FLORENCE, ITALY – A novel intravenous prodrug that results in formation of nitroxyl once inside the body showed several potentially beneficial hemodynamic effects during a single, 6-hour infusion in a controlled proof-of-concept study with 46 patients hospitalized with advanced heart failure with reduced ejection fraction.

While receiving the drug, patients showed “statistically significant and clinically meaningful” reductions in pulmonary capillary wedge pressure and in pulmonary artery diastolic pressure, two of the studies three primary endpoints, Dr. Veselin Mitrovic said at a meeting held by the Heart Failure Association of the ESC.

For the study’s third primary endpoint, a change in cardiac index, treatment with the drug led to increased cardiac output using noninvasive measures, especially at the highest tested dose, as well as in all of the subset of treated patients in whom cardiac index was measured by thermodilution.

On the safety side, the drug appeared safe and well tolerated at all four tested doses, while causing no episodes of symptomatic hypotension and no increase in heart rate. Transient, asymptomatic reductions in blood pressure were similar in the treated and control patients.

Mitchel L. Zoler/Frontline Medical News

“This is a very interesting and exciting drug that went in the right direction,” summed up Dr. Mitrovic, professor of cardiology at Goethe University in Frankfurt, Germany, and head of the department of cardiovascular research at the Kerckhoff Clinic in Bad Nauheim, Germany.

“This is the first demonstration of safety and preliminary efficacy in patients with advanced heart failure,” he said in an interview. “We had a very good clinical signal in a relatively small study. We now need a larger study.”

The drug “improved myocardial function in several ways: inotropy, lusitropy, and unloading. It also causes arterial vasodilation and increased stroke volume,” Dr. Mitrovic said. “Other drugs with a positive inotropic effect increase myocardial oxygen consumption; but with this drug, we see a neutral effect on mixed venous oxygen saturation. It balances myocardial oxygen consumption by its effect on unloading and reduced vascular resistance. This is a big advantage.”

Each molecule of nitroxyl is made from single atoms of hydrogen, nitrogen, and oxygen, and its physiologic action is distinct from nitric monoxide. Nitroxyl improves calcium efficiency and recycling without producing intracellular calcium overload, and its effects are not mediated by cyclic AMP or cyclic GMP.

The dose-ranging study enrolled 34 patients with New York Heart Association class III heart failure and 11 with class IV. All patients had to have a left ventricular ejection fraction of 40% or less, and their actual ejection fractions averaged about 25%.

When measured after 2, 4, and 6 hours of infusion, pulmonary capillary wedge pressure (PCWP) fell by an average of about 5 mm Hg, compared with baseline, among patients who received the three highest-dose infusions of the nitroxyl prodrug, known as CXL-1427, and by an average of about 3 mm Hg in those who received the lowest dose.

That effect had disappeared when PCWP was remeasured 2 hours after the end of the 6-hour infusion, and the 11 patients randomized to placebo showed no change at any time point in PCWP. The average declines in PCWP in each of the four dose groups were statistically significant changes, compared with the control patients.

All the drug-treated patients showed an average drop in pulmonary artery systolic pressure of about 5 mm Hg, compared with baseline, and about 3-4 mm Hg in pulmonary artery diastolic pressure. The patients who received the highest dose of CXL-1427 had an average drop in their right artery pressure of about 4 mm Hg. All of those decreases were statistically significant, compared with the lack of any measurable changes in the control patients.

Total peripheral resistance also showed statistically significant declines relative to baseline in all the treated patients when these decreases were compared with the controls.

CXL-1427 was initially developed by Cardioxyl Pharmaceuticals. Bristol-Myers Squibb acquired the company in late 2015. The study was sponsored by Cardioxyl. Dr. Mitrovic has been a consultant to Bayer, Cardiorentis, and Novartis.

[email protected]

On Twitter @mitchelzoler

FLORENCE, ITALY – A novel intravenous prodrug that results in formation of nitroxyl once inside the body showed several potentially beneficial hemodynamic effects during a single, 6-hour infusion in a controlled proof-of-concept study with 46 patients hospitalized with advanced heart failure with reduced ejection fraction.

While receiving the drug, patients showed “statistically significant and clinically meaningful” reductions in pulmonary capillary wedge pressure and in pulmonary artery diastolic pressure, two of the studies three primary endpoints, Dr. Veselin Mitrovic said at a meeting held by the Heart Failure Association of the ESC.

For the study’s third primary endpoint, a change in cardiac index, treatment with the drug led to increased cardiac output using noninvasive measures, especially at the highest tested dose, as well as in all of the subset of treated patients in whom cardiac index was measured by thermodilution.

On the safety side, the drug appeared safe and well tolerated at all four tested doses, while causing no episodes of symptomatic hypotension and no increase in heart rate. Transient, asymptomatic reductions in blood pressure were similar in the treated and control patients.

Mitchel L. Zoler/Frontline Medical News

“This is a very interesting and exciting drug that went in the right direction,” summed up Dr. Mitrovic, professor of cardiology at Goethe University in Frankfurt, Germany, and head of the department of cardiovascular research at the Kerckhoff Clinic in Bad Nauheim, Germany.

“This is the first demonstration of safety and preliminary efficacy in patients with advanced heart failure,” he said in an interview. “We had a very good clinical signal in a relatively small study. We now need a larger study.”

The drug “improved myocardial function in several ways: inotropy, lusitropy, and unloading. It also causes arterial vasodilation and increased stroke volume,” Dr. Mitrovic said. “Other drugs with a positive inotropic effect increase myocardial oxygen consumption; but with this drug, we see a neutral effect on mixed venous oxygen saturation. It balances myocardial oxygen consumption by its effect on unloading and reduced vascular resistance. This is a big advantage.”

Each molecule of nitroxyl is made from single atoms of hydrogen, nitrogen, and oxygen, and its physiologic action is distinct from nitric monoxide. Nitroxyl improves calcium efficiency and recycling without producing intracellular calcium overload, and its effects are not mediated by cyclic AMP or cyclic GMP.

The dose-ranging study enrolled 34 patients with New York Heart Association class III heart failure and 11 with class IV. All patients had to have a left ventricular ejection fraction of 40% or less, and their actual ejection fractions averaged about 25%.

