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2.
Sleep Health ; 2021 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-33741321

RESUMO

STUDY OBJECTIVES: We examined the most important correlates to sleep duration and efficiency from a comprehensive array of multilevel factors. METHODS: Baseline data from a cohort of 216 Black/African American smokers aged 40-65 years were examined. The binary outcomes of healthy sleep duration (6-8 h/night) and efficiency (≥85%) were ascertained from 14 consecutive days of actigraphy. Seventy-three independent variables from socio-demographic, individual behavioral, individual physiological, interpersonal, and community domains were assessed. Random survival forest decision trees were generated for each outcome, and variable importance metrics used to rank the predictive abilities of exposure variables. The 5 most predictive exposure variables for each outcome were entered into a regression model of the respective outcome (with age and sex). RESULTS: Study participants (N = 216) had a mean age of 54.57 years (SD = 6.17) and 57% were male. Healthy sleep duration was achieved by 56.5% and healthy sleep efficiency by 13.6% of the sample. Regression models showed every additional minute of light physical activity was associated with 1% increased odds, while every unit decrease in the inflammation marker of interleukin-8 was associated with 12% increased odds, of achieving a healthy sleep duration. Every unit increase in total social support was associated with a 34% increased odds, while every unit increase in the hazardous drinking score corresponded with 30% decreased odds, of achieving healthy sleep efficiency. CONCLUSIONS: Light physical activity, social support, and alcohol consumption may be key modifiable intervention targets to improving sleep duration and sleep efficiency in this population.

3.
Artigo em Inglês | MEDLINE | ID: mdl-33780602

RESUMO

Background: Comorbid disease is a risk factor for severe COVID-19 infection, however, initial rates of chronic obstructive pulmonary disease (COPD) in case series were low and severity of COVID-19 in COPD patients was variable. Methods: We performed a retrospective study of patients admitted with COVID-19 and evaluated outcomes in those with and without COPD and/or emphysema. Patients were identified as having COPD if they had a diagnosis in the medical record and a history of airflow-obstruction on spirometry, or a history of tobacco use and prescribed long-acting bronchodilator(s). Computed tomography scans were evaluated by radiologists. Propensity matching was performed for age, body-mass index (BMI), and serologic data correlated with severity of COVID-19 disease (D-dimer, C-reactive protein, ferritin, fibrinogen, absolute lymphocyte count, lymphocyte percentage, and lactate dehydrogenase). Results: Of 577 patients admitted with COVID-19, 103 had a diagnosis of COPD and/or emphysema. The COPD/emphysema cohort was older (67 vs 58, p<0.0001) than the other cohort and had a lower BMI. Among unmatched cohorts those with COPD/emphysema had higher rates of intensive care unit (ICU) admission (35% vs 24.9%, p=0.036) and maximal respiratory support requirements, with more frequent invasive mechanical ventilation (21.4% vs 11.8%), but no significant difference in mortality. After propensity-matching there was no difference in ICU admission, maximal respiratory support requirements, or mortality. Univariate and multivariate regression analyses yielded similar results. Discussion: Our propensity-matched retrospective cohort study suggests that patients hospitalized with COVID-19 that have COPD and/or emphysema may not have worse outcomes than those without these comorbid conditions.

