COPD

Medicare exacts a penalty whenever it deems that hospitals have too many patients with chronic obstructive pulmonary disease who have been re-admitted within 30 days of discharge for care related to the disease. For acute-care hospitals the solution to reducing chronic obstructive pulmonary disease (COPD) re-admissions has been elusive, but members of a COPD chronic care management collaborative think they have found at least a partial solution.

Among 33 centers participating in the performance improvement program, the aggregated cost avoidance for emergency department (ED) visits was estimated at $351,000, and the savings for hospital re-visits avoided was an estimated $2.6 million, reported Valerie Press, MD, MPH, from the University of Chicago, and co-authors from the health care performance-improvement company Vizient.

The investigators described their chronic care management collaborative in a thematic poster presented during the American Thoracic Society’s virtual international conference (Abstract A1688).

“I’ve been working in the space of COPD re-admissions pretty much since Medicare started its penalty program,” Dr. Press said in an interview.

“At both my own institution and nationally, we’ve been trying to understand the policy that went into place to reduce what was considered to be excessive readmissions after a COPD admission, but there really wasn’t a lot of evidence to suggest how to do this at the time the policy went into place,” she said.

The Centers for Medicare & Medicaid Services (CMS) initiated its Hospital Readmission Reduction Program for COPD in 2014.

“The challenge with COPD is that we have not found really successful interventions to decrease readmissions,” commented Laura C. Myers, MD, MPH, in an interview. Dr. Myers, who studies optimal care delivery models for patients with COPD at Kaiser Permanente Northern California in Oakland, was not involved in the study.

She said that although the aggregate cost savings in the study by Dr. Press and colleagues are relatively modest, “if you extrapolate across the country, then those numbers could potentially be impressive.”
 

Collaboration details

Dr. Press was a subject matter expert for the collaborative, which included 47 Vizient member sites in the Southeast, Southwest, Midwest, and Northeast and Northwest coasts. Of these centers, 33 completed both parts of the collaboration.

The program included bi-monthly didactic sessions and site report and discussion sessions with peer-to-peer networking for a total of 6 months. During the sessions, meeting participants discussed best practices, received expert coaching, and provided progress updates on performance improvement projects.

“The goal was for them to identify the gaps or needs they had at their hospitals or practices, and then to try to put in place one or more interventions,” Dr. Press said. “This wasn’t a research program. It wasn’t standardized, and not all hospitals had to do the same program.”

The participants submitted reports for baseline and post-collaboration periods on both an intervention’s “reach,” defined as the percentage of patients who received a specified intervention, and on two outcome measures.

The interventions measured included spirometry, follow-up visits scheduled within 7 to 14 days of discharge, patients receiving COPD education, pulmonary referrals, and adherence to the COPD clinical pathway.

The outcome measures were the rate of COPD-related ED visits and hospital readmissions.
 

Revisits reduced

At the end of the program, 83% of participating sites had reductions in either ED visits or readmissions, and of this group, five sites had decreases in both measures.

Among all sites with improved metrics, the average rate of COPD-related ED revisits declined from 12.7% to 9%, and average inpatient readmissions declined from 20.1% to 15.6%.

As noted, the estimated cost savings in ED revisits avoided was $351,00, and the estimated savings in hospital readmission costs was $2.6 million.

“Although the centers didn’t have to participate in both parts, we did see in our results that the programs that participated fully had better results,” Dr. Press said.

“Historically, we’ve had such difficulty in decreasing COPD readmissions, and it’s nice to see something that actually works, both for patients and for conserving health resources,” Dr. Myers commented.

The study was supported by Vizient. Dr. Press disclosed honoraria from the company in her role as subject matter expert. Dr. Myers reported no conflicts of interest.

Medicare exacts a penalty whenever it deems that hospitals have too many patients with chronic obstructive pulmonary disease who have been re-admitted within 30 days of discharge for care related to the disease. For acute-care hospitals the solution to reducing chronic obstructive pulmonary disease (COPD) re-admissions has been elusive, but members of a COPD chronic care management collaborative think they have found at least a partial solution.

Among 33 centers participating in the performance improvement program, the aggregated cost avoidance for emergency department (ED) visits was estimated at $351,000, and the savings for hospital re-visits avoided was an estimated $2.6 million, reported Valerie Press, MD, MPH, from the University of Chicago, and co-authors from the health care performance-improvement company Vizient.

The investigators described their chronic care management collaborative in a thematic poster presented during the American Thoracic Society’s virtual international conference (Abstract A1688).

“I’ve been working in the space of COPD re-admissions pretty much since Medicare started its penalty program,” Dr. Press said in an interview.

“At both my own institution and nationally, we’ve been trying to understand the policy that went into place to reduce what was considered to be excessive readmissions after a COPD admission, but there really wasn’t a lot of evidence to suggest how to do this at the time the policy went into place,” she said.

The Centers for Medicare & Medicaid Services (CMS) initiated its Hospital Readmission Reduction Program for COPD in 2014.

“The challenge with COPD is that we have not found really successful interventions to decrease readmissions,” commented Laura C. Myers, MD, MPH, in an interview. Dr. Myers, who studies optimal care delivery models for patients with COPD at Kaiser Permanente Northern California in Oakland, was not involved in the study.

She said that although the aggregate cost savings in the study by Dr. Press and colleagues are relatively modest, “if you extrapolate across the country, then those numbers could potentially be impressive.”
 

Collaboration details

Dr. Press was a subject matter expert for the collaborative, which included 47 Vizient member sites in the Southeast, Southwest, Midwest, and Northeast and Northwest coasts. Of these centers, 33 completed both parts of the collaboration.

The program included bi-monthly didactic sessions and site report and discussion sessions with peer-to-peer networking for a total of 6 months. During the sessions, meeting participants discussed best practices, received expert coaching, and provided progress updates on performance improvement projects.

“The goal was for them to identify the gaps or needs they had at their hospitals or practices, and then to try to put in place one or more interventions,” Dr. Press said. “This wasn’t a research program. It wasn’t standardized, and not all hospitals had to do the same program.”

The participants submitted reports for baseline and post-collaboration periods on both an intervention’s “reach,” defined as the percentage of patients who received a specified intervention, and on two outcome measures.

The interventions measured included spirometry, follow-up visits scheduled within 7 to 14 days of discharge, patients receiving COPD education, pulmonary referrals, and adherence to the COPD clinical pathway.

The outcome measures were the rate of COPD-related ED visits and hospital readmissions.
 

Revisits reduced

At the end of the program, 83% of participating sites had reductions in either ED visits or readmissions, and of this group, five sites had decreases in both measures.

Among all sites with improved metrics, the average rate of COPD-related ED revisits declined from 12.7% to 9%, and average inpatient readmissions declined from 20.1% to 15.6%.

As noted, the estimated cost savings in ED revisits avoided was $351,00, and the estimated savings in hospital readmission costs was $2.6 million.

“Although the centers didn’t have to participate in both parts, we did see in our results that the programs that participated fully had better results,” Dr. Press said.