When measured after 2, 4, and 6 hours of infusion, pulmonary capillary wedge pressure (PCWP) fell by an average of about 5 mm Hg, compared with baseline, among patients who received the three highest-dose infusions of the nitroxyl prodrug, known as CXL-1427, and by an average of about 3 mm Hg in those who received the lowest dose.

That effect had disappeared when PCWP was remeasured 2 hours after the end of the 6-hour infusion, and the 11 patients randomized to placebo showed no change at any time point in PCWP. The average declines in PCWP in each of the four dose groups were statistically significant changes, compared with the control patients.

All the drug-treated patients showed an average drop in pulmonary artery systolic pressure of about 5 mm Hg, compared with baseline, and about 3-4 mm Hg in pulmonary artery diastolic pressure. The patients who received the highest dose of CXL-1427 had an average drop in their right artery pressure of about 4 mm Hg. All of those decreases were statistically significant, compared with the lack of any measurable changes in the control patients.

Total peripheral resistance also showed statistically significant declines relative to baseline in all the treated patients when these decreases were compared with the controls.

CXL-1427 was initially developed by Cardioxyl Pharmaceuticals. Bristol-Myers Squibb acquired the company in late 2015. The study was sponsored by Cardioxyl. Dr. Mitrovic has been a consultant to Bayer, Cardiorentis, and Novartis.

[email protected]

On Twitter @mitchelzoler

FLORENCE, ITALY – A novel intravenous prodrug that results in formation of nitroxyl once inside the body showed several potentially beneficial hemodynamic effects during a single, 6-hour infusion in a controlled proof-of-concept study with 46 patients hospitalized with advanced heart failure with reduced ejection fraction.

While receiving the drug, patients showed “statistically significant and clinically meaningful” reductions in pulmonary capillary wedge pressure and in pulmonary artery diastolic pressure, two of the studies three primary endpoints, Dr. Veselin Mitrovic said at a meeting held by the Heart Failure Association of the ESC.

For the study’s third primary endpoint, a change in cardiac index, treatment with the drug led to increased cardiac output using noninvasive measures, especially at the highest tested dose, as well as in all of the subset of treated patients in whom cardiac index was measured by thermodilution.

On the safety side, the drug appeared safe and well tolerated at all four tested doses, while causing no episodes of symptomatic hypotension and no increase in heart rate. Transient, asymptomatic reductions in blood pressure were similar in the treated and control patients.

Mitchel L. Zoler/Frontline Medical News

“This is a very interesting and exciting drug that went in the right direction,” summed up Dr. Mitrovic, professor of cardiology at Goethe University in Frankfurt, Germany, and head of the department of cardiovascular research at the Kerckhoff Clinic in Bad Nauheim, Germany.

“This is the first demonstration of safety and preliminary efficacy in patients with advanced heart failure,” he said in an interview. “We had a very good clinical signal in a relatively small study. We now need a larger study.”

The drug “improved myocardial function in several ways: inotropy, lusitropy, and unloading. It also causes arterial vasodilation and increased stroke volume,” Dr. Mitrovic said. “Other drugs with a positive inotropic effect increase myocardial oxygen consumption; but with this drug, we see a neutral effect on mixed venous oxygen saturation. It balances myocardial oxygen consumption by its effect on unloading and reduced vascular resistance. This is a big advantage.”

Each molecule of nitroxyl is made from single atoms of hydrogen, nitrogen, and oxygen, and its physiologic action is distinct from nitric monoxide. Nitroxyl improves calcium efficiency and recycling without producing intracellular calcium overload, and its effects are not mediated by cyclic AMP or cyclic GMP.

The dose-ranging study enrolled 34 patients with New York Heart Association class III heart failure and 11 with class IV. All patients had to have a left ventricular ejection fraction of 40% or less, and their actual ejection fractions averaged about 25%.

When measured after 2, 4, and 6 hours of infusion, pulmonary capillary wedge pressure (PCWP) fell by an average of about 5 mm Hg, compared with baseline, among patients who received the three highest-dose infusions of the nitroxyl prodrug, known as CXL-1427, and by an average of about 3 mm Hg in those who received the lowest dose.

That effect had disappeared when PCWP was remeasured 2 hours after the end of the 6-hour infusion, and the 11 patients randomized to placebo showed no change at any time point in PCWP. The average declines in PCWP in each of the four dose groups were statistically significant changes, compared with the control patients.

All the drug-treated patients showed an average drop in pulmonary artery systolic pressure of about 5 mm Hg, compared with baseline, and about 3-4 mm Hg in pulmonary artery diastolic pressure. The patients who received the highest dose of CXL-1427 had an average drop in their right artery pressure of about 4 mm Hg. All of those decreases were statistically significant, compared with the lack of any measurable changes in the control patients.

Total peripheral resistance also showed statistically significant declines relative to baseline in all the treated patients when these decreases were compared with the controls.

CXL-1427 was initially developed by Cardioxyl Pharmaceuticals. Bristol-Myers Squibb acquired the company in late 2015. The study was sponsored by Cardioxyl. Dr. Mitrovic has been a consultant to Bayer, Cardiorentis, and Novartis.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – In patients with Barrett’s esophagus (BE), acid suppression with proton pump inhibitors (PPIs) and, to a lesser extent, histamine₂ receptor antagonists (H₂RA) reduced the risk of progression to esophageal adenocarcinoma (EAC), according to the findings from a study reported at the annual Digestive Disease Week.

Both treatments were independently associated with reduced risk of progression to cancer in the nested, case-control study. Taking PPIs reduced the risk of developing EAC by 69% and taking H₂RAs reduced the risk by 45%.

“There are no concrete guidelines regarding use of PPIs for patients with Barrett’s esophagus,” said presenting author Dr Mimi C. Tan, a postdoctoral research fellow at Baylor College of Medicine in Houston. “The guidelines for these agents are based on symptoms of reflux. Although this study does not tell us for sure, it looks like taking these medications [in Barrett’s esophagus] prevents cancer. The effect is stronger with PPIs, but H₂RAs still have an effect.”

Alice Goodman

The incidence of BE is increasing in the United States, and BE is the only known risk factor for EAC.

“There is a knowledge gap, with a deficiency of studies of cases with longitudinal follow-up in a cohort of BE patients examining the effects of PPIs and H₂RAs on progression to EAC,” Dr. Tan explained. “We conducted this study in a large cohort of BE patients and hypothesized that acid suppression with PPIs and H₂RAs would decrease the risk of EAC.”