4.
BMJ Open Respir Res ; 8(1)2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33762361

RESUMO

INTRODUCTION: Acute pulmonary embolism (PE) remains a common cause for morbidity and mortality in patients over 65 years. Given the increased risk of bleeding in the elderly population with the use of systemic thrombolysis, catheter-directed therapy (CDT) is being increasingly used for the treatment of submassive PE. Nevertheless, the safety of CDT in the elderly population is not well studied. We, therefore, aimed to evaluate the safety of CDT in our elderly patients. METHODS: We conducted a retrospective observational study of consecutive patients aged >65 years with a diagnosis of PE from our Pulmonary Embolism Response Team database. We compared the treatment outcomes of CDT versus anticoagulation (AC) in elderly. Propensity score matching was used to construct two matched cohorts for final outcomes analysis. RESULTS: Of 346 patients with acute PE, 138 were >65 years, and of these, 18 were treated with CDT. Unmatched comparison between CDT and AC cohorts demonstrated similar in-hospital mortality (11.1% vs 5.6%, p=0.37) and length of stay (LOS) (3.81 vs 5.02 days, p=0.5395), respectively. The results from the propensity-matched cohort mirrored results of the unmatched cohort with no significant difference between CDT and AC in-hospital mortality (11.8% vs 5.9%, p=0.545) or median LOS (3.76 vs 4.21 days, p=0.77), respectively. CONCLUSION: In this observational study using propensity score-matched analysis, we found that patients >65 years who were treated with CDT for management of acute PE had similar mortality and LOS compared with those treated with AC. Further studies are required to confirm these findings.

5.
Artigo em Inglês | MEDLINE | ID: mdl-33692621

RESUMO

Purpose: Among patients with chronic obstructive pulmonary disease (COPD), adherence to inhaled medication leads to fewer exacerbations and improved health status. The goal of the present study was to evaluate the effects of medication reminders via the BreatheMate device on adherence in patients with COPD. Patients and Methods: A 6-month, phase 4, randomized, multicenter, open-label US study (NCT02864342) enrolled 138 patients aged ≥40 years with moderate to very severe COPD and ≥10 pack-year smoking history. Patients in the intervention (n = 68) and control (n = 70) groups received the BreatheMate device, smartphone application, and vouchers to redeem pressurized metered-dose inhalers (pMDIs) for the prescribed 2 puffs of budesonide/formoterol 160/4.5 µg twice daily. The intervention group also received twice-daily electronic reminders to take budesonide/formoterol. The primary endpoint was the mean number of sets of adherent puffs/day (4 puffs: 2 puffs within 60 minutes, twice daily) over 6 months. Secondary endpoints included adherence by three 60-day intervals, usage days, prescription refills, and Clinical COPD Questionnaire (CCQ) score. Study enrollment terminated early due to issues with inconsistent syncing. Results: A higher mean proportion of adherent days (77.6% vs 60.2%; P <0.001) and sets of adherent puffs/day (1.61 vs 1.33; P <0.001) were recorded for the intervention group versus the control group. Intervention group adherence was higher than that of the control group for each 60-day interval (P <0.001); the intervention group was 3.07 (95% confidence interval: 1.49-6.52) times more likely than the control group to be adherent for ≥80% of study days. Overuse (>2 sets of 2 puffs/day), underuse (<2 sets of 2 puffs/day), and no use days were lower in the intervention group versus control (P <0.05). Patients aged ≥65 years had higher adherence (P <0.001). Conclusion: Medication reminders through the BreatheMate device and application produced greater adherence to inhaled therapy in patients with COPD.

