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Does Anyone Really Understand Nutrition Labels?

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Study shows that most people are either unable to read or follow nutrition labels, causing an increase in overeating.

In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.

The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.

About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.

Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.

Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.

One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.

Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.

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Study shows that most people are either unable to read or follow nutrition labels, causing an increase in overeating.
Study shows that most people are either unable to read or follow nutrition labels, causing an increase in overeating.

In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.

The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.

About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.

Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.

Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.

One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.

Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.

In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.

The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.

About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.

Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.

Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.

One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.

Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.

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Nebulized glycopyrrolate improves lung function in COPD

Comment by Eric Gartman, MD, FCCP
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– Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*

There are currently no nebulized LAMAs approved for use in the U.S.

Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.

Debra Beck/Frontline Medical News
Dr. Jill Ohar
“Glycopyrrolate works,” reported Dr. Ohar. “It improves FEV1 [at week 12], not only in the statistically significant manner but in a clinically significant manner, both at the 25-microgram and 50-microgram dose…And when you cut the data according to FEV1, you again see a statistically significant improvement regardless [of whether] your FEV1 at baseline was less than 50% of predicted versus greater than or equal to 50%.”

Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.

Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.

The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.

Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.

“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.

GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.

Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.

Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.

*This article was updated on Nov. 6, 2017.
 

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Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.

Dr. Eric J. Gartman
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Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.

Dr. Eric J. Gartman
Body

Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.

Dr. Eric J. Gartman
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Comment by Eric Gartman, MD, FCCP
Comment by Eric Gartman, MD, FCCP

 

– Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*

There are currently no nebulized LAMAs approved for use in the U.S.

Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.

Debra Beck/Frontline Medical News
Dr. Jill Ohar
“Glycopyrrolate works,” reported Dr. Ohar. “It improves FEV1 [at week 12], not only in the statistically significant manner but in a clinically significant manner, both at the 25-microgram and 50-microgram dose…And when you cut the data according to FEV1, you again see a statistically significant improvement regardless [of whether] your FEV1 at baseline was less than 50% of predicted versus greater than or equal to 50%.”

Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.

Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.

The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.

Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.

“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.

GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.

Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.

Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.

*This article was updated on Nov. 6, 2017.
 

 

– Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*

There are currently no nebulized LAMAs approved for use in the U.S.

Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.

Debra Beck/Frontline Medical News
Dr. Jill Ohar
“Glycopyrrolate works,” reported Dr. Ohar. “It improves FEV1 [at week 12], not only in the statistically significant manner but in a clinically significant manner, both at the 25-microgram and 50-microgram dose…And when you cut the data according to FEV1, you again see a statistically significant improvement regardless [of whether] your FEV1 at baseline was less than 50% of predicted versus greater than or equal to 50%.”

Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.

Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.

The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.

Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.

“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.

GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.

Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.

Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.

*This article was updated on Nov. 6, 2017.
 

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Key clinical point: Nebulized glycopyrrolate improved lung function and was well tolerated irrespective of baseline lung function or age.

Major finding: Statistically and clinically meaningful improvements in trough FEV1 at 12 weeks were seen in individuals, regardless of their baseline FEV1 % predicted.

Data source: Pooled findings from 2 RCTs, GOLDEN 3 and GOLDEN 4, that together included 1,294 moderate-to-very severe COPD patients.

Disclosures: Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.

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Remimazolam surpasses midazolam for bronchoscopy sedation

Comment by Eric Gartman, MD, FCCP
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– An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.

The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Gerard A. Silvestri
Paion, the company developing remimazolam, plans to combine data from this bronchoscopy study with data collected from other procedural studies that included patients undergoing colonoscopy and upper gastrointestinal endoscopy, and seek U.S. Food & Drug Administration approval for the drug in 2018, according to a written statement.

The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.

All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.

This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.

“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.

Mitchel L. Zoler/Frontline Medical News
Dr. Matthew B. Stanbrook
Midazolam is the current “workhorse” sedative, but “we can do better,” commented Matthew B. Stanbrook, MD, a pulmonologist at the University of Toronto. “There would be some benefit from a sedative with faster onset and offset,” he said in an interview.

Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.

The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
 
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Dr. Eric J. Gartman
This medication may represent a valuable addition to our options for moderate sedation during procedures - in that its main benefit seems to be in its onset of sedation. It will be important to assess this study's outcome data once published - especially with regard to the driver of the differences seen between groups in the composite primary outcome (i.e., successfully completing a procedure would be the important primary endpoint to most, and we should be interested to see if it was the dosing/time-based outcomes that drove the primary outcome differences between the groups). Further, if there are significant cost differences between these two medications, this will certainly limit their incorporation into practice unless there are significant differences in patient-centered outcomes.
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Dr. Eric J. Gartman
This medication may represent a valuable addition to our options for moderate sedation during procedures - in that its main benefit seems to be in its onset of sedation. It will be important to assess this study's outcome data once published - especially with regard to the driver of the differences seen between groups in the composite primary outcome (i.e., successfully completing a procedure would be the important primary endpoint to most, and we should be interested to see if it was the dosing/time-based outcomes that drove the primary outcome differences between the groups). Further, if there are significant cost differences between these two medications, this will certainly limit their incorporation into practice unless there are significant differences in patient-centered outcomes.
Body

Dr. Eric J. Gartman
This medication may represent a valuable addition to our options for moderate sedation during procedures - in that its main benefit seems to be in its onset of sedation. It will be important to assess this study's outcome data once published - especially with regard to the driver of the differences seen between groups in the composite primary outcome (i.e., successfully completing a procedure would be the important primary endpoint to most, and we should be interested to see if it was the dosing/time-based outcomes that drove the primary outcome differences between the groups). Further, if there are significant cost differences between these two medications, this will certainly limit their incorporation into practice unless there are significant differences in patient-centered outcomes.
Title
Comment by Eric Gartman, MD, FCCP
Comment by Eric Gartman, MD, FCCP

 

– An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.

The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Gerard A. Silvestri
Paion, the company developing remimazolam, plans to combine data from this bronchoscopy study with data collected from other procedural studies that included patients undergoing colonoscopy and upper gastrointestinal endoscopy, and seek U.S. Food & Drug Administration approval for the drug in 2018, according to a written statement.

The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.

All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.

This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.

“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.

Mitchel L. Zoler/Frontline Medical News
Dr. Matthew B. Stanbrook
Midazolam is the current “workhorse” sedative, but “we can do better,” commented Matthew B. Stanbrook, MD, a pulmonologist at the University of Toronto. “There would be some benefit from a sedative with faster onset and offset,” he said in an interview.

Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.

The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
 

 

– An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.

The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Gerard A. Silvestri
Paion, the company developing remimazolam, plans to combine data from this bronchoscopy study with data collected from other procedural studies that included patients undergoing colonoscopy and upper gastrointestinal endoscopy, and seek U.S. Food & Drug Administration approval for the drug in 2018, according to a written statement.

The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.

All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.

This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.

The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.

“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.

Mitchel L. Zoler/Frontline Medical News
Dr. Matthew B. Stanbrook
Midazolam is the current “workhorse” sedative, but “we can do better,” commented Matthew B. Stanbrook, MD, a pulmonologist at the University of Toronto. “There would be some benefit from a sedative with faster onset and offset,” he said in an interview.

Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.

The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
 
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Key clinical point: Remimazolam, an investigational sedative, showed faster onset and offset compared with midazolam and also resulted in significantly more successful bronchoscopy procedures.

Major finding: The rate of successful bronchoscopies was 83% with remimazolam, 34% with midazolam, and 5% with placebo.

Data source: A multicenter, phase III trial with 431 patients.

Disclosures: The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.

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Event-free survival at 24 months predicts outcomes in peripheral T-cell lymphomas

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Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

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Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

 

Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

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Key clinical point: Event-free survival at 24 months (EFS24) stratifies outcomes in peripheral T-cell lymphomas.

