Age, Race, and Insurance Status May Effect Initial Sarcoidosis Severity

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Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Biologics May Improve Outcomes in Overlapping COPD and Asthma

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Mon, 06/03/2024 - 16:38

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

 

 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

 

 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

 

 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

The study received no outside funding. The researchers and Dr. Baldomero had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Dupilumab May Reduce Exacerbations in COPD, Type 2 Inflammation

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Thu, 06/06/2024 - 13:13

Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

 

 

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

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Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

 

 

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

Dupilumab significantly reduced exacerbations and improved lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation, based on data from more than 900 individuals.

Data from a phase 3 trial known as NOTUS were presented at the American Thoracic Society’s international conference and published simultaneously in The New England Journal of Medicine.

Dupilumab, a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is approved for many conditions characterized by type 2 inflammation, wrote Surya P. Bhatt, MD, of The University of Alabama at Birmingham, and colleagues in the NEJM study.

“Last year, we showed in the BOREAS trial that dupilumab was very effective in lowering exacerbation frequency in patients with COPD who continued to have frequent exacerbations despite being on maximal inhaled therapy,” Dr. Bhatt said in an interview.

12 Months of COPD, Triple Inhaler Therapy

In the NOTUS study, the researchers randomized 470 adults with uncontrolled COPD and type 2 inflammation (defined as a blood eosinophil count of ≥ 300 cells/µL) to 300-mg subcutaneous dupilumab and 465 to a placebo every 2 weeks. Patients were enrolled between July 2020 and May 2023.

The study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy (an inhaled glucocorticoid agent plus long-acting muscarinic antagonist [LAMA]–long-acting beta-agonist [LABA] or LAMA-LABA alone) for at least 3 months and at a stable dose for at least 1 month. All participants were current or former smokers with a smoking history of at least 10 pack-years.

The primary endpoint was a reduction in the annualized rate of moderate or severe COPD exacerbations at 52 weeks.

At 52 weeks, the annualized rate of moderate or severe exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P < .001).

Patients in the dupilumab group also saw a significantly greater improvement in lung function compared with individuals in the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL). This improvement was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).

Improvement in respiratory symptom severity based on the St. George’s Respiratory Questionnaire was another secondary endpoint, and changes in total score were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).

Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period. Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively, and adverse events resulting in death occurred in 2.6% and 1.5%, respectively. The most common adverse events were COVID-19, which occurred in 9.4% and 8.2% of the dupilumab and placebo patients, respectively, followed by headache, COPD, and nasopharyngitis. Major adverse cardiovascular events occurred in three patients in the dupilumab group and seven patients in the placebo group.

The findings were limited by several factors including the reduced sample size for 52-week endpoints because of the earlier analysis and the primarily White study population, the researchers noted. The study was conducted in part during the COVID-19 pandemic period, which contributed to healthcare disruptions and behavior changes that decreased exposure to viral respiratory infections, they wrote in their discussion. However, the results were strengthened by the large numbers and international population without other major pulmonary diseases, such as asthma, and the 34% reduction in exacerbations with dupilumab vs placebo is clinically significant, they said.

 

 

Data May Drive US Food and Drug Administration (FDA) Approval

In the BOREAS trial, dupilumab also improved lung function and quality of life, with no notable safety concerns. “As with any trial evaluating the efficacy and safety of a medication, it is important to confirm the findings in a replicative study,” said Dr. Bhatt. “With NOTUS, we confirmed the findings of BOREAS,” and the researchers were reassured by the substantial reduction in exacerbation frequency and the replication of key secondary outcomes, he said.

With the NOTUS study, “two randomized trials have now shown near identical reductions in exacerbation frequency in a difficult-to-treat population of patients with COPD with type 2 inflammation and frequent exacerbations,” as well as a significant and meaningful improvement in lung function, Dr. Bhatt said in an interview. “We hope these trials pave for the way for regulatory body approval of dupilumab for clinical use,” he said. Looking ahead, more studies are needed to test the potential disease modification effects of dupilumab in patients with COPD, he added.

Potential Change in Patient Management

Approximately 20%-40% of patients with COPD have type 2 inflammation with elevated blood eosinophil count, and this subset of patients has an increased risk for exacerbations, with worsening lung function and quality of life, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.

Prior phase 3 studies have shown that dupilumab, a blocker of IL-4 and IL-13 pathways, could effectively reduce exacerbations and improve lung function in these patients, and the NOTUS study aimed to confirm the findings in a larger, more diverse population, said Dr. Narendra, who was not involved in the study.

The NOTUS study represents a paradigm shift in the management of COPD patients with type 2 inflammation, said Narendra. “This study validates the previous BOREAS trial and has shown that dupilumab reduces exacerbations, improves lung function and quality of life, and potentially slows disease progression,” she said.

If approved, potential barriers to the use of dupilumab in practice include cost and insurance coverage, education and dissemination of study findings, and limited data on side effects, said Dr. Narendra.

“While the NOTUS study provides valuable insights into the efficacy and safety of dupilumab over 52 weeks, longer-term studies are needed to understand the sustained benefits and risks of continued treatment,” Dr. Narendra told this news organization. “Studies comparing dupilumab with other biological agents and newer COPD treatments could provide insights into its relative efficacy and position in treatment protocols,” she said.

In addition, further research into dupilumab’s underlying mechanisms could provide deeper insights into the pathophysiology of type 2 inflammation in COPD and inform the development of new treatments, Dr. Narendra said. “These steps will help integrate dupilumab more effectively into clinical practice and optimize its use for COPD patients with type 2 inflammation,” she noted.

Dupilumab is undergoing Priority Review by the FDA as an add-on maintenance therapy for adults with uncontrolled COPD and type 2 inflammation, with a target action date of June 27, 2024, according to a company press release.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Narendra had no financial conflicts to disclose but serves on the Editorial Advisory Board of CHEST Physician.

A version of this article appeared on Medscape.com.

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Understudied Patients With COPD Benefit From BLVR

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Changed
Mon, 06/03/2024 - 16:04

Bronchoscopic lung volume reduction (BLVR) significantly improved lung function in a subset of patients with chronic obstructive pulmonary disease (COPD) with alpha-1 antitrypsin deficiency (AATD), based on data from more than 200 individuals.

BLVR has shown promising results in previous studies for carefully selected patients with COPD, said Michael J. Nicholson, DO, of Temple University Hospital, Philadelphia. However, those with AATD have often been excluded from large BLVR trials, so data on its effectiveness in this population are limited, he said.

“The distinct pathophysiology of AATD poses challenges in extrapolating findings from trials involving COPD patients without AATD,” Dr. Nicholson noted. “Variations in affected lung lobes and disease progression are major differences between the AATD and non-AATD populations; we sought to examine if BLVR could provide significant, sustained benefit to AATD patients despite their differences from the typical COPD cohort,” he said.