6.
Crit Care Med ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33590996

RESUMO

OBJECTIVE: Management of patients experiencing massive pulmonary embolism-related cardiac arrest is controversial. Venoarterial extracorporeal membranous oxygenation has emerged as a potential therapeutic option for these patients. We performed a systematic review assessing survival and predictors of mortality in patients with massive PE-related cardiac arrest with venoarterial extracorporeal membranous oxygenation use. DATA SOURCES: A literature search was started on February 16, 2020, and completed on March 16, 2020, using PubMed, Embase, Cochrane Central, Cinahl, and Web of Science. STUDY SELECTION: We included all available literature that reported survival to discharge in patients managed with venoarterial extracorporeal membranous oxygenation for massive PE-related cardiac arrest. DATA EXTRACTION: We extracted patient characteristics, treatment details, and outcomes. DATA SYNTHESIS: About 301 patients were included in our systemic review from 77 selected articles (total screened, n = 1,115). About 183 out of 301 patients (61%) survived to discharge. Patients (n = 51) who received systemic thrombolysis prior to cannulation had similar survival compared with patients who did not (67% vs 61%, respectively; p = 0.48). There was no significant difference in risk of death if PE was the primary reason for admission or not (odds ratio, 1.62; p = 0.35) and if extracorporeal membranous oxygenation cannulation occurred in the emergency department versus other hospital locations (odds ratio, 2.52; p = 0.16). About 53 of 60 patients (88%) were neurologically intact at discharge or follow-up. Multivariate analysis demonstrated three-fold increase in the risk of death for patients greater than 65 years old (adjusted odds ratio, 3.08; p = 0.03) and six-fold increase if cannulation occurred during cardiopulmonary resuscitation (adjusted odds ratio, 5.67; p = 0.03). CONCLUSIONS: Venoarterial extracorporeal membranous oxygenation has an emerging role in the management of massive PE-related cardiac arrest with 61% survival. Systemic thrombolysis preceding venoarterial extracorporeal membranous oxygenation did not confer a statistically significant increase in risk of death, yet age greater than 65 and cannulation during cardiopulmonary resuscitation were associated with a three- and six-fold risks of death, respectively.

7.
Ann Am Thorac Soc ; 2021 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-33631079

RESUMO

RATIONALE: Diagnosis of chronic obstructive pulmonary disease (COPD) relies on abnormal spirometry. However, spirometry may underestimate the effects of smoking, missing smokers with respiratory disease that have minimal or no airflow obstruction. OBJECTIVES: Develop a multi-dimensional definition of a lung-related "resilient smoker" that is useful in research studies; then identify a resilient smoker subgroup in the SPIROMICS cohort using this definition. METHODS: We performed a three-round modified Delphi survey among a panel of COPD experts to identify and reach a consensus on clinical and radiographic domains to be included in a lung-related resilient smoker definition. Consensus on domains of resilience was defined as ≥80% of experts voting "agree" or "strongly agree" on a 5-point Likert scale. The Delphi-derived definition of resilience was applied to SPIROMICS to identify resilient smokers, whom we then characterized using known biomarkers of COPD. RESULTS: Consensus was achieved on 6 of 12 diagnostic items which include: cough and sputum production, dyspnea, radiographic measures of emphysema and small airways disease, exacerbations, and decline in FEV1. Although 892 SPIROMICS participants were classified as smokers with preserved lung function by spirometry, only 149 participants (16.7%) qualified as resilient smokers by our definition. Blood biomarker expression of C-reactive protein (CRP) and soluble tumor necrosis receptor factor1A (sTNFRSF1A) was lower in resilient than non-resilient smokers (P=0.02 and P=0.03). CONCLUSIONS: A Delphi-derived consensus definition of resilient smoker identified 83.3% of smokers with preserved spirometry as "non-resilient" based on the presence of adverse effects of smoking on the lung. Resilient smokers were biologically distinct from non-resilient smokers based on CRP measurements. Clinical trial registered with ClinicalTrials.gov (NCT01969344).

