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AGA aims to increase awareness of exocrine pancreatic insufficiency
The update, which was led by Anna M. Buchner, MD, PhD, University of Pennsylvania, Philadelphia, includes 15 best practice advice statements based on available literature and expert opinion.
“EPI is frequently underdiagnosed and, as a result, patients are often not treated appropriately,” the authors wrote in Gastroenterology. “There is an urgent need to increase awareness of and treatment for this condition.”
To this end, the authors offered guidance spanning the patient journey, with recommendations broadly grouped into four categories: clinical features and risk factors, diagnostic strategies, treatment approaches, and disease monitoring.
Clinical features and risk factors
The CPU begins by listing the key clinical features of EPI, including bloating, excessive flatulence, fat-soluble vitamin deficiencies, protein-calorie malnutrition, steatorrhea with or without diarrhea, and weight loss.
The authors went on to suggest that EPI should also be considered in patients with high-risk clinical conditions, including previous pancreatic surgery, chronic pancreatitis, cystic fibrosis, pancreatic ductal adenocarcinoma, and relapsing acute pancreatitis.
Similarly, suspicion should be increased for individuals with moderate-risk clinical conditions, such as prior intestinal surgery, Zollinger-Ellison syndrome, longstanding diabetes mellitus, and duodenal diseases such as celiac and Crohn’s disease.
Diagnostic strategies
The primary diagnostic tool for EPI is the fecal elastase test, according to the update. Levels below 100 mcg/g indicate EPI, whereas levels between 100-200 mcg/g are considered indeterminate. The investigators noted that this test can be conducted even during pancreatic enzyme replacement therapy (PERT).
Other tests for EPI are rarely used, such as fecal fat testing, which must be performed on a high-fat diet, and quantitative testing, which is generally impractical for routine clinical use.
The authors also noted that a therapeutic trial of PERT is an unreliable method for diagnosing EPI.
“Patients with nonspecific symptoms, such as bloating, excess gas, and foul-smelling or floating stools may note some improvement in these symptoms while taking PERT, but these symptoms are nonspecific and symptomatic changes may be a placebo effect or masking other disorders, such as celiac disease, causing delays in a correct diagnosis,” they wrote.
While cross-sectional imaging methods such as CT scans, MRI, and endoscopic ultrasound play a significant role in detecting other pancreatic diseases, they cannot identify EPI. Breath tests and direct pancreatic function tests do hold promise, but they are not widely available in the United States.
Treatment strategies
Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.
PERT formulations are all equally effective at equivalent doses, according to the update, but non–enteric-coated preparations require concurrent H2 or proton pump inhibitor therapy. PERT should be taken during meals, with an initial adult dose of at least 40,000 USP units of lipase during each meal. Half that dose may be considered for snacks, with further dosage refinements based on meal size and fat content.
Dietary modifications may include supplementation with fat-soluble vitamins alongside smaller, more frequent, low- to moderate-fat meals. Very-low-fat diets should be avoided, the authors cautioned.
Surveillance
EPI treatment success can be identified by reduction in steatorrhea and associated gastrointestinal symptoms, as well as weight gain, improved muscle mass and function, and enhanced fat-soluble vitamin levels, Dr. Whitcomb and colleagues wrote, noting that a dual-energy x-ray absorptiometry scan also should be performed at baseline, then repeated every 1-2 years.
The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.
The update, which was led by Anna M. Buchner, MD, PhD, University of Pennsylvania, Philadelphia, includes 15 best practice advice statements based on available literature and expert opinion.
“EPI is frequently underdiagnosed and, as a result, patients are often not treated appropriately,” the authors wrote in Gastroenterology. “There is an urgent need to increase awareness of and treatment for this condition.”
To this end, the authors offered guidance spanning the patient journey, with recommendations broadly grouped into four categories: clinical features and risk factors, diagnostic strategies, treatment approaches, and disease monitoring.
Clinical features and risk factors
The CPU begins by listing the key clinical features of EPI, including bloating, excessive flatulence, fat-soluble vitamin deficiencies, protein-calorie malnutrition, steatorrhea with or without diarrhea, and weight loss.
The authors went on to suggest that EPI should also be considered in patients with high-risk clinical conditions, including previous pancreatic surgery, chronic pancreatitis, cystic fibrosis, pancreatic ductal adenocarcinoma, and relapsing acute pancreatitis.
Similarly, suspicion should be increased for individuals with moderate-risk clinical conditions, such as prior intestinal surgery, Zollinger-Ellison syndrome, longstanding diabetes mellitus, and duodenal diseases such as celiac and Crohn’s disease.
Diagnostic strategies
The primary diagnostic tool for EPI is the fecal elastase test, according to the update. Levels below 100 mcg/g indicate EPI, whereas levels between 100-200 mcg/g are considered indeterminate. The investigators noted that this test can be conducted even during pancreatic enzyme replacement therapy (PERT).
Other tests for EPI are rarely used, such as fecal fat testing, which must be performed on a high-fat diet, and quantitative testing, which is generally impractical for routine clinical use.
The authors also noted that a therapeutic trial of PERT is an unreliable method for diagnosing EPI.
“Patients with nonspecific symptoms, such as bloating, excess gas, and foul-smelling or floating stools may note some improvement in these symptoms while taking PERT, but these symptoms are nonspecific and symptomatic changes may be a placebo effect or masking other disorders, such as celiac disease, causing delays in a correct diagnosis,” they wrote.
While cross-sectional imaging methods such as CT scans, MRI, and endoscopic ultrasound play a significant role in detecting other pancreatic diseases, they cannot identify EPI. Breath tests and direct pancreatic function tests do hold promise, but they are not widely available in the United States.
Treatment strategies
Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.
PERT formulations are all equally effective at equivalent doses, according to the update, but non–enteric-coated preparations require concurrent H2 or proton pump inhibitor therapy. PERT should be taken during meals, with an initial adult dose of at least 40,000 USP units of lipase during each meal. Half that dose may be considered for snacks, with further dosage refinements based on meal size and fat content.
Dietary modifications may include supplementation with fat-soluble vitamins alongside smaller, more frequent, low- to moderate-fat meals. Very-low-fat diets should be avoided, the authors cautioned.
Surveillance
EPI treatment success can be identified by reduction in steatorrhea and associated gastrointestinal symptoms, as well as weight gain, improved muscle mass and function, and enhanced fat-soluble vitamin levels, Dr. Whitcomb and colleagues wrote, noting that a dual-energy x-ray absorptiometry scan also should be performed at baseline, then repeated every 1-2 years.
The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.
The update, which was led by Anna M. Buchner, MD, PhD, University of Pennsylvania, Philadelphia, includes 15 best practice advice statements based on available literature and expert opinion.