Major finding: Five-year overall survival for those who achieved EFS24 was 78% vs. 11% for those who did not.

Data source: Multinational cohort study that included 775 patients with newly diagnosed PTCL who were evaluated for EFS24 as a predictive endpoint.

Disclosures: The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

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IGRA preferred test for latent TB diagnosis

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– U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.

Debra Beck/Frontline Medical News
Dr. Adam Green
“Epidemiological models have indicated that in order to eliminate the threat of TB in the United States, it will require a strategy of targeting latent tuberculosis infection specifically among foreign-born individuals,” he said during his presentation. “This highlights the need for us practitioners on the front line to have sound knowledge of identification, screening, and management of latent TB infection, especially given the multiple modalities for diagnosis.”

Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.

While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.

Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.

Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”

Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.

One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.

To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.

“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”

The authors reported there were no product or funding disclosures relevant to this study.
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– U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.

Debra Beck/Frontline Medical News
Dr. Adam Green
“Epidemiological models have indicated that in order to eliminate the threat of TB in the United States, it will require a strategy of targeting latent tuberculosis infection specifically among foreign-born individuals,” he said during his presentation. “This highlights the need for us practitioners on the front line to have sound knowledge of identification, screening, and management of latent TB infection, especially given the multiple modalities for diagnosis.”

Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.

While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.

Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.

Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”

Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.

One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.

To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.

“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”

The authors reported there were no product or funding disclosures relevant to this study.

 

– U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.

Debra Beck/Frontline Medical News
Dr. Adam Green
“Epidemiological models have indicated that in order to eliminate the threat of TB in the United States, it will require a strategy of targeting latent tuberculosis infection specifically among foreign-born individuals,” he said during his presentation. “This highlights the need for us practitioners on the front line to have sound knowledge of identification, screening, and management of latent TB infection, especially given the multiple modalities for diagnosis.”

Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.

While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.

Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.

Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”

Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.

One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.

To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.

“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”

The authors reported there were no product or funding disclosures relevant to this study.
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Key clinical point: Most physicians queried preferred IGRAs over TST for the detection of latent TB infection.

Major finding: Of the 304 respondents to a survey, 78% said they preferred IGRAs over TST for TB testing and 91% reported having a good understanding of how to use and interpret IGRAs.

Data source: Online survey of 304 pulmonary and infectious disease attending physicians and fellows from U.S.-based academic programs.

Disclosures: The authors reported there were no product or funding disclosures relevant to this study.

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Nivolumab linked to CNS disorder in case report

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Autoimmune encephalitis may be a potentially severe complication of immune checkpoint inhibitor therapy, a case report suggests.

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Autoimmune encephalitis may be a potentially severe complication of immune checkpoint inhibitor therapy, a case report suggests.

 

Autoimmune encephalitis may be a potentially severe complication of immune checkpoint inhibitor therapy, a case report suggests.

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FROM THE EUROPEAN JOURNAL OF CANCER

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Key clinical point: Autoimmune encephalitis may be a potential complication of checkpoint inhibitor therapy.

Major finding: A patient with B-cell non-Hodgkin lymphoma presented with double vision, ataxia, impaired speech, and mild cognitive dysfunction following treatment with nivolumab. Examination of a brain lesion showed a T cell–dominated inflammatory process thought to be autoimmune in origin.

Data source: A case report of a 53-year-old man with B-cell non-Hodgkin lymphoma (B-NHL) who received nivolumab maintenance treatment.

Disclosures: The authors declared no conflicts of interest and did not receive grant support for the research.

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Rural Communities Have High Rates of Suicide

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CDC finds suicide rates have increased significantly and are especially high in certain geographic areas.

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

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CDC finds suicide rates have increased significantly and are especially high in certain geographic areas.
CDC finds suicide rates have increased significantly and are especially high in certain geographic areas.

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

More than half a million people committed suicide between 2001 and 2015, according to the CDC. Rural counties consistently had higher rates than those of metropolitan areas. “While we’ve seen many causes of death come down in recent years, suicide rates have increased more than 20% from 2001 to 2015,” said Brenda Fitzgerald, MD, CDC director. “And this is especially concerning in rural areas.”

