Pulmonology

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

Use of inhalers with long-acting muscarinic antagonists and long-acting beta-agonists reduced COPD exacerbations and pneumonia hospitalizations compared with inhalers with corticosteroids and long-acting beta-agonists, based on data from more than 30,000 individuals.

Current clinical guidelines for chronic obstructive pulmonary disease (COPD) patients recommend inhalers with long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) over those with inhaled corticosteroids (ICSs) and LABAs, but data comparing the two formulations have been inconsistent, and concerns about generalizability persist, wrote William B. Feldman, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in JAMA Internal Medicine, the researchers reviewed data from a commercial insurance claims database of individuals diagnosed with COPD who filled a new prescription for a LAMA-LABA inhaler or ICS-LABA inhaler between Jan. 1, 2014, and Dec. 31, 2019. Patients with asthma and those younger than 40 years were excluded. The study population included 137,833 individuals with a mean age of 70.2 years; 50.4% were female. Of the 107,004 ICS-LABA users and 30,829 LAMA-LABA users, 30,216 matched pairs were included in a 1:1 propensity score matched study. The primary outcomes were effectiveness, based on the rate of first moderate or severe COPD exacerbation, and safety, based on the rate of first pneumonia hospitalization.

Use of LAMA-LABA inhalers was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation and a 20% reduction in the rate of first pneumonia hospitalization compared with use of ICS-LABA (hazard ratios 0.92 and 0.80, respectively). The absolute rate reductions with LAMA-LABA inhalers for first moderate or severe COPD exacerbations and for first pneumonia hospitalizations were was 43.0 events per 1,000 person-years and 91.8 events per person-years, respectively.

The overall rates of total moderate to severe COPD and pneumonia hospitalizations were 5% and 17% lower, respectively, among patients who used LAMA-LABA than those treated with ICS-LABA. The results were consistently robust in subgroup and sensitivity analyses, the researchers wrote in their discussion. However, the results must be interpreted cautiously in comparison to other large studies because of the significant differences in the cohorts of patients studied, notably that most patients in the current study had no received previous inhaler therapy.

The study findings were limited by several factors including the relatively short follow-up time and reliance on prescription fills as an indicator of medication use, the researchers noted. Other limitations included notable differences between the LAMA-LABA patients and ICS-LABA patients, such as more severe COPD and less access to respiratory care, they wrote.

Although the current study is not the definitive answer to conflicting results from previous trials, it is the largest know to date to compare LAMA-LABA with ICS-LABA, and the results support LAMA-LABA as the preferred therapy for COPD patients, the researchers concluded.
 

Findings clarify clinical practice guidelines

“This study was required to provide clarity regarding the optimal choice of treatment for COPD given conflicting data from other recent trials,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview.

“The study findings reinforce the benefits of combined LAMA-LABA in improving clinical outcomes in COPD in a real-world setting,” and the data provide further support for choosing LAMA-LABA over ICS-LABA in COPD patients, said Dr. Pal, who was not involved in the study.

However, availability and affordability of LAMA-LABA inhalers may be barriers to expanding their use in clinical practice, he noted.

“Additional research is needed to accurately define which patient populations would benefit most from the therapy and whether patients who have previously been stabilized on ICS-LABA would derive additional benefit from a change in therapy,” Dr. Pal said.

The study was supported by the National Heart, Lung, and Blood Institute and funding from the Commonwealth Fund and Arnold Ventures.

Dr. Feldman disclosed receiving personal fees from Alosa Health and Aetion, serving as an expert witness in litigation against inhaler manufacturers, and receiving an honorarium for a presentation to Blue Cross Blue Shield of Massachusetts unrelated to the current study. Dr. Pal had no financial conflicts to disclose.

Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.

PRISm occurs in approximately 10% of the general population and has been identified as a predictor of adverse health outcomes including cardiorespiratory morbidity and mortality, Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.

“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.

In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.

The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.

The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).

Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).

The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.

PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.

The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.

Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.

The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.

However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.

The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com

Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.

