CHEST 2014

AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

AUSTIN, TEX. – Inhaled corticosteroids can be successfully withdrawn without increasing the risk of exacerbations in patients who have chronic obstructive pulmonary disease and are receiving dual bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and a long-acting beta₂-agonist (LABA), according to findings from the WISDOM study.

However, inhaled corticosteroid (ICS) withdrawal should be conducted with caution, as a small but statistically significantly greater decrease in lung function occurred in patients who withdrew completely, compared with those who did not during the 12-month, double-blind, parallel-group study, Dr. Helgo Magnussen reported at the annual meeting of the American College of Chest Physicians.

“In patients with severe but stable COPD who are receiving combination therapy with tiotropium, salmeterol and ICS, a stepwise withdrawal of ICS was noninferior to continuation of ICS with respect to the risk of moderate or severe exacerbations. Despite this, if you do [withdraw ICS] – and we believe you can try to withdraw ICS – please observe the symptoms and lung function, because we found this signal [for decreased lung function],” he said.

Study subjects were 2,485 adults over age 40 years with severe or very severe COPD and a history of exacerbations. All patients received triple therapy with the LAMA tiotropium at 18 mcg four times daily, the LABA salmeterol at 50 mcg twice daily, and the ICS fluticasone at 500 mcg twice daily for a 6-week run-in period.

The patients were randomized to continue the triple therapy or to undergo ICS withdrawal over 12 weeks, with a dose reduction every 6 weeks.

ICS withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval, compared with continued ICS with respect to moderate or severe COPD exacerbation (hazard ratio, 1.06), but the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second (FEV₁) at week 18 was 38 mL greater in the ICS withdrawal group, said Dr. Magnussen of the Pulmonary Research Institute at Lung Clinic Grosshansdorf (Germany), Airway Research Center North.

A similar between-group difference of 43 mL was seen at week 52, he said, noting that this did not differ significantly from the difference seen at week 18, demonstrating that there is no further decline in lung function after complete ICS withdrawal at week 18.

Also, the decline in lung function – even at the peak decrease in function at week 18, was not associated with an increase in dyspnea; the difference in change from baseline in the modified Medical Research Council (mMRC) dyspnea scale was nonsignificant for ICS withdrawal, compared with ICS continuation at week 18 or week 52. The change from baseline in the St. George’s Respiratory Questionnaire (SGRQ) total score was 0.55 with ICS withdrawal, compared with –0.42 with ICS at week 27, and 1.15, compared with –0.07 for withdrawal vs. continuation, respectively, at week 52. This difference, though statistically significant, was not considered clinically relevant, Dr. Magnussen said.

ICS treatment is recommended along with long-acting bronchodilators in patients with frequent exacerbations of severe COPD, but the benefits of ICS use in addition to dual bronchodilator therapy have not been fully elucidated, he said.

The findings of the WISDOM study (N. Engl. J. Med. 2014;371:1285-94), suggest that ICS discontinuation is possible.This study was funded by Boehringer Ingelheim. Dr. Magnussen reported receiving consultant fees and/or serving on a speakers bureau or advisory committee for Almirall, Boehringer Ingelheim, Chiesi, Berli-Chemi, and Novartis. His employer, the Pulmonary Research Institute, received payments for conducting the study.

AUSTIN, TEX. – Inhaled corticosteroids can be successfully withdrawn without increasing the risk of exacerbations in patients who have chronic obstructive pulmonary disease and are receiving dual bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and a long-acting beta₂-agonist (LABA), according to findings from the WISDOM study.

However, inhaled corticosteroid (ICS) withdrawal should be conducted with caution, as a small but statistically significantly greater decrease in lung function occurred in patients who withdrew completely, compared with those who did not during the 12-month, double-blind, parallel-group study, Dr. Helgo Magnussen reported at the annual meeting of the American College of Chest Physicians.

“In patients with severe but stable COPD who are receiving combination therapy with tiotropium, salmeterol and ICS, a stepwise withdrawal of ICS was noninferior to continuation of ICS with respect to the risk of moderate or severe exacerbations. Despite this, if you do [withdraw ICS] – and we believe you can try to withdraw ICS – please observe the symptoms and lung function, because we found this signal [for decreased lung function],” he said.

Study subjects were 2,485 adults over age 40 years with severe or very severe COPD and a history of exacerbations. All patients received triple therapy with the LAMA tiotropium at 18 mcg four times daily, the LABA salmeterol at 50 mcg twice daily, and the ICS fluticasone at 500 mcg twice daily for a 6-week run-in period.