Patients With COPD and AATD

In a study presented at the American Thoracic Society (ATS) 2024 International Conference, Dr. Nicholson and colleagues reviewed data from 238 adults with COPD including 14 with AATD who underwent BLVR at a single center between August 2018 and December 2022. Pulmonary function test data were collected at baseline and at a median of 7 months post-BLVR. The mean age of patients with AATD was 61.5 years, and 79% were men.

The primary outcome was the percentage of patients with forced expiratory volume per second (FEV1) improvement greater than 15%. Half of the patients with AATD achieved this outcome, with a median improvement in FEV1 of 110 mL and a significant difference in pre- and post-BLVR FEV1 volume based on a Wilcoxon signed rank test (W = 11.5; P < .05).

Patients with AATD also showed significant improvement in several secondary outcomes including BODE index, residual volume (RV), total lung capacity (TLC), RV/TLC ratio, and inspiratory capacity/RV ratio between pre- and post-BLVR.

“The sustained improvements seen at 7 months post-BLVR in patients with lower lobe disease were unexpected and promising,” Dr. Nicholson said in an interview. “In contrast to the National Emphysema Treatment Trial (NETT), which found lung volume reduction surgery ineffective for lower lobe disease, our study revealed significant improvements in lower lobe disease following BLVR,” he said. The sustained improvements up to 7 months post-BLVR are encouraging, given clinical concerns that the ongoing destruction of lung tissue in AATD could cause initial BLVR improvements to regress, he added.

Overall, the results suggest that BLVR is an effective therapy for appropriately selected patients with AATD and COPD, and that significant improvement in lung function can be achieved regardless of the affected lobe, Dr. Nicholson said.

“The primary obstacles to widespread BLVR implementation include the scarcity of equipment, as well as insufficient education and training for pulmonologists outside of major academic institutions,” Dr. Nicholson told this news organization. “Successful outcomes in BLVR require clinicians to have a deep understanding of patient selection criteria, extensive training in BLVR techniques, and access to the necessary technology within their facilities,” he said. However, BLVR has been integrated into pulmonary and interventional pulmonary fellowships nationwide, which paves the way for a new generation of pulmonologists to expand the use of the procedure, he said.

Looking ahead, prospective examination of BLVR vs the current standard of care in patients with AATD would provide invaluable data, Dr. Nicholson said. Since the presentation of the study at the meeting, additional patient data have been added to the analysis and increased the power of the findings, he said. “We intend to extend our assessment of pulmonary function testing beyond 7 months post-BLVR to evaluate the persistence of improvements in the long term,” he added.

 

 

Study Confirms Benefits for Wider Patient Population

“Lung volume reduction is an important intervention in patients with severe emphysema,” said David M. Mannino, MD, of the University of Kentucky, Lexington, Kentucky, in an interview. Most emphysema is in the upper lobes, but it tends to occur more in the lower lobes in patients with AATD, said Dr. Mannino, who was not involved in the study.

The findings were not especially surprising, but they were reassuring, Dr. Mannino told this news organization. “We know this intervention works in those with severe emphysema,” and it was helpful to confirm similar success in patients with AATD, he said.

The implications for practice are that BLVR is both a safe and an effective intervention for patients with lower or upper lobe emphysema, although longer-term follow-up studies are needed, he said.

The study received no outside funding. Dr. Nicholson and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Bronchoscopic lung volume reduction (BLVR) significantly improved lung function in a subset of patients with chronic obstructive pulmonary disease (COPD) with alpha-1 antitrypsin deficiency (AATD), based on data from more than 200 individuals.

BLVR has shown promising results in previous studies for carefully selected patients with COPD, said Michael J. Nicholson, DO, of Temple University Hospital, Philadelphia. However, those with AATD have often been excluded from large BLVR trials, so data on its effectiveness in this population are limited, he said.

“The distinct pathophysiology of AATD poses challenges in extrapolating findings from trials involving COPD patients without AATD,” Dr. Nicholson noted. “Variations in affected lung lobes and disease progression are major differences between the AATD and non-AATD populations; we sought to examine if BLVR could provide significant, sustained benefit to AATD patients despite their differences from the typical COPD cohort,” he said.

Patients With COPD and AATD

In a study presented at the American Thoracic Society (ATS) 2024 International Conference, Dr. Nicholson and colleagues reviewed data from 238 adults with COPD including 14 with AATD who underwent BLVR at a single center between August 2018 and December 2022. Pulmonary function test data were collected at baseline and at a median of 7 months post-BLVR. The mean age of patients with AATD was 61.5 years, and 79% were men.

The primary outcome was the percentage of patients with forced expiratory volume per second (FEV1) improvement greater than 15%. Half of the patients with AATD achieved this outcome, with a median improvement in FEV1 of 110 mL and a significant difference in pre- and post-BLVR FEV1 volume based on a Wilcoxon signed rank test (W = 11.5; P < .05).

Patients with AATD also showed significant improvement in several secondary outcomes including BODE index, residual volume (RV), total lung capacity (TLC), RV/TLC ratio, and inspiratory capacity/RV ratio between pre- and post-BLVR.

“The sustained improvements seen at 7 months post-BLVR in patients with lower lobe disease were unexpected and promising,” Dr. Nicholson said in an interview. “In contrast to the National Emphysema Treatment Trial (NETT), which found lung volume reduction surgery ineffective for lower lobe disease, our study revealed significant improvements in lower lobe disease following BLVR,” he said. The sustained improvements up to 7 months post-BLVR are encouraging, given clinical concerns that the ongoing destruction of lung tissue in AATD could cause initial BLVR improvements to regress, he added.

Overall, the results suggest that BLVR is an effective therapy for appropriately selected patients with AATD and COPD, and that significant improvement in lung function can be achieved regardless of the affected lobe, Dr. Nicholson said.

“The primary obstacles to widespread BLVR implementation include the scarcity of equipment, as well as insufficient education and training for pulmonologists outside of major academic institutions,” Dr. Nicholson told this news organization. “Successful outcomes in BLVR require clinicians to have a deep understanding of patient selection criteria, extensive training in BLVR techniques, and access to the necessary technology within their facilities,” he said. However, BLVR has been integrated into pulmonary and interventional pulmonary fellowships nationwide, which paves the way for a new generation of pulmonologists to expand the use of the procedure, he said.

Looking ahead, prospective examination of BLVR vs the current standard of care in patients with AATD would provide invaluable data, Dr. Nicholson said. Since the presentation of the study at the meeting, additional patient data have been added to the analysis and increased the power of the findings, he said. “We intend to extend our assessment of pulmonary function testing beyond 7 months post-BLVR to evaluate the persistence of improvements in the long term,” he added.

 

 

Study Confirms Benefits for Wider Patient Population

“Lung volume reduction is an important intervention in patients with severe emphysema,” said David M. Mannino, MD, of the University of Kentucky, Lexington, Kentucky, in an interview. Most emphysema is in the upper lobes, but it tends to occur more in the lower lobes in patients with AATD, said Dr. Mannino, who was not involved in the study.