Related: Suicide Federal Health Data Trends

Suicide rates in rural counties were 17.32 per 100,000 people compared with 14.86 in small-to-medium metropolitan counties and 11.92 in large metropolitan counties. Rates for American Indian/Alaska Native non-Hispanics were the highest.

The researchers note that, at some points, different negative factors had more impact. For instance, rural communities were harder hit by housing foreclosures, poverty, and unemployment due to the recession. However, the researchers also point out that suicide rates were on the rise before the recession began.

“The trends in suicide rates…are magnified in rural areas,” said James Mercy, PhD, director of CDC’s Division of Violence Prevention. “This report underscores the need for suicide prevention strategies that are specifically tailored for these communities.” To that end, the CDC recently released a compilation of evidence-based strategies that have the greatest prevention potential. The set includes examples of programs that can be customized to fit the cultural needs of different groups. In North Dakota, for instance, the program Sources of Strength was developed for tribal communities to promote connectedness between youth and adults.

Related: Improving Veteran Engagement With Mental Health Care

The Health Resource and Service Administration (HRSA) also has developed activities to address suicide in rural areas, including epidemiologic studies, research, telemedicine, and programs addressing primary health care providers.

https://www.cdc.gov/violenceprevention/pub/technical-packages.html

https://www.hrsa.gov/ruralhealth

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VIDEO: Balanced crystalloids protect kidney better than saline

Fluid switch has big impact for small cost
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– Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.

Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.

“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.

“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.

At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.

The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.

This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.

The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.

The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.

The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.

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Mitchel L. Zoler/Frontline Medical News
Dr. Bennett P. deBoisblanc
The SMART and SALT-ED trials were awesome and beautifully planned. The researchers used a pragmatic design that is the wave of the future. The incremental benefit from balanced crystalloid fluids was small, about 1%, but it’s a cheap solution. If you administer 7 L of fluid to a patient the incremental cost compared with 0.9% saline is about $45. Based on the number needed to treat that the studies found, this means it would cost less than $5,000 extra to prevent one major adverse kidney event. Nothing else in the ICU or ED compares with that. It’s a phenomenal impact from a low-tech intervention.

Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.

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Mitchel L. Zoler/Frontline Medical News
Dr. Bennett P. deBoisblanc
The SMART and SALT-ED trials were awesome and beautifully planned. The researchers used a pragmatic design that is the wave of the future. The incremental benefit from balanced crystalloid fluids was small, about 1%, but it’s a cheap solution. If you administer 7 L of fluid to a patient the incremental cost compared with 0.9% saline is about $45. Based on the number needed to treat that the studies found, this means it would cost less than $5,000 extra to prevent one major adverse kidney event. Nothing else in the ICU or ED compares with that. It’s a phenomenal impact from a low-tech intervention.

Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.

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Mitchel L. Zoler/Frontline Medical News
Dr. Bennett P. deBoisblanc
The SMART and SALT-ED trials were awesome and beautifully planned. The researchers used a pragmatic design that is the wave of the future. The incremental benefit from balanced crystalloid fluids was small, about 1%, but it’s a cheap solution. If you administer 7 L of fluid to a patient the incremental cost compared with 0.9% saline is about $45. Based on the number needed to treat that the studies found, this means it would cost less than $5,000 extra to prevent one major adverse kidney event. Nothing else in the ICU or ED compares with that. It’s a phenomenal impact from a low-tech intervention.

Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.

Title
Fluid switch has big impact for small cost
Fluid switch has big impact for small cost

– Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.

Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.

“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.

“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.

At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.

The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.

This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.

The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.

The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.

The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.

– Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.

Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.

“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.

“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.

At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.

The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.

This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.

The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.

The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.

The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.

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Key clinical point: IV fluids with balanced crystalloids outperformed 0.9% saline for preventing death, need for renal replacement therapy, and persistent renal dysfunction in a pair of randomized trials with more than 29,000 patients.