The patients were randomized to continue the triple therapy or to undergo ICS withdrawal over 12 weeks, with a dose reduction every 6 weeks.

ICS withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval, compared with continued ICS with respect to moderate or severe COPD exacerbation (hazard ratio, 1.06), but the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second (FEV₁) at week 18 was 38 mL greater in the ICS withdrawal group, said Dr. Magnussen of the Pulmonary Research Institute at Lung Clinic Grosshansdorf (Germany), Airway Research Center North.

A similar between-group difference of 43 mL was seen at week 52, he said, noting that this did not differ significantly from the difference seen at week 18, demonstrating that there is no further decline in lung function after complete ICS withdrawal at week 18.

Also, the decline in lung function – even at the peak decrease in function at week 18, was not associated with an increase in dyspnea; the difference in change from baseline in the modified Medical Research Council (mMRC) dyspnea scale was nonsignificant for ICS withdrawal, compared with ICS continuation at week 18 or week 52. The change from baseline in the St. George’s Respiratory Questionnaire (SGRQ) total score was 0.55 with ICS withdrawal, compared with –0.42 with ICS at week 27, and 1.15, compared with –0.07 for withdrawal vs. continuation, respectively, at week 52. This difference, though statistically significant, was not considered clinically relevant, Dr. Magnussen said.

ICS treatment is recommended along with long-acting bronchodilators in patients with frequent exacerbations of severe COPD, but the benefits of ICS use in addition to dual bronchodilator therapy have not been fully elucidated, he said.

The findings of the WISDOM study (N. Engl. J. Med. 2014;371:1285-94), suggest that ICS discontinuation is possible.This study was funded by Boehringer Ingelheim. Dr. Magnussen reported receiving consultant fees and/or serving on a speakers bureau or advisory committee for Almirall, Boehringer Ingelheim, Chiesi, Berli-Chemi, and Novartis. His employer, the Pulmonary Research Institute, received payments for conducting the study.

AUSTIN, TEX. – Inhaled corticosteroids can be successfully withdrawn without increasing the risk of exacerbations in patients who have chronic obstructive pulmonary disease and are receiving dual bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and a long-acting beta₂-agonist (LABA), according to findings from the WISDOM study.

However, inhaled corticosteroid (ICS) withdrawal should be conducted with caution, as a small but statistically significantly greater decrease in lung function occurred in patients who withdrew completely, compared with those who did not during the 12-month, double-blind, parallel-group study, Dr. Helgo Magnussen reported at the annual meeting of the American College of Chest Physicians.

“In patients with severe but stable COPD who are receiving combination therapy with tiotropium, salmeterol and ICS, a stepwise withdrawal of ICS was noninferior to continuation of ICS with respect to the risk of moderate or severe exacerbations. Despite this, if you do [withdraw ICS] – and we believe you can try to withdraw ICS – please observe the symptoms and lung function, because we found this signal [for decreased lung function],” he said.

Study subjects were 2,485 adults over age 40 years with severe or very severe COPD and a history of exacerbations. All patients received triple therapy with the LAMA tiotropium at 18 mcg four times daily, the LABA salmeterol at 50 mcg twice daily, and the ICS fluticasone at 500 mcg twice daily for a 6-week run-in period.

The patients were randomized to continue the triple therapy or to undergo ICS withdrawal over 12 weeks, with a dose reduction every 6 weeks.

ICS withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval, compared with continued ICS with respect to moderate or severe COPD exacerbation (hazard ratio, 1.06), but the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second (FEV₁) at week 18 was 38 mL greater in the ICS withdrawal group, said Dr. Magnussen of the Pulmonary Research Institute at Lung Clinic Grosshansdorf (Germany), Airway Research Center North.

A similar between-group difference of 43 mL was seen at week 52, he said, noting that this did not differ significantly from the difference seen at week 18, demonstrating that there is no further decline in lung function after complete ICS withdrawal at week 18.

Also, the decline in lung function – even at the peak decrease in function at week 18, was not associated with an increase in dyspnea; the difference in change from baseline in the modified Medical Research Council (mMRC) dyspnea scale was nonsignificant for ICS withdrawal, compared with ICS continuation at week 18 or week 52. The change from baseline in the St. George’s Respiratory Questionnaire (SGRQ) total score was 0.55 with ICS withdrawal, compared with –0.42 with ICS at week 27, and 1.15, compared with –0.07 for withdrawal vs. continuation, respectively, at week 52. This difference, though statistically significant, was not considered clinically relevant, Dr. Magnussen said.