The findings were not especially surprising, but they were reassuring, Dr. Mannino told this news organization. “We know this intervention works in those with severe emphysema,” and it was helpful to confirm similar success in patients with AATD, he said.

The implications for practice are that BLVR is both a safe and an effective intervention for patients with lower or upper lobe emphysema, although longer-term follow-up studies are needed, he said.

The study received no outside funding. Dr. Nicholson and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Bronchoscopic lung volume reduction (BLVR) significantly improved lung function in a subset of patients with chronic obstructive pulmonary disease (COPD) with alpha-1 antitrypsin deficiency (AATD), based on data from more than 200 individuals.

BLVR has shown promising results in previous studies for carefully selected patients with COPD, said Michael J. Nicholson, DO, of Temple University Hospital, Philadelphia. However, those with AATD have often been excluded from large BLVR trials, so data on its effectiveness in this population are limited, he said.

“The distinct pathophysiology of AATD poses challenges in extrapolating findings from trials involving COPD patients without AATD,” Dr. Nicholson noted. “Variations in affected lung lobes and disease progression are major differences between the AATD and non-AATD populations; we sought to examine if BLVR could provide significant, sustained benefit to AATD patients despite their differences from the typical COPD cohort,” he said.

Patients With COPD and AATD

In a study presented at the American Thoracic Society (ATS) 2024 International Conference, Dr. Nicholson and colleagues reviewed data from 238 adults with COPD including 14 with AATD who underwent BLVR at a single center between August 2018 and December 2022. Pulmonary function test data were collected at baseline and at a median of 7 months post-BLVR. The mean age of patients with AATD was 61.5 years, and 79% were men.

The primary outcome was the percentage of patients with forced expiratory volume per second (FEV1) improvement greater than 15%. Half of the patients with AATD achieved this outcome, with a median improvement in FEV1 of 110 mL and a significant difference in pre- and post-BLVR FEV1 volume based on a Wilcoxon signed rank test (W = 11.5; P < .05).

Patients with AATD also showed significant improvement in several secondary outcomes including BODE index, residual volume (RV), total lung capacity (TLC), RV/TLC ratio, and inspiratory capacity/RV ratio between pre- and post-BLVR.

“The sustained improvements seen at 7 months post-BLVR in patients with lower lobe disease were unexpected and promising,” Dr. Nicholson said in an interview. “In contrast to the National Emphysema Treatment Trial (NETT), which found lung volume reduction surgery ineffective for lower lobe disease, our study revealed significant improvements in lower lobe disease following BLVR,” he said. The sustained improvements up to 7 months post-BLVR are encouraging, given clinical concerns that the ongoing destruction of lung tissue in AATD could cause initial BLVR improvements to regress, he added.

Overall, the results suggest that BLVR is an effective therapy for appropriately selected patients with AATD and COPD, and that significant improvement in lung function can be achieved regardless of the affected lobe, Dr. Nicholson said.

“The primary obstacles to widespread BLVR implementation include the scarcity of equipment, as well as insufficient education and training for pulmonologists outside of major academic institutions,” Dr. Nicholson told this news organization. “Successful outcomes in BLVR require clinicians to have a deep understanding of patient selection criteria, extensive training in BLVR techniques, and access to the necessary technology within their facilities,” he said. However, BLVR has been integrated into pulmonary and interventional pulmonary fellowships nationwide, which paves the way for a new generation of pulmonologists to expand the use of the procedure, he said.

Looking ahead, prospective examination of BLVR vs the current standard of care in patients with AATD would provide invaluable data, Dr. Nicholson said. Since the presentation of the study at the meeting, additional patient data have been added to the analysis and increased the power of the findings, he said. “We intend to extend our assessment of pulmonary function testing beyond 7 months post-BLVR to evaluate the persistence of improvements in the long term,” he added.

 

 

Study Confirms Benefits for Wider Patient Population

“Lung volume reduction is an important intervention in patients with severe emphysema,” said David M. Mannino, MD, of the University of Kentucky, Lexington, Kentucky, in an interview. Most emphysema is in the upper lobes, but it tends to occur more in the lower lobes in patients with AATD, said Dr. Mannino, who was not involved in the study.

The findings were not especially surprising, but they were reassuring, Dr. Mannino told this news organization. “We know this intervention works in those with severe emphysema,” and it was helpful to confirm similar success in patients with AATD, he said.

The implications for practice are that BLVR is both a safe and an effective intervention for patients with lower or upper lobe emphysema, although longer-term follow-up studies are needed, he said.

The study received no outside funding. Dr. Nicholson and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Educational Tool Reduces Unnecessary Inhaler Use in ILD

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Mon, 06/03/2024 - 15:34

Use of an electronic tool contributed to the deprescribing of unnecessary inhalers in patients with interstitial lung disease (ILD), based on data from nearly 200 individuals.

Patients with ILD often have symptoms that overlap with those of obstructive airways diseases, Stephanie Nevison, MD, of the University of Toronto, and colleagues wrote in a study presented at the American Thoracic Society’s international conference.

These patients may be started on inhalers to improve their symptoms but with no expected physiologic benefit, and inappropriate use of inhalers may lead to not only unnecessary side effects but also increased health care costs and environmental impact, they noted.

“Our aim was twofold: To quantify the extent of inappropriate inhaler use in patients with ILD and to discontinue them where appropriate,” the researchers wrote.

“We hypothesized that inappropriate inhaler use in ILD is common and that an electronic initiative would improve deprescribing rates,” they said.

The researchers conducted a quality improvement project in an ILD clinic at a single center. They reviewed 5 months of baseline data for 191 patients with ILD to assess baseline frequency of inappropriate inhaler use, defined as one or more of the following criteria: Reported asthma history, smoking history of > 15 pack/years, emphysema on chest CT, patient-reported benefits from therapy, airflow obstruction, or bronchodilator response on spirometry.

A total of 48 patients (25.1%) were on inhalers, and 15 (7.8%) had no indication for them (9% of new referrals and 7% of follow-up patients). The most-prescribed inhalers for patients with no indication were corticosteroids (10 patients), short-acting beta-agonists (8 patients), and long-acting beta-agonists (7 patients).

None of the patients on inhalers received counseling about discontinuing their use. The results of the baseline assessment were shared with clinicians along with education about reducing unnecessary inhaler use in the form of a prompt linked to electronic medical records to discuss deprescription of unnecessary inhalers.

The electronic intervention was applied in 400 of 518 patient encounters, and the researchers reviewed data over another 5-month period. A total of 99 patients were on inhalers, and 3.3% had no indication (5.3% of new referrals and 3.0% of follow-up patients). In the wake of the intervention, “all patients on unnecessary inhalers were counseled on deprescribing, representing a significant increase compared to the preintervention period,” the researchers wrote.
 

Intervention Shows Potential to Curb Unnecessary Inhaler Use

More research is needed as the findings were limited by the relatively small sample size and use of data from a single center, the researchers noted.

However, the results suggest that electronic reminders are effective for prompting a review of inhaler use, and deprescribing inappropriate inhalers for patients with ILD could reduce the potential for adverse events associated with their use, they concluded.

