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The Liver Meeting 2016 debrief – key abstracts
BOSTON – Amid a plethora of quality research, several abstracts stood out at the annual meeting of the American Association for the Study of Liver Diseases, Arun J. Sanyal, MD, said during the final debrief.
He focused first on nonalcoholic fatty liver disease (NAFLD), which has lacked rigorous studies of disease evolution. Consequently, “current therapeutic development is based on small retrospective data sets with heterogenous populations,” Dr. Sanyal said. Therefore, he and his associates correlated serial biopsies with clinical data (abstract 37). The results confirmed the waxing and waning nature of NAFLD and linked regressing or progressive fibrosis to several factors, including NAFLD Disease Activity score (NAS). NAFLD and nonalcoholic steatohepatitis (NASH) are “not two different diseases, it’s the same disease,” Dr. Sanyal said. “Establishing disease activity as a driver of disease progression is highly relevant for development of noninvasive biomarkers, and also gives us a foundation for the development of clinical trials in this space.”
Several studies of NASH biomarkers yielded notable results at the meeting. In the largest study to date of circulating microRNAs as markers of NASH, (LB2) the miRNAs 34a, 122a, and 200a distinguished patients with and without NAS scores of at least 4 and at least stage 2 fibrosis with areas under the receiver operating characteristic curve (AUROC) between 0.59 and 0.80. “MicroRNAs appear promising, but likely need to be combined with additional biomarkers,” Dr. Sanyal said.
He also noted a study (abstract 40) in which metabolomics of liquid biopsies comprehensively evaluated NAFLD, including fibrosis stage, with AUROCs up to 0.95. Metabolomics “holds promise as a diagnostic tool that can be operationalized for point-of-care testing,” he said.
When it comes to NAFLD, hepatologists “often struggle with what to tell our patients about alcohol,” Dr. Sanyal said. To help clarify the issue, abstract 31 compared NAFLD patients who did or did not report habitually consuming up to two drinks a day in formal prospective questionnaires. After adjustment for baseline histology, abstainers and modest drinkers did not differ on any measure of histologic change, except that abstainers had a greater decrease in steatosis on follow-up biopsy. These findings negate several retrospective studies by suggesting that alcohol consumption does not positively affect the trajectory of NAFLD, Dr. Sanyal concluded.
Many new compounds for treating NASH are in early development, he noted. Among those further along the pipeline, the immunomodulator and CCR2/CCR5 inhibitor cenicriviroc (CVC) missed its primary endpoint (improved NAS and no worsening of fibrosis) but was associated with significantly improved fibrosis without worsening of NASH in the phase 2b CENTAUR study (LB1).
“We also saw highly promising evidence for the effects of ASK1 [apoptosis signal regulating kinase] inhibition on hepatic fibrosis and disease activity in NASH,” Dr. Sanyal added. In a randomized phase II trial (LB3), the ASK1 inhibitor GS-4997 was associated with significant improvement in fibrosis without worsening of NASH when given in combination with simtuzumab, and also improved liver stiffness and magnetic resonance imaging–estimated proton density fat fraction (MRI-PDFF). “These very promising and exciting results need confirmation in more advanced, placebo-controlled trials,” Dr. Sanyal said.
Studies of alcohol use disorders of the liver confirmed that prednisolone has marginal benefits, that the benefits of steroids in general are offset by sepsis, and that pentoxifylline produced no mortality benefit, Dr. Sanyal noted. In studies of primary biliary cirrhosis, the farnesoid-X receptor agonist obeticholic acid (OCA), which was approved by the Food and Drug Administration in 2016, was associated with significantly improved AST to Platelet Ratio Index (APRI) and liver stiffness measures by transient elastography at doses of 10 mg or titrated from 5 mg to 10 mg, with or without ursodeoxycholic acid (abstract 209). In another study, patients with PBC who received norUDCA, a side chain–shortened version of UDCA, experienced decreases in serum ALP levels that were dose dependent and differed significantly from trends in the placebo group (abstract 210).
In another study, the investigational ileal bile acid transporter inhibitor GSK2330672 was associated with significant reductions in itch, compared with placebo, and with lower serum bile acids among pruritic PBC patients (abstract 205). Treatment was associated with diarrhea, but it was usually mild and transient.
Dr. Sanyal concluded by reviewing several studies of cirrhosis and hepatic encephalopathy. In a prospective randomized controlled trial (abstract 247), lactulose with albumin significantly outperformed lactulose monotherapy for reversing hepatic encephalopathy, reducing hospital stays, and preventing mortality, especially sepsis-related death.
In another multicenter, 24-week, phase IV open-label study (abstract 248), 25% of patients experienced breakthrough hepatic encephalopathy when treated with rifaximin monotherapy, compared with only 14% of patients who received both rifaximin and lactulose.
Finally, in a phase II trial (abstract 2064), rifaximin immediate-release (40 mg) significantly outperformed placebo in terms of cirrhosis-related mortality, hospitalizations for cirrhosis, and breakthrough hepatic encephalopathy. The takeaways? “Use albumin with lactulose for acute hepatic encephalopathy,” Dr. Sanyal said. “Rifaximin with lactulose is better than rifaximin alone for secondary prophylaxis, and rifaximin immediate-release may decrease the need for hospitalization and the first bout of hepatic encephalopathy.”
The Liver Meeting next convenes October 20-24, 2017, in Washington, D.C.
Dr. Sanyal disclosed ties to Genfit, NewCo, Akarna, Elsevier, UptoDate, Novartis, Pfizer, Lilly, Astra Zeneca, and a number of other companies.
BOSTON – Amid a plethora of quality research, several abstracts stood out at the annual meeting of the American Association for the Study of Liver Diseases, Arun J. Sanyal, MD, said during the final debrief.
He focused first on nonalcoholic fatty liver disease (NAFLD), which has lacked rigorous studies of disease evolution. Consequently, “current therapeutic development is based on small retrospective data sets with heterogenous populations,” Dr. Sanyal said. Therefore, he and his associates correlated serial biopsies with clinical data (abstract 37). The results confirmed the waxing and waning nature of NAFLD and linked regressing or progressive fibrosis to several factors, including NAFLD Disease Activity score (NAS). NAFLD and nonalcoholic steatohepatitis (NASH) are “not two different diseases, it’s the same disease,” Dr. Sanyal said. “Establishing disease activity as a driver of disease progression is highly relevant for development of noninvasive biomarkers, and also gives us a foundation for the development of clinical trials in this space.”
Several studies of NASH biomarkers yielded notable results at the meeting. In the largest study to date of circulating microRNAs as markers of NASH, (LB2) the miRNAs 34a, 122a, and 200a distinguished patients with and without NAS scores of at least 4 and at least stage 2 fibrosis with areas under the receiver operating characteristic curve (AUROC) between 0.59 and 0.80. “MicroRNAs appear promising, but likely need to be combined with additional biomarkers,” Dr. Sanyal said.