PRISm occurs in approximately 10% of the general population and has been identified as a predictor of adverse health outcomes including cardiorespiratory morbidity and mortality, Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.

“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.

In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.

The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.

The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).

Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).

The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.

PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.

The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.

Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.

The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.

However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.

The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com

Among adults with type 2 diabetes, the presence of preserved ratio impaired spirometry (PRISm) was significantly associated with increased risk of mortality and both macro- and microvascular complications, as well as increased mortality, based on data from more than 20,000 individuals.

PRISm occurs in approximately 10% of the general population and has been identified as a predictor of adverse health outcomes including cardiorespiratory morbidity and mortality, Guochen Li, MD, of the Medical College of Soochow University, Suzhou, China, and colleagues wrote.

“A growing number of studies have demonstrated that impaired lung function and type 2 diabetes could trigger shared pathophysiological injuries, such as microangiopathy and chronic inflammation,” they said, but the potential role of PRISm as an early predictor of adverse outcomes in patients with type 2 diabetes has not been fully examined.

In a study published in the journal Chest, the researchers reviewed data from 20,047 individuals with type 2 diabetes in the UK Biobank, a population-based cohort of adults aged 37-73 years recruited between 2006 and 2010.

The main exposure was lung function based on spirometry. PRISm was defined as predicted forced expiratory volume per second (FEV1) less than 80%, with an FEV1/ forced vital capacity (FVC) ratio of at least 0.70. Individuals with normal spirometry (defined as predicted FEV1 ≥ 80% with an FEV1/FVC ratio ≥ 0.70) served as controls.

The primary outcomes were major complications of type 2 diabetes including macrovascular events (myocardial infarction, unstable angina, coronary heart disease [CHD], ischemic stroke, and any type of stroke), microvascular events (diabetic retinopathy and diabetic kidney disease) and mortality (all-cause, cardiovascular, and respiratory).

Overall, 16.9% of study participants (3385 patients) had obstructive spirometry and 22.6% (4521 patients) had PRISm. Compared with individuals with normal spirometry, those with PRISm were more likely to be current smokers, obese, and living in economically disadvantaged areas. Individuals with PRISm also were significantly more likely to be long-term patients with diabetes who were taking glucose-lowering or lipid-lowering drugs (P < .001 for all).

The median follow-up for each of the type 2 diabetes complications and mortality was approximately 12 years. Over this time, 5.0% of patients developed incident MI, 1.3% developed unstable angina, 15.6% had CHD, 3.5% had an ischemic stroke, and 4.7% had any type of stroke. As for microvascular events, 7.8% developed diabetic retinopathy and 6.7% developed diabetic kidney disease. A total of 2588 patients died during the study period (15.1%), including 544 from cardiovascular disease and 319 from respiratory disease.

PRISm was significantly associated with increased risk of each of the complications and mortality types. These associations persisted after adjusting for lifestyle and other factors. The fully adjusted hazard ratios for PRISm versus normal spirometry were 1.23 for MI, 1.23 for unstable angina, 1.21 for CHD, 1.38 for ischemic stroke, 1.41 for any type of stroke, 1.31 for diabetic retinopathy, and 1.38 for diabetic kidney disease. Adjusted HRs for mortality were 1.34, 1.60, and 1.56 for all-cause, cardiovascular, and respiratory mortality, respectively.

The researchers also found that adding PRISm to an office-based risk score significantly improved the risk classification and predictive power for type 2 diabetes complications with the exception of unstable angina and mortality. They found little evidence for an association with sex, smoking, or PRISm duration and any mortality types. However, in subgroup analyses by age, sex, and duration of diabetes, PRISm remained associated with increased risk of macrovascular and microvascular complications, as well as mortality.

Potential mechanisms for the association between PRISm and diabetes complications include the role of insulin resistance in the exacerbation of lung damage in patients with type 2 diabetes, the increased rate of supplemental oxygen use among individuals with PRISm, and the increased prevalence of pulmonary artery enlargement in the PRISm subjects, the researchers wrote.

