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There was no significant difference in cardiovascular events or major bleeding between patients with established atherosclerotic cardiovascular disease (ASCVD) assigned to a daily aspirin dose of 81 mg and those assigned 325 mg in the open-label, pragmatic ADAPTABLE trial.

The results were presented at the American College of Cardiology’s 70th Annual Scientific Session and simultaneously published online in 

“There really hasn’t been a clear answer about what is the most effective and safe dose of aspirin for these patients,” said lead author William Schuyler Jones, MD, associate professor of medicine, Duke University Medical Center, Durham, North Carolina, in a 

“Instead, there have been conflicting findings, with some research suggesting 81 mg may reduce the risk of bleeding, but the higher dose may provide more effective prevention of heart attacks and stroke. However, these earlier studies have primarily investigated aspirin—either 81 or 325 mg daily dose—compared with placebo, whereas ADAPTABLE was a direct comparison of the two doses.”

To determine the optimal dose of aspirin in patients with ASCVD, Jones and colleagues randomly assigned 15 076 participants with existing ASCVD from 40 centers in the US to receive 81 mg or 325 mg of daily aspirin.

“We found that there is no difference between the two doses in terms of effectiveness and safety, and we think that because the 81 mg dose had better long-term adherence, it may be the best choice for patients."

Researchers collected information about patients’ medical histories and clinical events during the study through electronic medical records and insurance documentation. Participants were enrolled from April 2016 to June 2019, and median follow-up was 26.2 months.

The primary effectiveness endpoint was a composite of all-cause mortality, hospitalization for myocardial infarction (MI), or hospitalization for stroke. The primary safety endpoint was hospitalization for major bleeding with an associated blood product transfusion.

Before randomization, most participants (96%) were already taking aspirin and 85.3% of these patients were previously taking 81 mg of daily aspirin.

Mortality, hospitalization for MI, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.91-1.14).

Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (HR, 1.18; 95% CI, 0.79-1.77).

“We found that there is no difference between the two doses in terms of effectiveness and safety, and we think that because the 81 mg dose had better long-term adherence, it may be the best choice for patients,” said Jones in the press release.

Patients who received 325 mg of aspirin had a higher incidence of dose switching compared to those who received 81 mg (41.6% vs 7.1%), as well as fewer median days of exposure to the assigned dose (434 days vs 650 days).

“Daily aspirin is an essential part of treatment for most people with heart disease. Patients and clinicians should use the information from the study to have a conversation about the dose of aspirin they prefer,” concluded Jones.

Articles

ACC.21: There was no difference found between high- and low-dose aspirin in terms of effectiveness and safety in patients with established CVD, according to new research. 

ACC.21: High- and Low-Dose Aspirin Both Effective for Patients with Established Cardiovascular Disease

Black patients from disadvantaged neighborhoods were significantly more likely to die within 5 years after a myocardial infarction (MI) than Black patients from wealthier neighborhoods and white patients from any socioeconomic background who survive an MI, report authors of a study being presented at the American College of Cardiology’s 70th Annual Scientific Session.

The study, led by Jesse Goitia, MD, a cardiovascular fellow at Kaiser Permanente Los Angeles Medical Center revealed that Black patients from disadvantaged neighborhoods were 19% more likely to die than white patients from well-resourced neighborhoods and 14% more likely to die than white patients from disadvantaged neighborhoods.

“A key takeaway from our study is that there are a lot of social and environmental factors that can affect a person’s outcome after a heart attack,” said Goitia, MD, 

. “I think that a broad, overarching approach to start addressing those factors at the neighborhood level would pay dividends for businesses, health insurers, providers and patients.”

The source of data for the study was the Kaiser Permanente Southern California hospital system where investigators analyzed records from 31 747 patients with health insurance who were treated for an MI between 2006-2016.