“Historically, we’ve had such difficulty in decreasing COPD readmissions, and it’s nice to see something that actually works, both for patients and for conserving health resources,” Dr. Myers commented.

The study was supported by Vizient. Dr. Press disclosed honoraria from the company in her role as subject matter expert. Dr. Myers reported no conflicts of interest.

Medicare exacts a penalty whenever it deems that hospitals have too many patients with chronic obstructive pulmonary disease who have been re-admitted within 30 days of discharge for care related to the disease. For acute-care hospitals the solution to reducing chronic obstructive pulmonary disease (COPD) re-admissions has been elusive, but members of a COPD chronic care management collaborative think they have found at least a partial solution.

Among 33 centers participating in the performance improvement program, the aggregated cost avoidance for emergency department (ED) visits was estimated at $351,000, and the savings for hospital re-visits avoided was an estimated $2.6 million, reported Valerie Press, MD, MPH, from the University of Chicago, and co-authors from the health care performance-improvement company Vizient.

The investigators described their chronic care management collaborative in a thematic poster presented during the American Thoracic Society’s virtual international conference (Abstract A1688).

“I’ve been working in the space of COPD re-admissions pretty much since Medicare started its penalty program,” Dr. Press said in an interview.

“At both my own institution and nationally, we’ve been trying to understand the policy that went into place to reduce what was considered to be excessive readmissions after a COPD admission, but there really wasn’t a lot of evidence to suggest how to do this at the time the policy went into place,” she said.

The Centers for Medicare & Medicaid Services (CMS) initiated its Hospital Readmission Reduction Program for COPD in 2014.

“The challenge with COPD is that we have not found really successful interventions to decrease readmissions,” commented Laura C. Myers, MD, MPH, in an interview. Dr. Myers, who studies optimal care delivery models for patients with COPD at Kaiser Permanente Northern California in Oakland, was not involved in the study.

She said that although the aggregate cost savings in the study by Dr. Press and colleagues are relatively modest, “if you extrapolate across the country, then those numbers could potentially be impressive.”
 

Collaboration details

Dr. Press was a subject matter expert for the collaborative, which included 47 Vizient member sites in the Southeast, Southwest, Midwest, and Northeast and Northwest coasts. Of these centers, 33 completed both parts of the collaboration.

The program included bi-monthly didactic sessions and site report and discussion sessions with peer-to-peer networking for a total of 6 months. During the sessions, meeting participants discussed best practices, received expert coaching, and provided progress updates on performance improvement projects.

“The goal was for them to identify the gaps or needs they had at their hospitals or practices, and then to try to put in place one or more interventions,” Dr. Press said. “This wasn’t a research program. It wasn’t standardized, and not all hospitals had to do the same program.”

The participants submitted reports for baseline and post-collaboration periods on both an intervention’s “reach,” defined as the percentage of patients who received a specified intervention, and on two outcome measures.

The interventions measured included spirometry, follow-up visits scheduled within 7 to 14 days of discharge, patients receiving COPD education, pulmonary referrals, and adherence to the COPD clinical pathway.

The outcome measures were the rate of COPD-related ED visits and hospital readmissions.
 

Revisits reduced

At the end of the program, 83% of participating sites had reductions in either ED visits or readmissions, and of this group, five sites had decreases in both measures.

Among all sites with improved metrics, the average rate of COPD-related ED revisits declined from 12.7% to 9%, and average inpatient readmissions declined from 20.1% to 15.6%.

As noted, the estimated cost savings in ED revisits avoided was $351,00, and the estimated savings in hospital readmission costs was $2.6 million.

“Although the centers didn’t have to participate in both parts, we did see in our results that the programs that participated fully had better results,” Dr. Press said.

“Historically, we’ve had such difficulty in decreasing COPD readmissions, and it’s nice to see something that actually works, both for patients and for conserving health resources,” Dr. Myers commented.

The study was supported by Vizient. Dr. Press disclosed honoraria from the company in her role as subject matter expert. Dr. Myers reported no conflicts of interest.

Adults in their 30s, 40s and 50s with chronic obstructive pulmonary disease (COPD) experience significant morbidity and excess mortality from the disease, results of a population-based study show.

Among adults aged 35-55 years with COPD in Ontario in a longitudinal population cohort study, the overall mortality rate was fivefold higher, compared with other adults in the same age range without COPD.

In contrast, the mortality rate among adults 65 years and older with COPD was 2.5-fold higher than that of their peers without COPD, reported Alina J. Blazer, MSc, MD, a clinical and research fellow at the University of Toronto.

“Overall, our study has shown that younger adults with COPD experience significant morbidity, as evidence by their elevated rates of health care use and excess mortality from their disease. This study provides further evidence that so-called ‘early’ COPD is not a benign disease, and suggests that we should focus clinical efforts on identifying COPD in younger patients, in the hopes that earlier intervention may improve their current health, reduce resource utilization, and prevent further disease progression,” she said during a minisymposium at the American Thoracic Society’s virtual international conference (Abstract A1131).

COPD is widely regarded as a disease affecting only older adults, but it can also occur in those younger than 65, and although it is commonly assumed that COPD diagnosed earlier in life will be milder in severity, this assumption has not been fully explored in real-world settings, Dr. Blazer said.

She and her colleagues conducted a study to examine disease burden as measured by health services utilization and mortality among younger adults with COPD, and compared the rates with those of older adults with COPD.

The sample for this study included 194,759 adults with COPD aged 35-55 years in Ontario in 2016. COPD was identified from health administrative data for three or more outpatient claims or one or more hospitalization claims for COPD over a 2-year period.

For context, the data were compared with those for 496,2113 COPD patients aged 65 years and older.

They found that, compared with their peers without the disease, younger adults had a 3.1-fold higher rate of hospitalization for any cause, a 2.2-fold higher rate of all-cause ED visits, and a 1.7-fold higher rate of outpatient visits for any cause.

In contrast, the comparative rates for seniors with versus without COPD were 2.1-fold, 1.8-fold, and 1.4-fold, respectively.

As noted before, the mortality rate for younger adults with COPD was 5-fold higher than for those without COPD, compared with 2.5-fold among older adults with COPD versus those without.
 

Earlier diagnosis, follow-up

“A very important talk,” commented session comoderator Valerie Press, MD, MPH, from the University of Chicago. “I know that there’s a lot of work to be done in earlier diagnosis in general, and I think starting with the younger population is a really important area.”

She asked Dr. Blazer about the possibility of asthma codiagnosis or misdiagnosis in the younger patients.

“We use a very specific, validated case definition in the study that our group has used before, and the specificity is over 96% for physician-diagnosed COPD, at the expense of sensitivity, so if anything we probably underestimated the rate of COPD in our study,” Dr. Blazer said.

Audience member Sherry Rogers, MD, an allergist and immunologist in private practice in Syracuse, N.Y., asked whether the investigators could determine what proportion of the excess mortality they saw was attributable to COPD.

“This was looking at all-cause mortality, so we don’t know that it’s necessarily all attributable to COPD per se but perhaps also to COPD-attributable comorbidities,” Dr. Blazer said. “It would be important to piece out the actual causes of mortality that are contributing to that elevated [morality] in that population.”