The findings were limited by several factors including the prospective design, the homogeneous population of individuals primarily of British or Irish ancestry, and the exclusion of diabetic neuropathy from the analysis, the researchers noted.

However, the results were strengthened by the large cohort, use of professional spirometry, and relatively long follow-up. “The findings underscore the relevance of PRISm for prognostic classification in type 2 diabetes and its potential for optimizing prevention strategies in this condition,” they concluded.

The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangsu Province, and the Priority Academic Program Development of Jiangsu Higher Education Institutions. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com

It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

Baseball legend Leroy “Satchel” Paige famously said that “age is a question of mind over matter: If you don’t mind, it doesn’t matter.”

But even the strongest and most supple minds can’t avoid the effects of advanced age and accompanying physical frailty, and for community-dwelling elderly with pulmonary diseases frailty is a predictor of both hospitalization and death, investigators have found.

For example, among 1,188 community-dwelling older adults enrolled in the Toledo (Spain) Study for Healthy Aging, declining pulmonary function measured by forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC) was associated with increased risk for frailty and hospitalization, and a more than twofold greater risk for death in participants both with and without respiratory diseases. These findings were reported by Walter Sepulveda-Loyola, PT, MSC, PhD, from the Faculty of Health and Social Sciences at Universidad de Las Americas in Santiago, Chile, and colleagues in the journal Heart & Lung.

Similarly, results of a meta-analysis performed by investigators at Jiangsu (China) University showed that among 13,203 patients with chronic obstructive pulmonary disease (COPD), frailty was associated with a more than 2.6-fold relative increase in risk for death from any cause, and “prefrailty,” an intermediate state between frailty and “robustness,” was associated with a 48% relative increase in all-cause mortality. Frailty was also associated with a 2.2-fold risk for COPD exacerbations of any severity, the authors reported in JAMDA: The Journal of Post-Acute and Long-Term Care Medicine.

The good (old) USA

In June 2023 the U.S. Census Bureau announced that the median age of the U.S. population is now 38.9 years, and according to a 2016 Census Bureau report funded by the National Institutes of Health, “America’s 65-and-over population is projected to nearly double over the next three decades, from 48 million to 88 million by 2050.”

With the graying of the U.S. population the burden on pulmonary and critical care experts will almost inevitably increase, as evidenced by research from Julien Cobert, MD, from the University of California, San Francisco, and colleagues.

The investigators looked at trends over time in older adults admitted to ICUs from 1988 through 2015 using data from the Health and Retirement Study (HRS), a nationally representative, longitudinal study of older adults. They found that rates of preexisting frailty, disability, and multimorbidity increased over the study period.

“Our findings suggest a growing prevalence of geriatric conditions among older adults admitted to the ICU, suggesting a pressing need to integrate geriatric principles into critical care medicine. Further research could examine if early interventions emphasizing physical, cognitive, mental health, delirium prevention, advance care planning, and rehabilitation individualized to critically ill elderly patients with preexisting geriatric conditions could improve ICU outcomes and post-ICU recovery,” they wrote in a study published in the journal CHEST.

In an editorial accompanying the study by Dr. Cobert and colleagues, Nathan E. Brummel, MD, from The Ohio State University College of Medicine and Davis Heart and Lung Research Institute in Columbus, said “the finding that nearly 30% of overall HRS participants were admitted to the ICU provides novel data about the extent to which older Americans are affected by critical illness. Because the number of older Americans is projected to continue to increase for the next 30 years or more, these data make clear the ongoing importance of aging-focused research and clinical care.”

Dr. Brummel also noted that older adults who are admitted to the ICU today are at greater risk for poor outcomes than those admitted in prior years, as evidenced by the increased prevalence of disability, frailty, and multimorbidity.

“Moreover, because the average age of those admitted to the ICU only changed by 1 year during the study, these data show that increases in vulnerability are not simply due to chronological age, and they suggest that to identify those with greater baseline vulnerability, screening for geriatric syndromes at ICU admission may be warranted,” he wrote.
 

