COPD

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD). The finding is a surprise, considering that GERD has been associated with more COPD exacerbations. GERD is also more common among patients with COPD than in the general population.

“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.

One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.

“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.

The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.

The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).

After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; ^P < .001), and acute heart failure (aOR, 0.762; P < .001).

Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).

There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.

It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.

He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.

The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.

Alam and Deokar disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD). The finding is a surprise, considering that GERD has been associated with more COPD exacerbations. GERD is also more common among patients with COPD than in the general population.

“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.

One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.

“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.

The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.

The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).

After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; ^P < .001), and acute heart failure (aOR, 0.762; P < .001).

Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).

There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.

It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.

He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.

The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.

Alam and Deokar disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD). The finding is a surprise, considering that GERD has been associated with more COPD exacerbations. GERD is also more common among patients with COPD than in the general population.

“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.

One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.

“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.

The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.

The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).

After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; ^P < .001), and acute heart failure (aOR, 0.762; P < .001).

Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).

There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.

It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.

He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.

The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.

Alam and Deokar disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.

“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.

“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.

To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.

The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.

The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.

The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.

Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.

“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.

The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.

The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.

“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.

The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
 

Changing Clinical Practice

“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.

Limitations and Next Steps

The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.

Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”

However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.

“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
 

In-Hospital Inhaler Education Falls Short

“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.

“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.

“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.

“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”

Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.

Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.

The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Pulmonology Data Trends 2024 is a supplement to CHEST Physician highlighting the latest breakthroughs in pulmonology research and treatments through a series of infographics.

Read more: 

Artificial Intelligence in Sleep Apnea
Ritwick Agrawal, MD, MS, FCCP

RSV Updates: Prophylaxis Approval and Hospitalization for Severe RSV
Riddhi Upadhyay, MD

Biologics in Asthma: Changing the Severe Asthma Paradigm
Shyam Subramanian, MD, FCCP

Updates in COPD Guidelines and Treatment
Dharani K. Narendra, MD, FCCP

Targeted Therapies and Surgical Resection for Lung Cancer: Evolving Treatment Options
Saadia A. Faiz, MD, FCCP

Closing the GAP in Idiopathic Pulmonary Fibrosis
Humayun Anjum, MD, FCCP

Severe Community-Acquired Pneumonia: Diagnostic Criteria, Treatment, and COVID-19
Sujith V. Cherian, MD, FCCP

Pulmonary Hypertension: Comorbidities and Novel Therapies
Mary Jo S. Farmer, MD, PhD, FCCP

The Genetic Side of Interstitial Lung Disease
Priya Balakrishnan, MD, MS, FCCP

Noninvasive Ventilation in Neuromuscular Disease
Sreelatha Naik, MD, FCCP, and Kelly Lobrutto, CRNP

Pulmonology Data Trends 2024 is a supplement to CHEST Physician highlighting the latest breakthroughs in pulmonology research and treatments through a series of infographics.

Read more: 

Artificial Intelligence in Sleep Apnea
Ritwick Agrawal, MD, MS, FCCP

RSV Updates: Prophylaxis Approval and Hospitalization for Severe RSV
Riddhi Upadhyay, MD

Biologics in Asthma: Changing the Severe Asthma Paradigm
Shyam Subramanian, MD, FCCP

Updates in COPD Guidelines and Treatment
Dharani K. Narendra, MD, FCCP

Targeted Therapies and Surgical Resection for Lung Cancer: Evolving Treatment Options
Saadia A. Faiz, MD, FCCP

Closing the GAP in Idiopathic Pulmonary Fibrosis
Humayun Anjum, MD, FCCP

Severe Community-Acquired Pneumonia: Diagnostic Criteria, Treatment, and COVID-19
Sujith V. Cherian, MD, FCCP

Pulmonary Hypertension: Comorbidities and Novel Therapies
Mary Jo S. Farmer, MD, PhD, FCCP

The Genetic Side of Interstitial Lung Disease
Priya Balakrishnan, MD, MS, FCCP

Noninvasive Ventilation in Neuromuscular Disease
Sreelatha Naik, MD, FCCP, and Kelly Lobrutto, CRNP

Pulmonology Data Trends 2024 is a supplement to CHEST Physician highlighting the latest breakthroughs in pulmonology research and treatments through a series of infographics.