8.
Artigo em Inglês | MEDLINE | ID: mdl-33610139

RESUMO

Background: Factors responsible for poor sleep quality in patients with chronic obstructive pulmonary disease (COPD) includes the effects of medications. The study evaluates the effect of the inhaled triple therapy with budesonide-formoterol-tiotropium versus placebo-tiotropium on sleep quality in COPD patients. Methods: Twenty-three patients (11 (48%) males; age 55 (51-60, 48-75) yrs; body mass index [BMI] 25 (22-30, 18-40) kg/m2; FEV1 1.10 (0.80-1.90, 0.60-2.80) L, 42 (31-62, 24-75) % predicted were studied. Ten patients were randomized to budesonide-formoterol-tiotropium and 13 patients to placebo-tiotropium. At baseline and after 28 days patients completed spirometry, polysomnography, an Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), COPD-specific St. George's Respiratory Questionnaire (SGRQ-C) and short form 36 (SF 36). Results: After 28 days there was a significant 29% increase in the bedtime FEV1 in the budesonide-formoterol-tiotropium group (from 0.75 (0.55-1.30, 0.50-2.40) L to 1.00 (0.75-1.55, 0.50-3.00) L p=0.031), with no change in the placebo-tiotropium group (from 1.20 (0.80-1.50, 0.60-1.90) L to 1.15 (0.75-1.55, 0.50-1.80) L, p=0.91). No change was found post treatment in sleep efficiency or total sleep time in both the budesonide-formoterol-tiotropium group (from 78 (72-92, 62-98)% to 88 (77-92, 40-98)%, p=0.70 and 290 (268-358, 252-382) min to 342 (303-358, 157-372) min, p=0.77, respectively) and the placebo-tiotropium group (from 82 (75-88, 46-93)% to 84 (77-87, 62-94)%, p=0.96 and 320 (292-350, 180-378) min to 339 (303-349, 241-366) min, p=0.79, respectively). While there was no change in the arousal index in the budesonide-formoterol-tiotropium group (9 (5-16, 0-48) arousals/hr to 14 (9-17, 2-36) arousals/hr, p=0.43), a significant increase was seen in the placebo-tiotropium group (11 (4-13, 3-32) arousals/hr to 17 (11-21, 2-33) arousals/hr, p=0.027). Similarly, there was no change in the ESS in the budesonide-formoterol-tiotropium group (6 (3-8, 0-11) to 6 (5-8, 0-11), p=0.44), but a marginally significant increase in the placebo-tiotropium group (8 (5-12, 2-18) to 10 (7-13, 5-18), p=0.07), with a significant difference in the ESS 28 days post treatment between the 2 groups (6 (5-8, 0-11) vs. 10 (7-13, 5-18), p=0.043). There was no significant change in nocturnal oxygenation, sleep architecture, PSQI, SGRQ-C, or SF 36 in both groups. Conclusion: In patients with COPD inhaled triple therapy with budesonide-formoterol-tiotropium as compared to placebo-tiotropium improves pulmonary function while preserving sleep quality and architecture.

9.
J Thromb Haemost ; 2021 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-33638931

RESUMO

BACKGROUND: Statins are widely used to lower lipids and reduce cardiovascular events. In vitro studies and small studies in patients with hyperlipidemias show statins inhibit tissue factor (TF) and blood coagulation mechanisms. We assessed the effects of simvastatin on TF and coagulation biomarkers in patients entered in STATCOPE, a multicenter, randomized, placebo-controlled trial of simvastatin (40 mg daily) versus placebo on exacerbation rates in patients with chronic obstructive pulmonary disease (COPD). METHODS: In 227 patients (114 simvastatin, 113 placebo; mean [± standard error of the mean] age 62 ± 0.53 years, 44.5% women) we measured (baseline, and 6 and 12 months): whole blood membrane TF-procoagulant activity (TF-PCA) and plasma factors VIIa, VII, VIII, fibrinogen, TF antigen, tissue factor pathway inhibitor (TFPI), thrombin-antithrombin complexes (TAT), and D-dimer. We excluded patients with diabetes, cardiovascular disease, and those taking or requiring a statin. RESULTS: In the statin group, there was a small increase in TF-PCA (from 25.18 ± 1.08 to 30.36 ± 1.10 U/ml; p = .03) over 12 months; factors VIIa and VIII, fibrinogen, TAT, and D-dimer did not change. Plasma TFPI (from 52.4 ± 1.75 to 44.7 ± 1.78 ng/ml; p < .0001) and FVIIC (1.23 ± 0.04 to 1.15 ± 0.03 U/ml; p = .03) decreased and correlated with total cholesterol levels. No changes in biomarkers were observed with placebo. CONCLUSIONS: In contrast to previous studies on statins, in COPD patients without diabetes, cardiovascular disease, or requiring a statin treatment, simvastatin (40 mg per day) did not decrease TF or factors VIIa and VIII, fibrinogen, TAT, or D-dimer. The decreases in TFPI and factor VII reflect the decrease in serum lipids.

11.
Eur J Radiol ; 136: 109561, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33516140

RESUMO

PURPOSE: For a successful bronchoscopic lung volume reduction coil treatment it is important to place the coils in the most emphysematous lobes. Therefore assessment of the lobe with greatest destruction is essential. Our aims were to investigate the level of agreement among expert reviewers of HRCT-scans in emphysema patients and the comparison with QCT (quantitative computed tomography) software. METHOD: Five experienced CT-assessors, conducted a visual assessment of the baseline HRCT-scans of emphysema patients who participated in the RENEW bronchoscopic lung volume reduction coil study. On the same HRCT-scans, a QCT analysis was performed. RESULTS: In total 134 HRCT-scans were rated by all 5 experts. All 5 CT-assessors agreed on which was the most destructed lobe in 61 % of the left lungs (ƙ:0.459) and 60 % of the right lungs (ƙ:0.370). The consensus of the 5 assessors matched the QCT in the left lung for 77 % of the patients (ƙ:0.425) and in the right lung for 82 % (ƙ:0.524). CONCLUSIONS: Our results show that the interobserver agreement between five expert CT-assessors was only fair to moderate when evaluating the most destructed lobe. CT-assessor consensus improved matching with QCT determination of lobar destruction compared to individual assessor determinations. Because some CT-features are associated with treatment outcomes and important for optimal patient selection of bronchoscopic lung volume reduction treatment, we recommend including more than one CT-reviewer and supported by QCT measurements.

12.
N Engl J Med ; 384(1): 20-30, 2021 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-33332779

RESUMO

BACKGROUND: Coronavirus disease 2019 (Covid-19) pneumonia is often associated with hyperinflammation. Despite the disproportionate incidence of Covid-19 among underserved and racial and ethnic minority populations, the safety and efficacy of the anti-interleukin-6 receptor antibody tocilizumab in patients from these populations who are hospitalized with Covid-19 pneumonia are unclear. METHODS: We randomly assigned (in a 2:1 ratio) patients hospitalized with Covid-19 pneumonia who were not receiving mechanical ventilation to receive standard care plus one or two doses of either tocilizumab (8 mg per kilogram of body weight intravenously) or placebo. Site selection was focused on the inclusion of sites enrolling high-risk and minority populations. The primary outcome was mechanical ventilation or death by day 28. RESULTS: A total of 389 patients underwent randomization, and the modified intention-to-treat population included 249 patients in the tocilizumab group and 128 patients in the placebo group; 56.0% were Hispanic or Latino, 14.9% were Black, 12.7% were American Indian or Alaska Native, 12.7% were non-Hispanic White, and 3.7% were of other or unknown race or ethnic group. The cumulative percentage of patients who had received mechanical ventilation or who had died by day 28 was 12.0% (95% confidence interval [CI], 8.5 to 16.9) in the tocilizumab group and 19.3% (95% CI, 13.3 to 27.4) in the placebo group (hazard ratio for mechanical ventilation or death, 0.56; 95% CI, 0.33 to 0.97; P = 0.04 by the log-rank test). Clinical failure as assessed in a time-to-event analysis favored tocilizumab over placebo (hazard ratio, 0.55; 95% CI, 0.33 to 0.93). Death from any cause by day 28 occurred in 10.4% of the patients in the tocilizumab group and 8.6% of those in the placebo group (weighted difference, 2.0 percentage points; 95% CI, -5.2 to 7.8). In the safety population, serious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group. CONCLUSIONS: In hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival. No new safety signals were identified. (Funded by Genentech; EMPACTA ClinicalTrials.gov number, NCT04372186.).


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , /tratamento farmacológico , Adulto , Idoso , /mortalidade , Progressão da Doença , Feminino , Hospitalização , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/tratamento farmacológico , Respiração Artificial , Taxa de Sobrevida
13.
J Clin Med ; 9(12)2020 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-33256044

RESUMO

High-flow nasal therapy (HFNT) is a unique system that delivers humidified, heated oxygen-enriched air via nasal cannula at high flow rates. It is a promising therapy for chronic obstructive pulmonary disease (COPD) patients. Several studies have examined the physiologic effects of this therapy in the patient population and have revealed that it improves mucociliary clearance, reduces nasopharyngeal dead space, and subsequently increases CO2 washout. It also improves alveolar recruitment and gas exchange. These mechanisms may explain the promising results observed in recently published studies that examined the role of HFNT in stable COPD patients.

14.
Pulm Ther ; 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33201438

RESUMO

INTRODUCTION: In the IMPACT trial, single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI or UMEC/VI dual therapy in patients with chronic obstructive pulmonary disease (COPD); however, pneumonia incidence was higher in FF-containing arms. As COPD is a growing problem in Asia, we compared the efficacy and safety of FF/UMEC/VI in Asia versus non-Asia regions. METHODS: IMPACT was a double-blind, 52-week trial in symptomatic COPD patients with ≥ 1 moderate/severe exacerbation in the prior year. This pre-specified analysis evaluated the annual rate of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score, mortality, and safety (including pneumonia) in Asia versus non-Asia regions. RESULTS: The intent-to-treat population comprised 10,355 patients (Asia n = 1644 [16%]). Rate ratios (95% confidence intervals) for moderate/severe exacerbations with FF/UMEC/VI were 0.89 (0.76-1.05) versus FF/VI and 0.86 (0.71-1.04) versus UMEC/VI in Asia, and 0.84 (0.79-0.90) and 0.74 (0.68-0.80) in non-Asia. Efficacy of FF/UMEC/VI on other endpoints was similar in both regions. There was an increased incidence of investigator-reported pneumonia in patients in Asia (FF/UMEC/VI: 13%; FF/VI: 14%; UMEC/VI: 6%) compared with non-Asia (FF/UMEC/VI: 6%; FF/VI: 5%; UMEC/VI: 4%). The increased risk of pneumonia in patients in Asia was most marked in patients with lower body mass index, lower lung function, and taking inhaled corticosteroids. In post hoc analysis of adjudicated on-treatment all-cause mortality, probabilities of death were numerically lower in both regions with FF/UMEC/VI (Asia: 1.16%; non-Asia: 1.35%) and FF/VI (Asia: 1.77%; non-Asia: 1.21%) versus UMEC/VI (Asia: 1.91%; non-Asia: 2.23%). CONCLUSIONS: FF/UMEC/VI provides similar benefits in COPD patients in Asia and non-Asia regions. Clinical benefits of treatment, including reduction in mortality risk, should be weighed against risk of pneumonia, taking account of all known risk factors. TRIAL REGISTRATION: ClinicalTrials.gov identification, NCT02164513.

15.
Artigo em Inglês | MEDLINE | ID: mdl-33211970

RESUMO

Currently the diagnosis of chronic obstructive pulmonary disease (COPD) requires the demonstration of airflow limitation, defined as a post-bronchodilator FEV1/FVC <0.7, a measurement that remains methodologically robust and widely available. FEV1 is one of the most powerful predictors of clinically relevant outcomes including symptoms, exacerbations and mortality. However, reliable data suggest that respiratory symptoms, in particular chronic bronchitis, airway abnormality and emphysema detected using modern imaging techniques such as computed tomography (CT), and certain physiologic measures including rapid decline in FEV1 and DLCO are present among individuals who do not meet spirometric criteria for COPD. These abnormalities may help to identify individuals at increased risk for developing airflow limitation in the future. Here, we review the evidence that support the use of the term "pre-COPD" in individuals with symptoms (e.g., "Non-Obstructive Chronic Bronchitis" (NOCB)), physiologic (e.g., low DLCO) and/or imaging abnormalities (e.g. CT emphysema) but spirometry in the normal range, who are at risk of developing COPD defined by a reduced FEV1/FVC ratio. We acknowledge, however, that further research on early disease in young individuals will be critical to develop a clinically operable definition of "pre-COPD" that demonstrates good sensitivity and specificity. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