Geriatric principles in the ICU

“I think what’s most important is that we think about patients from a geriatric principles standpoint, not just when they’re admitted to the hospital but especially when they’re admitted to the ICU,” Dr. Cobert said in an interview.

“The first step is ensuring that we’re asking questions about their underlying comorbidities, especially around frailty, hearing, vision loss, falls, multimorbidities, polypharmacy – things that are primarily done on the outpatient side in geriatric clinics, but things that we should probably be a little bit more cognizant of, given that we’re starting to see higher rates of patients coming in with these issues,” he said.

Critical care specialists need to take a more holistic approach and try to understand as best they can each patients’ goals and then determine whether the ICU staff are acting in concordance with those goals, he emphasized.

For example, ICU clinicians should try to understand whether patients were losing function or having mobility difficulties before hospital and ICU admission, and what they hope to retain when or if they are discharged. ICU staff can then try as much as reasonably possible to minimize interventions that could contribute to impairment after discharge.
 

Frailty and COPD in the ICU

There are special considerations for frail elderly with obstructive airway disease, Dr. Cobert noted.

Patients with advanced COPD, for example, are likely to be on home oxygen.

“Home oxygen is a big deal,” he said. “It can definitely help with functioning and there’s potentially a mortality benefit in certain populations. But that said, it’s a flammable object that they have to carry around and lug with them all the time. It contributes to falls, it’s tethering, it’s life-limiting in many ways.”

In addition, many patients with COPD have multiple re-hospitalizations, and for clinicians the challenge is “understanding what their goals are, what their motivations are, especially when they live with dyspnea, with advanced lung disease. Is intubation within their goals of care? Has their functional status been declining over time? Are there things that we can optimize holistically and globally as their COPD advances over time?”

Another important component of critical care for the frail elderly is consideration of patients’ palliative care needs and what their symptoms and symptom burdens were like prior to hospitalizations.

“The ICU experience and the critical illness experience may serve as an inflexion point – more likely a downward inflection point – whereby their needs increase, their symptoms can worsen, and their health, especially their global health, worsens. Their preexisting geriatric conditions might be a moving target after another hit and another traumatic stressor like the ICU setting,” Dr. Cobert said.

The study by Dr. Cobert and colleagues was supported by the National Institute on Aging. Dr. Cobert had no reported conflicts of interest.

Baseball legend Leroy “Satchel” Paige famously said that “age is a question of mind over matter: If you don’t mind, it doesn’t matter.”

But even the strongest and most supple minds can’t avoid the effects of advanced age and accompanying physical frailty, and for community-dwelling elderly with pulmonary diseases frailty is a predictor of both hospitalization and death, investigators have found.

For example, among 1,188 community-dwelling older adults enrolled in the Toledo (Spain) Study for Healthy Aging, declining pulmonary function measured by forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC) was associated with increased risk for frailty and hospitalization, and a more than twofold greater risk for death in participants both with and without respiratory diseases. These findings were reported by Walter Sepulveda-Loyola, PT, MSC, PhD, from the Faculty of Health and Social Sciences at Universidad de Las Americas in Santiago, Chile, and colleagues in the journal Heart & Lung.

Similarly, results of a meta-analysis performed by investigators at Jiangsu (China) University showed that among 13,203 patients with chronic obstructive pulmonary disease (COPD), frailty was associated with a more than 2.6-fold relative increase in risk for death from any cause, and “prefrailty,” an intermediate state between frailty and “robustness,” was associated with a 48% relative increase in all-cause mortality. Frailty was also associated with a 2.2-fold risk for COPD exacerbations of any severity, the authors reported in JAMDA: The Journal of Post-Acute and Long-Term Care Medicine.

The good (old) USA

In June 2023 the U.S. Census Bureau announced that the median age of the U.S. population is now 38.9 years, and according to a 2016 Census Bureau report funded by the National Institutes of Health, “America’s 65-and-over population is projected to nearly double over the next three decades, from 48 million to 88 million by 2050.”