The study included a cohort of 29,536 male veterans diagnosed with BE between 2004 and 2009 identified in the national Veterans Affairs Corporate Data Warehouse. Of those, 760 had an ICD-9 diagnosis of EAC. Cases of incident BE (in patients who developed EAC) were matched with controls with BE who did not develop cancer by the time of each EAC diagnosis in the corresponding case. Cases were followed until 2011.

After exclusions, the final analysis was based on 311 cases with EAC after BE and 856 matched controls with no EAC. Use of acid suppression was based on reports of medications dispensed at a Veteran’s Affairs pharmacy.

In general, patients with EAC were significantly more overweight and obese than controls (86.8% versus 80.6%, respectively, P = .04) and were more often cigarette smokers than controls (19% versus 13%, respectively, P = .02).

Cases were less likely than controls to fill at least one prescription for a PPI: 65% of cases versus 83% of controls. Dr Tan said the number of H₂RA users was much smaller; 8% of cases had at least one prescription for an H₂RA, compared with 14% of controls.

For PPIs, duration of use was not associated with risk, whereas the opposite was true for H₂RA users.

“This was an observational study, not a randomized trial, so we can’t say with certainty that PPI and H₂RA use reduce the risk of cancer,” Dr. Tan cautioned. “But the study suggests that there may be a role for these medications. Further study is needed.”

In a separate interview, Dr Tan noted that the risk of developing EAC in people with BE is low – 0.5% per year.

During the question and answer session following her presentation, an audience member said that it is interesting and disturbing that so many BE patients are not on acid suppression.

“There are no clear cut guidelines that state that BE patients should be on a PPI,” Dr Tan noted. “Maybe that’s why primary care doctors are not prescribing them.”

In a talk after Dr Tan’s presentation, Dr Stuart Spechler of UT Southwestern Medical Center, Dallas, noted that it appears that clonal diversity at diagnosis of BE identifies patients likely to develop EAC.

“This raises a concern: If these cells are predestined to become cancer, can they achieve salvation through good acts?” Dr. Spechler asked. “Dr Tan’s study suggests that they can. The malignant potential of BE may be predetermined, and acid suppression therapy reduces the risk of progression to EAC.”

Dr. Tan had no financial disclosures to report.

SAN DIEGO – In patients with Barrett’s esophagus (BE), acid suppression with proton pump inhibitors (PPIs) and, to a lesser extent, histamine₂ receptor antagonists (H₂RA) reduced the risk of progression to esophageal adenocarcinoma (EAC), according to the findings from a study reported at the annual Digestive Disease Week.

Both treatments were independently associated with reduced risk of progression to cancer in the nested, case-control study. Taking PPIs reduced the risk of developing EAC by 69% and taking H₂RAs reduced the risk by 45%.

“There are no concrete guidelines regarding use of PPIs for patients with Barrett’s esophagus,” said presenting author Dr Mimi C. Tan, a postdoctoral research fellow at Baylor College of Medicine in Houston. “The guidelines for these agents are based on symptoms of reflux. Although this study does not tell us for sure, it looks like taking these medications [in Barrett’s esophagus] prevents cancer. The effect is stronger with PPIs, but H₂RAs still have an effect.”

Alice Goodman

The incidence of BE is increasing in the United States, and BE is the only known risk factor for EAC.

“There is a knowledge gap, with a deficiency of studies of cases with longitudinal follow-up in a cohort of BE patients examining the effects of PPIs and H₂RAs on progression to EAC,” Dr. Tan explained. “We conducted this study in a large cohort of BE patients and hypothesized that acid suppression with PPIs and H₂RAs would decrease the risk of EAC.”

The study included a cohort of 29,536 male veterans diagnosed with BE between 2004 and 2009 identified in the national Veterans Affairs Corporate Data Warehouse. Of those, 760 had an ICD-9 diagnosis of EAC. Cases of incident BE (in patients who developed EAC) were matched with controls with BE who did not develop cancer by the time of each EAC diagnosis in the corresponding case. Cases were followed until 2011.

After exclusions, the final analysis was based on 311 cases with EAC after BE and 856 matched controls with no EAC. Use of acid suppression was based on reports of medications dispensed at a Veteran’s Affairs pharmacy.

In general, patients with EAC were significantly more overweight and obese than controls (86.8% versus 80.6%, respectively, P = .04) and were more often cigarette smokers than controls (19% versus 13%, respectively, P = .02).

Cases were less likely than controls to fill at least one prescription for a PPI: 65% of cases versus 83% of controls. Dr Tan said the number of H₂RA users was much smaller; 8% of cases had at least one prescription for an H₂RA, compared with 14% of controls.

For PPIs, duration of use was not associated with risk, whereas the opposite was true for H₂RA users.

“This was an observational study, not a randomized trial, so we can’t say with certainty that PPI and H₂RA use reduce the risk of cancer,” Dr. Tan cautioned. “But the study suggests that there may be a role for these medications. Further study is needed.”

In a separate interview, Dr Tan noted that the risk of developing EAC in people with BE is low – 0.5% per year.

During the question and answer session following her presentation, an audience member said that it is interesting and disturbing that so many BE patients are not on acid suppression.

“There are no clear cut guidelines that state that BE patients should be on a PPI,” Dr Tan noted. “Maybe that’s why primary care doctors are not prescribing them.”

In a talk after Dr Tan’s presentation, Dr Stuart Spechler of UT Southwestern Medical Center, Dallas, noted that it appears that clonal diversity at diagnosis of BE identifies patients likely to develop EAC.

“This raises a concern: If these cells are predestined to become cancer, can they achieve salvation through good acts?” Dr. Spechler asked. “Dr Tan’s study suggests that they can. The malignant potential of BE may be predetermined, and acid suppression therapy reduces the risk of progression to EAC.”

Dr. Tan had no financial disclosures to report.

SAN DIEGO – In patients with Barrett’s esophagus (BE), acid suppression with proton pump inhibitors (PPIs) and, to a lesser extent, histamine₂ receptor antagonists (H₂RA) reduced the risk of progression to esophageal adenocarcinoma (EAC), according to the findings from a study reported at the annual Digestive Disease Week.

Both treatments were independently associated with reduced risk of progression to cancer in the nested, case-control study. Taking PPIs reduced the risk of developing EAC by 69% and taking H₂RAs reduced the risk by 45%.