Patients were each assigned a neighborhood disadvantage score calculated using the Area Deprivation Index (ADI)--a validated index based on 17 socioeconomic variables that determine the level of disadvantage in a given area based on address. Based on score, patients were divided into 2 groups:

neighborhood: neighborhood national ranking between 1st - 25th percentile

neighborhood group: ranking between 26th - 100th percentile

ADI scoring placed 62.7% (19 904 patients) in the well-resourced neighborhood group and 37.3% (11 843 patients) in the disadvantaged neighborhood group.

Based on an average follow up of 5 years and after multivariable adjustment for age, sex, race/ethnicity, comorbidities, and medications, living in a disadvantaged neighborhood was independently associated with increased all-cause mortality after MI (hazard ratio [HR] 1.05; 95% confidence interval [CI] 1.01-1.08; p = 0.016).

Black patients from disadvantaged neighborhoods had the worst mortality of all racial/ethnic groups compared to White patients from well-resourced neighborhoods (HR 1.19; 95% CI 1.11-1.28; p<.001) as well as White patients from disadvantaged neighborhoods (HR 1.14; 95% CI 1.06-1.23; p<.001).

Outcomes among Black patients from well-resourced neighborhoods were similar to those of White patients from comparable neighborhoods.

Goita said the results have implications for addressing social determinants of health and, equally important, to help inform clinical care for patients at the individual level. “Recognizing where a patient is coming from can help providers think more about their approach to follow-up care and how to best arrange that.”

He offered the example of a patient who is having trouble arranging transportation to a clinic--for that person, he said, more frequent check-ins by phone, when feasible, might be preferable to in-person clinic visits when feasible.

Goita noted that the trends he and colleagues observed in their study would probably be similar or possibly more pronounced in other parts of the country, particularly in areas where access to health insurance varies by neighborhood.

The authors conclude by calling for further research into neighborhood disadvantage to address racial disparities and improve mortality after MI.

Dr Goitia will virtually present the study, “

Racial differences in the effects of neighborhood disadvantage on long term survival after acute myocardial infarction,"

ACC.21: Black patients from disadvantaged neighborhoods were found almost 20%  more likely to die within 5 years of MI than white patients from well-resourced ones in a new study. 

ACC.21: Survival After MI Far Worse for Black Patients from Disadvantaged Neighborhoods  

In a new analysis to be presented at the upcoming American Thoracic Society International Conference, being held virtually May 14-19, 2021, tezepelumab treatment was found to be beneficial in patients with severe, uncontrolled asthma requiring maintenance oral corticosteroids (mOCS).

“In adults and adolescents with severe, uncontrolled asthma requiring mOCS, additional treatment with tezepelumab resulted in a numerically lower rate of exacerbations, and clinically meaningful improvements in lung function, quality of life and asthma symptoms versus placebo,” authors stated in the abstract. 

Researchers aimed to assess the efficacy of tezepelumab—a potential first-in-class human monoclonal antibody that blocks thymic stromal lymphopoietin—in a subgroup of patients from the pivotal phase 3 

NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study of 1061 patients aged 12-80 years with severe, uncontrolled asthma receiving medium- or high-dose inhaled corticosteroids with ≥1 additional controller medication with or without mOCS. Participants were randomized 1:1 to receive tezepelumab 210 mg subcutaneously or placebo every 4 weeks for 52 weeks.

In the current analysis, researchers examined 100 participants who were receiving mOCS (tezepelumab, n=49; placebo, n=51) at baseline and throughout the study period. The primary endpoint was annualized asthma exacerbation rate (AAER) over 52 weeks.

The secondary endpoints included pre-bronchodilator forced expiratory volume in 1 second (FEV1) and Asthma Control Questionnaire-6 (ACQ-6), Asthma Quality of Life Questionnaire (AQLQ), and Asthma Symptom Diary (ASD) scores.

The results showed that patients who received tezepelumab had a numerically lower AAER than those who received placebo (2.12 vs 2.94, 28% reduction). Compared with placebo, tezepelumab improved pre-bronchodilator FEV1 as well as ACQ-6, AQLQ, and ASD scores.

