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Anders Løkke,1,2 Ole Hilberg,1,2 Peter Lange,3,4 Rikke Ibsen,5 Gunilla Telg,6 Georgios Stratelis,6 Jesper Lykkegaard7 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5i2Minds, Aarhus, Denmark; 6AstraZeneca Nordic, Södertälje, Sweden; 7Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, DenmarkCorrespondence: Anders Løkke, Department of Medicine, Little Belt Hospital, Vejle, Denmark, Email Anders.Lokke@rsyd.dkObjective: Patients with chronic obstructive pulmonary disease (COPD) commonly present with cardiovascular disease (CVD). We investigated the association between COPD exacerbations and major cardiovascular (CV) events in a COPD population with a history of CVD.Methods: This population-based and register-based cohort study identified all Danish COPD patients aged ≥ 40 years who visited a hospital-based, pulmonary outpatient clinic for COPD between 1st January, 2010, and 31st December, 2016, from a nationwide COPD registry. Patients with a history of a major CV event 36‒6 months prior to their COPD measurement date and no CV event 6 months before this date were included. During a 6-month assessment period, the risks of a new CV event (hospitalization with fatal/non-fatal stroke, myocardial infarction, or heart failure) and moderate and severe COPD exacerbations were evaluated. Odds ratios with 95% confidence intervals for CV events and death were estimated using adjusted logistic regression models.Results: Of the 1501 COPD patients included, 55% experienced a COPD exacerbation and 13% experienced both an exacerbation and a CV event during follow-up (6 months). The odds of a CV event were 1.5 times higher in patients with a moderate exacerbation and more than 6-times higher in those with a severe exacerbation vs patients with no exacerbation(s). The majority of CV events occurred within 30 days post exacerbation in patients who experienced both an exacerbation and a CV event. In total, 113 patients died during the study period: 28% of deaths were caused by CVD and 72% by reasons other than CVD, mostly COPD.Conclusion: In patients with known CVD, severe COPD exacerbations are associated with increased odds of major CV events that occur within 30 days post exacerbation, highlighting the need to prevent exacerbations in COPD patients with concomitant CVD to potentially improve both respiratory and CV health.Keywords: concomitant cardiovascular disease, respiratory health, cardiovascular health, prevention, real-world evidence

Anders Løkke,1,2 Ole Hilberg,1,2 Peter Lange,3,4 Rikke Ibsen,5 Georgios Stratelis,6,7 Sofie de Fine Licht,6 Jesper Lykkegaard8 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5i2Minds, Aarhus, Denmark; 6AstraZeneca Nordic, Södertälje, Sweden; 7Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden; 8Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, DenmarkCorrespondence: Anders Løkke, Email Anders.Lokke@rsyd.dkIntroduction: Studies have shown that exacerbation in chronic obstructive pulmonary disease (COPD) increases the risk of further exacerbations. Our aim was to investigate the impact of a single moderate exacerbation on the odds of subsequent exacerbations and death in GOLD B COPD patients.Methods: This hospital-based nationwide, cohort study in Denmark included all patients ≥ 40 years of age with an in- and/or outpatient ICD-10 J44 diagnosis (COPD Register, 2008– 2014). Index was date of first registered modified Medical Research Council (mMRC) score ≥ 2; baseline period was 12 months pre-index. At index, patients were grouped as: B0, no exacerbation; and B1, one moderate exacerbation during the previous year, and followed for three consecutive years in 2008– 2017 for development of moderate- (short-term use of prednisolone or prednisone) and severe (emergency visit or hospitalization) exacerbations and death. Using B0 as reference, the odds ratio (OR) for exacerbation and death in GOLD B1 was estimated with multinominal logistic regression and a Cox model estimated the hazard ratio for exacerbation accounting for recurrent events.Results: In total, 8,453 patients (mean age 70 years, 51% male) were included, of which GOLD B0 4,545 and GOLD B1 3,908 patients. During the 3-year follow-up, 34.1% and 24.9% of GOLD B0 and B1, respectively, had none or one moderate exacerbation whereas 61.9% and 71.2% of B0 and B1, respectively, had a severe trajectory with multiple moderate and/or a severe exacerbation or died. In B1 patients, the OR for 1 moderate, ≥ 2 moderate exacerbations, ≥ 1 severe exacerbation was 1.58 [CI 1.33– 1.87], 2.60 [2.19– 3.08], 2.08 [1.76– 2.45], respectively, and 1.85 [1.57– 2.17] for death compared with B0.Conclusion: One moderate exacerbation in COPD patients with high symptom burden increases the odds of subsequent exacerbations and death during the three following years. The results emphasize the importance of preventing exacerbations in GOLD B patients.Keywords: COPD, exacerbation, dyspnea, GOLD, mortality, epidemiology