She added that the next step could include examining rates of specialty referrals and pharmacotherapy to see whether younger patients with COPD are receiving appropriate care, and to ascertain how they are being followed.

The study was supported by the University of Toronto and Sunnybrook Research Institute. Dr. Blazer reported no conflicts of interest to disclose.

Adults in their 30s, 40s and 50s with chronic obstructive pulmonary disease (COPD) experience significant morbidity and excess mortality from the disease, results of a population-based study show.

Among adults aged 35-55 years with COPD in Ontario in a longitudinal population cohort study, the overall mortality rate was fivefold higher, compared with other adults in the same age range without COPD.

In contrast, the mortality rate among adults 65 years and older with COPD was 2.5-fold higher than that of their peers without COPD, reported Alina J. Blazer, MSc, MD, a clinical and research fellow at the University of Toronto.

“Overall, our study has shown that younger adults with COPD experience significant morbidity, as evidence by their elevated rates of health care use and excess mortality from their disease. This study provides further evidence that so-called ‘early’ COPD is not a benign disease, and suggests that we should focus clinical efforts on identifying COPD in younger patients, in the hopes that earlier intervention may improve their current health, reduce resource utilization, and prevent further disease progression,” she said during a minisymposium at the American Thoracic Society’s virtual international conference (Abstract A1131).

COPD is widely regarded as a disease affecting only older adults, but it can also occur in those younger than 65, and although it is commonly assumed that COPD diagnosed earlier in life will be milder in severity, this assumption has not been fully explored in real-world settings, Dr. Blazer said.

She and her colleagues conducted a study to examine disease burden as measured by health services utilization and mortality among younger adults with COPD, and compared the rates with those of older adults with COPD.

The sample for this study included 194,759 adults with COPD aged 35-55 years in Ontario in 2016. COPD was identified from health administrative data for three or more outpatient claims or one or more hospitalization claims for COPD over a 2-year period.

For context, the data were compared with those for 496,2113 COPD patients aged 65 years and older.

They found that, compared with their peers without the disease, younger adults had a 3.1-fold higher rate of hospitalization for any cause, a 2.2-fold higher rate of all-cause ED visits, and a 1.7-fold higher rate of outpatient visits for any cause.

In contrast, the comparative rates for seniors with versus without COPD were 2.1-fold, 1.8-fold, and 1.4-fold, respectively.

As noted before, the mortality rate for younger adults with COPD was 5-fold higher than for those without COPD, compared with 2.5-fold among older adults with COPD versus those without.
 

Earlier diagnosis, follow-up

“A very important talk,” commented session comoderator Valerie Press, MD, MPH, from the University of Chicago. “I know that there’s a lot of work to be done in earlier diagnosis in general, and I think starting with the younger population is a really important area.”

She asked Dr. Blazer about the possibility of asthma codiagnosis or misdiagnosis in the younger patients.

“We use a very specific, validated case definition in the study that our group has used before, and the specificity is over 96% for physician-diagnosed COPD, at the expense of sensitivity, so if anything we probably underestimated the rate of COPD in our study,” Dr. Blazer said.

Audience member Sherry Rogers, MD, an allergist and immunologist in private practice in Syracuse, N.Y., asked whether the investigators could determine what proportion of the excess mortality they saw was attributable to COPD.

“This was looking at all-cause mortality, so we don’t know that it’s necessarily all attributable to COPD per se but perhaps also to COPD-attributable comorbidities,” Dr. Blazer said. “It would be important to piece out the actual causes of mortality that are contributing to that elevated [morality] in that population.”

She added that the next step could include examining rates of specialty referrals and pharmacotherapy to see whether younger patients with COPD are receiving appropriate care, and to ascertain how they are being followed.

The study was supported by the University of Toronto and Sunnybrook Research Institute. Dr. Blazer reported no conflicts of interest to disclose.

Adults in their 30s, 40s and 50s with chronic obstructive pulmonary disease (COPD) experience significant morbidity and excess mortality from the disease, results of a population-based study show.

Among adults aged 35-55 years with COPD in Ontario in a longitudinal population cohort study, the overall mortality rate was fivefold higher, compared with other adults in the same age range without COPD.

In contrast, the mortality rate among adults 65 years and older with COPD was 2.5-fold higher than that of their peers without COPD, reported Alina J. Blazer, MSc, MD, a clinical and research fellow at the University of Toronto.

“Overall, our study has shown that younger adults with COPD experience significant morbidity, as evidence by their elevated rates of health care use and excess mortality from their disease. This study provides further evidence that so-called ‘early’ COPD is not a benign disease, and suggests that we should focus clinical efforts on identifying COPD in younger patients, in the hopes that earlier intervention may improve their current health, reduce resource utilization, and prevent further disease progression,” she said during a minisymposium at the American Thoracic Society’s virtual international conference (Abstract A1131).

COPD is widely regarded as a disease affecting only older adults, but it can also occur in those younger than 65, and although it is commonly assumed that COPD diagnosed earlier in life will be milder in severity, this assumption has not been fully explored in real-world settings, Dr. Blazer said.

She and her colleagues conducted a study to examine disease burden as measured by health services utilization and mortality among younger adults with COPD, and compared the rates with those of older adults with COPD.

The sample for this study included 194,759 adults with COPD aged 35-55 years in Ontario in 2016. COPD was identified from health administrative data for three or more outpatient claims or one or more hospitalization claims for COPD over a 2-year period.

For context, the data were compared with those for 496,2113 COPD patients aged 65 years and older.

They found that, compared with their peers without the disease, younger adults had a 3.1-fold higher rate of hospitalization for any cause, a 2.2-fold higher rate of all-cause ED visits, and a 1.7-fold higher rate of outpatient visits for any cause.

In contrast, the comparative rates for seniors with versus without COPD were 2.1-fold, 1.8-fold, and 1.4-fold, respectively.

As noted before, the mortality rate for younger adults with COPD was 5-fold higher than for those without COPD, compared with 2.5-fold among older adults with COPD versus those without.
 

Earlier diagnosis, follow-up

“A very important talk,” commented session comoderator Valerie Press, MD, MPH, from the University of Chicago. “I know that there’s a lot of work to be done in earlier diagnosis in general, and I think starting with the younger population is a really important area.”

She asked Dr. Blazer about the possibility of asthma codiagnosis or misdiagnosis in the younger patients.

“We use a very specific, validated case definition in the study that our group has used before, and the specificity is over 96% for physician-diagnosed COPD, at the expense of sensitivity, so if anything we probably underestimated the rate of COPD in our study,” Dr. Blazer said.

Audience member Sherry Rogers, MD, an allergist and immunologist in private practice in Syracuse, N.Y., asked whether the investigators could determine what proportion of the excess mortality they saw was attributable to COPD.

“This was looking at all-cause mortality, so we don’t know that it’s necessarily all attributable to COPD per se but perhaps also to COPD-attributable comorbidities,” Dr. Blazer said. “It would be important to piece out the actual causes of mortality that are contributing to that elevated [morality] in that population.”

