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Black patients present as sicker, more likely to receive liver transplant
PHILADELPHIA – Black patients are more likely to be put on a transplant list because of acute liver failure, be listed as status 1, and receive a liver transplant, compared with white patients, according to a recent presentation at the annual meeting of the American College of Gastroenterology.
Lauren D. Nephew, MD, MSCE, of Indiana University in Indianapolis, and her colleagues performed a retrospective cohort study of black and white patients with a minimum age of 18 years in the United Network of Organ Sharing database who were wait-listed for a liver transplantation during 2002-2016. They examined patient clinical characteristics, acute liver failure (ALF) etiologies, wait-list status, and posttransplant survival outcomes through Kaplan Meier analysis.
“We really wanted to explore this topic in patients with acute liver failure, some of the sickest patients that we see,” Dr. Nephew said in her presentation. “We wanted to really determine whether or not there were differences in clinical characteristics and etiologies of acute liver failure in patients by race who are listed for liver transplantation.”
“Then, we wanted to compare wait-list outcomes,” she added, such as “differences by race in liver transplantation or wait-list removal because of death or becoming too sick for transplant.”
There were 11,289 patients in the white ALF group and 2,112 patients in the black ALF group; 2,876 (25.5%) of patients in the white ALF and 790 (37.4%) in the black ALF group were listed as status 1, which indicated an expected survival of 7 days or less. There were similar clinical characteristics for the white and black ALF status 1 patients regarding age (34.2 years vs. 36.3 years), Model for End-Stage Liver Disease (MELD) score (34 vs. 36; P less than .001), international normalized ratio (INR) test (mean 4.5 vs. mean 5.0; P = .001), creatinine levels (2.1 mg/dL vs. 1.9 mg/dL; P less than .001), and percentage of patients who were hepatic encephalopathy grade 3 or 4 (60.0% vs. 63.2%; P = .10). However, Dr. Nephew noted significantly higher bilirubin levels in the black ALF status 1 cohort (17.9 mg/dL), compared with the white ALF status 1 cohort (11.3 mg/dL; P less than .001).
The causes for ALF in each group included drug-induced liver failure (white status 1 cohort, 34.1%; black status 1 cohort, 20.6%), autoimmune hepatitis (2.7% vs. 9.4%), Wilson’s disease (0.58% vs. 0.13%), unknown etiology (34.5% vs. 42.5%), and other etiology (22.9% vs. 17%). For patients who underwent liver transplant and wait-list removal, there were no significant differences in wait-list removal “despite black patients being sicker at presentation,” Dr. Nephew said. Black patients were more likely to be listed to status 1 and transplanted at 62% (490 patients), compared with white patients at 53% (1,524 patients). There were 713 white patients (24.8%) removed from the transplant list, compared with 114 (13.8%) of black patients.
“If you are transplanted and you don’t die, then you are likely removed from the list for other reasons, and the most common reason is that you improved and became well, and so white patients were significantly more likely to be removed from the wait-list because of improvement, compared with black patients,” Dr. Nephew said.
In a competing risk analysis, the researchers found the hazard ratio for white patients who were status 1 and removed from the wait-list because of death or becoming too sick was 1.04 (95% confidence interval, 0.89-1.21) and those white patients who were listed as status 1 and then transplanted was 1.2 (95% CI, 1.08-1.30). In a multivariate analysis, the hazard ratio for white patients who were listed as status 1 and transplanted, which contained bilirubin at transplant, was 1.08 (95% CI, 0.98-1.19). Kaplan Meier 1-year survival post-transplant was 82.8% in white patients and 79.6% in black patients (P = .09).
“I think the question that we’ve been asking ourselves is, is this because black patients are presenting later with their acute liver disease and are sicker at presentation, or do they just have worse liver disease inherently on presentation that drove these findings?” Dr. Nephew said.
Dr. Nephew reports no relevant conflicts of interest.
SOURCE: Nephew L et al. ACG 2018, Presentation 59.
PHILADELPHIA – Black patients are more likely to be put on a transplant list because of acute liver failure, be listed as status 1, and receive a liver transplant, compared with white patients, according to a recent presentation at the annual meeting of the American College of Gastroenterology.
Lauren D. Nephew, MD, MSCE, of Indiana University in Indianapolis, and her colleagues performed a retrospective cohort study of black and white patients with a minimum age of 18 years in the United Network of Organ Sharing database who were wait-listed for a liver transplantation during 2002-2016. They examined patient clinical characteristics, acute liver failure (ALF) etiologies, wait-list status, and posttransplant survival outcomes through Kaplan Meier analysis.
“We really wanted to explore this topic in patients with acute liver failure, some of the sickest patients that we see,” Dr. Nephew said in her presentation. “We wanted to really determine whether or not there were differences in clinical characteristics and etiologies of acute liver failure in patients by race who are listed for liver transplantation.”
“Then, we wanted to compare wait-list outcomes,” she added, such as “differences by race in liver transplantation or wait-list removal because of death or becoming too sick for transplant.”
There were 11,289 patients in the white ALF group and 2,112 patients in the black ALF group; 2,876 (25.5%) of patients in the white ALF and 790 (37.4%) in the black ALF group were listed as status 1, which indicated an expected survival of 7 days or less. There were similar clinical characteristics for the white and black ALF status 1 patients regarding age (34.2 years vs. 36.3 years), Model for End-Stage Liver Disease (MELD) score (34 vs. 36; P less than .001), international normalized ratio (INR) test (mean 4.5 vs. mean 5.0; P = .001), creatinine levels (2.1 mg/dL vs. 1.9 mg/dL; P less than .001), and percentage of patients who were hepatic encephalopathy grade 3 or 4 (60.0% vs. 63.2%; P = .10). However, Dr. Nephew noted significantly higher bilirubin levels in the black ALF status 1 cohort (17.9 mg/dL), compared with the white ALF status 1 cohort (11.3 mg/dL; P less than .001).
The causes for ALF in each group included drug-induced liver failure (white status 1 cohort, 34.1%; black status 1 cohort, 20.6%), autoimmune hepatitis (2.7% vs. 9.4%), Wilson’s disease (0.58% vs. 0.13%), unknown etiology (34.5% vs. 42.5%), and other etiology (22.9% vs. 17%). For patients who underwent liver transplant and wait-list removal, there were no significant differences in wait-list removal “despite black patients being sicker at presentation,” Dr. Nephew said. Black patients were more likely to be listed to status 1 and transplanted at 62% (490 patients), compared with white patients at 53% (1,524 patients). There were 713 white patients (24.8%) removed from the transplant list, compared with 114 (13.8%) of black patients.
“If you are transplanted and you don’t die, then you are likely removed from the list for other reasons, and the most common reason is that you improved and became well, and so white patients were significantly more likely to be removed from the wait-list because of improvement, compared with black patients,” Dr. Nephew said.
In a competing risk analysis, the researchers found the hazard ratio for white patients who were status 1 and removed from the wait-list because of death or becoming too sick was 1.04 (95% confidence interval, 0.89-1.21) and those white patients who were listed as status 1 and then transplanted was 1.2 (95% CI, 1.08-1.30). In a multivariate analysis, the hazard ratio for white patients who were listed as status 1 and transplanted, which contained bilirubin at transplant, was 1.08 (95% CI, 0.98-1.19). Kaplan Meier 1-year survival post-transplant was 82.8% in white patients and 79.6% in black patients (P = .09).
“I think the question that we’ve been asking ourselves is, is this because black patients are presenting later with their acute liver disease and are sicker at presentation, or do they just have worse liver disease inherently on presentation that drove these findings?” Dr. Nephew said.
Dr. Nephew reports no relevant conflicts of interest.
SOURCE: Nephew L et al. ACG 2018, Presentation 59.
PHILADELPHIA – Black patients are more likely to be put on a transplant list because of acute liver failure, be listed as status 1, and receive a liver transplant, compared with white patients, according to a recent presentation at the annual meeting of the American College of Gastroenterology.
Lauren D. Nephew, MD, MSCE, of Indiana University in Indianapolis, and her colleagues performed a retrospective cohort study of black and white patients with a minimum age of 18 years in the United Network of Organ Sharing database who were wait-listed for a liver transplantation during 2002-2016. They examined patient clinical characteristics, acute liver failure (ALF) etiologies, wait-list status, and posttransplant survival outcomes through Kaplan Meier analysis.
“We really wanted to explore this topic in patients with acute liver failure, some of the sickest patients that we see,” Dr. Nephew said in her presentation. “We wanted to really determine whether or not there were differences in clinical characteristics and etiologies of acute liver failure in patients by race who are listed for liver transplantation.”
“Then, we wanted to compare wait-list outcomes,” she added, such as “differences by race in liver transplantation or wait-list removal because of death or becoming too sick for transplant.”
There were 11,289 patients in the white ALF group and 2,112 patients in the black ALF group; 2,876 (25.5%) of patients in the white ALF and 790 (37.4%) in the black ALF group were listed as status 1, which indicated an expected survival of 7 days or less. There were similar clinical characteristics for the white and black ALF status 1 patients regarding age (34.2 years vs. 36.3 years), Model for End-Stage Liver Disease (MELD) score (34 vs. 36; P less than .001), international normalized ratio (INR) test (mean 4.5 vs. mean 5.0; P = .001), creatinine levels (2.1 mg/dL vs. 1.9 mg/dL; P less than .001), and percentage of patients who were hepatic encephalopathy grade 3 or 4 (60.0% vs. 63.2%; P = .10). However, Dr. Nephew noted significantly higher bilirubin levels in the black ALF status 1 cohort (17.9 mg/dL), compared with the white ALF status 1 cohort (11.3 mg/dL; P less than .001).
The causes for ALF in each group included drug-induced liver failure (white status 1 cohort, 34.1%; black status 1 cohort, 20.6%), autoimmune hepatitis (2.7% vs. 9.4%), Wilson’s disease (0.58% vs. 0.13%), unknown etiology (34.5% vs. 42.5%), and other etiology (22.9% vs. 17%). For patients who underwent liver transplant and wait-list removal, there were no significant differences in wait-list removal “despite black patients being sicker at presentation,” Dr. Nephew said. Black patients were more likely to be listed to status 1 and transplanted at 62% (490 patients), compared with white patients at 53% (1,524 patients). There were 713 white patients (24.8%) removed from the transplant list, compared with 114 (13.8%) of black patients.
“If you are transplanted and you don’t die, then you are likely removed from the list for other reasons, and the most common reason is that you improved and became well, and so white patients were significantly more likely to be removed from the wait-list because of improvement, compared with black patients,” Dr. Nephew said.
In a competing risk analysis, the researchers found the hazard ratio for white patients who were status 1 and removed from the wait-list because of death or becoming too sick was 1.04 (95% confidence interval, 0.89-1.21) and those white patients who were listed as status 1 and then transplanted was 1.2 (95% CI, 1.08-1.30). In a multivariate analysis, the hazard ratio for white patients who were listed as status 1 and transplanted, which contained bilirubin at transplant, was 1.08 (95% CI, 0.98-1.19). Kaplan Meier 1-year survival post-transplant was 82.8% in white patients and 79.6% in black patients (P = .09).
“I think the question that we’ve been asking ourselves is, is this because black patients are presenting later with their acute liver disease and are sicker at presentation, or do they just have worse liver disease inherently on presentation that drove these findings?” Dr. Nephew said.
Dr. Nephew reports no relevant conflicts of interest.
SOURCE: Nephew L et al. ACG 2018, Presentation 59.
REPORTING FROM ACG 2018
Key clinical point: Black patients are sicker than white patients when they present with acute liver failure and are awaiting liver transplantation.
Major finding: Black patients with acute liver failure were more likely to be wait-listed, listed as status 1, and have higher Model for End-Stage Liver Disease (MELD) scores, creatinine levels, and INR tests, compared with white patients.
Study details: A retrospective cohort analysis of patients with acute liver failure awaiting a liver transplant in the United Network of Organ Sharing database.
Disclosures: Dr. Nephew reports no relevant conflicts of interest.
Source: Nephew L et al. ACG 2018, Presentation 59.
Increased incidence of GI, colorectal cancers seen in young, obese patients
PHILADELPHIA – Researchers have identified a link between obesity and an increased incidence rate of gastrointestinal (GI) cancers in younger patients as well as an increased rate of colorectal, esophageal, and pancreatic cancer resections in obese patients of various ages, according to an award-winning presentation at the annual meeting of the American College of Gastroenterology.
“These findings strengthen a contributing role of obesity in etiology as well as increasing incidence of these cancers, and call for more efforts targeting obesity,” Hisham Hussan, MD, assistant professor at The Ohio State University Wexner Medical Center in Columbus, stated in his presentation.
The abstract, presented by Dr. Hussan, received an American College of Gastroenterology Category Award in the subject of obesity. He noted in his presentation that the obesity rate in U.S. adults exceeded 37% in 2014. In addition, the temporal changes of obesity-related GI cancers with regard to age-specific groups are not known, he said.
“There’s sufficient evidence linking obesity to certain [GI cancers], such as esophagus, colon, pancreas, and gastric,” Dr. Hussan said. “However, the impact of rising obesity prevalence on the incidence of these obesity-related GI cancers is unknown.”
Dr. Hussan and his colleagues sought to investigate the incidence of obesity-related GI cancers by age group as well as whether there was an association between obesity-related GI cancers in both obese and nonobese patients.
“Our hypothesis is that the incidence of some obesity-related GI cancers is rising in some age groups, and we suspect that this corresponds with increasing rates of obese patients undergoing these cancerous resections,” he said in his presentation.
The researchers evaluated cancer incidence trends in the Surveillance, Epidemiology and End Results (SEER) database between 2002 and 2013 as well as obesity trends from 91,116 obese patients (7.16%) and 1,181,127 nonobese patients (92.84%) in the National Inpatient Sample (NIS) database who underwent cancer resection surgeries. Of these, 93.1% of patients underwent colorectal and 4.4% of patients underwent gastric cancer resections. Patients were considered obese if they had a body mass index of at least 30 kg/m2. The researchers examined annual trends for incidence rates of obesity-related GI cancers by age group and obesity-related GI cancer resection by age and obesity, using a joinpoint regression analysis to determine the percentage change per year.
In patients aged between 20 and 49 years, the incidence of colorectal cancer increased by 1.5% compared with a decrease of 1.5% in patients aged between 50 and 64 years old, a 3.8% decrease in patients aged 65-74 years, and a 3.9% decrease in patients who were a minimum of 75 years old. Gastric cancer incidence also increased by 0.7% in patients aged between 20 and 49 years compared with a 0.5%, 1.1%, and 1.8% decrease among patients who were aged 50-64 years, 65-74 years, and at least 75 years, respectively. There was an increased cancer incidence among patients in the 20- to 49-year-old age group (0.8%), 50- to 64-year-old age group (1.0%), 65- to 74-year-old age group (0.7%), and the 75-and-older group (1.0%). Esophageal cancer was associated with a decreased incidence in the 20- to 49-year-old group (1.8%), 50- to 64-year-old group (1.1%), 65- to 74-year-old age group (1.2%), and the 75-and-older group (0.7%)
For obese patients who underwent colorectal cancer resection, there was a 13.1% increase in the 18- to 49-year-old group, a 10.3% increase in the 50- to 64-year-old group, an 11.3% increase in the 65- to 74-year-old group, and a 12.8% increase in the 75-year-or-older group, compared with an overall decreased incidence in the nonobese group. There was an increased rate of pancreatic cancer resections for obese patients in the 50-to 64-year-old group (26.9%) and 65- to 74-year-old group (27.6%), compared with nonobese patients. Patients in the 18- to 49-year-old group (11.2%), 50- to 64-year-old group (14.6%), and 65- to 74-year-old group (25.7%) also had a higher incidence of esophageal cancer resections.
The limitations of the study included defining BMI at the time of surgery, which does not account for weight loss due to cachexia, and relying on ICD-9 codes for obesity, which “may not be reliable in some cases.
“However, we [saw] an increase in obese patients who come for resection, so it could have probably been more pronounced if we had accounted for obesity at the earlier age before diagnosis,” he added.
Dr. Hussan reports no relevant conflicts of interest.
SOURCE: Hussan H. ACG 2018, Presentation 34.
PHILADELPHIA – Researchers have identified a link between obesity and an increased incidence rate of gastrointestinal (GI) cancers in younger patients as well as an increased rate of colorectal, esophageal, and pancreatic cancer resections in obese patients of various ages, according to an award-winning presentation at the annual meeting of the American College of Gastroenterology.
“These findings strengthen a contributing role of obesity in etiology as well as increasing incidence of these cancers, and call for more efforts targeting obesity,” Hisham Hussan, MD, assistant professor at The Ohio State University Wexner Medical Center in Columbus, stated in his presentation.
The abstract, presented by Dr. Hussan, received an American College of Gastroenterology Category Award in the subject of obesity. He noted in his presentation that the obesity rate in U.S. adults exceeded 37% in 2014. In addition, the temporal changes of obesity-related GI cancers with regard to age-specific groups are not known, he said.
“There’s sufficient evidence linking obesity to certain [GI cancers], such as esophagus, colon, pancreas, and gastric,” Dr. Hussan said. “However, the impact of rising obesity prevalence on the incidence of these obesity-related GI cancers is unknown.”
Dr. Hussan and his colleagues sought to investigate the incidence of obesity-related GI cancers by age group as well as whether there was an association between obesity-related GI cancers in both obese and nonobese patients.
“Our hypothesis is that the incidence of some obesity-related GI cancers is rising in some age groups, and we suspect that this corresponds with increasing rates of obese patients undergoing these cancerous resections,” he said in his presentation.
The researchers evaluated cancer incidence trends in the Surveillance, Epidemiology and End Results (SEER) database between 2002 and 2013 as well as obesity trends from 91,116 obese patients (7.16%) and 1,181,127 nonobese patients (92.84%) in the National Inpatient Sample (NIS) database who underwent cancer resection surgeries. Of these, 93.1% of patients underwent colorectal and 4.4% of patients underwent gastric cancer resections. Patients were considered obese if they had a body mass index of at least 30 kg/m2. The researchers examined annual trends for incidence rates of obesity-related GI cancers by age group and obesity-related GI cancer resection by age and obesity, using a joinpoint regression analysis to determine the percentage change per year.
In patients aged between 20 and 49 years, the incidence of colorectal cancer increased by 1.5% compared with a decrease of 1.5% in patients aged between 50 and 64 years old, a 3.8% decrease in patients aged 65-74 years, and a 3.9% decrease in patients who were a minimum of 75 years old. Gastric cancer incidence also increased by 0.7% in patients aged between 20 and 49 years compared with a 0.5%, 1.1%, and 1.8% decrease among patients who were aged 50-64 years, 65-74 years, and at least 75 years, respectively. There was an increased cancer incidence among patients in the 20- to 49-year-old age group (0.8%), 50- to 64-year-old age group (1.0%), 65- to 74-year-old age group (0.7%), and the 75-and-older group (1.0%). Esophageal cancer was associated with a decreased incidence in the 20- to 49-year-old group (1.8%), 50- to 64-year-old group (1.1%), 65- to 74-year-old age group (1.2%), and the 75-and-older group (0.7%)
For obese patients who underwent colorectal cancer resection, there was a 13.1% increase in the 18- to 49-year-old group, a 10.3% increase in the 50- to 64-year-old group, an 11.3% increase in the 65- to 74-year-old group, and a 12.8% increase in the 75-year-or-older group, compared with an overall decreased incidence in the nonobese group. There was an increased rate of pancreatic cancer resections for obese patients in the 50-to 64-year-old group (26.9%) and 65- to 74-year-old group (27.6%), compared with nonobese patients. Patients in the 18- to 49-year-old group (11.2%), 50- to 64-year-old group (14.6%), and 65- to 74-year-old group (25.7%) also had a higher incidence of esophageal cancer resections.
The limitations of the study included defining BMI at the time of surgery, which does not account for weight loss due to cachexia, and relying on ICD-9 codes for obesity, which “may not be reliable in some cases.
“However, we [saw] an increase in obese patients who come for resection, so it could have probably been more pronounced if we had accounted for obesity at the earlier age before diagnosis,” he added.
Dr. Hussan reports no relevant conflicts of interest.
SOURCE: Hussan H. ACG 2018, Presentation 34.
PHILADELPHIA – Researchers have identified a link between obesity and an increased incidence rate of gastrointestinal (GI) cancers in younger patients as well as an increased rate of colorectal, esophageal, and pancreatic cancer resections in obese patients of various ages, according to an award-winning presentation at the annual meeting of the American College of Gastroenterology.
“These findings strengthen a contributing role of obesity in etiology as well as increasing incidence of these cancers, and call for more efforts targeting obesity,” Hisham Hussan, MD, assistant professor at The Ohio State University Wexner Medical Center in Columbus, stated in his presentation.
The abstract, presented by Dr. Hussan, received an American College of Gastroenterology Category Award in the subject of obesity. He noted in his presentation that the obesity rate in U.S. adults exceeded 37% in 2014. In addition, the temporal changes of obesity-related GI cancers with regard to age-specific groups are not known, he said.
“There’s sufficient evidence linking obesity to certain [GI cancers], such as esophagus, colon, pancreas, and gastric,” Dr. Hussan said. “However, the impact of rising obesity prevalence on the incidence of these obesity-related GI cancers is unknown.”
Dr. Hussan and his colleagues sought to investigate the incidence of obesity-related GI cancers by age group as well as whether there was an association between obesity-related GI cancers in both obese and nonobese patients.
“Our hypothesis is that the incidence of some obesity-related GI cancers is rising in some age groups, and we suspect that this corresponds with increasing rates of obese patients undergoing these cancerous resections,” he said in his presentation.
The researchers evaluated cancer incidence trends in the Surveillance, Epidemiology and End Results (SEER) database between 2002 and 2013 as well as obesity trends from 91,116 obese patients (7.16%) and 1,181,127 nonobese patients (92.84%) in the National Inpatient Sample (NIS) database who underwent cancer resection surgeries. Of these, 93.1% of patients underwent colorectal and 4.4% of patients underwent gastric cancer resections. Patients were considered obese if they had a body mass index of at least 30 kg/m2. The researchers examined annual trends for incidence rates of obesity-related GI cancers by age group and obesity-related GI cancer resection by age and obesity, using a joinpoint regression analysis to determine the percentage change per year.
In patients aged between 20 and 49 years, the incidence of colorectal cancer increased by 1.5% compared with a decrease of 1.5% in patients aged between 50 and 64 years old, a 3.8% decrease in patients aged 65-74 years, and a 3.9% decrease in patients who were a minimum of 75 years old. Gastric cancer incidence also increased by 0.7% in patients aged between 20 and 49 years compared with a 0.5%, 1.1%, and 1.8% decrease among patients who were aged 50-64 years, 65-74 years, and at least 75 years, respectively. There was an increased cancer incidence among patients in the 20- to 49-year-old age group (0.8%), 50- to 64-year-old age group (1.0%), 65- to 74-year-old age group (0.7%), and the 75-and-older group (1.0%). Esophageal cancer was associated with a decreased incidence in the 20- to 49-year-old group (1.8%), 50- to 64-year-old group (1.1%), 65- to 74-year-old age group (1.2%), and the 75-and-older group (0.7%)
For obese patients who underwent colorectal cancer resection, there was a 13.1% increase in the 18- to 49-year-old group, a 10.3% increase in the 50- to 64-year-old group, an 11.3% increase in the 65- to 74-year-old group, and a 12.8% increase in the 75-year-or-older group, compared with an overall decreased incidence in the nonobese group. There was an increased rate of pancreatic cancer resections for obese patients in the 50-to 64-year-old group (26.9%) and 65- to 74-year-old group (27.6%), compared with nonobese patients. Patients in the 18- to 49-year-old group (11.2%), 50- to 64-year-old group (14.6%), and 65- to 74-year-old group (25.7%) also had a higher incidence of esophageal cancer resections.
The limitations of the study included defining BMI at the time of surgery, which does not account for weight loss due to cachexia, and relying on ICD-9 codes for obesity, which “may not be reliable in some cases.
“However, we [saw] an increase in obese patients who come for resection, so it could have probably been more pronounced if we had accounted for obesity at the earlier age before diagnosis,” he added.
Dr. Hussan reports no relevant conflicts of interest.
SOURCE: Hussan H. ACG 2018, Presentation 34.
REPORTING FROM ACG 2018
Key clinical point: There is a higher incidence of colorectal and gastric cancer among obese patients under 50 years old.
Major finding: Obese patients of all age ranges had a higher rate of colorectal cancer resections, obese patients 75 and younger had a significantly higher incidence of esophageal cancer resections, and obese patients aged between 50 and 74 years had a higher rate of pancreatic resections, compared with nonobese patients.
Study details: A database analysis of cancer incidence trends in the Surveillance, Epidemiology, and End Results database and patient cancer incidence and obesity trends in the National Inpatient Sample database between 2002 and 2013.
Disclosures: Dr. Hussan reports no conflicts of interest.
Source: Hussan H. ACG 2018, Presentation 34.
Low-FODMAP diet improves fecal incontinence in patients with loose stool
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
Use AGA’s patient education materials to help your patients better understand the low-FODMAP diet, which can be found at http://ow.ly/Xfqj30maODu
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
Use AGA’s patient education materials to help your patients better understand the low-FODMAP diet, which can be found at http://ow.ly/Xfqj30maODu
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
Use AGA’s patient education materials to help your patients better understand the low-FODMAP diet, which can be found at http://ow.ly/Xfqj30maODu
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
REPORTING FROM ACG 2018
Key clinical point: Patients who underwent formal dietary teaching for a fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet showed associated improvements in fecal incontinence.
Major finding: Among patients with fecal incontinence, 64.6% experienced improvement; of these, 88.1% of responders had a greater than 50% reduction in fecal incontinence and 35.7% experienced complete resolution of fecal incontinence.
Study details: A retrospective chart review of 65 patients with fecal incontinence who received formal dietary teaching at the Michigan Bowel Control clinic.
Disclosures: Dr. Menees reports being a consultant for Synergy.
Source: Menees SB et al. ACG 2018. Presentation 9.
Low-FODMAP diet improves fecal incontinence in patients with loose stool
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
PHILADELPHIA – A low fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet was associated with improvement in fecal incontinence in 64.6% of patients who received dietary training, according to recent research presented at the American College of Gastroenterology annual meeting.
“In this case series, the low-FODMAP diet improved fecal incontinence in two-thirds of patients with fecal incontinence and loose stools,” Stacy Menees, MD, MS, assistant professor at the University of Michigan in Ann Arbor, said in her presentation.
Dr. Menees and her colleagues performed a retrospective chart review of 65 patients in the Michigan Bowel Control clinic with fecal incontinence (FI) “without alarming features” who were recommended a low FODMAP diet and received formal dietary teaching between August 2012 and December 2017. Patients received the teaching from a Michigan Medicine gastrointestinal dietitian. The dietitians performed a semi-quantitative analysis of patient response, including complete response, Dr. Menees said.
If we are going to help people with fecal incontinence, the key is to concentrate on the area of their stool consistency,” she explained. “We know that foods high in fermentable oligo-, di-, and monosaccharides and polyols, otherwise known as FODMAPS, can cause diarrhea and urgency.”
These FODMAP foods can include fruits with fructose exceeding glucose, fructan-containing vegetables, wheat-based products, sorbitol- and lactose-containing foods, and raffinose-containing foods, Dr. Menees said.
“We know from observations in data and research from the Monash University and our own group that patients with irritable bowel syndrome who are on a [low-]FODMAP diet [get relief from] their symptoms,” she added.
Most of the patients were female, and most were white. The mean age was 61.9 years, and mean body mass index was 26.7 kg/m2. Among the patients, 27.7% had irritable bowel syndrome (IBS), 9.2% had inflammatory bowel disease (IBD), 16.9% had diabetes mellitus, and 20% had a prior cholecystectomy.
With regard to reports of loose stool and FI, 46.1% of patients said they had loose stool daily with a mean of 2.8 loose bowel movements daily. More than half of the patients (60.5%) reported FI daily; 37.8% said they experienced weekly FI, and 4.6% reported monthly FI. The number of patients reporting FI was higher than 100% because some patients reported in the chart that they had FI daily or weekly, Dr. Menees said.
FI improvement was reported by 64.6% of patients, with 88.1% of responders having a greater than 50% reduction in FI and 35.7% of patients experiencing complete resolution of FI. There were no serious adverse events in the study, Dr. Menees noted.
“The three patients with postinfection IBS and fecal incontinence had no response to a low-FODMAP diet,” she said. “Our dietitians noted that onion and garlic were the triggers that were most often identified.”
Limitations include the retrospective chart review design and small number of patients, which may overestimate or underestimate the study results, and the fact that the study was done at a tertiary care center, Dr. Menees said.
“We are nearing the completion of a confirmatory, prospective, pilot randomized clinical trial to confirm the efficacy of a low-FODMAP diet in patients who suffer from fecal incontinence and loose stools,” she concluded.
Dr. Menees reports being a consultant for Synergy.
SOURCE: Menees SB et al. ACG 2018. Presentation 9.
REPORTING FROM ACG 2018
Key clinical point: Patients who underwent formal dietary teaching for a fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet showed associated improvements in fecal incontinence.
Major finding: Among patients with fecal incontinence, 64.6% experienced improvement; of these, 88.1% of responders had a greater than 50% reduction in fecal incontinence and 35.7% experienced complete resolution of fecal incontinence.
Study details: A retrospective chart review of 65 patients with fecal incontinence who received formal dietary teaching at the Michigan Bowel Control clinic.
Disclosures: Dr. Menees reports being a consultant for Synergy.
Source: Menees SB et al. ACG 2018. Presentation 9.
Endocrine Society updates guidelines for congenital adrenal hyperplasia
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Amitriptyline may be an alternative treatment for chronic low back pain
Low-dose amitriptyline improved disability outcomes at 3 months for patients with chronic low back pain but did not improve outcomes in disability, work absences, and pain intensity at 6 months in a randomized trial comparing it against benztropine mesylate; however, researchers say the antidepressant holds promise in being an effective treatment for people with the condition.
While amitriptyline did not meet the primary endpoint of pain reduction at 6 months, the results showed statistically significant disability improvement and a potential therapeutic effect for the treatment of low back pain (LBP), wrote the study’s first author, Donna M. Urquhart, PhD, of the department of epidemiology and preventive medicine at Monash University, Melbourne, and her colleagues.
“This finding is important given that LBP is the leading cause of disability globally, effective treatments for LBP are limited, and there is currently an epidemic of escalated usage of narcotics, with more than 50% of narcotic prescriptions issued to people with LBP,” Dr. Urquhart and her colleagues wrote in their study, published Oct. 1 in JAMA Internal Medicine.
“Although the improvements in pain intensity, general health, and fear of movement/reinjury at 6 months did not reach statistical significance, they suggest that low-dose amitriptyline may have an effect with a larger sample size,” the investigators wrote. “These findings provide support for large-scale clinical trials, with an escalating dose as required, to determine the treatment effectiveness of amitriptyline.”
Dr. Urquhart and her colleagues performed a double-blinded, randomized, controlled trial of 118 patients with chronic LBP who received either low-dose amitriptyline (25 mg per day) or an active comparator (benztropine mesylate, 1 mg per day) for 6 months. Patients were aged 18-75 years, with chronic LBP without a specific cause for a minimum of 3 months. Outcomes for pain intensity, disability, and work absence were measured via the Visual Analog Scale and Descriptor Differential Scale, Roland Morris Disability Questionnaire, and Short Form Health and Labour Questionnaire, respectively.
At 3-month follow-up, patients in the low-dose amitriptyline group reported less disability, compared with the benztropine mesylate group (adjusted difference, –1.62; 95% confidence interval, –2.88 to –0.36). However, there was no significant difference in the reductions in pain at 3 months between the two groups group (adjusted difference, –1.05; 95% CI, –7.87 to 5.78) or in the trial’s primary endpoint of pain at 6 months (adjusted difference, –7.81; 95% CI, –15.7 to 0.10). There was also no significant difference in disability at 6 months (adjusted difference, –0.98; 95% CI, –2.42 to 0.46).
Similarly, there were no significant differences between groups at 3 months regarding work absence (adjusted difference, 0.86; 95% CI, 0.32-2.31) or work hindrance at 3 months (adjusted difference, 0.78; 95% CI, 0.29-2.08), as well as work absence (adjusted difference, 1.51; 95% CI, 0.43-5.38) and hindrance at 6 months (adjusted difference, 0.53; 95% CI, 0.19-1.51). With regard to adverse effects, there were no significant between-group differences at the 3-month or 6-month follow-up visits in the number of patients who had moderate to severe symptoms at baseline (35% assigned to amitriptyline vs. 41% assigned to benztropine mesylate) or at 6 months (26% vs. 32%, respectively), and the percentage of patients who withdrew from the study was 12% in each group.
The National Health and Medical Research Council supported the study. The authors report no relevant conflicts of interest.
SOURCE: Urquhart DM et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4222.
Low-dose amitriptyline improved disability outcomes at 3 months for patients with chronic low back pain but did not improve outcomes in disability, work absences, and pain intensity at 6 months in a randomized trial comparing it against benztropine mesylate; however, researchers say the antidepressant holds promise in being an effective treatment for people with the condition.
While amitriptyline did not meet the primary endpoint of pain reduction at 6 months, the results showed statistically significant disability improvement and a potential therapeutic effect for the treatment of low back pain (LBP), wrote the study’s first author, Donna M. Urquhart, PhD, of the department of epidemiology and preventive medicine at Monash University, Melbourne, and her colleagues.
“This finding is important given that LBP is the leading cause of disability globally, effective treatments for LBP are limited, and there is currently an epidemic of escalated usage of narcotics, with more than 50% of narcotic prescriptions issued to people with LBP,” Dr. Urquhart and her colleagues wrote in their study, published Oct. 1 in JAMA Internal Medicine.
“Although the improvements in pain intensity, general health, and fear of movement/reinjury at 6 months did not reach statistical significance, they suggest that low-dose amitriptyline may have an effect with a larger sample size,” the investigators wrote. “These findings provide support for large-scale clinical trials, with an escalating dose as required, to determine the treatment effectiveness of amitriptyline.”
Dr. Urquhart and her colleagues performed a double-blinded, randomized, controlled trial of 118 patients with chronic LBP who received either low-dose amitriptyline (25 mg per day) or an active comparator (benztropine mesylate, 1 mg per day) for 6 months. Patients were aged 18-75 years, with chronic LBP without a specific cause for a minimum of 3 months. Outcomes for pain intensity, disability, and work absence were measured via the Visual Analog Scale and Descriptor Differential Scale, Roland Morris Disability Questionnaire, and Short Form Health and Labour Questionnaire, respectively.
At 3-month follow-up, patients in the low-dose amitriptyline group reported less disability, compared with the benztropine mesylate group (adjusted difference, –1.62; 95% confidence interval, –2.88 to –0.36). However, there was no significant difference in the reductions in pain at 3 months between the two groups group (adjusted difference, –1.05; 95% CI, –7.87 to 5.78) or in the trial’s primary endpoint of pain at 6 months (adjusted difference, –7.81; 95% CI, –15.7 to 0.10). There was also no significant difference in disability at 6 months (adjusted difference, –0.98; 95% CI, –2.42 to 0.46).
Similarly, there were no significant differences between groups at 3 months regarding work absence (adjusted difference, 0.86; 95% CI, 0.32-2.31) or work hindrance at 3 months (adjusted difference, 0.78; 95% CI, 0.29-2.08), as well as work absence (adjusted difference, 1.51; 95% CI, 0.43-5.38) and hindrance at 6 months (adjusted difference, 0.53; 95% CI, 0.19-1.51). With regard to adverse effects, there were no significant between-group differences at the 3-month or 6-month follow-up visits in the number of patients who had moderate to severe symptoms at baseline (35% assigned to amitriptyline vs. 41% assigned to benztropine mesylate) or at 6 months (26% vs. 32%, respectively), and the percentage of patients who withdrew from the study was 12% in each group.
The National Health and Medical Research Council supported the study. The authors report no relevant conflicts of interest.
SOURCE: Urquhart DM et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4222.
Low-dose amitriptyline improved disability outcomes at 3 months for patients with chronic low back pain but did not improve outcomes in disability, work absences, and pain intensity at 6 months in a randomized trial comparing it against benztropine mesylate; however, researchers say the antidepressant holds promise in being an effective treatment for people with the condition.
While amitriptyline did not meet the primary endpoint of pain reduction at 6 months, the results showed statistically significant disability improvement and a potential therapeutic effect for the treatment of low back pain (LBP), wrote the study’s first author, Donna M. Urquhart, PhD, of the department of epidemiology and preventive medicine at Monash University, Melbourne, and her colleagues.
“This finding is important given that LBP is the leading cause of disability globally, effective treatments for LBP are limited, and there is currently an epidemic of escalated usage of narcotics, with more than 50% of narcotic prescriptions issued to people with LBP,” Dr. Urquhart and her colleagues wrote in their study, published Oct. 1 in JAMA Internal Medicine.
“Although the improvements in pain intensity, general health, and fear of movement/reinjury at 6 months did not reach statistical significance, they suggest that low-dose amitriptyline may have an effect with a larger sample size,” the investigators wrote. “These findings provide support for large-scale clinical trials, with an escalating dose as required, to determine the treatment effectiveness of amitriptyline.”
Dr. Urquhart and her colleagues performed a double-blinded, randomized, controlled trial of 118 patients with chronic LBP who received either low-dose amitriptyline (25 mg per day) or an active comparator (benztropine mesylate, 1 mg per day) for 6 months. Patients were aged 18-75 years, with chronic LBP without a specific cause for a minimum of 3 months. Outcomes for pain intensity, disability, and work absence were measured via the Visual Analog Scale and Descriptor Differential Scale, Roland Morris Disability Questionnaire, and Short Form Health and Labour Questionnaire, respectively.
At 3-month follow-up, patients in the low-dose amitriptyline group reported less disability, compared with the benztropine mesylate group (adjusted difference, –1.62; 95% confidence interval, –2.88 to –0.36). However, there was no significant difference in the reductions in pain at 3 months between the two groups group (adjusted difference, –1.05; 95% CI, –7.87 to 5.78) or in the trial’s primary endpoint of pain at 6 months (adjusted difference, –7.81; 95% CI, –15.7 to 0.10). There was also no significant difference in disability at 6 months (adjusted difference, –0.98; 95% CI, –2.42 to 0.46).
Similarly, there were no significant differences between groups at 3 months regarding work absence (adjusted difference, 0.86; 95% CI, 0.32-2.31) or work hindrance at 3 months (adjusted difference, 0.78; 95% CI, 0.29-2.08), as well as work absence (adjusted difference, 1.51; 95% CI, 0.43-5.38) and hindrance at 6 months (adjusted difference, 0.53; 95% CI, 0.19-1.51). With regard to adverse effects, there were no significant between-group differences at the 3-month or 6-month follow-up visits in the number of patients who had moderate to severe symptoms at baseline (35% assigned to amitriptyline vs. 41% assigned to benztropine mesylate) or at 6 months (26% vs. 32%, respectively), and the percentage of patients who withdrew from the study was 12% in each group.
The National Health and Medical Research Council supported the study. The authors report no relevant conflicts of interest.
SOURCE: Urquhart DM et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4222.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Amitriptyline, an antidepressant, improved disability outcomes at 3 months for patients with chronic low back pain.
Major finding: Low-dose amitriptyline reduced disability at 3 months but did not significantly improve pain intensity, disability, or work absences at 6 months, compared with patients taking benztropine mesylate.
Study details: A 6-month, double-blinded, randomized, controlled trial of low-dose amitriptyline or benztropine mesylate in 118 patients with chronic low back pain.
Disclosures: The National Health and Medical Research Council supported the study. The authors report no relevant conflicts of interest.
Source: Urquhart DM et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4222.
Teens who vape are likely to add cigarette smoking
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
FROM NICOTINE & TOBACCO RESEARCH
Key clinical point: Adolescents who use e-cigarettes are more likely to progress to cigarette use, while continuing to vape.
Major finding: There was a significant bidirectional association between e-cigarette use and cigarette use, and some third factors such as alcohol use, marijuana use, and mental health.
Study details: A longitudinal study of adolescents aged 16-20 years enrolled in a substance use prevention program.
Disclosures: This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
Source: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
Web-based lifestyle program aids in weight loss for NAFLD patients
A web-based intervention for management of nonalcoholic fatty liver disease – which researchers said may help reach busy or remote patients not able to attend in-person sessions – had a similar number of patients reach a target weight-loss goal of at least 10% of body weight, compared with a group-based intervention.
“The use of web education in the management of noncommunicable diseases has long been suggested, considering the huge number of cases at risk and patients’ needs,” wrote Arianna Mazzotti, MD, of the department of medical and surgical sciences, Alma Mater University, Bologna, Italy, and her colleagues. Their report was published in the Journal of Hepatology.
“The majority of cases are in an age range where job constraints make it difficult to implement a systematic face-to-face or group approach, whereas the eHealth procedures may keep the contact between patients and therapists without disrupting normal daily living.”
Dr. Mazzotti and her colleagues studied 716 patients with nonalcoholic fatty liver disease (NAFLD) at the university between January 2010 and December 2015 who attended either a web-based NAFLD intervention (278 patients) or an in-person, group-based lifestyle modification program (438 patients). Patients in the web-based intervention tended to be younger males with a higher education level, similar mean body mass index (33 kg/m2), and significantly lower blood pressure and rates of type 2 diabetes mellitus. The primary outcome included weight loss of at least 10%; secondary outcomes included changes in weight, changes in lifestyle, surrogate markers of steatosis and fibrosis, and alanine aminotransferase (ALT) within normal limits, researchers said.
The group-based program consisted of five 2-hour weekly sessions counseling patients on diet and physical activity, whereas the web-based intervention reproduced these sessions in addition to questionnaires, “highly interactive” slides, examples, and games as well as a mechanism to ask questions. Regardless of intervention, patients attended a 6-month in-person follow-up where they received treatment and reinforcement for comorbidities such as type 2 diabetes mellitus.
In the web-based intervention, 76% of patients attended the 6-month follow-up, 58% attended the 12-month follow-up, and 43% attended the 24-month follow-up, compared with 87%, 80%, and 69% of patients in the group-based intervention, respectively. Patients in the web-based intervention had a significantly decreased intake of calories after 6 months (273 kcal/day vs. 193 kcal/day; P = .006) compared with the group-based intervention. Physical activity significantly increased at 6 months for both groups, but there were no significant differences between groups.
Body weight decreased for the web-based intervention by 3.4% at 6 months, 4.9% at 12 months, and 5.5% at 24 months, compared with 3.1% at 6 months, 4.0% at 12 months, and 4.2% at 24 months in the group-based intervention. There was a nearly two-point reduction in body mass index for both groups, with 20% of web-based intervention patients and 15% of group-based intervention patients achieving the 10% weight-loss target; and, when the researchers performed a logistic regression analysis, the web-based intervention group was not associated with less short- and long-term 10% weight reduction after attrition rates and confounders were adjusted for.
At 24-month follow-up, the researchers found a decrease in ALT levels by an average of 22 ± 32 mU/mL, with the web-based intervention group having normalized ALT levels in 18% of cases at 6 months, 32% at 12 months, and 35% at 24 months, compared with 16% of cases at 6 months, 22% of cases at 12 months, and 29% of cases at 24 months in the group-based intervention. Compared with the group-based intervention, there was a higher reduction in fatty liver index scores at 12-month follow-up (71.3 vs. 78.0; P less than .001) and 24-month follow-up (68.9 vs. 76.3; P = .002) for the web-based intervention group. The researchers noted NAFLD fibrosis score and Fib-4 scores were reduced in both groups.
“The [web-based intervention] program might be extended to other units and/or general practitioners, increasing its impact in the community in prevention and treatment of progressive NAFLD,” Dr. Mazzotti and her colleagues wrote. “It might also be superimposed to drug treatment in the most severe cases, with possible additive effects.”
This study was supported by a grant from the European Community Seventh Framework Program. The authors report no relevant conflicts of interest.
*This story was updated on 10/4/2018.
SOURCE: Mazzotti A et al. J Hepatol. 2018 Oct 2. doi: 10.1016/j.jhep.2018.07.013.
A web-based intervention for management of nonalcoholic fatty liver disease – which researchers said may help reach busy or remote patients not able to attend in-person sessions – had a similar number of patients reach a target weight-loss goal of at least 10% of body weight, compared with a group-based intervention.
“The use of web education in the management of noncommunicable diseases has long been suggested, considering the huge number of cases at risk and patients’ needs,” wrote Arianna Mazzotti, MD, of the department of medical and surgical sciences, Alma Mater University, Bologna, Italy, and her colleagues. Their report was published in the Journal of Hepatology.
“The majority of cases are in an age range where job constraints make it difficult to implement a systematic face-to-face or group approach, whereas the eHealth procedures may keep the contact between patients and therapists without disrupting normal daily living.”
Dr. Mazzotti and her colleagues studied 716 patients with nonalcoholic fatty liver disease (NAFLD) at the university between January 2010 and December 2015 who attended either a web-based NAFLD intervention (278 patients) or an in-person, group-based lifestyle modification program (438 patients). Patients in the web-based intervention tended to be younger males with a higher education level, similar mean body mass index (33 kg/m2), and significantly lower blood pressure and rates of type 2 diabetes mellitus. The primary outcome included weight loss of at least 10%; secondary outcomes included changes in weight, changes in lifestyle, surrogate markers of steatosis and fibrosis, and alanine aminotransferase (ALT) within normal limits, researchers said.
The group-based program consisted of five 2-hour weekly sessions counseling patients on diet and physical activity, whereas the web-based intervention reproduced these sessions in addition to questionnaires, “highly interactive” slides, examples, and games as well as a mechanism to ask questions. Regardless of intervention, patients attended a 6-month in-person follow-up where they received treatment and reinforcement for comorbidities such as type 2 diabetes mellitus.
In the web-based intervention, 76% of patients attended the 6-month follow-up, 58% attended the 12-month follow-up, and 43% attended the 24-month follow-up, compared with 87%, 80%, and 69% of patients in the group-based intervention, respectively. Patients in the web-based intervention had a significantly decreased intake of calories after 6 months (273 kcal/day vs. 193 kcal/day; P = .006) compared with the group-based intervention. Physical activity significantly increased at 6 months for both groups, but there were no significant differences between groups.
Body weight decreased for the web-based intervention by 3.4% at 6 months, 4.9% at 12 months, and 5.5% at 24 months, compared with 3.1% at 6 months, 4.0% at 12 months, and 4.2% at 24 months in the group-based intervention. There was a nearly two-point reduction in body mass index for both groups, with 20% of web-based intervention patients and 15% of group-based intervention patients achieving the 10% weight-loss target; and, when the researchers performed a logistic regression analysis, the web-based intervention group was not associated with less short- and long-term 10% weight reduction after attrition rates and confounders were adjusted for.
At 24-month follow-up, the researchers found a decrease in ALT levels by an average of 22 ± 32 mU/mL, with the web-based intervention group having normalized ALT levels in 18% of cases at 6 months, 32% at 12 months, and 35% at 24 months, compared with 16% of cases at 6 months, 22% of cases at 12 months, and 29% of cases at 24 months in the group-based intervention. Compared with the group-based intervention, there was a higher reduction in fatty liver index scores at 12-month follow-up (71.3 vs. 78.0; P less than .001) and 24-month follow-up (68.9 vs. 76.3; P = .002) for the web-based intervention group. The researchers noted NAFLD fibrosis score and Fib-4 scores were reduced in both groups.
“The [web-based intervention] program might be extended to other units and/or general practitioners, increasing its impact in the community in prevention and treatment of progressive NAFLD,” Dr. Mazzotti and her colleagues wrote. “It might also be superimposed to drug treatment in the most severe cases, with possible additive effects.”
This study was supported by a grant from the European Community Seventh Framework Program. The authors report no relevant conflicts of interest.
*This story was updated on 10/4/2018.
SOURCE: Mazzotti A et al. J Hepatol. 2018 Oct 2. doi: 10.1016/j.jhep.2018.07.013.
A web-based intervention for management of nonalcoholic fatty liver disease – which researchers said may help reach busy or remote patients not able to attend in-person sessions – had a similar number of patients reach a target weight-loss goal of at least 10% of body weight, compared with a group-based intervention.
“The use of web education in the management of noncommunicable diseases has long been suggested, considering the huge number of cases at risk and patients’ needs,” wrote Arianna Mazzotti, MD, of the department of medical and surgical sciences, Alma Mater University, Bologna, Italy, and her colleagues. Their report was published in the Journal of Hepatology.
“The majority of cases are in an age range where job constraints make it difficult to implement a systematic face-to-face or group approach, whereas the eHealth procedures may keep the contact between patients and therapists without disrupting normal daily living.”
Dr. Mazzotti and her colleagues studied 716 patients with nonalcoholic fatty liver disease (NAFLD) at the university between January 2010 and December 2015 who attended either a web-based NAFLD intervention (278 patients) or an in-person, group-based lifestyle modification program (438 patients). Patients in the web-based intervention tended to be younger males with a higher education level, similar mean body mass index (33 kg/m2), and significantly lower blood pressure and rates of type 2 diabetes mellitus. The primary outcome included weight loss of at least 10%; secondary outcomes included changes in weight, changes in lifestyle, surrogate markers of steatosis and fibrosis, and alanine aminotransferase (ALT) within normal limits, researchers said.
The group-based program consisted of five 2-hour weekly sessions counseling patients on diet and physical activity, whereas the web-based intervention reproduced these sessions in addition to questionnaires, “highly interactive” slides, examples, and games as well as a mechanism to ask questions. Regardless of intervention, patients attended a 6-month in-person follow-up where they received treatment and reinforcement for comorbidities such as type 2 diabetes mellitus.
In the web-based intervention, 76% of patients attended the 6-month follow-up, 58% attended the 12-month follow-up, and 43% attended the 24-month follow-up, compared with 87%, 80%, and 69% of patients in the group-based intervention, respectively. Patients in the web-based intervention had a significantly decreased intake of calories after 6 months (273 kcal/day vs. 193 kcal/day; P = .006) compared with the group-based intervention. Physical activity significantly increased at 6 months for both groups, but there were no significant differences between groups.
Body weight decreased for the web-based intervention by 3.4% at 6 months, 4.9% at 12 months, and 5.5% at 24 months, compared with 3.1% at 6 months, 4.0% at 12 months, and 4.2% at 24 months in the group-based intervention. There was a nearly two-point reduction in body mass index for both groups, with 20% of web-based intervention patients and 15% of group-based intervention patients achieving the 10% weight-loss target; and, when the researchers performed a logistic regression analysis, the web-based intervention group was not associated with less short- and long-term 10% weight reduction after attrition rates and confounders were adjusted for.
At 24-month follow-up, the researchers found a decrease in ALT levels by an average of 22 ± 32 mU/mL, with the web-based intervention group having normalized ALT levels in 18% of cases at 6 months, 32% at 12 months, and 35% at 24 months, compared with 16% of cases at 6 months, 22% of cases at 12 months, and 29% of cases at 24 months in the group-based intervention. Compared with the group-based intervention, there was a higher reduction in fatty liver index scores at 12-month follow-up (71.3 vs. 78.0; P less than .001) and 24-month follow-up (68.9 vs. 76.3; P = .002) for the web-based intervention group. The researchers noted NAFLD fibrosis score and Fib-4 scores were reduced in both groups.
“The [web-based intervention] program might be extended to other units and/or general practitioners, increasing its impact in the community in prevention and treatment of progressive NAFLD,” Dr. Mazzotti and her colleagues wrote. “It might also be superimposed to drug treatment in the most severe cases, with possible additive effects.”
This study was supported by a grant from the European Community Seventh Framework Program. The authors report no relevant conflicts of interest.
*This story was updated on 10/4/2018.
SOURCE: Mazzotti A et al. J Hepatol. 2018 Oct 2. doi: 10.1016/j.jhep.2018.07.013.
FROM THE JOURNAL OF HEPATOLOGY
Key clinical point: A web-based lifestyle modification intervention was similarly effective as a group intervention in reducing weight for patients with nonalcoholic fatty liver disease.
Major finding: In the web-based intervention, body weight decreased by 3.4% at 6 months, 4.9% at 12 months, and 5.5% at 24 months, compared with 3.1% at 6 months, 4.0% at 12 months, and 4.2% at 24 months in the group-based intervention. A similar number of patients in both groups achieved the 10% weight-loss target.
Study details: An observational study of 716 patients participating in web-based or group nonalcoholic fatty liver disease interventions at the University of Bologna between January 2010 and December 2015.
Disclosures: The European Community Seventh Framework Program supported the study. The authors report no conflicts of interest.
Source: Mazzotti A et al. J Hepatol. 2018 Oct 2. doi: 10.1016/j.jhep.2018.07.013.
Concurrent ‘never event’ prescribing may worsen dementia in Parkinson’s
Nearly half of Medicare beneficiaries with Parkinson’s disease were concurrently prescribed a high-potency anticholinergic medication and an acetylcholinesterase inhibitor, with higher rates of potential prescribing errors seen among women and Hispanic patients, according to a cross-sectional analysis of Centers for Medicare & Medicaid Services data published in JAMA Neurology.
“Coadministration of a drug with high anticholinergic activity and an [acetylcholinesterase inhibitor] represents a frank prescribing error because these drugs have opposing pharmacologic effects,” wrote Sneha Mantri, MD, of the Parkinson’s Disease Research, Education, and Clinical Center at the Philadelphia VA Medical Center, and her colleagues. “In patients with Parkinson disease, who bear additional risks of cognitive impairment and vulnerability to anticholinergic activity, coprescribing of an [acetylcholinesterase inhibitor] and a high-potency anticholinergic medication can be considered a never event because it is a medication error likely to contribute to disability.”
Dr. Mantri and her colleagues analyzed the inpatient, outpatient, and prescription data of 268,407 Medicare beneficiaries with Parkinson’s, of whom 73,093 patients (27.2%) were prescribed a minimum of one antidementia medication fill. Patients were mean 78.9 years old, and the demographics of the Medicare beneficiaries were 50.1% male, 86.7% white, 5.5% black, 2.7% Hispanic, 2.7% Asian, and 0.7% Native American. The most common antidementia prescriptions were donepezil hydrochloride (63.0%), memantine hydrochloride (41.8%), and rivastigmine tartrate (26.4%). The researchers measured medications in cases of coprescription with potential anticholinergic (ACH) activity using the Anticholinergic Cognitive Burden Scale.
They found antidementia medication use was associated with patients who were black (adjusted odds ratio, 1.33; 95% confidence interval, 1.28-1.38) and Hispanic (aOR, 1.28; 95% CI, 1.22-1.35). Meanwhile, a negative association was found between Native American patients and antidementia medication use (aOR, 0.62; 95% CI, 0.51-0.74) compared with white patients and women (aOR, 0.85; 95% CI, 0.84-0.87) compared with men. The researchers noted that 28,495 patients (44.5%) were prescribed concurrently one high-potency anticholinergic and acetylcholinesterase inhibitors, with higher rates of prescribing seen for Hispanic (aOR, 1.11; 95% CI, 1.00-1.23) and women (aOR, 1.30; 95% CI, 1.25-1.35). High prevalence clusters of this type of prescribing were statistically high in the Southern and Midwestern states, they added.
Limitations included the study of a single year of data and the absence of conclusive data of dementia prevalence among Parkinson’s patients based on antidementia medication use alone and potential off-label use of antidementia medication analyzed in the study, the researchers said.
“In determining whether anticholinergic drug exposure has a causal role in clinical dementia in Parkinson disease, future studies may take a clinical trial approach, in which high-potency anticholinergic medications are replaced with lower-potency alternatives, and the change in cognitive testing and cognitive trajectory are measured,” Dr. Mantri and her colleagues wrote. “Such an approach will allow the calculation of anticholinergic drug safety in terms that are easily understood, such as number needed to harm.”
This study was funded by a grant from the National Institute of Neurological Diseases and Stroke of the National Institutes of Health. The authors report no relevant conflicts of interest.
SOURCE: Mantri S et al. JAMA Neurol. 2018 Oct 1. doi: 10.1001/jamaneurol.2018.2820.
Describing the prescribing patterns of antidementia medication for patients with Parkinson’s disease is useful, particularly with regard to black and Hispanic patients, but the analysis by Sneha Mantri, MD, and her colleagues has methodological issues that limit its impact, wrote Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, wrote in an editorial.
While the researchers used the Anticholinergic Cognitive Burden (ACB) Scale and graded acetylcholinesterase inhibitor and high anticholinergic (ACH) activity medication combinations with the highest ACB score (3 on a scale of 0 to 3) and labeled them as a prescribing error, the ACB scale score alone should not be the sole determination of whether a prescription combination is deemed an error, the authors said.
“A problem, however, arises in defining the coadministration of an antidementia drug and a medication with high ACH activity as a prescribing error or a never event in all clinical circumstances,” the authors wrote. “Across the literature in this area, the most important principle repeatedly emphasized was that these resources are intended to identify potentially inappropriate medication (not inappropriate medications), and the recommendations and ratings provided cannot replace patient-specific clinical judgment.”
Further, medications such as clozapine and quetiapine fumarate are often prescribed for patients with Parkinson’s disease–related psychosis as a standard of care; those medications also have an ACB score of 3, which would label them as prescribing errors and never events under the study by Mantri et al., the authors continued.
“Variability in ACH activity scoring methods is an additional concern, as no criterion standard exists for ranking relative ACH activity and the scores for medications to treat Parkinson disease (such as quetiapine for Parkinson disease psychosis) can markedly differ between the scales commonly used (such as the ACB Scale),” they wrote.
Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, are affiliated with the Fixel Center for Neurological Diseases in the department of neurology at the University of Florida in Gainesville. These comments summarize their editorial (JAMA Neurol. 2018 Oct 1 doi: 10.1001/jamaneurol.2018.2826).They reported no relevant conflicts of interest.
Describing the prescribing patterns of antidementia medication for patients with Parkinson’s disease is useful, particularly with regard to black and Hispanic patients, but the analysis by Sneha Mantri, MD, and her colleagues has methodological issues that limit its impact, wrote Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, wrote in an editorial.
While the researchers used the Anticholinergic Cognitive Burden (ACB) Scale and graded acetylcholinesterase inhibitor and high anticholinergic (ACH) activity medication combinations with the highest ACB score (3 on a scale of 0 to 3) and labeled them as a prescribing error, the ACB scale score alone should not be the sole determination of whether a prescription combination is deemed an error, the authors said.
“A problem, however, arises in defining the coadministration of an antidementia drug and a medication with high ACH activity as a prescribing error or a never event in all clinical circumstances,” the authors wrote. “Across the literature in this area, the most important principle repeatedly emphasized was that these resources are intended to identify potentially inappropriate medication (not inappropriate medications), and the recommendations and ratings provided cannot replace patient-specific clinical judgment.”
Further, medications such as clozapine and quetiapine fumarate are often prescribed for patients with Parkinson’s disease–related psychosis as a standard of care; those medications also have an ACB score of 3, which would label them as prescribing errors and never events under the study by Mantri et al., the authors continued.
“Variability in ACH activity scoring methods is an additional concern, as no criterion standard exists for ranking relative ACH activity and the scores for medications to treat Parkinson disease (such as quetiapine for Parkinson disease psychosis) can markedly differ between the scales commonly used (such as the ACB Scale),” they wrote.
Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, are affiliated with the Fixel Center for Neurological Diseases in the department of neurology at the University of Florida in Gainesville. These comments summarize their editorial (JAMA Neurol. 2018 Oct 1 doi: 10.1001/jamaneurol.2018.2826).They reported no relevant conflicts of interest.
Describing the prescribing patterns of antidementia medication for patients with Parkinson’s disease is useful, particularly with regard to black and Hispanic patients, but the analysis by Sneha Mantri, MD, and her colleagues has methodological issues that limit its impact, wrote Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, wrote in an editorial.
While the researchers used the Anticholinergic Cognitive Burden (ACB) Scale and graded acetylcholinesterase inhibitor and high anticholinergic (ACH) activity medication combinations with the highest ACB score (3 on a scale of 0 to 3) and labeled them as a prescribing error, the ACB scale score alone should not be the sole determination of whether a prescription combination is deemed an error, the authors said.
“A problem, however, arises in defining the coadministration of an antidementia drug and a medication with high ACH activity as a prescribing error or a never event in all clinical circumstances,” the authors wrote. “Across the literature in this area, the most important principle repeatedly emphasized was that these resources are intended to identify potentially inappropriate medication (not inappropriate medications), and the recommendations and ratings provided cannot replace patient-specific clinical judgment.”
Further, medications such as clozapine and quetiapine fumarate are often prescribed for patients with Parkinson’s disease–related psychosis as a standard of care; those medications also have an ACB score of 3, which would label them as prescribing errors and never events under the study by Mantri et al., the authors continued.
“Variability in ACH activity scoring methods is an additional concern, as no criterion standard exists for ranking relative ACH activity and the scores for medications to treat Parkinson disease (such as quetiapine for Parkinson disease psychosis) can markedly differ between the scales commonly used (such as the ACB Scale),” they wrote.
Christopher W. Hess, MD, Michael S. Okun, MD, and Adolfo Ramirez-Zamora, MD, are affiliated with the Fixel Center for Neurological Diseases in the department of neurology at the University of Florida in Gainesville. These comments summarize their editorial (JAMA Neurol. 2018 Oct 1 doi: 10.1001/jamaneurol.2018.2826).They reported no relevant conflicts of interest.
Nearly half of Medicare beneficiaries with Parkinson’s disease were concurrently prescribed a high-potency anticholinergic medication and an acetylcholinesterase inhibitor, with higher rates of potential prescribing errors seen among women and Hispanic patients, according to a cross-sectional analysis of Centers for Medicare & Medicaid Services data published in JAMA Neurology.
“Coadministration of a drug with high anticholinergic activity and an [acetylcholinesterase inhibitor] represents a frank prescribing error because these drugs have opposing pharmacologic effects,” wrote Sneha Mantri, MD, of the Parkinson’s Disease Research, Education, and Clinical Center at the Philadelphia VA Medical Center, and her colleagues. “In patients with Parkinson disease, who bear additional risks of cognitive impairment and vulnerability to anticholinergic activity, coprescribing of an [acetylcholinesterase inhibitor] and a high-potency anticholinergic medication can be considered a never event because it is a medication error likely to contribute to disability.”
Dr. Mantri and her colleagues analyzed the inpatient, outpatient, and prescription data of 268,407 Medicare beneficiaries with Parkinson’s, of whom 73,093 patients (27.2%) were prescribed a minimum of one antidementia medication fill. Patients were mean 78.9 years old, and the demographics of the Medicare beneficiaries were 50.1% male, 86.7% white, 5.5% black, 2.7% Hispanic, 2.7% Asian, and 0.7% Native American. The most common antidementia prescriptions were donepezil hydrochloride (63.0%), memantine hydrochloride (41.8%), and rivastigmine tartrate (26.4%). The researchers measured medications in cases of coprescription with potential anticholinergic (ACH) activity using the Anticholinergic Cognitive Burden Scale.
They found antidementia medication use was associated with patients who were black (adjusted odds ratio, 1.33; 95% confidence interval, 1.28-1.38) and Hispanic (aOR, 1.28; 95% CI, 1.22-1.35). Meanwhile, a negative association was found between Native American patients and antidementia medication use (aOR, 0.62; 95% CI, 0.51-0.74) compared with white patients and women (aOR, 0.85; 95% CI, 0.84-0.87) compared with men. The researchers noted that 28,495 patients (44.5%) were prescribed concurrently one high-potency anticholinergic and acetylcholinesterase inhibitors, with higher rates of prescribing seen for Hispanic (aOR, 1.11; 95% CI, 1.00-1.23) and women (aOR, 1.30; 95% CI, 1.25-1.35). High prevalence clusters of this type of prescribing were statistically high in the Southern and Midwestern states, they added.
Limitations included the study of a single year of data and the absence of conclusive data of dementia prevalence among Parkinson’s patients based on antidementia medication use alone and potential off-label use of antidementia medication analyzed in the study, the researchers said.
“In determining whether anticholinergic drug exposure has a causal role in clinical dementia in Parkinson disease, future studies may take a clinical trial approach, in which high-potency anticholinergic medications are replaced with lower-potency alternatives, and the change in cognitive testing and cognitive trajectory are measured,” Dr. Mantri and her colleagues wrote. “Such an approach will allow the calculation of anticholinergic drug safety in terms that are easily understood, such as number needed to harm.”
This study was funded by a grant from the National Institute of Neurological Diseases and Stroke of the National Institutes of Health. The authors report no relevant conflicts of interest.
SOURCE: Mantri S et al. JAMA Neurol. 2018 Oct 1. doi: 10.1001/jamaneurol.2018.2820.
Nearly half of Medicare beneficiaries with Parkinson’s disease were concurrently prescribed a high-potency anticholinergic medication and an acetylcholinesterase inhibitor, with higher rates of potential prescribing errors seen among women and Hispanic patients, according to a cross-sectional analysis of Centers for Medicare & Medicaid Services data published in JAMA Neurology.
“Coadministration of a drug with high anticholinergic activity and an [acetylcholinesterase inhibitor] represents a frank prescribing error because these drugs have opposing pharmacologic effects,” wrote Sneha Mantri, MD, of the Parkinson’s Disease Research, Education, and Clinical Center at the Philadelphia VA Medical Center, and her colleagues. “In patients with Parkinson disease, who bear additional risks of cognitive impairment and vulnerability to anticholinergic activity, coprescribing of an [acetylcholinesterase inhibitor] and a high-potency anticholinergic medication can be considered a never event because it is a medication error likely to contribute to disability.”
Dr. Mantri and her colleagues analyzed the inpatient, outpatient, and prescription data of 268,407 Medicare beneficiaries with Parkinson’s, of whom 73,093 patients (27.2%) were prescribed a minimum of one antidementia medication fill. Patients were mean 78.9 years old, and the demographics of the Medicare beneficiaries were 50.1% male, 86.7% white, 5.5% black, 2.7% Hispanic, 2.7% Asian, and 0.7% Native American. The most common antidementia prescriptions were donepezil hydrochloride (63.0%), memantine hydrochloride (41.8%), and rivastigmine tartrate (26.4%). The researchers measured medications in cases of coprescription with potential anticholinergic (ACH) activity using the Anticholinergic Cognitive Burden Scale.
They found antidementia medication use was associated with patients who were black (adjusted odds ratio, 1.33; 95% confidence interval, 1.28-1.38) and Hispanic (aOR, 1.28; 95% CI, 1.22-1.35). Meanwhile, a negative association was found between Native American patients and antidementia medication use (aOR, 0.62; 95% CI, 0.51-0.74) compared with white patients and women (aOR, 0.85; 95% CI, 0.84-0.87) compared with men. The researchers noted that 28,495 patients (44.5%) were prescribed concurrently one high-potency anticholinergic and acetylcholinesterase inhibitors, with higher rates of prescribing seen for Hispanic (aOR, 1.11; 95% CI, 1.00-1.23) and women (aOR, 1.30; 95% CI, 1.25-1.35). High prevalence clusters of this type of prescribing were statistically high in the Southern and Midwestern states, they added.
Limitations included the study of a single year of data and the absence of conclusive data of dementia prevalence among Parkinson’s patients based on antidementia medication use alone and potential off-label use of antidementia medication analyzed in the study, the researchers said.
“In determining whether anticholinergic drug exposure has a causal role in clinical dementia in Parkinson disease, future studies may take a clinical trial approach, in which high-potency anticholinergic medications are replaced with lower-potency alternatives, and the change in cognitive testing and cognitive trajectory are measured,” Dr. Mantri and her colleagues wrote. “Such an approach will allow the calculation of anticholinergic drug safety in terms that are easily understood, such as number needed to harm.”
This study was funded by a grant from the National Institute of Neurological Diseases and Stroke of the National Institutes of Health. The authors report no relevant conflicts of interest.
SOURCE: Mantri S et al. JAMA Neurol. 2018 Oct 1. doi: 10.1001/jamaneurol.2018.2820.
FROM JAMA NEUROLOGY
Key clinical point: Medicare beneficiaries with Parkinson’s disease often are concurrently prescribed a high-potency anticholinergic medication and an acetylcholinesterase inhibitor.
Major finding: More than 44% of patients experienced at least one never event, with higher rates of potential prescribing errors seen in Hispanic patients (adjusted OR, 1.11) and women (adjusted OR, 1.30).
Study details: An analysis of inpatient, outpatient, and prescription data for 268,407 Medicare beneficiaries with Parkinson’s disease over 12 months.
Disclosures: This study was funded by a grant from the National Institute of Neurological Diseases and Stroke of the National Institutes of Health. The authors reported no relevant conflicts of interest.
Source: Mantri S et al. JAMA Neurol. 2018 Oct 1. doi: 10.1001/jamaneurol.2018.2820.
No significant VTE risk for women taking noncyclic COCs
Women who use combined oral contraceptives (COC) without hormone-free or low-dose hormone intervals have a slightly elevated, but not statistically significant, risk of venous thromboembolism (VTE), compared with women who use cyclic COCs, according to research published in JAMA Internal Medicine.
Jie Li, PhD, from the Center for Drug Evaluation and Research, and colleagues performed a retrospective cohort study of 733,007 women aged 18-50 years in the Sentinel Distributed Database from 2007 to 2015 who received low-dose extended and continuous cycle (210,691 women; mean age, 30 years) COCs or cyclic COCs (522,316 women; mean age, 29 years). Continuous cycle COCs were defined as an 84/7 cycle or a 365/0 cycle, while cyclic COCs were 21/7 cycles.
The researchers noted some baseline differences between the two groups, with gynecologic conditions occurring in 40% of the noncyclic group, compared with 32% in the cyclic group; cardiovascular and metabolic conditions occurring in 7% of noncyclic women, compared with 5% of cyclic women; inflammatory disease occurring in 3% of noncyclic women, compared with 2% of cyclic women; and a slightly higher rate of health care services use in the noncyclic group, compared with the cyclic group.
Dr. Li and associates found 228 cases of VTE in the noncyclic group and 297 cases in the cyclic group, with an incidence rate of 1.54 (95% confidence interval, 1.34-1.74) per 1,000 person-years for noncyclic users and 0.83 (95% CI, 0.74-0.93) per 1,000 person-years for cyclic users (crude hazard ratio, 1.84; 95% CI, 1.53-2.21).
However, propensity score matching lowered the incidence rate to 1.44 (95% CI, 1.24-1.64) per 1,000 person-years for the noncyclic group and raised it to 1.09 (95% CI, 0.92-1.27) per 1,000 person-years for the cyclic group, for an adjusted hazard ratio of 1.32 (95% CI, 1.07-1.64), which does not show “strong evidence” of VTE risk based on a small absolute risk difference of 0.27 cases per 1,000 persons, the researchers said. They added that there might be residual or unmeasured confounding, perhaps for potential concurrent medication use or incompletely measured covariates.
“Accordingly, we do not recommend selective prescribing of COCs based on the cyclic and continuous/extended type,” Dr. Li and colleagues wrote. “Clinicians should prescribe COCs based on patients’ individual risk factors and preferences.”
The Sentinel Initiative is funded by a contract from the Department of Health and Human Services. The authors reported no relevant conflicts of interest.
SOURCE: Li J et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4251.
Women who use combined oral contraceptives (COC) without hormone-free or low-dose hormone intervals have a slightly elevated, but not statistically significant, risk of venous thromboembolism (VTE), compared with women who use cyclic COCs, according to research published in JAMA Internal Medicine.
Jie Li, PhD, from the Center for Drug Evaluation and Research, and colleagues performed a retrospective cohort study of 733,007 women aged 18-50 years in the Sentinel Distributed Database from 2007 to 2015 who received low-dose extended and continuous cycle (210,691 women; mean age, 30 years) COCs or cyclic COCs (522,316 women; mean age, 29 years). Continuous cycle COCs were defined as an 84/7 cycle or a 365/0 cycle, while cyclic COCs were 21/7 cycles.
The researchers noted some baseline differences between the two groups, with gynecologic conditions occurring in 40% of the noncyclic group, compared with 32% in the cyclic group; cardiovascular and metabolic conditions occurring in 7% of noncyclic women, compared with 5% of cyclic women; inflammatory disease occurring in 3% of noncyclic women, compared with 2% of cyclic women; and a slightly higher rate of health care services use in the noncyclic group, compared with the cyclic group.
Dr. Li and associates found 228 cases of VTE in the noncyclic group and 297 cases in the cyclic group, with an incidence rate of 1.54 (95% confidence interval, 1.34-1.74) per 1,000 person-years for noncyclic users and 0.83 (95% CI, 0.74-0.93) per 1,000 person-years for cyclic users (crude hazard ratio, 1.84; 95% CI, 1.53-2.21).
However, propensity score matching lowered the incidence rate to 1.44 (95% CI, 1.24-1.64) per 1,000 person-years for the noncyclic group and raised it to 1.09 (95% CI, 0.92-1.27) per 1,000 person-years for the cyclic group, for an adjusted hazard ratio of 1.32 (95% CI, 1.07-1.64), which does not show “strong evidence” of VTE risk based on a small absolute risk difference of 0.27 cases per 1,000 persons, the researchers said. They added that there might be residual or unmeasured confounding, perhaps for potential concurrent medication use or incompletely measured covariates.
“Accordingly, we do not recommend selective prescribing of COCs based on the cyclic and continuous/extended type,” Dr. Li and colleagues wrote. “Clinicians should prescribe COCs based on patients’ individual risk factors and preferences.”
The Sentinel Initiative is funded by a contract from the Department of Health and Human Services. The authors reported no relevant conflicts of interest.
SOURCE: Li J et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4251.
Women who use combined oral contraceptives (COC) without hormone-free or low-dose hormone intervals have a slightly elevated, but not statistically significant, risk of venous thromboembolism (VTE), compared with women who use cyclic COCs, according to research published in JAMA Internal Medicine.
Jie Li, PhD, from the Center for Drug Evaluation and Research, and colleagues performed a retrospective cohort study of 733,007 women aged 18-50 years in the Sentinel Distributed Database from 2007 to 2015 who received low-dose extended and continuous cycle (210,691 women; mean age, 30 years) COCs or cyclic COCs (522,316 women; mean age, 29 years). Continuous cycle COCs were defined as an 84/7 cycle or a 365/0 cycle, while cyclic COCs were 21/7 cycles.
The researchers noted some baseline differences between the two groups, with gynecologic conditions occurring in 40% of the noncyclic group, compared with 32% in the cyclic group; cardiovascular and metabolic conditions occurring in 7% of noncyclic women, compared with 5% of cyclic women; inflammatory disease occurring in 3% of noncyclic women, compared with 2% of cyclic women; and a slightly higher rate of health care services use in the noncyclic group, compared with the cyclic group.
Dr. Li and associates found 228 cases of VTE in the noncyclic group and 297 cases in the cyclic group, with an incidence rate of 1.54 (95% confidence interval, 1.34-1.74) per 1,000 person-years for noncyclic users and 0.83 (95% CI, 0.74-0.93) per 1,000 person-years for cyclic users (crude hazard ratio, 1.84; 95% CI, 1.53-2.21).
However, propensity score matching lowered the incidence rate to 1.44 (95% CI, 1.24-1.64) per 1,000 person-years for the noncyclic group and raised it to 1.09 (95% CI, 0.92-1.27) per 1,000 person-years for the cyclic group, for an adjusted hazard ratio of 1.32 (95% CI, 1.07-1.64), which does not show “strong evidence” of VTE risk based on a small absolute risk difference of 0.27 cases per 1,000 persons, the researchers said. They added that there might be residual or unmeasured confounding, perhaps for potential concurrent medication use or incompletely measured covariates.
“Accordingly, we do not recommend selective prescribing of COCs based on the cyclic and continuous/extended type,” Dr. Li and colleagues wrote. “Clinicians should prescribe COCs based on patients’ individual risk factors and preferences.”
The Sentinel Initiative is funded by a contract from the Department of Health and Human Services. The authors reported no relevant conflicts of interest.
SOURCE: Li J et al. JAMA Intern Med. 2018 Oct 1. doi: 10.1001/jamainternmed.2018.4251.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Continuous or extended cycle combined oral contraceptive (COC) use was associated with a slightly elevated, but not statistically significant, risk of venous thromboembolism.
Major finding: The adjusted hazard ratio for women taking continuous/extended COCs was 1.32 (95% confidence interval, 1.07-1.74), compared with women taking noncyclic COCs, but the absolute risk difference between the two groups was low (0.27 per 1,000 persons).
Study details: A retrospective cohort study of 210,691 women with continuous/extended COC use and 522,316 women with cyclic COC use.
Disclosures: The Sentinel Initiative is funded by a contract from the Department of Health and Human Services. The authors reported no relevant conflicts of interest.
Source: Li J et al. JAMA Intern Med. 2018 Oct 1. doi:10.1001/jamainternmed.2018.4251.