ICS treatment is recommended along with long-acting bronchodilators in patients with frequent exacerbations of severe COPD, but the benefits of ICS use in addition to dual bronchodilator therapy have not been fully elucidated, he said.

The findings of the WISDOM study (N. Engl. J. Med. 2014;371:1285-94), suggest that ICS discontinuation is possible.This study was funded by Boehringer Ingelheim. Dr. Magnussen reported receiving consultant fees and/or serving on a speakers bureau or advisory committee for Almirall, Boehringer Ingelheim, Chiesi, Berli-Chemi, and Novartis. His employer, the Pulmonary Research Institute, received payments for conducting the study.

AUSTIN, TEX. – Higher baseline alpha-1 proteinase inhibitor level, higher body mass index, and female gender may be associated with improved response to alpha-1 proteinase inhibitor augmentation therapy, according to an analysis of data from RAPID.

Better responses to therapy in the trial, as compared with placebo and as measured by mean computed tomography-assessed rate of change in adjusted P15 lung density at total lung capacity, occurred among the 79 female subjects (1.45 g/L per year), and among the 60, 58, and 59 patients with high functional, antigenic, or intermediate functional alpha-1 proteinase inhibitor (A_1-PI) levels, respectively (1.08, 1.23, and 1.38 g/L per year), Dr. James Stocks reported at the annual meeting of the American College of Chest Physicians.

The differences in the rate of change with treatment vs. placebo in these subgroups were statistically significant, said Dr. Stocks of the University of Texas Health Science Center at Tyler.

Greater differences in favor of A1-PI – with a trend toward statistical significance – were also seen in the 21 patients with a body mass index of 30 kg/m² or greater (2.21 g/L per year), the 86 patients under age 54 years (0.96 g/L year), the 87 patients with a carbon monoxide diffusion capacity at or below the median at baseline (0.90 g/L per year), the 8 patients with lower exercise capacity, defined by 400 m or less walked (0.99 g/L per year), and the 88 patients with St. George’s Respiratory Questionnaire symptoms scores at or below the median at baseline (0.93 g/L per year), he said.

RAPID (Randomized, Placebo-Controlled Trial in Alpha-1 Proteinase Inhibitor Deficiency) – the single largest clinical trial of A_1-PI augmentation therapy – included 180 A_1-PI–deficient patients and demonstrated that weekly intravenous A_1-PI therapy at a dose of 60 g/kg per week for 2 years slows progression of emphysema. The annual rate of decline in CT-measured lung density was 34%, compared with placebo. Those findings were reported in May 2013.

According to the current analysis, A_1-PI augmentation appears to be efficacious across a wide range of subgroups, Dr. Stocks said. Those with higher BMI may have experienced greater benefit because of receiving a greater amount of A_1-PI as a result of weight-based dosing. Younger patients may have experienced greater benefit because of being in the earlier stages of disease, with less emphysematous lung damage and lung density loss.

“It is important to note that were no multiplicity adjustments made in the analysis, and no tests for interaction within a subgroup were significant, so no subgroup could be said to be particularly favored as being suitable for treatment with A_1-PI,” he said. It does appear, however, that earlier treatment may help to reduce overall progression of emphysema in affected patients, and that baseline factors such as higher baseline A_1-PI, BMI, and gender may impact treatment benefit, he said.

This study was funded by CSL Behring. Dr. Stocks reported receiving funds as an investigator for the commercially sponsored clinical trial.

AUSTIN, TEX. – Higher baseline alpha-1 proteinase inhibitor level, higher body mass index, and female gender may be associated with improved response to alpha-1 proteinase inhibitor augmentation therapy, according to an analysis of data from RAPID.

Better responses to therapy in the trial, as compared with placebo and as measured by mean computed tomography-assessed rate of change in adjusted P15 lung density at total lung capacity, occurred among the 79 female subjects (1.45 g/L per year), and among the 60, 58, and 59 patients with high functional, antigenic, or intermediate functional alpha-1 proteinase inhibitor (A_1-PI) levels, respectively (1.08, 1.23, and 1.38 g/L per year), Dr. James Stocks reported at the annual meeting of the American College of Chest Physicians.

The differences in the rate of change with treatment vs. placebo in these subgroups were statistically significant, said Dr. Stocks of the University of Texas Health Science Center at Tyler.

Greater differences in favor of A1-PI – with a trend toward statistical significance – were also seen in the 21 patients with a body mass index of 30 kg/m² or greater (2.21 g/L per year), the 86 patients under age 54 years (0.96 g/L year), the 87 patients with a carbon monoxide diffusion capacity at or below the median at baseline (0.90 g/L per year), the 8 patients with lower exercise capacity, defined by 400 m or less walked (0.99 g/L per year), and the 88 patients with St. George’s Respiratory Questionnaire symptoms scores at or below the median at baseline (0.93 g/L per year), he said.