“These findings support the benefits of tezepelumab in patients with severe, OCS-dependent asthma,” authors concluded.

Effect of tezepelumab in oral corticosteroid-dependent patients with severe asthma: Results from the phase 3 NAVIGATOR study

, also appears in the Online Abstracts issue of the 

American Journal of Respiratory and Critical Care Medicine.

ATS 2021: In a subgroup of oral corticosteroid-dependent patients with severe asthma from the newly released NAVIGATOR study, tezepelumab reduced exacerbations and improved lung function.

ATS 2021: Tezepelumab Reduces Exacerbations in Oral Corticosteroid-dependent Patients with Severe Asthma

Among adults with asthma reporting the impact of COVID-19-related stress, more than half experienced an asthma exacerbation since the pandemic began and just under half reported uncontrolled asthma, according to a new study.

Authors of the study, presented at the American Thoracic Society International Conference, held virtually May 14-19, 2021, say the significant dose-response relationship they observed should prompt health care professionals to assess patients with asthma for potential emotional distress and to provide mental health care or referrals. 

Here are the study details, at-a-glance.  

COVID-19-related stress and uncontrolled asthma among adults

also appears in the Online Abstracts issue of the

ATS.2021: Odds of uncontrolled asthma in response to pandemic-related stress increased in a significant dose-response manner among adult respondents to a new survey. 

ATS.2021: Study Finds Odds of Uncontrolled Asthma Increase with Higher Pandemic-related Stress

A study to be presented this weekend at the virtual American College of Cardiology’s 70th Scientific Sessions (ACC.21) underscores the underappreciated threat of prediabetes to cardiovascular health.

Specifically, analysis of data from a large health system database found the presence of prediabetes nearly doubled the risk for major adverse cardiovascular events (MACE) vs normoglycemia.

Prediabetes has generally been considered “no big deal,” said Adrian Michel, MD, internal medicine resident at Beaumont Hospital-Royal Oak, in Michigan, 

 "But we found that prediabetes itself can significantly boost someone's chance of having a major cardiovascular event, even if they never progress to having diabetes" 

Michel added that the focus on prevention needs to start earlier. "Instead of preventing diabetes, we need to shift focus and prevent prediabetes."

The role of prediabetes as a risk factor for CV morbidity and mortality is far less clear than that for frank type 2 diabetes (T2D). Yet, the Centers for Disease Control and Prevention estimates that 1 in 3 Americans have prediabetes compared with 1 in 10 who have diabetes, according to the statement from from the American College of Cardiology.

To investigate the potential connection, Michel and a team of colleagues from Beaumont Health conducted a single-center retrospective chart review, collecting data from 25 829 patients treated within the Beaumont Health System between 2006 and 2020.

Based on 2 A1c levels obtained at least 5 years apart, patients were divided into a group with prediabetes sustained through the study period (n=12 691) and a control group in which normoglycemia was maintained during the study (n=13 138). For study purposes, prediabetes was defined as A1c between 5.7-6.4%.

The strongest relationship between prediabetes and MACE was seen in men, Blacks, and those with personal risk factors for or a family history of CVD.
The highest rates of CV events among all participants were among those with overweight and were higher even than among those with obesity--a finding worth further study, said Michel.

Participant age ranged from 18 to 104 years. All patients were followed for the 14-year study period. ICD codes were used to identify occurrences of MACE and investigators used Chi-Square analysis to compare event rates between groups.

Analysis found that MACE occurred among 18% of patients in the prediabetes group and 11% in patients in the control group over a median of 5 years follow-up. Comparison of the groups using Chi-Square analysis found that prediabetes was associated with nearly twice the risk of experiencing a major adverse cardiovascular event (17.07; 95% CI, 17.3-18.63 vs 11.01; 95% CI, 10.48-11.55; 

These results, according to the authors’ statement, remained significant even after adjustment for factors including age, gender, BMI, blood pressure, cholesterol, sleep apnea, smoking status, and peripheral artery disease.