“There are no concrete guidelines regarding use of PPIs for patients with Barrett’s esophagus,” said presenting author Dr Mimi C. Tan, a postdoctoral research fellow at Baylor College of Medicine in Houston. “The guidelines for these agents are based on symptoms of reflux. Although this study does not tell us for sure, it looks like taking these medications [in Barrett’s esophagus] prevents cancer. The effect is stronger with PPIs, but H₂RAs still have an effect.”

Alice Goodman

The incidence of BE is increasing in the United States, and BE is the only known risk factor for EAC.

“There is a knowledge gap, with a deficiency of studies of cases with longitudinal follow-up in a cohort of BE patients examining the effects of PPIs and H₂RAs on progression to EAC,” Dr. Tan explained. “We conducted this study in a large cohort of BE patients and hypothesized that acid suppression with PPIs and H₂RAs would decrease the risk of EAC.”

The study included a cohort of 29,536 male veterans diagnosed with BE between 2004 and 2009 identified in the national Veterans Affairs Corporate Data Warehouse. Of those, 760 had an ICD-9 diagnosis of EAC. Cases of incident BE (in patients who developed EAC) were matched with controls with BE who did not develop cancer by the time of each EAC diagnosis in the corresponding case. Cases were followed until 2011.

After exclusions, the final analysis was based on 311 cases with EAC after BE and 856 matched controls with no EAC. Use of acid suppression was based on reports of medications dispensed at a Veteran’s Affairs pharmacy.

In general, patients with EAC were significantly more overweight and obese than controls (86.8% versus 80.6%, respectively, P = .04) and were more often cigarette smokers than controls (19% versus 13%, respectively, P = .02).

Cases were less likely than controls to fill at least one prescription for a PPI: 65% of cases versus 83% of controls. Dr Tan said the number of H₂RA users was much smaller; 8% of cases had at least one prescription for an H₂RA, compared with 14% of controls.

For PPIs, duration of use was not associated with risk, whereas the opposite was true for H₂RA users.

“This was an observational study, not a randomized trial, so we can’t say with certainty that PPI and H₂RA use reduce the risk of cancer,” Dr. Tan cautioned. “But the study suggests that there may be a role for these medications. Further study is needed.”

In a separate interview, Dr Tan noted that the risk of developing EAC in people with BE is low – 0.5% per year.

During the question and answer session following her presentation, an audience member said that it is interesting and disturbing that so many BE patients are not on acid suppression.

“There are no clear cut guidelines that state that BE patients should be on a PPI,” Dr Tan noted. “Maybe that’s why primary care doctors are not prescribing them.”

In a talk after Dr Tan’s presentation, Dr Stuart Spechler of UT Southwestern Medical Center, Dallas, noted that it appears that clonal diversity at diagnosis of BE identifies patients likely to develop EAC.

“This raises a concern: If these cells are predestined to become cancer, can they achieve salvation through good acts?” Dr. Spechler asked. “Dr Tan’s study suggests that they can. The malignant potential of BE may be predetermined, and acid suppression therapy reduces the risk of progression to EAC.”

Dr. Tan had no financial disclosures to report.

SAN DIEGO – Bile acid salts in the stool may be a potential biomarker for recurrent episodes of Clostridium difficile infection, a preliminary study suggests.

Although the finding needs to be validated in a prospective study, it could have therapeutic implications, the study investigators said.

“If our results are validated, we could take bile salt profiles of patients who come in with their first episode of C. difficile infection and, using this biomarker, adjust therapy accordingly,” said study lead author Dr. Jessica Allegretti, who presented the findings at the annual Digestive Disease Week. “A patient at high risk of recurrence could get fecal transplant earlier. Right now, fecal transplant is used for recurrent infection.”

Alice Goodman

C. difficile represents a major public health threat, and recurrent disease complicates 20%-30% of cases.

The disease is communicated by spores that are resistant to heat and antibiotics, and they germinate in the gastrointestinal tract. Bile acids are part of that process. Bile acids assist in the digestion of fat, and a small proportion pass into the colon where primary bile acids undergo transformation into secondary bile acids such as deoxycholate and lithocholate.

In vitro, primary acids can stimulate C. difficile, explained Dr. Allegretti of Brigham and Women’s Hospital, Cambridge, Mass. “Antibiotic therapy may ablate critical members of the microbiota. We aimed to assess bile acid profiles in patients with C. difficile infection, compared with controls, to understand their role in pathogenesis and hopefully identify a biomarker for recurrence.”

The cross-sectional study collected serum and a single stool sample from three groups of 60 patients: patients with a first episode of C. difficile (fCDI) prior to antibiotics (20 patients), patients with a recurrent episode (rCDI) on treatment with chronic vancomycin at the time of sampling (19), and healthy controls who were fecal transplant donors (21).

The researchers sequenced stool microbial components and conducted bile salt metabolomic profiling. Significant differences were revealed in microbial analysis of the stool samples: Primary bile salts (which induce germination) were significantly elevated in rCDI, compared with fCDI and controls – while secondary bile salts in the stool (which are protective) such as deoxycholate and lithocholate were significantly elevated in controls, compared with fCDI and rCDI (P = .0002 and P = .0007, respectively).

“The same trends were seen in the plasma samples, but were less dramatic than in the stool,” Dr. Allegretti noted.

The median predicted bile salt hydrolase (BSH) gene abundance in rCDI was 20% of the median value in controls (P = .001), and it also was significantly lower than fCDI (P = .001). No significant difference was seen between predicted BSH gene abundance between controls and the fCDI groups.

“An association with reduced predicted bacterial bile salt hydrolase gene abundance may be associated with a diminished capacity to metabolize bile acids,” she said.

The difference in BSH gene abundance between controls and rCDI was largely due to changes in the abundance of 10 bacterial taxa, Dr. Allegretti said.

“This study reinforces the importance of bile salts in CDI and demonstrates for the first time in humans that this shift can be appreciated as early as the first episode of CDI in patients who are antibiotic naive,” Dr Allegretti said.

She noted that rCDI samples were collected in patients on chronic antibiotic therapy, and that may explain some of the decrease in biological microdiversity seen in the study.

In search of a biomarker, “secondary bile acids clearly seem to be the winner, and for now, stool seems to make more sense than blood for samples,” she stated.

Dr. Allegretti and her colleagues are conducting a prospective validation study.

The American College of Gastroenterology funded the study.