RAPID (Randomized, Placebo-Controlled Trial in Alpha-1 Proteinase Inhibitor Deficiency) – the single largest clinical trial of A_1-PI augmentation therapy – included 180 A_1-PI–deficient patients and demonstrated that weekly intravenous A_1-PI therapy at a dose of 60 g/kg per week for 2 years slows progression of emphysema. The annual rate of decline in CT-measured lung density was 34%, compared with placebo. Those findings were reported in May 2013.

According to the current analysis, A_1-PI augmentation appears to be efficacious across a wide range of subgroups, Dr. Stocks said. Those with higher BMI may have experienced greater benefit because of receiving a greater amount of A_1-PI as a result of weight-based dosing. Younger patients may have experienced greater benefit because of being in the earlier stages of disease, with less emphysematous lung damage and lung density loss.

“It is important to note that were no multiplicity adjustments made in the analysis, and no tests for interaction within a subgroup were significant, so no subgroup could be said to be particularly favored as being suitable for treatment with A_1-PI,” he said. It does appear, however, that earlier treatment may help to reduce overall progression of emphysema in affected patients, and that baseline factors such as higher baseline A_1-PI, BMI, and gender may impact treatment benefit, he said.

This study was funded by CSL Behring. Dr. Stocks reported receiving funds as an investigator for the commercially sponsored clinical trial.

AUSTIN, TEX. – Higher baseline alpha-1 proteinase inhibitor level, higher body mass index, and female gender may be associated with improved response to alpha-1 proteinase inhibitor augmentation therapy, according to an analysis of data from RAPID.

Better responses to therapy in the trial, as compared with placebo and as measured by mean computed tomography-assessed rate of change in adjusted P15 lung density at total lung capacity, occurred among the 79 female subjects (1.45 g/L per year), and among the 60, 58, and 59 patients with high functional, antigenic, or intermediate functional alpha-1 proteinase inhibitor (A_1-PI) levels, respectively (1.08, 1.23, and 1.38 g/L per year), Dr. James Stocks reported at the annual meeting of the American College of Chest Physicians.

The differences in the rate of change with treatment vs. placebo in these subgroups were statistically significant, said Dr. Stocks of the University of Texas Health Science Center at Tyler.

Greater differences in favor of A1-PI – with a trend toward statistical significance – were also seen in the 21 patients with a body mass index of 30 kg/m² or greater (2.21 g/L per year), the 86 patients under age 54 years (0.96 g/L year), the 87 patients with a carbon monoxide diffusion capacity at or below the median at baseline (0.90 g/L per year), the 8 patients with lower exercise capacity, defined by 400 m or less walked (0.99 g/L per year), and the 88 patients with St. George’s Respiratory Questionnaire symptoms scores at or below the median at baseline (0.93 g/L per year), he said.

RAPID (Randomized, Placebo-Controlled Trial in Alpha-1 Proteinase Inhibitor Deficiency) – the single largest clinical trial of A_1-PI augmentation therapy – included 180 A_1-PI–deficient patients and demonstrated that weekly intravenous A_1-PI therapy at a dose of 60 g/kg per week for 2 years slows progression of emphysema. The annual rate of decline in CT-measured lung density was 34%, compared with placebo. Those findings were reported in May 2013.

According to the current analysis, A_1-PI augmentation appears to be efficacious across a wide range of subgroups, Dr. Stocks said. Those with higher BMI may have experienced greater benefit because of receiving a greater amount of A_1-PI as a result of weight-based dosing. Younger patients may have experienced greater benefit because of being in the earlier stages of disease, with less emphysematous lung damage and lung density loss.

“It is important to note that were no multiplicity adjustments made in the analysis, and no tests for interaction within a subgroup were significant, so no subgroup could be said to be particularly favored as being suitable for treatment with A_1-PI,” he said. It does appear, however, that earlier treatment may help to reduce overall progression of emphysema in affected patients, and that baseline factors such as higher baseline A_1-PI, BMI, and gender may impact treatment benefit, he said.

This study was funded by CSL Behring. Dr. Stocks reported receiving funds as an investigator for the commercially sponsored clinical trial.

AUSTIN, TEX. – Race, gender, and care setting appear to predict ventilator-associated pneumonia, according to an analysis of data from the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample.