Dea Kejlberg Andelius,1 Ole Hilberg,2,3 Rikke Ibsen,4 Anders Løkke2,3 1Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Department of Medicine, Vejle, Little Belt Hospital, Vejle, Denmark; 3Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 4i2minds, Aarhus, 8000, DenmarkCorrespondence: Dea Kejlberg Andelius Email dea-jensen@hotmail.comBackground: Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that is mainly caused by smoking, and most patients with COPD are either former or current smokers. The optimal way to slow down disease progression and reduce overall mortality is for patients to stop smoking. Patients with COPD are known to have lower socio-economic status and to be more nicotine-dependent than most other smokers and therefore face difficulties when attempting to quit smoking. Pharmacological smoking cessation treatment is known to be the most effective. However, the extent to which this treatment is actually offered to Danish smokers with COPD is unknown.Aim: The aim of this study was to investigate if patients with COPD were more likely to redeem a prescription for smoking cessation medication compared with matched controls.Materials and Methods: The study was designed as a registry-based, non-interventional case-control study. All Danish patients with COPD (ICD-10-code J 44 chronic obstructive pulmonary disease) diagnosed between 2009 and 2015 were included (130,797 cases). Controls (252,216) were matched on age, gender and geography. Primary outcome was the number of redeemed prescriptions for smoking cessation medication.Results: We found that 12% of patients with COPD redeemed a prescription for smoking cessation medication during the eight-year study period. The odds ratio (OR) for redeeming a prescription on smoking cessation medicine was OR 6.22 for patients with COPD compared with their matched controls. We also found that patients with COPD were more likely to redeem smoking cessation medication if they were younger, female or single.Conclusion: There is substantial room for improvement with respect to pharmacological smoking cessation treatment in Danish patients with COPD. In-depth knowledge of factors contributing to the patients choice of smoking cessation treatment might allow for more personalized guidance of patients with COPD.Keywords: nicotine, bupropion, varenicline, smoking cessation, COPD