She added that the next step could include examining rates of specialty referrals and pharmacotherapy to see whether younger patients with COPD are receiving appropriate care, and to ascertain how they are being followed.

The study was supported by the University of Toronto and Sunnybrook Research Institute. Dr. Blazer reported no conflicts of interest to disclose.

The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

The benefits of a triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist combination extend to patients with moderate as well as severe chronic obstructive pulmonary disease (COPD).

That’s according to investigators in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567).

In a subanalysis of data on patients with moderate COPD who were enrolled in the comparison trial, the single-inhaler combination of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol fumarate (BGF) showed benefits in terms of COPD exacerbations, lung function, symptoms, and quality-of-life compared with either of two dual therapy combinations (glycopyrrolate or budesonide with formoterol [GFF/BFF]).

“A moderate benefit:risk ratio was demonstrated in patients with moderate COPD, consistent with the results of the overall ETHOS population, indicating the results of the ETHOS study were not driven by patients with severe or very severe COPD,” wrote Gary T. Ferguson, MD, from the Pulmonary Research Institute of Southeast Michigan in Farmington Hills, and colleagues. Their poster was presented during the American Thoracic Society’s virtual international conference. (Abstract A2244).

As reported at ATS 2020, in the overall ETHOS population of 8,509 patients with moderate to very severe COPD the annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320-mcg and 160-mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol.

Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, Klaus F. Rabe, MD, PhD, of LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues found.
 

Subanalysis details

At the 2021 iteration of ATS, ETHOS investigator Dr. Ferguson and colleagues reported results for 613 patients with moderate COPD assigned to BGF 320 mcg, 604 assigned to BGF 160 mcg, 596 assigned to GFF, and 614 randomized to BFF.

Baseline demographic and clinical characteristics were similar among the groups, including age, sex, smoking status, mean COPD Assessment Test (CAT) score, mean blood eosinophil count, ICS use at screening, exacerbations in the previous year, mean postbronchodilator forced expiratory volume in 1 second (FEV₁) percentage of predicted, and mean postbronchodilator percentage reversibility.

A modified intention-to-treat (ITT) analysis showed that the rate of moderate or severe exacerbations over 52 weeks with BGF 320 mcg was 21% lower than with GFF (P = .0123), but only 4% lower than with BFF, a difference that was not statistically significant.

The BGF 160-mg dose was associated with a 30% reduction in exacerbations vs. GFF (P = .0002), and with a nonsignificant reduction of 15% compared with BFF.

­There was a numerical but not statistically significant improvement from baseline at week 24 in morning pre-dose trough FEV₁ between the BGF 320-mcg dose and GFF (difference 47 mL), and a significant improvement (90 mL) with BGF compared with BFF (P = .0006). The BGF 160-mcg dose was associated with a larger improvement (89 mL) compared with BFF (P = .0004) but not with GFF.

The FEV₁ area under the curve (AUC) of receiver operating characteristics from 0 to 4 hours was superior with BGF at both doses compared with both GFF and BFF.

Patients who used BGF 320 mcg also used significantly less rescue medication over 24 weeks compared with patients who used GFF (P < .0001) or BFF (P = .0001). There were no significant differences in rescue medication use between the BGF 160-mg dose and either of the dual therapy combinations.

Time to clinically important deterioration – defined as a greater than ­100 mL decrease in trough FEV₁, or a ­4 units increase in St. George’s Respiratory Questionnaire total score, or a treatment-emergent moderate/severe COPD exacerbation occurring up to week 52 – was significantly longer with the 320-mcg but not 160-mcg BGF dose compared with GFF (P = .0295) or BFF (P = .0172).
 

Safety

Treatment-emergent adverse events (TEAEs) occurred in about two-thirds of patients in each trial arm, although TEAEs related to study treatment were more common with the two triple-therapy combinations and with BFF than with GFF.

TEAEs leading to study discontinuation occurred in 5.5% of patients on BGF 320 mcg, 4% on BGF 160 mcg, 4.5% on GFF, and 3.2% on BFF.

Confirmed major adverse cardiovascular events occurred in 0.8% and 1.5% in the BGF 320- and 160-mcg groups, respectively, in 1.8% of patients in the GFF arm, and 1.5% in the BFF arm.

Confirmed pneumonia was seen in 2.6% of patients in each BGF arm, 2.2% in the GFF arm, and 3.6% in the BFF arm.
 

Selected population

In a comment, David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, noted that the enrollment criteria for ETHOS tended to skew the population toward patients with severe disease.

In the trial, all patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of FEV₁ to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

“The question was whether they would see the same results in people with more moderate impairment, and the answer in this subanalysis is ‘yes.’ The findings weren’t identical between patients with severe and moderate disease, but there were similarities with what was seen in the overall ETHOS study,” he said.

The ETHOS Trial was supported by Pearl Therapeutics. Dr. Ferguson reported grants, personal fees, and nonfinancial support from AstraZeneca during the conduct of the study; and grants, fees, and nonfinancial support from Pearl and others. Dr. Mannino reports recruitment to an advisory board for AstraZeneca.

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

Sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with chronic obstructive pulmonary disease (COPD) may point to different criteria for diagnosing cardiac comorbidities in women and men, a retrospective analysis suggests.

Among 2,046 patients in the German COSYCONET (COPD and Systemic Consequences–Comorbidities Net) cohort, most functional parameters and comorbidities and several items on the COPD Assessment Test (CAT) differed significantly between men and women.

In addition, there were sex-specific differences in the association between symptoms and cardiac disease, Franziska C. Trudzinski, MD, from the University of Heidelberg (Germany), and colleagues reported.

(Note: Although the authors used the term “gender” to distinguish male from female, this news organization has used the term “sex” in this article to refer to biological attributes of individual patients rather than personal identity.)

“[Sex]-specific differences in COPD comprised not only differences in the level of symptoms, comorbidities, and functional alterations but also differences in their mutual relationships. This was reflected in different sets of predictors for cardiac disease,” they wrote in a thematic poster presented at the American Thoracic Society’s virtual international conference.
 

GOLD standard

The investigators conducted an analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease from the COSYCONET COPD cohort.

They looked at the patients’ clinical history, comorbidities, lung function, CAT scores, and modified Medical Research Council (mMRC) dyspnea score.

The authors used multivariate regression analysis to model potential sex-related differences in the relationship between symptoms in general and CAT items in particular, and the pattern of comorbidities and functional alterations.

They also performed logistic regression analyses to identify predictors for cardiac disease, defined as myocardial infarction, heart failure, or coronary artery disease. The analyses were controlled for age, body mass index (BMI), smoking status, mMRC, CAT items, and z scores of forced expiratory volume in 1 second/forced vital capacity ratio.

The investigators found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough (item 1), phlegm (item 2), and energy (item 8; P < .05 for all comparisons).

In logistic regression analysis, predictors for cardiac disease in men were energy (CAT item 8), mMRC score, smoking status, BMI, age, and spirometric lung function.