He also noted a study (abstract 40) in which metabolomics of liquid biopsies comprehensively evaluated NAFLD, including fibrosis stage, with AUROCs up to 0.95. Metabolomics “holds promise as a diagnostic tool that can be operationalized for point-of-care testing,” he said.
When it comes to NAFLD, hepatologists “often struggle with what to tell our patients about alcohol,” Dr. Sanyal said. To help clarify the issue, abstract 31 compared NAFLD patients who did or did not report habitually consuming up to two drinks a day in formal prospective questionnaires. After adjustment for baseline histology, abstainers and modest drinkers did not differ on any measure of histologic change, except that abstainers had a greater decrease in steatosis on follow-up biopsy. These findings negate several retrospective studies by suggesting that alcohol consumption does not positively affect the trajectory of NAFLD, Dr. Sanyal concluded.
Many new compounds for treating NASH are in early development, he noted. Among those further along the pipeline, the immunomodulator and CCR2/CCR5 inhibitor cenicriviroc (CVC) missed its primary endpoint (improved NAS and no worsening of fibrosis) but was associated with significantly improved fibrosis without worsening of NASH in the phase 2b CENTAUR study (LB1).
“We also saw highly promising evidence for the effects of ASK1 [apoptosis signal regulating kinase] inhibition on hepatic fibrosis and disease activity in NASH,” Dr. Sanyal added. In a randomized phase II trial (LB3), the ASK1 inhibitor GS-4997 was associated with significant improvement in fibrosis without worsening of NASH when given in combination with simtuzumab, and also improved liver stiffness and magnetic resonance imaging–estimated proton density fat fraction (MRI-PDFF). “These very promising and exciting results need confirmation in more advanced, placebo-controlled trials,” Dr. Sanyal said.
Studies of alcohol use disorders of the liver confirmed that prednisolone has marginal benefits, that the benefits of steroids in general are offset by sepsis, and that pentoxifylline produced no mortality benefit, Dr. Sanyal noted. In studies of primary biliary cirrhosis, the farnesoid-X receptor agonist obeticholic acid (OCA), which was approved by the Food and Drug Administration in 2016, was associated with significantly improved AST to Platelet Ratio Index (APRI) and liver stiffness measures by transient elastography at doses of 10 mg or titrated from 5 mg to 10 mg, with or without ursodeoxycholic acid (abstract 209). In another study, patients with PBC who received norUDCA, a side chain–shortened version of UDCA, experienced decreases in serum ALP levels that were dose dependent and differed significantly from trends in the placebo group (abstract 210).
In another study, the investigational ileal bile acid transporter inhibitor GSK2330672 was associated with significant reductions in itch, compared with placebo, and with lower serum bile acids among pruritic PBC patients (abstract 205). Treatment was associated with diarrhea, but it was usually mild and transient.
Dr. Sanyal concluded by reviewing several studies of cirrhosis and hepatic encephalopathy. In a prospective randomized controlled trial (abstract 247), lactulose with albumin significantly outperformed lactulose monotherapy for reversing hepatic encephalopathy, reducing hospital stays, and preventing mortality, especially sepsis-related death.
In another multicenter, 24-week, phase IV open-label study (abstract 248), 25% of patients experienced breakthrough hepatic encephalopathy when treated with rifaximin monotherapy, compared with only 14% of patients who received both rifaximin and lactulose.
Finally, in a phase II trial (abstract 2064), rifaximin immediate-release (40 mg) significantly outperformed placebo in terms of cirrhosis-related mortality, hospitalizations for cirrhosis, and breakthrough hepatic encephalopathy. The takeaways? “Use albumin with lactulose for acute hepatic encephalopathy,” Dr. Sanyal said. “Rifaximin with lactulose is better than rifaximin alone for secondary prophylaxis, and rifaximin immediate-release may decrease the need for hospitalization and the first bout of hepatic encephalopathy.”
The Liver Meeting next convenes October 20-24, 2017, in Washington, D.C.
Dr. Sanyal disclosed ties to Genfit, NewCo, Akarna, Elsevier, UptoDate, Novartis, Pfizer, Lilly, Astra Zeneca, and a number of other companies.
BOSTON – Amid a plethora of quality research, several abstracts stood out at the annual meeting of the American Association for the Study of Liver Diseases, Arun J. Sanyal, MD, said during the final debrief.
He focused first on nonalcoholic fatty liver disease (NAFLD), which has lacked rigorous studies of disease evolution. Consequently, “current therapeutic development is based on small retrospective data sets with heterogenous populations,” Dr. Sanyal said. Therefore, he and his associates correlated serial biopsies with clinical data (abstract 37). The results confirmed the waxing and waning nature of NAFLD and linked regressing or progressive fibrosis to several factors, including NAFLD Disease Activity score (NAS). NAFLD and nonalcoholic steatohepatitis (NASH) are “not two different diseases, it’s the same disease,” Dr. Sanyal said. “Establishing disease activity as a driver of disease progression is highly relevant for development of noninvasive biomarkers, and also gives us a foundation for the development of clinical trials in this space.”
Several studies of NASH biomarkers yielded notable results at the meeting. In the largest study to date of circulating microRNAs as markers of NASH, (LB2) the miRNAs 34a, 122a, and 200a distinguished patients with and without NAS scores of at least 4 and at least stage 2 fibrosis with areas under the receiver operating characteristic curve (AUROC) between 0.59 and 0.80. “MicroRNAs appear promising, but likely need to be combined with additional biomarkers,” Dr. Sanyal said.
He also noted a study (abstract 40) in which metabolomics of liquid biopsies comprehensively evaluated NAFLD, including fibrosis stage, with AUROCs up to 0.95. Metabolomics “holds promise as a diagnostic tool that can be operationalized for point-of-care testing,” he said.
When it comes to NAFLD, hepatologists “often struggle with what to tell our patients about alcohol,” Dr. Sanyal said. To help clarify the issue, abstract 31 compared NAFLD patients who did or did not report habitually consuming up to two drinks a day in formal prospective questionnaires. After adjustment for baseline histology, abstainers and modest drinkers did not differ on any measure of histologic change, except that abstainers had a greater decrease in steatosis on follow-up biopsy. These findings negate several retrospective studies by suggesting that alcohol consumption does not positively affect the trajectory of NAFLD, Dr. Sanyal concluded.
Many new compounds for treating NASH are in early development, he noted. Among those further along the pipeline, the immunomodulator and CCR2/CCR5 inhibitor cenicriviroc (CVC) missed its primary endpoint (improved NAS and no worsening of fibrosis) but was associated with significantly improved fibrosis without worsening of NASH in the phase 2b CENTAUR study (LB1).
“We also saw highly promising evidence for the effects of ASK1 [apoptosis signal regulating kinase] inhibition on hepatic fibrosis and disease activity in NASH,” Dr. Sanyal added. In a randomized phase II trial (LB3), the ASK1 inhibitor GS-4997 was associated with significant improvement in fibrosis without worsening of NASH when given in combination with simtuzumab, and also improved liver stiffness and magnetic resonance imaging–estimated proton density fat fraction (MRI-PDFF). “These very promising and exciting results need confirmation in more advanced, placebo-controlled trials,” Dr. Sanyal said.