“EPI is frequently underdiagnosed and, as a result, patients are often not treated appropriately,” the authors wrote in Gastroenterology. “There is an urgent need to increase awareness of and treatment for this condition.”
To this end, the authors offered guidance spanning the patient journey, with recommendations broadly grouped into four categories: clinical features and risk factors, diagnostic strategies, treatment approaches, and disease monitoring.
Clinical features and risk factors
The CPU begins by listing the key clinical features of EPI, including bloating, excessive flatulence, fat-soluble vitamin deficiencies, protein-calorie malnutrition, steatorrhea with or without diarrhea, and weight loss.
The authors went on to suggest that EPI should also be considered in patients with high-risk clinical conditions, including previous pancreatic surgery, chronic pancreatitis, cystic fibrosis, pancreatic ductal adenocarcinoma, and relapsing acute pancreatitis.
Similarly, suspicion should be increased for individuals with moderate-risk clinical conditions, such as prior intestinal surgery, Zollinger-Ellison syndrome, longstanding diabetes mellitus, and duodenal diseases such as celiac and Crohn’s disease.
Diagnostic strategies
The primary diagnostic tool for EPI is the fecal elastase test, according to the update. Levels below 100 mcg/g indicate EPI, whereas levels between 100-200 mcg/g are considered indeterminate. The investigators noted that this test can be conducted even during pancreatic enzyme replacement therapy (PERT).
Other tests for EPI are rarely used, such as fecal fat testing, which must be performed on a high-fat diet, and quantitative testing, which is generally impractical for routine clinical use.
The authors also noted that a therapeutic trial of PERT is an unreliable method for diagnosing EPI.
“Patients with nonspecific symptoms, such as bloating, excess gas, and foul-smelling or floating stools may note some improvement in these symptoms while taking PERT, but these symptoms are nonspecific and symptomatic changes may be a placebo effect or masking other disorders, such as celiac disease, causing delays in a correct diagnosis,” they wrote.
While cross-sectional imaging methods such as CT scans, MRI, and endoscopic ultrasound play a significant role in detecting other pancreatic diseases, they cannot identify EPI. Breath tests and direct pancreatic function tests do hold promise, but they are not widely available in the United States.
Treatment strategies
Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.
PERT formulations are all equally effective at equivalent doses, according to the update, but non–enteric-coated preparations require concurrent H2 or proton pump inhibitor therapy. PERT should be taken during meals, with an initial adult dose of at least 40,000 USP units of lipase during each meal. Half that dose may be considered for snacks, with further dosage refinements based on meal size and fat content.
Dietary modifications may include supplementation with fat-soluble vitamins alongside smaller, more frequent, low- to moderate-fat meals. Very-low-fat diets should be avoided, the authors cautioned.
Surveillance
EPI treatment success can be identified by reduction in steatorrhea and associated gastrointestinal symptoms, as well as weight gain, improved muscle mass and function, and enhanced fat-soluble vitamin levels, Dr. Whitcomb and colleagues wrote, noting that a dual-energy x-ray absorptiometry scan also should be performed at baseline, then repeated every 1-2 years.
The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.
FROM GASTROENTEROLOGY
AGA issues CPU for CRC screening, postpolypectomy surveillance
Led by Rachel B. Issaka, MD, of Fred Hutchinson Cancer Center, Seattle, the Clinical Practice Update focuses primarily on time frames for surveillance based on known risk factors, plus a caution against widespread use of emerging risk-stratification tools that need more real-world evidence among diverse populations.
“Based on current evidence, risk stratification for initiating CRC screening or surveillance should be based on age, family history, predisposing hereditary CRC syndromes, prior screening, or other CRC predisposing conditions,” the authors wrote in Gastroenterology.
With these parameters in mind, Dr. Issaka and colleagues issued nine best practice advice statements, noting that systematic reviews were not conducted, so statements are not rated based on quality of evidence or strength of presented considerations.
To begin, the investigators characterized two risk strata for CRC. Individuals with a first-degree relative who was diagnosed with CRC have an increased risk of CRC, particularly if that relative was diagnosed before age 50. In contrast, people with no such family history, or a personal history of CRC, hereditary CRC syndromes, inflammatory bowel disease, or other predisposing conditions, have average risk for CRC.
Those with average risk should start CRC screening at age 45, while those with high risk should start screening at age 40, or 10 years before the age of diagnosis of their youngest affected relative, whichever is sooner.
“The age to initiate screening according to family history of CRC could be optimized based on the number of affected family members, age at diagnosis of the affected relatives, as well as the 10-year cumulative incidence of CRC according to age within a specific source population (e.g., country),” the investigators wrote. “However, in the absence of widely available risk calculators developed for such risk-adapted screenings, a simplified approach to consider is initiating screening approximately 10 years before the age of diagnosis of the youngest affected relative or at age 40 years.”
The decision to screen and conduct postpolypectomy surveillance beyond age 75 should factor in risks, benefits, screening history, and comorbidities.
According to Dr. Issaka and colleagues, individuals with average risk can choose between several options for screening based on preference and availability, including fecal immunochemical test, colonoscopy, flexible sigmoidoscopy plus fecal immunochemical test, multitarget stool DNA fecal immunochemical test, and computed tomography colonography. Those with high risk, however, should undergo colonoscopy.
The final best practice advice statement offers a word of caution against widespread use of new risk-stratification tools for CRC and postpolypectomy surveillance that have yet to demonstrate real-world effectiveness and cost-effectiveness in diverse populations.
“Validation within diverse racial and ethnic populations is critical for models that include genetic factors, because genetic discovery studies have focused largely on individuals with European ancestry, and because risk-relevant genetic factors may vary according to individual’s origin of genetic ancestry,” the investigators wrote. “Although many studies differentiate individuals by race and ethnicity, which may capture some information about the likely presence of certain genetic variants, ancestry is a better predictor and should be captured in validation studies.”
The update was commissioned and approved by the AGA, and supported by the National Cancer Institute of the National Institutes of Health. The investigators disclosed relationships with Geneoscopy, CellMax Life, Universal Diagnostics, and others.
Led by Rachel B. Issaka, MD, of Fred Hutchinson Cancer Center, Seattle, the Clinical Practice Update focuses primarily on time frames for surveillance based on known risk factors, plus a caution against widespread use of emerging risk-stratification tools that need more real-world evidence among diverse populations.
“Based on current evidence, risk stratification for initiating CRC screening or surveillance should be based on age, family history, predisposing hereditary CRC syndromes, prior screening, or other CRC predisposing conditions,” the authors wrote in Gastroenterology.
With these parameters in mind, Dr. Issaka and colleagues issued nine best practice advice statements, noting that systematic reviews were not conducted, so statements are not rated based on quality of evidence or strength of presented considerations.