In women, however, only age was significantly predictive for cardiac disease.

“Our findings give hints how diagnostic information might be used differently in men and women,” Dr. Trudzinski and colleagues wrote.
 

Reassuring data

David Mannino, MD, medical director of the COPD Foundation, who was not involved in the study, said in an interview that sex differences in COPD presentation and severity are common.

“In general, men and women report symptoms differently. For example, women don’t report a whole lot of chronic bronchitis and phlegm, although they may have it,” he said, “whereas men may report less dyspnea. It varies, but in general we know that men and women, even with the same type of disease, report symptoms differently.”

Comorbidities also differ between the sexes, he noted. Women more frequently have osteoporosis, and men more frequently have heart disease, as borne out in the study. The prevalence of heart disease among patients in the study was approximately 2.5 times higher in men than women.

“It’s reassuring, because what we’re seeing is similar to what we’ve seen in other [studies] with regards to comorbidities,” he said.

The study was sponsored by Philipps University Marburg Medical Center, Germany. The authors and Dr. Mannino have reported no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

Single breath diffusion capacity for carbon monoxide shows greater decline over time in COPD patients compared with controls, but declines significantly more in women compared with men, according to data from 602 adults with a history of smoking.

In previous studies, diffusion capacity for carbon monoxide (DLco) has been associated with decreased exercise capacity and poor health status in patients with COPD, but its association as a measure of disease progression has not been well studied, wrote Ciro Casanova, MD, of Hospital Universitario La Candelaria, Spain, and colleagues.

In a study published in the journal CHEST^®, the researchers identified 506 adult smokers with COPD and 96 adult smoker controls without COPD. Lung function based on single breath DLco was measured each year for 5 years. The study population was part of the COPH History Assessment in SpaiN (CHAIN), an ongoing observational study of adults with COPD. COPD was defined as a history of at least 10 pack-years of smoking and a post-bronchodilator FEV₁/FVC greater than 0.7 after 400 micrograms of albuterol, the researchers said.

During the 5-year period, the average overall annual decline in DLco was 1.34% in COPD patients, compared with .04% in non-COPD controls (P = .004). Among COPD patients, age, body mass index, FEV₁%, and active smoking were not associated with longitudinal change in DLco values, the researchers said.

Notably, women with COPD at baseline had lower baseline DLco values compared with men (11.37%) and a significantly steeper decline in DLco (.89%) compared with men (P = .039). “Being a woman was the only factor that related to the annual rate of change in DLco,” the researchers said.

In a subgroup analysis, the researchers identified 305 COPD patients and 69 non-COPD controls who had at least 3 DLco measurements over the 5-year study period. In this group, 16.4% patients with COPD and 4.3% smokers without COPD showed significant yearly declines in DLco of –4.139% and –4.440%, respectively. Among COPD patients, significantly more women than men showed significant DLco declines (26% vs. 14%, P = .005). No significant differences were observed in mortality or hospitalizations per patient-year for COPD patients with and without DLco decline, the researchers said.

The study findings were limited by several factors including the lack of annual measurements of DLco among some patients, potential variability in the instruments used to measure DLco, and the absence of computerized tomography data for the chest, the researchers noted. However, the results support the value of the test for COPD progression when conducted at 3- to 4-year intervals, given the slow pace of the decline, they said. More research is needed, but “women seem to have a different susceptibility to cigarette smoke in the alveolar or pulmonary vascular domains,” they added.

DLco remains a valuable marker

The study is important because the usual longitudinal decline of diffusion capacity, an important physiological parameter in patients with COPD, was unknown, Juan P. de Torres, MD, of Queen’s University, Kingston, Ont., said in an interview.

“The finding of a different longitudinal decline of DLco in women was a surprise,” said Dr. de Torres, who was a coauthor on the study. “We knew from previous works from our group that COPD has a different clinical and prognostic behavior in women with COPD, but this specific finding is novel and important,” he said.

“These results provide information about the testing frequency (3-4 years) needed to use DLco as a marker of COPD progression in clinical practice,” Dr. de Torres added.

“What is the driving cause of this sex difference is unknown. We speculate that different causes of low DLco in COPD such as degree of emphysema, interstitial lung abnormalities, and pulmonary hypertension, may have a different prevalence and progression in women with COPD,” he said.

Looking ahead, “Large studies including an adequate sample of women with COPD is urgently needed because they will be the main face of COPD in the near future,” said Dr. de Torres. “Sex difference in their physiological characteristics, the reason to explain those differences and how they behave longitudinally is also urgently needed,” he added. 

The study was supported in part by AstraZeneca and by the COPD research program of the Spanish Respiratory Society. The researchers and Dr. de Torres had no financial conflicts to disclose.

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

rfranki@mdedge.com

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

rfranki@mdedge.com

The list of medical comorbidities associated with high risk for severe COVID-19 now includes moderate to severe asthma, diabetes, and substance use disorders, according to the Centers for Disease Control and Prevention.

The CDC’s latest list consists of 17 conditions or groups of related conditions that may increase patients’ risk of developing severe outcomes of COVID-19, the CDC said on a web page intended for the general public.

On a separate page, the CDC defines severe outcomes “as hospitalization, admission to the intensive care unit, intubation or mechanical ventilation, or death.”

Asthma is included in the newly expanded list with other chronic lung diseases such as chronic obstructive pulmonary disease and cystic fibrosis; the list’s heart disease entry covers coronary artery disease, heart failure, cardiomyopathies, and hypertension, the CDC said.

rfranki@mdedge.com

An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.

The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.

“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.

According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.

“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”

The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.

“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”

The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.

“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.

Another common reason is habit.

“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”

The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.

“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
 

Acute bronchitis with COPD exacerbations

Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.

Community-acquired pneumonia

The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.

Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
 

UTIs: Uncomplicated cystitis and pyelonephritis

For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.

This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
 

Cellulitis

MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.

This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
 

Continuing to get the message out

Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.

“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”

Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.

Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.

The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.

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

An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.

The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.

“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.

According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.

“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”

The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.

“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”

The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.

“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.

Another common reason is habit.

“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”

The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.

“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
 

Acute bronchitis with COPD exacerbations

Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.

Community-acquired pneumonia

The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.

Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
 

UTIs: Uncomplicated cystitis and pyelonephritis

For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.

This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
 

Cellulitis

MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.

This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
 

Continuing to get the message out

Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.

“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”

Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.

Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.

The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.

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

An antibiotic course of 5 days is usually just as effective as longer courses but with fewer side effects and decreased overall antibiotic exposure for a number of common bacterial conditions, according to new clinical guidelines published by the American College of Physicians.

The guidelines focus on treatment of uncomplicated cases involving pneumonia, urinary tract infections (UTIs), cellulitis, chronic obstructive pulmonary disease (COPD) exacerbations, and acute bronchitis. The goal of the guidelines is to continue improving antibiotic stewardship given the increasing threat of antibiotic resistance and the adverse effects of antibiotics.

