score we do not detect recurrence, probably for years,” Dr. Regueiro said in the interview.

What about waiting to offer treatment?

Results from the POCER trial, also conducted internationally at a number of centers, support this approach.

In the trial, 174 postoperative patients at high risk for recurrence were randomly assigned in a 2:1 ratio to either standard care – colonoscopy at 18 months – or to receive a colonoscopy at 6 months, followed by medication if there was an endoscopic recurrence of i-2 or greater.

Both study arms were given metronidazole 400 mg twice a day for 3 months. If patients were intolerant, the dose was reduced to 200 mg twice daily or was stopped altogether. If they were high risk but medication naive, patients were given azathioprine 2 mg/kg or 6-mercaptopurine 1.5 mg/kg once daily, beginning within 1 month after surgery. Patients intolerant to this regime were administered adalimumab 160/80/40 mg accordingly, every other week.

At 18 months, those patients who’d been observed endoscopically at 6 months and given medication if necessary had a 49% rate of recurrence compared with 67% in the group given standard care, a statistically significant difference.

However, when Dr. Regueiro, who was not directly involved with the POCER trial, conducted an informal review of the data, he found that patients who’d been on thiopurines had an endoscopic recurrence rate at 6 months of 45% vs. the 21% rate in the adalimumab patients. “This means that waiting on anti-TNF and giving thiopurine meant nearly half the patients had recurrence in 6 months, compared with anti-TNF treated patients.”

So then, when should biologics enter the treatment picture?

Again, look to the risk profile, said Dr. Regueiro. Patients who are 30 years of age or younger, have ileocolonic disease, smoke, have penetrating disease, or have already had two or more surgeries or had a short duration between time of diagnosis and surgery are considered at high risk for return of the disease.

In his own practice, Dr. Regueiro said he puts all but the low-risk patients on some form of immediate postoperative medication. Patients at moderate risk, such as those who have had a resection within 10 years of diagnosis, receive 6-mercaptopurine or azathioprine plus metronidazole (if tolerated) and are given colonoscopy at 6-12 months postoperatively. If there is a recurrence at that point, then he will start the patient on an anti-TNF. If not, then he sees them again in 1-3 years for a colonoscopy. Dr. Regueiro treats patients at high risk for recurrence more frequently with combination therapies, immediately setting them on a regimen of anti-TNF plus immunosuppressive therapy followed by a 6-12 month postoperative colonoscopy after which he adjusts treatment if there is active disease, including increasing the dose of the biologic or switching to another one.

But just what length of time actually constitutes “immediately after surgery?” In the PREVENT trial, clinicians had up to 45 days to begin therapy, although Dr. Regueiro said he prefers to start between 2 and 4 weeks postsurgery, a number with which panel moderator Dr. David T. Rubin, codirector of the University of Chicago Digestive Diseases Center, agreed.

While these study results help pinpoint the range for when to use biologics, Dr. Regueiro said in the interview, “Future study is need to determine the ‘tipping point’ where postoperative Crohn’s disease recurrence results in significant bowel damage and renders medications ineffective. Finding the ‘biologic sweet spot’ of when to start aggressive therapy versus a ‘wait and watch’ approach remains the question.”

Dr. Regueiro disclosed he is a consultant for AbbVie, Janssen, UCB, Pfizer, and Takeda.

[email protected]

On Twitter @whitneymcknight

ORLANDO – To delay or prevent recurrence of Crohn’s disease in patients after they’ve undergone ileocolonic resectioning, the ultimate question is where the “sweet spot” is for timing biologic therapy.

“In 2016, symptoms will still guide treatment,” said Dr. Miguel D. Regueiro, professor of medicine at the University of Pittsburgh and clinical medical director of the University’s IBD Center, during the clinical track of this year’s annual Advances in Inflammatory Bowel Diseases meeting, sponsored by the Crohn’s and Colitis Foundation of America. But when it comes to the exact timing of administering anti–tumor necrosis factor (TNF) agents, clinicians should look to risk factors for recurrence.

Whitney McKnight/Frontline Medical News

The notion that immediate treatment with a biologic after surgical resectioning is best is supported by phase III data from the international, multicenter PREVENT trial, for which Dr. Regueiro was principal investigator. It demonstrated that at week 79 and week 104, immediate treatment with the biologic infliximab 5 mg/kg every 8 weeks postsurgery in patients with high risk for recurrence (smokers, those with penetrating or fistulizing disease, or a history of resectioning) resulted in lower but not statistically significant rates of the composite endpoint of clinical recurrence and endoscopic scores greater than 2, when compared with placebo (P = .097 at 76 weeks and P = .098 at 104 weeks).

Dr. Regueiro noted in an interview that often, even though endoscopic recurrence scores might be high, following surgery, patients are in clinical remission and so do not report any symptoms. He noted that when only endoscopic outcomes prior to or at week 76 in the PREVENT trial were analyzed as the secondary endpoint, there was a statistically significant difference when compared with placebo: The 147 randomly assigned study arm participants had a recurrence rate of 22.4% vs. 51.3% in 150 controls (P less than .001). Further, Rutgeerts scores equal or greater than i-3 occurred in 83.1% of participants in the placebo group, compared with 28.4% in the infliximab group at week 76.

“The take-home message is that surgery induces a deep remission where patient’s ‘feel well’ and by using a clinical symptom score we do not detect recurrence, probably for years,” Dr. Regueiro said in the interview.

What about waiting to offer treatment?

Results from the POCER trial, also conducted internationally at a number of centers, support this approach.

In the trial, 174 postoperative patients at high risk for recurrence were randomly assigned in a 2:1 ratio to either standard care – colonoscopy at 18 months – or to receive a colonoscopy at 6 months, followed by medication if there was an endoscopic recurrence of i-2 or greater.