Of significant concern was the finding that risk of having a CV event was still elevated among patients with prediabetes even after A1c was lowered to a normal range. Events occurred in just over 10.5% of these patients compared with 6% of those with no diabetes or prediabetes.

"As clinicians, we need to spend more time educating our patients about the risk of elevated blood sugar levels and what it means for their heart health and consider starting medication much earlier or more aggressively, and advising on risk factor modification, including advice on exercise and adopting a healthy diet,” Michel said.

“Prediabetes associated with an increase in major adverse cardiovascular events”

 will be presented virtually by Adrian Michele, MD, at ACC.2021 on Sunday, May 16, at 2:30 pm ET.

ACC.21: Findings from a study released in advance of the ACC annual meeting suggest that prediabetes confers nearly twice the risk of major cardiovascular events vs normoglycemia.  

ACC.21: Prediabetes Significantly Increases Risk for MACE, According to New Findings 

Patients with late-onset asthma and elevations in common biomarkers of inflammation may be at greatest risk for exacerbation-prone asthma while those with early-onset disease and similar biomarker elevations have the poorest lung function, according to results of a new study being presented at the upcoming American Thoracic Society International Conference, being held virtually May 14-19, 2021.

Type-2 inflammation has emerged as an important element in asthma phenotyping and research supports differences by age at onset as another. Plasma Il-6 level is a strong predictor of both asthma exacerbations and poorer lung function. Only partially understood, however, is the intersection of IL-6 with type-2 inflammation which the authors hypothesized would identify a high-risk asthma phenotype when found in a patient with late-onset disease.

Using data from the NHLBI's Severe Asthma Research Program 3, investigators identified 370 patients with baseline plasma IL-6 levels. Early- and late-onset asthma were defined as onset at age ≤12 or >12 years.

Participants were categorized by baseline elevations in 2 standard biomarkers of T2 inflammation: absolute blood eosinophils ≥300 cells/uL and/or FeNO>24 ppb and by IL-6 concentration (defined by median split [</> 1.77 pg/mL]).

Groups were identified as early- vs Iate-onset, T2 Lo, T2 Intermediate or T2 Hi (0, 1 or 2 T2 biomarker elevations), and each of these groups further defined by IL-6 Hi vs IL-6 Lo.

Exacerbations were defined as a corticosteroid burst of ≥3 days, an ED visit, or hospitalization.

Twelve asthma phenotypes were identified, 

ranging in size from 13 to 44 participants. IL-6 levels did not vary by IL-6 Hi subgroup.

older patients more likely to be late-onset and IL-6-Hi

e: Asians more likely to be late-onset, T2-Hi, IL-6-Lo)

 among late-onset T2 Hi/IL-6 Hi patients than in 9 of the 11 other subgroups (except early-onset T2-Hi/IL-6 Hi [p=0.14] and late-onset T2 Hi/IL-6 Lo [p=0.1]).

n contrast, FEV1% predicted was generally lower

 in the 6 IL-6 Hi groups, but lowest in the group of early-onset T2 Hi/IL-6 Hi.

 in the 4 T2 Hi groups but tended to be lower in T2-Hi/IL-6 Hi vs the IL-6 Lo groups.

, with higher T2 and IL-6 Hi groups, despite their older age. In contrast, 

 in early-onset asthma with no apparent impact by IL-6 and minimally by T2 phenotype.

The authors note that stratifying asthma patients using “4 simple metrics” identifies distinct asthma phenotypes that may benefit from different approaches to treatment such as strengthened prevention efforts in phenotypes at higher risk of dangerous exacerbations (late onset, elevated inflammatory biomarkers) and a focus on medication adjustment and adherence monitoring in those with poor lung function (early onset, elevated  biomarkers.)

Age at onset, available T2 biomarkers and IL-6 levels jointly define at-risk asthma phenotypes

ATS.2021. Study authors categorized asthma patients using age at onset, T2 biomarkers, and IL-6 levels, creating 12 phenotypes for additional study. 
 

