University of Groningen Effectiveness and Safety of Medicines Used in COPD Patients Wang, Yuanyuan

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University of Groningen Effectiveness and Safety of Medicines Used in COPD Patients Wang, Yuanyuan University of Groningen Effectiveness and safety of medicines used in COPD patients Wang, Yuanyuan DOI: 10.33612/diss.123921981 IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2020 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Wang, Y. (2020). Effectiveness and safety of medicines used in COPD patients: pharmacoepidemiological studies. University of Groningen. https://doi.org/10.33612/diss.123921981 Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license. More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne- amendment. Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 09-10-2021 Efectiveness and safety of medicines used in COPD patients Pharmacoepidemiological studies Yuanyuan Wang Paranymphs: Jurjen van der Schans Yanni Li Efectiveness and safety of medicines used in COPD patients Pharmacoepidemiological studies ISBN: 978-94-034-2555-9 (printed version) ISBN: 978-94-034-2554-2 (electric version) Author: Yuanyuan Wang Cover-design: IRINA SHI (photo) & Of Page (content) Printing: Of Page (www.ofpage.nl) The studies presented in this thesis were funded by University of Groningen and the China Scholarship Council (CSC) Scholarship. This thesis was conducted within the Groningen University Institute for Drug Exploration (GUIDE). Printing of this thesis was fnancially supported by the University of Groningen and the Graduate School of Science and Engineering (GSSE). Copyright ©Yuanyuan Wang, 2020, Groningen, The Netherlands. All rights reserved. No part of this book may be reproduced or transmitted in any form by any means, electronically or mechanically by photocopying, recording, or otherwise, without the written permission of the author. The copy right of previously published chapters of this thesis remains with the publisher or journal. Effectiveness and safety of medicines used in COPD patients Pharmacoepidemiological studies PhD thesis to obtain the degree of PhD at the University of Groningen on the authority of the Rector Magnificus Prof. C. Wijmenga and in accordance with the decision by the College of Deans. This thesis will be defended in public on Friday 8 May 2020 at 14.30 hours by Yuanyuan Wang born on 15 February 1988 in Henan, China Supervisors Prof. Ha Prof. H.M. oeen Assessment Committee Prof. T..M. erheij Prof. van der Palen Prof. tienstra Supervisors TABLE OF CONTENTS Prof. Ha Prof. H.M. oeen Chapter 1 General Introduction 7 Part I Efects of antibiotic use for COPD exacerbations and potential DDIs during COPD exacerbation management Assessment Committee Prof. T..M. erheij Chapter 2 Efects of Prophylactic Antibiotics on Patients with Stable COPD: 21 Prof. van der Palen A Systematic Review and Meta-Analysis of Prof. tienstra Randomized Controlled Trials Chapter 3 The infuence of age on real-life efects of doxycycline for 43 acute exacerbations among COPD outpatients: a population-based cohort study Chapter 4 Real-world short- and long-term efects of antibiotic therapy on 61 acute exacerbations of COPD in outpatients: a cohort study under the PharmLines Initiative Chapter 5 Improving antibacterial prescribing safety in 81 the management of COPD exacerbations: systematic review of observational and clinical studies on potential drug interactions associated with frequently prescribed antibacterials among COPD Patients Part II Neuropsychiatric safety of varenicline use for smoking cessation and the application of prescription sequence symmetry analysis in drug safety evaluation Chapter 6 Neuropsychiatric safety of varenicline in the general and 119 COPD population with and without psychiatric disorders: a retrospective inception cohort study in a real-world setting Chapter 7 Risk of neuropsychiatric adverse events associated with 145 varenicline treatment for smoking cessation: a prescription sequence symmetry analysis Chapter 8 Efect estimate comparison between the prescription 165 sequence symmetry analysis and parallel group study designs: a systematic review Chapter 9 General discussion 183 Chapter 10 Summary 197 Samenvatting 201 Acknowledgement 204 List of publications 208 About the author 211 CHAPTER 1 General Introduction General Introduction GENERAL INTRODUCTION 1 Chronic obstructive pulmonary disease According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) report 2020, Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airfow limitation. Such symptoms are caused by airway and/or alveolar abnormalities usually triggered by signifcant exposure to noxious particles or gases.1 Cigarette smoking is the main independent causal risk factor for COPD with indoor and outdoor air pollution and occupational exposure to dust and noxious particles also being the risk factors for COPD.2 Moreover, host factors that may contribute to the development of COPD include age, genetics, airway hyper responsiveness and abnormal lung development.3-5 The prevalence of COPD varies across countries as well as regions within countries. According to the fndings of a global meta-analysis, the number of COPD cases increased to 384 million in 2010, with a global prevalence of 12% (ranging between 8% and 15%).6 COPD is commonly diagnosed in individuals aged 40 years or older based on the presence of associated symptoms and risk factors. However, a defnitive COPD diagnosis requires the performance of spirometry. The presence of a post- bronchodilator FEV1/FVC < 0.7 confrms the presence of airfow limitation and results in a COPD diagnosis. COPD patients are currently categorized into four GOLD stages of severity of airfow limitations based on the predicted value of FEV1: mild (stage I, FEV1 ≥ 80% predicted), moderate (stage II, 50% ≤ FEV1 < 80% predicted), severe (stage III, 1 30% ≤ FEV1 < 80% predicted) and very severe (stage IV, FEV1 < 30% predicted). A large prevalence study estimated that the rate of COPD for GOLD stage II and higher is around 10% in the general population, and a little higher in men than women (11.8% and 8.5%, respectively).7 COPD is one of the leading causes of morbidity and mortality worldwide.8 Its burden is predicted to increase in the coming decades as a result of continuous exposure to risk factors in developing countries and aging of the population worldwide, particularly in high-income countries.9 Smoking cessation interventions, increased physical activity, and early diagnosis and treatment of related comorbidities are considered key measures for reducing the health-economic burden of COPD. 10 Up to now, the key goals of COPD treatment have been to improve patients’ prognosis and prevent the disease from worsening. The main treatment used in the daily management of mild and moderate COPD is pharmacotherapy. Bronchodilators, including short- and long-acting β2-agonists (SABA and LABA) and short- and long-acting anticholinergics (SAMA and LAMA) are essential for managing and preventing symptoms, and combined treatment (SABA/SAMA, LABA/LAMA or LABA/ICS) may be used as appropriate. Non- 9 Chapter 1 pharmacological treatment comprises pulmonary rehabilitation (e.g., exercise training, education, and behavioral change).11 Oxygen therapy is necessary for patients with very severe COPD and lung surgery may also be necessary. Exacerbations of COPD and antibiotic use An exacerbation of COPD is defned as an acute worsening of respiratory symptoms that necessitates additional therapy.1 COPD patients can periodically experience acute exacerbations that may accelerate the decline in lung function, reduce the quality of life, and increase mortality and health-care costs.12,13 14 Infections, especially bacterial infections, and infammation are thought to be an important trigger for exacerbations of COPD. Previous studies have found that bacteria are responsible for around 40% to 50% of exacerbations.15,16 S. pneumoniae, H. infuenza, P. aeruginosa, M. catarrhalis, A. baumannii, and S. aureus were the most frequently reported bacteria that cause exacerbations of COPD.16-18 According to the GOLD guideline, the main goals in treatment of COPD exacerbations are minimizing the negative impact of the current exacerbation and preventing subsequent exacerbations.1 Because almost 40% of exacerbations are bacteria-caused respiratory tract infections,16 the use of antibiotics has become a common component in the management of acute exacerbations among COPD patients, both in terms of treatment and prevention.1,19 Notably, recommendations in prophylactic use of antibiotics in the management
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