16.
Artigo em Inglês | MEDLINE | ID: mdl-33156982

RESUMO

Background: The IMPACT trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings. Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed. Results: Overall, 10,355 patients were enrolled, 3164 from WE, 2639 from NA. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and NA (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in WE, but not NA. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in NA but not WE. Conclusion: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in WE and NA; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.

17.
Artigo em Inglês | MEDLINE | ID: mdl-33180550

RESUMO

BACKGROUND: The relative roles of mucus plugs and emphysema in mechanisms of airflow limitation and hypoxemia in smokers with chronic obstructive pulmonary disease (COPD) are uncertain. METHODS: We analyzed computed tomography (CT) lung images and lung function in participants in the Subpopulations and Intermediate Outcome Measures in COPD Study. Radiologists scored mucus plugs on CT lung images and imaging software automatically quantified percent emphysema. Unadjusted and adjusted relationships between mucus plug score, percent emphysema, and lung function were determined using regression. RESULTS: Among 400 smokers, 229 (57%) had mucus plugs and 207 (52%) had emphysema and subgroups could be identified with mucus dominant and emphysema dominant disease. Only 33% of smokers with high mucus plug scores had mucus symptoms. Mucus plug score and percent emphysema were independently associated with lower values for forced expiratory volume in one second and peripheral oxygen saturation (p values < 0.001). The relationships between mucus plug score and lung function outcomes were strongest in smokers with limited emphysema (p values <0.001). Compared to smokers with low mucus plug scores, those with high scores had worse COPD Assessment Test scores (17.4 ± 7.7 vs. 14.4 ± 13.3), more frequent annual exacerbations (0.75 ± 1.1 vs. 0.43 ± 0.85), and shorter 6-minute walk distance (329 ± 115 vs. 392 ± 117 meters)(p values < 0.001). CONCLUSION: Symptomatically silent mucus plugs are highly prevalent in smokers and independently associate with lung function outcomes. These data provide rationale for targeting mucus-high/emphysema-low COPD patients in clinical trials of muco-active treatments.

18.
Artigo em Inglês | MEDLINE | ID: mdl-33146552

RESUMO

The SARS-CoV-2 pandemic has raised many questions about the management of COPD patients and whether modifications of their therapy are required. It has raised questions about recognising and differentiating COVID-19 from COPD given the similarity of the symptoms. It is unclear whether COPD patients are at increased risk of becoming infected with SARS-CoV-2. During periods of high prevalence of COVID-19, spirometry should be used when essential for COPD diagnosis and/or to assess lung function status for interventional procedures or surgery. COPD patients should follow basic infection control measures including social distancing, hand washing and wearing a mask or face covering. Although data are limited, inhaled corticosteroids, long-acting bronchodilators, roflumilast, or chronic macrolides should continue to be used as indicated for stable COPD management. Systemic steroids and antibiotics should be used in COPD exacerbations according to the usual indications. Differentiating symptoms of COVID-19 infection from chronic underlying symptoms or those of an COPD exacerbation may be challenging. If there is suspicion for COVID-19, testing for SARS-CoV-2 should be considered. Patients who developed moderate to severe COVID-19, including hospitalization and pneumonia, should be treated with evolving pharmacotherapeutic approaches, as appropriate, including remdesivir, dexamethasone, and anticoagulation. Managing acute respiratory failure should include appropriate oxygen supplementation, prone positioning, noninvasive ventilation, and protective lung ventilation in patients with ARDS. Patients who develop mild COVID-19 should be followed as normal. Patients who developed moderate or worse COVID-19 should be monitored more frequently than normally with particular attention to the need for oxygen therapy. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