With the graying of the U.S. population the burden on pulmonary and critical care experts will almost inevitably increase, as evidenced by research from Julien Cobert, MD, from the University of California, San Francisco, and colleagues.

The investigators looked at trends over time in older adults admitted to ICUs from 1988 through 2015 using data from the Health and Retirement Study (HRS), a nationally representative, longitudinal study of older adults. They found that rates of preexisting frailty, disability, and multimorbidity increased over the study period.

“Our findings suggest a growing prevalence of geriatric conditions among older adults admitted to the ICU, suggesting a pressing need to integrate geriatric principles into critical care medicine. Further research could examine if early interventions emphasizing physical, cognitive, mental health, delirium prevention, advance care planning, and rehabilitation individualized to critically ill elderly patients with preexisting geriatric conditions could improve ICU outcomes and post-ICU recovery,” they wrote in a study published in the journal CHEST.

In an editorial accompanying the study by Dr. Cobert and colleagues, Nathan E. Brummel, MD, from The Ohio State University College of Medicine and Davis Heart and Lung Research Institute in Columbus, said “the finding that nearly 30% of overall HRS participants were admitted to the ICU provides novel data about the extent to which older Americans are affected by critical illness. Because the number of older Americans is projected to continue to increase for the next 30 years or more, these data make clear the ongoing importance of aging-focused research and clinical care.”

Dr. Brummel also noted that older adults who are admitted to the ICU today are at greater risk for poor outcomes than those admitted in prior years, as evidenced by the increased prevalence of disability, frailty, and multimorbidity.

“Moreover, because the average age of those admitted to the ICU only changed by 1 year during the study, these data show that increases in vulnerability are not simply due to chronological age, and they suggest that to identify those with greater baseline vulnerability, screening for geriatric syndromes at ICU admission may be warranted,” he wrote.
 

Geriatric principles in the ICU

“I think what’s most important is that we think about patients from a geriatric principles standpoint, not just when they’re admitted to the hospital but especially when they’re admitted to the ICU,” Dr. Cobert said in an interview.

“The first step is ensuring that we’re asking questions about their underlying comorbidities, especially around frailty, hearing, vision loss, falls, multimorbidities, polypharmacy – things that are primarily done on the outpatient side in geriatric clinics, but things that we should probably be a little bit more cognizant of, given that we’re starting to see higher rates of patients coming in with these issues,” he said.

Critical care specialists need to take a more holistic approach and try to understand as best they can each patients’ goals and then determine whether the ICU staff are acting in concordance with those goals, he emphasized.

For example, ICU clinicians should try to understand whether patients were losing function or having mobility difficulties before hospital and ICU admission, and what they hope to retain when or if they are discharged. ICU staff can then try as much as reasonably possible to minimize interventions that could contribute to impairment after discharge.
 

Frailty and COPD in the ICU

There are special considerations for frail elderly with obstructive airway disease, Dr. Cobert noted.

Patients with advanced COPD, for example, are likely to be on home oxygen.

“Home oxygen is a big deal,” he said. “It can definitely help with functioning and there’s potentially a mortality benefit in certain populations. But that said, it’s a flammable object that they have to carry around and lug with them all the time. It contributes to falls, it’s tethering, it’s life-limiting in many ways.”

In addition, many patients with COPD have multiple re-hospitalizations, and for clinicians the challenge is “understanding what their goals are, what their motivations are, especially when they live with dyspnea, with advanced lung disease. Is intubation within their goals of care? Has their functional status been declining over time? Are there things that we can optimize holistically and globally as their COPD advances over time?”

Another important component of critical care for the frail elderly is consideration of patients’ palliative care needs and what their symptoms and symptom burdens were like prior to hospitalizations.

“The ICU experience and the critical illness experience may serve as an inflexion point – more likely a downward inflection point – whereby their needs increase, their symptoms can worsen, and their health, especially their global health, worsens. Their preexisting geriatric conditions might be a moving target after another hit and another traumatic stressor like the ICU setting,” Dr. Cobert said.