SAN DIEGO – Bile acid salts in the stool may be a potential biomarker for recurrent episodes of Clostridium difficile infection, a preliminary study suggests.

Although the finding needs to be validated in a prospective study, it could have therapeutic implications, the study investigators said.

“If our results are validated, we could take bile salt profiles of patients who come in with their first episode of C. difficile infection and, using this biomarker, adjust therapy accordingly,” said study lead author Dr. Jessica Allegretti, who presented the findings at the annual Digestive Disease Week. “A patient at high risk of recurrence could get fecal transplant earlier. Right now, fecal transplant is used for recurrent infection.”

Alice Goodman

C. difficile represents a major public health threat, and recurrent disease complicates 20%-30% of cases.

The disease is communicated by spores that are resistant to heat and antibiotics, and they germinate in the gastrointestinal tract. Bile acids are part of that process. Bile acids assist in the digestion of fat, and a small proportion pass into the colon where primary bile acids undergo transformation into secondary bile acids such as deoxycholate and lithocholate.

In vitro, primary acids can stimulate C. difficile, explained Dr. Allegretti of Brigham and Women’s Hospital, Cambridge, Mass. “Antibiotic therapy may ablate critical members of the microbiota. We aimed to assess bile acid profiles in patients with C. difficile infection, compared with controls, to understand their role in pathogenesis and hopefully identify a biomarker for recurrence.”

The cross-sectional study collected serum and a single stool sample from three groups of 60 patients: patients with a first episode of C. difficile (fCDI) prior to antibiotics (20 patients), patients with a recurrent episode (rCDI) on treatment with chronic vancomycin at the time of sampling (19), and healthy controls who were fecal transplant donors (21).

The researchers sequenced stool microbial components and conducted bile salt metabolomic profiling. Significant differences were revealed in microbial analysis of the stool samples: Primary bile salts (which induce germination) were significantly elevated in rCDI, compared with fCDI and controls – while secondary bile salts in the stool (which are protective) such as deoxycholate and lithocholate were significantly elevated in controls, compared with fCDI and rCDI (P = .0002 and P = .0007, respectively).

“The same trends were seen in the plasma samples, but were less dramatic than in the stool,” Dr. Allegretti noted.

The median predicted bile salt hydrolase (BSH) gene abundance in rCDI was 20% of the median value in controls (P = .001), and it also was significantly lower than fCDI (P = .001). No significant difference was seen between predicted BSH gene abundance between controls and the fCDI groups.

“An association with reduced predicted bacterial bile salt hydrolase gene abundance may be associated with a diminished capacity to metabolize bile acids,” she said.

The difference in BSH gene abundance between controls and rCDI was largely due to changes in the abundance of 10 bacterial taxa, Dr. Allegretti said.

“This study reinforces the importance of bile salts in CDI and demonstrates for the first time in humans that this shift can be appreciated as early as the first episode of CDI in patients who are antibiotic naive,” Dr Allegretti said.

She noted that rCDI samples were collected in patients on chronic antibiotic therapy, and that may explain some of the decrease in biological microdiversity seen in the study.

In search of a biomarker, “secondary bile acids clearly seem to be the winner, and for now, stool seems to make more sense than blood for samples,” she stated.

Dr. Allegretti and her colleagues are conducting a prospective validation study.

The American College of Gastroenterology funded the study.

SAN DIEGO – Bile acid salts in the stool may be a potential biomarker for recurrent episodes of Clostridium difficile infection, a preliminary study suggests.

Although the finding needs to be validated in a prospective study, it could have therapeutic implications, the study investigators said.

“If our results are validated, we could take bile salt profiles of patients who come in with their first episode of C. difficile infection and, using this biomarker, adjust therapy accordingly,” said study lead author Dr. Jessica Allegretti, who presented the findings at the annual Digestive Disease Week. “A patient at high risk of recurrence could get fecal transplant earlier. Right now, fecal transplant is used for recurrent infection.”

Alice Goodman

C. difficile represents a major public health threat, and recurrent disease complicates 20%-30% of cases.

The disease is communicated by spores that are resistant to heat and antibiotics, and they germinate in the gastrointestinal tract. Bile acids are part of that process. Bile acids assist in the digestion of fat, and a small proportion pass into the colon where primary bile acids undergo transformation into secondary bile acids such as deoxycholate and lithocholate.

In vitro, primary acids can stimulate C. difficile, explained Dr. Allegretti of Brigham and Women’s Hospital, Cambridge, Mass. “Antibiotic therapy may ablate critical members of the microbiota. We aimed to assess bile acid profiles in patients with C. difficile infection, compared with controls, to understand their role in pathogenesis and hopefully identify a biomarker for recurrence.”

The cross-sectional study collected serum and a single stool sample from three groups of 60 patients: patients with a first episode of C. difficile (fCDI) prior to antibiotics (20 patients), patients with a recurrent episode (rCDI) on treatment with chronic vancomycin at the time of sampling (19), and healthy controls who were fecal transplant donors (21).

The researchers sequenced stool microbial components and conducted bile salt metabolomic profiling. Significant differences were revealed in microbial analysis of the stool samples: Primary bile salts (which induce germination) were significantly elevated in rCDI, compared with fCDI and controls – while secondary bile salts in the stool (which are protective) such as deoxycholate and lithocholate were significantly elevated in controls, compared with fCDI and rCDI (P = .0002 and P = .0007, respectively).

“The same trends were seen in the plasma samples, but were less dramatic than in the stool,” Dr. Allegretti noted.

The median predicted bile salt hydrolase (BSH) gene abundance in rCDI was 20% of the median value in controls (P = .001), and it also was significantly lower than fCDI (P = .001). No significant difference was seen between predicted BSH gene abundance between controls and the fCDI groups.

“An association with reduced predicted bacterial bile salt hydrolase gene abundance may be associated with a diminished capacity to metabolize bile acids,” she said.

The difference in BSH gene abundance between controls and rCDI was largely due to changes in the abundance of 10 bacterial taxa, Dr. Allegretti said.

“This study reinforces the importance of bile salts in CDI and demonstrates for the first time in humans that this shift can be appreciated as early as the first episode of CDI in patients who are antibiotic naive,” Dr Allegretti said.

She noted that rCDI samples were collected in patients on chronic antibiotic therapy, and that may explain some of the decrease in biological microdiversity seen in the study.