ATS.2021: At-risk Asthma Phenotypes Defined Using 4 Simple Metrics 

"Targeting factors associated with exacerbations...may improve patient survival and reduce burden of these events on society and health plans." 

The risk of morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) may increase among those with moderate exacerbation, and even more so for severe exacerbation, suggests new research being presented at the upcoming American Thoracic Society International Conference, held May 14-19, 2021.

Researchers performed a modeling activity to estimate the risk for mortality and severe COPD exacerbation events over 5 years using data from a real-world observational study of patients with COPD (HERA-II) and applying corresponding death rates from the ETHOS trial.

The HERA-II study examined exacerbations and health care utilization in 1.55 million patients with COPD using commercial, state, and federal insurance databases.

, whose primary endpoint was annual rate of moderate or severe COPD exacerbations, demonstrated the safety and efficacy of triple combination therapy with budesonide, glycopyrrolate, and formoterol fumarate vs glycopyrrolate/formoterol fumarate and budesonide/formoterol fumarate.

In the current analysis, investigators used data from HERA-II to estimate exacerbation transition 

matrices over a 5-year study period for 4 categories:

A. No exacerbation
B. 1 moderate exacerbation
C. ≥2 moderate exacerbations, but no severe exacerbation
D. ≥1 severe exacerbation

The results showed that the 5-year mortality risk was highest for patient category D (42.6%), followed by category C (18.1%), category B (15.2%), and category A (9.9%). The risk of severe exacerbation and/or death (composite endpoint) for each category was projected to be 29.3%, 49.0%, 57.3%, and 77.0% at 5 years, respectively.

Researchers also found that compared to category A, the unadjusted mean relative risks of death for categories B-D were 1.53, 1.82, and 4.30; unadjusted mean relative risks for the composite endpoint were 1.68, 1.96, and 2.63, respectively.

“Our models suggest that risk of mortality and morbidity in COPD patients is projected to increase among those with even one moderate exacerbation; more so for patients with ≥1 severe exacerbation,” concluded authors. “Targeting factors associated with exacerbations, such as comorbidities and suboptimal maintenance treatment, may improve patient survival and reduce burden of these events on society and health plans.”

Prediction of 5 year severe exacerbation and mortality risk by baseline exacerbation status in the US-application of the ETHOS trial to a real-world analysis of COPD patients

ATS 2021: The risk of morbidity and death in patients with COPD increases among those with moderate exacerbation, and even more so for severe exacerbation, new research suggests.

ATS 2021: Severe COPD Exacerbations May be Associated with Increased Mortality Risk

 being presented at the upcoming American Thoracic Society International Conference, to be held virtually May 14-19, 2021, researchers estimate that by 2050 the US will lead the Americas in number of patients with chronic obstructive pulmonary disease (COPD) and prevalence of COPD.

The prevalence of COPD “in the Americas is expected to be on the rise, since important risk factors such as air pollution, vaping, and smoking are increasing in certain regions,” wrote authors. “We sought to estimate the prevalence of COPD in the year 2050 based on current values for these risk factors, recognizing major population growth and aging in the Americas during this time.”

Using publicly available data, researchers used a time-in-state model to generate an estimated count of patients aged ≥25 years with COPD by country, age, sex, and year strata from 2020 to 2050.

Researchers assumed the change in the number of patients with COPD over time was, “a function of the aging of the population and projected population growth,” but assumed no change in COPD risk factors during the study period.

Thirty-six countries in the Americas where COPD data were available were included in the analysis.

The investigators project that there will be more than 65 million persons living with COPD in 2050, which reflects a prevalence of 7.8%of the population aged ≥25 years. From 2020 to 2050, they predict a 75.6% increase in the number of patients with COPD in the Americas, based on aging and population growth.

The authors estimate that by 2050, the US will have the highest projected number of patients with COPD (31.3 million), followed by Brazil (12.3 million), Mexico (5.7 million), Canada (3.3 million), and Colombia (2.9 million).

