Elliot Israel1, Nicolas Roche2, Richard J Martin3, Gene Colice4, Paul M Dorinsky5, Dirkje S Postma6, Theresa W Guilbert7, Willem M C van Aalderen8, Jonathan Grigg9, Elizabeth V Hillyer10, Anne Burden10, Julie von Ziegenweidt10, Victoria Thomas10, David B Price10,11. 1. 1 Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 2. 2 Cochin Hospital Group, Assistance Publique-Hôpitaux de Paris, University of Paris Descartes, Paris, France. 3. 3 National Jewish Health and University of Colorado Denver, Denver, Colorado. 4. 4 Washington Hospital Center and George Washington University School of Medicine, Washington, DC. 5. 5 Cipla Europe NV, Antwerp, Belgium. 6. 6 Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 7. 7 Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio. 8. 8 Emma Children's Hospital Academisch Medisch Centrum, Amsterdam, The Netherlands; and. 9. 9 Blizard Institute, Queen Mary University of London. 10. 10 Research in Real-Life, Ltd, Cambridge, and. 11. 11 Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom.
Abstract
RATIONALE: Guidelines advocate adding long-acting β-agonist (LABA) to inhaled corticosteroid as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, less than 5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement the results of randomized trials with narrow entry criteria. OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of various types of inhaled corticosteroid as compared with add-on LABA. METHODS: We performed a historical matched cohort study using large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid versus added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations. MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over one outcome year were comparable with increased inhaled corticosteroid dose versus added LABA. The adjusted odds ratios (95% confidence interval) for achieving asthma control with increased inhaled corticosteroid dose versus inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n = 3,036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n = 809 per cohort). The adjusted rate ratios (95% confidence interval) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status. CONCLUSIONS: When applied to a broad primary care population, antiinflammatory therapy using increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.
RATIONALE: Guidelines advocate adding long-acting β-agonist (LABA) to inhaled corticosteroid as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, less than 5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement the results of randomized trials with narrow entry criteria. OBJECTIVES: To compare the effectiveness of stepping up asthma therapy with an increased dose of various types of inhaled corticosteroid as compared with add-on LABA. METHODS: We performed a historical matched cohort study using large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid versus added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations. MEASUREMENTS AND MAIN RESULTS: The odds of asthma control and rates of severe exacerbations over one outcome year were comparable with increased inhaled corticosteroid dose versus added LABA. The adjusted odds ratios (95% confidence interval) for achieving asthma control with increased inhaled corticosteroid dose versus inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n = 3,036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n = 809 per cohort). The adjusted rate ratios (95% confidence interval) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status. CONCLUSIONS: When applied to a broad primary care population, antiinflammatory therapy using increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.
Authors: David B Price; Gene Colice; Elliot Israel; Nicolas Roche; Dirkje S Postma; Theresa W Guilbert; Willem M C van Aalderen; Jonathan Grigg; Elizabeth V Hillyer; Victoria Thomas; Richard J Martin Journal: ERJ Open Res Date: 2016-05-26
Authors: Gene Colice; David Price; Maria Gerhardsson de Verdier; Karma Rabon-Stith; Christopher Ambrose; Katherine Cappell; Debra E Irwin; Paul Juneau; Anna Vlahiotis Journal: Pragmat Obs Res Date: 2017-12-01
Authors: Anne Burden; Nicolas Roche; Cristiana Miglio; Elizabeth V Hillyer; Dirkje S Postma; Ron Mc Herings; Jetty A Overbeek; Javaria Mona Khalid; Daniela van Eickels; David B Price Journal: Pragmat Obs Res Date: 2017-03-22
Authors: Nicolas Roche; Jonathan D Campbell; Jerry A Krishnan; Guy Brusselle; Alison Chisholm; Leif Bjermer; Mike Thomas; Eric van Ganse; Maarten van den Berge; George Christoff; Jennifer Quint; Nikolaos G Papadopoulos; David Price Journal: Clin Transl Allergy Date: 2019-03-27 Impact factor: 5.871
Authors: Jaco Voorham; Nicolas Roche; Hicham Benhaddi; Marianka van der Tol; Victoria Carter; Job F M van Boven; Leif Bjermer; Marc Miravitlles; David B Price Journal: BMJ Open Date: 2018-10-27 Impact factor: 2.692