The current study is important because some patients with ILD may not benefit from inhaler use, David Mannino, MD, of the University of Kentucky, Lexington, said in an interview. In the study, “I was a bit surprised that only 3.3% of patients had no indication for them; this seems rather low,” said Dr. Mannino, who was not involved in the study.

Use of an electronic system that evaluates patients and flags inappropriate therapy is an effective way to decrease overprescribing of medications, Dr. Mannino told this news organization.

As for additional research, application of the tool used in this study to other pulmonary populations could be interesting and potentially useful, he said.

The study received no outside funding. The researchers and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Use of an electronic tool contributed to the deprescribing of unnecessary inhalers in patients with interstitial lung disease (ILD), based on data from nearly 200 individuals.

Patients with ILD often have symptoms that overlap with those of obstructive airways diseases, Stephanie Nevison, MD, of the University of Toronto, and colleagues wrote in a study presented at the American Thoracic Society’s international conference.

These patients may be started on inhalers to improve their symptoms but with no expected physiologic benefit, and inappropriate use of inhalers may lead to not only unnecessary side effects but also increased health care costs and environmental impact, they noted.

“Our aim was twofold: To quantify the extent of inappropriate inhaler use in patients with ILD and to discontinue them where appropriate,” the researchers wrote.

“We hypothesized that inappropriate inhaler use in ILD is common and that an electronic initiative would improve deprescribing rates,” they said.

The researchers conducted a quality improvement project in an ILD clinic at a single center. They reviewed 5 months of baseline data for 191 patients with ILD to assess baseline frequency of inappropriate inhaler use, defined as one or more of the following criteria: Reported asthma history, smoking history of > 15 pack/years, emphysema on chest CT, patient-reported benefits from therapy, airflow obstruction, or bronchodilator response on spirometry.

A total of 48 patients (25.1%) were on inhalers, and 15 (7.8%) had no indication for them (9% of new referrals and 7% of follow-up patients). The most-prescribed inhalers for patients with no indication were corticosteroids (10 patients), short-acting beta-agonists (8 patients), and long-acting beta-agonists (7 patients).

None of the patients on inhalers received counseling about discontinuing their use. The results of the baseline assessment were shared with clinicians along with education about reducing unnecessary inhaler use in the form of a prompt linked to electronic medical records to discuss deprescription of unnecessary inhalers.

The electronic intervention was applied in 400 of 518 patient encounters, and the researchers reviewed data over another 5-month period. A total of 99 patients were on inhalers, and 3.3% had no indication (5.3% of new referrals and 3.0% of follow-up patients). In the wake of the intervention, “all patients on unnecessary inhalers were counseled on deprescribing, representing a significant increase compared to the preintervention period,” the researchers wrote.
 

Intervention Shows Potential to Curb Unnecessary Inhaler Use

More research is needed as the findings were limited by the relatively small sample size and use of data from a single center, the researchers noted.

However, the results suggest that electronic reminders are effective for prompting a review of inhaler use, and deprescribing inappropriate inhalers for patients with ILD could reduce the potential for adverse events associated with their use, they concluded.

The current study is important because some patients with ILD may not benefit from inhaler use, David Mannino, MD, of the University of Kentucky, Lexington, said in an interview. In the study, “I was a bit surprised that only 3.3% of patients had no indication for them; this seems rather low,” said Dr. Mannino, who was not involved in the study.

Use of an electronic system that evaluates patients and flags inappropriate therapy is an effective way to decrease overprescribing of medications, Dr. Mannino told this news organization.

As for additional research, application of the tool used in this study to other pulmonary populations could be interesting and potentially useful, he said.

The study received no outside funding. The researchers and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Use of an electronic tool contributed to the deprescribing of unnecessary inhalers in patients with interstitial lung disease (ILD), based on data from nearly 200 individuals.

Patients with ILD often have symptoms that overlap with those of obstructive airways diseases, Stephanie Nevison, MD, of the University of Toronto, and colleagues wrote in a study presented at the American Thoracic Society’s international conference.

These patients may be started on inhalers to improve their symptoms but with no expected physiologic benefit, and inappropriate use of inhalers may lead to not only unnecessary side effects but also increased health care costs and environmental impact, they noted.

“Our aim was twofold: To quantify the extent of inappropriate inhaler use in patients with ILD and to discontinue them where appropriate,” the researchers wrote.

“We hypothesized that inappropriate inhaler use in ILD is common and that an electronic initiative would improve deprescribing rates,” they said.

The researchers conducted a quality improvement project in an ILD clinic at a single center. They reviewed 5 months of baseline data for 191 patients with ILD to assess baseline frequency of inappropriate inhaler use, defined as one or more of the following criteria: Reported asthma history, smoking history of > 15 pack/years, emphysema on chest CT, patient-reported benefits from therapy, airflow obstruction, or bronchodilator response on spirometry.

A total of 48 patients (25.1%) were on inhalers, and 15 (7.8%) had no indication for them (9% of new referrals and 7% of follow-up patients). The most-prescribed inhalers for patients with no indication were corticosteroids (10 patients), short-acting beta-agonists (8 patients), and long-acting beta-agonists (7 patients).

None of the patients on inhalers received counseling about discontinuing their use. The results of the baseline assessment were shared with clinicians along with education about reducing unnecessary inhaler use in the form of a prompt linked to electronic medical records to discuss deprescription of unnecessary inhalers.

The electronic intervention was applied in 400 of 518 patient encounters, and the researchers reviewed data over another 5-month period. A total of 99 patients were on inhalers, and 3.3% had no indication (5.3% of new referrals and 3.0% of follow-up patients). In the wake of the intervention, “all patients on unnecessary inhalers were counseled on deprescribing, representing a significant increase compared to the preintervention period,” the researchers wrote.
 

Intervention Shows Potential to Curb Unnecessary Inhaler Use

More research is needed as the findings were limited by the relatively small sample size and use of data from a single center, the researchers noted.

However, the results suggest that electronic reminders are effective for prompting a review of inhaler use, and deprescribing inappropriate inhalers for patients with ILD could reduce the potential for adverse events associated with their use, they concluded.

The current study is important because some patients with ILD may not benefit from inhaler use, David Mannino, MD, of the University of Kentucky, Lexington, said in an interview. In the study, “I was a bit surprised that only 3.3% of patients had no indication for them; this seems rather low,” said Dr. Mannino, who was not involved in the study.

Use of an electronic system that evaluates patients and flags inappropriate therapy is an effective way to decrease overprescribing of medications, Dr. Mannino told this news organization.

As for additional research, application of the tool used in this study to other pulmonary populations could be interesting and potentially useful, he said.

The study received no outside funding. The researchers and Dr. Mannino had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Catch-and-Treat Strategy Identifies Undiagnosed Asthma and COPD

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— You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

 

 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.

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— You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

 

 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.

