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Asthma Epidemiology, Treatment and Exacerbations in Real Life

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Asthma Epidemiology, Treatment and Exacerbations in Real Life ASTHMA EPIDEMIOLOGY, TREATMENT AND EXACERBATIONS IN REAL LIFE Marjolein Engelkes The work presented in this thesis was conducted at the Department of Medical Informatics and the Department of Pediatric Pulmonology of the Erasmus Medical Center, Rotterdam, the Netherlands. The contribution of all the participating patients, physicians, pharmacists and staff of the IPCI database, the PHARMO Database Network and the EU-ADR alliance is greatly acknowledged. The research in this thesis is supported by grants from the Netherlands Organisation for Health Research and Development (ZonMw; priority for medicines for children) and by the stichting astma bestrijding. Financial support for the publication of this thesis was kindly provided by Erasmus Medical Cen- ter, Chiesi, Longfonds, Interdisciplinary Processing of Clinical Information (IPCI) group of the department of Medical Informatics, Bayer, het Nederlands Bijwerkingen Fonds, Stichting Astma Bestrijding and Fagron. Cover lay-out: Johan Krijt Cover photo: Arthimedes/Shutterstock.com Printed by: Drukwerkconsultancy © Marjolein Engelkes, 2016 - www.estate-studie.nl For articles published or accepted for publication, the copyright has been transferred to the respective publisher. No part of this thesis may be reproduced, stored in a retrieval system, or transmitted in any form or by any means without permission of the author, or when appropri- ate, of the publishers of the manuscript. ASTHMA EPIDEMIOLOGY, TREATMENT AND EXACERBATIONS IN REAL LIFE Astma: epidemiologie, behandeling en exacerbaties in de praktijk Proefschrift ter verkrijging van de graad van doctor aan de Erasmus Universiteit Rotterdam op gezag van de rector magnificus prof. dr. H.A.P. Pols en volgens besluit van het College voor Promoties. De openbare verdediging zal plaatsvinden op woensdag 1 juni 2016 om 13:30 uur door Marjolein Engelkes geboren te Sittard Promotiecommissie: Promotoren: Prof. dr. M.C.J.M. Sturkenboom Prof. dr. J.C. de Jongste Overige leden: Prof. dr. P.J.E. Bindels Prof. dr. G.G.O. Brusselle Dr. S.W. Turner Copromotoren: Dr. K.M.C. Verhamme Dr. H.M. Janssens CONTENTS CHAPTER 1 GENERAL INTRODUCTION 7 CHAPTER 2 EPIDEMIOLOGY OF ASTHMA 19 2.1 Automatic generation of case-detection algorithms to identify 21 children with asthma from large electronic health record databases 2.2 Time trends in the incidence, prevalence and age at diagnosis of 39 asthma in children CHAPTER 3 ASTHMA CONTROL 55 3.1 Incidence and risk factors of severe asthma exacerbations in children 57 in primary care 3.2 Multinational multidatabase cohort study of mortality and risk 73 factors for mortality in patients with asthma and severe asthma CHAPTER 4 ASTHMA TREATMENT 103 4.1 Prescription patterns, adherence and characteristics of 105 non-adherence in children with asthma in primary care 4.2 Medication adherence and the risk of severe asthma exacerbations 125 - a systematic review CHAPTER 5 PREFERENCE POLICY 145 5.1 Brand versus generic inhalation medication use and frequency of 147 switching in children and adults: a population-based cohort study 5.2 Switching between brand and generic inhaled medication and the 165 risk of moderate to severe asthma exacerbations in patients with asthma - a case control study CHAPTER 6 GENERAL DISCUSSION 187 CHAPTER 7 SUMMARY / SAMENVATTING 203 APPENDICES 209 List of abbreviations 211 List of publications 213 PhD portfolio 215 Dankwoord 217 About the author 221 GENERAL 1 INTRODUCTION INTRODUCTION Asthma is a highly prevalent and chronic respiratory condition affecting 300 million people worldwide. 1 Asthma is a potentially serious chronic disease that imposes a substantial burden on patients, their families and the community. It causes disability by respiratory symptoms, exacerbations with sometimes urgent health resource utilization, reducing the patient’s quality of life and may be fatal. 2 It is estimated that asthma accounted for about 345,000 deaths worldwide in 2010. 3 There is no cure for asthma, but it can generally be controlled through tailored stepwise treatment as described by asthma management guidelines. Despite available therapies, asthma control in clinical practice is suboptimal in real life and much lower than in clinical trials. To see developments in epidemiology and to understand the full burden of asthma, it is important to have up-to-date, real world data on treatment and exacerbations in population based cohorts. The computerization of medical care has largely facilitated this as they capture detailed and time stamped data on disease, population and medication use and reflect real life, which is essential to conduct these studies. In this thesis we focus on the epidemiology of asthma, asthma treatment and asthma control in daily practice and we used different Dutch and international electronic health care databases. Symptoms and pathophysiology of asthma Asthma is a chronic, episodic, heterogeneous disorder of the airways, characterized by wheez- ing, shortness of breath, chest tightness and cough that vary over time. Chronic airway in- flammation is an important aspect of asthma pathophysiology. 