The strongest predictor of ventilator-associated pneumonia (VAP) was mechanical ventilation for more than 96 hours (odds ratio, 13.64) in an analysis of 13,082 patients who developed the condition. The study subjects were among the 905,000 patients who required mechanical ventilation between 2008 and 2011 and who were available for analysis. The study was controlled for known VAP risk factors, including age, chronic lung disease, altered level of consciousness, acute respiratory distress syndrome, nasogastric tube, aspiration, comorbid conditions, chest surgery, hospital characteristics, and insurance status, Dr. Kathan Mehta of the University of Pittsburgh Medical Center, reported at the annual meeting of the American College of Chest Physicians.

Black patients, men, and those who were treated at a teaching hospital were also at significantly increased risk for VAP (OR, 1.23, 1.33, and 1.64, respectively), Dr. Mehta said.

VAP is an important cause of morbidity and mortality in hospitalized patients requiring mechanical ventilation. A number of risk factors have been associated with high incidence of VAP, but the role of epidemiologic factors in VAP development has been largely unknown, he said.

The current findings – from the one of the largest available comprehensive hospital discharge datasets on mechanical ventilation – have implications for preventing VAP and for improving the diagnosis and treatment of VAP. The at-risk population may benefit from higher suspicion for VAP for early diagnosis and treatment, and from aggressive measures to prevent VAP,” he said. Dr. Mehta reported having no disclosures.

AUSTIN, TEX. – Race, gender, and care setting appear to predict ventilator-associated pneumonia, according to an analysis of data from the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample.

The strongest predictor of ventilator-associated pneumonia (VAP) was mechanical ventilation for more than 96 hours (odds ratio, 13.64) in an analysis of 13,082 patients who developed the condition. The study subjects were among the 905,000 patients who required mechanical ventilation between 2008 and 2011 and who were available for analysis. The study was controlled for known VAP risk factors, including age, chronic lung disease, altered level of consciousness, acute respiratory distress syndrome, nasogastric tube, aspiration, comorbid conditions, chest surgery, hospital characteristics, and insurance status, Dr. Kathan Mehta of the University of Pittsburgh Medical Center, reported at the annual meeting of the American College of Chest Physicians.

Black patients, men, and those who were treated at a teaching hospital were also at significantly increased risk for VAP (OR, 1.23, 1.33, and 1.64, respectively), Dr. Mehta said.

VAP is an important cause of morbidity and mortality in hospitalized patients requiring mechanical ventilation. A number of risk factors have been associated with high incidence of VAP, but the role of epidemiologic factors in VAP development has been largely unknown, he said.

The current findings – from the one of the largest available comprehensive hospital discharge datasets on mechanical ventilation – have implications for preventing VAP and for improving the diagnosis and treatment of VAP. The at-risk population may benefit from higher suspicion for VAP for early diagnosis and treatment, and from aggressive measures to prevent VAP,” he said. Dr. Mehta reported having no disclosures.

AUSTIN, TEX. – Race, gender, and care setting appear to predict ventilator-associated pneumonia, according to an analysis of data from the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample.

The strongest predictor of ventilator-associated pneumonia (VAP) was mechanical ventilation for more than 96 hours (odds ratio, 13.64) in an analysis of 13,082 patients who developed the condition. The study subjects were among the 905,000 patients who required mechanical ventilation between 2008 and 2011 and who were available for analysis. The study was controlled for known VAP risk factors, including age, chronic lung disease, altered level of consciousness, acute respiratory distress syndrome, nasogastric tube, aspiration, comorbid conditions, chest surgery, hospital characteristics, and insurance status, Dr. Kathan Mehta of the University of Pittsburgh Medical Center, reported at the annual meeting of the American College of Chest Physicians.

Black patients, men, and those who were treated at a teaching hospital were also at significantly increased risk for VAP (OR, 1.23, 1.33, and 1.64, respectively), Dr. Mehta said.

VAP is an important cause of morbidity and mortality in hospitalized patients requiring mechanical ventilation. A number of risk factors have been associated with high incidence of VAP, but the role of epidemiologic factors in VAP development has been largely unknown, he said.

The current findings – from the one of the largest available comprehensive hospital discharge datasets on mechanical ventilation – have implications for preventing VAP and for improving the diagnosis and treatment of VAP. The at-risk population may benefit from higher suspicion for VAP for early diagnosis and treatment, and from aggressive measures to prevent VAP,” he said. Dr. Mehta reported having no disclosures.

AUSTIN, TEX. – Use of acid-suppressing drugs was associated with more severe presentation, longer hospital stay, and increased mortality among patients with community-acquired pneumonia presenting to an inner city community hospital, according to a retrospective analysis.