Read more: 

Artificial Intelligence in Sleep Apnea
Ritwick Agrawal, MD, MS, FCCP

RSV Updates: Prophylaxis Approval and Hospitalization for Severe RSV
Riddhi Upadhyay, MD

Biologics in Asthma: Changing the Severe Asthma Paradigm
Shyam Subramanian, MD, FCCP

Updates in COPD Guidelines and Treatment
Dharani K. Narendra, MD, FCCP

Targeted Therapies and Surgical Resection for Lung Cancer: Evolving Treatment Options
Saadia A. Faiz, MD, FCCP

Closing the GAP in Idiopathic Pulmonary Fibrosis
Humayun Anjum, MD, FCCP

Severe Community-Acquired Pneumonia: Diagnostic Criteria, Treatment, and COVID-19
Sujith V. Cherian, MD, FCCP

Pulmonary Hypertension: Comorbidities and Novel Therapies
Mary Jo S. Farmer, MD, PhD, FCCP

The Genetic Side of Interstitial Lung Disease
Priya Balakrishnan, MD, MS, FCCP

Noninvasive Ventilation in Neuromuscular Disease
Sreelatha Naik, MD, FCCP, and Kelly Lobrutto, CRNP

Click to view more from Pulmonology Data Trends 2024. 

Click to view more from Pulmonology Data Trends 2024. 

Click to view more from Pulmonology Data Trends 2024. 

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at an unreasonably high annual cost, authors of a cost and effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second within 0-12 hours of administration, compared with placebo. In addition, patients were reported to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High cost barrier

But as authors of the analysis from the Boston, Massachusetts–based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Vernona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7,500-$12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests.

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides.”

As previously reported, as many as one in six persons with COPD in the United States miss or delay COPD medication doses because of high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher-volume sales, affording the drugmaker a comparable profit with the higher-cost but lower-volume option.
 

Good drug, high price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added healthcare costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug not yet available?

However, providers have not yet had direct experience with the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of Advance Practice Provider and Clinical Services for Colorado Springs Pulmonary Consultants, president and founder of the Association of Pulmonary Advance Practice Providers, and a member of the CHEST Physician Editorial Board.

CHEST

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at an unreasonably high annual cost, authors of a cost and effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second within 0-12 hours of administration, compared with placebo. In addition, patients were reported to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High cost barrier

But as authors of the analysis from the Boston, Massachusetts–based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Vernona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7,500-$12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests.

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides.”

As previously reported, as many as one in six persons with COPD in the United States miss or delay COPD medication doses because of high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher-volume sales, affording the drugmaker a comparable profit with the higher-cost but lower-volume option.
 

Good drug, high price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added healthcare costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug not yet available?

However, providers have not yet had direct experience with the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of Advance Practice Provider and Clinical Services for Colorado Springs Pulmonary Consultants, president and founder of the Association of Pulmonary Advance Practice Providers, and a member of the CHEST Physician Editorial Board.

CHEST

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at an unreasonably high annual cost, authors of a cost and effectiveness analysis say.

Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer.

In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second within 0-12 hours of administration, compared with placebo. In addition, patients were reported to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group.
 

High cost barrier

But as authors of the analysis from the Boston, Massachusetts–based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Vernona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7,500-$12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests.

“Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” said David Rind, MD, chief medical officer of ICER in a statement.

In an interview, Dr. Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. “Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don’t have money for other things. So I’m worried about the fact that this price is too high compared to the benefit it provides.”

As previously reported, as many as one in six persons with COPD in the United States miss or delay COPD medication doses because of high drug costs. “I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won’t even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug,” Dr. Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher-volume sales, affording the drugmaker a comparable profit with the higher-cost but lower-volume option.
 

Good drug, high price

An independent appraisal committee for ICER determined that “current evidence is adequate to demonstrate a net health benefit for ensifentrine added to maintenance therapy when compared to maintenance therapy alone.”

But ICER also issued an access and affordability alert “to signal to stakeholders and policymakers that the amount of added healthcare costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services.” ICER recommends that payers should include coverage for smoking cessation therapies, and that drug manufacturers “set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.”

“This looks like a pretty good drug,” Dr. Rind said. “It looks quite safe and I think there will be a lot of patients, particularly those who are having frequent exacerbations, who this would be appropriate for, particularly once they’ve maxed out existing therapies, but maybe even earlier than that. And if the price comes down to the point that patients can really access this and providers can access it, people really should look at this as a potential therapy.”
 

Drug not yet available?

However, providers have not yet had direct experience with the new medication. “We haven’t been able to prescribe it yet,” said Corinne Young, MSN, FNP-C, FCCP, director of Advance Practice Provider and Clinical Services for Colorado Springs Pulmonary Consultants, president and founder of the Association of Pulmonary Advance Practice Providers, and a member of the CHEST Physician Editorial Board.

CHEST