— You can’t treat patients if you can’t find them. But as investigators in a randomized controlled trial showed, a case-finding method based on spirometry results can identify individuals in the community with undiagnosed chronic obstructive pulmonary disease (COPD) or asthma whose lives could be significantly improved with proper care.

Once they have been identified and randomly assigned to be treated by a pulmonologist and asthma-COPD educator according to clinical guidelines, these previously undiagnosed patients have significant improvements in health care utilization, lung function, symptoms, and quality of life compared with patients randomly assigned to treatment by a general practitioner.

“By diagnosing people early and treating them intensively, you can really improve their quality of life,” said lead investigator Shawn D. Aaron, MD, from the Ottawa Hospital Research Institute and University of Ottawa, Ontario, Canada.

Even those patients in the study who were randomly assigned to receive care from a general practice physician had improvements in lung function and quality of life, although on a smaller scale than patients assigned to a specialty team, Dr. Aaron said at the American Thoracic Society’s international conference.

He reported results of the study in a late-breaking oral abstract session. The study findings were also published online in The New England Journal of Medicine.
 

Undiagnosed diseases

“The simple problem is that 70% of individuals with asthma or COPD are likely undiagnosed,” Dr. Aaron said.

He noted that the 2007-2012 US National Health and Nutritional Examination Survey found obstructive lung disease in 13% of randomly selected US adults, but 71% of these people had never been diagnosed with asthma or COPD.

“So our questions were in this study: One, can we find adults with undiagnosed asthma or COPD in the community? The second question was: If we find them, are they sick? And the third and most important question was: Can we treat them early and improve their health outcomes?” he said.

Asthma and COPD both present with similar respiratory symptoms, including dyspnea, cough, wheeze, and/or chest tightness, and the two conditions share expiratory airflow obstruction as a common physiologic impairment that can be detected with spirometry.
 

Study details

To identify participants, the investigators hired a commercial survey firm to contact households asking whether any member aged 18 years or older had respiratory symptoms such as shortness of breath, wheezing, increased mucus or sputum production, or prolonged cough in the past 6 months. Those who responded yes were then contacted by a trial coordinator, and the symptomatic household member was asked to complete the Asthma Screening Questionnaire over the phone. Participants aged 60 years or older and those younger than 60 years with a score of 6 or higher on the asthma screen also completed the COPD Diagnostic Questionnaire.

Those with a score of 6 or higher on the asthma screen or 20 or higher on the COPD screen were invited to undergo spirometry at a trial site.

The investigators ultimately identified 508 adults with undiagnosed asthma or COPD and randomly assigned them on an equal basis to an intervention group (253 patients) or control group (255 patients).

In the intervention group treatment was provided by a study pulmonologist and asthma-COPD educator who started guideline-based care. Patients were prescribed inhalers and were taught how to use them, and many were given action plans that included smoking cessation aids, exercise and weight counseling, and vaccinations against influenza and pneumonia.

Participants assigned to the control group would receive usual care provided by their primary care practitioner.
 

 

 

Improvements abound

During the 12 months of the study, 92% of patients in the intervention group and 60% in the control group were started on new medications for their condition. 

Only 13.4% of those in the intervention group received either no respiratory treatments or a short-acting beta 2 agonist only during the entire trial period compared with 49.8% of controls, “so the usual care arm was undertreated relative to the intervention arm, and because of that under-treatment we saw a tremendous difference in the primary outcome,” Dr. Aaron said.

The primary outcome, the annualized rate of patient-initiated healthcare utilization for respiratory illness, was significantly lower in the intervention group, translating into an incidence rate ratio of 0.48 (P < .001).

Secondary outcomes were also better in the intervention group. For example, total scores on the St. George Respiratory Questionnaire (SGRQ) declined by 10.2 points from baseline in intervention group compared with a 6.8-point drop in the usual-care group. The mean difference was 3.5 points (P = .009). Lower scores on the 0-100 SGRQ scale indicate better health status.

Similarly, total scores on the COPD Assessment Test, a scale of 0-40 with lower scores indicating better health, declined by 3.8 points and 2.6 points, respectively, over 12 months, for a mean difference of 1.3 points (P = .03).

In addition, those in the intervention arm had a 119-mL improvement in forced expiratory volume in 1 second over the 12 months of the study compared with only a 22-mL improvement in the usual-care group.
 

Translatable results?

Dr. Aaron acknowledged that the investigators could have chosen to keep those who were assigned to the control group unaware of their diagnosis during the study but because all patients enrolled were symptomatic, it would have been unethical to do so. All participants were informed of their diagnosis at randomization, and the information was conveyed to each patient’s primary care practitioner as well.

In fact, many patients in the control group decided to seek treatment for either asthma or COPD after learning of their diagnosis, which may have contributed to improved outcomes in the control arm, he said.

“What this means is if you make the diagnosis early in the community, and at least have them see a primary care practitioner, they will improve their quality of life and their health status,” he concluded.

Ravi Kalhan, MD, MS, from the Northwestern University Feinberg School Of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the case-finding model used in the trial would be difficult to replicate elsewhere.

“This idea of seeking out undiagnosed people by doing spirometry, so-called ‘case finding’ as they described it, testing highly symptomatic people with spirometry, is really challenging in the US, because symptoms are not collected proactively very much,” he said.

Persons with acute respiratory symptoms in the US typically seek healthcare at urgent-care clinics or have unscheduled visits with their primary care physicians, “and by all accounts those people should have spirometry, but they just don’t in the US, as best as I can tell,” he added.

He agreed that getting patients to a specialist can result in better outcomes but said that implementing a systematic approach such as the one described in the study would be extremely difficult in the fragmented US healthcare system.

Dr. Kalhan’s co-moderator, Nuala J. Meyer, MD, MS, from the Hospital of the University of Pennsylvania, Philadelphia, told Chest Physician that “it was interesting that even those who were not in the intervention group but had these details passed on to their primary care physicians still had improvements,” and that it would be beneficial if primary care practitioners were routinely informed about the results of urgent care visits.

She added, however, that in the US the flow of information between urgent care clinics, primary care offices, and specialty clinics is problematic, suggesting that symptomatic patients may not always receive the additional care that they need.

The study was supported by the Canadian Institutes of Health Research. Dr. Aaron, Dr. Kalhan, and Dr. Meyer all reported having no relevant disclosures. 

A version of this article appeared on Medscape.com.

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Diet and exercise improve cardiac function, QoL in PAH

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Wed, 05/29/2024 - 15:36

— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

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— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

— A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News
Dr. Gustavo A. Heresi

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

 

 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

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Hold the antianaerobics in the ICU whenever possible

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Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News
Dr. Robert P. Dickson

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

 

 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

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Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News
Dr. Robert P. Dickson

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

 

 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News
Dr. Robert P. Dickson

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

 

 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

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Space: The final frontier of public health, air pollution data

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Fri, 05/24/2024 - 15:12

– No matter where on earth you live, there’s likely to be an eye in the sky hovering overhead, and that’s a good thing, at least when it comes to satellite monitoring of air quality, said scientists from the National Aeronautics and Space Administration (NASA).

