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Faustine Dalon,1 Gilles Devouassoux,2,3 Manon Belhassen,1,4 Gaëlle Nachbaur,5 Camille Correia Da Silva,5 Lynda Sail,5 Flore Jacoud,1 Christos Chouaid,6 Eric Van Ganse1,2,41PELyon, PharmacoEpidemiology, Lyon, France; 2Pulmonary Department, Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France; 3EA 7426, PI3, Inflammation & Immunité de L’épithélium Respiratoire, Université Claude-Bernard-Lyon1, Lyon, France; 4EA 7425 HESPER Health Services and Performance Research, Université Claude-Bernard-Lyon1, Lyon, France; 5GlaxoSmithKline France, Pharmaco Epidemiology and Health Economics and Outcomes Research, Rueil-Malmaison, France; 6Pulmonary Department, CHI de Créteil, Créteil, FranceCorrespondence: Faustine DalonPELyon, Immeuble Le Solaris, 210 Avenue Jean Jaurès, Lyon 69007, FranceTel +33 481 099 605Email faustine.dalon@pelyon.frPurpose: This study assessed therapy persistence in patients with chronic obstructive pulmonary disease (COPD) in France, and the impact of non-persistence on exacerbations and described COPD-related healthcare resource use (HRU).Methods: Patients aged ≥45 years who received ≥1 dispensed bronchodilator per quarter over three consecutive quarters between 2007 and 2014 and initiated specific COPD therapy were selected from the Echantillon Généraliste des Bénéficiaires (EGB) database. Persistence, defined as the absence of dispensing gaps of >90 days, was measured at 12 months. Exacerbations were compared between persistent and non-persistent patients during follow-up after patient matching and adjustment for confounding factors. COPD-related HRU during follow-up was described.Results: Among 4020 patients with COPD, 2164 initiated a specific therapy. Of these, 54.4% stopped treatment within 12 months. Persistence with all COPD therapy regimens was low, particularly for inhaled corticosteroid (ICS; 25.6%) and ICS/twice-daily long-acting beta-agonist (39.4%) regimens. Among 721 persistent patients who were matched with 721 non-persistent patients, there was no difference in the number of moderate or severe exacerbations at 12 months. However, medical procedures (for instance, pulmonary function testing and chest X-rays) were more frequently observed among persistent patients than among non-persistent patients, suggesting worse disease severity.Conclusion: Patients receiving specific treatment(s) for COPD demonstrated low persistence for all examined therapy regimens, with no clear impact of persistence status on the frequency of exacerbations at 12 months.Keywords: COPD, therapy, persistence, exacerbations, healthcare resource use

Faustine Dalon,1 Nicolas Roche,2 Manon Belhassen,1 Maëva Nolin,1 Hervé Pegliasco,3 Gaëtan Deslée,4 Bruno Housset,5 Philippe Devillier,6 Eric Van Ganse1,7–81Pharmacoepidemiology Department, PELyon, Lyon, France; 2Respiratory Medicine, Cochin Hospital, AP-HP and Paris Descartes University (EA2511), Sorbonne Paris Cité, Paris, France; 3Pulmonary Department, European Hospital, Marseille, France; 4Pulmonary Department, INSERM U1250, Maison Blanche University Hospital, Reims, France; 5Pulmonary Department, CHI de Créteil, University Paris Est Créteil, Créteil, France; 6Department of Airway Diseases, UPRES EA 220, Foch Hospital, Paris-Saclay University, Suresnes, France; 7EA 7425 Hesper Health Services and Performance Research, Claude-Bernard University, Lyon, France; 8Respiratory Medicine, Croix-rousse Hospital, Lyon, FranceCorrespondence: Faustine DalonPELyon, 11 Rue Guillaume Paradin, Lyon 69008, FranceTel +33 47 877 1024Fax +33 47 877 8660Email faustine.dalon@univ-lyon1.frPurposes: Following a hospitalization for COPD, dual and triple therapies were compared in terms of persistence and relations with outcomes (exacerbations, health care resource use and costs).Methods: This was a historical observational database study. All patients aged ≥45 hospitalized for COPD between 2007 and 2015 were identified in a 1/97th, random sample of French claims data. Patients receiving dual therapy within 60 days after hospitalization were compared to patients receiving triple therapy, after propensity score matching on disease severity.Results: Of the 3,089 patients hospitalized for COPD, 1,538 (49.8%) received either dual or triple therapy in the 2 months following inclusion, and 1,500 (48.6%) had at least 30 days of follow-up available; 846 (27.4%) received dual therapy, and 654 (21.2%) received triple therapy. After matching, the number of exacerbations was 2.4 per year in the dual vs 2.3 in the triple group (p=0.45). Among newly treated patients (n=206), persistence at 12 months was similar in the dual and triple groups (48% vs 41%, respectively, p=0.37). As compared to patients on dual therapy, more patients on triple therapy received oral corticosteroids (49.1 vs 40.4%, p=0.003) or were hospitalized for any reason (67%vs 55.8%, p=0.0001) or for COPD (35.3 vs 25.1%, p=0.0002) during follow-up. Cost of care was higher for patients on triple than for those on dual therapy (€11,877.1 vs €9,825.1, p=0.01).Conclusion: Following hospitalizations for COPD, patients on dual and triple therapy experienced recurrent exacerbations, limited adherence to therapies and high cost of care. Patients on triple therapy appeared more severe than those on dual therapy, as reflected by exacerbations and health care resource use.Keywords: COPD, therapy, persistence, exacerbations, health care resource use