The study by Dr. Cobert and colleagues was supported by the National Institute on Aging. Dr. Cobert had no reported conflicts of interest.

Baseball legend Leroy “Satchel” Paige famously said that “age is a question of mind over matter: If you don’t mind, it doesn’t matter.”

But even the strongest and most supple minds can’t avoid the effects of advanced age and accompanying physical frailty, and for community-dwelling elderly with pulmonary diseases frailty is a predictor of both hospitalization and death, investigators have found.

For example, among 1,188 community-dwelling older adults enrolled in the Toledo (Spain) Study for Healthy Aging, declining pulmonary function measured by forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC) was associated with increased risk for frailty and hospitalization, and a more than twofold greater risk for death in participants both with and without respiratory diseases. These findings were reported by Walter Sepulveda-Loyola, PT, MSC, PhD, from the Faculty of Health and Social Sciences at Universidad de Las Americas in Santiago, Chile, and colleagues in the journal Heart & Lung.

Similarly, results of a meta-analysis performed by investigators at Jiangsu (China) University showed that among 13,203 patients with chronic obstructive pulmonary disease (COPD), frailty was associated with a more than 2.6-fold relative increase in risk for death from any cause, and “prefrailty,” an intermediate state between frailty and “robustness,” was associated with a 48% relative increase in all-cause mortality. Frailty was also associated with a 2.2-fold risk for COPD exacerbations of any severity, the authors reported in JAMDA: The Journal of Post-Acute and Long-Term Care Medicine.

The good (old) USA

In June 2023 the U.S. Census Bureau announced that the median age of the U.S. population is now 38.9 years, and according to a 2016 Census Bureau report funded by the National Institutes of Health, “America’s 65-and-over population is projected to nearly double over the next three decades, from 48 million to 88 million by 2050.”

With the graying of the U.S. population the burden on pulmonary and critical care experts will almost inevitably increase, as evidenced by research from Julien Cobert, MD, from the University of California, San Francisco, and colleagues.

The investigators looked at trends over time in older adults admitted to ICUs from 1988 through 2015 using data from the Health and Retirement Study (HRS), a nationally representative, longitudinal study of older adults. They found that rates of preexisting frailty, disability, and multimorbidity increased over the study period.

“Our findings suggest a growing prevalence of geriatric conditions among older adults admitted to the ICU, suggesting a pressing need to integrate geriatric principles into critical care medicine. Further research could examine if early interventions emphasizing physical, cognitive, mental health, delirium prevention, advance care planning, and rehabilitation individualized to critically ill elderly patients with preexisting geriatric conditions could improve ICU outcomes and post-ICU recovery,” they wrote in a study published in the journal CHEST.

In an editorial accompanying the study by Dr. Cobert and colleagues, Nathan E. Brummel, MD, from The Ohio State University College of Medicine and Davis Heart and Lung Research Institute in Columbus, said “the finding that nearly 30% of overall HRS participants were admitted to the ICU provides novel data about the extent to which older Americans are affected by critical illness. Because the number of older Americans is projected to continue to increase for the next 30 years or more, these data make clear the ongoing importance of aging-focused research and clinical care.”

Dr. Brummel also noted that older adults who are admitted to the ICU today are at greater risk for poor outcomes than those admitted in prior years, as evidenced by the increased prevalence of disability, frailty, and multimorbidity.

“Moreover, because the average age of those admitted to the ICU only changed by 1 year during the study, these data show that increases in vulnerability are not simply due to chronological age, and they suggest that to identify those with greater baseline vulnerability, screening for geriatric syndromes at ICU admission may be warranted,” he wrote.
 

Geriatric principles in the ICU

“I think what’s most important is that we think about patients from a geriatric principles standpoint, not just when they’re admitted to the hospital but especially when they’re admitted to the ICU,” Dr. Cobert said in an interview.