To begin, the investigators characterized two risk strata for CRC. Individuals with a first-degree relative who was diagnosed with CRC have an increased risk of CRC, particularly if that relative was diagnosed before age 50. In contrast, people with no such family history, or a personal history of CRC, hereditary CRC syndromes, inflammatory bowel disease, or other predisposing conditions, have average risk for CRC.
Those with average risk should start CRC screening at age 45, while those with high risk should start screening at age 40, or 10 years before the age of diagnosis of their youngest affected relative, whichever is sooner.
“The age to initiate screening according to family history of CRC could be optimized based on the number of affected family members, age at diagnosis of the affected relatives, as well as the 10-year cumulative incidence of CRC according to age within a specific source population (e.g., country),” the investigators wrote. “However, in the absence of widely available risk calculators developed for such risk-adapted screenings, a simplified approach to consider is initiating screening approximately 10 years before the age of diagnosis of the youngest affected relative or at age 40 years.”
The decision to screen and conduct postpolypectomy surveillance beyond age 75 should factor in risks, benefits, screening history, and comorbidities.
According to Dr. Issaka and colleagues, individuals with average risk can choose between several options for screening based on preference and availability, including fecal immunochemical test, colonoscopy, flexible sigmoidoscopy plus fecal immunochemical test, multitarget stool DNA fecal immunochemical test, and computed tomography colonography. Those with high risk, however, should undergo colonoscopy.
The final best practice advice statement offers a word of caution against widespread use of new risk-stratification tools for CRC and postpolypectomy surveillance that have yet to demonstrate real-world effectiveness and cost-effectiveness in diverse populations.
“Validation within diverse racial and ethnic populations is critical for models that include genetic factors, because genetic discovery studies have focused largely on individuals with European ancestry, and because risk-relevant genetic factors may vary according to individual’s origin of genetic ancestry,” the investigators wrote. “Although many studies differentiate individuals by race and ethnicity, which may capture some information about the likely presence of certain genetic variants, ancestry is a better predictor and should be captured in validation studies.”
The update was commissioned and approved by the AGA, and supported by the National Cancer Institute of the National Institutes of Health. The investigators disclosed relationships with Geneoscopy, CellMax Life, Universal Diagnostics, and others.
Led by Rachel B. Issaka, MD, of Fred Hutchinson Cancer Center, Seattle, the Clinical Practice Update focuses primarily on time frames for surveillance based on known risk factors, plus a caution against widespread use of emerging risk-stratification tools that need more real-world evidence among diverse populations.
“Based on current evidence, risk stratification for initiating CRC screening or surveillance should be based on age, family history, predisposing hereditary CRC syndromes, prior screening, or other CRC predisposing conditions,” the authors wrote in Gastroenterology.
With these parameters in mind, Dr. Issaka and colleagues issued nine best practice advice statements, noting that systematic reviews were not conducted, so statements are not rated based on quality of evidence or strength of presented considerations.
To begin, the investigators characterized two risk strata for CRC. Individuals with a first-degree relative who was diagnosed with CRC have an increased risk of CRC, particularly if that relative was diagnosed before age 50. In contrast, people with no such family history, or a personal history of CRC, hereditary CRC syndromes, inflammatory bowel disease, or other predisposing conditions, have average risk for CRC.
Those with average risk should start CRC screening at age 45, while those with high risk should start screening at age 40, or 10 years before the age of diagnosis of their youngest affected relative, whichever is sooner.
“The age to initiate screening according to family history of CRC could be optimized based on the number of affected family members, age at diagnosis of the affected relatives, as well as the 10-year cumulative incidence of CRC according to age within a specific source population (e.g., country),” the investigators wrote. “However, in the absence of widely available risk calculators developed for such risk-adapted screenings, a simplified approach to consider is initiating screening approximately 10 years before the age of diagnosis of the youngest affected relative or at age 40 years.”
The decision to screen and conduct postpolypectomy surveillance beyond age 75 should factor in risks, benefits, screening history, and comorbidities.
According to Dr. Issaka and colleagues, individuals with average risk can choose between several options for screening based on preference and availability, including fecal immunochemical test, colonoscopy, flexible sigmoidoscopy plus fecal immunochemical test, multitarget stool DNA fecal immunochemical test, and computed tomography colonography. Those with high risk, however, should undergo colonoscopy.
The final best practice advice statement offers a word of caution against widespread use of new risk-stratification tools for CRC and postpolypectomy surveillance that have yet to demonstrate real-world effectiveness and cost-effectiveness in diverse populations.
“Validation within diverse racial and ethnic populations is critical for models that include genetic factors, because genetic discovery studies have focused largely on individuals with European ancestry, and because risk-relevant genetic factors may vary according to individual’s origin of genetic ancestry,” the investigators wrote. “Although many studies differentiate individuals by race and ethnicity, which may capture some information about the likely presence of certain genetic variants, ancestry is a better predictor and should be captured in validation studies.”
The update was commissioned and approved by the AGA, and supported by the National Cancer Institute of the National Institutes of Health. The investigators disclosed relationships with Geneoscopy, CellMax Life, Universal Diagnostics, and others.
FROM GASTROENTEROLOGY
Solid therapeutic hierarchy for eosinophilic esophagitis still unclear
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
, shows a meta-analysis published in Gut.
Among agents available outside of clinical trials, the corticosteroid budesonide had the broadest evidence base for efficacy, while EoE-specific topical steroids typically outperformed adapted asthma formulations, wrote authors who were led by Edoardo Savarino, MD, PhD, of the department of surgery, oncology and gastroenterology at the University of Padua, Italy.
The AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters published clinical practice guidelines for eosinophilic esophagitis in 2020. The group issued 12 recommendations with only 1, the topical use of glucocorticosteroids over no treatment, being a “strong recommendation.” Both the AGA/JTF guidelines and guidelines issued May 23, 2022 , by the British Society of Gastroenterology and British Society of Pediatric Gastroenterology, Hepatology and Nutrition, recommend the use of proton pump inhibitors (PPIs) and topical glucocorticosteroids in certain cases. Neither set of guidelines addresses the use of dupilumab, which was approved in the United States on May 20, 2022, for adults and pediatric patients 12 years and older, and in January of this year by the European Commission for the same condition.
The current study is a meta-analysis that compared data from 1,813 subjects with active EoE who participated in 15 randomized controlled trials. All drugs tested in EoE were included, each compared against one another and placebo. Efficacy was characterized by induction of histological remission, symptomatic response, and endoscopic response. Topical steroids formulated for EoE were evaluated separately from off-label topical steroids for asthma.
This approach yielded a litany of efficacy findings.
Of note, budesonide orally disintegrating tablets ranked first for histological remission defined by no more than 15 eosinophils/high-powered field (HPF), while lirentelimab was best at achieving the lesser used histological remission threshold of 6 eosinophils/HPF. On the same topic of inducing histological remission, EoE-specific steroid formulations, along with dupilumab, showed greater efficacy than off-label topical steroids.