Of 866 patients admitted with community-acquired pneumonia (CAP) between 2010 and 2013, 468 (54%) were on acid suppression, and those patients were significantly more likely than those not on acid suppression to present with positive blood cultures (12% vs. 5.5%) and thrombocytopenia (22% vs. 17%). The difference between the groups in length of stay (10.51 days vs. 8.96 days, respectively), and mortality (15.1% vs. 11.5%, respectively) trended toward significance, Dr. Bikash Bhattarai reported at the annual meeting of the American College of Chest Physicians.

Study subjects included 419 men and 447 women, most of whom (86%) were African American. About half (53%) were smokers. The study excluded patients with suspected aspiration pneumonia and those who were immunosuppressed.

The groups were similar with respect to demographic characteristics, but patients with comorbidities, including chronic obstructive pulmonary disease, diabetes, previous stroke, or neoplastic diseases, were more likely to be on acid suppression, said Dr. Bhattarai of the Interfaith Medical Center in Brooklyn, N.Y.

Gastrointestinal symptoms are very common in the general population – as is the use of either prescribed or over-the-counter medication for acid suppression to treat them, he said, adding that it has been shown that reduction of gastric acid secretion permits colonization of the upper gastrointestinal tract with oral bacteria and is therefore considered a risk factor for CAP.

The findings of this analysis are limited by the retrospective, observational nature of the study, and additional subgroup analyses – including an analysis based on whether patients in the acid suppression group were being treated with proton pump inhibitors or histamine₂ blockers could be useful, he said, acknowledging that some data suggest that proton pump inhibitor use is associated with greater risk.

“Acid-suppressing drugs should be used with caution, and we strongly encourage using those medications only when indicated,” he said.

Dr. Bhattarai reported having no disclosures.

AUSTIN, TEX. – Use of acid-suppressing drugs was associated with more severe presentation, longer hospital stay, and increased mortality among patients with community-acquired pneumonia presenting to an inner city community hospital, according to a retrospective analysis.

Of 866 patients admitted with community-acquired pneumonia (CAP) between 2010 and 2013, 468 (54%) were on acid suppression, and those patients were significantly more likely than those not on acid suppression to present with positive blood cultures (12% vs. 5.5%) and thrombocytopenia (22% vs. 17%). The difference between the groups in length of stay (10.51 days vs. 8.96 days, respectively), and mortality (15.1% vs. 11.5%, respectively) trended toward significance, Dr. Bikash Bhattarai reported at the annual meeting of the American College of Chest Physicians.

Study subjects included 419 men and 447 women, most of whom (86%) were African American. About half (53%) were smokers. The study excluded patients with suspected aspiration pneumonia and those who were immunosuppressed.

The groups were similar with respect to demographic characteristics, but patients with comorbidities, including chronic obstructive pulmonary disease, diabetes, previous stroke, or neoplastic diseases, were more likely to be on acid suppression, said Dr. Bhattarai of the Interfaith Medical Center in Brooklyn, N.Y.

Gastrointestinal symptoms are very common in the general population – as is the use of either prescribed or over-the-counter medication for acid suppression to treat them, he said, adding that it has been shown that reduction of gastric acid secretion permits colonization of the upper gastrointestinal tract with oral bacteria and is therefore considered a risk factor for CAP.

The findings of this analysis are limited by the retrospective, observational nature of the study, and additional subgroup analyses – including an analysis based on whether patients in the acid suppression group were being treated with proton pump inhibitors or histamine₂ blockers could be useful, he said, acknowledging that some data suggest that proton pump inhibitor use is associated with greater risk.

“Acid-suppressing drugs should be used with caution, and we strongly encourage using those medications only when indicated,” he said.

Dr. Bhattarai reported having no disclosures.

AUSTIN, TEX. – Use of acid-suppressing drugs was associated with more severe presentation, longer hospital stay, and increased mortality among patients with community-acquired pneumonia presenting to an inner city community hospital, according to a retrospective analysis.

Of 866 patients admitted with community-acquired pneumonia (CAP) between 2010 and 2013, 468 (54%) were on acid suppression, and those patients were significantly more likely than those not on acid suppression to present with positive blood cultures (12% vs. 5.5%) and thrombocytopenia (22% vs. 17%). The difference between the groups in length of stay (10.51 days vs. 8.96 days, respectively), and mortality (15.1% vs. 11.5%, respectively) trended toward significance, Dr. Bikash Bhattarai reported at the annual meeting of the American College of Chest Physicians.