“The first step is ensuring that we’re asking questions about their underlying comorbidities, especially around frailty, hearing, vision loss, falls, multimorbidities, polypharmacy – things that are primarily done on the outpatient side in geriatric clinics, but things that we should probably be a little bit more cognizant of, given that we’re starting to see higher rates of patients coming in with these issues,” he said.

Critical care specialists need to take a more holistic approach and try to understand as best they can each patients’ goals and then determine whether the ICU staff are acting in concordance with those goals, he emphasized.

For example, ICU clinicians should try to understand whether patients were losing function or having mobility difficulties before hospital and ICU admission, and what they hope to retain when or if they are discharged. ICU staff can then try as much as reasonably possible to minimize interventions that could contribute to impairment after discharge.
 

Frailty and COPD in the ICU

There are special considerations for frail elderly with obstructive airway disease, Dr. Cobert noted.

Patients with advanced COPD, for example, are likely to be on home oxygen.

“Home oxygen is a big deal,” he said. “It can definitely help with functioning and there’s potentially a mortality benefit in certain populations. But that said, it’s a flammable object that they have to carry around and lug with them all the time. It contributes to falls, it’s tethering, it’s life-limiting in many ways.”

In addition, many patients with COPD have multiple re-hospitalizations, and for clinicians the challenge is “understanding what their goals are, what their motivations are, especially when they live with dyspnea, with advanced lung disease. Is intubation within their goals of care? Has their functional status been declining over time? Are there things that we can optimize holistically and globally as their COPD advances over time?”

Another important component of critical care for the frail elderly is consideration of patients’ palliative care needs and what their symptoms and symptom burdens were like prior to hospitalizations.

“The ICU experience and the critical illness experience may serve as an inflexion point – more likely a downward inflection point – whereby their needs increase, their symptoms can worsen, and their health, especially their global health, worsens. Their preexisting geriatric conditions might be a moving target after another hit and another traumatic stressor like the ICU setting,” Dr. Cobert said.

The study by Dr. Cobert and colleagues was supported by the National Institute on Aging. Dr. Cobert had no reported conflicts of interest.

Topline

Long-term mortality rates among individuals who have had a pulmonary embolism are significantly higher than rates in the general population.

Methodology

Researchers investigated long-term outcomes of patients with pulmonary embolism in a single-center registry.

They followed 896 patients for up to 14 years.

Data were from consecutive cases treated between May 2005 and December 2017.
 

Takeaway

The total follow-up time was 3,908 patient-years (median, 3.1 years).

One-year and five-year mortality rates were 19.7% (95% confidence interval, 17.2%-22.4%) and 37.1% (95% CI, 33.6%-40.5%), respectively, for patients with pulmonary embolism.

The most frequent causes of death were cancer (28.5%), pulmonary embolism (19.4%), infections (13.9%), and cardiovascular events (11.6%).

Late mortality (>30 days) was more frequent than in the general population for patients with cancer (5-year standardized mortality ratio, 2.77; 95% CI, 2.41-3.16) and for patients without cancer (1.80; 95% CI, 1.50-2.14), compared with expected rates.
 

In practice

“The mortality risk of pulmonary embolism patients remained elevated compared to the general population throughout the follow-up period,” stated Johannes Eckelt, Clinic of Cardiology and Pneumology, University Medical Center Göttingen (Germany).

Source

“Long-term Mortality in Pulmonary Embolism: Results in a Single-Center Registry,” by Mr. Eckelt and colleagues was published in Research and Practice in Thrombosis and Haemostasis.

Limitations

Owing to the single-center study design, selection bias cannot be excluded, limiting the generalizability of the study findings, the authors stated.
 

Disclosures

The authors have disclosed no relevant financial relationships.

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

Topline

Long-term mortality rates among individuals who have had a pulmonary embolism are significantly higher than rates in the general population.

Methodology

Researchers investigated long-term outcomes of patients with pulmonary embolism in a single-center registry.

They followed 896 patients for up to 14 years.

Data were from consecutive cases treated between May 2005 and December 2017.
 

Takeaway

The total follow-up time was 3,908 patient-years (median, 3.1 years).