The investigators also highlighted that budesonide suspension and tablets were significantly better than placebo in terms of failure to achieve symptom improvement and failure to achieve endoscopic improvement according to EoE Endoscopic Reference Score.
Collectively, the analysis showed that most available drugs are significantly more effective than placebo for treating EoE, yet differences in study designs and population characteristics stand in the way of a clear road map to treatment selection.
“In summary, this network meta-analysis supports the efficacy of most available drugs over placebo for the treatment of EoE. All EoE-specific steroid formulations and dupilumab ranked higher than off-label topical steroids for the induction of histological remission in active EoE, and most EoE-specific steroid formulations and dupilumab ranked higher than esomeprazole, despite having comparable safety,” the authors wrote. “These results prompt further research to better understand the mechanisms underlying symptom generation in EoE, to target their cause and achieve better outcomes.”
Joy Weiling Chang, MD, a gastroenterologist and assistant professor of medicine at the University of Michigan Medicine, Ann Arbor, offered a similar perspective.
“This study tells us that we still need more data to establish this clear hierarchy of medication treatments,” she said in an interview.
Still, Dr. Chang added, these findings are applicable to clinical practice. Because most EoE drugs demonstrate significant efficacy over placebo, and the best starting option remains unclear, then shared decision-making should focus on patient preferences, she said in an interview.
“As clinicians, we need to be working with our patients to consider which strategies work best for their lifestyles,” Dr. Chang said.
The investigators disclosed relationships with AbbVie, Biogen, Sanofi, and others. Dr. Chang reported consulting fees for Sanofi-Regeneron, the maker of Dupixent.
FROM GUT
Rectal cancer risk is markedly higher at 10 years post colectomy
, shows a Danish population-based cohort study.
These findings suggest that more intensive long-term surveillance is needed for colectomized patients with IBD, wrote researchers who were led by Tine Jess, MD, DMSc, of the Center for Molecular Prediction of Inflammatory Bowel Disease, Aalborg University, Copenhagen.
“Our nationwide population-based cohort study covering 4 decades shows that despite a relatively low absolute number of RC cases following colectomy for IBD, the risk of RC is markedly increased 10 years after the surgery. This calls for better long-term surveillance of colectomized IBD patients,” the authors wrote in Gastro Hep Advances.
Previous studies have suggested that patients with IBD have an increased risk of rectal cancer after colectomy, but these data “cannot stand alone,” and “need to be confirmed in other unselected patient cohorts,” investigators wrote.
The new study was based on an analysis of data from more than 9 million individuals in the Danish Civil Registration System between 1978 and 2018. The analyses were restricted to risk of rectal cancer in the population with diverted rectum.
The final dataset included 4,931 patients with IBD who had subtotal colectomy and diverted rectum, 49,251 matched patients with IBD who did not undergo colectomy, and 246,550 matched individuals without IBD to serve as a background population. Within these groups, rectal cancer occurred at a rate of 0.9%, 0.4%, and 0.4%, respectively, hinting at an increased risk of rectal cancer after colectomy among patients with IBD.
This signal was clarified by comparing rates of rectal cancer 10 years before and after colectomy. Rates 10 years before colectomy were not significantly different between groups.
Comparing colectomized IBD patients with the noncolectomized IBD patients at the 10-year postcolectomy mark revealed an eightfold increased risk of rectal cancer (hazard ratio, 7.56; 95% confidence interval, 5.21-10.86). Risk was slightly lower for patients with Crohn’s disease (HR, 5.10; 95% CI, 2.41-10.81) than for those with ulcerative colitis (HR, 9.42; 95% CI, 6.18-14.36).
A comparison at the same time point for colectomized IBD patients versus the background population showed an even higher relative risk for rectal cancer, up 10-fold (HR, 10.01; 95% CI, 7.20-13.94).
Despite variations in surgical methods, researchers concluded that the long-term risk of rectal cancer post colectomy increased among patients with IBD.
The findings should inform surveillance guidelines, they wrote.
“To reduce the risk of CRC in IBD, endoscopic surveillance guidelines have been developed both nationally and internationally. However, guidelines do not include clear recommendations for patients with a residual rectum, ileo-rectal anastomosis, or ileal pouch-anal anastomosis. The Danish guidelines, the Danish Society of Gastroenterology and Hepatology, mention a potential increased risk of rectal cancer post colectomy ... The European Crohn’s and Colitis Organization guideline consensus paper ‘European Evidence-based Consensus: Inflammatory Bowel Disease and Malignancies’ mentions that ‘the risk of rectal cancer is relatively high in IBD patients after subtotal colectomy’ [but] without further recommendation,” study authors wrote.
The study was supported by Laege Carl Emil Friis, Hustru Olga Doris Friis, and the Danish National Research Foundation. The investigators disclosed no conflicts of interest.
Rectal cancer risk in colectomized IBD patients is poorly understood, and most guidelines do not specify unique surveillance protocols for this subset of patients. As such, gastroenterologists are often left using their best judgement to decide surveillance intervals in this group.
In a Danish population-based cohort study, Akimenko and colleagues identify a markedly increased risk of rectal cancer 10 years after colectomy in patients with a diverted rectum. This risk is 8-fold compared to a matched IBD cohort without colectomy, 10-fold compared to the background population, and is slightly higher in ulcerative colitis than Crohn’s disease. The relative risk is similar to that identified in a Swedish nationwide study.
The study benefits from a large, unselected cohort and its use of a matched IBD population without colectomy. However, it is not sufficiently powered to assess cancer risk in patients with IRA or IPAA, thus limiting its generalizability. The lengthy 40-year inclusion period, while providing strength in numbers, may also impact the study findings, as significant changes have occurred in IBD management during this timeframe.
The authors herald an important reminder that post-colectomy IBD patients are not ‘out of the woods’ with regards to rectal cancer risk. Inconsistency exists amongst providers when it comes to surveillance intervals in these patients.
The study highlights the need for specific surveillance guidelines for this group, particularly in patients with a diverted rectum. Additional studies are needed to assess risk in patients with IRA or IPAA.
Dr. Maté Gergely is an assistant professor of medicine within the division of gastroenterology at Washington University School of Medicine, St. Louis. He has no relevant disclosures.
Rectal cancer risk in colectomized IBD patients is poorly understood, and most guidelines do not specify unique surveillance protocols for this subset of patients. As such, gastroenterologists are often left using their best judgement to decide surveillance intervals in this group.
In a Danish population-based cohort study, Akimenko and colleagues identify a markedly increased risk of rectal cancer 10 years after colectomy in patients with a diverted rectum. This risk is 8-fold compared to a matched IBD cohort without colectomy, 10-fold compared to the background population, and is slightly higher in ulcerative colitis than Crohn’s disease. The relative risk is similar to that identified in a Swedish nationwide study.