“Any use of antibiotics (including necessary use) has downstream effects outside of treating infection,” Dawn Nolt, MD, MPH, a professor of pediatric infection disease at Oregon Health & Science University, Portland, said in an interview. Dr. Nolt was not involved in developing these guidelines. “Undesirable outcomes include allergic reactions, diarrhea, and antibiotic-resistant bacteria. When we reduce unnecessary antibiotic, we reduce undesirable outcomes,” she said.

According to background information in the paper, 1 in 10 patients receives an antibiotic prescription during visits, yet nearly a third of these (30%) are unnecessary and last too long, especially for sinusitis and bronchitis. Meanwhile, overuse of antibiotics, particularly broad-spectrum ones, leads to resistance and adverse effects in up to 20% of patients.

“Prescribing practices can vary based on the type of provider, the setting where the antibiotic is being prescribed, what geographic area you are looking at, the medical reason for which the antibiotic is being prescribed, the actual germ being targeted, and the type of patient,” Dr. Nolt said. “But this variability can be reduced when prescribing providers are aware and follow best practice standards as through this article.”

The new ACP guidelines are a distillation of recommendations from preexisting infectious disease organizations, Dr. Nolt said, but aimed specifically at those practicing internal medicine.

“We define appropriate antibiotic use as prescribing the right antibiotic at the right dose for the right duration for a specific condition,” Rachael A. Lee, MD, MSPH, of the University of Alabama at Birmingham, and colleagues wrote in the article detailing the new guidelines. “Despite evidence and guidelines supporting shorter durations of antibiotic use, many physicians do not prescribe short-course therapy, frequently defaulting to 10-day courses regardless of the condition.”

The reasons for this default response vary. Though some clinicians prescribe longer courses specifically to prevent antibiotic resistance, no evidence shows that continuing to take antibiotics after symptoms have resolved actually reduces likelihood of resistance, the authors noted.

“In fact, resistance is a documented side effect of prolonged antibiotic use due to natural selection pressure,” they wrote.

Another common reason is habit.

“This was the ‘conventional wisdom’ for so long, just trying to make sure all bacteria causing the infection were completely eradicated, with no stragglers that had been exposed to the antibiotic but were not gone and now could evolve into resistant organisms,” Jacqueline W. Fincher, MD, a primary care physician and president of the ACP, said in an interview. “While antibiotic stewardship has been very important for over a decade, we now have more recent head-to-head studies/data showing that, in these four conditions, shorter courses of treatment are just as efficacious with less side effects and adverse events.”

The researchers reviewed all existing clinical guidelines related to bronchitis with COPD exacerbations, community-acquired pneumonia, UTIs, and cellulitis, as well as any other relevant studies in the literature. Although they did not conduct a formal systematic review, they compiled the guidelines specifically for all internists, family physicians and other clinicians caring for patients with these conditions.

“Although most patients with these infections will be seen in the outpatient setting, these best-practice advice statements also apply to patients who present in the inpatient setting,” the authors wrote. They also note the importance of ensuring the patient has the correct diagnosis and appropriate corresponding antibiotic prescription. “If a patient is not improving with appropriate antibiotics, it is important for the clinician to reassess for other causes of symptoms rather than defaulting to a longer duration of antibiotic therapy,” they wrote, calling a longer course “the exception and not the rule.”
 

Acute bronchitis with COPD exacerbations

Antibiotic treatment for COPD exacerbations and acute uncomplicated bronchitis with signs of a bacterial infection should last no longer than 5 days. The authors define this condition as an acute respiratory infection with a normal chest x-ray, most often caused by a virus. Although patients with bronchitis do not automatically need antibiotics if there’s no evidence of pneumonia, the authors did advise antibiotics in cases involving COPD and a high likelihood of bacterial infection. Clinicians should base their choice of antibiotics on the most common bacterial etiology: Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Ideal candidates for therapy may include aminopenicillin with clavulanic acid, a macrolide, or a tetracycline.

Community-acquired pneumonia

The initial course of antibiotics should be at least 5 days for pneumonia and only extended after considering validated evidence of the patient’s clinical stability, such as resuming normal vital signs, mental activity, and the ability to eat. Multiple randomized, controlled trials have shown no improved benefit from longer courses, though longer courses are linked to increased adverse events and mortality.

Again, antibiotics used should “cover common pathogens, such as S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, and Staphylococcus aureus, and atypical pathogens, such as Legionella species,” the authors wrote. Options include “amoxicillin, doxycycline, or a macrolide for healthy adults or a beta-lactam with a macrolide or a respiratory fluoroquinolone in patients with comorbidities.”
 

UTIs: Uncomplicated cystitis and pyelonephritis

For women’s bacterial cystitis – 75% of which is caused by Escherichia coli – the guidelines recommend nitrofurantoin for 5 days, trimethoprim-sulfamethoxazole for 3 days, or fosfomycin as a single dose. For uncomplicated pyelonephritis in both men and women, clinicians can consider fluoroquinolones for 5-7 days or trimethoprim-sulfamethoxazole for 14 days, depending on antibiotic susceptibility.

This recommendation does not include UTIs in women who are pregnant or UTIs with other functional abnormalities present, such as obstruction. The authors also intentionally left out acute bacterial prostatitis because of its complexity and how long it can take to treat.
 

Cellulitis

MRSA, which has been increasing in prevalence, is a leading cause of skin and soft-tissue infections, such as necrotizing infections, cellulitis, and erysipelas. Unless the patient has penetrating trauma, evidence of MRSA infection elsewhere, injection drug use, nasal colonization of MRSA, or systemic inflammatory response syndrome, the guidelines recommend a 5- to 6-day course of cephalosporin, penicillin, or clindamycin, extended only if the infection has not improved in 5 days. Further research can narrow down the most appropriate treatment course.

This guidance does not apply to purulent cellulitis, such as conditions with abscesses, furuncles, or carbuncles that typically require incision and drainage.
 

Continuing to get the message out

Dr. Fincher emphasized the importance of continuing to disseminate messaging for clinicians about reducing unnecessary antibiotic use.

“In medicine we are constantly bombarded with new information. It is those patients and disease states that we see and treat every day that are especially important for us as physicians and other clinicians to keep our skills and knowledge base up to date when it comes to use of antibiotics,” Dr. Fincher said in an interview. “We just need to continue to educate and push out the data, guidelines, and recommendations.”

Dr. Nolt added that it’s important to emphasize how to translate these national recommendations into local practices since local guidance can also raise awareness and encourage local compliance.

Other strategies for reducing overuse of antibiotics “include restriction on antibiotics available at health care systems (formulary restriction), not allowing use of antibiotics unless there is discussion about the patient’s case (preauthorization), and reviewing cases of patients on antibiotics and advising on next steps (prospective audit and feedback),” she said.

The research was funded by the ACP. Dr. Lee has received personal fees from this news organization and Prime Education. Dr. Fincher owns stock in Johnson & Johnson and Procter and Gamble. Dr. Nolt and the article’s coauthors disclosed no relevant financial relationships.

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

Patients with COPD may benefit from stepped-up treatment of short-term disease progression with triple therapy to stave off longer-term exacerbations and all-cause mortality.