In search of a biomarker, “secondary bile acids clearly seem to be the winner, and for now, stool seems to make more sense than blood for samples,” she stated.

Dr. Allegretti and her colleagues are conducting a prospective validation study.

The American College of Gastroenterology funded the study.

SAN DIEGO – The tetracyclic antidepressant mirtazapine significantly improved indicators of functional dyspepsia and psychological distress in a single-center, randomized, placebo-controlled, double-blinded trial of 116 adults.

After 3 months of treatment, the mirtazapine group had significantly less nausea, early satiety, depression, somatization, hostility, and phobic anxiety, compared with the control group (all P values < .05), Dr. Yaoyao Gong reported at the annual Digestive Disease Week. Most patients began improving after 1-2 weeks of mirtazapine therapy, she added.

“We assume that mirtazapine might improve functional dyspepsia by improving depression and anxiety, reducing visceral sensitivity, and through its prokinetic effects on gastrointestinal transit,” said Dr. Gong, who is at the gastroenterology department of Nanjing Medical University, China.

Amy Karon

Mirtazapine is a presynaptic alpha-2 antagonist that also blocks the 5-HT2a, 5-HT2c, 5-HT3, and H-1 receptors. This atypical antidepressant reduced visceral hypersensitivity and increased gastric accommodation, gastric emptying, and colonic transit time in animal studies, and improved weight loss, early satiety, and nausea in a recent U.S. placebo-controlled pilot trial (Clin Gastroenterol Hepatol. 2016 Mar;14[3]:385-92).

As a biopsychosocial disorder, functional dyspepsia involves both physical and psychological symptoms, Dr. Gong noted. To explore how mirtazapine affects both realms, she and her associates randomized outpatients meeting Rome III functional dyspepsia criteria who also been diagnosed by a psychiatrist with anxiety, depression, or somatization disorder to receive either mirtazapine, 15 mg per day (61 patients) or placebo (55 patients). Both groups also received omeprazole, 30 mg per day, and mosapride, 5 mg three times a day. Patients were mostly in their early 40s, none was taking SSRIs or MAOIs, they had no history of abdominal surgery or upper endoscopy lesions, and they had negative ¹³C urea breath tests for Helicobacter pylori infection.

After 3 months of treatment, mirtazapine was associated with significantly lower 7-point Likert scales for nausea and early satiety, compared with standard care alone, said Dr. Gong. Mirtazapine did not significantly improve the other Rome III criteria for functional dyspepsia, but general overall score was significantly lower than for the control group.

In addition, the mirtazapine group had a “markedly better” average Symptom Checklist (SCL)-90 score, compared with the control group, and individual measures of depression, somatization, hostility, and phobic anxiety also were significantly lower than for controls (P < .05).

Mirtazapine did not significantly affect overall anxiety, a frequent psychological feature of functional dyspepsia. Mirtazapine was most often associated with dry mouth, although the researchers did not measure weight gain, another common adverse effect of the medication.

None of the patients stopped treatment because of adverse effects. The study group was too small to look at the separate effects of mirtazapine on epigastric pain and postprandial distress syndrome, Dr. Gong noted.

“We plan to assess these patients again after 12 months of treatment,” she said.

Dr. Gong did not report funding sources and had no disclosures.

SAN DIEGO – The tetracyclic antidepressant mirtazapine significantly improved indicators of functional dyspepsia and psychological distress in a single-center, randomized, placebo-controlled, double-blinded trial of 116 adults.

After 3 months of treatment, the mirtazapine group had significantly less nausea, early satiety, depression, somatization, hostility, and phobic anxiety, compared with the control group (all P values < .05), Dr. Yaoyao Gong reported at the annual Digestive Disease Week. Most patients began improving after 1-2 weeks of mirtazapine therapy, she added.

“We assume that mirtazapine might improve functional dyspepsia by improving depression and anxiety, reducing visceral sensitivity, and through its prokinetic effects on gastrointestinal transit,” said Dr. Gong, who is at the gastroenterology department of Nanjing Medical University, China.

Amy Karon

Mirtazapine is a presynaptic alpha-2 antagonist that also blocks the 5-HT2a, 5-HT2c, 5-HT3, and H-1 receptors. This atypical antidepressant reduced visceral hypersensitivity and increased gastric accommodation, gastric emptying, and colonic transit time in animal studies, and improved weight loss, early satiety, and nausea in a recent U.S. placebo-controlled pilot trial (Clin Gastroenterol Hepatol. 2016 Mar;14[3]:385-92).

As a biopsychosocial disorder, functional dyspepsia involves both physical and psychological symptoms, Dr. Gong noted. To explore how mirtazapine affects both realms, she and her associates randomized outpatients meeting Rome III functional dyspepsia criteria who also been diagnosed by a psychiatrist with anxiety, depression, or somatization disorder to receive either mirtazapine, 15 mg per day (61 patients) or placebo (55 patients). Both groups also received omeprazole, 30 mg per day, and mosapride, 5 mg three times a day. Patients were mostly in their early 40s, none was taking SSRIs or MAOIs, they had no history of abdominal surgery or upper endoscopy lesions, and they had negative ¹³C urea breath tests for Helicobacter pylori infection.

After 3 months of treatment, mirtazapine was associated with significantly lower 7-point Likert scales for nausea and early satiety, compared with standard care alone, said Dr. Gong. Mirtazapine did not significantly improve the other Rome III criteria for functional dyspepsia, but general overall score was significantly lower than for the control group.

In addition, the mirtazapine group had a “markedly better” average Symptom Checklist (SCL)-90 score, compared with the control group, and individual measures of depression, somatization, hostility, and phobic anxiety also were significantly lower than for controls (P < .05).

Mirtazapine did not significantly affect overall anxiety, a frequent psychological feature of functional dyspepsia. Mirtazapine was most often associated with dry mouth, although the researchers did not measure weight gain, another common adverse effect of the medication.

None of the patients stopped treatment because of adverse effects. The study group was too small to look at the separate effects of mirtazapine on epigastric pain and postprandial distress syndrome, Dr. Gong noted.

“We plan to assess these patients again after 12 months of treatment,” she said.

Dr. Gong did not report funding sources and had no disclosures.

SAN DIEGO – The tetracyclic antidepressant mirtazapine significantly improved indicators of functional dyspepsia and psychological distress in a single-center, randomized, placebo-controlled, double-blinded trial of 116 adults.

