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      COPD from an everyday primary care point of view

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          Abstract

          Introduction:

          The purpose of this study is to use real world evidence on treatment use to evaluate drug superiority within the same treatment group.

          Methods:

          Retrospective cohort analysis using the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP). Data includes longitudinal routine clinical data extracted from practice records of 7,890,485 patients. All subjects with an incident diagnosis of COPD in the database BIFAP between January 1 2010 and December 31 2012 were included in the cohort study. Cox regression analysis was performed to compare the hazard of COPD exacerbation outcome of the four principal cohorts (no therapy, monotherapy, double therapies with and without corticoids, and triple therapy) and within each principal cohort between the different treatment combinations.

          Results:

          27,739 patients with COPD were included in the analysis. The median age was 64 years, male proportion was 69% and 70% were smokers. 58,042.9 person--years of follow-up were obtained for the cohort with a mean follow-up of 2.09 years per subject. The strongest factor associated with an increased risk of exacerbation was suffering an exacerbation the previous year (HR = 1.82[1.76--1.87 95%CI]). No differences were found between the most frequent monotherapies, double therapies without corticoid, or triple therapy. When comparing the different combinations of double therapies with corticoid, salmeterol/fluticasone combination (HR = 1.16[1.08--1.24]) revealed a higher adjusted hazard of exacerbation when compared with formoterol/budesonide.

          Conclusions:

          Treatment with a combination of budesonide/formoterol was associated with lower exacerbations than the treatment with fluticasone/salmeterol. The analysis did not reveal any differences in terms of exacerbation in monotherapy, double therapy without corticoids, and triple therapy combinations.

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          Most cited references20

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          Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study.

          We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease (COPD) and a history of at least one moderate to severe exacerbation in the previous 12 months.
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            Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study

            Introduction We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD. Methods This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy. Patients were randomized to receive UMEC/VI (62.5/25 µg once daily) via a multidose dry powder inhaler (ELLIPTA) followed by TIO/OLO (5/5 µg once daily) via a soft mist inhaler (Respimat), each for 8 weeks with an interim 3-week washout or vice versa. The primary end point was the change from baseline in trough FEV1 at week 8 with a noninferiority margin of − 50 mL in the per-protocol (PP) population. The incidence of adverse events was also assessed. Results In total, 236 patients (mean age 64.4 years, 60% male) were included in the intent-to-treat population and 227 were included in the PP population. UMEC/VI treatment was noninferior in the PP population and superior in the intent-to-treat population to TIO/OLO treatment with regard to trough FEV1 at week 8 [FEV1 change from baseline 180 mL vs 128 mL; difference 52 mL (95% confidence interval 28–77 mL); p < 0.001]. Patients receiving UMEC/VI had twofold increased odds of experiencing a clinically meaningful increase (100 mL or more) from baseline in trough FEV1 at week 8 compared with patients receiving TIO/OLO (odds ratio 2.05; 95% confidence interval 1.34–3.14). Adverse events occurred in 25% of patients in the UMEC/VI group and in 31% of patients in the TIO/OLO group. Conclusion In this first direct comparison of two once-daily fixed-dose LAMA/LABA combinations, superiority was observed for the primary end point of trough FEV1 at week 8 with UMEC/VI compared with TIO/OLO in patients with symptomatic COPD. Both treatments had similar safety profiles. These findings confirm the results of previous indirect LAMA/LABA comparisons, and show that an efficacy gradient exists within the LAMA/LABA class. Trial Registration ClinicalTrials.gov identifier NCT02799784. Funding GlaxoSmithKline. Electronic supplementary material The online version of this article (doi:10.1007/s12325-017-0626-4) contains supplementary material, which is available to authorized users.
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              Long-acting muscarinic antagonist (LAMA) plus long-acting beta-agonist (LABA) versus LABA plus inhaled corticosteroid (ICS) for stable chronic obstructive pulmonary disease (COPD)

              Three classes of inhaler medications are used to manage chronic obstructive pulmonary disease (COPD): long-acting beta-agonists (LABA), long-acting muscarinic antagonists (LAMA), and inhaled corticosteroids (ICS). When two classes of medications are required, LAMA plus LABA (LAMA+LABA) and LABA plus ICS (LABA+ICS) are often selected because these combinations can be administered via a single medication device. The previous Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidance recommended LABA+ICS as the first-line treatment for managing stable COPD in high-risk people of categories C and D. However, the updated GOLD 2017 guidance recommends LAMA+LABA over LABA+ICS.
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                Author and article information

                Journal
                J Family Med Prim Care
                J Family Med Prim Care
                JFMPC
                Journal of Family Medicine and Primary Care
                Wolters Kluwer - Medknow (India )
                2249-4863
                2278-7135
                August 2019
                28 August 2019
                : 8
                : 8
                : 2644-2650
                Affiliations
                [1 ] Family Physician, Centro de Salud Puerta de Madrid, Atención Primaria de Madrid, Spain
                [2 ] Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria, Spanish Agency of Medicines and Medical Devices, Madrid, Spain
                Author notes
                Address for correspondence: Dr. Antonio L. Aguilar-Shea, Especialista en Medicina Familiar y Comunitaria, E.A.P. Puerta de Madrid, Avda del Ejército 61, 28802 Alcalá de Henares, Madrid. E-mail: antonio.aguilar@ 123456salud.madrid.org
                Article
                JFMPC-8-2644
                10.4103/jfmpc.jfmpc_477_19
                6753803
                3b18c9f3-fb62-40b5-a14e-5f424c7e1bad
                Copyright: © 2019 Journal of Family Medicine and Primary Care

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

                History
                : 19 June 2019
                : 20 June 2019
                : 12 July 2019
                Categories
                Original Article

                chronic obstructive pulmonary disease,exacerbations,inhaled corticosteroids,inhaled therapy,long-acting β2-agonist,long-acting muscarinic antagonist,observational study,primary care

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