The study benefits from a large, unselected cohort and its use of a matched IBD population without colectomy. However, it is not sufficiently powered to assess cancer risk in patients with IRA or IPAA, thus limiting its generalizability. The lengthy 40-year inclusion period, while providing strength in numbers, may also impact the study findings, as significant changes have occurred in IBD management during this timeframe.
The authors herald an important reminder that post-colectomy IBD patients are not ‘out of the woods’ with regards to rectal cancer risk. Inconsistency exists amongst providers when it comes to surveillance intervals in these patients.
The study highlights the need for specific surveillance guidelines for this group, particularly in patients with a diverted rectum. Additional studies are needed to assess risk in patients with IRA or IPAA.
Dr. Maté Gergely is an assistant professor of medicine within the division of gastroenterology at Washington University School of Medicine, St. Louis. He has no relevant disclosures.
Rectal cancer risk in colectomized IBD patients is poorly understood, and most guidelines do not specify unique surveillance protocols for this subset of patients. As such, gastroenterologists are often left using their best judgement to decide surveillance intervals in this group.
In a Danish population-based cohort study, Akimenko and colleagues identify a markedly increased risk of rectal cancer 10 years after colectomy in patients with a diverted rectum. This risk is 8-fold compared to a matched IBD cohort without colectomy, 10-fold compared to the background population, and is slightly higher in ulcerative colitis than Crohn’s disease. The relative risk is similar to that identified in a Swedish nationwide study.
The study benefits from a large, unselected cohort and its use of a matched IBD population without colectomy. However, it is not sufficiently powered to assess cancer risk in patients with IRA or IPAA, thus limiting its generalizability. The lengthy 40-year inclusion period, while providing strength in numbers, may also impact the study findings, as significant changes have occurred in IBD management during this timeframe.
The authors herald an important reminder that post-colectomy IBD patients are not ‘out of the woods’ with regards to rectal cancer risk. Inconsistency exists amongst providers when it comes to surveillance intervals in these patients.
The study highlights the need for specific surveillance guidelines for this group, particularly in patients with a diverted rectum. Additional studies are needed to assess risk in patients with IRA or IPAA.
Dr. Maté Gergely is an assistant professor of medicine within the division of gastroenterology at Washington University School of Medicine, St. Louis. He has no relevant disclosures.
, shows a Danish population-based cohort study.
These findings suggest that more intensive long-term surveillance is needed for colectomized patients with IBD, wrote researchers who were led by Tine Jess, MD, DMSc, of the Center for Molecular Prediction of Inflammatory Bowel Disease, Aalborg University, Copenhagen.
“Our nationwide population-based cohort study covering 4 decades shows that despite a relatively low absolute number of RC cases following colectomy for IBD, the risk of RC is markedly increased 10 years after the surgery. This calls for better long-term surveillance of colectomized IBD patients,” the authors wrote in Gastro Hep Advances.
Previous studies have suggested that patients with IBD have an increased risk of rectal cancer after colectomy, but these data “cannot stand alone,” and “need to be confirmed in other unselected patient cohorts,” investigators wrote.
The new study was based on an analysis of data from more than 9 million individuals in the Danish Civil Registration System between 1978 and 2018. The analyses were restricted to risk of rectal cancer in the population with diverted rectum.
The final dataset included 4,931 patients with IBD who had subtotal colectomy and diverted rectum, 49,251 matched patients with IBD who did not undergo colectomy, and 246,550 matched individuals without IBD to serve as a background population. Within these groups, rectal cancer occurred at a rate of 0.9%, 0.4%, and 0.4%, respectively, hinting at an increased risk of rectal cancer after colectomy among patients with IBD.
This signal was clarified by comparing rates of rectal cancer 10 years before and after colectomy. Rates 10 years before colectomy were not significantly different between groups.
Comparing colectomized IBD patients with the noncolectomized IBD patients at the 10-year postcolectomy mark revealed an eightfold increased risk of rectal cancer (hazard ratio, 7.56; 95% confidence interval, 5.21-10.86). Risk was slightly lower for patients with Crohn’s disease (HR, 5.10; 95% CI, 2.41-10.81) than for those with ulcerative colitis (HR, 9.42; 95% CI, 6.18-14.36).
A comparison at the same time point for colectomized IBD patients versus the background population showed an even higher relative risk for rectal cancer, up 10-fold (HR, 10.01; 95% CI, 7.20-13.94).
Despite variations in surgical methods, researchers concluded that the long-term risk of rectal cancer post colectomy increased among patients with IBD.
The findings should inform surveillance guidelines, they wrote.
“To reduce the risk of CRC in IBD, endoscopic surveillance guidelines have been developed both nationally and internationally. However, guidelines do not include clear recommendations for patients with a residual rectum, ileo-rectal anastomosis, or ileal pouch-anal anastomosis. The Danish guidelines, the Danish Society of Gastroenterology and Hepatology, mention a potential increased risk of rectal cancer post colectomy ... The European Crohn’s and Colitis Organization guideline consensus paper ‘European Evidence-based Consensus: Inflammatory Bowel Disease and Malignancies’ mentions that ‘the risk of rectal cancer is relatively high in IBD patients after subtotal colectomy’ [but] without further recommendation,” study authors wrote.
The study was supported by Laege Carl Emil Friis, Hustru Olga Doris Friis, and the Danish National Research Foundation. The investigators disclosed no conflicts of interest.
, shows a Danish population-based cohort study.
These findings suggest that more intensive long-term surveillance is needed for colectomized patients with IBD, wrote researchers who were led by Tine Jess, MD, DMSc, of the Center for Molecular Prediction of Inflammatory Bowel Disease, Aalborg University, Copenhagen.
“Our nationwide population-based cohort study covering 4 decades shows that despite a relatively low absolute number of RC cases following colectomy for IBD, the risk of RC is markedly increased 10 years after the surgery. This calls for better long-term surveillance of colectomized IBD patients,” the authors wrote in Gastro Hep Advances.
Previous studies have suggested that patients with IBD have an increased risk of rectal cancer after colectomy, but these data “cannot stand alone,” and “need to be confirmed in other unselected patient cohorts,” investigators wrote.
The new study was based on an analysis of data from more than 9 million individuals in the Danish Civil Registration System between 1978 and 2018. The analyses were restricted to risk of rectal cancer in the population with diverted rectum.
The final dataset included 4,931 patients with IBD who had subtotal colectomy and diverted rectum, 49,251 matched patients with IBD who did not undergo colectomy, and 246,550 matched individuals without IBD to serve as a background population. Within these groups, rectal cancer occurred at a rate of 0.9%, 0.4%, and 0.4%, respectively, hinting at an increased risk of rectal cancer after colectomy among patients with IBD.
This signal was clarified by comparing rates of rectal cancer 10 years before and after colectomy. Rates 10 years before colectomy were not significantly different between groups.
Comparing colectomized IBD patients with the noncolectomized IBD patients at the 10-year postcolectomy mark revealed an eightfold increased risk of rectal cancer (hazard ratio, 7.56; 95% confidence interval, 5.21-10.86). Risk was slightly lower for patients with Crohn’s disease (HR, 5.10; 95% CI, 2.41-10.81) than for those with ulcerative colitis (HR, 9.42; 95% CI, 6.18-14.36).
A comparison at the same time point for colectomized IBD patients versus the background population showed an even higher relative risk for rectal cancer, up 10-fold (HR, 10.01; 95% CI, 7.20-13.94).
Despite variations in surgical methods, researchers concluded that the long-term risk of rectal cancer post colectomy increased among patients with IBD.
The findings should inform surveillance guidelines, they wrote.
“To reduce the risk of CRC in IBD, endoscopic surveillance guidelines have been developed both nationally and internationally. However, guidelines do not include clear recommendations for patients with a residual rectum, ileo-rectal anastomosis, or ileal pouch-anal anastomosis. The Danish guidelines, the Danish Society of Gastroenterology and Hepatology, mention a potential increased risk of rectal cancer post colectomy ... The European Crohn’s and Colitis Organization guideline consensus paper ‘European Evidence-based Consensus: Inflammatory Bowel Disease and Malignancies’ mentions that ‘the risk of rectal cancer is relatively high in IBD patients after subtotal colectomy’ [but] without further recommendation,” study authors wrote.
The study was supported by Laege Carl Emil Friis, Hustru Olga Doris Friis, and the Danish National Research Foundation. The investigators disclosed no conflicts of interest.
FROM GASTRO HEP ADVANCES
AGA CPU: Essentials to prevent complications with ostomies
The American Gastroenterological Association has published a new Clinical Practice Update for the management of enteral ostomies, which are common in the management of patients with colorectal cancer, inflammatory bowel disease, diverticular disease, intestinal trauma, and intestinal perforation.
Approximately 750,000 people in the United States live with an ostomy, including colostomy, ileostomy, and continent ileostomy. Complications and challenges with self-care are common among patients with an enteral stoma, but most available guidance documents fail to offer management principles beyond the immediate perioperative period, wrote authors of the guidance which was led by Traci Hedrick, MD, of the University of Virginia Health, Charlottesville.
The update was published online in Clinical Gastroenterology and Hepatology. It includes best practice updates for managing short- and long-term complications, and perioperative considerations.
Early high ostomy output, defined by ostomy output greater than fluid intake that occurs within 3 weeks of stoma formation, causing dehydration, is a short-term complication associated with ostomies. It is more common among patients with an ileostomy than a colostomy, and requires rapid evaluation for infection and other associated complications. The cornerstone of treatment is rehydration, usually intravenously during hospital stay. Additional treatments may include bulking agents, antimotility agents, antisecretory agents, anti-inflammatory agents, adaptation-promoting agents, and surgery to reverse the ostomy.
Other short-term complications include ostomy leakage, stomal retraction, and mucocutaneous separation.
Dermatological problems are the most common of long-term complications. These typically involve skin irritation due to leakage. Other dermatological complaints include folliculitis, fungal rash, and allergic reaction to the appliance. Each of these must be addressed based on the nature and underlying cause of the complication.
Other long-term complications include chronic high ostomy output, parastomal hernia, and stomal prolapse.
Clinicians should also be aware of the psychological impact on patients. They may fear having a leakage or emitting an odor. They may also have anxiety in disclosing having an ostomy to partners and fear travel. “Difficulty with self-care should be addressed through preoperative and postoperative education. Preoperative education and stoma site marking has been shown to improve quality of life and decrease peristomal skin and pouching complications,” the authors wrote.
Health care providers should discuss and manage expectations for life with an ostomy, including managing ostomy output, maintaining pouching appliances, and the regular passage of mucus from the native rectum.
“High-quality ostomy care begins at the preoperative visit with wound ostomy and continence consultation. Stoma education and counseling are essential to prevent complications and manage patient expectations for living with a stoma. The early diagnosis and management of both early and late ostomy complications require ongoing communication between patients and care teams. Multidisciplinary coordination is imperative to prevent hospital readmissions and to improve the quality of life for our patients living with ostomies,” the authors wrote.
This Clinical Practice Update was commissioned by the AGA Institute. The investigators disclosed relationships with Johnson & Johnson, AbbVie, BMS, and others.
The American Gastroenterological Association has published a new Clinical Practice Update for the management of enteral ostomies, which are common in the management of patients with colorectal cancer, inflammatory bowel disease, diverticular disease, intestinal trauma, and intestinal perforation.
Approximately 750,000 people in the United States live with an ostomy, including colostomy, ileostomy, and continent ileostomy. Complications and challenges with self-care are common among patients with an enteral stoma, but most available guidance documents fail to offer management principles beyond the immediate perioperative period, wrote authors of the guidance which was led by Traci Hedrick, MD, of the University of Virginia Health, Charlottesville.
The update was published online in Clinical Gastroenterology and Hepatology. It includes best practice updates for managing short- and long-term complications, and perioperative considerations.
Early high ostomy output, defined by ostomy output greater than fluid intake that occurs within 3 weeks of stoma formation, causing dehydration, is a short-term complication associated with ostomies. It is more common among patients with an ileostomy than a colostomy, and requires rapid evaluation for infection and other associated complications. The cornerstone of treatment is rehydration, usually intravenously during hospital stay. Additional treatments may include bulking agents, antimotility agents, antisecretory agents, anti-inflammatory agents, adaptation-promoting agents, and surgery to reverse the ostomy.
Other short-term complications include ostomy leakage, stomal retraction, and mucocutaneous separation.
Dermatological problems are the most common of long-term complications. These typically involve skin irritation due to leakage. Other dermatological complaints include folliculitis, fungal rash, and allergic reaction to the appliance. Each of these must be addressed based on the nature and underlying cause of the complication.
Other long-term complications include chronic high ostomy output, parastomal hernia, and stomal prolapse.
Clinicians should also be aware of the psychological impact on patients. They may fear having a leakage or emitting an odor. They may also have anxiety in disclosing having an ostomy to partners and fear travel. “Difficulty with self-care should be addressed through preoperative and postoperative education. Preoperative education and stoma site marking has been shown to improve quality of life and decrease peristomal skin and pouching complications,” the authors wrote.
Health care providers should discuss and manage expectations for life with an ostomy, including managing ostomy output, maintaining pouching appliances, and the regular passage of mucus from the native rectum.
“High-quality ostomy care begins at the preoperative visit with wound ostomy and continence consultation. Stoma education and counseling are essential to prevent complications and manage patient expectations for living with a stoma. The early diagnosis and management of both early and late ostomy complications require ongoing communication between patients and care teams. Multidisciplinary coordination is imperative to prevent hospital readmissions and to improve the quality of life for our patients living with ostomies,” the authors wrote.
This Clinical Practice Update was commissioned by the AGA Institute. The investigators disclosed relationships with Johnson & Johnson, AbbVie, BMS, and others.
The American Gastroenterological Association has published a new Clinical Practice Update for the management of enteral ostomies, which are common in the management of patients with colorectal cancer, inflammatory bowel disease, diverticular disease, intestinal trauma, and intestinal perforation.
Approximately 750,000 people in the United States live with an ostomy, including colostomy, ileostomy, and continent ileostomy. Complications and challenges with self-care are common among patients with an enteral stoma, but most available guidance documents fail to offer management principles beyond the immediate perioperative period, wrote authors of the guidance which was led by Traci Hedrick, MD, of the University of Virginia Health, Charlottesville.
The update was published online in Clinical Gastroenterology and Hepatology. It includes best practice updates for managing short- and long-term complications, and perioperative considerations.
Early high ostomy output, defined by ostomy output greater than fluid intake that occurs within 3 weeks of stoma formation, causing dehydration, is a short-term complication associated with ostomies. It is more common among patients with an ileostomy than a colostomy, and requires rapid evaluation for infection and other associated complications. The cornerstone of treatment is rehydration, usually intravenously during hospital stay. Additional treatments may include bulking agents, antimotility agents, antisecretory agents, anti-inflammatory agents, adaptation-promoting agents, and surgery to reverse the ostomy.
Other short-term complications include ostomy leakage, stomal retraction, and mucocutaneous separation.
Dermatological problems are the most common of long-term complications. These typically involve skin irritation due to leakage. Other dermatological complaints include folliculitis, fungal rash, and allergic reaction to the appliance. Each of these must be addressed based on the nature and underlying cause of the complication.
Other long-term complications include chronic high ostomy output, parastomal hernia, and stomal prolapse.
Clinicians should also be aware of the psychological impact on patients. They may fear having a leakage or emitting an odor. They may also have anxiety in disclosing having an ostomy to partners and fear travel. “Difficulty with self-care should be addressed through preoperative and postoperative education. Preoperative education and stoma site marking has been shown to improve quality of life and decrease peristomal skin and pouching complications,” the authors wrote.
Health care providers should discuss and manage expectations for life with an ostomy, including managing ostomy output, maintaining pouching appliances, and the regular passage of mucus from the native rectum.
“High-quality ostomy care begins at the preoperative visit with wound ostomy and continence consultation. Stoma education and counseling are essential to prevent complications and manage patient expectations for living with a stoma. The early diagnosis and management of both early and late ostomy complications require ongoing communication between patients and care teams. Multidisciplinary coordination is imperative to prevent hospital readmissions and to improve the quality of life for our patients living with ostomies,” the authors wrote.
This Clinical Practice Update was commissioned by the AGA Institute. The investigators disclosed relationships with Johnson & Johnson, AbbVie, BMS, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AGA CPU focuses on noninvasive tests in patients with NAFLD
Noninvasive testing allows for routine risk stratification and long-term monitoring of patients with nonalcoholic fatty liver disease (NAFLD), offering a safer, more practical approach than biopsy, according to a recent Clinical Practice Update Expert Review by the American Gastroenterological Association.
The update, published online in Gastroenterology, includes eight best practice advice statements.
“The health care burden of longitudinal management of patients with NAFLD is significant. The emergence and utilization of noninvasive testing (NIT) in gastroenterology practices has the potential to significantly enhance the care of patients with NAFLD by improving detection of patients with advanced fibrosis who are at increased risk for cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC), thereby facilitating timely clinical management,” wrote authors who were led by Julia J. Wattacheril, MD, MPH, of the Columbia University–New York Presbyterian Hospital nonalcoholic fatty liver disease program and center for liver disease and transplantation.
“In this Expert Review, we have provided clinicians with best practice advice for optimal utilization of NITs in patients with NAFLD,” the authors wrote.
Consensus best practice for implementing NITs in practice are scarce, giving rise to the present clinical practice update. The expert panel reviewed available evidence for these tests during longitudinal care of patients with advanced fibrosis as a means of predicting liver-related outcomes and informing treatment decisions.
The first statement encourages use of NITs for risk stratification during the diagnosis of NAFLD, typically in the form of clinical calculators like fibrosis 4 index (FIB-4), vibration controlled transient elastography (VCTE), shear wave
elastography (SWE), or magnetic resonance elastography (MRE), all of which have been validated in NAFLD.
“Ultrasound-based 3-dimensional elastography (Velacur) and iron-corrected T1 magnetic resonance imaging, although used less frequently, are emerging technologies,” the panelists noted.
Second, the update suggests that patients with a FIB-4 less than 1.3 are unlikely to have advanced hepatic fibrosis, based on this threshold’s strong negative predictive value (NPV).
Still, clinicians should remember that this FIB-4 threshold may be less reliable among patients younger than 35 years or older than 65 years, making it necessary to also consider other clinical measurements, according to the update. The third best practice advice encourages use of two or more NITs among patients with a FIB-4 score greater than 1.3.
The fourth piece of best practice advice suggests that clinicians follow manufacturer’s specifications when implementing NITs, as misuse may lead to “discordant results and adverse events.”
Fifth, to increase the positive predictive value (PPV) for detecting advanced fibrosis, NITs are best interpreted in the context of relevant clinical data, such as physical exam and endoscopy findings.
Next, the document encourages use of liver biopsy when NIT findings are discordant or indeterminate, conflict with findings from other test modalities, or if alternative, non–NAFLD etiologies are suspected.
The penultimate best practice advice suggests use of NITs for serial longitudinal disease monitoring, with signs of progression or regression used to guide clinical decisions.
“Additional evidence for longitudinal prediction of fibrosis regression and progression and response to intervention (lifestyle and pharmacologic) is needed in trials and real-world clinical practice,” Dr. Wattacheril and colleagues noted.
Finally, the clinical practice update advises surveillance of liver complications, such as hepatocellular carcinoma, among patients with NIT results that suggest advanced fibrosis (F3) or cirrhosis (F4).
This clinical practice update was commissioned by the AGA Institute. The investigators disclosed relationships with AstraZeneca, BMS, Novo Nordisk, and others.
Noninvasive testing allows for routine risk stratification and long-term monitoring of patients with nonalcoholic fatty liver disease (NAFLD), offering a safer, more practical approach than biopsy, according to a recent Clinical Practice Update Expert Review by the American Gastroenterological Association.
The update, published online in Gastroenterology, includes eight best practice advice statements.
“The health care burden of longitudinal management of patients with NAFLD is significant. The emergence and utilization of noninvasive testing (NIT) in gastroenterology practices has the potential to significantly enhance the care of patients with NAFLD by improving detection of patients with advanced fibrosis who are at increased risk for cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC), thereby facilitating timely clinical management,” wrote authors who were led by Julia J. Wattacheril, MD, MPH, of the Columbia University–New York Presbyterian Hospital nonalcoholic fatty liver disease program and center for liver disease and transplantation.
“In this Expert Review, we have provided clinicians with best practice advice for optimal utilization of NITs in patients with NAFLD,” the authors wrote.
Consensus best practice for implementing NITs in practice are scarce, giving rise to the present clinical practice update. The expert panel reviewed available evidence for these tests during longitudinal care of patients with advanced fibrosis as a means of predicting liver-related outcomes and informing treatment decisions.
The first statement encourages use of NITs for risk stratification during the diagnosis of NAFLD, typically in the form of clinical calculators like fibrosis 4 index (FIB-4), vibration controlled transient elastography (VCTE), shear wave
elastography (SWE), or magnetic resonance elastography (MRE), all of which have been validated in NAFLD.
“Ultrasound-based 3-dimensional elastography (Velacur) and iron-corrected T1 magnetic resonance imaging, although used less frequently, are emerging technologies,” the panelists noted.
Second, the update suggests that patients with a FIB-4 less than 1.3 are unlikely to have advanced hepatic fibrosis, based on this threshold’s strong negative predictive value (NPV).
Still, clinicians should remember that this FIB-4 threshold may be less reliable among patients younger than 35 years or older than 65 years, making it necessary to also consider other clinical measurements, according to the update. The third best practice advice encourages use of two or more NITs among patients with a FIB-4 score greater than 1.3.
The fourth piece of best practice advice suggests that clinicians follow manufacturer’s specifications when implementing NITs, as misuse may lead to “discordant results and adverse events.”
Fifth, to increase the positive predictive value (PPV) for detecting advanced fibrosis, NITs are best interpreted in the context of relevant clinical data, such as physical exam and endoscopy findings.
Next, the document encourages use of liver biopsy when NIT findings are discordant or indeterminate, conflict with findings from other test modalities, or if alternative, non–NAFLD etiologies are suspected.
The penultimate best practice advice suggests use of NITs for serial longitudinal disease monitoring, with signs of progression or regression used to guide clinical decisions.
“Additional evidence for longitudinal prediction of fibrosis regression and progression and response to intervention (lifestyle and pharmacologic) is needed in trials and real-world clinical practice,” Dr. Wattacheril and colleagues noted.
Finally, the clinical practice update advises surveillance of liver complications, such as hepatocellular carcinoma, among patients with NIT results that suggest advanced fibrosis (F3) or cirrhosis (F4).
This clinical practice update was commissioned by the AGA Institute. The investigators disclosed relationships with AstraZeneca, BMS, Novo Nordisk, and others.
Noninvasive testing allows for routine risk stratification and long-term monitoring of patients with nonalcoholic fatty liver disease (NAFLD), offering a safer, more practical approach than biopsy, according to a recent Clinical Practice Update Expert Review by the American Gastroenterological Association.
The update, published online in Gastroenterology, includes eight best practice advice statements.
“The health care burden of longitudinal management of patients with NAFLD is significant. The emergence and utilization of noninvasive testing (NIT) in gastroenterology practices has the potential to significantly enhance the care of patients with NAFLD by improving detection of patients with advanced fibrosis who are at increased risk for cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC), thereby facilitating timely clinical management,” wrote authors who were led by Julia J. Wattacheril, MD, MPH, of the Columbia University–New York Presbyterian Hospital nonalcoholic fatty liver disease program and center for liver disease and transplantation.
“In this Expert Review, we have provided clinicians with best practice advice for optimal utilization of NITs in patients with NAFLD,” the authors wrote.
Consensus best practice for implementing NITs in practice are scarce, giving rise to the present clinical practice update. The expert panel reviewed available evidence for these tests during longitudinal care of patients with advanced fibrosis as a means of predicting liver-related outcomes and informing treatment decisions.
The first statement encourages use of NITs for risk stratification during the diagnosis of NAFLD, typically in the form of clinical calculators like fibrosis 4 index (FIB-4), vibration controlled transient elastography (VCTE), shear wave
elastography (SWE), or magnetic resonance elastography (MRE), all of which have been validated in NAFLD.
“Ultrasound-based 3-dimensional elastography (Velacur) and iron-corrected T1 magnetic resonance imaging, although used less frequently, are emerging technologies,” the panelists noted.
Second, the update suggests that patients with a FIB-4 less than 1.3 are unlikely to have advanced hepatic fibrosis, based on this threshold’s strong negative predictive value (NPV).
Still, clinicians should remember that this FIB-4 threshold may be less reliable among patients younger than 35 years or older than 65 years, making it necessary to also consider other clinical measurements, according to the update. The third best practice advice encourages use of two or more NITs among patients with a FIB-4 score greater than 1.3.
The fourth piece of best practice advice suggests that clinicians follow manufacturer’s specifications when implementing NITs, as misuse may lead to “discordant results and adverse events.”
Fifth, to increase the positive predictive value (PPV) for detecting advanced fibrosis, NITs are best interpreted in the context of relevant clinical data, such as physical exam and endoscopy findings.
Next, the document encourages use of liver biopsy when NIT findings are discordant or indeterminate, conflict with findings from other test modalities, or if alternative, non–NAFLD etiologies are suspected.
The penultimate best practice advice suggests use of NITs for serial longitudinal disease monitoring, with signs of progression or regression used to guide clinical decisions.
“Additional evidence for longitudinal prediction of fibrosis regression and progression and response to intervention (lifestyle and pharmacologic) is needed in trials and real-world clinical practice,” Dr. Wattacheril and colleagues noted.
Finally, the clinical practice update advises surveillance of liver complications, such as hepatocellular carcinoma, among patients with NIT results that suggest advanced fibrosis (F3) or cirrhosis (F4).
This clinical practice update was commissioned by the AGA Institute. The investigators disclosed relationships with AstraZeneca, BMS, Novo Nordisk, and others.
FROM GASTROENTEROLOGY
Crohn’s disease indicators manifest years before diagnosis
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AAP advises against low-carb diets for children with diabetes
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
FROM PEDIATRICS
Frequency and duration of GERD symptoms associated with poor sleep
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
FROM JAMA NETWORK OPEN
IBD study characterizes biologic adherence, confirms nonadherence risk factors
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
FROM GASTRO HEP ADVANCES