Studies of alcohol use disorders of the liver confirmed that prednisolone has marginal benefits, that the benefits of steroids in general are offset by sepsis, and that pentoxifylline produced no mortality benefit, Dr. Sanyal noted. In studies of primary biliary cirrhosis, the farnesoid-X receptor agonist obeticholic acid (OCA), which was approved by the Food and Drug Administration in 2016, was associated with significantly improved AST to Platelet Ratio Index (APRI) and liver stiffness measures by transient elastography at doses of 10 mg or titrated from 5 mg to 10 mg, with or without ursodeoxycholic acid (abstract 209). In another study, patients with PBC who received norUDCA, a side chain–shortened version of UDCA, experienced decreases in serum ALP levels that were dose dependent and differed significantly from trends in the placebo group (abstract 210).
In another study, the investigational ileal bile acid transporter inhibitor GSK2330672 was associated with significant reductions in itch, compared with placebo, and with lower serum bile acids among pruritic PBC patients (abstract 205). Treatment was associated with diarrhea, but it was usually mild and transient.
Dr. Sanyal concluded by reviewing several studies of cirrhosis and hepatic encephalopathy. In a prospective randomized controlled trial (abstract 247), lactulose with albumin significantly outperformed lactulose monotherapy for reversing hepatic encephalopathy, reducing hospital stays, and preventing mortality, especially sepsis-related death.
In another multicenter, 24-week, phase IV open-label study (abstract 248), 25% of patients experienced breakthrough hepatic encephalopathy when treated with rifaximin monotherapy, compared with only 14% of patients who received both rifaximin and lactulose.
Finally, in a phase II trial (abstract 2064), rifaximin immediate-release (40 mg) significantly outperformed placebo in terms of cirrhosis-related mortality, hospitalizations for cirrhosis, and breakthrough hepatic encephalopathy. The takeaways? “Use albumin with lactulose for acute hepatic encephalopathy,” Dr. Sanyal said. “Rifaximin with lactulose is better than rifaximin alone for secondary prophylaxis, and rifaximin immediate-release may decrease the need for hospitalization and the first bout of hepatic encephalopathy.”
The Liver Meeting next convenes October 20-24, 2017, in Washington, D.C.
Dr. Sanyal disclosed ties to Genfit, NewCo, Akarna, Elsevier, UptoDate, Novartis, Pfizer, Lilly, Astra Zeneca, and a number of other companies.
AT THE LIVER MEETING 2016
VIDEO: Hepato-adrenal syndrome is an under-recognized source of ICU morbidity
BOSTON – Patients with serious liver disease who also had hepato-adrenal syndrome had significantly longer hospital stays; these patients had significantly longer ICU courses as well.
According to a recent study of this under-recognized syndrome, patients with cirrhosis, acute liver failure, or acute liver injury who also had clinically significant adrenocortical dysfunction had longer hospital stays when compared to patients without hepato-adrenal syndrome (HAS).
Presenting the study findings at a poster session at the annual meeting of the American Association for the Study of Liver Disease, Christina Lindenmeyer, MD, and her associates noted that the longer stays for HAS patients with serious liver disease held true even after adjustment for gender, blood glucose levels, and Child-Pugh score (median 29 days, HAS; 17 days, non-HAS; P = .001).
Further, the patients with HAS were more likely to have a prolonged ICU stay, after multivariable analysis adjusted for a variety of factors including the need for mechanical ventilation, age, bilirubin level, Model for End-stage Liver Disease (MELD) score, and severity of encephalopathy (13.5 vs. 4.9 days; P = .002).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Patients with cirrhosis commonly have hypotension, and I think it’s underrecognized that the elevated levels of endotoxin and the low levels of lipoprotein circulating in patients with cirrhosis can lead to adrenocortical dysfunction,” Dr. Lindenmeyer said in a video interview.
The single-center study enrolled ICU patients with cirrhosis, acute liver injury, and/or acute liver failure who had random cortisol or adrenocorticotropin-releasing hormone (ACTH) stimulation test results. From 2008 to 2014, the tertiary care center saw 69 patients meeting these criteria; 32 patients (46%) had HAS. The mean age was 57.4 years, and 63.8% of enrolled patients were male. There were no significant differences in these demographics between the groups. Serum bicarbonate was higher in patients with HAS (21.4 vs. 17.5 mEq/L; P = .020); other blood chemistries, mean arterial pressures, and the MELD and Child-Pugh scores did not differ significantly between groups.
Dr. Lindenmeyer, a fellow in the Cleveland Clinic’s department of gastroenterology and hepatology, said that the accepted definition of HAS is a random cortisol level of less than 15 mcg/dL in “patients who were highly stressed in the ICU, typically with respiratory failure or hypotension,” she said. For non-ICU patients, the random cortisol level should be less than 20 mcg/dL. An alternative criterion is a post-ACTH stimulation test cortisol level of less than 20 mcg/dL.
Though there was no statistically significant difference between in-hospital mortality for those patients meeting HAS criteria, the trend was actually for those patients to have lower in-hospital mortality (44% vs. 51%; P = .53). This was true even after correction for MELD scores and serum potassium levels. Dr. Lindenmeyer said these results were “a little surprising,” and noted that the study didn’t examine 90-day or 1-year mortality. “That would be something interesting to look at,” she said.
“Early recognition and treatment of HAS may improve judicious allocation of critical care and hospital resources,” wrote Dr. Lindenmeyer and her colleagues.
Dr. Lindenmeyer reported no conflicts of interest, and there were no outside sources of funding reported.
koakes@frontlinemedcom.com
On Twitter @karioakes
BOSTON – Patients with serious liver disease who also had hepato-adrenal syndrome had significantly longer hospital stays; these patients had significantly longer ICU courses as well.
According to a recent study of this under-recognized syndrome, patients with cirrhosis, acute liver failure, or acute liver injury who also had clinically significant adrenocortical dysfunction had longer hospital stays when compared to patients without hepato-adrenal syndrome (HAS).
Presenting the study findings at a poster session at the annual meeting of the American Association for the Study of Liver Disease, Christina Lindenmeyer, MD, and her associates noted that the longer stays for HAS patients with serious liver disease held true even after adjustment for gender, blood glucose levels, and Child-Pugh score (median 29 days, HAS; 17 days, non-HAS; P = .001).
Further, the patients with HAS were more likely to have a prolonged ICU stay, after multivariable analysis adjusted for a variety of factors including the need for mechanical ventilation, age, bilirubin level, Model for End-stage Liver Disease (MELD) score, and severity of encephalopathy (13.5 vs. 4.9 days; P = .002).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Patients with cirrhosis commonly have hypotension, and I think it’s underrecognized that the elevated levels of endotoxin and the low levels of lipoprotein circulating in patients with cirrhosis can lead to adrenocortical dysfunction,” Dr. Lindenmeyer said in a video interview.