The US also will have the highest projected prevalence of COPD in 2050 (11.6%), followed by Canada (9.7%), Uruguay (8.9%), Cuba (8.4%), and Puerto Rico (8%).

“We view our estimates as conservative, as we anticipate worsening of COPD risk factors, particularly in developing countries included in the analysis,” authors concluded. “Efforts to address the anticipated rise in burden will require coordinated efforts with advocacy, prevention, screening, diagnosis, and treatment.”

An estimate of the Americas’ prevalence of chronic obstructive pulmonary disease in 2050

, also appears in the Online Abstracts issue of the

 American Journal of Respiratory and Critical Care Medicine.

In an abstract being presenting at the upcoming ATS 2021 International Conference, researchers estimate that by 2050 the US will lead the Americas in prevalence of COPD.

ATS 2021: Researchers Project Burden of COPD Will be Worse in 2050, Especially in US

Elevated prevalence among young Black women of obesity, hypertension, hyperlipidemia, and other lifestyle-related factors may place them at increased risk for early development of cardiovascular disease (CVD), according to findings of a

 to be presented at the American College of Cardiology’s 70th Annual Scientific Session, being held virtually from May 15 - 17, 2021.

Research in years past has focused attention on the burden of CVD among young Black women but the current study is unique in its shift to investigating the age at which key risk factors for CVD emerge in this population in a community setting. 

Study findings revealed high rates of lifestyle-linked, and thus modifiable, risk factors in the study cohort as early as their 20s and 30s.

“Young people should be the healthiest members of our population with normal body weight and normal blood pressure,” said lead study author Nishant Vatsa, MD, an internal medicine resident at Emory University Hospital in Atlanta. He called the detection of obesity and hypertension in younger adult Black women "worrisome."

Interventions to prevent the evolution of CVD risk factors in the first place need to start early, emphasized Vatsa, citing education on healthy dietary choices and the benefits of exercise, improved access to health care and to healthy foods and safe areas for physical activity.

Vatsa and colleagues analyzed information collected between 2015-2018 from 945 Black women enrolled in the 10 000 Women community health screening project in Atlanta. Data were collected on socioeconomic (education, income, health insurance), lifestyle (smoking, diet, exercise), and CVD risk factors. The data were then separated into 3 three 20-year age cohorts: 

Cohorts were compared using pairwise analysis adjusted for socioeconomic factors.

, a measure considered clinically obese.  

 group compared to other groups (p<.05), mean (SD) 20-39y: 30.7(8.3); 40-59y: 32.4(7.0); ≥60y: 31.0(6.0) kg/m

 from an average of 122 mmHg in the youngest group (20-39y) to 142 mmHg in the oldest group (p<.001), 20-39y: 122(15.3); 40-59y: 132.7 (19.1); ≥60y: 141.8(19.5) mmHg 

 among younger Black women than older (p<.001), 20-39y: 173(33.3); 40-59y: 194.1(38.3); ≥60y: 196.8(39.7) mg/dL

Nearly 1 out of 3 women aged 20-39 years reported eating fast food at least 3 times per week and 2 out of 5 consumed more than the recommended amount of salt daily. 
The  proportions were also high in middle-aged women but lower among those older than age 60 years.

LDL levels in the younger cohort were higher 

than in the middle aged and older groups (p<.001 and 0.01, respectively), 20-39y: 87.9(65.8); 40-59y: 66.7(60.5); ≥60y: 70.7(61.9) mg/dL

Black women (≥60y) than among either of the younger groups (p=0.03), 20-39y: 58.1(16.6); 40-59y: 59.3(16.8); ≥60y: 63.1(17.2) mg/dL

More Black women aged ≥60 yo limited salt intake

 compared to younger Black women (p≤.001) and consumed fast food fewer than 3 times a week vs younger women (p<.001), [20-39y: 68.1%; 40-59y: 74.4%; ≥60y: 85.7%

“Diet and exercise play a major role in blood pressure and weight,” said Vatsa. Underscoring the findings, he issued a call to action for improved interventions: 

“Primary care providers, prevention-based clinics and community organizations can facilitate interventions proven to mitigate these risk factors. Providers that treat young Black women need to be mindful of cardiovascular preventive care and be armed with resources and education.”