Study subjects included 419 men and 447 women, most of whom (86%) were African American. About half (53%) were smokers. The study excluded patients with suspected aspiration pneumonia and those who were immunosuppressed.

The groups were similar with respect to demographic characteristics, but patients with comorbidities, including chronic obstructive pulmonary disease, diabetes, previous stroke, or neoplastic diseases, were more likely to be on acid suppression, said Dr. Bhattarai of the Interfaith Medical Center in Brooklyn, N.Y.

Gastrointestinal symptoms are very common in the general population – as is the use of either prescribed or over-the-counter medication for acid suppression to treat them, he said, adding that it has been shown that reduction of gastric acid secretion permits colonization of the upper gastrointestinal tract with oral bacteria and is therefore considered a risk factor for CAP.

The findings of this analysis are limited by the retrospective, observational nature of the study, and additional subgroup analyses – including an analysis based on whether patients in the acid suppression group were being treated with proton pump inhibitors or histamine₂ blockers could be useful, he said, acknowledging that some data suggest that proton pump inhibitor use is associated with greater risk.

“Acid-suppressing drugs should be used with caution, and we strongly encourage using those medications only when indicated,” he said.

Dr. Bhattarai reported having no disclosures.

AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine₂ blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine₂ blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

AUSTIN, TEX. – Use of proton pump inhibitors and steroids was independently associated with recurrences of Clostridium difficile–associated diarrhea among patients in an intensive care unit, based on a retrospective chart review reported at the annual meeting of the American College of Chest Physicians.

Recurrences were noted in 268 of 2,019 patients who were admitted to a single intensive care unit during a 6-year period and were initially treated successfully for C. difficile–associated diarrhea (CDAD). In a univariate analysis, recurrence was correlated with use of proton pump inhibitors (PPIs) and steroids, but not with age, male gender, or length of hospital stay. After adjusting for age, sex, length of stay, and treatment used, the relationships between recurrence and PPI and steroid use remained statistically significant (P = .0331 and P = .0305, respectively), Dr. Ala Nijim of Akron (Ohio) General Medical Center.

The study subjects comprised 798 men and 1,221 women with an average age of 68 years and an average hospital length of stay of 10 days. Severe disease was present in 233 patients, and 51 had cancer.

CDAD in this study was defined as at least three episodes of loose stools in less than 24 hours with a positive C. difficile toxin assay. Recurrence was defined as a second positive stool test within 90 days following complete resolution of a previous episode of diarrhea episode and cessation of treatment comprising a 10-day period.

Data suggest that the rate of CDAD recurrence is between 10% and 25% at a cost of between $3.2 and $4.8 billion, Dr. Nijim said.

Glucocorticoids are known risk factors for acquiring CDAD, likely due to their immunosuppressive effects, and PPIs have also been suggested as risk factors for acquiring CDAD, although the findings have been mixed. Likewise, treatment with metronidazole for an initial episode has been linked with treatment failure and recurrence risk. In the current study, one of the largest to date to evaluate factors associated with CDAD recurrence, both PPIs and glucocorticoids were shown to be associated with recurrence risk, but no link was found between metronidazole or any CDAD treatment modality and recurrence, Dr. Nijim said.

Though limited by the single-center, retrospective study design and its inherent information and selection biases, the study includes a large ICU patient sample, and the findings suggest that intensivists should watch carefully for recurrence in patients using PPIs and/or steroids.

Also, clinicians should think carefully before starting patients on PPIs – and perhaps use histamine₂ blockers instead – in patients with a history of CDAD, she said.

Dr. Nijim reported having no disclosures.

AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

AUSTIN, TEX. – Ultrasound plus real-time transthoracic echocardiography sped up placements of central venous catheters and rule outs of insertion-related pneumothorax, compared with ultrasound alone in a prospective, randomized, controlled study of 60 patients in the medical intensive care unit of a single center.

Compared to conventional ultrasound placement with x-ray confirmation, ultrasound plus transthoracic echocardiography also reduced the time to approval of the line for use, Dr. Dileep Raman reported at the annual meeting of the American College of Chest Physicians.

Waiting for a chest x-ray adds anywhere from 16 minutes to 2 hours to the approval of line use, according to the literature. Ultrasound is “a cheap bedside tool that can be repeatedly used to reduce the amount of chest x-rays for line placement and insertion” and indeed reduced the need for chest x-ray to confirm central venous catheter (CVC) position – without adding to procedure time, he said.