Both study arms were given metronidazole 400 mg twice a day for 3 months. If patients were intolerant, the dose was reduced to 200 mg twice daily or was stopped altogether. If they were high risk but medication naive, patients were given azathioprine 2 mg/kg or 6-mercaptopurine 1.5 mg/kg once daily, beginning within 1 month after surgery. Patients intolerant to this regime were administered adalimumab 160/80/40 mg accordingly, every other week.

At 18 months, those patients who’d been observed endoscopically at 6 months and given medication if necessary had a 49% rate of recurrence compared with 67% in the group given standard care, a statistically significant difference.

However, when Dr. Regueiro, who was not directly involved with the POCER trial, conducted an informal review of the data, he found that patients who’d been on thiopurines had an endoscopic recurrence rate at 6 months of 45% vs. the 21% rate in the adalimumab patients. “This means that waiting on anti-TNF and giving thiopurine meant nearly half the patients had recurrence in 6 months, compared with anti-TNF treated patients.”

So then, when should biologics enter the treatment picture?

Again, look to the risk profile, said Dr. Regueiro. Patients who are 30 years of age or younger, have ileocolonic disease, smoke, have penetrating disease, or have already had two or more surgeries or had a short duration between time of diagnosis and surgery are considered at high risk for return of the disease.

In his own practice, Dr. Regueiro said he puts all but the low-risk patients on some form of immediate postoperative medication. Patients at moderate risk, such as those who have had a resection within 10 years of diagnosis, receive 6-mercaptopurine or azathioprine plus metronidazole (if tolerated) and are given colonoscopy at 6-12 months postoperatively. If there is a recurrence at that point, then he will start the patient on an anti-TNF. If not, then he sees them again in 1-3 years for a colonoscopy. Dr. Regueiro treats patients at high risk for recurrence more frequently with combination therapies, immediately setting them on a regimen of anti-TNF plus immunosuppressive therapy followed by a 6-12 month postoperative colonoscopy after which he adjusts treatment if there is active disease, including increasing the dose of the biologic or switching to another one.

But just what length of time actually constitutes “immediately after surgery?” In the PREVENT trial, clinicians had up to 45 days to begin therapy, although Dr. Regueiro said he prefers to start between 2 and 4 weeks postsurgery, a number with which panel moderator Dr. David T. Rubin, codirector of the University of Chicago Digestive Diseases Center, agreed.

While these study results help pinpoint the range for when to use biologics, Dr. Regueiro said in the interview, “Future study is need to determine the ‘tipping point’ where postoperative Crohn’s disease recurrence results in significant bowel damage and renders medications ineffective. Finding the ‘biologic sweet spot’ of when to start aggressive therapy versus a ‘wait and watch’ approach remains the question.”

Dr. Regueiro disclosed he is a consultant for AbbVie, Janssen, UCB, Pfizer, and Takeda.

[email protected]

On Twitter @whitneymcknight

The Centers for Medicare & Medicaid Services today issued its final rule on prior authorization for certain durable medical equipment, prosthetics, orthotics, and supplies.

The rule moves necessary documentation earlier in the approval process, requiring all relevant coverage, coding, and clinical documentation to be completed before certain goods are provided to a beneficiary and before the claim is submitted for payment, according to a CMS statement published Dec. 30 in the Federal Register.

Prior authorization is an effective way to reduce or prevent questionable billing practices and improper payments for durable medical equipment, prosthetics, orthotics, and supplies, according to the statement.

The rule includes review and approval timeframes and a provision for expedited claims in which delayed approval could adversely impact a beneficiary’s health.

Some of the items subject to “frequent unnecessary utilization” include certain powered air mattresses, continuous airway pressure devices, power wheelchairs, oxygen concentrators, and prosthetic limbs (especially for lower extremities).

[email protected]

On Twitter @whitneymcknight

The Centers for Medicare & Medicaid Services today issued its final rule on prior authorization for certain durable medical equipment, prosthetics, orthotics, and supplies.

The rule moves necessary documentation earlier in the approval process, requiring all relevant coverage, coding, and clinical documentation to be completed before certain goods are provided to a beneficiary and before the claim is submitted for payment, according to a CMS statement published Dec. 30 in the Federal Register.

Prior authorization is an effective way to reduce or prevent questionable billing practices and improper payments for durable medical equipment, prosthetics, orthotics, and supplies, according to the statement.

The rule includes review and approval timeframes and a provision for expedited claims in which delayed approval could adversely impact a beneficiary’s health.

Some of the items subject to “frequent unnecessary utilization” include certain powered air mattresses, continuous airway pressure devices, power wheelchairs, oxygen concentrators, and prosthetic limbs (especially for lower extremities).

[email protected]

On Twitter @whitneymcknight

The Centers for Medicare & Medicaid Services today issued its final rule on prior authorization for certain durable medical equipment, prosthetics, orthotics, and supplies.

The rule moves necessary documentation earlier in the approval process, requiring all relevant coverage, coding, and clinical documentation to be completed before certain goods are provided to a beneficiary and before the claim is submitted for payment, according to a CMS statement published Dec. 30 in the Federal Register.

Prior authorization is an effective way to reduce or prevent questionable billing practices and improper payments for durable medical equipment, prosthetics, orthotics, and supplies, according to the statement.

The rule includes review and approval timeframes and a provision for expedited claims in which delayed approval could adversely impact a beneficiary’s health.

Some of the items subject to “frequent unnecessary utilization” include certain powered air mattresses, continuous airway pressure devices, power wheelchairs, oxygen concentrators, and prosthetic limbs (especially for lower extremities).

[email protected]

On Twitter @whitneymcknight

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight