Positive airway pressure (PAP) treatment reduces glycated hemoglobin (HbA1c) levels in obstructive sleep apnea patients with concomitant weight loss: Longitudinal data from the ESADA.

Patients with obstructive sleep apnea (OSA) are at increased risk of developing metabolic disease such as diabetes. The effects of positive airway pressure on glycemic control are contradictory. We therefore evaluated the change in glycated hemoglobin (HbA1c) in a large cohort of OSA patients after long-term treatment with positive airway pressure. HbA1c levels were assessed in a subsample of the European Sleep Apnea Database [n=1608] at baseline and at long-term follow up with positive airway pressure therapy (mean 378.9±423.0 days). In a regression analysis, treatment response was controlled for important confounders. Overall, HbA1c decreased from 5.98±1.01% to 5.93±0.98% (p=0.001). Patient subgroups with a more pronounced HbA1c response included patients with diabetes (-0.15±1.02, p=0.019), those with severe OSA baseline (-0.10±0.68, p=0.005), those with morbid obesity (-0.20±0.81, p<0.001). The strongest HbA1c reduction was observed in patients with a concomitant weight reduction >5 kilos (-0.38±0.99, p<0.001). In robust regression analysis, severe OSA (p=0.038) and morbid obesity (p=0.005) at baseline, and weight reduction >5 kilos (p<0.001) during follow up were independently associated with a reduction of HbA1c following PAP treatment. In contrast, PAP treatment alone without weight reduction was not associated with significant Hb1Ac reduction. In conclusion, positive airway pressure therapy is associated with HbA1c reduction in patients with severe OSA, in morbidly obese patients. and most obviously in those with significant weight lost during the follow-up. Our study underlines the importance to combine positive airway pressure use with adjustments in lifestyle to substantially modify metabolic complications in OSA.

Superior hypertension control with betablockade in the European Sleep Apnea Database.

AIMS: Arterial hypertension is highly prevalent and difficult to control in patients with obstructive sleep apnea (OSA). High sympathoadrenergic activity is a hallmark physiological phenomenon in OSA. We hypothesized that an antihypertensive drug with inhibitory properties on this activity, such as beta blockers (BBs), may be particularly efficacious in OSA patients. METHODS: Hypertensive OSA patients receiving blood pressure-lowing treatment in the European Sleep Apnea Database (ESADA) (n = 5818, 69% men, age 58 ±â€Š11 years, body mass index 33 ±â€Š7 kg/m2, apnea hypopnea index 34 ±â€Š26 events/h) were analyzed. Reported medications [BB, diuretic, renin-angiotensin blocker (RAB), calcium channel blocker (CCB), and centrally acting antihypertensive (CAH)] were classified according to ATC code. Office blood pressure was compared in patients with monotherapy or combination therapy controlling for confounders. RESULTS: Poorly controlled SBP according to the ESC/ESH guidelines was found in 66% of patients. Patients receiving monotherapy with RAB, CCB or CAH had 2.2 (95% CI 1.4-3.0), 3.0 (1.9-4.1) and 3.0 (1.7-4.7) mmHg higher SBP compared with those on BB (adjusted model, P = 0.007, 0.008 and 0.017, respectively). In those with a combination of two antihypertensive drugs, SBP was 5.5 (4.0-7.1), 5.1 (3.7-6.6), 4.3 (2.5-6.1) and 3.1 (1.6-4.6) mmHg higher in those on CCB/RAB, BB/RAB, BB/CCB or diuretic/RAB compared with those on BB/diuretic (adjusted model, P < 0.001, <0.001, 0.018 and 0.036, respectively). CONCLUSION: Poorly controlled blood pressure was common in OSA patients with antihypertensive medication. Treatment with BB alone or BB in combination with a diuretic was associated with the lowest systolic pressure in this large clinical cohort.

Psychological distress in patients with obstructive sleep apnoea: The role of hostility and coping self-efficacy.

We aimed to assess whether hostility and coping self-efficacy are associated with psychological distress in obstructive sleep apnoea patients. Furthermore, we examined whether coping self-efficacy mediates the association between hostility and psychological distress. We included 150 obstructive sleep apnoea patients (Apnoea-Hypopnoea Index ⩾5; 68% male; mean age: 48.9 ± 9.5 years). Regression models showed that hostility and poor coping self-efficacy were strongly associated with psychological distress in obstructive sleep apnoea patients. All assessed coping self-efficacy dimensions mediated the association between hostility and psychological distress. Coping self-efficacy for stopping unpleasant emotions and thoughts showed the strongest association with a lower level of psychological distress.

Suicidal ideation in patients with obstructive sleep apnoea and its relationship with disease severity, sleep-related problems and social support.

We aimed to assess the prevalence of suicidal ideation and to examine the relationships between obstructive sleep apnoea severity, sleep-related problems, social support and suicidal ideation in obstructive sleep apnoea patients. We included 149 patients (68% male; mean age, 48.99 ± 9.57 years) with diagnosed obstructive sleep apnoea (Apnoea-Hypopnoea Index ⩾5) based on full-night polysomnography. The prevalence of suicidal ideation among obstructive sleep apnoea patients was 20.1 per cent. Structural equation modelling showed that suicidal ideation in obstructive sleep apnoea was strongly related to poor sleep quality and high fatigue levels. No relationship between social support and suicidal ideation in obstructive sleep apnoea patients was found.

Erickson solution-focused coaching for weight management in obese patients with obstructive sleep apnoea: ECOHEALTH pilot study.

Coaching as a lifestyle modification approach to weight management is insufficiently explored in obstructive sleep apnoea. We investigated anthropometry and body composition after 20 weeks of Erickson coaching in 26 obstructive sleep apnoea patients (19 males; 47.6 ± 2.4 years). Body weight, neck circumference, waist-to-hip ratio and %body fat significantly decreased after 20 weeks. The mean weight loss was 5.2 per cent ± 1.0 per cent; 20 (77%) participants achieved target reduction of >3 per cent. Coaching session attendance (p = 0.006) and reaching personal goal related to physical performance (p = 0.044) were independently associated with weight loss (multiple regression model R2 = 0.608, p < 0.001). Erickson solution-focused coaching supports adherence to healthy lifestyle and weight reduction in obstructive sleep apnoea.

Quality of life of obstructive sleep apnoea patients receiving continuous positive airway pressure treatment: A systematic review and meta-analysis.

BACKGROUND: Previous studies have shown conflicting results on the effect of continuous positive airway pressure (CPAP) on quality of life (QoL) in obstructive sleep apnoea (OSA) patients. OBJECTIVES: To evaluate the effect of CPAP on QoL in OSA patients compared to sham CPAP, placebo pills, and conservative treatment. METHODS: Studies were identified via Web of Knowledge, PubMed, PsychInfo, CINAHL, EMBASE, OpenGrey, and the Cochrane Library. Subgroup analyses and sensitivity analyses were conducted to assess the robustness of the findings. RESULTS: Meta-analysis of 13 randomised controlled trials showed no significant differences in overall and psychological QoL comparing values of CPAP treated patients with controls; however, physical QoL improved. CPAP significantly affected the overall QoL in studies with controls receiving sham CPAP, parallel design, low risk of bias, and mild OSA patients. CONCLUSION: CPAP treatment may help to improve physical symptoms of OSA, whereas impaired psychological QoL still cannot be alleviated.

Association of JAG1 gene polymorphism with systemic blood pressure in patients with obstructive sleep apnea: a prospective cohort study.

AIM: To assess the effects of single nucleotide polymorphisms (SNPs) on blood pressure control in patients with obstructive sleep apnea (OSA). METHODS: This prospective observational cohort study, conducted between 2004 and 2014, examined the associations of SNPs of JAG1, GUCY1A3-GUCY1B3, SH2B3, and NPR3-C5orf23 genes with systolic and diastolic blood pressure (SBP, DBP) in 1179 adults evaluated for OSA with overnight polysomnography. Genotyping was performed by unlabeled probe melting analysis. RESULTS: The patients were predominantly male (69.6%, mean age 52±11 years, apnea-hypopnea index 34±31 episodes/h). Only JAG1 genotype was associated with SBP and DBP: compared with AA homozygotes, G allele carriers (pooled GG and AG genotype) had significantly higher morning SBP (132±19 vs 129±18 mm Hg; P=0.009) and morning and evening DBP (85±11 vs 83±10 mm Hg, P=0.004; 86±10 vs 84±10 mm Hg, P=0.012, respectively); the differences remained significant after the correction for multiple SNPs testing. In multivariate analyses, oxygen desaturation index and JAG1 genotype independently predicted morning SBP (P=0.001, P=0.003, respectively) and DBP (P<0.001, P=0.005, respectively), and evening SBP (P=0.019, P=0.048, respectively) and DBP (P=0.018, P=0.018, respectively). CONCLUSION: This is the first replication study of the SNPs recently linked to arterial hypertension in general population by genome-wide association studies. Our findings suggest that JAG1 genotype is related to blood pressure control in OSA: G allele was associated with higher morning and evening SBP and DBP.

Determinants of CAT (COPD Assessment Test) scores in a population of patients with COPD in central and Eastern Europe: The POPE study.

BACKGROUND: The COPD Assessment Test (CAT) has been proposed to help guide therapy in chronic obstructive pulmonary disease (COPD). It is important to understand the distribution of scores in different COPD populations and their determinants. METHODS: The POPE study is an international, observational cross-sectional study of COPD subjects in 11 Central and Eastern European countries aimed at characterizing COPD phenotypes. Here we report the analysis of CAT scores with the objective of identifying their determinants, evaluating symptom load and investigating the distribution of scores among the participating countries. Additionally, we investigated the discrepancies between the CAT and modified Medical Research Council (mMRC) scores when used to classify patients according to the GOLD strategy. RESULTS: The study included 3452 patients (69.2% men, mean forced expiratory volume in 1 s (FEV1% predicted) 52.5%). The mean CAT score was 17.5 (SD = 7.8), ranging from 15.1 in Hungary to 21.2 in Bulgaria. Multiple linear regression analysis showed six variables significantly associated with CAT scores: depression, number of previous exacerbations, 6-min walking distance, FEV1(%), mMRC and country and explained 47.2% of the variance of CAT. According to either CAT or mMRC, up to 23.9% patients would be classified in different GOLD groups. CONCLUSIONS: The CAT score may be predicted by factors related to COPD severity, depression and exercise capacity, with significant differences in the distribution of CAT scores in different countries. According to our results CAT >10 is not equivalent to mMRC >2 for assessing symptom burden. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02119494.

Are disease severity, sleep-related problems, and anxiety associated with work functioning in patients with obstructive sleep apnoea?

Purpose: To examine whether Obstructive Sleep Apnoea severity, sleep-related problems, and anxiety are associated with work functioning in Obstructive Sleep Apnoea patients, when controlled for age, gender and type of occupation. To investigate whether anxiety moderates the associations between sleep-related problems and work functioning. Materials and methods: We included 105 Obstructive Sleep Apnoea patients (70% male; mean age 46.62 ± 9.79 years). All patients completed the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Beck Anxiety Inventory, and the Work Role Functioning Questionnaire-2.0. Results: Obstructive Sleep Apnoea-severity, poor nighttime sleep quality, and anxiety were univariately associated with impaired work functioning. Multivariate analyzes revealed that poor perceived sleep quality was more strongly associated with work functioning than sleep efficiency and daily disturbances. Anxiety was strongly associated with impaired work functioning. After adding anxiety, the explained variance in work functioning increased from 20% to 25%. Anxiety moderated the association between low and medium levels of nighttime sleep quality problems and work functioning. Conclusions: Poor perceived sleep quality and anxiety were strongly associated with impaired work functioning in Obstructive Sleep Apnoea patients. These findings may help to optimize management, standard treatment, and work functioning in people with Obstructive Sleep Apnoea when confirmed in longitudinal studies. Implications for Rehabilitation Studies show an impairment of functional status, including work functioning, in obstructive sleep apnea patients. Aside from physical disorders, obstructive sleep apnea patients often experience mental problems, such as anxiety. As many people with obstructive sleep apnea are undiagnosed, our results demonstrate to employers and healthcare professionals the need to encourage patients for obstructive sleep apnea screening, especially in the situation of impaired work functioning, increased anxiety, and poor sleep quality. The associations between obstructive sleep apnea, sleep and anxiety might increase the awareness of health professionals towards optimizing diagnostic accuracy and standard treatment.

Use of the Clinical Global Impression scale in sleep apnea patients - Results from the ESADA database.

OBJECTIVE/BACKGROUND: The Clinical Global Impression scale (CGI) reflects the clinician's assessment of the disease impact on patient's global functioning. We assessed predictors of CGI scale rating in patients with obstructive sleep apnea (OSA). PATIENTS/METHODS: Consecutive patients with suspected OSA (n = 7581) were identified in the European Sleep Apnea Database (ESADA). Anthropometrics, comorbidities, apnea severity obtained by polygraphy or polysomnography, and daytime sleepiness [Epworth Sleepiness Scale (ESS)] were assessed. The CGI 7-point scale was completed at the end of the diagnostic process (CGI-severity, ie, CGI-S) and, in a subpopulation, at treatment follow-up (CGI-Improvement). RESULTS: CGI-S was rated mild to moderate in 44% of patients. CGI rating at any given apnea intensity was worse in women than in men (p < 0.01). Patients undergoing polygraphy (n = 5075) were more frequently rated as severely ill compared to those studied with polysomnography (19.0% vs 13.0%, p < 0.001). In patients aged ≤65 years, CGI scoring was generally better than in the elderly despite a similar degree of OSA (eg, 'normal, not ill' 24.2% vs 15.3%, p < 0.01, respectively). Independent predictors of CGI rating included age, BMI, AHI, ESS, cardio-metabolic comorbidities, and diagnosis based on polygraphy. CGI-improvement rating (Beta = -0.406, p < 0.01) was superior to sleep apnea severity or ESS-score (Beta = 0.052 and -0.021, p = 0.154 and 0.538 respectively) at baseline for prediction of good CPAP compliance at follow-up. CONCLUSIONS: CGI rating is confounded by gender, age class and the type of sleep diagnostic method. As OSA phenotypes differ, CGI may contribute as a clinical tool to reflect the significance of clinical disease.

Erickson health coaching: An innovative approach for weight management in obese patients with obstructive sleep apnoea?

Obstructive sleep apnoea (OSA) is a highly prevalent medical condition and amajor cardiovascular risk factor. Obesity is present in ∼70% of patients with OSA, nevertheless, continuous positive airway pressure (CPAP) ventilation - the gold standard therapy for moderate and severe OSA - has no appreciable long-term beneficial effects on obesity, body composition, energy metabolism, physical activities or the incidence of major cardiovascular events. Therefore, effective weight loss strategies in conjunction with CPAP therapy in OSA are critically needed. Since lifestyle interventions may positively impact body weight, there is a strong rationale to testing the hypothesis that Erikson coaching intervention as a form of lifestyle intervention to obese patients with OSA may increase their adherence to healthy lifestyle behaviour and thus result in weight reduction, improved body composition (reduction in %body fat) and improvements in glucose and lipid metabolism. There are three lines of evidence to justify testing this hypothesis: First, health coaching significantly facilitates uptake of healthy behaviours across a broad variety of chronic conditions; second, several randomized clinical trials suggested positive impact of health coaching on weight management and on cardiometabolic risk factors in overweight/obese otherwise healthy persons; third, Erickson coaching approach empowers the three key elements of health coaching (patient-centeredness, patient-determined goals, use of a self-discovery process) further, namely by introducing two other specific core elements into the coaching process: a) solution-focus and outcome frame, b) orientation at the patient-formulated positive outcomes (i.e., positive values resulting from behavioural change). Importantly, results of our recent pilot observational cohort study suggested that Erickson coaching is a powerful tool to address behavioural modification in obesity. In conclusion, testing our hypothesis may have significant clinical implications: if clinical randomized trials indicate that Erickson health coaching is an efficient approach to behavioural change and weight management in OSA then combining Erickson coaching with CPAP therapy may result in reductions in cardiovascular morbidity and mortality in these high-risk patients.

Social support, mastery, sleep-related problems and their association with functional status in untreated obstructive sleep apnoea patients.

BACKGROUND: Social support and mastery are important aspects in the treatment of chronic diseases, however their role in connection with Obstructive Sleep Apnoea (OSA) remains unclear. OBJECTIVES: The study examined the associations between social support, mastery, sleep-related problems and functional status in untreated OSA patients. METHODS: All patients in this cross-sectional study completed the Multidimensional Scale of Perceived Social Support, the Pearlin Mastery Scale, the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire. Multiple linear regression and mediation analyses were used to analyse the data. RESULTS: Participants were 150 newly diagnosed OSA patients (Apnoea-Hypopnoea Index-AHI≥5; 68% male; mean age 48.9 ± 9.5years). Compared with social support, mastery was more strongly associated with functional status. The indirect effects of sleep-related problems on functional status via mastery varied between 17.7% and 23.3%. CONCLUSIONS: Supporting OSA patients' sense of mastery may significantly contribute to better disease management.

Inhaled therapies in patients with moderate COPD in clinical practice: current thinking.

COPD is a complex, heterogeneous condition. Even in the early clinical stages, COPD carries a significant burden, with breathlessness frequently leading to a reduction in exercise capacity and changes that correlate with long-term patient outcomes and mortality. Implementation of an effective management strategy is required to reduce symptoms, preserve lung function, quality of life, and exercise capacity, and prevent exacerbations. However, current clinical practice frequently differs from published guidelines on the management of COPD. This review focuses on the current scientific evidence and expert opinion on the management of moderate COPD: the symptoms arising from moderate airflow obstruction and the burden these symptoms impose, how physical activity can improve disease outcomes, the benefits of dual bronchodilation in COPD, and the limited evidence for the benefits of inhaled corticosteroids in this disease. We emphasize the importance of maximizing bronchodilation in COPD with inhaled dual-bronchodilator treatment, enhancing patient-related outcomes, and enabling the withdrawal of inhaled corticosteroids in COPD in well-defined patient groups.

Phenotypes of COPD patients with a smoking history in Central and Eastern Europe: the POPE Study.

Chronic obstructive pulmonary disease (COPD) represents a major health problem in Central and Eastern European (CEE) countries; however, there are no data regarding clinical phenotypes of these patients in this region.Participation in the Phenotypes of COPD in Central and Eastern Europe (POPE) study was offered to stable patients with COPD in a real-life setting. The primary aim of this study was to assess the prevalence of phenotypes according to predefined criteria. Secondary aims included analysis of differences in symptom load, comorbidities and pharmacological treatment.3362 patients with COPD were recruited in 10 CEE countries. 63% of the population were nonexacerbators, 20.4% frequent exacerbators with chronic bronchitis, 9.5% frequent exacerbators without chronic bronchitis and 6.9% were classified as asthma-COPD overlap. Differences in the distribution of phenotypes between countries were observed, with the highest heterogeneity observed in the nonexacerbator cohort and the lowest heterogeneity observed in the asthma-COPD cohort. There were statistically significant differences in symptom load, lung function, comorbidities and treatment between these phenotypes.The majority of patients with stable COPD in CEE are nonexacerbators; however, there are distinct differences in surrogates of disease severity and therapy between predefined COPD phenotypes.

Severity of nocturnal hypoxia and daytime hypercapnia predicts CPAP failure in patients with COPD and obstructive sleep apnea overlap syndrome.

BACKGROUND: Obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) are independent risk factors for cardiovascular diseases. In patients with OSA and concurrent COPD, continuous positive airway pressure (CPAP) therapy improves survival. Nevertheless, a significant proportion of such patients do not tolerate CPAP. The aim of the present study was to analyze early predictors of CPAP failure in patients with OSA and concurrent COPD, and to evaluate the effects of bilevel positive airway pressure (BiPAP) in this high-risk group of patients. METHODS: A post hoc analysis from the database of 2100 patients diagnosed with OSA between 2012 and 2014 identified 84 subjects as having concomitant COPD and meeting inclusion criteria. Demographic data, pulmonary function tests, OSA parameters, blood gases, response to CPAP and BiPAP titration, and two months of therapy were collected. A multivariate model was generated to find determinants of CPAP failure. RESULTS: Primary CPAP failure was found in 23% of patients who were more obese (p = 0.018), had worse lung function, lower PO2 (p = 0.023) and higher PCO2 while awake (p < 0.001), and more sleep time with an SpO2 < 90% (CT90%) (p < 0.001) compared to those who responded to CPAP. In multivariate analysis, PCO2 while awake [odds ratio (OR) 29.5, confidence interval (CI) 2.22-391, p = 0.010] and CT90% (OR 1.06, CI 1.01-1.11, p = 0.017) independently predicted CPAP failure after adjustments for covariates. The BiPAP therapy was well tolerated and effectively alleviated hypercapnia in all patients with primary CPAP failure. CONCLUSIONS: Daytime hypercapnia and nocturnal hypoxia are independent predictors of early CPAP failure in patients with the OSA-COPD overlap syndrome.

Anti- and Pro-apoptotic Bcl2 Proteins Distribution and Metabolic Profile in Human Coronary Aorta Endothelial Cells Before and After HypPDT.

Understanding apoptosis regulatory mechanisms in endothelial cells (ECs) has great importance for the development of novel therapy strategies for cancer and cardiovascular pathologies. An oxidative stress with the generation of reactive oxygen species (ROS) is a common mechanism causing ECs' dysfunction and apoptosis. The generation of ROS can be triggered by various stimuli including photodynamic therapy (PDT). In most PDT treatments, photosensitizer (PS) is administered systemically, and thus, possibility of high exposure to PS in the ECs remains high. PS accumulation in ECs may be clinically relevant even without PDT, if PS molecules affect the pro-apoptotic cascade without illumination. In the present work, we focused on Hypericin (Hyp) and HypPDT effects on the cell viability, oxidative stress, and the distribution of Bcl2 family members in human coronary artery endothelial (HCAEC) cells. Our findings show that the presence of Hyp itself has an effect on cell viability, oxidative stress, and the distribution of Bcl2 family members, without affecting the mitochondria function. In contrast, HypPDT resulted in mitochondria dysfunction, further increase of oxidative stress and effect on the distribution of Bcl2 family members, and in primarily necrotic type of death in HCAEC cells.

Airway hyperresponsiveness in chronic obstructive pulmonary disease: A marker of asthma-chronic obstructive pulmonary disease overlap syndrome?

BACKGROUND: The impact of airway hyperreactivity (AHR) on respiratory mortality and systemic inflammation among patients with chronic obstructive pulmonary disease (COPD) is largely unknown. We used data from 2 large studies to determine the relationship between AHR and FEV1 decline, respiratory mortality, and systemic inflammation. OBJECTIVES: We sought to determine the relationship of AHR with FEV1 decline, respiratory mortality, and systemic inflammatory burden in patients with COPD in the Lung Health Study (LHS) and the Groningen Leiden Universities Corticosteroids in Obstructive Lung Disease (GLUCOLD) study. METHODS: The LHS enrolled current smokers with mild-to-moderate COPD (n = 5887), and the GLUCOLD study enrolled former and current smokers with moderate-to-severe COPD (n = 51). For the primary analysis, we defined AHR by a methacholine provocation concentration of 4 mg/mL or less, which led to a 20% reduction in FEV1 (PC20). RESULTS: The primary outcomes were FEV1 decline, respiratory mortality, and biomarkers of systemic inflammation. Approximately 24% of LHS participants had AHR. Compared with patients without AHR, patients with AHR had a 2-fold increased risk of respiratory mortality (hazard ratio, 2.38; 95% CI, 1.38-4.11; P = .002) and experienced an accelerated FEV1 decline by 13.2 mL/y in the LHS (P = .007) and by 12.4 mL/y in the much smaller GLUCOLD study (P = .079). Patients with AHR had generally reduced burden of systemic inflammatory biomarkers than did those without AHR. CONCLUSIONS: AHR is common in patients with mild-to-moderate COPD, affecting 1 in 4 patients and identifies a distinct subset of patients who have increased risk of disease progression and mortality. AHR may represent a spectrum of the asthma-COPD overlap phenotype that urgently requires disease modification.

Sarcopenic Obesity, Functional Outcomes, and Systemic Inflammation in Patients With Chronic Obstructive Pulmonary Disease.

BACKGROUND: Both loss of muscle mass (ie, sarcopenia) and obesity adversely impact clinically important outcomes in patients with chronic obstructive pulmonary disease (COPD). Currently, there are only a few studies in patients with COPD with sarcopenia and concurrent obesity, termed sarcopenic obesity (SO). OBJECTIVE: To explore the effects of SO on exercise capacity, health status, and systemic inflammation in COPD. DESIGN/SETTINGS/PARTICIPANTS: Baseline data collected from a total of 2548 participants (2000 patients with COPD, mean age (SD), 63.5 (7.1) years; and 548 controls, 54.8 (9.0) years) from ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study, a multicenter longitudinal observational study, were used. MEASUREMENTS: All participants were divided into 4 body composition phenotypes using bioelectrical impedance analysis: (1) normal body composition, (2) obesity, (3) sarcopenia, and (4) SO. In patients with COPD, the 6-minute walking distance, disease-specific health status, and plasma inflammatory markers were compared among the respective body composition groups. RESULTS: Patients with COPD were 3 times more likely to present with SO compared with controls without COPD (odds ratio [OR] 3.3, 95% confidence interval [CI] 2.0-5.4, P < .001). In patients with COPD, SO was related to reduced 6-minute walking distance (-28.0 m, 95% CI -45.6 to -10.4), P < .01) and to higher systemic inflammatory burden (an elevation of at least 2 inflammatory markers, OR 1.6, 95% CI 1.1-2.5, P = .028) compared with the normal body composition group after adjustments for age, sex, smoking, body mass index, and airflow limitation. CONCLUSIONS: Our findings suggest that SO is associated with worse physical performance and higher systemic inflammatory burden compared with other body composition phenotypes in patients with COPD. TRIAL REGISTRY: ClinicalTrials.gov no. NCT00292552.

POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) constitutes a major health challenge in Central and Eastern European (CEE) countries. However, clinical phenotypes, symptom load, and treatment habits of patients with COPD in CEE countries remain largely unknown. This paper provides a rationale for phenotyping COPD and describes the methodology of a large study in CEE. METHODS/DESIGN: The POPE study is an international, multicenter, observational cross-sectional survey of patients with COPD in CEE. Participation in the study is offered to all consecutive outpatients with stable COPD in 84 centers across the CEE region if they fulfill the following criteria: age >40 years, smoking history ≥10 pack-years, a confirmed diagnosis of COPD with postbronchodilator FEV1/FVC <0.7, and absence of COPD exacerbation ≥4 weeks. Medical history, risk factors for COPD, comorbidities, lung function parameters, symptoms, and pharmaceutical and nonpharmaceutical treatment are recorded. The POPE project is registered in ClinicalTrials.gov with the identifier NCT02119494. OUTCOMES: The primary aim of the POPE study was to phenotype patients with COPD in a real-life setting within CEE countries using predefined classifications. Secondary aims of the study included analysis of differences in symptoms, and diagnostic and therapeutic behavior in participating CEE countries. CONCLUSION: There is increasing acceptance toward a phenotype-driven therapeutic approach in COPD. The POPE study may contribute to reveal important information regarding phenotypes and therapy in real-life CEE.