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Study finds differences for HCC in women
SAN DIEGO – Hepatocellular carcinoma is the third leading cause of cancer-related death in the United States and its incidence is increasing worldwide. While it affects men much more frequently than women, approximately 4 to 1, the differences in risk factors between men and women have never been studied.
At the annual Digestive Disease Week, Meaghan Phipps, MD, of New York–Presbyterian Hospital, described in a video interview how she and her colleagues set up a retrospective study of these differences in 5,327 patients at five large academic centers around the country. She and her colleagues found that women tended to present later, and with less severe disease, which was more likely to be treated with resection than transplantation. Women had better overall survival. Women were significantly more likely to present without cirrhosis and with nonalcoholic fatty liver disease than were men. Dr. Phipps noted that they did not characterize the women in their study by menopausal status, and suggested that this would be an important thing to look at in a future prospective study because it has long been thought that estrogen confers some protection against hepatocellular carcinoma.
SAN DIEGO – Hepatocellular carcinoma is the third leading cause of cancer-related death in the United States and its incidence is increasing worldwide. While it affects men much more frequently than women, approximately 4 to 1, the differences in risk factors between men and women have never been studied.
At the annual Digestive Disease Week, Meaghan Phipps, MD, of New York–Presbyterian Hospital, described in a video interview how she and her colleagues set up a retrospective study of these differences in 5,327 patients at five large academic centers around the country. She and her colleagues found that women tended to present later, and with less severe disease, which was more likely to be treated with resection than transplantation. Women had better overall survival. Women were significantly more likely to present without cirrhosis and with nonalcoholic fatty liver disease than were men. Dr. Phipps noted that they did not characterize the women in their study by menopausal status, and suggested that this would be an important thing to look at in a future prospective study because it has long been thought that estrogen confers some protection against hepatocellular carcinoma.
SAN DIEGO – Hepatocellular carcinoma is the third leading cause of cancer-related death in the United States and its incidence is increasing worldwide. While it affects men much more frequently than women, approximately 4 to 1, the differences in risk factors between men and women have never been studied.
At the annual Digestive Disease Week, Meaghan Phipps, MD, of New York–Presbyterian Hospital, described in a video interview how she and her colleagues set up a retrospective study of these differences in 5,327 patients at five large academic centers around the country. She and her colleagues found that women tended to present later, and with less severe disease, which was more likely to be treated with resection than transplantation. Women had better overall survival. Women were significantly more likely to present without cirrhosis and with nonalcoholic fatty liver disease than were men. Dr. Phipps noted that they did not characterize the women in their study by menopausal status, and suggested that this would be an important thing to look at in a future prospective study because it has long been thought that estrogen confers some protection against hepatocellular carcinoma.
REPORTING FROM DDW 2019
Rivaroxaban tied to higher GI bleeding than other NOACs
SAN DIEGO – Patients on rivaroxaban had significantly higher rates of GI bleeding, compared with those taking apixaban or dabigatran, results from a large population-based study showed.
“This may be due to the fact that rivaroxaban is administered as a single daily dose as opposed to the other two non–vitamin K anticoagulants [NOACs], which are given twice daily,” lead study author Arnar B. Ingason said at the annual Digestive Disease Week. “This may lead to a greater variance in plasma drug concentration, making these patients more susceptible to bleeding.”
Mr. Ingason, a medical student at the University of Iceland, Reykjavik, said that although several studies have compared warfarin with NOACs, it remains unclear which NOAC has the most favorable GI profile. In an effort to improve the research in this area, he and his associates performed a nationwide, population-based study during March 2014–Jan. 2018 to compare the GI bleeding risk of patients receiving rivaroxaban to that of a combined pool of patients receiving either apixaban or dabigatran. They drew from the Icelandic Medicine Registry, which contains all outpatient drug prescriptions in the country. Next, the researchers linked the personal identification numbers of patients to the Landspitali University diagnoses registry, which includes more than 90% of all patients hospitalized for GI bleeding. They used 1:1 nearest neighbor propensity score for matching and Kaplan-Meier survival estimates and Cox regression to compare rates of GI bleeding. The study outcome of interest was any clinically relevant GI bleeding.
Mr. Ingason reported that the baseline characteristics were similar between the rivaroxaban group and the apixaban/dabigatran group. They matched for several variables, including age, sex, Charlson score, the proportion being anticoagulant naive, moderate to severe renal disease, moderate to severe liver disease, any prior bleeding, and any prior thrombotic events.
During the study period, 3,473 patients received rivaroxaban, 1,901 received apixaban, and 1,086 received dabigatran. After propensity score matching, the researchers compared 2,635 patients who received rivaroxaban with 2,365 patients who received either apixaban or dabigatran. They found that patients in the rivaroxaban group had significantly higher rates of GI bleeding, compared with in the apixaban/dabigatran group (1.2 and. 0.6 events per 100 patient-years, respectively). This yielded a hazard ratio of 2.02, “which means that patients receiving rivaroxaban are twice as likely to get GI bleeding compared to patients on apixaban or dabigatran,” Mr. Ingason said. When the researchers examined the entire unmatched cohort of patients, the rivaroxaban group also had significantly higher rates of GI bleeding, compared with the apixaban/dabigatran group (1.0 and 0.6 events per 100 patient-years; HR, 1.75).
Mr. Ingason and his colleagues observed that patients in the rivaroxaban group had higher rates of GI bleeding, compared with the apixaban/dabigatran group, during the entire follow-up period. At the end of year 4, the rivaroxaban group had a 4% cumulative event rate of GI bleeding, compared with 1.8% for the apixaban/dabigatran group, a highly significant difference at P = .0057).
When a meeting attendee asked Mr. Ingason why patients taking apixaban or dabigatran were combined into one group, he said that it was done to increase the power of their study. “Our theory was that rivaroxaban was different because it is administered as a single daily dose, while the others are given twice daily,” he said. The researchers reported having no financial disclosures.
SAN DIEGO – Patients on rivaroxaban had significantly higher rates of GI bleeding, compared with those taking apixaban or dabigatran, results from a large population-based study showed.
“This may be due to the fact that rivaroxaban is administered as a single daily dose as opposed to the other two non–vitamin K anticoagulants [NOACs], which are given twice daily,” lead study author Arnar B. Ingason said at the annual Digestive Disease Week. “This may lead to a greater variance in plasma drug concentration, making these patients more susceptible to bleeding.”
Mr. Ingason, a medical student at the University of Iceland, Reykjavik, said that although several studies have compared warfarin with NOACs, it remains unclear which NOAC has the most favorable GI profile. In an effort to improve the research in this area, he and his associates performed a nationwide, population-based study during March 2014–Jan. 2018 to compare the GI bleeding risk of patients receiving rivaroxaban to that of a combined pool of patients receiving either apixaban or dabigatran. They drew from the Icelandic Medicine Registry, which contains all outpatient drug prescriptions in the country. Next, the researchers linked the personal identification numbers of patients to the Landspitali University diagnoses registry, which includes more than 90% of all patients hospitalized for GI bleeding. They used 1:1 nearest neighbor propensity score for matching and Kaplan-Meier survival estimates and Cox regression to compare rates of GI bleeding. The study outcome of interest was any clinically relevant GI bleeding.
Mr. Ingason reported that the baseline characteristics were similar between the rivaroxaban group and the apixaban/dabigatran group. They matched for several variables, including age, sex, Charlson score, the proportion being anticoagulant naive, moderate to severe renal disease, moderate to severe liver disease, any prior bleeding, and any prior thrombotic events.
During the study period, 3,473 patients received rivaroxaban, 1,901 received apixaban, and 1,086 received dabigatran. After propensity score matching, the researchers compared 2,635 patients who received rivaroxaban with 2,365 patients who received either apixaban or dabigatran. They found that patients in the rivaroxaban group had significantly higher rates of GI bleeding, compared with in the apixaban/dabigatran group (1.2 and. 0.6 events per 100 patient-years, respectively). This yielded a hazard ratio of 2.02, “which means that patients receiving rivaroxaban are twice as likely to get GI bleeding compared to patients on apixaban or dabigatran,” Mr. Ingason said. When the researchers examined the entire unmatched cohort of patients, the rivaroxaban group also had significantly higher rates of GI bleeding, compared with the apixaban/dabigatran group (1.0 and 0.6 events per 100 patient-years; HR, 1.75).
Mr. Ingason and his colleagues observed that patients in the rivaroxaban group had higher rates of GI bleeding, compared with the apixaban/dabigatran group, during the entire follow-up period. At the end of year 4, the rivaroxaban group had a 4% cumulative event rate of GI bleeding, compared with 1.8% for the apixaban/dabigatran group, a highly significant difference at P = .0057).
When a meeting attendee asked Mr. Ingason why patients taking apixaban or dabigatran were combined into one group, he said that it was done to increase the power of their study. “Our theory was that rivaroxaban was different because it is administered as a single daily dose, while the others are given twice daily,” he said. The researchers reported having no financial disclosures.
SAN DIEGO – Patients on rivaroxaban had significantly higher rates of GI bleeding, compared with those taking apixaban or dabigatran, results from a large population-based study showed.
“This may be due to the fact that rivaroxaban is administered as a single daily dose as opposed to the other two non–vitamin K anticoagulants [NOACs], which are given twice daily,” lead study author Arnar B. Ingason said at the annual Digestive Disease Week. “This may lead to a greater variance in plasma drug concentration, making these patients more susceptible to bleeding.”
Mr. Ingason, a medical student at the University of Iceland, Reykjavik, said that although several studies have compared warfarin with NOACs, it remains unclear which NOAC has the most favorable GI profile. In an effort to improve the research in this area, he and his associates performed a nationwide, population-based study during March 2014–Jan. 2018 to compare the GI bleeding risk of patients receiving rivaroxaban to that of a combined pool of patients receiving either apixaban or dabigatran. They drew from the Icelandic Medicine Registry, which contains all outpatient drug prescriptions in the country. Next, the researchers linked the personal identification numbers of patients to the Landspitali University diagnoses registry, which includes more than 90% of all patients hospitalized for GI bleeding. They used 1:1 nearest neighbor propensity score for matching and Kaplan-Meier survival estimates and Cox regression to compare rates of GI bleeding. The study outcome of interest was any clinically relevant GI bleeding.
Mr. Ingason reported that the baseline characteristics were similar between the rivaroxaban group and the apixaban/dabigatran group. They matched for several variables, including age, sex, Charlson score, the proportion being anticoagulant naive, moderate to severe renal disease, moderate to severe liver disease, any prior bleeding, and any prior thrombotic events.
During the study period, 3,473 patients received rivaroxaban, 1,901 received apixaban, and 1,086 received dabigatran. After propensity score matching, the researchers compared 2,635 patients who received rivaroxaban with 2,365 patients who received either apixaban or dabigatran. They found that patients in the rivaroxaban group had significantly higher rates of GI bleeding, compared with in the apixaban/dabigatran group (1.2 and. 0.6 events per 100 patient-years, respectively). This yielded a hazard ratio of 2.02, “which means that patients receiving rivaroxaban are twice as likely to get GI bleeding compared to patients on apixaban or dabigatran,” Mr. Ingason said. When the researchers examined the entire unmatched cohort of patients, the rivaroxaban group also had significantly higher rates of GI bleeding, compared with the apixaban/dabigatran group (1.0 and 0.6 events per 100 patient-years; HR, 1.75).
Mr. Ingason and his colleagues observed that patients in the rivaroxaban group had higher rates of GI bleeding, compared with the apixaban/dabigatran group, during the entire follow-up period. At the end of year 4, the rivaroxaban group had a 4% cumulative event rate of GI bleeding, compared with 1.8% for the apixaban/dabigatran group, a highly significant difference at P = .0057).
When a meeting attendee asked Mr. Ingason why patients taking apixaban or dabigatran were combined into one group, he said that it was done to increase the power of their study. “Our theory was that rivaroxaban was different because it is administered as a single daily dose, while the others are given twice daily,” he said. The researchers reported having no financial disclosures.
REPORTING FROM DDW 2019
Fewer antibiotics prescribed with PCR than conventional stool testing
SAN DIEGO – However, antibiotics were still prescribed for more than one in three patients tested by any method.
“A positive test by any modality did result in decreased utilization of endoscopy, radiology, and antibiotic prescribing, but this effect appeared to be much greater for the GI PCR assay,” said Jordan Axelrad, MD, speaking at the annual Digestive Disease Week.
“Overall, patients who received GI PCR were 12% less likely to undergo endoscopy, 7% less likely to undergo abdominal radiography, and 11% less likely to be prescribed any antibiotic,” compared with patients who were tested by conventional stool culture, said Dr. Axelrad, a gastroenterologist at New York University.
In a cross-sectional study, Dr. Axelrad and his coauthors looked at patients who underwent stool testing for the 26 months before (n = 5,986) and after (n = 9,402) March 2015, when Dr. Axelrad’s home institution switched from conventional stool culture to the GI PCR panel. For the earlier time period, the investigators included patients who received stool culture both with and without an ova and parasites exam, as well as those who underwent enzyme-linked immunosorbent assay viral testing for rotavirus and adenovirus.
Patient demographic data were included as study variables; additionally, the study tracked utilization of endoscopy, abdominal, or other radiology studies, and ED visits for 30 days after testing. They also included any antibiotic prescribing within the 14 days post testing.
Roughly one-third of patients were tested as outpatients, 1 in 10 in the ED, and the remainder as inpatients. Patient age was a mean 46.7 years for the culture group, and 45.5 years for the GI PCR group.
The multiplex PCR test used in the study tested for 12 gastrointestinal pathogenic bacteria, 4 parasites, and 5 viruses.
As expected, PCR testing yielded a higher positive test rate than conventional stool testing, even when EIA tests were included (29.2% vs. 4.1%). In the 2,746 patients with a positive GI PCR test, a total of 3,804 pathogens were identified. Adenovirus accounted for 39% of these positive results. Positive bacterial results were seen in about 65.0% of the positive subgroup, with Escherichia coli subtypes seen in 51.7% of the positive tests.
Overall, positive results for viruses, bacteria, and multiple pathogens were more likely with GI PCR testing, compared with conventional testing (P = .001 for all). Parasites accounted for only 8.2% of the positive PCR test results, but this was significantly more than the 3.7% seen with conventional testing (P = .011).
At the 14-day mark post testing, “Patients who underwent a GI panel were less likely to be prescribed any antibiotic. But overall, antibiotics were fairly common in both groups,” said Dr. Axelrad, noting that 41% of patients who underwent stool culture received an antibiotic by 14 days, compared with 36% for patients who underwent a GI PCR panel (P = .001).
By the end of 30 days, most patients in each group had not received an endoscopic procedure, with significantly more procedure-free patients in the PCR group (91.6% vs. 90.4%; P = .008).
Against a backdrop of slightly higher overall radiology utilization in the PCR group – potentially attributable to practice trends over time – abdominal radiology was less likely for these patients than for the culture group (11.4% vs. 12.8%; P = .011).
The 30-day ED visit rate was low and similar between groups (11.4% for PCR vs. 12.8% for culture; P = .116).
The much quicker turnaround for the GI PCR panel didn’t translate into a shorter length of stay, though: Inpatient length of stay was a median 5 days in both groups.
“We feel that the outcomes that we noted were likely due to the increased sensitivity and specificity” of the PCR-based testing, said Dr. Axelrad. “Obviously, if you have more pathogen-positive findings, you may be less likely to order extensive testing. And if you’ve identified something like norovirus, you may feel reassured, and not order further testing.”
Dr. Axelrad pointed out that his institution’s overall PCR positivity rates were lower than the 70% rates some other studies have reported. “We feel that, given our large sample size, our results may more accurately reflect clinical practice, and perhaps that lower positivity rate may reflect increased use of this test in an inpatient setting,” he said. “We’re looking at that.”
Study limitations included the retrospective nature of the study. “Also, as we all know, PCR testing fails to discriminate between active infection and asymptomatic colonization,” raising questions about whether a positive PCR test really indicates true infection, noted Dr. Axelrad.
“Coupled with a high-sensitivity rapid turnaround, there’s the potential to reduce costs, but the cost-effectiveness of these assays has not been fully determined. There are several studies looking at this,” with results still to come, he said.
The notable reduction in antibiotic prescribing for those patients who received PCR-based testing means that GI PCR panels could be a useful tool to promote antibiotic stewardship, though Dr. Axelrad also noted that “antibiotics were still used in about a third of all patients.”
Dr. Axelrad reported no outside sources of funding. He has performed consulting services for and received research funding from BioFire, which manufactured the GI PCR assay used in the study, but BioFire did not fund this research.
SOURCE: Axelrad J et al. DDW 2019, Presentation 978.
SAN DIEGO – However, antibiotics were still prescribed for more than one in three patients tested by any method.
“A positive test by any modality did result in decreased utilization of endoscopy, radiology, and antibiotic prescribing, but this effect appeared to be much greater for the GI PCR assay,” said Jordan Axelrad, MD, speaking at the annual Digestive Disease Week.
“Overall, patients who received GI PCR were 12% less likely to undergo endoscopy, 7% less likely to undergo abdominal radiography, and 11% less likely to be prescribed any antibiotic,” compared with patients who were tested by conventional stool culture, said Dr. Axelrad, a gastroenterologist at New York University.
In a cross-sectional study, Dr. Axelrad and his coauthors looked at patients who underwent stool testing for the 26 months before (n = 5,986) and after (n = 9,402) March 2015, when Dr. Axelrad’s home institution switched from conventional stool culture to the GI PCR panel. For the earlier time period, the investigators included patients who received stool culture both with and without an ova and parasites exam, as well as those who underwent enzyme-linked immunosorbent assay viral testing for rotavirus and adenovirus.
Patient demographic data were included as study variables; additionally, the study tracked utilization of endoscopy, abdominal, or other radiology studies, and ED visits for 30 days after testing. They also included any antibiotic prescribing within the 14 days post testing.
Roughly one-third of patients were tested as outpatients, 1 in 10 in the ED, and the remainder as inpatients. Patient age was a mean 46.7 years for the culture group, and 45.5 years for the GI PCR group.
The multiplex PCR test used in the study tested for 12 gastrointestinal pathogenic bacteria, 4 parasites, and 5 viruses.
As expected, PCR testing yielded a higher positive test rate than conventional stool testing, even when EIA tests were included (29.2% vs. 4.1%). In the 2,746 patients with a positive GI PCR test, a total of 3,804 pathogens were identified. Adenovirus accounted for 39% of these positive results. Positive bacterial results were seen in about 65.0% of the positive subgroup, with Escherichia coli subtypes seen in 51.7% of the positive tests.
Overall, positive results for viruses, bacteria, and multiple pathogens were more likely with GI PCR testing, compared with conventional testing (P = .001 for all). Parasites accounted for only 8.2% of the positive PCR test results, but this was significantly more than the 3.7% seen with conventional testing (P = .011).
At the 14-day mark post testing, “Patients who underwent a GI panel were less likely to be prescribed any antibiotic. But overall, antibiotics were fairly common in both groups,” said Dr. Axelrad, noting that 41% of patients who underwent stool culture received an antibiotic by 14 days, compared with 36% for patients who underwent a GI PCR panel (P = .001).
By the end of 30 days, most patients in each group had not received an endoscopic procedure, with significantly more procedure-free patients in the PCR group (91.6% vs. 90.4%; P = .008).
Against a backdrop of slightly higher overall radiology utilization in the PCR group – potentially attributable to practice trends over time – abdominal radiology was less likely for these patients than for the culture group (11.4% vs. 12.8%; P = .011).
The 30-day ED visit rate was low and similar between groups (11.4% for PCR vs. 12.8% for culture; P = .116).
The much quicker turnaround for the GI PCR panel didn’t translate into a shorter length of stay, though: Inpatient length of stay was a median 5 days in both groups.
“We feel that the outcomes that we noted were likely due to the increased sensitivity and specificity” of the PCR-based testing, said Dr. Axelrad. “Obviously, if you have more pathogen-positive findings, you may be less likely to order extensive testing. And if you’ve identified something like norovirus, you may feel reassured, and not order further testing.”
Dr. Axelrad pointed out that his institution’s overall PCR positivity rates were lower than the 70% rates some other studies have reported. “We feel that, given our large sample size, our results may more accurately reflect clinical practice, and perhaps that lower positivity rate may reflect increased use of this test in an inpatient setting,” he said. “We’re looking at that.”
Study limitations included the retrospective nature of the study. “Also, as we all know, PCR testing fails to discriminate between active infection and asymptomatic colonization,” raising questions about whether a positive PCR test really indicates true infection, noted Dr. Axelrad.
“Coupled with a high-sensitivity rapid turnaround, there’s the potential to reduce costs, but the cost-effectiveness of these assays has not been fully determined. There are several studies looking at this,” with results still to come, he said.
The notable reduction in antibiotic prescribing for those patients who received PCR-based testing means that GI PCR panels could be a useful tool to promote antibiotic stewardship, though Dr. Axelrad also noted that “antibiotics were still used in about a third of all patients.”
Dr. Axelrad reported no outside sources of funding. He has performed consulting services for and received research funding from BioFire, which manufactured the GI PCR assay used in the study, but BioFire did not fund this research.
SOURCE: Axelrad J et al. DDW 2019, Presentation 978.
SAN DIEGO – However, antibiotics were still prescribed for more than one in three patients tested by any method.
“A positive test by any modality did result in decreased utilization of endoscopy, radiology, and antibiotic prescribing, but this effect appeared to be much greater for the GI PCR assay,” said Jordan Axelrad, MD, speaking at the annual Digestive Disease Week.
“Overall, patients who received GI PCR were 12% less likely to undergo endoscopy, 7% less likely to undergo abdominal radiography, and 11% less likely to be prescribed any antibiotic,” compared with patients who were tested by conventional stool culture, said Dr. Axelrad, a gastroenterologist at New York University.
In a cross-sectional study, Dr. Axelrad and his coauthors looked at patients who underwent stool testing for the 26 months before (n = 5,986) and after (n = 9,402) March 2015, when Dr. Axelrad’s home institution switched from conventional stool culture to the GI PCR panel. For the earlier time period, the investigators included patients who received stool culture both with and without an ova and parasites exam, as well as those who underwent enzyme-linked immunosorbent assay viral testing for rotavirus and adenovirus.
Patient demographic data were included as study variables; additionally, the study tracked utilization of endoscopy, abdominal, or other radiology studies, and ED visits for 30 days after testing. They also included any antibiotic prescribing within the 14 days post testing.
Roughly one-third of patients were tested as outpatients, 1 in 10 in the ED, and the remainder as inpatients. Patient age was a mean 46.7 years for the culture group, and 45.5 years for the GI PCR group.
The multiplex PCR test used in the study tested for 12 gastrointestinal pathogenic bacteria, 4 parasites, and 5 viruses.
As expected, PCR testing yielded a higher positive test rate than conventional stool testing, even when EIA tests were included (29.2% vs. 4.1%). In the 2,746 patients with a positive GI PCR test, a total of 3,804 pathogens were identified. Adenovirus accounted for 39% of these positive results. Positive bacterial results were seen in about 65.0% of the positive subgroup, with Escherichia coli subtypes seen in 51.7% of the positive tests.
Overall, positive results for viruses, bacteria, and multiple pathogens were more likely with GI PCR testing, compared with conventional testing (P = .001 for all). Parasites accounted for only 8.2% of the positive PCR test results, but this was significantly more than the 3.7% seen with conventional testing (P = .011).
At the 14-day mark post testing, “Patients who underwent a GI panel were less likely to be prescribed any antibiotic. But overall, antibiotics were fairly common in both groups,” said Dr. Axelrad, noting that 41% of patients who underwent stool culture received an antibiotic by 14 days, compared with 36% for patients who underwent a GI PCR panel (P = .001).
By the end of 30 days, most patients in each group had not received an endoscopic procedure, with significantly more procedure-free patients in the PCR group (91.6% vs. 90.4%; P = .008).
Against a backdrop of slightly higher overall radiology utilization in the PCR group – potentially attributable to practice trends over time – abdominal radiology was less likely for these patients than for the culture group (11.4% vs. 12.8%; P = .011).
The 30-day ED visit rate was low and similar between groups (11.4% for PCR vs. 12.8% for culture; P = .116).
The much quicker turnaround for the GI PCR panel didn’t translate into a shorter length of stay, though: Inpatient length of stay was a median 5 days in both groups.
“We feel that the outcomes that we noted were likely due to the increased sensitivity and specificity” of the PCR-based testing, said Dr. Axelrad. “Obviously, if you have more pathogen-positive findings, you may be less likely to order extensive testing. And if you’ve identified something like norovirus, you may feel reassured, and not order further testing.”
Dr. Axelrad pointed out that his institution’s overall PCR positivity rates were lower than the 70% rates some other studies have reported. “We feel that, given our large sample size, our results may more accurately reflect clinical practice, and perhaps that lower positivity rate may reflect increased use of this test in an inpatient setting,” he said. “We’re looking at that.”
Study limitations included the retrospective nature of the study. “Also, as we all know, PCR testing fails to discriminate between active infection and asymptomatic colonization,” raising questions about whether a positive PCR test really indicates true infection, noted Dr. Axelrad.
“Coupled with a high-sensitivity rapid turnaround, there’s the potential to reduce costs, but the cost-effectiveness of these assays has not been fully determined. There are several studies looking at this,” with results still to come, he said.
The notable reduction in antibiotic prescribing for those patients who received PCR-based testing means that GI PCR panels could be a useful tool to promote antibiotic stewardship, though Dr. Axelrad also noted that “antibiotics were still used in about a third of all patients.”
Dr. Axelrad reported no outside sources of funding. He has performed consulting services for and received research funding from BioFire, which manufactured the GI PCR assay used in the study, but BioFire did not fund this research.
SOURCE: Axelrad J et al. DDW 2019, Presentation 978.
REPORTING FROM DDW 2019
Novel oral drug shows early promise for IBD
SAN DIEGO – A novel oral drug for inflammatory bowel disease showed good safety and efficacy data in preliminary clinical trial results.
Among a group of 32 patients with ulcerative colitis, the investigative drug ABX464 showed a decrease in Mayo score of over 50% and a drop in fecal calprotectin to near-normal levels. The safety profile was reassuring, and results were durable at the 9-month mark.
Coauthor Jean-Marc Steens, MD, presented results of the randomized, double-blind, placebo-controlled phase 2a study at the annual Digestive Disease Week®, and noted that ABX464 is also being investigated as antiviral therapy for individuals with HIV/AIDS.
“Despite the major advances in the last 10 years with the introduction of biologics and [Janus kinase] inhibitors, there is still a huge unmet medical need for these patients,” said Dr. Steens, chief medical officer of Abivax (Paris), in an interview. “Large phase 3 studies with these recent drugs have shown that about two-thirds of the patients show a clinical response during induction, but that half of these responders will lose their response within the next 6-12 months. The safety profile of these drugs also includes severe infections, which is a major concern,” he said.
Dr. Steens presented the findings on behalf of first author Severine Vermeire, MD, chair of the department of chronic diseases, metabolism, and aging at Catholic University, Leuven, Belgium.
ABX464, a small-molecule oral medication, has been evaluated for safety among more than 180 patients with HIV as well as the patients with ulcerative colitis (UC) studied in the current trial. The drug increases expression of the microRNA precursor miR-124, with the result that “the inflammatory brake is applied,” explained Dr. Steens.
In the present study, whose primary outcome was safety, 23 patients with moderate to severe active UC were randomized to ABX464 50 mg once daily, and 9 to placebo. Patients were included if they had failed or were intolerant to immunomodulators, anti–tumor necrosis factor–alpha therapies, vedolizumab, or corticosteroids; the two groups had balanced disease and demographic characteristics. At baseline, patients had a total Mayo score of 6-12, and an endoscopic subscore of 2 or 3.
Three patients withdrew from the ABX464 arm by the end of 8 weeks: one because of adverse events (AEs), one withdrew consent, and the third declined to undergo endoscopy at the 8-week mark.
All treatment-emergent AEs were mild or moderate, with gastrointestinal disorders occurring in eight of the ABX464 patients and two placebo patients (34.8% and 22.2%, respectively.) Five ABX-464 patients (21.7%) experienced nervous system symptoms – mostly headaches, said Dr. Steens. No patients in the placebo arm had headache or other neurological AEs.
By the end of 8 weeks, 30% of the intention-to-treat ABX464 group was in clinical remission, compared with 11% of the placebo group; this was not a statistically significant difference (P = .16). The proportion of ABX464 patients who had a clinical response just missed statistical significance, compared with placebo (61% versus 33%; P = 06).
However, significant endoscopic improvement was seen in the ABX464 arm, with 43% having a Mayo endoscopy subscore of 0 or 1, compared with 11% in the placebo arm (P = .03).
The total Mayo score dropped by 53% in the ABX464 group, compared with 27% in the placebo group (P = .03); a partial Mayo score dropped by 62% for those in the active arm, compared with 32% in the placebo arm (P = .02).
“The major finding from the induction study was that all endpoints were going in the same direction in favor of ABX464, even reaching statistical significance for endoscopy as well, and total and partial Mayo score,” said Dr. Steens.
Patients underwent rectal biopsies at the end of 8 weeks, and miR-124 expression increased more than sevenfold from baseline for those taking ABX464, compared with a small increase in the placebo group (7.69- versus 1.46-fold; P = .004). Expression of miR-124 in total blood also increased – by over 800-fold – at study day 28 for the ABX464 arm. Levels were sustained at more than 700-fold at study day 56 in this group. Placebo arm participants saw an insignificant rise in miR-124 blood levels.
Dr. Steens reported that 22 patients, including 7 who had originally been placebo arm participants, continued into the maintenance phase of the study. Nineteen patients have now had a median of over 400 days of exposure to ABX464, with sustained significant improvement in partial Mayo scores from a baseline of 6 to scores below 2 at 6 and 9 months. Fecal calprotectin scores have dropped from a median 1,044 mcg/g at baseline to 23.5 mcg/g at 9 months.
Next steps include the 12-month assessment, which includes another endoscopy, said Dr. Steens. Also, a phase 2b study is seeking to enroll 232 patients who have moderate to severe ulcerative colitis, with room within the enrollment scheme for new study sites, said Dr. Steens. This larger study will have arms in which the current 50-mg oral dose is doubled and halved, as well as a placebo arm, he said. The medication will also be trialed for Crohn’s disease and rheumatoid arthritis.
The small sample size is an inherent limitation of this early-stage clinical trial, noted Dr. Steens.
Dr. Steens reported being an employee and holding shares in Abivax, which funded the study.
SOURCE: Vermeire S et al. DDW 2019, Abstract 1007.
SAN DIEGO – A novel oral drug for inflammatory bowel disease showed good safety and efficacy data in preliminary clinical trial results.
Among a group of 32 patients with ulcerative colitis, the investigative drug ABX464 showed a decrease in Mayo score of over 50% and a drop in fecal calprotectin to near-normal levels. The safety profile was reassuring, and results were durable at the 9-month mark.
Coauthor Jean-Marc Steens, MD, presented results of the randomized, double-blind, placebo-controlled phase 2a study at the annual Digestive Disease Week®, and noted that ABX464 is also being investigated as antiviral therapy for individuals with HIV/AIDS.
“Despite the major advances in the last 10 years with the introduction of biologics and [Janus kinase] inhibitors, there is still a huge unmet medical need for these patients,” said Dr. Steens, chief medical officer of Abivax (Paris), in an interview. “Large phase 3 studies with these recent drugs have shown that about two-thirds of the patients show a clinical response during induction, but that half of these responders will lose their response within the next 6-12 months. The safety profile of these drugs also includes severe infections, which is a major concern,” he said.
Dr. Steens presented the findings on behalf of first author Severine Vermeire, MD, chair of the department of chronic diseases, metabolism, and aging at Catholic University, Leuven, Belgium.
ABX464, a small-molecule oral medication, has been evaluated for safety among more than 180 patients with HIV as well as the patients with ulcerative colitis (UC) studied in the current trial. The drug increases expression of the microRNA precursor miR-124, with the result that “the inflammatory brake is applied,” explained Dr. Steens.
In the present study, whose primary outcome was safety, 23 patients with moderate to severe active UC were randomized to ABX464 50 mg once daily, and 9 to placebo. Patients were included if they had failed or were intolerant to immunomodulators, anti–tumor necrosis factor–alpha therapies, vedolizumab, or corticosteroids; the two groups had balanced disease and demographic characteristics. At baseline, patients had a total Mayo score of 6-12, and an endoscopic subscore of 2 or 3.
Three patients withdrew from the ABX464 arm by the end of 8 weeks: one because of adverse events (AEs), one withdrew consent, and the third declined to undergo endoscopy at the 8-week mark.
All treatment-emergent AEs were mild or moderate, with gastrointestinal disorders occurring in eight of the ABX464 patients and two placebo patients (34.8% and 22.2%, respectively.) Five ABX-464 patients (21.7%) experienced nervous system symptoms – mostly headaches, said Dr. Steens. No patients in the placebo arm had headache or other neurological AEs.
By the end of 8 weeks, 30% of the intention-to-treat ABX464 group was in clinical remission, compared with 11% of the placebo group; this was not a statistically significant difference (P = .16). The proportion of ABX464 patients who had a clinical response just missed statistical significance, compared with placebo (61% versus 33%; P = 06).
However, significant endoscopic improvement was seen in the ABX464 arm, with 43% having a Mayo endoscopy subscore of 0 or 1, compared with 11% in the placebo arm (P = .03).
The total Mayo score dropped by 53% in the ABX464 group, compared with 27% in the placebo group (P = .03); a partial Mayo score dropped by 62% for those in the active arm, compared with 32% in the placebo arm (P = .02).
“The major finding from the induction study was that all endpoints were going in the same direction in favor of ABX464, even reaching statistical significance for endoscopy as well, and total and partial Mayo score,” said Dr. Steens.
Patients underwent rectal biopsies at the end of 8 weeks, and miR-124 expression increased more than sevenfold from baseline for those taking ABX464, compared with a small increase in the placebo group (7.69- versus 1.46-fold; P = .004). Expression of miR-124 in total blood also increased – by over 800-fold – at study day 28 for the ABX464 arm. Levels were sustained at more than 700-fold at study day 56 in this group. Placebo arm participants saw an insignificant rise in miR-124 blood levels.
Dr. Steens reported that 22 patients, including 7 who had originally been placebo arm participants, continued into the maintenance phase of the study. Nineteen patients have now had a median of over 400 days of exposure to ABX464, with sustained significant improvement in partial Mayo scores from a baseline of 6 to scores below 2 at 6 and 9 months. Fecal calprotectin scores have dropped from a median 1,044 mcg/g at baseline to 23.5 mcg/g at 9 months.
Next steps include the 12-month assessment, which includes another endoscopy, said Dr. Steens. Also, a phase 2b study is seeking to enroll 232 patients who have moderate to severe ulcerative colitis, with room within the enrollment scheme for new study sites, said Dr. Steens. This larger study will have arms in which the current 50-mg oral dose is doubled and halved, as well as a placebo arm, he said. The medication will also be trialed for Crohn’s disease and rheumatoid arthritis.
The small sample size is an inherent limitation of this early-stage clinical trial, noted Dr. Steens.
Dr. Steens reported being an employee and holding shares in Abivax, which funded the study.
SOURCE: Vermeire S et al. DDW 2019, Abstract 1007.
SAN DIEGO – A novel oral drug for inflammatory bowel disease showed good safety and efficacy data in preliminary clinical trial results.
Among a group of 32 patients with ulcerative colitis, the investigative drug ABX464 showed a decrease in Mayo score of over 50% and a drop in fecal calprotectin to near-normal levels. The safety profile was reassuring, and results were durable at the 9-month mark.
Coauthor Jean-Marc Steens, MD, presented results of the randomized, double-blind, placebo-controlled phase 2a study at the annual Digestive Disease Week®, and noted that ABX464 is also being investigated as antiviral therapy for individuals with HIV/AIDS.
“Despite the major advances in the last 10 years with the introduction of biologics and [Janus kinase] inhibitors, there is still a huge unmet medical need for these patients,” said Dr. Steens, chief medical officer of Abivax (Paris), in an interview. “Large phase 3 studies with these recent drugs have shown that about two-thirds of the patients show a clinical response during induction, but that half of these responders will lose their response within the next 6-12 months. The safety profile of these drugs also includes severe infections, which is a major concern,” he said.
Dr. Steens presented the findings on behalf of first author Severine Vermeire, MD, chair of the department of chronic diseases, metabolism, and aging at Catholic University, Leuven, Belgium.
ABX464, a small-molecule oral medication, has been evaluated for safety among more than 180 patients with HIV as well as the patients with ulcerative colitis (UC) studied in the current trial. The drug increases expression of the microRNA precursor miR-124, with the result that “the inflammatory brake is applied,” explained Dr. Steens.
In the present study, whose primary outcome was safety, 23 patients with moderate to severe active UC were randomized to ABX464 50 mg once daily, and 9 to placebo. Patients were included if they had failed or were intolerant to immunomodulators, anti–tumor necrosis factor–alpha therapies, vedolizumab, or corticosteroids; the two groups had balanced disease and demographic characteristics. At baseline, patients had a total Mayo score of 6-12, and an endoscopic subscore of 2 or 3.
Three patients withdrew from the ABX464 arm by the end of 8 weeks: one because of adverse events (AEs), one withdrew consent, and the third declined to undergo endoscopy at the 8-week mark.
All treatment-emergent AEs were mild or moderate, with gastrointestinal disorders occurring in eight of the ABX464 patients and two placebo patients (34.8% and 22.2%, respectively.) Five ABX-464 patients (21.7%) experienced nervous system symptoms – mostly headaches, said Dr. Steens. No patients in the placebo arm had headache or other neurological AEs.
By the end of 8 weeks, 30% of the intention-to-treat ABX464 group was in clinical remission, compared with 11% of the placebo group; this was not a statistically significant difference (P = .16). The proportion of ABX464 patients who had a clinical response just missed statistical significance, compared with placebo (61% versus 33%; P = 06).
However, significant endoscopic improvement was seen in the ABX464 arm, with 43% having a Mayo endoscopy subscore of 0 or 1, compared with 11% in the placebo arm (P = .03).
The total Mayo score dropped by 53% in the ABX464 group, compared with 27% in the placebo group (P = .03); a partial Mayo score dropped by 62% for those in the active arm, compared with 32% in the placebo arm (P = .02).
“The major finding from the induction study was that all endpoints were going in the same direction in favor of ABX464, even reaching statistical significance for endoscopy as well, and total and partial Mayo score,” said Dr. Steens.
Patients underwent rectal biopsies at the end of 8 weeks, and miR-124 expression increased more than sevenfold from baseline for those taking ABX464, compared with a small increase in the placebo group (7.69- versus 1.46-fold; P = .004). Expression of miR-124 in total blood also increased – by over 800-fold – at study day 28 for the ABX464 arm. Levels were sustained at more than 700-fold at study day 56 in this group. Placebo arm participants saw an insignificant rise in miR-124 blood levels.
Dr. Steens reported that 22 patients, including 7 who had originally been placebo arm participants, continued into the maintenance phase of the study. Nineteen patients have now had a median of over 400 days of exposure to ABX464, with sustained significant improvement in partial Mayo scores from a baseline of 6 to scores below 2 at 6 and 9 months. Fecal calprotectin scores have dropped from a median 1,044 mcg/g at baseline to 23.5 mcg/g at 9 months.
Next steps include the 12-month assessment, which includes another endoscopy, said Dr. Steens. Also, a phase 2b study is seeking to enroll 232 patients who have moderate to severe ulcerative colitis, with room within the enrollment scheme for new study sites, said Dr. Steens. This larger study will have arms in which the current 50-mg oral dose is doubled and halved, as well as a placebo arm, he said. The medication will also be trialed for Crohn’s disease and rheumatoid arthritis.
The small sample size is an inherent limitation of this early-stage clinical trial, noted Dr. Steens.
Dr. Steens reported being an employee and holding shares in Abivax, which funded the study.
SOURCE: Vermeire S et al. DDW 2019, Abstract 1007.
REPORTING FROM DDW 2019
Key clinical point: A novel oral small molecule’s potent anti-inflammatory effect over 8 weeks was associated with significant endoscopic improvement, reduced Mayo scores, and a trend toward clinical response, compared with placebo.
Major finding: Study details: Randomized, double-blind, placebo-controlled study of 32 patients with moderate to severe ulcerative colitis.
Disclosures: The study was sponsored by Abivax. Dr. Steens is an employee of and holds shares of Abivax.
Source: Vermeire S et al. DDW, Abstract 1007.
Novel molecular panel found to aid in eosinophilic gastritis diagnosis
SAN DIEGO – A new scoring system based on a set of 18 informative genes was sufficient to diagnose cases of eosinophilic gastritis, results from a molecular analysis showed.
The system, known as EG diagnostic panel 18 (EGDP18), “can provide clinicians with a better diagnostic classification of ambiguous cases of eosinophilic gastritis, indicating a strong correlation with disease severity,” lead study author Tetsuo Shoda, MD, PhD, said at the annual Digestive Disease Week®.“The EG molecular profile also strongly correlates with particular endoscopic and histological features, thus providing insight into pathogenesis for EG.”
In an effort to develop an EG diagnostic panel, to validate its utility for EG diagnosis and management, and to better understand disease pathogenesis, Dr. Shoda and his colleagues used RNA sequencing to generate genome-wide gene expression profiles from gastric biopsies. Next, they developed an EG diagnostic panel focusing on a set of 48 informative genes, and analyzed its performance in a discovery cohort (55 EG and 39 controls) and subsequently an independent validation cohort (67 EG and 27 controls). The EGDP score was calculated by summation of delta CT values of the most highly dysregulated 18 genes. For diagnosis, the researchers calculated the area under the receiver operating characteristic curve (AUC), and used Spearman correlation to analyze associations.
Dr. Shoda, a research fellow at Cincinnati Children’s Hospital Medical Center, reported that the EGDP18 score identified active EG patients in both cohorts (P less than .0001, AUC equal to or greater than 0.95). In the discovery cohort, a score of less than zero resulted in a sensitivity of 95.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.8%. In the validation cohort, a score of less than zero resulted in a sensitivity of 88.9%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 94.1%.
The researchers observed a significant inverse correlation between the EGDP18 score and gastric eosinophil counts cross-sectionally and longitudinally. The score also showed comparable levels and high correlation between the gastric antrum and body. In addition, when analyzed by EGDP18 score, 63% of ambiguous tissue eosinophils were found to be molecularly equivalent to active EG, “suggesting the capacity to offer an objective cutoff for EG diagnosis,” Dr. Shoda said.
The researchers reported having no financial disclosures.
SOURCE: Shoda T et al. DDW 2019, Abstract 165. doi: 10.1016/S0016-5085(19)36878-7.
SAN DIEGO – A new scoring system based on a set of 18 informative genes was sufficient to diagnose cases of eosinophilic gastritis, results from a molecular analysis showed.
The system, known as EG diagnostic panel 18 (EGDP18), “can provide clinicians with a better diagnostic classification of ambiguous cases of eosinophilic gastritis, indicating a strong correlation with disease severity,” lead study author Tetsuo Shoda, MD, PhD, said at the annual Digestive Disease Week®.“The EG molecular profile also strongly correlates with particular endoscopic and histological features, thus providing insight into pathogenesis for EG.”
In an effort to develop an EG diagnostic panel, to validate its utility for EG diagnosis and management, and to better understand disease pathogenesis, Dr. Shoda and his colleagues used RNA sequencing to generate genome-wide gene expression profiles from gastric biopsies. Next, they developed an EG diagnostic panel focusing on a set of 48 informative genes, and analyzed its performance in a discovery cohort (55 EG and 39 controls) and subsequently an independent validation cohort (67 EG and 27 controls). The EGDP score was calculated by summation of delta CT values of the most highly dysregulated 18 genes. For diagnosis, the researchers calculated the area under the receiver operating characteristic curve (AUC), and used Spearman correlation to analyze associations.
Dr. Shoda, a research fellow at Cincinnati Children’s Hospital Medical Center, reported that the EGDP18 score identified active EG patients in both cohorts (P less than .0001, AUC equal to or greater than 0.95). In the discovery cohort, a score of less than zero resulted in a sensitivity of 95.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.8%. In the validation cohort, a score of less than zero resulted in a sensitivity of 88.9%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 94.1%.
The researchers observed a significant inverse correlation between the EGDP18 score and gastric eosinophil counts cross-sectionally and longitudinally. The score also showed comparable levels and high correlation between the gastric antrum and body. In addition, when analyzed by EGDP18 score, 63% of ambiguous tissue eosinophils were found to be molecularly equivalent to active EG, “suggesting the capacity to offer an objective cutoff for EG diagnosis,” Dr. Shoda said.
The researchers reported having no financial disclosures.
SOURCE: Shoda T et al. DDW 2019, Abstract 165. doi: 10.1016/S0016-5085(19)36878-7.
SAN DIEGO – A new scoring system based on a set of 18 informative genes was sufficient to diagnose cases of eosinophilic gastritis, results from a molecular analysis showed.
The system, known as EG diagnostic panel 18 (EGDP18), “can provide clinicians with a better diagnostic classification of ambiguous cases of eosinophilic gastritis, indicating a strong correlation with disease severity,” lead study author Tetsuo Shoda, MD, PhD, said at the annual Digestive Disease Week®.“The EG molecular profile also strongly correlates with particular endoscopic and histological features, thus providing insight into pathogenesis for EG.”
In an effort to develop an EG diagnostic panel, to validate its utility for EG diagnosis and management, and to better understand disease pathogenesis, Dr. Shoda and his colleagues used RNA sequencing to generate genome-wide gene expression profiles from gastric biopsies. Next, they developed an EG diagnostic panel focusing on a set of 48 informative genes, and analyzed its performance in a discovery cohort (55 EG and 39 controls) and subsequently an independent validation cohort (67 EG and 27 controls). The EGDP score was calculated by summation of delta CT values of the most highly dysregulated 18 genes. For diagnosis, the researchers calculated the area under the receiver operating characteristic curve (AUC), and used Spearman correlation to analyze associations.
Dr. Shoda, a research fellow at Cincinnati Children’s Hospital Medical Center, reported that the EGDP18 score identified active EG patients in both cohorts (P less than .0001, AUC equal to or greater than 0.95). In the discovery cohort, a score of less than zero resulted in a sensitivity of 95.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.8%. In the validation cohort, a score of less than zero resulted in a sensitivity of 88.9%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 94.1%.
The researchers observed a significant inverse correlation between the EGDP18 score and gastric eosinophil counts cross-sectionally and longitudinally. The score also showed comparable levels and high correlation between the gastric antrum and body. In addition, when analyzed by EGDP18 score, 63% of ambiguous tissue eosinophils were found to be molecularly equivalent to active EG, “suggesting the capacity to offer an objective cutoff for EG diagnosis,” Dr. Shoda said.
The researchers reported having no financial disclosures.
SOURCE: Shoda T et al. DDW 2019, Abstract 165. doi: 10.1016/S0016-5085(19)36878-7.
REPORTING FROM DDW 2019
Persistent fatigue plagues many IBD patients
SAN DIEGO – .
“Fatigue is one of the most heard complaints in the clinic,” lead study author Nynke Z. Borren, MD, said in an interview at the annual Digestive Disease Week.® “In the past few years there has been more interest because we know there is a communication system between the gut and the brain. Some studies suggest that biologic therapy improves fatigue symptoms, but it’s really correlated with disease activity.”
In an effort to define the longitudinal trajectory of fatigue in IBD patients initiating treatment with infliximab, adalimumab, vedolizumab, or ustekinumab, Dr. Borren, a research fellow at the Massachusetts General Hospital Crohn’s and Colitis Center, Boston, and colleagues prospectively enrolled 206 patients with Crohn’s disease and 120 patients with ulcerative colitis. They used the seven-point fatigue question in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) to define fatigue. A score of four or less for this question was used to define fatigue. To validate this question, the researchers used two widely used questionnaires: the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and the Multidimensional Fatigue inventory (MFI). Next, they used multivariable regression models to examine the independent association between attainment of clinical remission and the resolution of fatigue.
Of the 326 patients, 134 initiated biologic therapy with infliximab or adalimumab, 129 with vedolizumab, and 63 with ustekinumab. Nearly two-thirds of all patients (198, or 61%) reported significant fatigue at baseline, which was associated with female sex, depressive symptoms, and disturbed sleep (P less than .001). Those reporting significant fatigue at baseline also had higher disease activity scores, compared with those without fatigue (P less than .001).
Among the 198 patients who reported fatigue at baseline, 70% remained fatigued at week 14, while 63% remained fatigued at week 30, and 61% remained fatigued at week 54. Dr. Borren and associates observed that at each of these time points, achieving clinical remission was associated with threefold lower likelihood of remaining fatigued. However, 35% of patients who achieved clinical remission experienced persistent fatigue at week 14, compared with 37% of patients at week 30 and 35% of patients at week 54.
The researchers observed no significant differences between the different therapies in the proportion of patients who remained fatigued. In addition to disease activity, disturbed sleep at baseline was associated with persistent fatigue at week 14 (OR 9.7) and at week 30 (OR 3.7).
“We think that gut dysbiosis might be involved in inducing fatigue,” Dr. Borren said. “In the beginning, we thought that it might be due to ongoing inflammation, but our research has shown that we find a less diverse gut microbiome in those patients with fatigue compared to patients without fatigue while they were in remission. There is something in the gut that influences the central nervous system. We are still exploring this.”
The researchers reported having no financial disclosures. The abstract received a “poster of distinction” honor at the meeting.
SAN DIEGO – .
“Fatigue is one of the most heard complaints in the clinic,” lead study author Nynke Z. Borren, MD, said in an interview at the annual Digestive Disease Week.® “In the past few years there has been more interest because we know there is a communication system between the gut and the brain. Some studies suggest that biologic therapy improves fatigue symptoms, but it’s really correlated with disease activity.”
In an effort to define the longitudinal trajectory of fatigue in IBD patients initiating treatment with infliximab, adalimumab, vedolizumab, or ustekinumab, Dr. Borren, a research fellow at the Massachusetts General Hospital Crohn’s and Colitis Center, Boston, and colleagues prospectively enrolled 206 patients with Crohn’s disease and 120 patients with ulcerative colitis. They used the seven-point fatigue question in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) to define fatigue. A score of four or less for this question was used to define fatigue. To validate this question, the researchers used two widely used questionnaires: the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and the Multidimensional Fatigue inventory (MFI). Next, they used multivariable regression models to examine the independent association between attainment of clinical remission and the resolution of fatigue.
Of the 326 patients, 134 initiated biologic therapy with infliximab or adalimumab, 129 with vedolizumab, and 63 with ustekinumab. Nearly two-thirds of all patients (198, or 61%) reported significant fatigue at baseline, which was associated with female sex, depressive symptoms, and disturbed sleep (P less than .001). Those reporting significant fatigue at baseline also had higher disease activity scores, compared with those without fatigue (P less than .001).
Among the 198 patients who reported fatigue at baseline, 70% remained fatigued at week 14, while 63% remained fatigued at week 30, and 61% remained fatigued at week 54. Dr. Borren and associates observed that at each of these time points, achieving clinical remission was associated with threefold lower likelihood of remaining fatigued. However, 35% of patients who achieved clinical remission experienced persistent fatigue at week 14, compared with 37% of patients at week 30 and 35% of patients at week 54.
The researchers observed no significant differences between the different therapies in the proportion of patients who remained fatigued. In addition to disease activity, disturbed sleep at baseline was associated with persistent fatigue at week 14 (OR 9.7) and at week 30 (OR 3.7).
“We think that gut dysbiosis might be involved in inducing fatigue,” Dr. Borren said. “In the beginning, we thought that it might be due to ongoing inflammation, but our research has shown that we find a less diverse gut microbiome in those patients with fatigue compared to patients without fatigue while they were in remission. There is something in the gut that influences the central nervous system. We are still exploring this.”
The researchers reported having no financial disclosures. The abstract received a “poster of distinction” honor at the meeting.
SAN DIEGO – .
“Fatigue is one of the most heard complaints in the clinic,” lead study author Nynke Z. Borren, MD, said in an interview at the annual Digestive Disease Week.® “In the past few years there has been more interest because we know there is a communication system between the gut and the brain. Some studies suggest that biologic therapy improves fatigue symptoms, but it’s really correlated with disease activity.”
In an effort to define the longitudinal trajectory of fatigue in IBD patients initiating treatment with infliximab, adalimumab, vedolizumab, or ustekinumab, Dr. Borren, a research fellow at the Massachusetts General Hospital Crohn’s and Colitis Center, Boston, and colleagues prospectively enrolled 206 patients with Crohn’s disease and 120 patients with ulcerative colitis. They used the seven-point fatigue question in the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) to define fatigue. A score of four or less for this question was used to define fatigue. To validate this question, the researchers used two widely used questionnaires: the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and the Multidimensional Fatigue inventory (MFI). Next, they used multivariable regression models to examine the independent association between attainment of clinical remission and the resolution of fatigue.
Of the 326 patients, 134 initiated biologic therapy with infliximab or adalimumab, 129 with vedolizumab, and 63 with ustekinumab. Nearly two-thirds of all patients (198, or 61%) reported significant fatigue at baseline, which was associated with female sex, depressive symptoms, and disturbed sleep (P less than .001). Those reporting significant fatigue at baseline also had higher disease activity scores, compared with those without fatigue (P less than .001).
Among the 198 patients who reported fatigue at baseline, 70% remained fatigued at week 14, while 63% remained fatigued at week 30, and 61% remained fatigued at week 54. Dr. Borren and associates observed that at each of these time points, achieving clinical remission was associated with threefold lower likelihood of remaining fatigued. However, 35% of patients who achieved clinical remission experienced persistent fatigue at week 14, compared with 37% of patients at week 30 and 35% of patients at week 54.
The researchers observed no significant differences between the different therapies in the proportion of patients who remained fatigued. In addition to disease activity, disturbed sleep at baseline was associated with persistent fatigue at week 14 (OR 9.7) and at week 30 (OR 3.7).
“We think that gut dysbiosis might be involved in inducing fatigue,” Dr. Borren said. “In the beginning, we thought that it might be due to ongoing inflammation, but our research has shown that we find a less diverse gut microbiome in those patients with fatigue compared to patients without fatigue while they were in remission. There is something in the gut that influences the central nervous system. We are still exploring this.”
The researchers reported having no financial disclosures. The abstract received a “poster of distinction” honor at the meeting.
REPORTING FROM DDW 2019
Coffee, tea, and soda all up GERD risk
SAN DIEGO – .
In an interview following the oral presentation, Raaj S. Mehta, MD, said that patients in his primary care panel at Massachusetts General Hospital, Boston, where he’s a senior resident, frequently came to him with GERD. In addition to questions about diet, patients frequently wanted to know which beverages might provoke or exacerbate their GERD.
In trying to help his patients, Dr. Mehta said he realized that there wasn’t a prospective evidence base to answer their questions about beverages and GERD, so he and his colleagues used data from the Nurses’ Health Study II (NHS II), a prospective cohort study, to look at the association between various beverages and the incidence of GERD.
“What’s exciting is that we were able to find that coffee, tea, and soda – all three – increase your risk for gastroesophageal reflux disease,” Dr. Mehta said in a video interview. “At the highest quintile level, so looking at people who consume six or more cups per day, you’re looking at maybe a 25%-35% increase in risk of reflux disease.”
There was a dose-response relationship as well: “You do see a slight increase as you go from one cup, to two, to three, and so on, all the way up to six cups” of the offending beverages, said Dr. Mehta.
Overall, the risk for GERD rose from 1.17 to 1.34 with coffee consumption as servings per day increased from less than one to six or more (P for trend less than .0001). Tea consumption was associated with increased GERD risk ranging from 1.08 to 1.26 as consumption rose (P for trend .001). For soda, the increased risk went from 1.12 at less than one serving daily, to 1.41 at four to five servings daily, and then fell to 1.29 at six or more daily servings (P for trend less than .0001).
Whether the beverages were caffeinated or not, said Dr. Mehta, only made a “minimal difference” in GERD risk.
“In contrast, we didn’t see an association for beverages like water, juice, and milk,” he said – reassuring findings in light of fruit juice’s anecdotal status as a GERD culprit.
The NHS II collected data every 2 years from 48,308 female nurses aged 42-62 years at the beginning of the study. Every 4 years dietary information was collected, and on the opposite 4-year cycle, participants answered questions about GERD. Medication use, including the incident use of proton pump inhibitors, was collected every 2 years.
Patients with baseline GERD or use of PPIs or H2 receptor antagonists were excluded from participation.
The quantity and type of beverages were assessed by food frequency questionnaires; other demographic, dietary, and medication variables were also gathered and used to adjust the statistical analysis.
A substitution analysis answered the “what-if” question of the effect of substituting two glasses of plain water daily for either coffee, tea, or soda. Dr. Mehta and colleagues saw a modest reduction in risk for GERD with this strategy.
In addition to the prospective nature of the study (abstract 514, doi: 10.1016/S0016-5085(19)37044-1), the large sample size, high follow-up rates, and well validated dietary data were all strengths, said Dr. Mehta. However, the study’s population is relatively homogeneous, and residual confounding couldn’t be excluded. Also, GERD was defined by self-report, though participants were asked to respond to clear, validated criteria.
For Dr. Mehta, he’s glad to have a clear answer to a common clinic question. “I think that this is one additional thing that I can recommend as a primary care provider to my patients when they come into my office,” he said.
Dr. Mehta reported no conflicts of interest.
Encourage your patients to visit the AGA GI Patient Center for education by specialists for patients about GERD symptoms and treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
SAN DIEGO – .
In an interview following the oral presentation, Raaj S. Mehta, MD, said that patients in his primary care panel at Massachusetts General Hospital, Boston, where he’s a senior resident, frequently came to him with GERD. In addition to questions about diet, patients frequently wanted to know which beverages might provoke or exacerbate their GERD.
In trying to help his patients, Dr. Mehta said he realized that there wasn’t a prospective evidence base to answer their questions about beverages and GERD, so he and his colleagues used data from the Nurses’ Health Study II (NHS II), a prospective cohort study, to look at the association between various beverages and the incidence of GERD.
“What’s exciting is that we were able to find that coffee, tea, and soda – all three – increase your risk for gastroesophageal reflux disease,” Dr. Mehta said in a video interview. “At the highest quintile level, so looking at people who consume six or more cups per day, you’re looking at maybe a 25%-35% increase in risk of reflux disease.”
There was a dose-response relationship as well: “You do see a slight increase as you go from one cup, to two, to three, and so on, all the way up to six cups” of the offending beverages, said Dr. Mehta.
Overall, the risk for GERD rose from 1.17 to 1.34 with coffee consumption as servings per day increased from less than one to six or more (P for trend less than .0001). Tea consumption was associated with increased GERD risk ranging from 1.08 to 1.26 as consumption rose (P for trend .001). For soda, the increased risk went from 1.12 at less than one serving daily, to 1.41 at four to five servings daily, and then fell to 1.29 at six or more daily servings (P for trend less than .0001).
Whether the beverages were caffeinated or not, said Dr. Mehta, only made a “minimal difference” in GERD risk.
“In contrast, we didn’t see an association for beverages like water, juice, and milk,” he said – reassuring findings in light of fruit juice’s anecdotal status as a GERD culprit.
The NHS II collected data every 2 years from 48,308 female nurses aged 42-62 years at the beginning of the study. Every 4 years dietary information was collected, and on the opposite 4-year cycle, participants answered questions about GERD. Medication use, including the incident use of proton pump inhibitors, was collected every 2 years.
Patients with baseline GERD or use of PPIs or H2 receptor antagonists were excluded from participation.
The quantity and type of beverages were assessed by food frequency questionnaires; other demographic, dietary, and medication variables were also gathered and used to adjust the statistical analysis.
A substitution analysis answered the “what-if” question of the effect of substituting two glasses of plain water daily for either coffee, tea, or soda. Dr. Mehta and colleagues saw a modest reduction in risk for GERD with this strategy.
In addition to the prospective nature of the study (abstract 514, doi: 10.1016/S0016-5085(19)37044-1), the large sample size, high follow-up rates, and well validated dietary data were all strengths, said Dr. Mehta. However, the study’s population is relatively homogeneous, and residual confounding couldn’t be excluded. Also, GERD was defined by self-report, though participants were asked to respond to clear, validated criteria.
For Dr. Mehta, he’s glad to have a clear answer to a common clinic question. “I think that this is one additional thing that I can recommend as a primary care provider to my patients when they come into my office,” he said.
Dr. Mehta reported no conflicts of interest.
Encourage your patients to visit the AGA GI Patient Center for education by specialists for patients about GERD symptoms and treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
SAN DIEGO – .
In an interview following the oral presentation, Raaj S. Mehta, MD, said that patients in his primary care panel at Massachusetts General Hospital, Boston, where he’s a senior resident, frequently came to him with GERD. In addition to questions about diet, patients frequently wanted to know which beverages might provoke or exacerbate their GERD.
In trying to help his patients, Dr. Mehta said he realized that there wasn’t a prospective evidence base to answer their questions about beverages and GERD, so he and his colleagues used data from the Nurses’ Health Study II (NHS II), a prospective cohort study, to look at the association between various beverages and the incidence of GERD.
“What’s exciting is that we were able to find that coffee, tea, and soda – all three – increase your risk for gastroesophageal reflux disease,” Dr. Mehta said in a video interview. “At the highest quintile level, so looking at people who consume six or more cups per day, you’re looking at maybe a 25%-35% increase in risk of reflux disease.”
There was a dose-response relationship as well: “You do see a slight increase as you go from one cup, to two, to three, and so on, all the way up to six cups” of the offending beverages, said Dr. Mehta.
Overall, the risk for GERD rose from 1.17 to 1.34 with coffee consumption as servings per day increased from less than one to six or more (P for trend less than .0001). Tea consumption was associated with increased GERD risk ranging from 1.08 to 1.26 as consumption rose (P for trend .001). For soda, the increased risk went from 1.12 at less than one serving daily, to 1.41 at four to five servings daily, and then fell to 1.29 at six or more daily servings (P for trend less than .0001).
Whether the beverages were caffeinated or not, said Dr. Mehta, only made a “minimal difference” in GERD risk.
“In contrast, we didn’t see an association for beverages like water, juice, and milk,” he said – reassuring findings in light of fruit juice’s anecdotal status as a GERD culprit.
The NHS II collected data every 2 years from 48,308 female nurses aged 42-62 years at the beginning of the study. Every 4 years dietary information was collected, and on the opposite 4-year cycle, participants answered questions about GERD. Medication use, including the incident use of proton pump inhibitors, was collected every 2 years.
Patients with baseline GERD or use of PPIs or H2 receptor antagonists were excluded from participation.
The quantity and type of beverages were assessed by food frequency questionnaires; other demographic, dietary, and medication variables were also gathered and used to adjust the statistical analysis.
A substitution analysis answered the “what-if” question of the effect of substituting two glasses of plain water daily for either coffee, tea, or soda. Dr. Mehta and colleagues saw a modest reduction in risk for GERD with this strategy.
In addition to the prospective nature of the study (abstract 514, doi: 10.1016/S0016-5085(19)37044-1), the large sample size, high follow-up rates, and well validated dietary data were all strengths, said Dr. Mehta. However, the study’s population is relatively homogeneous, and residual confounding couldn’t be excluded. Also, GERD was defined by self-report, though participants were asked to respond to clear, validated criteria.
For Dr. Mehta, he’s glad to have a clear answer to a common clinic question. “I think that this is one additional thing that I can recommend as a primary care provider to my patients when they come into my office,” he said.
Dr. Mehta reported no conflicts of interest.
Encourage your patients to visit the AGA GI Patient Center for education by specialists for patients about GERD symptoms and treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
REPORTING FROM DDW 2019
Asymptomatic gallstones seldom require surgical intervention
“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.
Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.
The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.
Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.
Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.
The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).
Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).
The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.
“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.
Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.
The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.
Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.
Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.
The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).
Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).
The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.
“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.
Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.
The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.
Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.
Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.
The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).
Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).
The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.
REPORTING FROM DDW 2019
Meta-analysis finds no link between PPI use and risk of dementia
The finding runs counter to recent studies, including a large pharmacoepidemiological claims data analysis from Germany, that propose an association between proton pump inhibitor (PPI) use and the development of dementia (JAMA Neurol. 2016;73[4]:410-6). “The issue with these studies is that they’re based on retrospective claims data and pharmacoepidemiological studies and insurance databases that don’t really give you a good causality basis,” lead study author Saad Alrajhi, MD, said in an interview at the annual Digestive Disease Week.
In an effort to better characterize the association between PPI exposure and dementia, Dr. Alrajhi, a gastroenterology fellow at McGill University, Montreal, and colleagues conducted a meta-analysis of all fully published randomized clinical trials or observational studies comparing use of PPIs and occurrence of dementia. The researchers queried Embase, MEDLINE, and ISI Web of Knowledge for relevant studies that were published from 1995 through September 2018. Next, they assessed the quality of the studies by using the Cochrane risk assessment tool for RCTs or the Newcastle-Ottawa Scale for observational studies.
As the primary outcome, the researchers compared dementia incidence after PPI exposure (experimental group) versus no PPI exposure (control group). Development of Alzheimer’s dementia was a secondary outcome. Sensitivity analyses consisted of excluding one study at a time, and assessing results among studies of highest qualities. Subgroup analyses included stratifying patients by age. To report odds ratios, Dr. Alrajhi and colleagues used fixed or random effects models based on the absence or presence of heterogeneity.
Of 549 studies assessed, 5 met the criteria for inclusion in the final analysis: 3 case-control studies and 2 cohort studies, with a total of 472,933 patients. All of the studies scored 8 or 9 on the Newcastle-Ottawa scale, indicating high quality. Significant heterogeneity was noted for all analyses. The researchers found that the incidence of dementia was not significantly increased among patients in the PPI-exposed group (odd ratio, 1.08 (95% confidence interval, 0.97-1.20; P = .18). Sensitivity analyses confirmed the robustness of the results. Subgroup analysis showed no between-group differences among studies that included a minimum age above 65 years (three studies) or less than age 65 (two studies). PPI exposure was not associated with the development of Alzheimer’s dementia (two studies) (OR, 1.32 (95% CI, 0.80-2.17; P = .27).
“In the absence of randomized trial evidence, a PPI prescribing approach based on appropriate utilization of guideline-based prescription should be done without the extra fear of the association of dementia,” Dr. Alrajhi said.
The researchers reported having no financial disclosures.
The finding runs counter to recent studies, including a large pharmacoepidemiological claims data analysis from Germany, that propose an association between proton pump inhibitor (PPI) use and the development of dementia (JAMA Neurol. 2016;73[4]:410-6). “The issue with these studies is that they’re based on retrospective claims data and pharmacoepidemiological studies and insurance databases that don’t really give you a good causality basis,” lead study author Saad Alrajhi, MD, said in an interview at the annual Digestive Disease Week.
In an effort to better characterize the association between PPI exposure and dementia, Dr. Alrajhi, a gastroenterology fellow at McGill University, Montreal, and colleagues conducted a meta-analysis of all fully published randomized clinical trials or observational studies comparing use of PPIs and occurrence of dementia. The researchers queried Embase, MEDLINE, and ISI Web of Knowledge for relevant studies that were published from 1995 through September 2018. Next, they assessed the quality of the studies by using the Cochrane risk assessment tool for RCTs or the Newcastle-Ottawa Scale for observational studies.
As the primary outcome, the researchers compared dementia incidence after PPI exposure (experimental group) versus no PPI exposure (control group). Development of Alzheimer’s dementia was a secondary outcome. Sensitivity analyses consisted of excluding one study at a time, and assessing results among studies of highest qualities. Subgroup analyses included stratifying patients by age. To report odds ratios, Dr. Alrajhi and colleagues used fixed or random effects models based on the absence or presence of heterogeneity.
Of 549 studies assessed, 5 met the criteria for inclusion in the final analysis: 3 case-control studies and 2 cohort studies, with a total of 472,933 patients. All of the studies scored 8 or 9 on the Newcastle-Ottawa scale, indicating high quality. Significant heterogeneity was noted for all analyses. The researchers found that the incidence of dementia was not significantly increased among patients in the PPI-exposed group (odd ratio, 1.08 (95% confidence interval, 0.97-1.20; P = .18). Sensitivity analyses confirmed the robustness of the results. Subgroup analysis showed no between-group differences among studies that included a minimum age above 65 years (three studies) or less than age 65 (two studies). PPI exposure was not associated with the development of Alzheimer’s dementia (two studies) (OR, 1.32 (95% CI, 0.80-2.17; P = .27).
“In the absence of randomized trial evidence, a PPI prescribing approach based on appropriate utilization of guideline-based prescription should be done without the extra fear of the association of dementia,” Dr. Alrajhi said.
The researchers reported having no financial disclosures.
The finding runs counter to recent studies, including a large pharmacoepidemiological claims data analysis from Germany, that propose an association between proton pump inhibitor (PPI) use and the development of dementia (JAMA Neurol. 2016;73[4]:410-6). “The issue with these studies is that they’re based on retrospective claims data and pharmacoepidemiological studies and insurance databases that don’t really give you a good causality basis,” lead study author Saad Alrajhi, MD, said in an interview at the annual Digestive Disease Week.
In an effort to better characterize the association between PPI exposure and dementia, Dr. Alrajhi, a gastroenterology fellow at McGill University, Montreal, and colleagues conducted a meta-analysis of all fully published randomized clinical trials or observational studies comparing use of PPIs and occurrence of dementia. The researchers queried Embase, MEDLINE, and ISI Web of Knowledge for relevant studies that were published from 1995 through September 2018. Next, they assessed the quality of the studies by using the Cochrane risk assessment tool for RCTs or the Newcastle-Ottawa Scale for observational studies.
As the primary outcome, the researchers compared dementia incidence after PPI exposure (experimental group) versus no PPI exposure (control group). Development of Alzheimer’s dementia was a secondary outcome. Sensitivity analyses consisted of excluding one study at a time, and assessing results among studies of highest qualities. Subgroup analyses included stratifying patients by age. To report odds ratios, Dr. Alrajhi and colleagues used fixed or random effects models based on the absence or presence of heterogeneity.
Of 549 studies assessed, 5 met the criteria for inclusion in the final analysis: 3 case-control studies and 2 cohort studies, with a total of 472,933 patients. All of the studies scored 8 or 9 on the Newcastle-Ottawa scale, indicating high quality. Significant heterogeneity was noted for all analyses. The researchers found that the incidence of dementia was not significantly increased among patients in the PPI-exposed group (odd ratio, 1.08 (95% confidence interval, 0.97-1.20; P = .18). Sensitivity analyses confirmed the robustness of the results. Subgroup analysis showed no between-group differences among studies that included a minimum age above 65 years (three studies) or less than age 65 (two studies). PPI exposure was not associated with the development of Alzheimer’s dementia (two studies) (OR, 1.32 (95% CI, 0.80-2.17; P = .27).
“In the absence of randomized trial evidence, a PPI prescribing approach based on appropriate utilization of guideline-based prescription should be done without the extra fear of the association of dementia,” Dr. Alrajhi said.
The researchers reported having no financial disclosures.
REPORTING FROM DDW 2019
Cultural competence behaviors linked to higher patient satisfaction scores
results from a single-center study showed.
“Cultural competence is valued by patients, and there is a potential for training providers to be more culturally competent, focusing on their behaviors,” lead study author Miquell O. Miller, MD, said at the annual Digestive Disease Week.
While the Society for Surgery of the Alimentary Tract (J Gastrointest Surg 2016;20[5]:879-84) and other medical organizations have recognized the importance of workforce diversity and cultural competence of providers, little is known of the relationship between cultural competence and patient-reported outcomes in surgery, said Dr. Miller, who is a general surgery resident at Stanford (Calif.) University. To investigate this relationship, she and her colleagues recruited surgeons, oncologists, gastroenterologists, and advanced practice providers to complete a validated online survey that measured two domains of cultural competency: awareness and behaviors. They matched these scores with the 10-item Press Ganey provider care scores from 2017 to 2018. Next, the researchers conducted a linear regression analysis with mixed effects to account for clustering of patients within providers. They also adjusted for provider bias by measuring social desirability, “which is the tendency for respondents to put a more socially appropriate answer as opposed to the true answer on the cultural competence survey,” Dr. Miller explained.
A total of 1,322 Press Ganey satisfaction surveys were available for 29 providers. Their mean age was 48 years, 59% were white, 72% were physicians, and 28% were advanced practice providers. They practiced in GI oncology (41%), gastroenterology (31%) and colorectal surgery (28%). Dr. Miller reported that providers who participated in the survey had a mean cultural awareness score of 6.2 out of a possible 7 points, while the mean cultural behavior score was a 4.1 out of a possible 7 points. She and her colleagues observed that providers who had high levels of cultural competence on the behavioral assessment were positively associated with Press Ganey patient satisfaction (P = .039).
“I think we do a poor job of training our providers to be culturally competent, but there are multiple ways to improve behaviors, by teaching people and by having real training for our providers,” Dr. Miller said.
She acknowledged certain limitations of the study, including its single-center design and the fact that not all providers had Press Ganey scores available. The study was funded by the Society for Surgery of the Alimentary Tract and the Black Academic Surgeons Resident Research Award. Dr. Miller reported having no financial disclosures.
results from a single-center study showed.
“Cultural competence is valued by patients, and there is a potential for training providers to be more culturally competent, focusing on their behaviors,” lead study author Miquell O. Miller, MD, said at the annual Digestive Disease Week.
While the Society for Surgery of the Alimentary Tract (J Gastrointest Surg 2016;20[5]:879-84) and other medical organizations have recognized the importance of workforce diversity and cultural competence of providers, little is known of the relationship between cultural competence and patient-reported outcomes in surgery, said Dr. Miller, who is a general surgery resident at Stanford (Calif.) University. To investigate this relationship, she and her colleagues recruited surgeons, oncologists, gastroenterologists, and advanced practice providers to complete a validated online survey that measured two domains of cultural competency: awareness and behaviors. They matched these scores with the 10-item Press Ganey provider care scores from 2017 to 2018. Next, the researchers conducted a linear regression analysis with mixed effects to account for clustering of patients within providers. They also adjusted for provider bias by measuring social desirability, “which is the tendency for respondents to put a more socially appropriate answer as opposed to the true answer on the cultural competence survey,” Dr. Miller explained.
A total of 1,322 Press Ganey satisfaction surveys were available for 29 providers. Their mean age was 48 years, 59% were white, 72% were physicians, and 28% were advanced practice providers. They practiced in GI oncology (41%), gastroenterology (31%) and colorectal surgery (28%). Dr. Miller reported that providers who participated in the survey had a mean cultural awareness score of 6.2 out of a possible 7 points, while the mean cultural behavior score was a 4.1 out of a possible 7 points. She and her colleagues observed that providers who had high levels of cultural competence on the behavioral assessment were positively associated with Press Ganey patient satisfaction (P = .039).
“I think we do a poor job of training our providers to be culturally competent, but there are multiple ways to improve behaviors, by teaching people and by having real training for our providers,” Dr. Miller said.
She acknowledged certain limitations of the study, including its single-center design and the fact that not all providers had Press Ganey scores available. The study was funded by the Society for Surgery of the Alimentary Tract and the Black Academic Surgeons Resident Research Award. Dr. Miller reported having no financial disclosures.
results from a single-center study showed.
“Cultural competence is valued by patients, and there is a potential for training providers to be more culturally competent, focusing on their behaviors,” lead study author Miquell O. Miller, MD, said at the annual Digestive Disease Week.
While the Society for Surgery of the Alimentary Tract (J Gastrointest Surg 2016;20[5]:879-84) and other medical organizations have recognized the importance of workforce diversity and cultural competence of providers, little is known of the relationship between cultural competence and patient-reported outcomes in surgery, said Dr. Miller, who is a general surgery resident at Stanford (Calif.) University. To investigate this relationship, she and her colleagues recruited surgeons, oncologists, gastroenterologists, and advanced practice providers to complete a validated online survey that measured two domains of cultural competency: awareness and behaviors. They matched these scores with the 10-item Press Ganey provider care scores from 2017 to 2018. Next, the researchers conducted a linear regression analysis with mixed effects to account for clustering of patients within providers. They also adjusted for provider bias by measuring social desirability, “which is the tendency for respondents to put a more socially appropriate answer as opposed to the true answer on the cultural competence survey,” Dr. Miller explained.
A total of 1,322 Press Ganey satisfaction surveys were available for 29 providers. Their mean age was 48 years, 59% were white, 72% were physicians, and 28% were advanced practice providers. They practiced in GI oncology (41%), gastroenterology (31%) and colorectal surgery (28%). Dr. Miller reported that providers who participated in the survey had a mean cultural awareness score of 6.2 out of a possible 7 points, while the mean cultural behavior score was a 4.1 out of a possible 7 points. She and her colleagues observed that providers who had high levels of cultural competence on the behavioral assessment were positively associated with Press Ganey patient satisfaction (P = .039).
“I think we do a poor job of training our providers to be culturally competent, but there are multiple ways to improve behaviors, by teaching people and by having real training for our providers,” Dr. Miller said.
She acknowledged certain limitations of the study, including its single-center design and the fact that not all providers had Press Ganey scores available. The study was funded by the Society for Surgery of the Alimentary Tract and the Black Academic Surgeons Resident Research Award. Dr. Miller reported having no financial disclosures.
REPORTING FROM DDW 2019