Non‐vitamin K antagonists oral anticoagulants (NOACs) have recently challenged vitamin‐K antagonists (VKAs) for stroke and systemic embolism prophylaxis in patients with non‐valvular atrial fibrillation (NVAF). Nevertheless, little information is available in routine clinical practice for France. The aim of this study is to describe the effectiveness and safety of apixaban, rivaroxaban, dabigatran or VKAs in routine clinical practice in adult NVAF patients for the prevention of stroke and systemic embolism in France. The NAXOS study is a nationwide observational retrospective cohort generated from the French national healthcare insurance database (SNIIRAM—a comprehensive in‐ and outpatient healthcare consumption database), consisting of eight distinct sub‐cohorts of anticoagulant‐naive or anticoagulant‐experienced patients diagnosed with NVAF, newly initiated with either NOACs (dabigatran, rivaroxaban or apixaban) or VKAs. Patients will be included if initiating a new anticoagulant treatment for AF during the study period from 1 January 2014 to 31 December 2016. Primary effectiveness outcome will be the incidence of stroke or systemic thromboembolic events; primary safety outcome will be the incidence of major bleeding during the exposure period. The NAXOS study will provide routine clinical practice data on the effectiveness and safety profiles of apixaban vs other NOACs and VKAs in the prevention of stroke and systemic embolism in adult patients with NVAF in clinical practice conditions in France.

Additional file 1: Table S1. ICD-10 codes for exclusion criteria. Table S2. ICD-10 codes for acute respiratory-related hospitalisations (main diagnosis). Table S3. Unadjusted incidence rates and cumulative incidence of mortality in patients newly treated in 2016 with antifibrotic drugs. Figure S1. Comparison of overall mortality in patients newly treated in 2016 with pirfenidone or nintedanib.

Inhaled corticosteroids (ICS) adherence is important for asthma management. Current evidence on the impact of ICS adherence on outcomes is mostly based on correlational analyses of between-person data. Although it is widely acknowledged that asthma outcomes fluctuate over time, evidence on predictors of within-person change is scarce. We aimed to quantify these fluctuations and the longitudinal relationships between ICS adherence and outcomes at both between- and within-person levels.A prospective cohort of persistent asthma patients in France and the UK (n=847, age 6−40 years) provided 3756 reports over up to 2 yearsviacomputer-assisted telephone interviews and text messages on ICS adherence, asthma control, reliever medication use and exacerbations. We examined adherence−outcome relationshipsvialongitudinal models, controlling for confounders, including severity.Considerable within-person variability was found for exacerbations (91%), asthma control (59%) and reliever use (52%); 431 (11.5%) reports signalled exacerbations and 2046 (54.5%) poor control. At between-person level, patients with higher average adherence were more likely to report asthma control (OR 1.25, 95% CI 1.06−1.47), but not asthma exacerbations (OR 0.99, 95% CI 0.87−1.12) or lower reliever use (b −0.0004, 95% CI −0.089−0.088). At within-person level, higher-than-usual adherence was associated with higher concomitant reliever use (b 0.092, 95% CI 0.053−0.131) and lower subsequent reliever use (b −0.047, 95% CI −0.005− −0.088); it was unrelated to asthma control (OR 0.93, 95% CI 0.84−1.02) or exacerbations (OR 1.04, 95% CI 0.94−1.16).Patients maintaining high ICS adherence over time have better asthma control. Temporarily increasing ICS adherence tends to be simultaneous to higher reliever use and reduces reliever use later on. Causes of within-person variation in outcomes require more investigation.