The single-center study enrolled ICU patients with cirrhosis, acute liver injury, and/or acute liver failure who had random cortisol or adrenocorticotropin-releasing hormone (ACTH) stimulation test results. From 2008 to 2014, the tertiary care center saw 69 patients meeting these criteria; 32 patients (46%) had HAS. The mean age was 57.4 years, and 63.8% of enrolled patients were male. There were no significant differences in these demographics between the groups. Serum bicarbonate was higher in patients with HAS (21.4 vs. 17.5 mEq/L; P = .020); other blood chemistries, mean arterial pressures, and the MELD and Child-Pugh scores did not differ significantly between groups.
Dr. Lindenmeyer, a fellow in the Cleveland Clinic’s department of gastroenterology and hepatology, said that the accepted definition of HAS is a random cortisol level of less than 15 mcg/dL in “patients who were highly stressed in the ICU, typically with respiratory failure or hypotension,” she said. For non-ICU patients, the random cortisol level should be less than 20 mcg/dL. An alternative criterion is a post-ACTH stimulation test cortisol level of less than 20 mcg/dL.
Though there was no statistically significant difference between in-hospital mortality for those patients meeting HAS criteria, the trend was actually for those patients to have lower in-hospital mortality (44% vs. 51%; P = .53). This was true even after correction for MELD scores and serum potassium levels. Dr. Lindenmeyer said these results were “a little surprising,” and noted that the study didn’t examine 90-day or 1-year mortality. “That would be something interesting to look at,” she said.
“Early recognition and treatment of HAS may improve judicious allocation of critical care and hospital resources,” wrote Dr. Lindenmeyer and her colleagues.
Dr. Lindenmeyer reported no conflicts of interest, and there were no outside sources of funding reported.
koakes@frontlinemedcom.com
On Twitter @karioakes
BOSTON – Patients with serious liver disease who also had hepato-adrenal syndrome had significantly longer hospital stays; these patients had significantly longer ICU courses as well.
According to a recent study of this under-recognized syndrome, patients with cirrhosis, acute liver failure, or acute liver injury who also had clinically significant adrenocortical dysfunction had longer hospital stays when compared to patients without hepato-adrenal syndrome (HAS).
Presenting the study findings at a poster session at the annual meeting of the American Association for the Study of Liver Disease, Christina Lindenmeyer, MD, and her associates noted that the longer stays for HAS patients with serious liver disease held true even after adjustment for gender, blood glucose levels, and Child-Pugh score (median 29 days, HAS; 17 days, non-HAS; P = .001).
Further, the patients with HAS were more likely to have a prolonged ICU stay, after multivariable analysis adjusted for a variety of factors including the need for mechanical ventilation, age, bilirubin level, Model for End-stage Liver Disease (MELD) score, and severity of encephalopathy (13.5 vs. 4.9 days; P = .002).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Patients with cirrhosis commonly have hypotension, and I think it’s underrecognized that the elevated levels of endotoxin and the low levels of lipoprotein circulating in patients with cirrhosis can lead to adrenocortical dysfunction,” Dr. Lindenmeyer said in a video interview.
The single-center study enrolled ICU patients with cirrhosis, acute liver injury, and/or acute liver failure who had random cortisol or adrenocorticotropin-releasing hormone (ACTH) stimulation test results. From 2008 to 2014, the tertiary care center saw 69 patients meeting these criteria; 32 patients (46%) had HAS. The mean age was 57.4 years, and 63.8% of enrolled patients were male. There were no significant differences in these demographics between the groups. Serum bicarbonate was higher in patients with HAS (21.4 vs. 17.5 mEq/L; P = .020); other blood chemistries, mean arterial pressures, and the MELD and Child-Pugh scores did not differ significantly between groups.
Dr. Lindenmeyer, a fellow in the Cleveland Clinic’s department of gastroenterology and hepatology, said that the accepted definition of HAS is a random cortisol level of less than 15 mcg/dL in “patients who were highly stressed in the ICU, typically with respiratory failure or hypotension,” she said. For non-ICU patients, the random cortisol level should be less than 20 mcg/dL. An alternative criterion is a post-ACTH stimulation test cortisol level of less than 20 mcg/dL.
Though there was no statistically significant difference between in-hospital mortality for those patients meeting HAS criteria, the trend was actually for those patients to have lower in-hospital mortality (44% vs. 51%; P = .53). This was true even after correction for MELD scores and serum potassium levels. Dr. Lindenmeyer said these results were “a little surprising,” and noted that the study didn’t examine 90-day or 1-year mortality. “That would be something interesting to look at,” she said.
“Early recognition and treatment of HAS may improve judicious allocation of critical care and hospital resources,” wrote Dr. Lindenmeyer and her colleagues.
Dr. Lindenmeyer reported no conflicts of interest, and there were no outside sources of funding reported.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT THE LIVER MEETING 2016
Key clinical point:
Major finding: Patients with HAS had a longer length of hospital stay (median 29 days, HAS; 17 days, non-HAS; P = .001)
Data source: Single-center study of 69 consecutively enrolled ICU patients with serious liver disease and random cortisol or adrenocorticotropin-releasing hormone results.
Disclosures: The study investigators reported no disclosures, and no external sources of funding.
Early TIPS effective in high-risk cirrhosis patients, but still underutilized
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
AT THE LIVER MEETING
Key clinical point:
Major finding: At 1 year post procedure, early TIPS was associated with better rates of survival and lower rates of adverse events, compared with those who did not receive early TIPS.
Data source: Multicenter, international observational study between 2011 and 2015 of 671 high-risk patients with cirrhosis managed according to current guidelines.
Disclosures: Dr. Hernandez-Gea did not have any relevant disclosures.
Texas reports local Zika transmission
On Nov. 28, public health officials there reported a case of Zika virus in a Brownsville woman who hadn’t traveled to Mexico or any other area with active Zika transmission. Brownsville sits on the border of Mexico at the state’s southern tip, and is home to Aedes species mosquitoes known to carry the virus. The area had recently been sprayed for mosquitoes.
Zika’s telltale genetic thumbprint was found in the woman’s urine, but her blood was negative, so the virus could no longer be spread from her by mosquito. She was not pregnant. There are no other suspected cases of local transmission, according to Texas officials.
“We knew it was only a matter of time before we saw a Zika case spread by a mosquito in Texas,” John Hellerstedt, MD, commissioner of the Texas Department of State Health Services, said in a statement. “We still don’t believe the virus will become widespread in Texas, but there could be more cases, so people need to protect themselves from mosquito bites, especially in parts of the state that stay relatively warm in the fall and winter.”
The state public health officials recommend testing all pregnant women who have traveled – or who have sexual partners who have traveled – to areas with active Zika transmission. In addition to Mexico, the list includes Southeast Asia, Central and South America, the Caribbean, Cape Verde, and Pacific islands including Tonga, Samoa, and Papua New Guinea.