Anders Løkke,1,2 Peter Lange,3,4 Jesper Lykkegaard,5 Rikke Ibsen,6 Maria Andersson,7 Sofie de Fine Licht,8 Ole Hilberg1,2 1Department of Medicine, Little Belt Hospital, Vejle, Denmark; 2Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 3Medical Department, Copenhagen University Hospital-Herlev, Herlev, Denmark; 4Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; 5Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark; 6i2Minds, Aarhus, Denmark; 7AstraZeneca Nordic, IVS & Health Economics, Södertälje, Sweden; 8AstraZeneca Nordic,Medical & Regulatory, Södertälje, SwedenCorrespondence: Anders LøkkeUniversity of Southern Denmark, Odense, DenmarkEmail Aloekke@gmail.comBackground: Chronic Obstructive Pulmonary Disease (COPD) carries a considerable economic burden, both for individuals and societies. This study aimed to assess direct and indirect costs associated with COPD, and how costs vary across disease severity.Methods: This was a nationwide, population-based cohort study utilizing Danish health registries. Patients; ≥ 40 years of age, with an in- and/or outpatient diagnosis of COPD (ICD-10 J44) in 2008– 2016, were identified in the nationwide Danish COPD Registry. Included patients were matched 1:4 to a population-based non-COPD reference population of 196,623 individuals by sex, year of birth, co-habitation status, and municipality. Patients were grouped by disease severity according to different characteristics including GOLD groups A-D, based on moderate (short-term oral corticosteroid use), presence of severe exacerbations (emergency visit or hospitalization) and symptom score. Index was the date of the first outpatient visit with a symptom score registration. The costs were calculated during a 12 months post-index follow-up.Results: In all, 49,826 patients with COPD (mean age 69.2 years, 52% females) were included. Total annual costs, including direct costs, costs for elderly care, and costs for retirement home, were higher for patients with COPD (€ 28,969) compared with the reference population (€ 10,6913). In GOLD groups A-D, the total direct costs were A: € 8,766, B: € 13,060, C: € 11,113, and D: € 17,749, respectively. A major driver of direct costs was severe exacerbations. The mean costs per moderate and severe exacerbation were € 888 and € 7,091, respectively, during 28 days of follow-up. The costs for non-COPD-related Health Care Resource Utilization were higher than the COPD-related costs in GOLD groups A-C, but not in GOLD group D.Conclusion: In this nationwide real-world study, total direct costs were three-fold higher among patients with COPD compared with the reference population. Severe exacerbations were a major driver of the direct costs. The costs increased with increasing disease severity.Keywords: COPD, exacerbations, symptoms, cost, GOLD

Objective: Information on borderline personality disorder (BPD) and its comorbidities is often limited to concentrate on a few diagnoses. The aim of the study was to use national register data to investigate all diagnostic co‐occurring mental health disorders and somatic diseases 3 years before and after initial BPD diagnosis compared with a matched control group. Method: The study was a register‐based cohort of 2756 patients with incident BPD (ICD F60.3) and 11,024 matched controls, during 2002–2016. Comorbidity data were classified into main disease groups, in accordance with the World Health Organization ICD‐10 criteria. Results: Almost half the patients had been diagnosed with mental and behavioral disorders before the BPD diagnosis as compared to 3% in the control group. Further, the co‐occurrence of diseases due to external causes of morbidity, including injury, self‐harm, and poisoning were more represented in the BPD group before diagnosis as compared to the control group. In addition, co‐occurring morbidity related to diseases in the circulatory, the respiratory, the digestive, the musculoskeletal, and the genitourinary system was more represented in the BPD group. After diagnosis, the proportion of patients with co‐occurring morbidity increased further in all main disease groups in the BPD group. As many as 87% of patients had mental and behavioral co‐occurring morbidity and 15% nervous diseases as compared with 3% and 4%, respectively, in the control group. Also, comorbidities related to external causes of morbidity, including for example, injury and self‐harm were more represented in the BPD group. The BPD group had more somatic co‐occurring morbidity, especially digestive, respiratory, circulatory, and endocrine diseases. Finally, the mortality over 12 years was statistically significantly higher in people with BPD than in the control group. Conclusion: Patients with BPD have higher odds for multiple physical health conditions and co‐occurrence of mental health disorders. [ABSTRACT FROM AUTHOR]

Poul Jennum,1,2 Philip Tønnesen,1 Rikke Ibsen,3 Jakob Kjellberg4 1Danish Center for Sleep Medicine, Department of Clinical Neurophysiology, Glostrup Hospital, Copenhagen, Denmark; 2Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark; 3itracks, Aarhus, Denmark, 4Danish National Institute for Local and Regional Government Research, Copenhagen, Denmark Background: More information is needed about the effect on mortality of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA), especially in women. Methods: We employed a historical cohort study design, using data from 25,389 patients with a diagnosis of OSA selected from the Danish National Patient Registry for the period 1999–2009. We used Cox proportional hazard function to evaluate the all-cause mortality from OSA in middle-aged and elderly males and females who were treated, or not, with CPAP. Results: Female OSA patients had a lower mortality than males, irrespective of whether they received CPAP treatment. CPAP treatment improved survival, as illustrated by the hazard ratio of 0.62 (P