In a special symposium held at the American Thoracic Society’s international conference, NASA health and air quality specialists described the use of space-based systems and earth science applications to improve understanding of respiratory health risks worldwide, and to help enrich pulmonary research with galaxies of data.

“Every day we download over 25 terabytes of data,” said John Haynes, MS, program manager for Health and Air Quality Applications in the Earth Action Program of the NASA Earth Science Division in Washington.

Neil Osterweil/MDedge News
John Haynes

“Many of the observation data sets are critical for healthy air quality applications: observation of land surface temperature, sea surface temperature, precipitation, fires and thermal anomalies, aerosols, just to name a few, and the really awesome news is this offering from our constellation of satellites is free and open access, available to everyone across the globe,” he said.

The mission of NASA’s Earth Action Program is “to enable people and organizations to apply insights from Earth science to benefit the economy, health, quality of life, and environment.”

Program staff work with both industry and nonprofit environmental advocacy and health groups to help inform their decisions and actions with Earth science information.

NASA supports the use of Earth observations to help monitor and manage infectious diseases and environmental health, toxins and pathogens that affect health, air quality standards, and to assess the effects of climate change on air quality and public health.

Mr. Haynes noted that worldwide, six major cities have incorporated NASA data on fine particulate matter smaller than 2.5 microns (PM2.5) into their climate action plans. These cities include Accra, Ghana; Addis Ababa, Ethiopia; Buenos Aires, Argentina; Guadalajara, Mexico; Lima, Peru; and Johannesburg, South Africa.
 

Monitoring pollution with TEMPO

There are more than 30 Earth-monitoring systems currently in orbit or soon to be launched, including NASA’s Tropospheric Emissions: Monitoring of Pollution (TEMPO), launched in April 2023, with first operations in August 2023. The instrument is in a geostationary orbit about 22,236 miles above the equator at longitudes that allow it to survey virtually all of North America — from coast to coast, and from southern Mexico, Cuba, Puerto Rico, and the Bahamas to Northern Canada.

TEMPO is part of a geostationary air quality satellite “constellation” or group that provides daylight observation over the entire Northern Hemisphere, explained Aaron Naeger, PhD, MS, mission applications lead for TEMPO at the NASA Marshall Space Flight Center in Huntsville, Alabama.

Until TEMPO, space-based instruments had relatively low spatial resolution and could only capture one image each day. In contrast, TEMPO can scan east-west each daylight hour across its entire coverage area (known as the Field of Regard), and even more frequently during early morning and late afternoon. This allows researchers to measure volumes of pollution, sources, and how these pollution levels vary over time. The system measures ozone levels, nitrogen dioxide (NO2,) formaldehyde, and aerosols.

More than 100 federal, state, local and tribal air quality agencies use the data captured by TEMPO to inform public health efforts.

Dr. Naeger gave examples of how the system can help identify public health hazards, including scans that showed high NO2 levels from cities, traffic corridors, power plants, oil and gas fields, and fires.

Similarly, the system detected unhealthy ozone and PM2.5 levels during prescribed burns in April 2024, as well as notable differences between weekdays and weekends in NO2 concentrations across California and the Front Range in Colorado. These showed higher levels along traffic corridors during weekdays related to increased traffic volumes and tailpipe emissions.
 

 

 

Fire and heat

Other NASA health and air quality initiatives include the FireAQ project, based at the University of Iowa in Iowa City, which provides free online weekly briefings on fire-related air quality concerns using data from TEMPO and other NASA satellite systems. The FireAQ project was described by Jun Wang, PhD, from the University of Iowa in Iowa City.

NASA also fosters collaborations to reduce health disparities in air quality and respiratory health in urban heat islands and other areas affected by extreme temperatures due to climate change, as discussed by Christopher K. Uejio, PhD, from Florida State University in Tallahassee.

Air pollution expert George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the session, said that the PM2.5 standard includes nontoxic particulate matter, such as soil, and misses sub-micron sized particles, and asked Mr. Haynes whether smaller particles were being measured in the studies he described.

Mr. Haynes replied that the systems do not directly measure PM2.5 but instead rely on aerosol optical depth, a measure of the extent to which atmospheric particles absorb or scatter sunlight.

Dr. Thurston, who in 1987 was coauthor of groundbreaking study showing the link between PM2.5 levels and mortality, is now an advocate for a tougher standard of measuring ambient ultrafine particles with an aerodynamic diameter less than .1 microns in size (PM1).

NASA health and climate data are available at https://www.earthdata.nasa.gov/.

Mr. Haynes and Dr. Naeger are NASA employees. Dr. Thurston had no relevant disclosures.

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– No matter where on earth you live, there’s likely to be an eye in the sky hovering overhead, and that’s a good thing, at least when it comes to satellite monitoring of air quality, said scientists from the National Aeronautics and Space Administration (NASA).

In a special symposium held at the American Thoracic Society’s international conference, NASA health and air quality specialists described the use of space-based systems and earth science applications to improve understanding of respiratory health risks worldwide, and to help enrich pulmonary research with galaxies of data.

“Every day we download over 25 terabytes of data,” said John Haynes, MS, program manager for Health and Air Quality Applications in the Earth Action Program of the NASA Earth Science Division in Washington.

Neil Osterweil/MDedge News
John Haynes

“Many of the observation data sets are critical for healthy air quality applications: observation of land surface temperature, sea surface temperature, precipitation, fires and thermal anomalies, aerosols, just to name a few, and the really awesome news is this offering from our constellation of satellites is free and open access, available to everyone across the globe,” he said.

The mission of NASA’s Earth Action Program is “to enable people and organizations to apply insights from Earth science to benefit the economy, health, quality of life, and environment.”

Program staff work with both industry and nonprofit environmental advocacy and health groups to help inform their decisions and actions with Earth science information.

NASA supports the use of Earth observations to help monitor and manage infectious diseases and environmental health, toxins and pathogens that affect health, air quality standards, and to assess the effects of climate change on air quality and public health.

Mr. Haynes noted that worldwide, six major cities have incorporated NASA data on fine particulate matter smaller than 2.5 microns (PM2.5) into their climate action plans. These cities include Accra, Ghana; Addis Ababa, Ethiopia; Buenos Aires, Argentina; Guadalajara, Mexico; Lima, Peru; and Johannesburg, South Africa.
 

Monitoring pollution with TEMPO

There are more than 30 Earth-monitoring systems currently in orbit or soon to be launched, including NASA’s Tropospheric Emissions: Monitoring of Pollution (TEMPO), launched in April 2023, with first operations in August 2023. The instrument is in a geostationary orbit about 22,236 miles above the equator at longitudes that allow it to survey virtually all of North America — from coast to coast, and from southern Mexico, Cuba, Puerto Rico, and the Bahamas to Northern Canada.

TEMPO is part of a geostationary air quality satellite “constellation” or group that provides daylight observation over the entire Northern Hemisphere, explained Aaron Naeger, PhD, MS, mission applications lead for TEMPO at the NASA Marshall Space Flight Center in Huntsville, Alabama.