Texas officials also recommend antibody testing of pregnant women in southern Texas if they have two or more symptoms – fever, itchy rash, joint pain, and eye redness – and anyone statewide with at least three symptoms.
As of Nov. 23, a total of 4,444 Zika cases have been reported to the Centers for Disease Control and Prevention in U.S. states and the District of Columbia. Just 182 of those cases were the result of local spread by mosquitoes in Florida. Puerto Rico has reported nearly 32,000 locally-transmitted cases.
The 257 previously confirmed cases in Texas were all associated with travel. Most were in the Houston and Dallas–Fort Worth areas.
Local and state health officials are working with the CDC to pinpoint how and where the Brownsville infection occurred. Mosquitoes are being trapped, and workers are going door to door to educate people about Zika and request urine samples to screen for infection.
On Nov. 28, public health officials there reported a case of Zika virus in a Brownsville woman who hadn’t traveled to Mexico or any other area with active Zika transmission. Brownsville sits on the border of Mexico at the state’s southern tip, and is home to Aedes species mosquitoes known to carry the virus. The area had recently been sprayed for mosquitoes.
Zika’s telltale genetic thumbprint was found in the woman’s urine, but her blood was negative, so the virus could no longer be spread from her by mosquito. She was not pregnant. There are no other suspected cases of local transmission, according to Texas officials.
“We knew it was only a matter of time before we saw a Zika case spread by a mosquito in Texas,” John Hellerstedt, MD, commissioner of the Texas Department of State Health Services, said in a statement. “We still don’t believe the virus will become widespread in Texas, but there could be more cases, so people need to protect themselves from mosquito bites, especially in parts of the state that stay relatively warm in the fall and winter.”
The state public health officials recommend testing all pregnant women who have traveled – or who have sexual partners who have traveled – to areas with active Zika transmission. In addition to Mexico, the list includes Southeast Asia, Central and South America, the Caribbean, Cape Verde, and Pacific islands including Tonga, Samoa, and Papua New Guinea.
Texas officials also recommend antibody testing of pregnant women in southern Texas if they have two or more symptoms – fever, itchy rash, joint pain, and eye redness – and anyone statewide with at least three symptoms.
As of Nov. 23, a total of 4,444 Zika cases have been reported to the Centers for Disease Control and Prevention in U.S. states and the District of Columbia. Just 182 of those cases were the result of local spread by mosquitoes in Florida. Puerto Rico has reported nearly 32,000 locally-transmitted cases.
The 257 previously confirmed cases in Texas were all associated with travel. Most were in the Houston and Dallas–Fort Worth areas.
Local and state health officials are working with the CDC to pinpoint how and where the Brownsville infection occurred. Mosquitoes are being trapped, and workers are going door to door to educate people about Zika and request urine samples to screen for infection.
On Nov. 28, public health officials there reported a case of Zika virus in a Brownsville woman who hadn’t traveled to Mexico or any other area with active Zika transmission. Brownsville sits on the border of Mexico at the state’s southern tip, and is home to Aedes species mosquitoes known to carry the virus. The area had recently been sprayed for mosquitoes.
Zika’s telltale genetic thumbprint was found in the woman’s urine, but her blood was negative, so the virus could no longer be spread from her by mosquito. She was not pregnant. There are no other suspected cases of local transmission, according to Texas officials.
“We knew it was only a matter of time before we saw a Zika case spread by a mosquito in Texas,” John Hellerstedt, MD, commissioner of the Texas Department of State Health Services, said in a statement. “We still don’t believe the virus will become widespread in Texas, but there could be more cases, so people need to protect themselves from mosquito bites, especially in parts of the state that stay relatively warm in the fall and winter.”
The state public health officials recommend testing all pregnant women who have traveled – or who have sexual partners who have traveled – to areas with active Zika transmission. In addition to Mexico, the list includes Southeast Asia, Central and South America, the Caribbean, Cape Verde, and Pacific islands including Tonga, Samoa, and Papua New Guinea.
Texas officials also recommend antibody testing of pregnant women in southern Texas if they have two or more symptoms – fever, itchy rash, joint pain, and eye redness – and anyone statewide with at least three symptoms.
As of Nov. 23, a total of 4,444 Zika cases have been reported to the Centers for Disease Control and Prevention in U.S. states and the District of Columbia. Just 182 of those cases were the result of local spread by mosquitoes in Florida. Puerto Rico has reported nearly 32,000 locally-transmitted cases.
The 257 previously confirmed cases in Texas were all associated with travel. Most were in the Houston and Dallas–Fort Worth areas.
Local and state health officials are working with the CDC to pinpoint how and where the Brownsville infection occurred. Mosquitoes are being trapped, and workers are going door to door to educate people about Zika and request urine samples to screen for infection.
VIDEO: Denosumab trumps risedronate in bone building for glucocorticoid-induced osteoporosis
WASHINGTON – Denosumab built significantly more bone at the hip and lumbar spine than did risedronate when given for 1 year to patients with glucocorticoid-induced osteoporosis in an ongoing 2-year, head-to-head, randomized trial.
Denosumab (Prolia) is currently approved for the treatment of postmenopausal osteoporosis, and it performed so well in the trial that it could be put forward for the indication of glucocorticoid-induced osteoporosis as well, Kenneth Saag, MD, said at the annual meeting of the American College of Rheumatology.
“I would say there is definitely potential for this as a new therapeutic option for these patients,” he said in a video interview about the trial’s primary outcome of denosumab’s noninferiority to risedronate in percentage change in bone mineral density (BMD) at the lumbar spine after 1 year and secondary outcomes of the superiority of denosumab over risedronate in total hip and lumbar spine BMD at 1 year.
Denosumab is a particularly intriguing treatment option for patients with glucocorticoid-induced osteoporosis. They experience a double hit on bone health: increased RANKL, a protein that stimulates osteoclast development, and decreased osteoprotegerin, a protein that inhibits osteoclasts. Denosumab is a RANKL-inhibitor and, as such, tamps down on osteoclastic bone remodeling, said Dr. Saag, vice chair of the department of medicine and director of the Center for Education and Research on Therapeutics at the University of Alabama at Birmingham.
The phase III trial comprised 795 patients who were taking corticosteroids for a variety of rheumatic diseases, including rheumatoid arthritis, polymyalgia rheumatica, and systemic lupus erythematosus, and randomized them to denosumab or risedronate, which is already FDA approved for glucocorticoid-induced bone loss. Patients were randomized to 24 months of subcutaneous denosumab 60 mg given every 6 months or oral risedronate 5-mg daily. The study is still ongoing to test secondary outcomes at 24 months.
The patients were split into those who were continuing glucocorticoid therapy (505) and those who were just initiating it (290). Patients’ mean age ranged from 61 to 67 years, with the glucocorticoid-initiating group (GC-I) being somewhat older. The mean daily prednisone-equivalent dose was 16 mg in that group and 12 mg in the glucocorticoid-continuing group (GC-C). The mean BMD T-scores in the GC-C group were –1.96 at the lumbar spine and –1.56 at the total hip. In the GC-I group, BMD T-scores were –1.06 at the lumbar spine and –0.98 at the total hip.