19.
Artigo em Inglês | MEDLINE | ID: mdl-33007162

RESUMO

RATIONALE: Black adults have worse health outcomes compared to white adults in certain chronic diseases, including Chronic Obstructive Pulmonary Disease (COPD). It is unclear if, and to what degree, disadvantage by individual and neighborhood socioeconomic status (SES) may contribute to racial disparities in COPD outcomes. METHODS: Individual and neighborhood-scale sociodemographic characteristics were determined in 2649 current or former adult smokers, with and without COPD, at recruitment into the SPIROMICS study. We assessed whether racial differences in symptom, functional and imaging outcomes (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT] score; modified Medical Research Council [mMRC] dyspnea scale; six-minute walk test distance [6MWD], CT scan metrics) and severe exacerbation risk were explained by individual or neighborhood SES. Using generalized linear mixed models regression, we compared respiratory outcomes by race, adjusting for confounders and individual-level and neighborhood-level descriptors of SES, both separately and sequentially. RESULTS: After adjusting for COPD risk factors, black participants had significantly worse respiratory symptoms and quality of life (mMRC, CAT and SGRQ), higher risk of severe exacerbations and higher percent emphysema, thicker airways (Pi10), and more air trapping on CT metrics compared to whites. Additionally, the association between black race and respiratory outcomes was attenuated but remained statistically significant after adjusting for individual-level SES, which explained up to 12% to 35% of racial disparities. Further adjustment showed that neighborhood-level SES explained another 26% to 54% of the racial disparities in respiratory outcomes. Even after accounting for both individual and neighborhood SES factors, black individuals continued to have increased severe exacerbation risk and persistently worse CT outcomes (emphysema, air trapping and airway wall thickness). CONCLUSIONS: Disadvantages by individual and neighborhood-level SES each partly explain disparities in respiratory outcomes between black individuals and whites. Strategies to narrow the gap in SES disadvantages may help to reduce race-related health disparities in COPD; however, further work is needed to identify additional risk factors contributing to persistent disparities.

20.
Chest ; 2020 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-33031829

RESUMO

BACKGROUND: In the IMPACT trial, single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI and UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations, with a similar safety profile. Research Question Does age have an effect on trial outcomes? STUDY DESIGN AND METHODS: IMPACT was a Phase III, double-blind, 52-week trial. Patients ≥40 years of age with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 mcg, FF/VI 100/25 mcg, or UMEC/VI 62.5/25 mcg. Endpoints assessed by age included annual rate of moderate/severe exacerbations, change from baseline (CFB) in trough forced expiratory volume in 1 second (FEV1), proportion of St George's Respiratory Questionnaire (SGRQ) responders (≥4 units decrease from baseline in SGRQ total score) and safety. RESULTS: The intent-to-treat population comprised 10,355 patients; 4724 (46%), 4225 (41%), and 1406 (14%) were ≤64, 65-74, and ≥75 years of age, respectively. FF/UMEC/VI reduced on-treatment moderate/severe exacerbation rates versus FF/VI (% reduction [95% confidence interval (CI)], ≤64 years: 8% [-1, 16], p=0.070; 65-74 years: 22% [14, 29], p<0.001; ≥75 years 18% [3, 31], p=0.021) and versus UMEC/VI (≤64 years: 16% [7, 25], p=0.002; 65-74 years: 33% [25, 41], p<0.001; ≥75 years 24% [6, 38], p=0.012), with greatest rate reduction seen in the 65-74 and ≥75 years subgroups. Post hoc analyses of CFB in trough FEV1, and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups. No new safety signals were identified. INTERPRETATION: FF/UMEC/VI reduced the rate of moderate/severe exacerbations and improved lung function and health status versus FF/VI and UMEC/VI irrespective of age for most endpoints, with a similar safety profile. CLINICAL TRIAL REGISTRATION: GSK (CTT116855/NCT02164513).

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