©moodboard/thinkstockphotos.com

Clinically important deterioration was a significant predictor of worsening disease and all-cause mortality in chronic obstructive pulmonary disease, a study based on data from more than 10,000 patients has shown.

For this study, clinically important deterioration (CID) as a measure of COPD is defined as a combination of change in lung function and/or health status, or a first acute moderate to severe COPD exacerbation, wrote MeiLan K. Han, MD, of the University of Michigan, Ann Arbor, and colleagues.

The study was published in ERJ Open Research The investigators analyzed data from the IMPACT trial, a phase III, double-blind, multicenter, 52-week study of symptomatic COPD patients aged 40 years and older.

In the intent-to-treat population, patients with symptomatic COPD and at least one moderate or severe exacerbation in the past year were randomized to a once-daily dose of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg (4,151 patients); FF/VI 100/25 mcg (4,134 patients); or UMEC/VI 62.5/25 mcg using a single dry-power inhaler (2,070 patients).

The researchers explored both the prognostic value of a CID event on future clinical outcomes and the impact of single-inhaler triple versus dual therapy on reducing CID risk. CID was defined as any of the following: moderate/severe exacerbation; deterioration in lung function (defined as a decrease of 100 mL or more from baseline in trough forced expiratory volume per second); or deterioration in health status based on increases of 4.0 units or more on the St George’s Respiratory Questionnaire (SGRQ) total score or 2.0 units or more on the COPD Assessment Test (CAT) score.

Overall, patients with a CID by 28 weeks had significantly increased exacerbation rates after week 28, as well as smaller improvements in lung function and health status at week 52 (P < .001 for all). In addition, CID patients had an increased risk of all-cause mortality after 28 weeks, compared with patients without CID. However, FF/UMEC/VI significantly reduced CID risk, compared with dual therapies, the researchers noted.

Based on the CID SGRQ definition, patients with CID had a 75% increase in moderate to severe exacerbations by week 28 and a 96% in severe exacerbations over weeks 29-52. The increases were similar using the CID CAT definition (72% and 91%, respectively).

Patients with CID also showed significantly reduced improvements in both lung function and health status after 1 year, and a significantly increased risk of all-cause mortality compared to patients without CID.

In comparing triple vs. double therapies, FF/UMEC/VI patients showed significant reductions in CID risk by 52 weeks, compared with patients treated with FF/VI and UMEC/VI. This difference was true across all subgroups, except for the subgroup of patients who were on long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) therapy prior to screening, the researchers said.

In addition, “treatment effect was greater at higher blood eosinophil counts for FF/UMEC/VI versus UMEC/VI,” the researchers noted.

The study findings were limited by several factors including the lack of CID as a primary endpoint, the relatively short 5-month follow-up period, and the use of a symptomatic patient population with an established risk of exacerbation, which could limit generalizability, the researchers noted. However, the findings support the value of preventing short-term CID and adding inhaled corticosteroids (ICS) or bronchodilation for patients in this study population, they said.
 

Data may help drive tailored treatments

“This study is a post hoc analysis of data from the IMPACT trial, an RCT examining triple therapy vs ICS/LABA vs LABA/LAMA,” Dr. Han, lead and corresponding author, said in an interview. “In this particular paper, we conducted a treatment independent analysis examining individuals who experienced clinically important deteriorations at week 28 and then compared outcomes at week 52 based on CID status at week 28. Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52, and increased risk of all-cause mortality after week 28 versus patients who were CID free,” she emphasized. “We also saw that FF/UMEC/VI significantly reduced CID risk versus dual therapies.” These data suggest that shorter-term changes are associated with longer term outcomes, and provide important information both for the purposes of clinical trials design as well as patient clinical assessments, she added.

Dr. Han said she was not surprised by the findings. “I think these results are consistent with prior analyses but suggest that short-term outcomes relate to longer-term ones,” she said. However, she stressed the need for individualized treatment.

“While there are relationships between symptoms, lung function, and exacerbations as demonstrated by these analyses, in any individual patient sometimes these three disease axes do not perfectly align,” she explained. Dr. Han’s main message for clinicians in practice is that optimization of triple therapy in patients with severe disease and high risk for exacerbations was associated not only with short-term improvements in symptoms and lung function, but also with longer-term reductions in exacerbations and mortality.

As for additional research, prospective studies using CID as a primary or secondary outcome would help validate the composite outcome in this study, as regulatory agencies have been slow to adopt composite outcomes, Dr. Han said.

Dr. Han disclosed relationships with GlaxoSmithKline, which funded the study, as well as AstraZeneca, Boehringer Ingelheim, Novartis, Sunovion, Mylan, Merck, and Verona.

Patients with COPD may benefit from stepped-up treatment of short-term disease progression with triple therapy to stave off longer-term exacerbations and all-cause mortality.

©moodboard/thinkstockphotos.com

Clinically important deterioration was a significant predictor of worsening disease and all-cause mortality in chronic obstructive pulmonary disease, a study based on data from more than 10,000 patients has shown.

For this study, clinically important deterioration (CID) as a measure of COPD is defined as a combination of change in lung function and/or health status, or a first acute moderate to severe COPD exacerbation, wrote MeiLan K. Han, MD, of the University of Michigan, Ann Arbor, and colleagues.

The study was published in ERJ Open Research The investigators analyzed data from the IMPACT trial, a phase III, double-blind, multicenter, 52-week study of symptomatic COPD patients aged 40 years and older.

In the intent-to-treat population, patients with symptomatic COPD and at least one moderate or severe exacerbation in the past year were randomized to a once-daily dose of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg (4,151 patients); FF/VI 100/25 mcg (4,134 patients); or UMEC/VI 62.5/25 mcg using a single dry-power inhaler (2,070 patients).

The researchers explored both the prognostic value of a CID event on future clinical outcomes and the impact of single-inhaler triple versus dual therapy on reducing CID risk. CID was defined as any of the following: moderate/severe exacerbation; deterioration in lung function (defined as a decrease of 100 mL or more from baseline in trough forced expiratory volume per second); or deterioration in health status based on increases of 4.0 units or more on the St George’s Respiratory Questionnaire (SGRQ) total score or 2.0 units or more on the COPD Assessment Test (CAT) score.

Overall, patients with a CID by 28 weeks had significantly increased exacerbation rates after week 28, as well as smaller improvements in lung function and health status at week 52 (P < .001 for all). In addition, CID patients had an increased risk of all-cause mortality after 28 weeks, compared with patients without CID. However, FF/UMEC/VI significantly reduced CID risk, compared with dual therapies, the researchers noted.

Based on the CID SGRQ definition, patients with CID had a 75% increase in moderate to severe exacerbations by week 28 and a 96% in severe exacerbations over weeks 29-52. The increases were similar using the CID CAT definition (72% and 91%, respectively).

Patients with CID also showed significantly reduced improvements in both lung function and health status after 1 year, and a significantly increased risk of all-cause mortality compared to patients without CID.

In comparing triple vs. double therapies, FF/UMEC/VI patients showed significant reductions in CID risk by 52 weeks, compared with patients treated with FF/VI and UMEC/VI. This difference was true across all subgroups, except for the subgroup of patients who were on long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) therapy prior to screening, the researchers said.