In the GC-C group, denosumab increased BMD significantly more than risedronate at both spine and hip. At the lumbar spine, denosumab was associated with a mean increase of 4.4% over baseline, compared with a 2.3% increase with risedronate. Total hip BMD increased 2.1% with denosumab and 0.6% with risedronate.
The results were similar in the GC-I group. Denosumab increased lumbar spine BMD by 3.8% over baseline, compared with an increase of 0.8% with risedronate. Total hip BMD increased 1.7% with denosumab and 0.2% with risedronate.
Denosumab was also associated with significantly greater increases in femoral neck BMD in both groups, Dr. Saag noted. There were no significant differences in markers of bone turnover between the treatment groups. Adverse events, including pneumonia, diverticulitis, and bronchitis, were similar.
Amgen, manufacturer of denosumab, is sponsoring the 24-month study. Dr. Saag has been a consultant for Amgen. One coauthor is an employee of Amgen, and others disclosed financial relationships with Amgen and other pharmaceutical companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
WASHINGTON – Denosumab built significantly more bone at the hip and lumbar spine than did risedronate when given for 1 year to patients with glucocorticoid-induced osteoporosis in an ongoing 2-year, head-to-head, randomized trial.
Denosumab (Prolia) is currently approved for the treatment of postmenopausal osteoporosis, and it performed so well in the trial that it could be put forward for the indication of glucocorticoid-induced osteoporosis as well, Kenneth Saag, MD, said at the annual meeting of the American College of Rheumatology.
“I would say there is definitely potential for this as a new therapeutic option for these patients,” he said in a video interview about the trial’s primary outcome of denosumab’s noninferiority to risedronate in percentage change in bone mineral density (BMD) at the lumbar spine after 1 year and secondary outcomes of the superiority of denosumab over risedronate in total hip and lumbar spine BMD at 1 year.
Denosumab is a particularly intriguing treatment option for patients with glucocorticoid-induced osteoporosis. They experience a double hit on bone health: increased RANKL, a protein that stimulates osteoclast development, and decreased osteoprotegerin, a protein that inhibits osteoclasts. Denosumab is a RANKL-inhibitor and, as such, tamps down on osteoclastic bone remodeling, said Dr. Saag, vice chair of the department of medicine and director of the Center for Education and Research on Therapeutics at the University of Alabama at Birmingham.
The phase III trial comprised 795 patients who were taking corticosteroids for a variety of rheumatic diseases, including rheumatoid arthritis, polymyalgia rheumatica, and systemic lupus erythematosus, and randomized them to denosumab or risedronate, which is already FDA approved for glucocorticoid-induced bone loss. Patients were randomized to 24 months of subcutaneous denosumab 60 mg given every 6 months or oral risedronate 5-mg daily. The study is still ongoing to test secondary outcomes at 24 months.
The patients were split into those who were continuing glucocorticoid therapy (505) and those who were just initiating it (290). Patients’ mean age ranged from 61 to 67 years, with the glucocorticoid-initiating group (GC-I) being somewhat older. The mean daily prednisone-equivalent dose was 16 mg in that group and 12 mg in the glucocorticoid-continuing group (GC-C). The mean BMD T-scores in the GC-C group were –1.96 at the lumbar spine and –1.56 at the total hip. In the GC-I group, BMD T-scores were –1.06 at the lumbar spine and –0.98 at the total hip.
In the GC-C group, denosumab increased BMD significantly more than risedronate at both spine and hip. At the lumbar spine, denosumab was associated with a mean increase of 4.4% over baseline, compared with a 2.3% increase with risedronate. Total hip BMD increased 2.1% with denosumab and 0.6% with risedronate.
The results were similar in the GC-I group. Denosumab increased lumbar spine BMD by 3.8% over baseline, compared with an increase of 0.8% with risedronate. Total hip BMD increased 1.7% with denosumab and 0.2% with risedronate.
Denosumab was also associated with significantly greater increases in femoral neck BMD in both groups, Dr. Saag noted. There were no significant differences in markers of bone turnover between the treatment groups. Adverse events, including pneumonia, diverticulitis, and bronchitis, were similar.
Amgen, manufacturer of denosumab, is sponsoring the 24-month study. Dr. Saag has been a consultant for Amgen. One coauthor is an employee of Amgen, and others disclosed financial relationships with Amgen and other pharmaceutical companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
WASHINGTON – Denosumab built significantly more bone at the hip and lumbar spine than did risedronate when given for 1 year to patients with glucocorticoid-induced osteoporosis in an ongoing 2-year, head-to-head, randomized trial.
Denosumab (Prolia) is currently approved for the treatment of postmenopausal osteoporosis, and it performed so well in the trial that it could be put forward for the indication of glucocorticoid-induced osteoporosis as well, Kenneth Saag, MD, said at the annual meeting of the American College of Rheumatology.
“I would say there is definitely potential for this as a new therapeutic option for these patients,” he said in a video interview about the trial’s primary outcome of denosumab’s noninferiority to risedronate in percentage change in bone mineral density (BMD) at the lumbar spine after 1 year and secondary outcomes of the superiority of denosumab over risedronate in total hip and lumbar spine BMD at 1 year.
Denosumab is a particularly intriguing treatment option for patients with glucocorticoid-induced osteoporosis. They experience a double hit on bone health: increased RANKL, a protein that stimulates osteoclast development, and decreased osteoprotegerin, a protein that inhibits osteoclasts. Denosumab is a RANKL-inhibitor and, as such, tamps down on osteoclastic bone remodeling, said Dr. Saag, vice chair of the department of medicine and director of the Center for Education and Research on Therapeutics at the University of Alabama at Birmingham.
The phase III trial comprised 795 patients who were taking corticosteroids for a variety of rheumatic diseases, including rheumatoid arthritis, polymyalgia rheumatica, and systemic lupus erythematosus, and randomized them to denosumab or risedronate, which is already FDA approved for glucocorticoid-induced bone loss. Patients were randomized to 24 months of subcutaneous denosumab 60 mg given every 6 months or oral risedronate 5-mg daily. The study is still ongoing to test secondary outcomes at 24 months.
The patients were split into those who were continuing glucocorticoid therapy (505) and those who were just initiating it (290). Patients’ mean age ranged from 61 to 67 years, with the glucocorticoid-initiating group (GC-I) being somewhat older. The mean daily prednisone-equivalent dose was 16 mg in that group and 12 mg in the glucocorticoid-continuing group (GC-C). The mean BMD T-scores in the GC-C group were –1.96 at the lumbar spine and –1.56 at the total hip. In the GC-I group, BMD T-scores were –1.06 at the lumbar spine and –0.98 at the total hip.