Until TEMPO, space-based instruments had relatively low spatial resolution and could only capture one image each day. In contrast, TEMPO can scan east-west each daylight hour across its entire coverage area (known as the Field of Regard), and even more frequently during early morning and late afternoon. This allows researchers to measure volumes of pollution, sources, and how these pollution levels vary over time. The system measures ozone levels, nitrogen dioxide (NO2,) formaldehyde, and aerosols.

More than 100 federal, state, local and tribal air quality agencies use the data captured by TEMPO to inform public health efforts.

Dr. Naeger gave examples of how the system can help identify public health hazards, including scans that showed high NO2 levels from cities, traffic corridors, power plants, oil and gas fields, and fires.

Similarly, the system detected unhealthy ozone and PM2.5 levels during prescribed burns in April 2024, as well as notable differences between weekdays and weekends in NO2 concentrations across California and the Front Range in Colorado. These showed higher levels along traffic corridors during weekdays related to increased traffic volumes and tailpipe emissions.
 

 

 

Fire and heat

Other NASA health and air quality initiatives include the FireAQ project, based at the University of Iowa in Iowa City, which provides free online weekly briefings on fire-related air quality concerns using data from TEMPO and other NASA satellite systems. The FireAQ project was described by Jun Wang, PhD, from the University of Iowa in Iowa City.

NASA also fosters collaborations to reduce health disparities in air quality and respiratory health in urban heat islands and other areas affected by extreme temperatures due to climate change, as discussed by Christopher K. Uejio, PhD, from Florida State University in Tallahassee.

Air pollution expert George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the session, said that the PM2.5 standard includes nontoxic particulate matter, such as soil, and misses sub-micron sized particles, and asked Mr. Haynes whether smaller particles were being measured in the studies he described.

Mr. Haynes replied that the systems do not directly measure PM2.5 but instead rely on aerosol optical depth, a measure of the extent to which atmospheric particles absorb or scatter sunlight.

Dr. Thurston, who in 1987 was coauthor of groundbreaking study showing the link between PM2.5 levels and mortality, is now an advocate for a tougher standard of measuring ambient ultrafine particles with an aerodynamic diameter less than .1 microns in size (PM1).

NASA health and climate data are available at https://www.earthdata.nasa.gov/.

Mr. Haynes and Dr. Naeger are NASA employees. Dr. Thurston had no relevant disclosures.

– No matter where on earth you live, there’s likely to be an eye in the sky hovering overhead, and that’s a good thing, at least when it comes to satellite monitoring of air quality, said scientists from the National Aeronautics and Space Administration (NASA).

In a special symposium held at the American Thoracic Society’s international conference, NASA health and air quality specialists described the use of space-based systems and earth science applications to improve understanding of respiratory health risks worldwide, and to help enrich pulmonary research with galaxies of data.

“Every day we download over 25 terabytes of data,” said John Haynes, MS, program manager for Health and Air Quality Applications in the Earth Action Program of the NASA Earth Science Division in Washington.

Neil Osterweil/MDedge News
John Haynes

“Many of the observation data sets are critical for healthy air quality applications: observation of land surface temperature, sea surface temperature, precipitation, fires and thermal anomalies, aerosols, just to name a few, and the really awesome news is this offering from our constellation of satellites is free and open access, available to everyone across the globe,” he said.

The mission of NASA’s Earth Action Program is “to enable people and organizations to apply insights from Earth science to benefit the economy, health, quality of life, and environment.”

Program staff work with both industry and nonprofit environmental advocacy and health groups to help inform their decisions and actions with Earth science information.

NASA supports the use of Earth observations to help monitor and manage infectious diseases and environmental health, toxins and pathogens that affect health, air quality standards, and to assess the effects of climate change on air quality and public health.

Mr. Haynes noted that worldwide, six major cities have incorporated NASA data on fine particulate matter smaller than 2.5 microns (PM2.5) into their climate action plans. These cities include Accra, Ghana; Addis Ababa, Ethiopia; Buenos Aires, Argentina; Guadalajara, Mexico; Lima, Peru; and Johannesburg, South Africa.
 

Monitoring pollution with TEMPO

There are more than 30 Earth-monitoring systems currently in orbit or soon to be launched, including NASA’s Tropospheric Emissions: Monitoring of Pollution (TEMPO), launched in April 2023, with first operations in August 2023. The instrument is in a geostationary orbit about 22,236 miles above the equator at longitudes that allow it to survey virtually all of North America — from coast to coast, and from southern Mexico, Cuba, Puerto Rico, and the Bahamas to Northern Canada.

TEMPO is part of a geostationary air quality satellite “constellation” or group that provides daylight observation over the entire Northern Hemisphere, explained Aaron Naeger, PhD, MS, mission applications lead for TEMPO at the NASA Marshall Space Flight Center in Huntsville, Alabama.

Until TEMPO, space-based instruments had relatively low spatial resolution and could only capture one image each day. In contrast, TEMPO can scan east-west each daylight hour across its entire coverage area (known as the Field of Regard), and even more frequently during early morning and late afternoon. This allows researchers to measure volumes of pollution, sources, and how these pollution levels vary over time. The system measures ozone levels, nitrogen dioxide (NO2,) formaldehyde, and aerosols.

More than 100 federal, state, local and tribal air quality agencies use the data captured by TEMPO to inform public health efforts.

Dr. Naeger gave examples of how the system can help identify public health hazards, including scans that showed high NO2 levels from cities, traffic corridors, power plants, oil and gas fields, and fires.

Similarly, the system detected unhealthy ozone and PM2.5 levels during prescribed burns in April 2024, as well as notable differences between weekdays and weekends in NO2 concentrations across California and the Front Range in Colorado. These showed higher levels along traffic corridors during weekdays related to increased traffic volumes and tailpipe emissions.
 

 

 

Fire and heat

Other NASA health and air quality initiatives include the FireAQ project, based at the University of Iowa in Iowa City, which provides free online weekly briefings on fire-related air quality concerns using data from TEMPO and other NASA satellite systems. The FireAQ project was described by Jun Wang, PhD, from the University of Iowa in Iowa City.

NASA also fosters collaborations to reduce health disparities in air quality and respiratory health in urban heat islands and other areas affected by extreme temperatures due to climate change, as discussed by Christopher K. Uejio, PhD, from Florida State University in Tallahassee.

Air pollution expert George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the session, said that the PM2.5 standard includes nontoxic particulate matter, such as soil, and misses sub-micron sized particles, and asked Mr. Haynes whether smaller particles were being measured in the studies he described.

Mr. Haynes replied that the systems do not directly measure PM2.5 but instead rely on aerosol optical depth, a measure of the extent to which atmospheric particles absorb or scatter sunlight.

Dr. Thurston, who in 1987 was coauthor of groundbreaking study showing the link between PM2.5 levels and mortality, is now an advocate for a tougher standard of measuring ambient ultrafine particles with an aerodynamic diameter less than .1 microns in size (PM1).