In the study, ultrasound plus transthoracic echocardiography reduced the use of bedside chest x-rays by 57% in 30 patients, compared with conventional ultrasound placement with x-ray confirmation in 29 patients. The mean time to line use was 25 minutes in the ultrasound plus echo group and 53.6 minutes in the conventional placement group, said Dr. Raman of the Cleveland Clinic.

The mean time to complete the procedure was 24.1 minutes in the intervention group, compared with 27.7 minutes in the x-ray confirmation group, he said. None of the study patients had pneumothoraces.

Study subjects were consecutive patients admitted to an intensive care unit at a tertiary care medical center. Both the intervention and control groups had central venous catheters inserted under ultrasound guidance, but the intervention group underwent real-time transthoracic echocardiography to assist in catheter positioning, as well as chest ultrasonography to exclude a pneumothorax. After this process was completed, the line was immediately cleared for use. If the catheter wasn’t detected in the right atrium, the patient was switched to the control group, which was treated using conventional techniques followed by standard chest x-ray.

The study groups were well matched with respect to age, body mass index, and APACHE III score.

Obtaining a chest x-ray to confirm line placement and to exclude pneumothorax remains the standard of care in most ICUs, but Dr. Raman said he and his colleagues dispute that chest x-ray should remain the standard, as it doesn’t identify the superior vena cava–right atrium junction. Also, in addition to reducing the need for chest x-ray, the ultrasound technique seems to give a better picture of line placement.

Additional studies are needed to look at safety and feasibility, because pneumothorax rates are low, and “60 patients is clearly not enough to see if we dented the pneumothorax rate,” he said.

Dr. Raman reported having no disclosures.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.

AUSTIN, TEX. – Exacerbation rates were lower and lung function improved when patients with moderate or severe chronic obstructive pulmonary disease received combined treatment with the inhaled corticosteroid (ICS) budesonide and the long-acting beta₂-agonist (LABA) formoterol, as compared with patients who receive formoterol alone.

In a post hoc analysis of pooled data from three randomized double-blind studies, exacerbation rates were lower in the 197 patients with moderate airflow limitations and in the 975 patients with severe airflow limitations who received combination therapy, compared with the 211 and 963 patients, respectively, who received only formoterol.

The differences were seen regardless of whether antibiotics were used, regardless of airflow limitation severity, and despite an overall lower exacerbation rate in those with moderate vs. severe disease, Dr. Donald Tashkin reported at the annual meeting of the American College of Chest Physicians.

The lowest rate of exacerbations, 0.4 per patient-treatment-year, was among those in the combination therapy group who were not treated with antibiotics – suggesting infection was not a factor in the exacerbation. The exacerbation rate was 0.7 per patient-treatment-year in those with moderate airflow limitation who received only formoterol. The respective exacerbation rates in patients with severe airflow limitation were 0.8 for those who received combination therapy and 1.0 in those who received only formoterol. The corresponding rates for exacerbations among those who were additionally treated with antibiotics were 0.5 vs. 0.8 and 0.9 vs. 1.2, said Dr. Tashkin of the University of California, Los Angeles.

Further, an overall greater percentage of patients receiving combination therapy met responder criteria for at least a 100-mL improvement in predose forced expiratory volume in 1 second (FEV₁). The rates were 47% vs. 39% for combination vs. formoterol alone in patients with moderate airflow limitation, and 34% vs. 29%, respectively, in patients with severe airflow limitations, he said.

The pooled data for this analysis were from two 12-month trials and one 6-month trial of COPD patients aged 40 years or older with at least one COPD exacerbation in the past year. Two of the trials (the 12-month SUN study and the 6-month SHINE study) were pivotal randomized, placebo-controlled, double-blind, double-dummy trials that led to the approval of the budesonide/formoterol combination therapy, and the third was a non–placebo-controlled study, Dr. Tashkin noted.

Moderate disease was defined as FEV₁ percent predicted of at least 50%, and severe disease was defined as FEV₁ percent predicted of less than 50%. Exacerbations were defined as COPD worsening that required treatment with oral corticosteroids and/or hospitalization.

Combination therapy was administered twice daily via pressurized metered-dose inhaler at a dose of 320 mcg budesonide/9 mcg formoterol; formoterol-only therapy was administered twice daily via dry-powder inhaler at a dose of 9 mcg.

This study was supported by AstraZeneca. Dr. Tashkin reported receiving consulting fees and/or serving on a speakers bureau or advisory committee for AstraZeneca, Sunovion, Theravance, Pearl, Boehringer Ingelheim, and Forest, and receiving research funding or grant money from Sunovion, Pearl, and GlaxoSmithKline.