In the GC-C group, denosumab increased BMD significantly more than risedronate at both spine and hip. At the lumbar spine, denosumab was associated with a mean increase of 4.4% over baseline, compared with a 2.3% increase with risedronate. Total hip BMD increased 2.1% with denosumab and 0.6% with risedronate.
The results were similar in the GC-I group. Denosumab increased lumbar spine BMD by 3.8% over baseline, compared with an increase of 0.8% with risedronate. Total hip BMD increased 1.7% with denosumab and 0.2% with risedronate.
Denosumab was also associated with significantly greater increases in femoral neck BMD in both groups, Dr. Saag noted. There were no significant differences in markers of bone turnover between the treatment groups. Adverse events, including pneumonia, diverticulitis, and bronchitis, were similar.
Amgen, manufacturer of denosumab, is sponsoring the 24-month study. Dr. Saag has been a consultant for Amgen. One coauthor is an employee of Amgen, and others disclosed financial relationships with Amgen and other pharmaceutical companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: In patients on continuous glucocorticoid therapy, denosumab increased BMD by 4.4% at the lumbar spine and 2.1% at the total hip, compared with increases of 2.3% and 0.6% with risedronate.
Data source: 12-month results of the 24-month, phase III study of 795 patients.
Disclosures: Amgen sponsored the study. Dr. Saag has been a consultant for the company. One coauthor is an employee of Amgen, and others disclosed financial relationships with Amgen and other pharmaceutical companies.
Study shows NJ tube and PEG-J on par for enteral nutrition, but each has complications
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively).
Data source: A retrospective review of 242 patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015.
Disclosures: Dr. Roch reported having no financial disclosures.
Surgery for bowel obstruction in cancer patients didn’t increase 90-day mortality
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: Compared with procedural treatment of bowel obstruction, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
Data source: A retrospective review of 490 patients with advanced cancer who required surgical consultation for bowel obstruction at MD Anderson Cancer Center, Houston, between January 2000 and May 2014.
Disclosures: Dr. Badgwell reported having no financial disclosures.
Recovery path complicated for trauma patients with VTE
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.” 
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Data source: A secondary analysis of 558 patients from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells.
Disclosures: The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
Open, laparoscopic, robotic approaches all sound for distal pancreatectomy
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Surgery was longest in the robotic group (243 minutes), but more patients in the open group needed transfusions (21% vs. 5% of the other groups).
Data source: The database review comprised 1,815 patients.
Disclosures: Dr. Xourafas had no financial disclosures.
Many premature infants receive reflux medication after NICU discharge
Three-quarters of premature infants who receive gastroesophageal reflux medications get those drugs after being discharged from neonatal intensive care units, despite questions about the safety and efficacy of the medications in premature infants.
In a retrospective study of 2,217 premature infants treated within the Children’s Hospital of Philadelphia primary care network from 2005 to 2009, 812 were treated with gastroesophageal reflux (GER) medications. Of this group, 77% were started on GER medication after neonatal intensive care unit (NICU) discharge, according to Jo Ann D’Agostino, DNP, CRNP, and her associates (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-1977).
Histamine-2 receptor antagonists were the most commonly prescribed GER medication, received by 90% of infants. Proton pump inhibitors were prescribed to 37% of infants, 22% received prokinetics, and 2% received cholinergics. During the first year of life, 40% of treated infants received multiple GER medications, with 73% of these infants receiving at least two medications simultaneously.
Risk factors associated with the use of multiple GER medications include a gestation period less than 32 weeks, feeding difficulty, tube feeding, a need for supplemental oxygen, and asthma.
“Because premature infants are a medically fragile group, the need for 1 acid suppression medication, let alone 2 or more in combination, should be given careful consideration. The potential impact of acid suppression on community-acquired illnesses has yet to be explored for this vulnerable population,” said Dr. D’Agostino of the department of pediatrics at the Children’s Hospital of Philadelphia, and her coauthors.
Infants who received GER treatment after NICU discharge were started on medication at a mean chronological age of 95 days and received medication for a mean of 294 days. Infants who started GER treatment while in the NICU received medication for a mean of 375 days.
A total of 743 infants were started on GER medications before the age of 6 months, and of this group, 43% were still being treated at the age of 1 year. Extended medication usage was associated with a gestational age under 32 weeks, chronic lung disease, airway malacia, and reactive airways disease.
A gestation period of less than 32 weeks was associated with a 31% increase in GER medication duration, compared with infants with a gestation period of 34-35 weeks, and a gestation period of less than 28 weeks was associated with a 50% increase in medication duration.
“Physiologic reflux symptoms are reported to peak at 4 months of age. Feeding issues are also common for premature infants. Whether this combination of issues is influencing the decision to start treatment, as opposed to actual GER disease, is an important distinction for providers to consider before starting medication,” Dr. D’Agostino and her associates noted.
“With uncertain evidence of efficacy, the rationale for using these medications in this high-risk population should be carefully evaluated,” they concluded.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
“Medications are frequently used to treat gastroesophageal reflux in premature infants,” wrote P. Brian Smith, MD, but “a number of these medications have been associated with significant harm” and the “short- or long-term benefits of GER medications in this population are undocumented.”
Histamine-2 receptor blockers, the most common GER medications, induce alterations to the fecal microbiota of premature infants by lowering microbial diversity and promoting overgrowth of Proteobacteria. “These alterations weaken the gastrointestinal tract’s protective barrier and render very low birth weight infants, already predisposed to [necrotizing enterocolitis] and other infections, even more vulnerable,” he noted.
“Infants receiving antacid therapy are also at increased risk of bacteremia, lower respiratory tract infections, aspiration pneumonia, and death,” he added.
“Pediatrics has a long history of widespread use of medications for which the risks did not outweigh the benefits. All drugs should be shown to be both safe and effective before use. [This study] has documented widespread, long-term use of medications that are likely neither,” he said.
Dr. Smith is with Duke University Medical Center, Durham, N.C. These comments are taken from an accompanying editorial (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-2849). Dr. Smith is a consultant for Astellas Pharma and Abbvie and receives grant support from Cempra Pharmaceuticals and Shionogi. Dr Smith receives salary support from the National Institutes of Health and the U.S. Food and Drug Administration.
“Medications are frequently used to treat gastroesophageal reflux in premature infants,” wrote P. Brian Smith, MD, but “a number of these medications have been associated with significant harm” and the “short- or long-term benefits of GER medications in this population are undocumented.”
Histamine-2 receptor blockers, the most common GER medications, induce alterations to the fecal microbiota of premature infants by lowering microbial diversity and promoting overgrowth of Proteobacteria. “These alterations weaken the gastrointestinal tract’s protective barrier and render very low birth weight infants, already predisposed to [necrotizing enterocolitis] and other infections, even more vulnerable,” he noted.
“Infants receiving antacid therapy are also at increased risk of bacteremia, lower respiratory tract infections, aspiration pneumonia, and death,” he added.