In addition, “treatment effect was greater at higher blood eosinophil counts for FF/UMEC/VI versus UMEC/VI,” the researchers noted.

The study findings were limited by several factors including the lack of CID as a primary endpoint, the relatively short 5-month follow-up period, and the use of a symptomatic patient population with an established risk of exacerbation, which could limit generalizability, the researchers noted. However, the findings support the value of preventing short-term CID and adding inhaled corticosteroids (ICS) or bronchodilation for patients in this study population, they said.
 

Data may help drive tailored treatments

“This study is a post hoc analysis of data from the IMPACT trial, an RCT examining triple therapy vs ICS/LABA vs LABA/LAMA,” Dr. Han, lead and corresponding author, said in an interview. “In this particular paper, we conducted a treatment independent analysis examining individuals who experienced clinically important deteriorations at week 28 and then compared outcomes at week 52 based on CID status at week 28. Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52, and increased risk of all-cause mortality after week 28 versus patients who were CID free,” she emphasized. “We also saw that FF/UMEC/VI significantly reduced CID risk versus dual therapies.” These data suggest that shorter-term changes are associated with longer term outcomes, and provide important information both for the purposes of clinical trials design as well as patient clinical assessments, she added.

Dr. Han said she was not surprised by the findings. “I think these results are consistent with prior analyses but suggest that short-term outcomes relate to longer-term ones,” she said. However, she stressed the need for individualized treatment.

“While there are relationships between symptoms, lung function, and exacerbations as demonstrated by these analyses, in any individual patient sometimes these three disease axes do not perfectly align,” she explained. Dr. Han’s main message for clinicians in practice is that optimization of triple therapy in patients with severe disease and high risk for exacerbations was associated not only with short-term improvements in symptoms and lung function, but also with longer-term reductions in exacerbations and mortality.

As for additional research, prospective studies using CID as a primary or secondary outcome would help validate the composite outcome in this study, as regulatory agencies have been slow to adopt composite outcomes, Dr. Han said.

Dr. Han disclosed relationships with GlaxoSmithKline, which funded the study, as well as AstraZeneca, Boehringer Ingelheim, Novartis, Sunovion, Mylan, Merck, and Verona.

Patients with COPD may benefit from stepped-up treatment of short-term disease progression with triple therapy to stave off longer-term exacerbations and all-cause mortality.

©moodboard/thinkstockphotos.com

Clinically important deterioration was a significant predictor of worsening disease and all-cause mortality in chronic obstructive pulmonary disease, a study based on data from more than 10,000 patients has shown.

For this study, clinically important deterioration (CID) as a measure of COPD is defined as a combination of change in lung function and/or health status, or a first acute moderate to severe COPD exacerbation, wrote MeiLan K. Han, MD, of the University of Michigan, Ann Arbor, and colleagues.

The study was published in ERJ Open Research The investigators analyzed data from the IMPACT trial, a phase III, double-blind, multicenter, 52-week study of symptomatic COPD patients aged 40 years and older.

In the intent-to-treat population, patients with symptomatic COPD and at least one moderate or severe exacerbation in the past year were randomized to a once-daily dose of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg (4,151 patients); FF/VI 100/25 mcg (4,134 patients); or UMEC/VI 62.5/25 mcg using a single dry-power inhaler (2,070 patients).

The researchers explored both the prognostic value of a CID event on future clinical outcomes and the impact of single-inhaler triple versus dual therapy on reducing CID risk. CID was defined as any of the following: moderate/severe exacerbation; deterioration in lung function (defined as a decrease of 100 mL or more from baseline in trough forced expiratory volume per second); or deterioration in health status based on increases of 4.0 units or more on the St George’s Respiratory Questionnaire (SGRQ) total score or 2.0 units or more on the COPD Assessment Test (CAT) score.

Overall, patients with a CID by 28 weeks had significantly increased exacerbation rates after week 28, as well as smaller improvements in lung function and health status at week 52 (P < .001 for all). In addition, CID patients had an increased risk of all-cause mortality after 28 weeks, compared with patients without CID. However, FF/UMEC/VI significantly reduced CID risk, compared with dual therapies, the researchers noted.

Based on the CID SGRQ definition, patients with CID had a 75% increase in moderate to severe exacerbations by week 28 and a 96% in severe exacerbations over weeks 29-52. The increases were similar using the CID CAT definition (72% and 91%, respectively).

Patients with CID also showed significantly reduced improvements in both lung function and health status after 1 year, and a significantly increased risk of all-cause mortality compared to patients without CID.

In comparing triple vs. double therapies, FF/UMEC/VI patients showed significant reductions in CID risk by 52 weeks, compared with patients treated with FF/VI and UMEC/VI. This difference was true across all subgroups, except for the subgroup of patients who were on long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) therapy prior to screening, the researchers said.

In addition, “treatment effect was greater at higher blood eosinophil counts for FF/UMEC/VI versus UMEC/VI,” the researchers noted.

The study findings were limited by several factors including the lack of CID as a primary endpoint, the relatively short 5-month follow-up period, and the use of a symptomatic patient population with an established risk of exacerbation, which could limit generalizability, the researchers noted. However, the findings support the value of preventing short-term CID and adding inhaled corticosteroids (ICS) or bronchodilation for patients in this study population, they said.
 

Data may help drive tailored treatments

“This study is a post hoc analysis of data from the IMPACT trial, an RCT examining triple therapy vs ICS/LABA vs LABA/LAMA,” Dr. Han, lead and corresponding author, said in an interview. “In this particular paper, we conducted a treatment independent analysis examining individuals who experienced clinically important deteriorations at week 28 and then compared outcomes at week 52 based on CID status at week 28. Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52, and increased risk of all-cause mortality after week 28 versus patients who were CID free,” she emphasized. “We also saw that FF/UMEC/VI significantly reduced CID risk versus dual therapies.” These data suggest that shorter-term changes are associated with longer term outcomes, and provide important information both for the purposes of clinical trials design as well as patient clinical assessments, she added.

Dr. Han said she was not surprised by the findings. “I think these results are consistent with prior analyses but suggest that short-term outcomes relate to longer-term ones,” she said. However, she stressed the need for individualized treatment.

“While there are relationships between symptoms, lung function, and exacerbations as demonstrated by these analyses, in any individual patient sometimes these three disease axes do not perfectly align,” she explained. Dr. Han’s main message for clinicians in practice is that optimization of triple therapy in patients with severe disease and high risk for exacerbations was associated not only with short-term improvements in symptoms and lung function, but also with longer-term reductions in exacerbations and mortality.

As for additional research, prospective studies using CID as a primary or secondary outcome would help validate the composite outcome in this study, as regulatory agencies have been slow to adopt composite outcomes, Dr. Han said.

Dr. Han disclosed relationships with GlaxoSmithKline, which funded the study, as well as AstraZeneca, Boehringer Ingelheim, Novartis, Sunovion, Mylan, Merck, and Verona.