NASA health and climate data are available at https://www.earthdata.nasa.gov/.

Mr. Haynes and Dr. Naeger are NASA employees. Dr. Thurston had no relevant disclosures.

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Debate on pulmonary safety of gas stoves: Is the risk just hot air?

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Thu, 05/23/2024 - 12:34

— While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.

In what the moderator called “one of the most agreeable debates yet,” experts presented their views on the risks that cooking with natural gas pose on pulmonary health, and discussed ways for mitigating that harm. The debate was held at the American Thoracic Society’s international conference.
 

PRO: Gas stoves cause lung disease

Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”

Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.

Neil Osterweil/MDedge News
Dr. John R. Balmes


“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.

The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.

The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.

Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
 

Con: More evidence needed

Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”

But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).

Neil Osterweil/MDedge News
Dr. Meredith C. McCormack


The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.

Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.

Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.

Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.

And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
 

 

 

On common ground

Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.

Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.

“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
 

End indoor combustion

George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.

Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.

“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.

Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.

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— While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.

In what the moderator called “one of the most agreeable debates yet,” experts presented their views on the risks that cooking with natural gas pose on pulmonary health, and discussed ways for mitigating that harm. The debate was held at the American Thoracic Society’s international conference.
 

PRO: Gas stoves cause lung disease

Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”

Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.

Neil Osterweil/MDedge News
Dr. John R. Balmes


“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.

The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.

The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.

Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
 

Con: More evidence needed

Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”

But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).

Neil Osterweil/MDedge News
Dr. Meredith C. McCormack


The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.

Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.

Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.

Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.

And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
 

 

 

On common ground

Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.

Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.

“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
 

End indoor combustion

George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.

Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.

“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.

Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.

— While there is currently no smoking gun definitively showing that indoor nitrogen dioxide (NO2) concentrations from gas appliances are a cause of pulmonary diseases, the circumstantial evidence of the baleful effects of gas stoves on lung function is pretty compelling, said participants in a pro-con debate.

In what the moderator called “one of the most agreeable debates yet,” experts presented their views on the risks that cooking with natural gas pose on pulmonary health, and discussed ways for mitigating that harm. The debate was held at the American Thoracic Society’s international conference.
 

PRO: Gas stoves cause lung disease

Arguing for the “pro” side, John R. Balmes, MD of the University of California, San Francisco, and a physician member of the California Air Resources Board, began by admitting that “I would never have said gas stoves cause lung disease, but that’s what they assigned me.”

Gamely proceeding anyway, Dr. Balmes noted that natural gas — methane — is a potent greenhouse gas, and that cooking with natural gas leads to generation of NO2 with high peak concentrations in the home, especially in the kitchen, but in other rooms as well.

Neil Osterweil/MDedge News
Dr. John R. Balmes


“We know that NO2 is an irritant gas that can cause bronchoconstriction, airway hyperresponsiveness and inflammation, and there’s increased risk of asthma and COPD exacerbations,” he said.

The US Environmental Protection Agency (EPA) outdoor ambient air standard for NO2 is 100 parts per billion (ppb) or lower, which are the levels needed to prevent asthma exacerbations. In separate meta-analyses there was a 1.05 rise in asthma incidence per every 2 ppb of NO2, and an increase of 1.07 in COPD incidence for every 5 ppb of NO2, Dr. Balmes noted.

The respiratory effects of gas stoves were revealed in a 2013 meta-analysis of 10 studies from North America and Europe, which showed a pooled odds ratio for current asthma of 1.34. Building on these data, authors of a 2022 paper estimated that 13% of childhood asthma could be prevented by elimination gas cooking.

Although the causative link is missing, the evidence is abundant that natural gas isn’t good for anyone, he acknowledged.
 

Con: More evidence needed

Arguing for the “con” side of the question, Meredith C. McCormack, MD, MHS, professor of medicine in the pulmonary and critical care division at Johns Hopkins University in Baltimore, said that “more definitive evidence is needed to define whether gas stoves cause lung disease.”

But Dr. McCormack didn’t let the natural gas industry off the hook, noting that a systematic review and meta-analysis of cooking with gas in high-, middle-, and low-income countries showed that domestic use of gas fuels vs. electric was associated with increased risk of asthma (1.11 overall), COPD (1.15), and pneumonia (1.26).

Neil Osterweil/MDedge News
Dr. Meredith C. McCormack


The link between gas and risk of asthma was significant only for adults, however, and the data on the risks for COPD and for pneumonia or other respiratory infections came almost exclusively from low-income countries, she noted.

Despite the lack of evidence for a causative link, however, Dr. McCormack pointed to evidence that indoor NO2 is an air pollutant that acts as a respiratory irritant, and that indoor NO2 levels in homes with gas stoves have been shown to be more than twice as high as those in homes with electric stoves.

Other evidence shows that indoor NO2 is associated with increased symptoms and use of rescue medications for children with asthma, and with shortness of breath, nocturnal symptoms, reduction in lung function, and exacerbations in COPD.

Still other studies have shown that exchanging a gas stove for an electric stove can reduce NO2 concentrations in the home by up to 50%, but there is still a need for clinical trial evidence of a health benefit for such an exchange, she said.

And even if a gas stove is swapped out for an electric or induction range, household members with asthma are exposed to other hazards, including second-hand smoke, cooking exhaust, candle or incense burning, outdoor particulate matter that finds its way indoors, mold, and mouse or cockroach allergens, she noted.
 

 

 

On common ground

Environmental interventions that can benefit all members of a household — not just those with obstructive pulmonary disease — include smoking cessation, charcoal filter-equipped air cleaners, stove hoods that vent outdoors, integrated pest management, hypoallergenic pillow and mattress covers, high efficiency particulate air (HEPA) vacuums, and mold and radon abatement.

Both Dr. Balmes and Dr. McCormack agreed in the end that gas stoves contribute to respiratory morbidity, and that both state and national policy changes are needed to support transition to cleaner indoor air, with financial incentives available for households with more modest incomes.

“For everyone, there is a climate-change mitigation imperative to transition away from gas appliances if we want to tackle the climate emergency,” Dr. Balmes said.
 

End indoor combustion

George D. Thurston, ScD, professor of medicine and population health at the NYU Grossman School of Medicine, who attended the debate, told Chest Physician that the participants talked about NO2 but didn’t touch on particulate pollution generated by gas stoves.

Burning natural gas produces particles that are very similar in composition to those produced by burning coal, oil, or diesel fuel, Dr. Thurston said, and he pointed out that interventions such as range hoods work only if they actually vent outdoors, and aren’t simply fans that recirculate the air within the home. And even when ventilation works as it should to move air out of the house, it only pumps it back into the atmosphere, where it contributes to climate change.

“We need combustion-free homes. That’s the unifying principle. We have to keep our eyes on that prize,” he said.

Dr. Balmes, Dr. McCormack, and Dr. Thurston all reported having no relevant disclosures.

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