One-year and five-year mortality rates were 19.7% (95% confidence interval, 17.2%-22.4%) and 37.1% (95% CI, 33.6%-40.5%), respectively, for patients with pulmonary embolism.

The most frequent causes of death were cancer (28.5%), pulmonary embolism (19.4%), infections (13.9%), and cardiovascular events (11.6%).

Late mortality (>30 days) was more frequent than in the general population for patients with cancer (5-year standardized mortality ratio, 2.77; 95% CI, 2.41-3.16) and for patients without cancer (1.80; 95% CI, 1.50-2.14), compared with expected rates.
 

In practice

“The mortality risk of pulmonary embolism patients remained elevated compared to the general population throughout the follow-up period,” stated Johannes Eckelt, Clinic of Cardiology and Pneumology, University Medical Center Göttingen (Germany).

Source

“Long-term Mortality in Pulmonary Embolism: Results in a Single-Center Registry,” by Mr. Eckelt and colleagues was published in Research and Practice in Thrombosis and Haemostasis.

Limitations

Owing to the single-center study design, selection bias cannot be excluded, limiting the generalizability of the study findings, the authors stated.
 

Disclosures

The authors have disclosed no relevant financial relationships.

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

Topline

Long-term mortality rates among individuals who have had a pulmonary embolism are significantly higher than rates in the general population.

Methodology

Researchers investigated long-term outcomes of patients with pulmonary embolism in a single-center registry.

They followed 896 patients for up to 14 years.

Data were from consecutive cases treated between May 2005 and December 2017.
 

Takeaway

The total follow-up time was 3,908 patient-years (median, 3.1 years).

One-year and five-year mortality rates were 19.7% (95% confidence interval, 17.2%-22.4%) and 37.1% (95% CI, 33.6%-40.5%), respectively, for patients with pulmonary embolism.

The most frequent causes of death were cancer (28.5%), pulmonary embolism (19.4%), infections (13.9%), and cardiovascular events (11.6%).

Late mortality (>30 days) was more frequent than in the general population for patients with cancer (5-year standardized mortality ratio, 2.77; 95% CI, 2.41-3.16) and for patients without cancer (1.80; 95% CI, 1.50-2.14), compared with expected rates.
 

In practice

“The mortality risk of pulmonary embolism patients remained elevated compared to the general population throughout the follow-up period,” stated Johannes Eckelt, Clinic of Cardiology and Pneumology, University Medical Center Göttingen (Germany).

Source

“Long-term Mortality in Pulmonary Embolism: Results in a Single-Center Registry,” by Mr. Eckelt and colleagues was published in Research and Practice in Thrombosis and Haemostasis.

Limitations

Owing to the single-center study design, selection bias cannot be excluded, limiting the generalizability of the study findings, the authors stated.
 

Disclosures

The authors have disclosed no relevant financial relationships.

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

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

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

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

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

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

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

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

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

This article was updated 7/5/23.

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

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

This article was updated 7/5/23.

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

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

This article was updated 7/5/23.

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.

Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).

“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
 

Screening much higher for other cancers

The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”

The USPSTF updated its recommendations for lung cancer screening in March 2021.

Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.

The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.

The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
 

Rates differ by state

Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).

Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).

The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).

Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
 

Work needed on all levels

Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.

“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.

She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).

Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.

Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.

“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”

“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.

One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.

Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.

Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).

“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
 

Screening much higher for other cancers

The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”

The USPSTF updated its recommendations for lung cancer screening in March 2021.

Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.

The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.

The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
 

Rates differ by state

Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).

Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).

The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).

Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
 

Work needed on all levels

Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.

“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.

She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).

Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.

Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.

“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”

“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.

One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.

Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.

Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).

“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
 

Screening much higher for other cancers

The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”

The USPSTF updated its recommendations for lung cancer screening in March 2021.

Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.

The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.

The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
 

Rates differ by state

Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).

Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).

The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).

Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
 

Work needed on all levels

Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.

“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.

She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).

Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.

Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.

“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”

“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.

One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.