Major finding: Balanced crystalloids reduced combined adverse renal events by 1.1% in ICU patients and 0.9% in ED patients.

Data source: The SMART and SALT-ED trials, both single-center studies with a total of 29,149 patients.

Disclosures: The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.

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Cardiogenic shock boosts PAH readmissions 10-fold

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– Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.

An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Kshitij Chatterjee
“We were surprised” that acute disorders – cardiogenic shock and acute kidney injury – played such a key role in triggering readmissions, said Dr. Chatterjee, a hospitalist at the University of Arkansas for Medical Science in Little Rock. He contrasted the impact of these acute disorders on PAH with the main drivers of rehospitalization for other diseases, such as COPD and pneumonia, that more often link with chronic comorbidities.

The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.

Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.

The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.

Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.

Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.

Dr. Chatterjee had no disclosures.
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– Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.

An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Kshitij Chatterjee
“We were surprised” that acute disorders – cardiogenic shock and acute kidney injury – played such a key role in triggering readmissions, said Dr. Chatterjee, a hospitalist at the University of Arkansas for Medical Science in Little Rock. He contrasted the impact of these acute disorders on PAH with the main drivers of rehospitalization for other diseases, such as COPD and pneumonia, that more often link with chronic comorbidities.

The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.

Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.

The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.

Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.

Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.

Dr. Chatterjee had no disclosures.

 

– Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.

An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.

Mitchel L. Zoler/Frontline Medical News
Dr. Kshitij Chatterjee
“We were surprised” that acute disorders – cardiogenic shock and acute kidney injury – played such a key role in triggering readmissions, said Dr. Chatterjee, a hospitalist at the University of Arkansas for Medical Science in Little Rock. He contrasted the impact of these acute disorders on PAH with the main drivers of rehospitalization for other diseases, such as COPD and pneumonia, that more often link with chronic comorbidities.

The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.

Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.

The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.

Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.

Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.

Dr. Chatterjee had no disclosures.
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Key clinical point: Cardiogenic shock, COPD, and acute kidney injury were independently associated with increased 30-day rehospitalization after index hospitalization for PAH.

Major finding: Patients with cardiogenic shock following PAH hospitalization had a 9.7-fold increased rate of 30-day rehospitalization, compared with patients without shock.

Data source: The National Readmissions Database, which included 776 index U.S. hospitalizations for pulmonary arterial hospitalization during 2013.

Disclosures: Dr. Chatterjee had no disclosures.

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Lung recovery high after ECMO in near-fatal pediatric asthma

Susan Millard, MD, FCCP, comments on pCO2
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– Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.

Debra L. Beck/Frontline Medical News
Dr. Rebecca Kohlberg-Davis


ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.

Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.

The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.

Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.

At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.

Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).

Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.

“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.

The authors reported having nothing to disclose.
Body

This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time. 

Dr. Susan Millard
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Body

This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time. 

Dr. Susan Millard
Body

This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time. 

Dr. Susan Millard
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Susan Millard, MD, FCCP, comments on pCO2
Susan Millard, MD, FCCP, comments on pCO2

 

– Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.

Debra L. Beck/Frontline Medical News
Dr. Rebecca Kohlberg-Davis


ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.

Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.

The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.

Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.

At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.

Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).

Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.

“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.

The authors reported having nothing to disclose.

 

– Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.

Debra L. Beck/Frontline Medical News
Dr. Rebecca Kohlberg-Davis


ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.

Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.

The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.

Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.

At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.

Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).

Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.

“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.

The authors reported having nothing to disclose.
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Key clinical point: ECMO is a life-saving option in children with asthma, but it is associated with significant complications.

Major finding: The use of ECMO resulted in lung recovery in 83% of pediatric patients with near-fatal asthma; 77% were discharged from the hospital.

Data source: Retrospective analysis of children with asthma treated with ECMO in the Extracorporeal Life Support Organization (ELSO) registry (n = 371).

Disclosures: The authors reported having nothing to disclose.

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