2 Effector cells are eosinophils, neutrophils, CD4+ T-lymphocytes and mast cells that contribute to the pathophysiological changes. 2, 4 These changes include airway inflammation, intermittent (reversible) airflow ob- struction, which is potentially reversible either spontaneously or with pharmacological inter- vention, bronchial hyperresponsiveness and airway wall remodelling. 2 Chronic inflammation, mucosal oedema due to increased vascular permeability, smooth muscle contraction and exces- sive mucus secretion contribute to airway obstruction. The smooth muscle cells cause exagger- ated bronchoconstriction in response to a wide range of specific and non-specific stimuli, this is called ‘bronchial hyperresponsiveness’. 5 In addition to the inflammatory response, character- istic structural changes, ‘airway remodelling’, are seen in the airways of asthma patients. 2, 6 In asthma the remodelling usually begins early and thickening of the airway wall may be present before asthma is diagnosed. 6 Epidemiology of asthma Asthma is a highly prevalent and chronic respiratory condition affecting 300 million people worldwide. 1 Data on prevalence of asthma has been described for various countries, based on data from cross-sectional studies. 7, 8 From these data was estimated that about 8.6% of the young adults experience asthma symptoms and 4.5% have been diagnosed with asthma and/ 10 Chapter 1 or are taking treatment for asthma. About 14% of the children worldwide suffer from asthma symptoms. 1 There are only few recent studies on the incidence and time trends of incidence and prevalence of asthma in children in Europe. Studies on incidence rates for asthma in children reported widely varying rates, ranging between 4.26 and 20.0 per 1000 per year. 9-24 The huge variation in incidence rates can be explained by differences in asthma definition, differences in the pop- ulation being studied, geographical factors, differences in calendar time, and reliability of data sources. 25 Data on time trends in asthma prevalence and incidence are conflicting.26 Treatment of asthma The most important goal in the treatment of asthma is to control symptoms and prevent ex- acerbations. Therapeutic targets are suppression of airway inflammation and relaxation of bronchial smooth muscle. Medication for asthma can be classified into the following two main categories; (1) reliever (rescue) medication, taken when needed, and acting quickly to reverse bronchoconstriction and (2) controller medications for daily maintenance treatment. Inhaled corticosteroids (ICS) are the controller treatment of first choice. Corticosteroids inhibit air- way inflammation by inhibiting multiple components of the inflammatory cascade, including the production of prostaglandins and leukotrienes by their action of phospholipase. They also inhibit cytokine gene transcription and increase gene transcription of β-receptors thereby in- 27 creasing the responsiveness to β2-agonists. Other options for maintenance treatment are long-acting β2-agonists (LABA) or leukotriene antagonists (LTRA). In asthma patients, LABAs should only be used in combination with ICS. When used in monotherapy, LABAs may mask underlying inflammation through symptom re- lief, as they do not control the inflammation. This increases the risk of severe asthma exacerba- tions and could eventually result in mortality. 27-30 LTRAs inhibit the binding of leukotrienes at the receptor level and block the inflammatory effects of leukotrienes. 27, 29 LTRAs are effective for long-term control of mild to moderate asthma. 27, 28 Several evidence-based guidelines for asthma treatment have been published. These include the GINA guidelines, which recommend a step-wise approach for adjustments of controller therapy to achieve good symptom control and minimize future risk of exacerbations. 2, 31, 32 If asthma is not well controlled, treatment should be stepped up until control is achieved. In children 5 years or older, treatment of uncontrolled asthma on a low dose of ICS include addition of long-acting β2-agonists (LABA) or leukotriene receptor antagonists (LTRA) or dou- bling the dose of ICS. (Figure 1) Adjustments in treatment should be done in a constant cycle of reviewing response, assessing symptoms and monitoring inhalation technique and adherence. It is not known how well guidelines are followed in real life. General introduction 11 Figure 1. From the Global Strategy for Asthma
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