After 3 months of treatment, the mirtazapine group had significantly less nausea, early satiety, depression, somatization, hostility, and phobic anxiety, compared with the control group (all P values < .05), Dr. Yaoyao Gong reported at the annual Digestive Disease Week. Most patients began improving after 1-2 weeks of mirtazapine therapy, she added.

“We assume that mirtazapine might improve functional dyspepsia by improving depression and anxiety, reducing visceral sensitivity, and through its prokinetic effects on gastrointestinal transit,” said Dr. Gong, who is at the gastroenterology department of Nanjing Medical University, China.

Amy Karon

Mirtazapine is a presynaptic alpha-2 antagonist that also blocks the 5-HT2a, 5-HT2c, 5-HT3, and H-1 receptors. This atypical antidepressant reduced visceral hypersensitivity and increased gastric accommodation, gastric emptying, and colonic transit time in animal studies, and improved weight loss, early satiety, and nausea in a recent U.S. placebo-controlled pilot trial (Clin Gastroenterol Hepatol. 2016 Mar;14[3]:385-92).

As a biopsychosocial disorder, functional dyspepsia involves both physical and psychological symptoms, Dr. Gong noted. To explore how mirtazapine affects both realms, she and her associates randomized outpatients meeting Rome III functional dyspepsia criteria who also been diagnosed by a psychiatrist with anxiety, depression, or somatization disorder to receive either mirtazapine, 15 mg per day (61 patients) or placebo (55 patients). Both groups also received omeprazole, 30 mg per day, and mosapride, 5 mg three times a day. Patients were mostly in their early 40s, none was taking SSRIs or MAOIs, they had no history of abdominal surgery or upper endoscopy lesions, and they had negative ¹³C urea breath tests for Helicobacter pylori infection.

After 3 months of treatment, mirtazapine was associated with significantly lower 7-point Likert scales for nausea and early satiety, compared with standard care alone, said Dr. Gong. Mirtazapine did not significantly improve the other Rome III criteria for functional dyspepsia, but general overall score was significantly lower than for the control group.

In addition, the mirtazapine group had a “markedly better” average Symptom Checklist (SCL)-90 score, compared with the control group, and individual measures of depression, somatization, hostility, and phobic anxiety also were significantly lower than for controls (P < .05).

Mirtazapine did not significantly affect overall anxiety, a frequent psychological feature of functional dyspepsia. Mirtazapine was most often associated with dry mouth, although the researchers did not measure weight gain, another common adverse effect of the medication.

None of the patients stopped treatment because of adverse effects. The study group was too small to look at the separate effects of mirtazapine on epigastric pain and postprandial distress syndrome, Dr. Gong noted.

“We plan to assess these patients again after 12 months of treatment,” she said.

Dr. Gong did not report funding sources and had no disclosures.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

• A robust interdisciplinary care team
• Customized, comprehensive care plans
• After-hours care and services
• Use of evidence-based clinical practice guidelines
• A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

• A robust interdisciplinary care team
• Customized, comprehensive care plans
• After-hours care and services
• Use of evidence-based clinical practice guidelines
• A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

The industry’s first certification for home health and hospices that provide top-caliber community-based palliative care services in the patient’s place of residence is being launched by The Joint Commission.

“As healthcare continues to evolve and the Affordable Care Act is beginning to impact the industry, one of the things that has come to light is that many patients over the years have experienced unnecessary hospitalization admissions when the management of their disease stage really required palliative care,” says Margherita Labson, RN, MSHSA, CPHQ, executive director of The Joint Commission’s Home Care Program. “For those of us in the home care environment in the community, we’ve always tried to manage this, but the current models of care didn’t really meet the needs of these patients because the Medicare benefit is an episodic payment program that’s built for rehab and restoration, not for maintenance.”

The Joint Commission’s new program, she says, provides value to patients, results in a lower rate of a necessary readmission, and contributes to patient satisfaction and improved outcomes of care.

Surveys for Community-Based Palliative Care (CBPC) Certification will begin on July 1. Certification is awarded for a three-year period, and the certification’s framework helps providers design, deliver, and validate patient-centered care and services. Key CBPC certification requirements include:

• A robust interdisciplinary care team
• Customized, comprehensive care plans
• After-hours care and services
• Use of evidence-based clinical practice guidelines
• A defined hand-off communications process

“This helps to address perhaps one of the key frustrations of hospitalists: the repeated readmissions of patients struggling with serious chronic illnesses,” Labson says. “It helps reduce the number of inappropriate hospital admissions and allows the hospitalist to focus on the admission and successful management of those patients that are appropriate for hospital intervention or acute-care intervention at that point.”

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.

Heart failure patients who had early follow-up (within seven days of discharge) with general medicine or cardiology providers had a lower risk of being readmitted to the hospital within 30 days, according to a study from Kaiser Permanente published in the journal Medical Care.

“We found that follow-up within the first seven days post-discharge—mostly done through in-person clinic visits—was independently associated with a 19% lower chance of readmission, whereas initial follow-up after seven days was not significantly associated with readmission,” says lead researcher Keane K. Lee, MD, MS, a cardiologist and research scientist with Kaiser Permanente. “Perhaps as important, we also observed that telephone visits, mostly done by non-physician providers, within seven days after hospital discharge were associated with a non-statistically significant trend toward lower 30-day readmission rates, even after carefully accounting for potential differences between patients.

“This finding that telephone visits could reduce readmissions has never been reported and has potentially important implications. Contact by telephone with non-physicians may be more convenient for patients and family members and be more practical and cost-effective when implemented on a large scale.”

Dr. Lee suggests hospitalists have a role in creating a system to reliably arrange this follow-up.

“Hospitalists serve as a key part of the process to help patients transition successfully from the hospital back home,” Dr. Lee says.

Reference

1. Lee KK, Yang J, Hernandez AF, Steimle AE, Go S. Post-discharge follow-up characteristics associated with 30-day readmission after heart failure hospitalization. Med Care. 2016;54(4):365-372.

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

SAN DIEGO – Obesity is a risk factor for colonic diverticulosis among women but not men, while a low-fiber diet was not found to be a risk factor in a recent study reported at the annual Digestive Disease Week.

“The classic teaching in medical school is that a low-fiber diet increases constipation, which in turn increases the risk of diverticula,” explained lead author Dr. Anne Peery, assistant professor of medicine at the University of North Carolina, Chapel Hill. “This is in textbooks and on your boards. But there is no association between low-fiber dietary intake and diverticula.

