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Zichen Ji,1,2 Julio Hernández-Vázquez,3 Irene Milagros Domínguez-Zabaleta,1 Ziyi Xia,2 José María Bellón-Cano,4 Virginia Gallo-González,1 Ismael Ali-García,3 Carmen Matesanz-Ruiz,3 Ana López-de-Andrés,5 Rodrigo Jiménez-García,6 María Jesús Buendía-García,3 Ángela Gómez-Sacristán,7 Walther Iván Girón-Matute,1,2,7 Luis Puente-Maestu,1,2,7 Javier de Miguel-Díez1,2,7 1Pulmonology Service, Gregorio Marañón General University Hospital, Madrid, Spain; 2Faculty of Medicine, Complutense University of Madrid, Madrid, Spain; 3Pulmonology Section, Infanta Leonor University Hospital, Madrid, Spain; 4Research Support Service, Gregorio Marañón Health Research Institute, Madrid, Spain; 5Preventive Medicine and Public Health Teaching and Research Unit, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, Spain; 6Public Health and Maternal and Child Health Department, Faculty of Medicine, Complutense University of Madrid, Madrid, Spain; 7Gregorio Marañón Health Research Institute, Madrid, SpainCorrespondence: Zichen JiPulmonology Service, Gregorio Marañón University General Hospital, Madrid 28007, SpainTel +34 617 882 547Email jizich72@gmail.comBackground: Chronic obstructive pulmonary disease (COPD) usually occurs alongside other conditions. Few studies on comorbidities have taken into account the phenotypes of COPD patients. The objective of this study is to evaluate the prevalence of comorbidities included in the Charlson index and their influence on the survival of patients with COPD, taking phenotypes into account.Methods: An observational study was conducted on a group of 273 patients who had COPD and underwent spirometry in the first half of 2011, with a median prospective follow-up period of 68.15 months. The survival of these patients was analyzed according to the presence of various comorbidities.Results: Of the 273 patients, 93 (34.1%) died within the follow-up period. An increased presence of chronic ischemic heart disease (CIHD), chronic heart failure (CHF), chronic kidney disease (CKD), and malignancy was found in deceased patients. All of these conditions shorten the survival of COPD patients globally; however, when considering phenotypes, only CHF influences the exacerbator with chronic bronchitis phenotype, CKD influences the non-exacerbator phenotype, and malignancy influences the positive bronchodilator test (BDT) and exacerbator with chronic bronchitis phenotypes. In the multivariate model, advanced age (hazard ratio, HR: 1.05; p=0.001), CHF (HR: 1.74; p=0.030), and the presence of malignancy (HR: 1.78; p=0.010) were observed as independent mortality risk factors.Conclusion: The survival is shorter in the presence of CIHD in overall COPD patients and also CHF, CKD, and malignancy for certain phenotypes. It is important to pay attention to these comorbidities in the comprehensive care of COPD patients.Keywords: COPD, phenotypes, comorbidities, risk factors, mortality, survival

Javier de Miguel-Díez,1 Ana López-de-Andres,2 Valentín Hernández-Barrera,2 José M de Miguel-Yanes,3 Manuel Méndez-Bailón,4 Rodrigo Jiménez-García2 1Respiratory Department, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid (UCM), Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain; 2Preventive Medicine and Public Health Teaching and Research Unit, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, Spain; 3Internal Medicine Department, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid (UCM), Madrid, Spain; 4Internal Medicine Department, Hospital Universitario Clínico San Carlos, Facultad de Medicina, Universidad Complutense de Madrid (UCM), Madrid, Spain Purpose: To describe trends from 2001 to 2015 in incidence and in-hospital outcomes of patients suffering or not suffering from COPD who had undergone lung transplantation (LTx) in Spain. Methods: We used the Spanish National Hospital Discharge Database to select all admissions for LTx. Incidence was estimated overall and according to the presence of COPD. Outcomes included infections, complications, length of hospital stay and in-hospital mortality (IHM). Results: We identified 2,896 admissions for LTx. Admission rates rose in COPD sufferers and non-COPD sufferers over time, with higher rates among COPD patients. COPD and non-COPD patients were older, but mean age was higher in COPD patients. Although there was a male predominance among patients, the proportion of women significantly increased over time in the COPD population. COPD patients had lower Charlson Comorbidity Index values than non-COPD patients (score ≥1, 25.83% and 31.6%, P

BACKGROUNDIncreasing age is a risk factor for COVID-19 severity and mortality; emerging science implicates GM-CSF and dysregulated myeloid cell responses in the pathophysiology of severe COVID-19.METHODSWe conducted a large, global, double-blind, randomized, placebo-controlled study evaluating a single 90 mg infusion of otilimab (human anti-GM-CSF monoclonal) plus standard of care in adults hospitalized with severe COVID-19 respiratory failure and systemic inflammation, stratified by age and clinical status. Primary outcome was the proportion of patients alive and free of respiratory failure at Day 28; secondary endpoints included all-cause mortality at Day 60.RESULTSOverall, 806 patients were randomized (1:1); 71% of patients receiving otilimab were alive and free of respiratory failure at Day 28 versus 67% receiving placebo, although this did not reach statistical significance (model-adjusted difference 5.3% [95% CI −0.8, 11.4]; p=0.09). However, there was a benefit in the pre-defined ≥70-year age group (model-adjusted difference 19.1% [95% CI 5.2, 33.1]; nominal p=0.009); these patients also had a reduction of 14.4% (95% CI 0.9, 27.9%; nominal p=0.04) in model-adjusted all-cause mortality at Day 60. Safety findings were comparable between otilimab and placebo, and consistent with severe COVID-19.CONCLUSIONSAlthough not statistically significant in the overall population, otilimab demonstrated a substantial benefit in patients aged ≥70, possibly reflecting a population that could benefit from therapeutic blocking of GM-CSF in severe COVID-19 where myeloid cell dysregulation is predominant. These findings are being confirmed in a further cohort of patients aged ≥70 in Part 2 of this study. (ClinicalTrials.gov number: NCT04376684).

Julio Hernández Vázquez,1 Ismael Ali García,1 Rodrigo Jiménez-García,2 Alejandro Álvaro Meca,2 Ana López de Andrés,2 Carmen Matesanz Ruiz,1 María Jesús Buendía García,1 Javier de Miguel Díez3 1Respiratory Department, Hospital Universitario Infanta Leonor, Madrid, Spain; 2Preventive Medicine and Public Health Teaching and Research Unit, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, Spain; 3Respiratory Department, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid (UCM), Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain Background: The aim of the study was to analyze the characteristics and survival of a group of patients with COPD according to their clinical phenotype.Patients and methods: The study population was selected from patients undergoing scheduled spirometry between January 1, 2011 and June 30, 2011 at the respiratory function laboratory of a teaching hospital and comprised those with a previous and confirmed diagnosis of COPD and forced expiratory volume in the first second (FEV1) of

Ana López-de-Andrés,1 José Luis del Barrio,1 Valentín Hernández-Barrera,1 Javier de Miguel-Díez,2 Isabel Jimenez-Trujillo,1 María Angeles Martinez-Huedo,3 Rodrigo Jimenez-García1 1Preventive Medicine and Public Health Teaching and Research Unit, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, Spain; 2Respiratory Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; 3Preventive Medicine and Public Health Department, Teaching and Research Unit, University Hospital La Paz, Madrid, Spain Aims: To investigate the association between migraine and diabetes mellitus while controlling for several socio-demographic characteristics, comorbidities, and lifestyle variables. We also aimed to identify which of these variables are associated with migraine among diabetics.Patients and methods: We conducted a cross-sectional study using data taken from the European Health Interview Surveys for Spain conducted in 2009/10 (n=22,188) and 2014 (n=22,842). We selected those subjects ≥40 years of age. Diabetes status was self-reported. One non-diabetic control was matched by the year of survey, age, and sex for each diabetic case. The presence of migraine was defined as the affirmative answer to both of the following questions: “Have you suffered migraine or frequent headaches over the last 12 months?” and “Has your physician confirmed the diagnosis?”. Independent variables included demographic and socio-economic characteristics, health status variables, lifestyle, and pain characteristics.Results: The prevalence of migraine was significantly higher among those suffering from diabetes (14.9% vs. 13.0%; p=0.021). The multivariable analysis showed that diabetes was not associated with a higher risk of migraine (adjusted OR 1.06; 95%CI 0.89–1.25). Among diabetic subjects, female sex, suffering concomitant mental disorders, respiratory disorders, neck pain, and low back pain were variables associated with suffering from migraine.Conclusion: We found no significant differences in the prevalence of migraine between ­diabetics and non-diabetic age- and sex-matched controls after controlling for possible confounders. Keywords: diabetes, headache, survey, self-rated health, comorbidities, pain medication

Summary Background Among patients presenting with pulmonary embolism (PE), those with diabetes are at increased risk to die than those without diabetes. The reasons have not been identified. We used the RIETE (Registro Informatizado Enfermedad Trombo Embolica) database to compare the mortality rate and the causes of death during anticoagulation in patients with PE according to the presence or absence of diabetes. Methods A matched retrospective cohort study from consecutively enrolled patients in RIETE, from 179 hospitals in 24 countries. For each patient with diabetes we selected two patients with no diabetes matched by age, sex and year of diagnosis of the PE. Results As of September 2017, there were 2010 PE patients with diabetes and two age-and-gender matched controls. Mean age was 74 ± 11 years, 46% were men. Patients with diabetes were more likely to have co-morbidities, to be using antiplatelets and to have more severe PE. During anticoagulation (median, 219 days), patients with diabetes had a higher mortality (hazard ratio [HR]: 1.45; 95% confidence intervals [CI]: 1.25–1.67) and a higher rate of arterial ischemic events (HR: 2.89; 95%CI: 1.71–4.94) than those without diabetes. On multivariable analysis, diabetes was not associated with an increased risk for death (HR: 1.26; 95%CI: 0.97–1.63). We also failed to find differences according to the use of antiplatelet drugs concomitantly. Conclusions In our cohort of patients with PE, diabetes was not an independent predictor for death. The influence of arterial events or antiplatelet drugs (if any) was low.