Helgo Magnussen1, Sarah Lucas2, Therese Lapperre3,4, Jennifer K Quint4, Ronald J Dandurand5, Nicolas Roche6, Alberto Papi7, David Price8,9, Marc Miravitlles10. 1. Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center of Lung Research, Grosshansdorf, Germany. 2. Respiratory Effectiveness Group, Ely, UK. 3. Department of Respiratory Medicine, Antwerp University Hospital, Edegem, Denmark. 4. Laboratory of Experimental Medicine and Paediatrics, University of Antwerp, Wilrijk, UK. 5. CIUSSS de L'Ouest-de-L'Île-de-Montréal, Montreal Chest Institute, Meakins-Christie Laboratories, Oscillometry Unit and Centre for Innovative Medicine, McGill University Health Centre and Research Institute, Montreal, QC, Canada. 6. Department of Respiratory Medicine, APHP-Centre University of Paris, UMR1016, Cochin Institute, Paris, France. 7. Section of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy. 8. Observational and Pragmatic Research Institute, Singapore, Singapore. 9. Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. 10. Pneumology Department, Hospital Universitari Vall D'Hebron, Vall D'Hebron Institut de Recerca (VHIR), CIBER de Enfermedades Respiratorias (CIBERES), Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain. marcm@separ.es.
Abstract
BACKGROUND: Inhaled corticosteroids (ICS) are indicated for prevention of exacerbations in patients with COPD, but they are frequently overprescribed. ICS withdrawal has been recommended by international guidelines in order to prevent side effects in patients in whom ICS are not indicated. METHOD: Observational comparative effectiveness study aimed to evaluate the effect of ICS withdrawal versus continuation of triple therapy (TT) in COPD patients in primary care. Data were obtained from the Optimum Patient Care Research Database (OPCRD) in the UK. RESULTS: A total of 1046 patients who withdrew ICS were matched 1:4 by time on TT to 4184 patients who continued with TT. Up to 76.1% of the total population had 0 or 1 exacerbation the previous year. After controlling for confounders, patients who discontinued ICS did not have an increased risk of moderate or severe exacerbations (adjusted HR: 1.04, 95% confidence interval (CI) 0.94-1.15; p = 0.441). However, rates of exacerbations managed in primary care (incidence rate ratio (IRR) 1.33, 95% CI 1.10-1.60; p = 0.003) or in hospital (IRR 1.72, 95% CI 1.03-2.86; p = 0.036) were higher in the cessation group. Unsuccessful ICS withdrawal was significantly and independently associated with more frequent courses of oral corticosteroids the previous year and with a blood eosinophil count ≥ 300 cells/μL. CONCLUSIONS: In this primary care population of patients with COPD, composed mostly of infrequent exacerbators, discontinuation of ICS from TT was not associated with an increased risk of exacerbation; however, the subgroup of patients with more frequent courses of oral corticosteroids and high blood eosinophil counts should not be withdrawn from ICS. Trial registration European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS30851).
BACKGROUND: Inhaled corticosteroids (ICS) are indicated for prevention of exacerbations in patients with COPD, but they are frequently overprescribed. ICS withdrawal has been recommended by international guidelines in order to prevent side effects in patients in whom ICS are not indicated. METHOD: Observational comparative effectiveness study aimed to evaluate the effect of ICS withdrawal versus continuation of triple therapy (TT) in COPDpatients in primary care. Data were obtained from the Optimum Patient Care Research Database (OPCRD) in the UK. RESULTS: A total of 1046 patients who withdrew ICS were matched 1:4 by time on TT to 4184 patients who continued with TT. Up to 76.1% of the total population had 0 or 1 exacerbation the previous year. After controlling for confounders, patients who discontinued ICS did not have an increased risk of moderate or severe exacerbations (adjusted HR: 1.04, 95% confidence interval (CI) 0.94-1.15; p = 0.441). However, rates of exacerbations managed in primary care (incidence rate ratio (IRR) 1.33, 95% CI 1.10-1.60; p = 0.003) or in hospital (IRR 1.72, 95% CI 1.03-2.86; p = 0.036) were higher in the cessation group. Unsuccessful ICS withdrawal was significantly and independently associated with more frequent courses of oral corticosteroids the previous year and with a blood eosinophil count ≥ 300 cells/μL. CONCLUSIONS: In this primary care population of patients with COPD, composed mostly of infrequent exacerbators, discontinuation of ICS from TT was not associated with an increased risk of exacerbation; however, the subgroup of patients with more frequent courses of oral corticosteroids and high blood eosinophil counts should not be withdrawn from ICS. Trial registration European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS30851).
Entities:
Keywords:
COPD; Effectiveness; Inhaled corticosteroids; