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VIDEO: Anesthesia services during colonoscopy increase risk of near-term complications
Receiving anesthesia services while undergoing a colonoscopy may not be in your patients’ best interest, as doing so could significantly increase the likelihood of patients experiencing serious complications within 30 days of the procedure.
This is according to a new study published in the April issue of Gastroenterology, in which Dr. Karen J. Wernli and her coinvestigators analyzed claims data, collected from the Truven Health MarketScan Research Database, related to 3,168,228 colonoscopy procedures that took place between 2008 and 2011, to determine whether patients who received anesthesia were at a higher risk of developing complications after the procedure (doi: 10.1053/j.gastro.2015.12.018).
Source: American Gastroenterological Association
“The involvement of anesthesia services for colonoscopy sedation, mainly to administer propofol, has increased accordingly, from 11.0% of colonoscopies in 2001 to 23.4% in 2006, with projections of more than 50% in 2015,” wrote Dr. Wernli of the Group Health Research Institute in Seattle, and her coauthors. “Whether the use of propofol is associated with higher rates of short-term complications compared with standard sedation is not well understood.”
Men and women whose data was included in the study were between 40 and 64 years of age; men accounted for 46.8% of those receiving standard sedation (53.2% women) and 46.5% of those receiving anesthesia services (53.5% women). A total of 4,939,993 individuals were initially screened for enrollment, with 39,784 excluded because of a previous colorectal cancer diagnosis, 240,038 for “noncancer exclusions,” and 1,491,943 for being enrolled in the study less than 1 year.
Standard sedation was done in 2,079,784 (65.6%) of the procedures included in the study, while the other 1,088,444 (34.4%) colonoscopies involved anesthesia services. Use of anesthesia services resulted in a 13% increase in likelihood for patients to experience some kind of complication within 30 days of colonoscopy (95% confidence interval, 1.12-1.14). The most common complications were perforation (odds ratio, 1.07; 95% CI, 1.00-1.15), hemorrhage (OR, 1.28; 95% CI, 1.27-1.30), abdominal pain (OR, 1.07; 95% CI, 1.05-1.08), complications secondary to anesthesia (OR, 1.15; 95% CI, 1.05-1.28), and “stroke and other central nervous system events” (OR, 1.04; 95% CI, 1.00-1.08).
Analysis of geographic distribution of colonoscopies performed with and without anesthesia services showed that all areas of the United States had a higher likelihood of postcolonoscopy complications associated with anesthesia except in the Southeast, where there was no association between the two. Additionally, in the western U.S., use of anesthesia services was less common than in any other geographic area, but was associated with a staggering 60% higher chance of complication within 30 days for patients who did opt for it.
“Although the use of anesthesia agents can directly impact colonoscopy outcomes, it is not solely the anesthesia agent that could lead to additional complications,” the study authors wrote. “In the absence of patient feedback, increased colonic-wall tension from colonoscopy pressure may not be identified by the endoscopist, and, consistent with our results, could lead to increased risks of colonic complications, such as perforation and abdominal pain.”
Dr. Wernli and her coauthors did not report any relevant financial disclosures.
We are approaching a time when half of all colonoscopies are performed with anesthesia assistance, most using propofol. Undeniably, some patients require anesthesia support for medical reasons, or because they do not sedate adequately with opiate-benzodiazepine combinations endoscopists can administer. The popularity of propofol-based anesthesia for routine colonoscopy, however, is based on several perceived benefits: patient demand for a discomfort-free procedure, rapid sedation followed by quick recovery, and good reimbursement for the anesthesia service itself, added to the benefits of faster overall procedure turnaround time. And presently, there is no disincentive — financial or otherwise — to continuing or expanding this practice. Colonoscopy with anesthesia looks like a win-win for both patient and endoscopist, as long as the added cost of anesthesia can be justified.
However, while anesthesia-assisted colonoscopy appears to possess several advantages, growing evidence suggests that a lower risk of complications is not one of them.
A smaller study (165,000 colonoscopies) using NCI SEER registry data suggested that adding anesthesia to colonoscopy may increase some adverse events. Cooper et al. (JAMA Intern Med. 2013;173:551-6) showed an increase in overall complications and, specifically, aspiration, although not in technical complications of colonoscopy, including perforation and splenic rupture. However, this study did not include patients who underwent polypectomy. Wernli, et al. now show evidence derived from over 3 million patients demonstrating that adding anesthesia to colonoscopy increases complications significantly — not only aspiration, but also technical aspects of colonoscopy, including perforation, bleeding, and abdominal pain.
Colonoscopy is extremely safe, so complications are infrequent. Thus, data sets of colonoscopy complications large enough to be statistically meaningful for studies of this type require an extraordinarily large patient pool. For this prospective, observational cohort study, the authors obtained the large sample size by mining administrative claims data for 3 years, not through examining clinical data. As a result, several assumptions were made. These 3 million colonoscopies represented all indications — not just colorectal cancer screening. Billing claims for anesthesia represented surrogate markers for administration of propofol-based anesthesia. While anesthesia assistance was associated with increased risk of perforation, hemorrhage, abdominal pain, anesthesia complications, and stroke; risk of perforation associated with anesthesia was increased only in patients who underwent polypectomy.
Study methodology and confounding variables aside, it is hard to ignore the core message here: a large body of data analyzed rigorously demonstrate that anesthesia support for colonoscopy increases risk of procedure-related complications.
Patients who are ill, have certain cardiopulmonary issues, or do not sedate adequately with moderate sedation benefit from anesthesia assistance for colonoscopy. But for patients undergoing routine colonoscopy, without such issues, who could safely undergo colonoscopy under moderate sedation without unreasonable discomfort, we must now ask ourselves and discuss with our patients honestly, not only whether the added cost of anesthesia is reasonable — but also whether the apparent added risk of anesthesia justifies perceived benefits.
Dr. John A. Martin is senior associate consultant and associate professor, associate chair for endoscopy, Mayo Clinic, Rochester, Minn. He has no conflicts of interest to disclose.
We are approaching a time when half of all colonoscopies are performed with anesthesia assistance, most using propofol. Undeniably, some patients require anesthesia support for medical reasons, or because they do not sedate adequately with opiate-benzodiazepine combinations endoscopists can administer. The popularity of propofol-based anesthesia for routine colonoscopy, however, is based on several perceived benefits: patient demand for a discomfort-free procedure, rapid sedation followed by quick recovery, and good reimbursement for the anesthesia service itself, added to the benefits of faster overall procedure turnaround time. And presently, there is no disincentive — financial or otherwise — to continuing or expanding this practice. Colonoscopy with anesthesia looks like a win-win for both patient and endoscopist, as long as the added cost of anesthesia can be justified.
However, while anesthesia-assisted colonoscopy appears to possess several advantages, growing evidence suggests that a lower risk of complications is not one of them.
A smaller study (165,000 colonoscopies) using NCI SEER registry data suggested that adding anesthesia to colonoscopy may increase some adverse events. Cooper et al. (JAMA Intern Med. 2013;173:551-6) showed an increase in overall complications and, specifically, aspiration, although not in technical complications of colonoscopy, including perforation and splenic rupture. However, this study did not include patients who underwent polypectomy. Wernli, et al. now show evidence derived from over 3 million patients demonstrating that adding anesthesia to colonoscopy increases complications significantly — not only aspiration, but also technical aspects of colonoscopy, including perforation, bleeding, and abdominal pain.
Colonoscopy is extremely safe, so complications are infrequent. Thus, data sets of colonoscopy complications large enough to be statistically meaningful for studies of this type require an extraordinarily large patient pool. For this prospective, observational cohort study, the authors obtained the large sample size by mining administrative claims data for 3 years, not through examining clinical data. As a result, several assumptions were made. These 3 million colonoscopies represented all indications — not just colorectal cancer screening. Billing claims for anesthesia represented surrogate markers for administration of propofol-based anesthesia. While anesthesia assistance was associated with increased risk of perforation, hemorrhage, abdominal pain, anesthesia complications, and stroke; risk of perforation associated with anesthesia was increased only in patients who underwent polypectomy.
Study methodology and confounding variables aside, it is hard to ignore the core message here: a large body of data analyzed rigorously demonstrate that anesthesia support for colonoscopy increases risk of procedure-related complications.
Patients who are ill, have certain cardiopulmonary issues, or do not sedate adequately with moderate sedation benefit from anesthesia assistance for colonoscopy. But for patients undergoing routine colonoscopy, without such issues, who could safely undergo colonoscopy under moderate sedation without unreasonable discomfort, we must now ask ourselves and discuss with our patients honestly, not only whether the added cost of anesthesia is reasonable — but also whether the apparent added risk of anesthesia justifies perceived benefits.
Dr. John A. Martin is senior associate consultant and associate professor, associate chair for endoscopy, Mayo Clinic, Rochester, Minn. He has no conflicts of interest to disclose.
We are approaching a time when half of all colonoscopies are performed with anesthesia assistance, most using propofol. Undeniably, some patients require anesthesia support for medical reasons, or because they do not sedate adequately with opiate-benzodiazepine combinations endoscopists can administer. The popularity of propofol-based anesthesia for routine colonoscopy, however, is based on several perceived benefits: patient demand for a discomfort-free procedure, rapid sedation followed by quick recovery, and good reimbursement for the anesthesia service itself, added to the benefits of faster overall procedure turnaround time. And presently, there is no disincentive — financial or otherwise — to continuing or expanding this practice. Colonoscopy with anesthesia looks like a win-win for both patient and endoscopist, as long as the added cost of anesthesia can be justified.
However, while anesthesia-assisted colonoscopy appears to possess several advantages, growing evidence suggests that a lower risk of complications is not one of them.
A smaller study (165,000 colonoscopies) using NCI SEER registry data suggested that adding anesthesia to colonoscopy may increase some adverse events. Cooper et al. (JAMA Intern Med. 2013;173:551-6) showed an increase in overall complications and, specifically, aspiration, although not in technical complications of colonoscopy, including perforation and splenic rupture. However, this study did not include patients who underwent polypectomy. Wernli, et al. now show evidence derived from over 3 million patients demonstrating that adding anesthesia to colonoscopy increases complications significantly — not only aspiration, but also technical aspects of colonoscopy, including perforation, bleeding, and abdominal pain.
Colonoscopy is extremely safe, so complications are infrequent. Thus, data sets of colonoscopy complications large enough to be statistically meaningful for studies of this type require an extraordinarily large patient pool. For this prospective, observational cohort study, the authors obtained the large sample size by mining administrative claims data for 3 years, not through examining clinical data. As a result, several assumptions were made. These 3 million colonoscopies represented all indications — not just colorectal cancer screening. Billing claims for anesthesia represented surrogate markers for administration of propofol-based anesthesia. While anesthesia assistance was associated with increased risk of perforation, hemorrhage, abdominal pain, anesthesia complications, and stroke; risk of perforation associated with anesthesia was increased only in patients who underwent polypectomy.
Study methodology and confounding variables aside, it is hard to ignore the core message here: a large body of data analyzed rigorously demonstrate that anesthesia support for colonoscopy increases risk of procedure-related complications.
Patients who are ill, have certain cardiopulmonary issues, or do not sedate adequately with moderate sedation benefit from anesthesia assistance for colonoscopy. But for patients undergoing routine colonoscopy, without such issues, who could safely undergo colonoscopy under moderate sedation without unreasonable discomfort, we must now ask ourselves and discuss with our patients honestly, not only whether the added cost of anesthesia is reasonable — but also whether the apparent added risk of anesthesia justifies perceived benefits.
Dr. John A. Martin is senior associate consultant and associate professor, associate chair for endoscopy, Mayo Clinic, Rochester, Minn. He has no conflicts of interest to disclose.
Receiving anesthesia services while undergoing a colonoscopy may not be in your patients’ best interest, as doing so could significantly increase the likelihood of patients experiencing serious complications within 30 days of the procedure.
This is according to a new study published in the April issue of Gastroenterology, in which Dr. Karen J. Wernli and her coinvestigators analyzed claims data, collected from the Truven Health MarketScan Research Database, related to 3,168,228 colonoscopy procedures that took place between 2008 and 2011, to determine whether patients who received anesthesia were at a higher risk of developing complications after the procedure (doi: 10.1053/j.gastro.2015.12.018).
Source: American Gastroenterological Association
“The involvement of anesthesia services for colonoscopy sedation, mainly to administer propofol, has increased accordingly, from 11.0% of colonoscopies in 2001 to 23.4% in 2006, with projections of more than 50% in 2015,” wrote Dr. Wernli of the Group Health Research Institute in Seattle, and her coauthors. “Whether the use of propofol is associated with higher rates of short-term complications compared with standard sedation is not well understood.”
Men and women whose data was included in the study were between 40 and 64 years of age; men accounted for 46.8% of those receiving standard sedation (53.2% women) and 46.5% of those receiving anesthesia services (53.5% women). A total of 4,939,993 individuals were initially screened for enrollment, with 39,784 excluded because of a previous colorectal cancer diagnosis, 240,038 for “noncancer exclusions,” and 1,491,943 for being enrolled in the study less than 1 year.
Standard sedation was done in 2,079,784 (65.6%) of the procedures included in the study, while the other 1,088,444 (34.4%) colonoscopies involved anesthesia services. Use of anesthesia services resulted in a 13% increase in likelihood for patients to experience some kind of complication within 30 days of colonoscopy (95% confidence interval, 1.12-1.14). The most common complications were perforation (odds ratio, 1.07; 95% CI, 1.00-1.15), hemorrhage (OR, 1.28; 95% CI, 1.27-1.30), abdominal pain (OR, 1.07; 95% CI, 1.05-1.08), complications secondary to anesthesia (OR, 1.15; 95% CI, 1.05-1.28), and “stroke and other central nervous system events” (OR, 1.04; 95% CI, 1.00-1.08).
Analysis of geographic distribution of colonoscopies performed with and without anesthesia services showed that all areas of the United States had a higher likelihood of postcolonoscopy complications associated with anesthesia except in the Southeast, where there was no association between the two. Additionally, in the western U.S., use of anesthesia services was less common than in any other geographic area, but was associated with a staggering 60% higher chance of complication within 30 days for patients who did opt for it.
“Although the use of anesthesia agents can directly impact colonoscopy outcomes, it is not solely the anesthesia agent that could lead to additional complications,” the study authors wrote. “In the absence of patient feedback, increased colonic-wall tension from colonoscopy pressure may not be identified by the endoscopist, and, consistent with our results, could lead to increased risks of colonic complications, such as perforation and abdominal pain.”
Dr. Wernli and her coauthors did not report any relevant financial disclosures.
Receiving anesthesia services while undergoing a colonoscopy may not be in your patients’ best interest, as doing so could significantly increase the likelihood of patients experiencing serious complications within 30 days of the procedure.
This is according to a new study published in the April issue of Gastroenterology, in which Dr. Karen J. Wernli and her coinvestigators analyzed claims data, collected from the Truven Health MarketScan Research Database, related to 3,168,228 colonoscopy procedures that took place between 2008 and 2011, to determine whether patients who received anesthesia were at a higher risk of developing complications after the procedure (doi: 10.1053/j.gastro.2015.12.018).
Source: American Gastroenterological Association
“The involvement of anesthesia services for colonoscopy sedation, mainly to administer propofol, has increased accordingly, from 11.0% of colonoscopies in 2001 to 23.4% in 2006, with projections of more than 50% in 2015,” wrote Dr. Wernli of the Group Health Research Institute in Seattle, and her coauthors. “Whether the use of propofol is associated with higher rates of short-term complications compared with standard sedation is not well understood.”
Men and women whose data was included in the study were between 40 and 64 years of age; men accounted for 46.8% of those receiving standard sedation (53.2% women) and 46.5% of those receiving anesthesia services (53.5% women). A total of 4,939,993 individuals were initially screened for enrollment, with 39,784 excluded because of a previous colorectal cancer diagnosis, 240,038 for “noncancer exclusions,” and 1,491,943 for being enrolled in the study less than 1 year.
Standard sedation was done in 2,079,784 (65.6%) of the procedures included in the study, while the other 1,088,444 (34.4%) colonoscopies involved anesthesia services. Use of anesthesia services resulted in a 13% increase in likelihood for patients to experience some kind of complication within 30 days of colonoscopy (95% confidence interval, 1.12-1.14). The most common complications were perforation (odds ratio, 1.07; 95% CI, 1.00-1.15), hemorrhage (OR, 1.28; 95% CI, 1.27-1.30), abdominal pain (OR, 1.07; 95% CI, 1.05-1.08), complications secondary to anesthesia (OR, 1.15; 95% CI, 1.05-1.28), and “stroke and other central nervous system events” (OR, 1.04; 95% CI, 1.00-1.08).
Analysis of geographic distribution of colonoscopies performed with and without anesthesia services showed that all areas of the United States had a higher likelihood of postcolonoscopy complications associated with anesthesia except in the Southeast, where there was no association between the two. Additionally, in the western U.S., use of anesthesia services was less common than in any other geographic area, but was associated with a staggering 60% higher chance of complication within 30 days for patients who did opt for it.
“Although the use of anesthesia agents can directly impact colonoscopy outcomes, it is not solely the anesthesia agent that could lead to additional complications,” the study authors wrote. “In the absence of patient feedback, increased colonic-wall tension from colonoscopy pressure may not be identified by the endoscopist, and, consistent with our results, could lead to increased risks of colonic complications, such as perforation and abdominal pain.”
Dr. Wernli and her coauthors did not report any relevant financial disclosures.
FROM GASTROENTEROLOGY
Key clinical point: Using anesthesia services on individuals receiving colonoscopy increases the overall risk of complications associated with the procedure.
Major finding: Colonoscopy patients who received anesthesia had a 13% higher risk of complication within 30 days, including perforation, hemorrhage, abdominal pain, and stroke.
Data source: A prospective cohort study of claims data from 3,168,228 colonoscopy procedures in the Truven Health MarketScan Research Databases from 2008 to 2011.
Disclosures: Funding provided by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Wernli and her coauthors did not report any relevant financial disclosures.
High gluten consumption early in life upped risk of celiac disease
Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.
The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.
In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).
The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.
Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.
The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
Long-suffering Swedish children probably have the highest rate of celiac disease in the world. This rate has dramatically increased. Why and why not? Previous studies have shown that it is not breastfeeding. It is not age or timing of introduction of gluten. It is not likely to be infections. This study shows that it is the amount of gluten that drives children with the highest genetic risk for celiac disease to develop the disease early in life. This conversion is preceded by a high intake of gluten. While these results alone should not determine general infant feeding practices, it suggests that if you are a Swedish child who carries these high-risk genes, high quantities of gluten early in life are not for you.
This study also raises the question of the effect high-dose gluten in adults at risk. Previously, studies have shown that the prevalence of celiac disease in adults in Sweden is not much different from the pediatric population. This study needs to be expanded to other Western populations where the rate of celiac disease is not so high. While nutritional engineering on a grand scale should not be undertaken lightly given the possibility of unexpected consequences, it behooves at least the Swedish population to perhaps reexamine their cultural practices of incorporating high gluten-containing cereals early in the lives of children, most especially those at particular risk for celiac disease.
Dr. Joseph A. Murray, AGAF, is professor of medicine, consultant, division of gastroenterology and hepatology, and department of immunology, and director of the Celiac Disease Program at the Mayo Clinic, Rochester, Minn.
Long-suffering Swedish children probably have the highest rate of celiac disease in the world. This rate has dramatically increased. Why and why not? Previous studies have shown that it is not breastfeeding. It is not age or timing of introduction of gluten. It is not likely to be infections. This study shows that it is the amount of gluten that drives children with the highest genetic risk for celiac disease to develop the disease early in life. This conversion is preceded by a high intake of gluten. While these results alone should not determine general infant feeding practices, it suggests that if you are a Swedish child who carries these high-risk genes, high quantities of gluten early in life are not for you.
This study also raises the question of the effect high-dose gluten in adults at risk. Previously, studies have shown that the prevalence of celiac disease in adults in Sweden is not much different from the pediatric population. This study needs to be expanded to other Western populations where the rate of celiac disease is not so high. While nutritional engineering on a grand scale should not be undertaken lightly given the possibility of unexpected consequences, it behooves at least the Swedish population to perhaps reexamine their cultural practices of incorporating high gluten-containing cereals early in the lives of children, most especially those at particular risk for celiac disease.
Dr. Joseph A. Murray, AGAF, is professor of medicine, consultant, division of gastroenterology and hepatology, and department of immunology, and director of the Celiac Disease Program at the Mayo Clinic, Rochester, Minn.
Long-suffering Swedish children probably have the highest rate of celiac disease in the world. This rate has dramatically increased. Why and why not? Previous studies have shown that it is not breastfeeding. It is not age or timing of introduction of gluten. It is not likely to be infections. This study shows that it is the amount of gluten that drives children with the highest genetic risk for celiac disease to develop the disease early in life. This conversion is preceded by a high intake of gluten. While these results alone should not determine general infant feeding practices, it suggests that if you are a Swedish child who carries these high-risk genes, high quantities of gluten early in life are not for you.
This study also raises the question of the effect high-dose gluten in adults at risk. Previously, studies have shown that the prevalence of celiac disease in adults in Sweden is not much different from the pediatric population. This study needs to be expanded to other Western populations where the rate of celiac disease is not so high. While nutritional engineering on a grand scale should not be undertaken lightly given the possibility of unexpected consequences, it behooves at least the Swedish population to perhaps reexamine their cultural practices of incorporating high gluten-containing cereals early in the lives of children, most especially those at particular risk for celiac disease.
Dr. Joseph A. Murray, AGAF, is professor of medicine, consultant, division of gastroenterology and hepatology, and department of immunology, and director of the Celiac Disease Program at the Mayo Clinic, Rochester, Minn.
Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.
The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.
In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).
The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.
Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.
The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
Children who were genetically susceptible to celiac disease and consumed high amounts of gluten at 12 months of age were at least twice as likely to develop the autoimmune disorder as genetically predisposed children who consumed less gluten, researchers reported in the March issue of Clinical Gastroenterology and Hepatology.
The association was similar among children who carried any of the major human leukocyte antigen (HLA) risk genotypes for celiac disease, said Dr. Carin Aronsson at Lund University in Sweden and her associates. “Because these HLA risk genotypes are widely distributed in the general population, these findings may have consequence for future infant feeding recommendations,” they said. They recommended repeating the study in other countries to confirm the link.
In order to develop celiac disease, patients must consume gluten and carry at least one of the relevant DR3-DQ2 and DR4-DQ8 HLA risk haplotypes. But because gluten is widely consumed in products containing wheat, rye, and barley, and because about half of whites have at least one of the two haplotypes, gluten intolerance probably depends on other environmental factors, the researchers said. To further study these factors, they compared 3-day food diaries collected at ages 9, 12, 18, and 24 months for 146 children with positive tissue transglutaminase autoantibody (tTGA) assays and biopsy-confirmed celiac disease (cases) and 436 tTGA-negative children (controls). Cases and controls were matched by age, sex, and HLA genotype (Clin Gastroenterol Hepatol. 2015 Oct 7. doi: 10.1016/j.cgh.2015.09.030).
The food diaries revealed higher gluten intake among cases, compared with controls, beginning at the age of 12 months, said the researchers. Notably, cases consumed a median of 4.9 g of gluten a day before tTGA seroconversion, 1 g more than the median amount for controls of the same age (odds ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .0002). Furthermore, significantly more cases than controls consumed the highest tertile of gluten, more than 5 g per day, before seroconversion (OR, 2.7; 95% CI, 1.7-4.1; P less than .0001). These associations were similar among children of all haplotype profiles and trended in the same direction among children with and without first-degree relatives with celiac disease.
Cases and controls resembled each other in terms of breastfeeding duration, age at first introduction to gluten, and total daily caloric intake, the investigators noted. “The prospective design of this birth cohort study enabled us to obtain the diet information before seroconversion of tTGA as a marker of celiac disease,” they said. “This eliminated the risk of reporting biases or a change in feeding habits because of the knowledge of serology results or disease status.” But they did not analyze the number of daily servings of foods that contained gluten. “We cannot exclude the possibility that the number of portions given frequently during the course of the day may have different effects on disease risk,” they said.
The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: High levels of gluten consumption in early life significantly increased the risk of celiac disease.
Major finding: The odds of celiac disease were more than twice as high among children who consumed more than 5 g of gluten a day, compared with those who consumed less gluten (OR, 2.65; P less than .0001).
Data source: A 1 to 3 matched nested case-control study of 146 children with biopsy-confirmed celiac disease (cases) and 436 tissue transglutaminase (tTGA)-negative controls.
Disclosures: The National Institutes of Health, Juvenile Diabetes Research Foundation, and the Centers for Disease Control and Prevention funded the study. The investigators had no disclosures.
Mirtazapine improves functional dyspepsia in small study
The antidepressant mirtazapine improved weight loss, early satiation, nausea, and other signs and symptoms in patients with functional dyspepsia, said the authors of a placebo-controlled pilot study published in the March issue of Clinical Gastroenterology and Hepatology.
The findings suggest that mirtazapine “has the potential to become the treatment of choice for functional dyspepsia in patients with weight loss, and evaluation in larger multicenter studies is warranted,” said Dr. Jan Tack and his associates at the University of Leuven, Belgium.
Functional dyspepsia, one of the most prevalent gastrointestinal disorders, is characterized by early satiation, postprandial fullness, and epigastric pain and burning in the absence of underlying systemic or metabolic disease. Up to 40% of affected patients lose weight, an “alarm symptom” that until now has lacked effective treatment, the researchers said.
Mirtazapine, an antagonist of the H1, alpha2, 5-hydroxytryptamine (5-HT)2c, and 5-HT3 receptors, often causes weight gain when used to treat depression. Therefore, the investigators designed a double-blind single-center pilot trial of 34 patients with functional dyspepsia who had lost more than 10% of their original body weight. After a 2-week run-in period, half the patients were randomized to 15 mg of mirtazapine every evening and the other half to placebo (Clin Gastroenterol Hepatol. 2016 Jan 9. doi: 10.1016/j.cgh.2015.09.043).
The average weight of placebo patients remained almost unchanged throughout the trial, while patients on mirtazapine gained an average of 2.5 + 0.6 kg by week 4 (P = .003 for between-group comparison) and 3.9 + 0.7 kg, or 6.4% of their original body weight, by week 8 (P less than .0001). Mean scores on a validated dyspepsia symptom severity (DSS) questionnaire improved significantly between baseline and weeks 4 (P = .003) and 8 (P = .017) for mirtazapine but not placebo. Directly comparing the two groups in terms of the DSS revealed a large effect size that trended toward significance (P = .06) at week 4 but not at week 8 (P = .55). However, mirtazapine significantly outperformed placebo in measures of early satiety, quality of life, gastrointestinal-specific anxiety, and nutrient tolerance, “mostly with large effect sizes,” the investigators said.
Mirtazapine did not affect epigastric pain or gastric emptying, and had little effect on postprandial fullness. Moreover, 2 of 17 patients in the mirtazapine group dropped out of the study because of unacceptable levels of drowsiness, which is a common side effect of the medication.
Many patients with functional dyspepsia respond inadequately to first-line treatment with acid-suppressive or prokinetic drugs, the investigators noted. While tegaserod, buspirone, and acotiamide can improve gastric accommodation, it is unknown if they promote weight gain. The results for mirtazapine are promising, but the pilot trial included only tertiary care patients, and the small sample size precluded separate analyses of patients with postprandial distress syndrome as opposed to epigastric pain syndrome, the researchers said.
The study was funded by Leuven University, the FWO, and the KU Leuven Special Research Fund. Mirtazapine and placebo were supplied by MSD Belgium. The investigators had no disclosures.
The antidepressant mirtazapine improved weight loss, early satiation, nausea, and other signs and symptoms in patients with functional dyspepsia, said the authors of a placebo-controlled pilot study published in the March issue of Clinical Gastroenterology and Hepatology.
The findings suggest that mirtazapine “has the potential to become the treatment of choice for functional dyspepsia in patients with weight loss, and evaluation in larger multicenter studies is warranted,” said Dr. Jan Tack and his associates at the University of Leuven, Belgium.
Functional dyspepsia, one of the most prevalent gastrointestinal disorders, is characterized by early satiation, postprandial fullness, and epigastric pain and burning in the absence of underlying systemic or metabolic disease. Up to 40% of affected patients lose weight, an “alarm symptom” that until now has lacked effective treatment, the researchers said.
Mirtazapine, an antagonist of the H1, alpha2, 5-hydroxytryptamine (5-HT)2c, and 5-HT3 receptors, often causes weight gain when used to treat depression. Therefore, the investigators designed a double-blind single-center pilot trial of 34 patients with functional dyspepsia who had lost more than 10% of their original body weight. After a 2-week run-in period, half the patients were randomized to 15 mg of mirtazapine every evening and the other half to placebo (Clin Gastroenterol Hepatol. 2016 Jan 9. doi: 10.1016/j.cgh.2015.09.043).
The average weight of placebo patients remained almost unchanged throughout the trial, while patients on mirtazapine gained an average of 2.5 + 0.6 kg by week 4 (P = .003 for between-group comparison) and 3.9 + 0.7 kg, or 6.4% of their original body weight, by week 8 (P less than .0001). Mean scores on a validated dyspepsia symptom severity (DSS) questionnaire improved significantly between baseline and weeks 4 (P = .003) and 8 (P = .017) for mirtazapine but not placebo. Directly comparing the two groups in terms of the DSS revealed a large effect size that trended toward significance (P = .06) at week 4 but not at week 8 (P = .55). However, mirtazapine significantly outperformed placebo in measures of early satiety, quality of life, gastrointestinal-specific anxiety, and nutrient tolerance, “mostly with large effect sizes,” the investigators said.
Mirtazapine did not affect epigastric pain or gastric emptying, and had little effect on postprandial fullness. Moreover, 2 of 17 patients in the mirtazapine group dropped out of the study because of unacceptable levels of drowsiness, which is a common side effect of the medication.
Many patients with functional dyspepsia respond inadequately to first-line treatment with acid-suppressive or prokinetic drugs, the investigators noted. While tegaserod, buspirone, and acotiamide can improve gastric accommodation, it is unknown if they promote weight gain. The results for mirtazapine are promising, but the pilot trial included only tertiary care patients, and the small sample size precluded separate analyses of patients with postprandial distress syndrome as opposed to epigastric pain syndrome, the researchers said.
The study was funded by Leuven University, the FWO, and the KU Leuven Special Research Fund. Mirtazapine and placebo were supplied by MSD Belgium. The investigators had no disclosures.
The antidepressant mirtazapine improved weight loss, early satiation, nausea, and other signs and symptoms in patients with functional dyspepsia, said the authors of a placebo-controlled pilot study published in the March issue of Clinical Gastroenterology and Hepatology.
The findings suggest that mirtazapine “has the potential to become the treatment of choice for functional dyspepsia in patients with weight loss, and evaluation in larger multicenter studies is warranted,” said Dr. Jan Tack and his associates at the University of Leuven, Belgium.
Functional dyspepsia, one of the most prevalent gastrointestinal disorders, is characterized by early satiation, postprandial fullness, and epigastric pain and burning in the absence of underlying systemic or metabolic disease. Up to 40% of affected patients lose weight, an “alarm symptom” that until now has lacked effective treatment, the researchers said.
Mirtazapine, an antagonist of the H1, alpha2, 5-hydroxytryptamine (5-HT)2c, and 5-HT3 receptors, often causes weight gain when used to treat depression. Therefore, the investigators designed a double-blind single-center pilot trial of 34 patients with functional dyspepsia who had lost more than 10% of their original body weight. After a 2-week run-in period, half the patients were randomized to 15 mg of mirtazapine every evening and the other half to placebo (Clin Gastroenterol Hepatol. 2016 Jan 9. doi: 10.1016/j.cgh.2015.09.043).
The average weight of placebo patients remained almost unchanged throughout the trial, while patients on mirtazapine gained an average of 2.5 + 0.6 kg by week 4 (P = .003 for between-group comparison) and 3.9 + 0.7 kg, or 6.4% of their original body weight, by week 8 (P less than .0001). Mean scores on a validated dyspepsia symptom severity (DSS) questionnaire improved significantly between baseline and weeks 4 (P = .003) and 8 (P = .017) for mirtazapine but not placebo. Directly comparing the two groups in terms of the DSS revealed a large effect size that trended toward significance (P = .06) at week 4 but not at week 8 (P = .55). However, mirtazapine significantly outperformed placebo in measures of early satiety, quality of life, gastrointestinal-specific anxiety, and nutrient tolerance, “mostly with large effect sizes,” the investigators said.
Mirtazapine did not affect epigastric pain or gastric emptying, and had little effect on postprandial fullness. Moreover, 2 of 17 patients in the mirtazapine group dropped out of the study because of unacceptable levels of drowsiness, which is a common side effect of the medication.
Many patients with functional dyspepsia respond inadequately to first-line treatment with acid-suppressive or prokinetic drugs, the investigators noted. While tegaserod, buspirone, and acotiamide can improve gastric accommodation, it is unknown if they promote weight gain. The results for mirtazapine are promising, but the pilot trial included only tertiary care patients, and the small sample size precluded separate analyses of patients with postprandial distress syndrome as opposed to epigastric pain syndrome, the researchers said.
The study was funded by Leuven University, the FWO, and the KU Leuven Special Research Fund. Mirtazapine and placebo were supplied by MSD Belgium. The investigators had no disclosures.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Mirtazapine treatment led to weight gain and a number of other improvements among patients with functional dyspepsia and weight loss.
Major finding: Patients regained an average of 6.5% of their original body weight on mirtazapine, and did not regain weight on placebo.
Data source: A single-center randomized double-blind study of 34 patients with functional dyspepsia.
Disclosures: Leuven University, the FWO, and the KU Leuven Special Research Fund helped fund the study. Mirtazapine and placebo were supplied by MSD Belgium. The investigators had no disclosures.
Study backed familial component of advanced adenoma risk
Siblings of patients with advanced adenoma had sixfold higher odds of having the tumors themselves, as compared with controls, said the authors of a blinded cross-sectional study reported in the March issue of Gastroenterology.
The results reinforce the need for early screening of individuals whose siblings have advanced adenoma, said Dr. Siew Ng at the Chinese University of Hong Kong and her associates. The risk of advanced adenoma was even higher when affected probands were younger than average or had multiple adenomas, the researchers added.
Most studies that have purported to study the familial risk of adenoma actually studied the risk of adenoma in persons whose first-degree relatives have colorectal cancer, according to Dr. Ng and her associates. Their study included 200 asymptomatic (“exposed”) siblings of individuals with advanced adenomas as diagnosed on colonoscopy, and 400 controls whose siblings had no family history of colorectal cancer or colonoscopic evidence of neoplasia. The researchers defined advanced adenomas as those measuring at least 10 mm or that had high-grade dysplasia or villous or tubulovillous characteristics. “We focused on advanced lesions, as they have the greatest malignant potential, and removing these lesions can reduce colorectal cancer incidence and mortality,” they said (Gastroenterology. 2015 Nov 14. doi: 10.1053/j.gastro.2015.11.003).
Exposed siblings were consistently more likely to have adenomas themselves, compared with the control group, said the investigators. For example, the prevalence of any advanced adenoma was 11.5% among exposed siblings compared with only 2.5% among controls (matched odds ratio, 6.05; 95% confidence interval, 2.7-13.4; P less than .001). Similarly, the prevalence of adenomas measuring at least 10 mm was 10.5% among exposed individuals and 1.8% among controls (mOR, 8.6; 95% CI, 3.4-21.4; P less than .001). The prevalence of villous adenomas was 5.5% among exposed individuals and 1.3% among controls (mOR, 6.3; 95% CI, 2.0-19.5; P = .001) and the prevalence of all colorectal adenomas was 39% among exposed individuals and 19% among controls (mOR, 3.3; 95% CI, 2.2-5.0; P less than .001). Finally, two cases of colorectal cancer were detected among the exposed siblings, while no such cases were detected among the controls.
The exposed siblings and controls resembled each other in terms of aspirin use, smoking, body mass index, and metabolic diseases, the researchers said. However, the probands with adenoma were identified from a consecutive group of patients, while control siblings were enrolled through a screening program, they said. Therefore, the groups might have differed in terms of unmeasured environmental risk factors for cancer, such as physical activity and dietary habits. They also noted the difficulties in obtaining accurate family histories of colonic neoplasia, especially distinguishing adenoma from advanced adenoma. Finally, Hong Kong is ethnically homogenous, and the data might not be generalizable to other populations, although Asia and Western countries do tend to have comparable rates of advanced adenoma in average-risk individuals and in families with histories of colorectal neoplasias.
The Research Grants Council of the Hong Kong Special Administrative Region funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
Current guidelines recommend early screening and shorter surveillance intervals in individuals with a first-degree relative (FDR) with colorectal cancer (CRC) (Gastroenterology. 2008;134:1570-950). Existing literature is limited by either lack of an appropriate comparison group or inability to assess adenoma risk in subjects who have an FDR with adenomas.
![]() |
Dr. Harini S. Naidu |
To date, this is the first prospective study to demonstrate increased prevalence of advanced adenomas in siblings of probands with advanced adenomas detected during colonoscopy. The authors should be congratulated on completing an organized, well-powered study using colonoscopy and histopathology and were careful to limit familial clustering by randomly selecting only one sibling from each family. Although this study has important findings, there are a few points worthy of consideration.
First, it would be helpful to understand whether the siblings shared both parents, one parent, or were adopted, as this would affect the genetic implications of the findings.
Second, the analysis did not stratify probands and siblings based on whether the colonoscopy included in the study was the first or second screening, or surveillance colonoscopy. The risk of advanced adenomas is expected to be different in someone with numerous normal colonoscopies, compared with someone undergoing their initial screening colonoscopy, and this point deserves clarification.
![]() |
Dr. Audrey H. Calderwood |
Third, it would be helpful to know how many siblings in each group were excluded due to previous adenomas, which bias results towards the null. For example, exclusion of high-risk individuals with previous adenomas in the control group may make the prevalence of adenoma detection appear lower if only lower-risk individuals are included.
Lastly, this study was performed in a uniform Asian patient population, and may not be generalizable to other populations. Validation in a more ethnically heterogeneous setting is warranted. Overall, this is a solid, clinically relevant study that can help inform the impact of family history of advanced adenomas on CRC screening recommendations.
In addition, the study’s findings corroborate the American College of Gastroenterology’s recommendations for earlier CRC screening at shorter surveillance intervals in patients who have FDRs with advanced adenomas detected at age less than 60, or two FDRs diagnosed with advanced adenomas at any age (Am J Gastroenterol. 2009;104:739–50).
Dr. Harini S. Naidu and Dr. Audrey H. Calderwood are in the section of gastroenterology, Boston University. The authors have no conflicts of interest to declare.
Current guidelines recommend early screening and shorter surveillance intervals in individuals with a first-degree relative (FDR) with colorectal cancer (CRC) (Gastroenterology. 2008;134:1570-950). Existing literature is limited by either lack of an appropriate comparison group or inability to assess adenoma risk in subjects who have an FDR with adenomas.
![]() |
Dr. Harini S. Naidu |
To date, this is the first prospective study to demonstrate increased prevalence of advanced adenomas in siblings of probands with advanced adenomas detected during colonoscopy. The authors should be congratulated on completing an organized, well-powered study using colonoscopy and histopathology and were careful to limit familial clustering by randomly selecting only one sibling from each family. Although this study has important findings, there are a few points worthy of consideration.
First, it would be helpful to understand whether the siblings shared both parents, one parent, or were adopted, as this would affect the genetic implications of the findings.
Second, the analysis did not stratify probands and siblings based on whether the colonoscopy included in the study was the first or second screening, or surveillance colonoscopy. The risk of advanced adenomas is expected to be different in someone with numerous normal colonoscopies, compared with someone undergoing their initial screening colonoscopy, and this point deserves clarification.
![]() |
Dr. Audrey H. Calderwood |
Third, it would be helpful to know how many siblings in each group were excluded due to previous adenomas, which bias results towards the null. For example, exclusion of high-risk individuals with previous adenomas in the control group may make the prevalence of adenoma detection appear lower if only lower-risk individuals are included.
Lastly, this study was performed in a uniform Asian patient population, and may not be generalizable to other populations. Validation in a more ethnically heterogeneous setting is warranted. Overall, this is a solid, clinically relevant study that can help inform the impact of family history of advanced adenomas on CRC screening recommendations.
In addition, the study’s findings corroborate the American College of Gastroenterology’s recommendations for earlier CRC screening at shorter surveillance intervals in patients who have FDRs with advanced adenomas detected at age less than 60, or two FDRs diagnosed with advanced adenomas at any age (Am J Gastroenterol. 2009;104:739–50).
Dr. Harini S. Naidu and Dr. Audrey H. Calderwood are in the section of gastroenterology, Boston University. The authors have no conflicts of interest to declare.
Current guidelines recommend early screening and shorter surveillance intervals in individuals with a first-degree relative (FDR) with colorectal cancer (CRC) (Gastroenterology. 2008;134:1570-950). Existing literature is limited by either lack of an appropriate comparison group or inability to assess adenoma risk in subjects who have an FDR with adenomas.
![]() |
Dr. Harini S. Naidu |
To date, this is the first prospective study to demonstrate increased prevalence of advanced adenomas in siblings of probands with advanced adenomas detected during colonoscopy. The authors should be congratulated on completing an organized, well-powered study using colonoscopy and histopathology and were careful to limit familial clustering by randomly selecting only one sibling from each family. Although this study has important findings, there are a few points worthy of consideration.
First, it would be helpful to understand whether the siblings shared both parents, one parent, or were adopted, as this would affect the genetic implications of the findings.
Second, the analysis did not stratify probands and siblings based on whether the colonoscopy included in the study was the first or second screening, or surveillance colonoscopy. The risk of advanced adenomas is expected to be different in someone with numerous normal colonoscopies, compared with someone undergoing their initial screening colonoscopy, and this point deserves clarification.
![]() |
Dr. Audrey H. Calderwood |
Third, it would be helpful to know how many siblings in each group were excluded due to previous adenomas, which bias results towards the null. For example, exclusion of high-risk individuals with previous adenomas in the control group may make the prevalence of adenoma detection appear lower if only lower-risk individuals are included.
Lastly, this study was performed in a uniform Asian patient population, and may not be generalizable to other populations. Validation in a more ethnically heterogeneous setting is warranted. Overall, this is a solid, clinically relevant study that can help inform the impact of family history of advanced adenomas on CRC screening recommendations.
In addition, the study’s findings corroborate the American College of Gastroenterology’s recommendations for earlier CRC screening at shorter surveillance intervals in patients who have FDRs with advanced adenomas detected at age less than 60, or two FDRs diagnosed with advanced adenomas at any age (Am J Gastroenterol. 2009;104:739–50).
Dr. Harini S. Naidu and Dr. Audrey H. Calderwood are in the section of gastroenterology, Boston University. The authors have no conflicts of interest to declare.
Siblings of patients with advanced adenoma had sixfold higher odds of having the tumors themselves, as compared with controls, said the authors of a blinded cross-sectional study reported in the March issue of Gastroenterology.
The results reinforce the need for early screening of individuals whose siblings have advanced adenoma, said Dr. Siew Ng at the Chinese University of Hong Kong and her associates. The risk of advanced adenoma was even higher when affected probands were younger than average or had multiple adenomas, the researchers added.
Most studies that have purported to study the familial risk of adenoma actually studied the risk of adenoma in persons whose first-degree relatives have colorectal cancer, according to Dr. Ng and her associates. Their study included 200 asymptomatic (“exposed”) siblings of individuals with advanced adenomas as diagnosed on colonoscopy, and 400 controls whose siblings had no family history of colorectal cancer or colonoscopic evidence of neoplasia. The researchers defined advanced adenomas as those measuring at least 10 mm or that had high-grade dysplasia or villous or tubulovillous characteristics. “We focused on advanced lesions, as they have the greatest malignant potential, and removing these lesions can reduce colorectal cancer incidence and mortality,” they said (Gastroenterology. 2015 Nov 14. doi: 10.1053/j.gastro.2015.11.003).
Exposed siblings were consistently more likely to have adenomas themselves, compared with the control group, said the investigators. For example, the prevalence of any advanced adenoma was 11.5% among exposed siblings compared with only 2.5% among controls (matched odds ratio, 6.05; 95% confidence interval, 2.7-13.4; P less than .001). Similarly, the prevalence of adenomas measuring at least 10 mm was 10.5% among exposed individuals and 1.8% among controls (mOR, 8.6; 95% CI, 3.4-21.4; P less than .001). The prevalence of villous adenomas was 5.5% among exposed individuals and 1.3% among controls (mOR, 6.3; 95% CI, 2.0-19.5; P = .001) and the prevalence of all colorectal adenomas was 39% among exposed individuals and 19% among controls (mOR, 3.3; 95% CI, 2.2-5.0; P less than .001). Finally, two cases of colorectal cancer were detected among the exposed siblings, while no such cases were detected among the controls.
The exposed siblings and controls resembled each other in terms of aspirin use, smoking, body mass index, and metabolic diseases, the researchers said. However, the probands with adenoma were identified from a consecutive group of patients, while control siblings were enrolled through a screening program, they said. Therefore, the groups might have differed in terms of unmeasured environmental risk factors for cancer, such as physical activity and dietary habits. They also noted the difficulties in obtaining accurate family histories of colonic neoplasia, especially distinguishing adenoma from advanced adenoma. Finally, Hong Kong is ethnically homogenous, and the data might not be generalizable to other populations, although Asia and Western countries do tend to have comparable rates of advanced adenoma in average-risk individuals and in families with histories of colorectal neoplasias.
The Research Grants Council of the Hong Kong Special Administrative Region funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
Siblings of patients with advanced adenoma had sixfold higher odds of having the tumors themselves, as compared with controls, said the authors of a blinded cross-sectional study reported in the March issue of Gastroenterology.
The results reinforce the need for early screening of individuals whose siblings have advanced adenoma, said Dr. Siew Ng at the Chinese University of Hong Kong and her associates. The risk of advanced adenoma was even higher when affected probands were younger than average or had multiple adenomas, the researchers added.
Most studies that have purported to study the familial risk of adenoma actually studied the risk of adenoma in persons whose first-degree relatives have colorectal cancer, according to Dr. Ng and her associates. Their study included 200 asymptomatic (“exposed”) siblings of individuals with advanced adenomas as diagnosed on colonoscopy, and 400 controls whose siblings had no family history of colorectal cancer or colonoscopic evidence of neoplasia. The researchers defined advanced adenomas as those measuring at least 10 mm or that had high-grade dysplasia or villous or tubulovillous characteristics. “We focused on advanced lesions, as they have the greatest malignant potential, and removing these lesions can reduce colorectal cancer incidence and mortality,” they said (Gastroenterology. 2015 Nov 14. doi: 10.1053/j.gastro.2015.11.003).
Exposed siblings were consistently more likely to have adenomas themselves, compared with the control group, said the investigators. For example, the prevalence of any advanced adenoma was 11.5% among exposed siblings compared with only 2.5% among controls (matched odds ratio, 6.05; 95% confidence interval, 2.7-13.4; P less than .001). Similarly, the prevalence of adenomas measuring at least 10 mm was 10.5% among exposed individuals and 1.8% among controls (mOR, 8.6; 95% CI, 3.4-21.4; P less than .001). The prevalence of villous adenomas was 5.5% among exposed individuals and 1.3% among controls (mOR, 6.3; 95% CI, 2.0-19.5; P = .001) and the prevalence of all colorectal adenomas was 39% among exposed individuals and 19% among controls (mOR, 3.3; 95% CI, 2.2-5.0; P less than .001). Finally, two cases of colorectal cancer were detected among the exposed siblings, while no such cases were detected among the controls.
The exposed siblings and controls resembled each other in terms of aspirin use, smoking, body mass index, and metabolic diseases, the researchers said. However, the probands with adenoma were identified from a consecutive group of patients, while control siblings were enrolled through a screening program, they said. Therefore, the groups might have differed in terms of unmeasured environmental risk factors for cancer, such as physical activity and dietary habits. They also noted the difficulties in obtaining accurate family histories of colonic neoplasia, especially distinguishing adenoma from advanced adenoma. Finally, Hong Kong is ethnically homogenous, and the data might not be generalizable to other populations, although Asia and Western countries do tend to have comparable rates of advanced adenoma in average-risk individuals and in families with histories of colorectal neoplasias.
The Research Grants Council of the Hong Kong Special Administrative Region funded the study. The investigators had no disclosures.
Source: American Gastroenterological Association
FROM GASTROENTEROLOGY
Key clinical point: Siblings of patients with advanced adenoma were substantially more likely to also have advanced adenomas as compared with controls.
Major finding: The odds of advanced adenomas among exposed siblings were six times greater than for controls (95% confidence interval, 2.7-13.4; P less than .001).
Data source: A cross-sectional study of 200 asymptomatic siblings of individuals with advanced adenomas and 400 controls whose siblings had no family history of colorectal cancer or colonoscopic evidence of neoplasia.
Disclosures: The Research Grants Council of the Hong Kong Special Administrative Region funded the study. The investigators had no disclosures.
MRI topped transient elastography for staging nonalcoholic fatty liver disease
Two magnetic resonance imaging (MRI) techniques topped transient elastography (TE) for diagnosing hepatic fibrosis and steatosis in patients with nonalcoholic fatty liver disease (NAFLD), according to a first-in-kind study.
Magnetic resonance elastography surpassed all other methods for staging fibrosis, while MRI-based measurement of proton density fat fraction (PDFF) was superior for grading steatosis, with liver biopsy used as the comparative gold standard, said Dr. Kento Imajo at Yokohama (Japan) City University Graduate School of Medicine and his associates. “Magnetic resonance imaging–based noninvasive assessment of liver fibrosis and steatosis is a potential alternative to liver biopsy in clinical practice,” the investigators wrote in the March issue of Gastroenterology.
Assessing liver fibrosis and steatosis is important for staging NAFLD. Although “useful” overall, transient elastography can be unreliable in morbidly obese NAFLD patients or those with ascites because of low-frequency vibrations created by the probe, the researchers noted. To compare TE with MRI-based magnetic resonance elastography and PDFF, they evaluated 142 patients with biopsy-confirmed NAFLD and 10 controls, all of whom they also assessed with five clinical scoring systems for fibrosis – the FIB4 index, the NAFLD fibrosis score, the aspartate aminotransferase (AST) to platelet ratio, the AST-to-alanine transaminase (ALT) ratio, and the BARD score (Gastroenterology. 2015 Dec 8. doi: 10.1053/j.gastro.2015.11.048).
Magnetic resonance elastography detected stage 2 or higher hepatic fibrosis with an area under the receiver operating characteristic (AUROC) curve value of 0.91 (95% confidence interval, 0.86-0.96), compared with 0.82 (0.74-0.89) for transient elastography (P = .001), the investigators reported. The AUROC for MRE also significantly exceeded the AUROCs for all five clinical indexes of fibrosis severity. Furthermore, MRI-based measurement of PDFF identified hepatic steatosis of grade 2 or higher with an AUROC curve value of 0.90 (95% CI, 0.82-0.97), which was significantly greater than the AUROC obtained by using TE to measure the controlled attenuation parameter (0.73; 95% CI, 0.64-0.81; P less than .001).
Adding a measure for serum keratin 18 fragments or ALT did not significantly improve the detection of nonalcoholic steatohepatitis or macrovesicular steatosis affecting at least 5% of hepatocytes by either MRI or TE, the researchers noted. While liver biopsy remains the gold standard for assessing NAFLD, it is associated with sampling errors and intra- and interobserver variability, and these errors could have affected their study results, they acknowledged. The study also did not account for hepatic perfusion, which can elevate liver stiffness measurement independently from liver disease.
Both the magnetic resonance elastography and PDFF techniques require specialized hardware and software that are available from several commercial suppliers, the researchers also noted.
The study was partially supported by the Japanese Ministry of Health, Labor, and Welfare, the Japanese Science and Technology Agency, and Kiban-B, Shingakujuturyouiki. The investigators had no disclosures.
Two magnetic resonance imaging (MRI) techniques topped transient elastography (TE) for diagnosing hepatic fibrosis and steatosis in patients with nonalcoholic fatty liver disease (NAFLD), according to a first-in-kind study.
Magnetic resonance elastography surpassed all other methods for staging fibrosis, while MRI-based measurement of proton density fat fraction (PDFF) was superior for grading steatosis, with liver biopsy used as the comparative gold standard, said Dr. Kento Imajo at Yokohama (Japan) City University Graduate School of Medicine and his associates. “Magnetic resonance imaging–based noninvasive assessment of liver fibrosis and steatosis is a potential alternative to liver biopsy in clinical practice,” the investigators wrote in the March issue of Gastroenterology.
Assessing liver fibrosis and steatosis is important for staging NAFLD. Although “useful” overall, transient elastography can be unreliable in morbidly obese NAFLD patients or those with ascites because of low-frequency vibrations created by the probe, the researchers noted. To compare TE with MRI-based magnetic resonance elastography and PDFF, they evaluated 142 patients with biopsy-confirmed NAFLD and 10 controls, all of whom they also assessed with five clinical scoring systems for fibrosis – the FIB4 index, the NAFLD fibrosis score, the aspartate aminotransferase (AST) to platelet ratio, the AST-to-alanine transaminase (ALT) ratio, and the BARD score (Gastroenterology. 2015 Dec 8. doi: 10.1053/j.gastro.2015.11.048).
Magnetic resonance elastography detected stage 2 or higher hepatic fibrosis with an area under the receiver operating characteristic (AUROC) curve value of 0.91 (95% confidence interval, 0.86-0.96), compared with 0.82 (0.74-0.89) for transient elastography (P = .001), the investigators reported. The AUROC for MRE also significantly exceeded the AUROCs for all five clinical indexes of fibrosis severity. Furthermore, MRI-based measurement of PDFF identified hepatic steatosis of grade 2 or higher with an AUROC curve value of 0.90 (95% CI, 0.82-0.97), which was significantly greater than the AUROC obtained by using TE to measure the controlled attenuation parameter (0.73; 95% CI, 0.64-0.81; P less than .001).
Adding a measure for serum keratin 18 fragments or ALT did not significantly improve the detection of nonalcoholic steatohepatitis or macrovesicular steatosis affecting at least 5% of hepatocytes by either MRI or TE, the researchers noted. While liver biopsy remains the gold standard for assessing NAFLD, it is associated with sampling errors and intra- and interobserver variability, and these errors could have affected their study results, they acknowledged. The study also did not account for hepatic perfusion, which can elevate liver stiffness measurement independently from liver disease.
Both the magnetic resonance elastography and PDFF techniques require specialized hardware and software that are available from several commercial suppliers, the researchers also noted.
The study was partially supported by the Japanese Ministry of Health, Labor, and Welfare, the Japanese Science and Technology Agency, and Kiban-B, Shingakujuturyouiki. The investigators had no disclosures.
Two magnetic resonance imaging (MRI) techniques topped transient elastography (TE) for diagnosing hepatic fibrosis and steatosis in patients with nonalcoholic fatty liver disease (NAFLD), according to a first-in-kind study.
Magnetic resonance elastography surpassed all other methods for staging fibrosis, while MRI-based measurement of proton density fat fraction (PDFF) was superior for grading steatosis, with liver biopsy used as the comparative gold standard, said Dr. Kento Imajo at Yokohama (Japan) City University Graduate School of Medicine and his associates. “Magnetic resonance imaging–based noninvasive assessment of liver fibrosis and steatosis is a potential alternative to liver biopsy in clinical practice,” the investigators wrote in the March issue of Gastroenterology.
Assessing liver fibrosis and steatosis is important for staging NAFLD. Although “useful” overall, transient elastography can be unreliable in morbidly obese NAFLD patients or those with ascites because of low-frequency vibrations created by the probe, the researchers noted. To compare TE with MRI-based magnetic resonance elastography and PDFF, they evaluated 142 patients with biopsy-confirmed NAFLD and 10 controls, all of whom they also assessed with five clinical scoring systems for fibrosis – the FIB4 index, the NAFLD fibrosis score, the aspartate aminotransferase (AST) to platelet ratio, the AST-to-alanine transaminase (ALT) ratio, and the BARD score (Gastroenterology. 2015 Dec 8. doi: 10.1053/j.gastro.2015.11.048).
Magnetic resonance elastography detected stage 2 or higher hepatic fibrosis with an area under the receiver operating characteristic (AUROC) curve value of 0.91 (95% confidence interval, 0.86-0.96), compared with 0.82 (0.74-0.89) for transient elastography (P = .001), the investigators reported. The AUROC for MRE also significantly exceeded the AUROCs for all five clinical indexes of fibrosis severity. Furthermore, MRI-based measurement of PDFF identified hepatic steatosis of grade 2 or higher with an AUROC curve value of 0.90 (95% CI, 0.82-0.97), which was significantly greater than the AUROC obtained by using TE to measure the controlled attenuation parameter (0.73; 95% CI, 0.64-0.81; P less than .001).
Adding a measure for serum keratin 18 fragments or ALT did not significantly improve the detection of nonalcoholic steatohepatitis or macrovesicular steatosis affecting at least 5% of hepatocytes by either MRI or TE, the researchers noted. While liver biopsy remains the gold standard for assessing NAFLD, it is associated with sampling errors and intra- and interobserver variability, and these errors could have affected their study results, they acknowledged. The study also did not account for hepatic perfusion, which can elevate liver stiffness measurement independently from liver disease.
Both the magnetic resonance elastography and PDFF techniques require specialized hardware and software that are available from several commercial suppliers, the researchers also noted.
The study was partially supported by the Japanese Ministry of Health, Labor, and Welfare, the Japanese Science and Technology Agency, and Kiban-B, Shingakujuturyouiki. The investigators had no disclosures.
FROM GASTROENTEROLOGY
Key clinical point: Two specialized MRI techniques surpassed transient elastography for staging fibrosis and steatosis in nonalcoholic fatty liver disease.
Major finding: The areas under the curve for magnetic resonance elastography and the proton density fat fraction measure were significantly greater than those for transient elastography and the TE-based controlled attenuation parameter (P is less than .001 for both comparisons).
Data source: A cross-sectional study of 142 patients with nonalcoholic fatty liver disease and 10 controls.
Disclosures: The study was partially supported by the Japanese Ministry of Health, Labor, and Welfare, the Japanese Science and Technology Agency, and Kiban-B, Shingakujuturyouiki. The investigators had no disclosures.
Minor residual staining found adequate for colonoscopy
A Boston Bowel Preparation Scale (BBPS) score of 2 – indicating mild residual staining and small stool fragments – was as good as the optimal preparation score of 3 for visualizing polyps and adenomas larger than 5 mm and advanced adenomas during colonoscopy, researchers said.
A score of 2 might increase the chances of missing smaller polyps, but is adequate for detecting clinically significant masses, Dr. Brian Clark of Yale University, New Haven, Conn., and his associates reported in the February issue of Gastroenterology. But a score of 1 – meaning that there is enough staining or stool to obscure the mucosa – significantly increased the chances of missing adenomas larger than 5 mm, they said. Patients should undergo early repeat colonoscopy if their BBPS score is 1 or 0 in any colon segment, they emphasized.
Source: American Gastroenterological Association
Bowel preparation for colonoscopy is considered adequate if endoscopists can detect polyps larger than 5 mm, but no prior study had quantified the amount of preparation needed. This prospective observational study assessed adequate preparation in terms of the BBPS, which scores each of three colon segments on a scale of 0 (solid stool covering the mucosa) to 3 points (entire mucosa seen well, with no residual staining). Study participants included 438 men aged 50-75 years who underwent screening or surveillance colonoscopy at a single Veterans Affairs center, followed by repeat colonoscopies within 60 days performed by different blinded endoscopists. The investigators excluded patients who scored 0 in all colon segments or had familial polyposis syndrome, inflammatory bowel disease, polyps so large that they could not be completely removed, or a history of colonic or rectal resection. In all, they analyzed 1,161 colon segments (Gastroenterology. 2015 Dec 7. doi: 10.1053/j.gastro.2015.09.041).
Endoscopists missed about 5% of adenomas greater than 5 mm, regardless of whether BBPS scores were 2 or 3 in a model that accounted for age, reason for colonoscopy, colon segment, number of polyps removed in the first examination, and endoscopist performing the procedure, the researchers said. But when BBPS scores were 1, endoscopists missed 16% of adenomas larger than 5 mm, a difference of about 10%. Furthermore, 43% of screening and surveillance intervals would have been incorrect had they been based solely on an initial examination for which scores were 1 in at least one segment. In contrast, only about 15% of intervals would have been incorrect for patients who scored 2 or 3 in all segments.
In all, 80% of patients were sufficiently prepared, having scored at least 2 in all segments on the first examination. “Determining whether a patient’s preparation quality is adequate is one of the most common and important decisions made by gastroenterologists each day,” the researchers said. Between 25% and 30% of screening and surveillance colonoscopies occur at “inappropriately shortened intervals,” often because of uncertainty about what constitutes adequate visualization, they added. Defining adequate visualization based on bowel preparation could save billions of dollars in health care costs every year, minimize complications from unnecessary procedures, and pinpoint those patients who truly need an early repeat colonoscopy to help prevent interval colorectal cancer, they emphasized.
The National Institutes of Health funded the study. The investigators had no disclosures.
We have seen a dramatic increase in attention to improving the adenoma detection rate (ADR) during colonoscopy because patients of endoscopists with a higher ADR have a lower risk of colorectal cancer after colonoscopy. One major contributor to missed adenomas is inadequate bowel preparation, though little was known about how best to define adequacy.
Dr. Jason Domonitz |
Clark and colleagues’ elegant tandem colonoscopy study helps address this knowledge gap using the Boston Bowel Preparation Scale (BBPS), a validated instrument that is easy to implement. They hypothesized that a BBPS colon-segment score of 2 was noninferior to a score of 3 for identifying adenomas greater than 5 mm, but that a BBPS colon-segment score of 1 would be inferior to scores of 2 or 3. Their findings support this hypothesis and give us long overdue data that we can now use to define an adequate bowel preparation. Given that the adenoma miss rate was 16% when the segment score was 1, but only about 5% with higher scores, it is reasonable to recommend repeat colonoscopy within 12 months if any segment score is less than 2. Otherwise, standard surveillance intervals should be recommended. Finally, unless and until other scoring systems are similarly validated, these findings should encourage the widespread adoption of the BBPS.
Dr. Jason A. Dominitz, AGAF, is the national program director for gastroenterology for the Veterans Health Administration and is professor of medicine in the division of gastroenterology at the University of Washington, Seattle. He has no conflicts of interest.
We have seen a dramatic increase in attention to improving the adenoma detection rate (ADR) during colonoscopy because patients of endoscopists with a higher ADR have a lower risk of colorectal cancer after colonoscopy. One major contributor to missed adenomas is inadequate bowel preparation, though little was known about how best to define adequacy.
Dr. Jason Domonitz |
Clark and colleagues’ elegant tandem colonoscopy study helps address this knowledge gap using the Boston Bowel Preparation Scale (BBPS), a validated instrument that is easy to implement. They hypothesized that a BBPS colon-segment score of 2 was noninferior to a score of 3 for identifying adenomas greater than 5 mm, but that a BBPS colon-segment score of 1 would be inferior to scores of 2 or 3. Their findings support this hypothesis and give us long overdue data that we can now use to define an adequate bowel preparation. Given that the adenoma miss rate was 16% when the segment score was 1, but only about 5% with higher scores, it is reasonable to recommend repeat colonoscopy within 12 months if any segment score is less than 2. Otherwise, standard surveillance intervals should be recommended. Finally, unless and until other scoring systems are similarly validated, these findings should encourage the widespread adoption of the BBPS.
Dr. Jason A. Dominitz, AGAF, is the national program director for gastroenterology for the Veterans Health Administration and is professor of medicine in the division of gastroenterology at the University of Washington, Seattle. He has no conflicts of interest.
We have seen a dramatic increase in attention to improving the adenoma detection rate (ADR) during colonoscopy because patients of endoscopists with a higher ADR have a lower risk of colorectal cancer after colonoscopy. One major contributor to missed adenomas is inadequate bowel preparation, though little was known about how best to define adequacy.
Dr. Jason Domonitz |
Clark and colleagues’ elegant tandem colonoscopy study helps address this knowledge gap using the Boston Bowel Preparation Scale (BBPS), a validated instrument that is easy to implement. They hypothesized that a BBPS colon-segment score of 2 was noninferior to a score of 3 for identifying adenomas greater than 5 mm, but that a BBPS colon-segment score of 1 would be inferior to scores of 2 or 3. Their findings support this hypothesis and give us long overdue data that we can now use to define an adequate bowel preparation. Given that the adenoma miss rate was 16% when the segment score was 1, but only about 5% with higher scores, it is reasonable to recommend repeat colonoscopy within 12 months if any segment score is less than 2. Otherwise, standard surveillance intervals should be recommended. Finally, unless and until other scoring systems are similarly validated, these findings should encourage the widespread adoption of the BBPS.
Dr. Jason A. Dominitz, AGAF, is the national program director for gastroenterology for the Veterans Health Administration and is professor of medicine in the division of gastroenterology at the University of Washington, Seattle. He has no conflicts of interest.
A Boston Bowel Preparation Scale (BBPS) score of 2 – indicating mild residual staining and small stool fragments – was as good as the optimal preparation score of 3 for visualizing polyps and adenomas larger than 5 mm and advanced adenomas during colonoscopy, researchers said.
A score of 2 might increase the chances of missing smaller polyps, but is adequate for detecting clinically significant masses, Dr. Brian Clark of Yale University, New Haven, Conn., and his associates reported in the February issue of Gastroenterology. But a score of 1 – meaning that there is enough staining or stool to obscure the mucosa – significantly increased the chances of missing adenomas larger than 5 mm, they said. Patients should undergo early repeat colonoscopy if their BBPS score is 1 or 0 in any colon segment, they emphasized.
Source: American Gastroenterological Association
Bowel preparation for colonoscopy is considered adequate if endoscopists can detect polyps larger than 5 mm, but no prior study had quantified the amount of preparation needed. This prospective observational study assessed adequate preparation in terms of the BBPS, which scores each of three colon segments on a scale of 0 (solid stool covering the mucosa) to 3 points (entire mucosa seen well, with no residual staining). Study participants included 438 men aged 50-75 years who underwent screening or surveillance colonoscopy at a single Veterans Affairs center, followed by repeat colonoscopies within 60 days performed by different blinded endoscopists. The investigators excluded patients who scored 0 in all colon segments or had familial polyposis syndrome, inflammatory bowel disease, polyps so large that they could not be completely removed, or a history of colonic or rectal resection. In all, they analyzed 1,161 colon segments (Gastroenterology. 2015 Dec 7. doi: 10.1053/j.gastro.2015.09.041).
Endoscopists missed about 5% of adenomas greater than 5 mm, regardless of whether BBPS scores were 2 or 3 in a model that accounted for age, reason for colonoscopy, colon segment, number of polyps removed in the first examination, and endoscopist performing the procedure, the researchers said. But when BBPS scores were 1, endoscopists missed 16% of adenomas larger than 5 mm, a difference of about 10%. Furthermore, 43% of screening and surveillance intervals would have been incorrect had they been based solely on an initial examination for which scores were 1 in at least one segment. In contrast, only about 15% of intervals would have been incorrect for patients who scored 2 or 3 in all segments.
In all, 80% of patients were sufficiently prepared, having scored at least 2 in all segments on the first examination. “Determining whether a patient’s preparation quality is adequate is one of the most common and important decisions made by gastroenterologists each day,” the researchers said. Between 25% and 30% of screening and surveillance colonoscopies occur at “inappropriately shortened intervals,” often because of uncertainty about what constitutes adequate visualization, they added. Defining adequate visualization based on bowel preparation could save billions of dollars in health care costs every year, minimize complications from unnecessary procedures, and pinpoint those patients who truly need an early repeat colonoscopy to help prevent interval colorectal cancer, they emphasized.
The National Institutes of Health funded the study. The investigators had no disclosures.
A Boston Bowel Preparation Scale (BBPS) score of 2 – indicating mild residual staining and small stool fragments – was as good as the optimal preparation score of 3 for visualizing polyps and adenomas larger than 5 mm and advanced adenomas during colonoscopy, researchers said.
A score of 2 might increase the chances of missing smaller polyps, but is adequate for detecting clinically significant masses, Dr. Brian Clark of Yale University, New Haven, Conn., and his associates reported in the February issue of Gastroenterology. But a score of 1 – meaning that there is enough staining or stool to obscure the mucosa – significantly increased the chances of missing adenomas larger than 5 mm, they said. Patients should undergo early repeat colonoscopy if their BBPS score is 1 or 0 in any colon segment, they emphasized.
Source: American Gastroenterological Association
Bowel preparation for colonoscopy is considered adequate if endoscopists can detect polyps larger than 5 mm, but no prior study had quantified the amount of preparation needed. This prospective observational study assessed adequate preparation in terms of the BBPS, which scores each of three colon segments on a scale of 0 (solid stool covering the mucosa) to 3 points (entire mucosa seen well, with no residual staining). Study participants included 438 men aged 50-75 years who underwent screening or surveillance colonoscopy at a single Veterans Affairs center, followed by repeat colonoscopies within 60 days performed by different blinded endoscopists. The investigators excluded patients who scored 0 in all colon segments or had familial polyposis syndrome, inflammatory bowel disease, polyps so large that they could not be completely removed, or a history of colonic or rectal resection. In all, they analyzed 1,161 colon segments (Gastroenterology. 2015 Dec 7. doi: 10.1053/j.gastro.2015.09.041).
Endoscopists missed about 5% of adenomas greater than 5 mm, regardless of whether BBPS scores were 2 or 3 in a model that accounted for age, reason for colonoscopy, colon segment, number of polyps removed in the first examination, and endoscopist performing the procedure, the researchers said. But when BBPS scores were 1, endoscopists missed 16% of adenomas larger than 5 mm, a difference of about 10%. Furthermore, 43% of screening and surveillance intervals would have been incorrect had they been based solely on an initial examination for which scores were 1 in at least one segment. In contrast, only about 15% of intervals would have been incorrect for patients who scored 2 or 3 in all segments.
In all, 80% of patients were sufficiently prepared, having scored at least 2 in all segments on the first examination. “Determining whether a patient’s preparation quality is adequate is one of the most common and important decisions made by gastroenterologists each day,” the researchers said. Between 25% and 30% of screening and surveillance colonoscopies occur at “inappropriately shortened intervals,” often because of uncertainty about what constitutes adequate visualization, they added. Defining adequate visualization based on bowel preparation could save billions of dollars in health care costs every year, minimize complications from unnecessary procedures, and pinpoint those patients who truly need an early repeat colonoscopy to help prevent interval colorectal cancer, they emphasized.
The National Institutes of Health funded the study. The investigators had no disclosures.
FROM GASTROENTEROLOGY
Key clinical point: Minor residual staining that does not obscure the bowel mucosa is adequate for detection of adenomas greater than 5 mm during surveillance or screening colonoscopy.
Major finding: Endoscopists missed about 5% of clinically significant adenomas, regardless of whether the Boston Bowel Preparation Score was 2 (minor residual staining) or 3 (entire mucosa seen well).
Data source: A blinded prospective observational study of 438 men at a single Veterans Affairs center.
Disclosures: The National Institutes of Health funded the study. The investigators had no disclosures.
Drug combo held up in real-world HCV study
A 12-week, ribavirin-free regimen achieved sustained virologic response for 85% of patients with genotype 1 hepatitis C virus (HCV) infection, researchers reported in the February issue of Gastroenterology.
“This represents one of the first applications of a highly effective HCV regimen outside clinical trials,” said Dr. Mark S. Sulkowski of John Hopkins University in Baltimore and his associates. Adding ribavirin to the simeprevir and sofosbuvir combination regimen did not improve sustained virologic response (SVR), but patients were less likely to achieve it if they had cirrhosis, current or prior hepatic decompensation, or a history of failing other protease inhibitors, the investigators said.
Novel hepatitis C therapies have yielded “substantially lower” rates of SVR and more side effects in everyday practice than in clinical trials, the investigators noted. To better understand how some of newest HCV drugs perform in the real world, they conducted an observational cohort study of the safety, tolerability, and efficacy of simeprevir plus sofosbuvir for treating genotype 1 HCV infections in academic and nonacademic settings (HCV-TARGET) (Gastroenterology 2015 doi: 10.1053/j.gastro.2015.10.013).
A total of 836 patients received once-daily simeprevir (150 mg) and sofosbuvir (400 mg), and 169 of them also received ribavirin. Most (61%) patients had genotype 1a infection and were white (76%), male (61%), and cirrhotic (59%); 13% were black. Patients usually were treatment experienced, having failed peginterferon and ribavirin either with (12%) or without (46%) telaprevir or boceprevir, the researchers said.
In all, 675 (84%) patients achieved SVR after 12 weeks of treatment (SVR12; 95% confidence interval, 81%-87%). Adding ribavirin to the combination PI regimen did not improve SVR, regardless of cirrhosis status, genetic subtype, or treatment history. However, crude SVR12 rates were only 75% for patients with hepatic decompensation and 81% for those with cirrhosis, and these patients had significantly lower adjusted odds of achieving SVR, compared with other patients. In hindsight, decompensated and cirrhotic patients might have needed 24 weeks of treatment, as the Food and Drug Administration now recommends based on the COSMOS trial results (Lancet. 2014;384[9956]:1756-65), the investigators said.
The adjusted model did not uncover a link between genotype 1 subtype and SVR, but only about 10% of patients were tested for the Q80K polymorphism, which is more common in genotype 1a infections and is associated with treatment resistance, the investigators noted. Crude SVR12 rates were 92% for patients with genotype 1b infection and 86% for those with 1a infection, they said.
Only 3% of patients stopped treatment; 2% did so because of side effects, and ribavirin did not significantly affect rates of treatment discontinuation, said the investigators. The most common side effects were fatigue, headache, nausea, rash, and insomnia. Serious adverse events affected 5% of patients and included gastrointestinal bleeding (0.5%), hepatic failure or encephalopathy (1.2%), and infections (1.1%).
Taken together, these results show that simeprevir and sofosbuvir effectively translate from the clinical trial setting into clinical practice, said the researchers. “Additional research is needed to understand which patients may benefit from different treatment regimens or longer treatment durations,” they emphasized.
The study was supported by the University of Florida at Gainesville, the University of North Carolina at Chapel Hill, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Kadmon, Merck, Vertex, and the National Institutes of Health. Dr. Sulkowski reported grants and personal fees from Gilead, Janssen, Achillion, Abbvie, Merck, and Bristol-Myers Squibb. Of 14 coinvestigators, 13 reported financial relationships with a number of pharmaceutical companies.
A 12-week, ribavirin-free regimen achieved sustained virologic response for 85% of patients with genotype 1 hepatitis C virus (HCV) infection, researchers reported in the February issue of Gastroenterology.
“This represents one of the first applications of a highly effective HCV regimen outside clinical trials,” said Dr. Mark S. Sulkowski of John Hopkins University in Baltimore and his associates. Adding ribavirin to the simeprevir and sofosbuvir combination regimen did not improve sustained virologic response (SVR), but patients were less likely to achieve it if they had cirrhosis, current or prior hepatic decompensation, or a history of failing other protease inhibitors, the investigators said.
Novel hepatitis C therapies have yielded “substantially lower” rates of SVR and more side effects in everyday practice than in clinical trials, the investigators noted. To better understand how some of newest HCV drugs perform in the real world, they conducted an observational cohort study of the safety, tolerability, and efficacy of simeprevir plus sofosbuvir for treating genotype 1 HCV infections in academic and nonacademic settings (HCV-TARGET) (Gastroenterology 2015 doi: 10.1053/j.gastro.2015.10.013).
A total of 836 patients received once-daily simeprevir (150 mg) and sofosbuvir (400 mg), and 169 of them also received ribavirin. Most (61%) patients had genotype 1a infection and were white (76%), male (61%), and cirrhotic (59%); 13% were black. Patients usually were treatment experienced, having failed peginterferon and ribavirin either with (12%) or without (46%) telaprevir or boceprevir, the researchers said.
In all, 675 (84%) patients achieved SVR after 12 weeks of treatment (SVR12; 95% confidence interval, 81%-87%). Adding ribavirin to the combination PI regimen did not improve SVR, regardless of cirrhosis status, genetic subtype, or treatment history. However, crude SVR12 rates were only 75% for patients with hepatic decompensation and 81% for those with cirrhosis, and these patients had significantly lower adjusted odds of achieving SVR, compared with other patients. In hindsight, decompensated and cirrhotic patients might have needed 24 weeks of treatment, as the Food and Drug Administration now recommends based on the COSMOS trial results (Lancet. 2014;384[9956]:1756-65), the investigators said.
The adjusted model did not uncover a link between genotype 1 subtype and SVR, but only about 10% of patients were tested for the Q80K polymorphism, which is more common in genotype 1a infections and is associated with treatment resistance, the investigators noted. Crude SVR12 rates were 92% for patients with genotype 1b infection and 86% for those with 1a infection, they said.
Only 3% of patients stopped treatment; 2% did so because of side effects, and ribavirin did not significantly affect rates of treatment discontinuation, said the investigators. The most common side effects were fatigue, headache, nausea, rash, and insomnia. Serious adverse events affected 5% of patients and included gastrointestinal bleeding (0.5%), hepatic failure or encephalopathy (1.2%), and infections (1.1%).
Taken together, these results show that simeprevir and sofosbuvir effectively translate from the clinical trial setting into clinical practice, said the researchers. “Additional research is needed to understand which patients may benefit from different treatment regimens or longer treatment durations,” they emphasized.
The study was supported by the University of Florida at Gainesville, the University of North Carolina at Chapel Hill, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Kadmon, Merck, Vertex, and the National Institutes of Health. Dr. Sulkowski reported grants and personal fees from Gilead, Janssen, Achillion, Abbvie, Merck, and Bristol-Myers Squibb. Of 14 coinvestigators, 13 reported financial relationships with a number of pharmaceutical companies.
A 12-week, ribavirin-free regimen achieved sustained virologic response for 85% of patients with genotype 1 hepatitis C virus (HCV) infection, researchers reported in the February issue of Gastroenterology.
“This represents one of the first applications of a highly effective HCV regimen outside clinical trials,” said Dr. Mark S. Sulkowski of John Hopkins University in Baltimore and his associates. Adding ribavirin to the simeprevir and sofosbuvir combination regimen did not improve sustained virologic response (SVR), but patients were less likely to achieve it if they had cirrhosis, current or prior hepatic decompensation, or a history of failing other protease inhibitors, the investigators said.
Novel hepatitis C therapies have yielded “substantially lower” rates of SVR and more side effects in everyday practice than in clinical trials, the investigators noted. To better understand how some of newest HCV drugs perform in the real world, they conducted an observational cohort study of the safety, tolerability, and efficacy of simeprevir plus sofosbuvir for treating genotype 1 HCV infections in academic and nonacademic settings (HCV-TARGET) (Gastroenterology 2015 doi: 10.1053/j.gastro.2015.10.013).
A total of 836 patients received once-daily simeprevir (150 mg) and sofosbuvir (400 mg), and 169 of them also received ribavirin. Most (61%) patients had genotype 1a infection and were white (76%), male (61%), and cirrhotic (59%); 13% were black. Patients usually were treatment experienced, having failed peginterferon and ribavirin either with (12%) or without (46%) telaprevir or boceprevir, the researchers said.
In all, 675 (84%) patients achieved SVR after 12 weeks of treatment (SVR12; 95% confidence interval, 81%-87%). Adding ribavirin to the combination PI regimen did not improve SVR, regardless of cirrhosis status, genetic subtype, or treatment history. However, crude SVR12 rates were only 75% for patients with hepatic decompensation and 81% for those with cirrhosis, and these patients had significantly lower adjusted odds of achieving SVR, compared with other patients. In hindsight, decompensated and cirrhotic patients might have needed 24 weeks of treatment, as the Food and Drug Administration now recommends based on the COSMOS trial results (Lancet. 2014;384[9956]:1756-65), the investigators said.
The adjusted model did not uncover a link between genotype 1 subtype and SVR, but only about 10% of patients were tested for the Q80K polymorphism, which is more common in genotype 1a infections and is associated with treatment resistance, the investigators noted. Crude SVR12 rates were 92% for patients with genotype 1b infection and 86% for those with 1a infection, they said.
Only 3% of patients stopped treatment; 2% did so because of side effects, and ribavirin did not significantly affect rates of treatment discontinuation, said the investigators. The most common side effects were fatigue, headache, nausea, rash, and insomnia. Serious adverse events affected 5% of patients and included gastrointestinal bleeding (0.5%), hepatic failure or encephalopathy (1.2%), and infections (1.1%).
Taken together, these results show that simeprevir and sofosbuvir effectively translate from the clinical trial setting into clinical practice, said the researchers. “Additional research is needed to understand which patients may benefit from different treatment regimens or longer treatment durations,” they emphasized.
The study was supported by the University of Florida at Gainesville, the University of North Carolina at Chapel Hill, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Kadmon, Merck, Vertex, and the National Institutes of Health. Dr. Sulkowski reported grants and personal fees from Gilead, Janssen, Achillion, Abbvie, Merck, and Bristol-Myers Squibb. Of 14 coinvestigators, 13 reported financial relationships with a number of pharmaceutical companies.
FROM GASTROENTEROLOGY
Key clinical point: Twelve weeks of simeprevir and sofosbuvir cured about 85% of real-world patients with genotype 1 hepatitis C virus infection.
Major finding: The unadjusted rate of SVR12 was 85% (95% CI, 82%-88%).
Data source: An analysis of an observational cohort study of protease inhibitor combination regimen with or without ribavirin for 836 patients (HCV-TARGET).
Disclosures: The study was supported by the University of Florida at Gainesville, the University of North Carolina at Chapel Hill, AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Kadmon, Merck, Vertex, and the National Institutes of Health. Dr. Sulkowski reported grants and personal fees from Gilead, Janssen, Achillion, Abbvie, Merck, and Bristol-Myers Squibb. Of 14 coinvestigators, 13 reported financial relationships with a number of pharmaceutical companies.
Factors within VA control could help prevent missed, canceled appointments
Opt-out scheduling protocols and long appointment lead times contributed significantly to missed and canceled colonoscopy appointments at Veterans Health Administration facilities, researchers reported in the February issue of Clinical Gastroenterology and Hepatology.
These factors are within the control of the Veterans Affairs and could be altered to improve productivity and efficiency, said Melissa Partin, Ph.D., of the Center for Chronic Disease Outcomes Research at the Minneapolis Veterans Affairs Health Care System in Minneapolis, and her associates.
Source: American Gastroenterological Association
Missed and canceled medical appointments are always a concern, but particularly so for colonoscopy clinics, where they incur an average daily net loss of $725, the investigators noted. Most clinics have limited colonoscopy capacity, and even a 30-day wait for diagnostic colonoscopy has been linked to “modest but significantly elevated” chances of detecting cancer on exam, they added. To better understand these problems, they separately examined predictors of missed and canceled appointments among 27,994 patients who had positive fecal occult blood tests with diagnostic colonoscopies scheduled at 69 VA facilities between 2009 and 2011 (Clin Gastroenterol Hepatol. 2015 Aug 21. doi: 10.1016/j.cgh.2015.07.051).
Having a life expectancy of 6 months or less and no personal history of polyps best predicted missing an appointment, with odds ratios of 2.74 for each factor, the researchers said. However, only 0.47% of patients had such a short life expectancy. Other significant predictors of missed appointments included being seen at the largest and most complex facilities (odds ratio, 2.69; P = .007), having both psychiatric and substance abuse disorders (OR, 1.82; P less than .0001), and the use of opt-out scheduling, in which patients were automatically scheduled rather than having to schedule appointments themselves (OR, 1.57; P = .02). Canceled appointments also were linked to opt-out scheduling, as well as to older age and having no history of polyps.
Most appointment lead times were 28 days, and each 12-day increase in lead time increased the odds of missing or canceling appointments by about 15% (P less than .0001). The problem could be curtailed by the Veterans Access, Choice and Accountability Act of 2014, which allows those who cannot schedule VA appointments within 30 days to receive care from eligible non–VA providers, the investigators said. “Future research should focus on assessing the effect of the Choice Act on colonoscopy appointment lead time and on developing and evaluating efficient and effective approaches to implementing the other clinic-level changes supported by our findings,” they added.
The study might have oversimplified or missed changes in protocols because it used single-item survey measures at one point in time, the investigators said. For some patients, the first appointment after the fecal occult blood test may have been for another procedure besides colonoscopy, they added. Furthermore, they did not distinguish between appointments canceled by patients versus clinics. “The VHA is a unique context, characterized by a predominantly male, low-income population with high rates of mental health and substance abuse diagnoses. Therefore, our findings may not generalize to other settings,” they added. “However, our findings do have important implications for a substantial population of health providers and consumers in this country, because the VHA is the largest integrated health care system in the United States.”
The study was funded by the Department of Veterans Affairs Clinical Science Service and Health Services Research & Development Service. The investigators had no disclosures.
Opt-out scheduling protocols and long appointment lead times contributed significantly to missed and canceled colonoscopy appointments at Veterans Health Administration facilities, researchers reported in the February issue of Clinical Gastroenterology and Hepatology.
These factors are within the control of the Veterans Affairs and could be altered to improve productivity and efficiency, said Melissa Partin, Ph.D., of the Center for Chronic Disease Outcomes Research at the Minneapolis Veterans Affairs Health Care System in Minneapolis, and her associates.
Source: American Gastroenterological Association
Missed and canceled medical appointments are always a concern, but particularly so for colonoscopy clinics, where they incur an average daily net loss of $725, the investigators noted. Most clinics have limited colonoscopy capacity, and even a 30-day wait for diagnostic colonoscopy has been linked to “modest but significantly elevated” chances of detecting cancer on exam, they added. To better understand these problems, they separately examined predictors of missed and canceled appointments among 27,994 patients who had positive fecal occult blood tests with diagnostic colonoscopies scheduled at 69 VA facilities between 2009 and 2011 (Clin Gastroenterol Hepatol. 2015 Aug 21. doi: 10.1016/j.cgh.2015.07.051).
Having a life expectancy of 6 months or less and no personal history of polyps best predicted missing an appointment, with odds ratios of 2.74 for each factor, the researchers said. However, only 0.47% of patients had such a short life expectancy. Other significant predictors of missed appointments included being seen at the largest and most complex facilities (odds ratio, 2.69; P = .007), having both psychiatric and substance abuse disorders (OR, 1.82; P less than .0001), and the use of opt-out scheduling, in which patients were automatically scheduled rather than having to schedule appointments themselves (OR, 1.57; P = .02). Canceled appointments also were linked to opt-out scheduling, as well as to older age and having no history of polyps.
Most appointment lead times were 28 days, and each 12-day increase in lead time increased the odds of missing or canceling appointments by about 15% (P less than .0001). The problem could be curtailed by the Veterans Access, Choice and Accountability Act of 2014, which allows those who cannot schedule VA appointments within 30 days to receive care from eligible non–VA providers, the investigators said. “Future research should focus on assessing the effect of the Choice Act on colonoscopy appointment lead time and on developing and evaluating efficient and effective approaches to implementing the other clinic-level changes supported by our findings,” they added.
The study might have oversimplified or missed changes in protocols because it used single-item survey measures at one point in time, the investigators said. For some patients, the first appointment after the fecal occult blood test may have been for another procedure besides colonoscopy, they added. Furthermore, they did not distinguish between appointments canceled by patients versus clinics. “The VHA is a unique context, characterized by a predominantly male, low-income population with high rates of mental health and substance abuse diagnoses. Therefore, our findings may not generalize to other settings,” they added. “However, our findings do have important implications for a substantial population of health providers and consumers in this country, because the VHA is the largest integrated health care system in the United States.”
The study was funded by the Department of Veterans Affairs Clinical Science Service and Health Services Research & Development Service. The investigators had no disclosures.
Opt-out scheduling protocols and long appointment lead times contributed significantly to missed and canceled colonoscopy appointments at Veterans Health Administration facilities, researchers reported in the February issue of Clinical Gastroenterology and Hepatology.
These factors are within the control of the Veterans Affairs and could be altered to improve productivity and efficiency, said Melissa Partin, Ph.D., of the Center for Chronic Disease Outcomes Research at the Minneapolis Veterans Affairs Health Care System in Minneapolis, and her associates.
Source: American Gastroenterological Association
Missed and canceled medical appointments are always a concern, but particularly so for colonoscopy clinics, where they incur an average daily net loss of $725, the investigators noted. Most clinics have limited colonoscopy capacity, and even a 30-day wait for diagnostic colonoscopy has been linked to “modest but significantly elevated” chances of detecting cancer on exam, they added. To better understand these problems, they separately examined predictors of missed and canceled appointments among 27,994 patients who had positive fecal occult blood tests with diagnostic colonoscopies scheduled at 69 VA facilities between 2009 and 2011 (Clin Gastroenterol Hepatol. 2015 Aug 21. doi: 10.1016/j.cgh.2015.07.051).
Having a life expectancy of 6 months or less and no personal history of polyps best predicted missing an appointment, with odds ratios of 2.74 for each factor, the researchers said. However, only 0.47% of patients had such a short life expectancy. Other significant predictors of missed appointments included being seen at the largest and most complex facilities (odds ratio, 2.69; P = .007), having both psychiatric and substance abuse disorders (OR, 1.82; P less than .0001), and the use of opt-out scheduling, in which patients were automatically scheduled rather than having to schedule appointments themselves (OR, 1.57; P = .02). Canceled appointments also were linked to opt-out scheduling, as well as to older age and having no history of polyps.
Most appointment lead times were 28 days, and each 12-day increase in lead time increased the odds of missing or canceling appointments by about 15% (P less than .0001). The problem could be curtailed by the Veterans Access, Choice and Accountability Act of 2014, which allows those who cannot schedule VA appointments within 30 days to receive care from eligible non–VA providers, the investigators said. “Future research should focus on assessing the effect of the Choice Act on colonoscopy appointment lead time and on developing and evaluating efficient and effective approaches to implementing the other clinic-level changes supported by our findings,” they added.
The study might have oversimplified or missed changes in protocols because it used single-item survey measures at one point in time, the investigators said. For some patients, the first appointment after the fecal occult blood test may have been for another procedure besides colonoscopy, they added. Furthermore, they did not distinguish between appointments canceled by patients versus clinics. “The VHA is a unique context, characterized by a predominantly male, low-income population with high rates of mental health and substance abuse diagnoses. Therefore, our findings may not generalize to other settings,” they added. “However, our findings do have important implications for a substantial population of health providers and consumers in this country, because the VHA is the largest integrated health care system in the United States.”
The study was funded by the Department of Veterans Affairs Clinical Science Service and Health Services Research & Development Service. The investigators had no disclosures.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Opt-out scheduling practices and long appointment lead times predicted missed and canceled colonoscopies at the VA.
Major finding: Estimated ratios for these predictors ranged between 1.12 and 1.57, and all were statistically significant.
Data source: An analysis of data from 27,994 patients who had positive fecal occult blood tests with diagnostic colonoscopies scheduled at 69 VA facilities between 2009 and 2011.
Disclosures: The study was funded by the Department of Veterans Affairs Clinical Science Service and Health Services Research and Development Service. The investigators had no disclosures.
Nonalcoholic fatty liver disease will keep rising ‘in near term’
Nonalcoholic fatty liver disease (NAFLD) almost tripled among United States veterans in a recent 9-year period, investigators reported in the February issue of Clinical Gastroenterology and Hepatology.
The trend “was evident in all racial groups, across all age groups, and in both genders,” said Dr. Fasiha Kanwal of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, both in Houston, and her associates. The increasing prevalence of NAFLD “is likely generalizable to nonveterans,” and will probably persist because of a “fairly steady” 2%-3% overall annual incidence and a steeper rise among younger individuals, they added. “Nonalcoholic fatty liver disease will continue to remain a major public health problem in the United States, at least in the near and intermediate future.”
Although NAFLD is the leading cause of chronic liver failure in the United States, few studies have examined its incidence or prevalence over time, which are key to predicting future disease burden. Therefore, the investigators analyzed data for more than 9.78 million patients who visited the VA at least once between 2003 and 2011. They defined NAFLD as at least two elevated alanine aminotransferase (ALT) values (greater than 40 IU/mL) separated by at least 6 months, with no history of positive serology for hepatitis B surface antigen or hepatitis C virus RNA, and no alcohol-related ICD-9 codes or positive AUDIT-C scores within a year of elevated ALT levels (Clin Gastroenterol Hepatol. 2015 Aug 7. doi: 10.1016/j.cgh.2015.08.010).
During the study period, more than 1.3 million patients, or 13.6%, met the definition of NAFLD, said the researchers. Age-adjusted incidence rates dropped slightly from 3.16% in 2003 to 2.5% in 2011, ranging between 2.3% and 2.7% in most years. Prevalence, however, rose from 6.3% in 2003 (95% confidence interval, 6.26%-6.3%) to 17.6% in 2011 (95% CI, 17.58%-17.65%), a 2.8-fold increase. Moreover, about one in five patients with NAFLD who visited the VA in 2011 was at risk for advanced fibrosis.
Among individuals who were younger than 45 years, the incidence of NAFLD rose from 2.3 to 4.3 cases per 100 persons (annual percentage change, 7.4%; 95% CI, 5.7% to 9.2%), the researchers also found. “Although recent studies show that the rate of increase in both obesity and diabetes, which are both major risk factors for NAFLD, may be slowing down in the U.S., this may not be the case in the VA, where the prevalence of obesity and diabetes is in fact higher than in the U.S. population,” they said.
In general, the findings mirror a recent analysis of the National Health and Nutrition Examination Survey (Aliment Pharmacol Ther. 2015 Jan;41[1]:65-76), according to the investigators. “The VA is the largest integrated health care system in the United States,” they added. “We believe that the sheer size of the veteran cohort, combined with a complete dearth of information regarding the burden of NAFLD in the VA, renders our findings highly significant. Furthermore, the VA is in a unique position to test and implement systemic changes in medical care delivery to improve the health care of NAFLD patients.”
The study was partially supported by the Michael E. DeBakey Veterans Affairs Medical Center. The researchers had no disclosures.
Kanwal and colleagues present an interesting study assessing the trends in the incidence and prevalence of NAFLD in the United States. Findings suggest that the annual incidence of NAFLD has generally been stable (2.2%-3.2%), while the prevalence of NAFLD has increased by 2.8-fold (6.3%-17.6%). These findings are consistent with the literature and provide additional evidence supporting the increasing burden of NAFLD. Although an important study, there are some limitations to the study design. First, the diagnosis of NAFLD was solely based on elevated liver enzymes, which can underestimate the true incidence and prevalence of NAFLD. In fact, in a recent meta-analysis, NAFLD prevalence based on liver enzymes was 13%, while NAFLD prevalence based on radiologic diagnosis was 25% (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Second, the study subjects came from the VA system, which may not be representative of the U.S. population (Patrick AFB, FL: Defense Equal Opportunity Management Institute, 2010). This is important because sex-specific differences in the prevalence of NAFLD have been reported (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Nevertheless, these limitations do not minimize the important contribution of this study. There appears to be an alarming increase in the burden of NAFLD within all the racial and age groups in the U.S. Further, this increase in the incidence and prevalence of NAFLD is especially significant among the younger age groups (less than 45 years). This finding is in contrast to others who have reported a higher prevalence in older subjects (Presented at AASLD 2015. San Francisco. Abstract #534). If confirmed, this younger cohort of patients with NAFLD can fuel the future burden of liver disease for the next few decades (JAMA. 2012;307:491-7). Given the current lack of an effective treatment for NAFLD, a national strategy to deal with this important and rising cause of chronic liver disease is urgently needed.
Dr. Zobair M. Younossi, MPH, FACG, AGAF, FAASLD, is chairman, department of medicine, Inova Fairfax Hospital; vice president for research, Inova Health System; professor of medicine, VCU-Inova Campus and Beatty Center for Integrated Research, Falls Church, Va. He has consulted for Gilead, AbbVie, Intercept, BMS, and GSK.
Kanwal and colleagues present an interesting study assessing the trends in the incidence and prevalence of NAFLD in the United States. Findings suggest that the annual incidence of NAFLD has generally been stable (2.2%-3.2%), while the prevalence of NAFLD has increased by 2.8-fold (6.3%-17.6%). These findings are consistent with the literature and provide additional evidence supporting the increasing burden of NAFLD. Although an important study, there are some limitations to the study design. First, the diagnosis of NAFLD was solely based on elevated liver enzymes, which can underestimate the true incidence and prevalence of NAFLD. In fact, in a recent meta-analysis, NAFLD prevalence based on liver enzymes was 13%, while NAFLD prevalence based on radiologic diagnosis was 25% (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Second, the study subjects came from the VA system, which may not be representative of the U.S. population (Patrick AFB, FL: Defense Equal Opportunity Management Institute, 2010). This is important because sex-specific differences in the prevalence of NAFLD have been reported (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Nevertheless, these limitations do not minimize the important contribution of this study. There appears to be an alarming increase in the burden of NAFLD within all the racial and age groups in the U.S. Further, this increase in the incidence and prevalence of NAFLD is especially significant among the younger age groups (less than 45 years). This finding is in contrast to others who have reported a higher prevalence in older subjects (Presented at AASLD 2015. San Francisco. Abstract #534). If confirmed, this younger cohort of patients with NAFLD can fuel the future burden of liver disease for the next few decades (JAMA. 2012;307:491-7). Given the current lack of an effective treatment for NAFLD, a national strategy to deal with this important and rising cause of chronic liver disease is urgently needed.
Dr. Zobair M. Younossi, MPH, FACG, AGAF, FAASLD, is chairman, department of medicine, Inova Fairfax Hospital; vice president for research, Inova Health System; professor of medicine, VCU-Inova Campus and Beatty Center for Integrated Research, Falls Church, Va. He has consulted for Gilead, AbbVie, Intercept, BMS, and GSK.
Kanwal and colleagues present an interesting study assessing the trends in the incidence and prevalence of NAFLD in the United States. Findings suggest that the annual incidence of NAFLD has generally been stable (2.2%-3.2%), while the prevalence of NAFLD has increased by 2.8-fold (6.3%-17.6%). These findings are consistent with the literature and provide additional evidence supporting the increasing burden of NAFLD. Although an important study, there are some limitations to the study design. First, the diagnosis of NAFLD was solely based on elevated liver enzymes, which can underestimate the true incidence and prevalence of NAFLD. In fact, in a recent meta-analysis, NAFLD prevalence based on liver enzymes was 13%, while NAFLD prevalence based on radiologic diagnosis was 25% (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Second, the study subjects came from the VA system, which may not be representative of the U.S. population (Patrick AFB, FL: Defense Equal Opportunity Management Institute, 2010). This is important because sex-specific differences in the prevalence of NAFLD have been reported (Hepatology. 2015 Dec 28. doi: 10.1002/hep.28431. [Epub ahead of print]). Nevertheless, these limitations do not minimize the important contribution of this study. There appears to be an alarming increase in the burden of NAFLD within all the racial and age groups in the U.S. Further, this increase in the incidence and prevalence of NAFLD is especially significant among the younger age groups (less than 45 years). This finding is in contrast to others who have reported a higher prevalence in older subjects (Presented at AASLD 2015. San Francisco. Abstract #534). If confirmed, this younger cohort of patients with NAFLD can fuel the future burden of liver disease for the next few decades (JAMA. 2012;307:491-7). Given the current lack of an effective treatment for NAFLD, a national strategy to deal with this important and rising cause of chronic liver disease is urgently needed.
Dr. Zobair M. Younossi, MPH, FACG, AGAF, FAASLD, is chairman, department of medicine, Inova Fairfax Hospital; vice president for research, Inova Health System; professor of medicine, VCU-Inova Campus and Beatty Center for Integrated Research, Falls Church, Va. He has consulted for Gilead, AbbVie, Intercept, BMS, and GSK.
Nonalcoholic fatty liver disease (NAFLD) almost tripled among United States veterans in a recent 9-year period, investigators reported in the February issue of Clinical Gastroenterology and Hepatology.
The trend “was evident in all racial groups, across all age groups, and in both genders,” said Dr. Fasiha Kanwal of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, both in Houston, and her associates. The increasing prevalence of NAFLD “is likely generalizable to nonveterans,” and will probably persist because of a “fairly steady” 2%-3% overall annual incidence and a steeper rise among younger individuals, they added. “Nonalcoholic fatty liver disease will continue to remain a major public health problem in the United States, at least in the near and intermediate future.”
Although NAFLD is the leading cause of chronic liver failure in the United States, few studies have examined its incidence or prevalence over time, which are key to predicting future disease burden. Therefore, the investigators analyzed data for more than 9.78 million patients who visited the VA at least once between 2003 and 2011. They defined NAFLD as at least two elevated alanine aminotransferase (ALT) values (greater than 40 IU/mL) separated by at least 6 months, with no history of positive serology for hepatitis B surface antigen or hepatitis C virus RNA, and no alcohol-related ICD-9 codes or positive AUDIT-C scores within a year of elevated ALT levels (Clin Gastroenterol Hepatol. 2015 Aug 7. doi: 10.1016/j.cgh.2015.08.010).
During the study period, more than 1.3 million patients, or 13.6%, met the definition of NAFLD, said the researchers. Age-adjusted incidence rates dropped slightly from 3.16% in 2003 to 2.5% in 2011, ranging between 2.3% and 2.7% in most years. Prevalence, however, rose from 6.3% in 2003 (95% confidence interval, 6.26%-6.3%) to 17.6% in 2011 (95% CI, 17.58%-17.65%), a 2.8-fold increase. Moreover, about one in five patients with NAFLD who visited the VA in 2011 was at risk for advanced fibrosis.
Among individuals who were younger than 45 years, the incidence of NAFLD rose from 2.3 to 4.3 cases per 100 persons (annual percentage change, 7.4%; 95% CI, 5.7% to 9.2%), the researchers also found. “Although recent studies show that the rate of increase in both obesity and diabetes, which are both major risk factors for NAFLD, may be slowing down in the U.S., this may not be the case in the VA, where the prevalence of obesity and diabetes is in fact higher than in the U.S. population,” they said.
In general, the findings mirror a recent analysis of the National Health and Nutrition Examination Survey (Aliment Pharmacol Ther. 2015 Jan;41[1]:65-76), according to the investigators. “The VA is the largest integrated health care system in the United States,” they added. “We believe that the sheer size of the veteran cohort, combined with a complete dearth of information regarding the burden of NAFLD in the VA, renders our findings highly significant. Furthermore, the VA is in a unique position to test and implement systemic changes in medical care delivery to improve the health care of NAFLD patients.”
The study was partially supported by the Michael E. DeBakey Veterans Affairs Medical Center. The researchers had no disclosures.
Nonalcoholic fatty liver disease (NAFLD) almost tripled among United States veterans in a recent 9-year period, investigators reported in the February issue of Clinical Gastroenterology and Hepatology.
The trend “was evident in all racial groups, across all age groups, and in both genders,” said Dr. Fasiha Kanwal of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, both in Houston, and her associates. The increasing prevalence of NAFLD “is likely generalizable to nonveterans,” and will probably persist because of a “fairly steady” 2%-3% overall annual incidence and a steeper rise among younger individuals, they added. “Nonalcoholic fatty liver disease will continue to remain a major public health problem in the United States, at least in the near and intermediate future.”
Although NAFLD is the leading cause of chronic liver failure in the United States, few studies have examined its incidence or prevalence over time, which are key to predicting future disease burden. Therefore, the investigators analyzed data for more than 9.78 million patients who visited the VA at least once between 2003 and 2011. They defined NAFLD as at least two elevated alanine aminotransferase (ALT) values (greater than 40 IU/mL) separated by at least 6 months, with no history of positive serology for hepatitis B surface antigen or hepatitis C virus RNA, and no alcohol-related ICD-9 codes or positive AUDIT-C scores within a year of elevated ALT levels (Clin Gastroenterol Hepatol. 2015 Aug 7. doi: 10.1016/j.cgh.2015.08.010).
During the study period, more than 1.3 million patients, or 13.6%, met the definition of NAFLD, said the researchers. Age-adjusted incidence rates dropped slightly from 3.16% in 2003 to 2.5% in 2011, ranging between 2.3% and 2.7% in most years. Prevalence, however, rose from 6.3% in 2003 (95% confidence interval, 6.26%-6.3%) to 17.6% in 2011 (95% CI, 17.58%-17.65%), a 2.8-fold increase. Moreover, about one in five patients with NAFLD who visited the VA in 2011 was at risk for advanced fibrosis.
Among individuals who were younger than 45 years, the incidence of NAFLD rose from 2.3 to 4.3 cases per 100 persons (annual percentage change, 7.4%; 95% CI, 5.7% to 9.2%), the researchers also found. “Although recent studies show that the rate of increase in both obesity and diabetes, which are both major risk factors for NAFLD, may be slowing down in the U.S., this may not be the case in the VA, where the prevalence of obesity and diabetes is in fact higher than in the U.S. population,” they said.
In general, the findings mirror a recent analysis of the National Health and Nutrition Examination Survey (Aliment Pharmacol Ther. 2015 Jan;41[1]:65-76), according to the investigators. “The VA is the largest integrated health care system in the United States,” they added. “We believe that the sheer size of the veteran cohort, combined with a complete dearth of information regarding the burden of NAFLD in the VA, renders our findings highly significant. Furthermore, the VA is in a unique position to test and implement systemic changes in medical care delivery to improve the health care of NAFLD patients.”
The study was partially supported by the Michael E. DeBakey Veterans Affairs Medical Center. The researchers had no disclosures.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: The prevalence of nonalcoholic fatty liver disease has risen substantially since 2003, and will probably keep increasing in the near term.
Major finding: Prevalence among veterans rose about 2.8 times between 2003 and 2011, mirroring trends reported in the general population.
Data source: An analysis of data from 9.78 million Veterans Affairs patients.
Disclosures: The study was partially supported by the Michael E. DeBakey Veterans Affairs Medical Center. The researchers had no disclosures.
Hepatitis C virus infection linked to cardiovascular death, disease, and stroke
Patients with hepatitis C virus (HCV) infection face a significantly increased risk of cardiovascular death, subclinical carotid thickening and atherosclerosis, and cerebrocardiovascular events, especially when they also have diabetes and hypertension, according to a systematic review and meta-analysis of 22 studies published in the January issue of Gastroenterology.
“To our knowledge, our meta-analysis clearly highlights, for the first time, that HCV infection increases the risk of cardiovascular disease-related mortality,” wrote Dr. Salvatore Petta and his associates at the University of Palermo, Italy. “We [also] found a twofold higher risk of subclinical carotid plaques among HCV-infected individuals compared to uninfected controls, without significant heterogeneity among studies, as well as an increased risk of carotid thickening. We observed a slightly significant increase in cerebrocardiovascular events among HCV-infected patients, despite the high heterogeneity among studies that was mostly related to the prevalence of diabetes mellitus and hypertension.”
A number of observational studies have reported cardiovascular outcomes in HCV-infected patients, but results have been “ambiguous,” Dr. Petta and his colleagues said. For their meta-analysis, they searched PubMed, Medline, EMBASE, the Cochrane Library, and reference lists of articles to identify studies published through July 2015 that either compared cardiovascular disease between HCV-infected and uninfected patients, or evaluated the prevalence of HCV infection among patients with cardiovascular disease. This literature search identified 12 case-control studies and 10 cohort studies. Outcome measures included carotid atherosclerosis (nine studies), intima media thickness (eight studies), coronary artery disease (seven studies), stroke (six studies), and cardiovascular mortality (three studies) (Gastroenterology. 2015 Sep 18. doi: 10.1053/j.gastro.2015.09.00).In the pooled analysis, the odds of cardiovascular death were 65% higher in HCV-infected patients, compared with uninfected individuals (95% confidence interval for this increase, 1.07%-2.56%). Compared with controls, HCV-infected patients also were at higher risk of carotid plaques (odds ratio, 2.27; 95% CI, 1.76-2.94), especially when they were smokers (P = .02). HCV infection also significantly increased the odds of carotid artery intima-media thickening (OR, 1.20; 95% CI, 1.03-1.40), and cerebrocardiovascular events (OR, 1.30; 95% CI, 1.10-1.55). However, subgroup analyses showed that HCV infection only increased the likelihood of cerebrocardiovascular events in populations with a more than 10% prevalence of diabetes or a more than 20% prevalence of hypertension (OR, 1.71; P less than .001 for both subgroup analyses).
Because the studies of cerebrocardiovascular events were heterogeneous, the researchers also stratified them by study design and by the average age of patients. Pooled odds ratios for the link between HCV infection and cerebrocardiovascular events remained significant at 1.21 for the cohort studies, 2.01 for the case-control studies, 2.46 among patients who averaged more than 50 years of age, and 1.35 among younger patients.
The Egger test for publication bias showed that the literature search was unlikely to have overlooked studies in terms of any of the outcome measures, the investigators noted. “From a clinical standpoint, the results of our meta-analysis suggest that HCV infection increases cardiovascular risk, particularly for individuals who already have cardiovascular risk factors, such as diabetes and hypertension,” they concluded. “Although effective and safe oral antiviral regimens are available, more information is needed to confirm whether anti-HCV medications will decrease cardiovascular risk, as suggested in some studies.”
The researchers reported having no funding sources or conflicts of interest.
Source: American Gastroenterological Association
Patients with hepatitis C virus (HCV) infection face a significantly increased risk of cardiovascular death, subclinical carotid thickening and atherosclerosis, and cerebrocardiovascular events, especially when they also have diabetes and hypertension, according to a systematic review and meta-analysis of 22 studies published in the January issue of Gastroenterology.
“To our knowledge, our meta-analysis clearly highlights, for the first time, that HCV infection increases the risk of cardiovascular disease-related mortality,” wrote Dr. Salvatore Petta and his associates at the University of Palermo, Italy. “We [also] found a twofold higher risk of subclinical carotid plaques among HCV-infected individuals compared to uninfected controls, without significant heterogeneity among studies, as well as an increased risk of carotid thickening. We observed a slightly significant increase in cerebrocardiovascular events among HCV-infected patients, despite the high heterogeneity among studies that was mostly related to the prevalence of diabetes mellitus and hypertension.”
A number of observational studies have reported cardiovascular outcomes in HCV-infected patients, but results have been “ambiguous,” Dr. Petta and his colleagues said. For their meta-analysis, they searched PubMed, Medline, EMBASE, the Cochrane Library, and reference lists of articles to identify studies published through July 2015 that either compared cardiovascular disease between HCV-infected and uninfected patients, or evaluated the prevalence of HCV infection among patients with cardiovascular disease. This literature search identified 12 case-control studies and 10 cohort studies. Outcome measures included carotid atherosclerosis (nine studies), intima media thickness (eight studies), coronary artery disease (seven studies), stroke (six studies), and cardiovascular mortality (three studies) (Gastroenterology. 2015 Sep 18. doi: 10.1053/j.gastro.2015.09.00).In the pooled analysis, the odds of cardiovascular death were 65% higher in HCV-infected patients, compared with uninfected individuals (95% confidence interval for this increase, 1.07%-2.56%). Compared with controls, HCV-infected patients also were at higher risk of carotid plaques (odds ratio, 2.27; 95% CI, 1.76-2.94), especially when they were smokers (P = .02). HCV infection also significantly increased the odds of carotid artery intima-media thickening (OR, 1.20; 95% CI, 1.03-1.40), and cerebrocardiovascular events (OR, 1.30; 95% CI, 1.10-1.55). However, subgroup analyses showed that HCV infection only increased the likelihood of cerebrocardiovascular events in populations with a more than 10% prevalence of diabetes or a more than 20% prevalence of hypertension (OR, 1.71; P less than .001 for both subgroup analyses).
Because the studies of cerebrocardiovascular events were heterogeneous, the researchers also stratified them by study design and by the average age of patients. Pooled odds ratios for the link between HCV infection and cerebrocardiovascular events remained significant at 1.21 for the cohort studies, 2.01 for the case-control studies, 2.46 among patients who averaged more than 50 years of age, and 1.35 among younger patients.
The Egger test for publication bias showed that the literature search was unlikely to have overlooked studies in terms of any of the outcome measures, the investigators noted. “From a clinical standpoint, the results of our meta-analysis suggest that HCV infection increases cardiovascular risk, particularly for individuals who already have cardiovascular risk factors, such as diabetes and hypertension,” they concluded. “Although effective and safe oral antiviral regimens are available, more information is needed to confirm whether anti-HCV medications will decrease cardiovascular risk, as suggested in some studies.”
The researchers reported having no funding sources or conflicts of interest.
Source: American Gastroenterological Association
Patients with hepatitis C virus (HCV) infection face a significantly increased risk of cardiovascular death, subclinical carotid thickening and atherosclerosis, and cerebrocardiovascular events, especially when they also have diabetes and hypertension, according to a systematic review and meta-analysis of 22 studies published in the January issue of Gastroenterology.
“To our knowledge, our meta-analysis clearly highlights, for the first time, that HCV infection increases the risk of cardiovascular disease-related mortality,” wrote Dr. Salvatore Petta and his associates at the University of Palermo, Italy. “We [also] found a twofold higher risk of subclinical carotid plaques among HCV-infected individuals compared to uninfected controls, without significant heterogeneity among studies, as well as an increased risk of carotid thickening. We observed a slightly significant increase in cerebrocardiovascular events among HCV-infected patients, despite the high heterogeneity among studies that was mostly related to the prevalence of diabetes mellitus and hypertension.”
A number of observational studies have reported cardiovascular outcomes in HCV-infected patients, but results have been “ambiguous,” Dr. Petta and his colleagues said. For their meta-analysis, they searched PubMed, Medline, EMBASE, the Cochrane Library, and reference lists of articles to identify studies published through July 2015 that either compared cardiovascular disease between HCV-infected and uninfected patients, or evaluated the prevalence of HCV infection among patients with cardiovascular disease. This literature search identified 12 case-control studies and 10 cohort studies. Outcome measures included carotid atherosclerosis (nine studies), intima media thickness (eight studies), coronary artery disease (seven studies), stroke (six studies), and cardiovascular mortality (three studies) (Gastroenterology. 2015 Sep 18. doi: 10.1053/j.gastro.2015.09.00).In the pooled analysis, the odds of cardiovascular death were 65% higher in HCV-infected patients, compared with uninfected individuals (95% confidence interval for this increase, 1.07%-2.56%). Compared with controls, HCV-infected patients also were at higher risk of carotid plaques (odds ratio, 2.27; 95% CI, 1.76-2.94), especially when they were smokers (P = .02). HCV infection also significantly increased the odds of carotid artery intima-media thickening (OR, 1.20; 95% CI, 1.03-1.40), and cerebrocardiovascular events (OR, 1.30; 95% CI, 1.10-1.55). However, subgroup analyses showed that HCV infection only increased the likelihood of cerebrocardiovascular events in populations with a more than 10% prevalence of diabetes or a more than 20% prevalence of hypertension (OR, 1.71; P less than .001 for both subgroup analyses).
Because the studies of cerebrocardiovascular events were heterogeneous, the researchers also stratified them by study design and by the average age of patients. Pooled odds ratios for the link between HCV infection and cerebrocardiovascular events remained significant at 1.21 for the cohort studies, 2.01 for the case-control studies, 2.46 among patients who averaged more than 50 years of age, and 1.35 among younger patients.
The Egger test for publication bias showed that the literature search was unlikely to have overlooked studies in terms of any of the outcome measures, the investigators noted. “From a clinical standpoint, the results of our meta-analysis suggest that HCV infection increases cardiovascular risk, particularly for individuals who already have cardiovascular risk factors, such as diabetes and hypertension,” they concluded. “Although effective and safe oral antiviral regimens are available, more information is needed to confirm whether anti-HCV medications will decrease cardiovascular risk, as suggested in some studies.”
The researchers reported having no funding sources or conflicts of interest.
Source: American Gastroenterological Association
FROM GASTROENTEROLOGY
Key clinical point: Patients with HCV infection are at increased risk of cardiovascular death, stroke, and subclinical carotid atherosclerosis and thickening.
Major finding: The pooled odds of cardiovascular death were 65% higher among infected, compared with uninfected individuals.
Data source: A systematic review and meta-analysis of 22 observational studies.
Disclosures: The researchers reported having no funding sources or conflicts of interest.