Vatsa also pointed to the disproportionate impact of the COVID-19 pandemic on Black and other communities of color that has both exacerbated and highlighted the barriers faced by young Black women in accessing preventive health care. Working to reduce impediments to building a heart-healthy lifestyle, said Vatsa, “can improve health in the near term and reduce the burden of heart disease for decades to come.”

Vatsa will present the study, “Cardiovascular risk factors in younger black women: results from the  10,000 Women Community Screening Project,” on Sunday, May 16, at 9:30 a.m. ET / 13:30 UTC.

ACC.21: High rates of obesity, hypertension, and hyperlipidemia found in Black women in their 20s and 30s are of significant concern, says the author of a study to be presented at the ACC meeting. 

Black Women at Risk Early in Life for Future Cardiovascular Disease  

In a subset of patients from the ETHOS study, triple combination therapy was found to be beneficial for those with moderate chronic obstructive pulmonary disease (COPD), according to a 

being presented at the upcoming American Thoracic Society International Conference, held May 14-19, 2021.

Led by Gary T. Ferguson, MD, one of the original co-authors of the ETHOS study, researchers aimed to demonstrate that triple combination therapy with budesonide, glycopyrrolate, and formoterol fumarate can not only benefit patients with severe or very severe COPD, but also with moderate COPD when compared with dual therapy.

To do this, researchers analyzed a subgroup of patients from the ETHOS study with moderate COPD based on post-bronchodilator lung function assessed during screening.

 was a phase 3, randomized, double-blind, 52-week study that evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate (BGF) at 2 dose levels (320/18/9.6 µg and 160/18/9.6 µg), compared to glycopyrrolate/formoterol fumarate (GFF) 18/9.6 µg and budesonide/formoterol fumarate (BFF) 320/9.6 µg in patients with moderate-to-very severe COPD.

Eligible participants had a postbronchodilator forced expiratory volume in 1 second (FEV

) 25%-65% of the predicted normal value and a documented history of ≥1 moderate or severe COPD exacerbation in the previous year. All treatments were administered via metered dose inhaler.

In the new analysis, researchers report results for the 2427 patients who had moderate COPD (FEV

 ≥50%) at baseline for the following endpoints:

St George’s Respiratory Questionnaire (SGRQ) scores

Time to clinically important deterioration (CID)

Results showed that BGF 320/18/9.6 µg and 160/18/9.6 µg reduced the rate of moderate or severe exacerbations vs GFF (rate ratios of 0.79 and 0.70, respectively; unadjusted p=0.0123 and p=0.0002), with numerical improvements seen for both doses of BGF vs BFF.

Researchers observed improvements in lung function outcomes (trough FEV

]) for both BGF doses vs the dual therapies, with larger benefits vs BFF than compared to GFF.

Also, a higher proportion of patients who received BGF 320/18/9.6 µg achieved the minimum clinically important difference in SGRQ score (decrease of ≥4 units; 53.7%) vs GFF (46.9%). Proportions were also numerically higher for BGF 320/18/9.6 µg vs BFF (50.6%) and for BGF 160/18/9.6 µg compared to both dual therapies.

“Consistent with the overall ETHOS population, BGF showed benefits versus dual therapies on exacerbations, CID, symptoms, and quality of life among patients with moderate COPD, with larger effects versus GFF on exacerbations and symptoms and larger effects versus BFF on lung function,” concluded authors. “Taken together, these findings demonstrate that triple therapy provides benefits for a wide spectrum of patients with COPD.”

American Thoracic Society 2021 International Conference: In a subset of patients from the ETHOS study, triple combination therapy was found beneficial for those with moderate COPD.

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