“Pediatrics has a long history of widespread use of medications for which the risks did not outweigh the benefits. All drugs should be shown to be both safe and effective before use. [This study] has documented widespread, long-term use of medications that are likely neither,” he said.
Dr. Smith is with Duke University Medical Center, Durham, N.C. These comments are taken from an accompanying editorial (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-2849). Dr. Smith is a consultant for Astellas Pharma and Abbvie and receives grant support from Cempra Pharmaceuticals and Shionogi. Dr Smith receives salary support from the National Institutes of Health and the U.S. Food and Drug Administration.
“Medications are frequently used to treat gastroesophageal reflux in premature infants,” wrote P. Brian Smith, MD, but “a number of these medications have been associated with significant harm” and the “short- or long-term benefits of GER medications in this population are undocumented.”
Histamine-2 receptor blockers, the most common GER medications, induce alterations to the fecal microbiota of premature infants by lowering microbial diversity and promoting overgrowth of Proteobacteria. “These alterations weaken the gastrointestinal tract’s protective barrier and render very low birth weight infants, already predisposed to [necrotizing enterocolitis] and other infections, even more vulnerable,” he noted.
“Infants receiving antacid therapy are also at increased risk of bacteremia, lower respiratory tract infections, aspiration pneumonia, and death,” he added.
“Pediatrics has a long history of widespread use of medications for which the risks did not outweigh the benefits. All drugs should be shown to be both safe and effective before use. [This study] has documented widespread, long-term use of medications that are likely neither,” he said.
Dr. Smith is with Duke University Medical Center, Durham, N.C. These comments are taken from an accompanying editorial (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-2849). Dr. Smith is a consultant for Astellas Pharma and Abbvie and receives grant support from Cempra Pharmaceuticals and Shionogi. Dr Smith receives salary support from the National Institutes of Health and the U.S. Food and Drug Administration.
Three-quarters of premature infants who receive gastroesophageal reflux medications get those drugs after being discharged from neonatal intensive care units, despite questions about the safety and efficacy of the medications in premature infants.
In a retrospective study of 2,217 premature infants treated within the Children’s Hospital of Philadelphia primary care network from 2005 to 2009, 812 were treated with gastroesophageal reflux (GER) medications. Of this group, 77% were started on GER medication after neonatal intensive care unit (NICU) discharge, according to Jo Ann D’Agostino, DNP, CRNP, and her associates (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-1977).
Histamine-2 receptor antagonists were the most commonly prescribed GER medication, received by 90% of infants. Proton pump inhibitors were prescribed to 37% of infants, 22% received prokinetics, and 2% received cholinergics. During the first year of life, 40% of treated infants received multiple GER medications, with 73% of these infants receiving at least two medications simultaneously.
Risk factors associated with the use of multiple GER medications include a gestation period less than 32 weeks, feeding difficulty, tube feeding, a need for supplemental oxygen, and asthma.
“Because premature infants are a medically fragile group, the need for 1 acid suppression medication, let alone 2 or more in combination, should be given careful consideration. The potential impact of acid suppression on community-acquired illnesses has yet to be explored for this vulnerable population,” said Dr. D’Agostino of the department of pediatrics at the Children’s Hospital of Philadelphia, and her coauthors.
Infants who received GER treatment after NICU discharge were started on medication at a mean chronological age of 95 days and received medication for a mean of 294 days. Infants who started GER treatment while in the NICU received medication for a mean of 375 days.
A total of 743 infants were started on GER medications before the age of 6 months, and of this group, 43% were still being treated at the age of 1 year. Extended medication usage was associated with a gestational age under 32 weeks, chronic lung disease, airway malacia, and reactive airways disease.
A gestation period of less than 32 weeks was associated with a 31% increase in GER medication duration, compared with infants with a gestation period of 34-35 weeks, and a gestation period of less than 28 weeks was associated with a 50% increase in medication duration.
“Physiologic reflux symptoms are reported to peak at 4 months of age. Feeding issues are also common for premature infants. Whether this combination of issues is influencing the decision to start treatment, as opposed to actual GER disease, is an important distinction for providers to consider before starting medication,” Dr. D’Agostino and her associates noted.
“With uncertain evidence of efficacy, the rationale for using these medications in this high-risk population should be carefully evaluated,” they concluded.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
Three-quarters of premature infants who receive gastroesophageal reflux medications get those drugs after being discharged from neonatal intensive care units, despite questions about the safety and efficacy of the medications in premature infants.
In a retrospective study of 2,217 premature infants treated within the Children’s Hospital of Philadelphia primary care network from 2005 to 2009, 812 were treated with gastroesophageal reflux (GER) medications. Of this group, 77% were started on GER medication after neonatal intensive care unit (NICU) discharge, according to Jo Ann D’Agostino, DNP, CRNP, and her associates (Pediatrics. 2016 Nov 23. doi: 10.1542/peds.2016-1977).
Histamine-2 receptor antagonists were the most commonly prescribed GER medication, received by 90% of infants. Proton pump inhibitors were prescribed to 37% of infants, 22% received prokinetics, and 2% received cholinergics. During the first year of life, 40% of treated infants received multiple GER medications, with 73% of these infants receiving at least two medications simultaneously.
Risk factors associated with the use of multiple GER medications include a gestation period less than 32 weeks, feeding difficulty, tube feeding, a need for supplemental oxygen, and asthma.
“Because premature infants are a medically fragile group, the need for 1 acid suppression medication, let alone 2 or more in combination, should be given careful consideration. The potential impact of acid suppression on community-acquired illnesses has yet to be explored for this vulnerable population,” said Dr. D’Agostino of the department of pediatrics at the Children’s Hospital of Philadelphia, and her coauthors.
Infants who received GER treatment after NICU discharge were started on medication at a mean chronological age of 95 days and received medication for a mean of 294 days. Infants who started GER treatment while in the NICU received medication for a mean of 375 days.
A total of 743 infants were started on GER medications before the age of 6 months, and of this group, 43% were still being treated at the age of 1 year. Extended medication usage was associated with a gestational age under 32 weeks, chronic lung disease, airway malacia, and reactive airways disease.
A gestation period of less than 32 weeks was associated with a 31% increase in GER medication duration, compared with infants with a gestation period of 34-35 weeks, and a gestation period of less than 28 weeks was associated with a 50% increase in medication duration.
“Physiologic reflux symptoms are reported to peak at 4 months of age. Feeding issues are also common for premature infants. Whether this combination of issues is influencing the decision to start treatment, as opposed to actual GER disease, is an important distinction for providers to consider before starting medication,” Dr. D’Agostino and her associates noted.
“With uncertain evidence of efficacy, the rationale for using these medications in this high-risk population should be carefully evaluated,” they concluded.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: 37% of infants in the study received GER medication, with 77% of prescriptions occurring after NICU discharge.
Data source: Retrospective study of 2,217 preterm infants in the primary care network of the Children’s Hospital of Philadelphia.
Disclosures: The study was funded by the National Institutes of Health. The authors have no relevant financial disclosures.