“There is, however, evidence from other studies that a high-fiber diet and increased physical activity decrease the risk of developing complications from diverticula,” Dr. Peery added. She noted that the study was designed to look at risk factors for developing diverticula, not at complications.

“The provocative findings from our study are twofold: We found that the prevalence of diverticula is higher in men and lower in women younger than age 50, and that obesity is a risk factor for diverticula in women but not in men,” Dr Peery said.

“The age-related gender differences we identified were quite surprising, and suggest that something is going on in women under the age of 50 that may be estrogen-related. This opens up an avenue of research,” she noted.

Colonic diverticula are common, and they are important because of complications such as hemorrhage, perforation, and inflammation. They also pose a substantial health burden, accounting for 2.5 million office visits and 4,500 deaths each year in the United States.

“Despite this, we know very little about risk factors for colonic diverticula,” Dr. Peery noted.

The prospective study recruited 624 patients between the ages of 30 years and 80 years undergoing a first screening colonoscopy between 2013 and 2015 at the University of North Carolina in Chapel Hill. Prior to undergoing the procedure, each participant was interviewed using validated instruments to assess diet and physical activity. Each participant had a detailed examination for colonic diverticula, with a research assistant present during the entire colonoscopy.

“The presence or absence of diverticula reported in previous studies were extracted from colonoscopy reports. Our study assessed risk factors prior to undergoing colonoscopy,” she emphasized. “This is one of the study strengths.”

Not surprisingly, the study showed that the prevalence of diverticula (or “tics”) increased with age. Younger than age 50, the prevalence was higher in men than in women, after which prevalence equalized with age.

In the study population, 124 men had diverticula and 150 did not; 136 women had diverticula and 214 did not. Women with diverticula were more likely to be older, white, and have a higher body mass index (BMI).

The investigators looked at several measures of obesity, including BMI, waist circumference, and waist-to-height ratio. Women with greater BMI were at increased risk for diverticula, a risk relationship that was not seen in men. The risk of developing six or more diverticula was more than twofold greater in obese women.

Men with a greater waist circumference (more than 102 cm) had no increased risk for diverticula, while women with a greater waist circumference (more than 88 cm) were at increased risk of any diverticula, as well as having six or more diverticula.

A similar pattern was observed for waist-to-height ratio, which some experts believe is related to obesity, according to Dr. Peery. No association was found in men. But for women, a high-risk waist-to-height ratio increased the risk of diverticula, and the risk of having six or more diverticula was almost twice as great in these women, compared with men.

The investigators then measured the association between dietary fiber and physical activity with diverticula. No associations with diverticula were found in any quartile (lowest to highest) for both physical activity and dietary fiber intake.

In an interview, Dr. Peery speculated on why women have a lower prevalence of “tics,” compared with men younger than age 50. She said there are gender-related differences in the way fat is stored and metabolized.

“Obese women have more visceral adiposity that men, and they tend to eat more carbohydrates, while obese men have higher alcohol and meat intake. These differences will be studied in greater depth as they relate to diverticula and complications,” she noted.

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

©s-c-s/Thinkstock

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.

SCOTTSDALE – Stevens-Johnson syndrome and toxic epidermal necrolysis are not quite as rare as previously thought, according to one of the first population-based epidemiologic studies of the disorders.

“The incidence of Stevens-Johnson syndrome appears to be higher than previously reported, though mortality rates are lower,” said Derek Hsu of Northwestern University in Chicago, together with his associates. Both diagnoses were linked to a number of immune system disorders, “suggesting that immune dysregulation contributes to these diseases,” the investigators added.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life-threatening mucocutaneous conditions that are usually triggered by medications or infections. In 1991, a population-based study in three U.S. states reported annual incidence rates of 7.1, 2.6, and 6.8 cases per million individuals for SJS, SJS/TEN, and TEN, respectively.

More recent studies have been limited mostly to case series, and the current incidence, mortality, and health care costs of those conditions among adults in the United States were unknown, Mr. Hsu and his coinvestigators noted.

Therefore, they analyzed data for 2009 through 2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the country. Using validated ICD-9 codes, the researchers extracted information on patients with Stevens-Johnson syndrome and/or toxic epidermal necrolysis. To improve the positive predictive value of the diagnostic codes, they excluded patients with concurrent diagnoses of bullous dermatoses or erythema multiforme major.

The estimated annual incidence of SJS ranged from 8.6 to 9.8 cases per million adults per year, with a mean of 9.3 cases per million population, Mr. Hsu and his coinvestigators reported at the annual meeting of the Society for Investigative Dermatology.

Rates of combined SJS/TEN and TEN were substantially lower, with means of 1.6 and 1.9 cases per million per year, respectively.

Inpatients who were black, Hispanic, Asian, Native American, or of mixed race or ethnicity were more likely to have those diagnoses than were white inpatients, as were Medicare and self-pay patients and patients with relatively more comorbidities.

Patients diagnosed with SJS stayed in the hospital an average of 9.8 days, incurring $21,407 in mean inflation-adjusted treatment costs, while patients with SJS/TEN or TEN stayed an average of more than 16 days, with associated costs of nearly $59,00 and $53,700, respectively. For all three diagnostic categories, length of stay and costs were significantly greater than among inpatients as a whole, Mr. Hsu and his associates noted.

Age- and sex-adjusted case-fatality rates were lower than previously reported, ranging from 3.7% to 7.5% for SJS (average, 4.7%), from 15.7% to 22.3% for SJS/TEN, and from 7.7% to 19% (average, 14.8%) for TEN. The risk of mortality increased very little after the affected body surface exceeded 10%, the researchers noted. Septicemia, other infections, renal failure, cancers, and older age all increased the risk of mortality.

After accounting for race, age, and sex, SJS/TEN were significantly associated with a number of comorbidities, including systemic lupus erythematosus, renal failure, liver disease, epilepsy, and HIV disease, as well as mycoplasma, tuberculosis, and other serious infections, the researchers also found.

In addition, SJS and TEN were significantly more likely among inpatients with non-Hodgkin lymphoma, multiple myeloma, and leukemia. “Further studies are needed to understand the mechanism of these associations,” the investigators said.

The Dermatology Foundation and the Agency for Healthcare Research and Quality funded the study. Mr. Hsu had no disclosures.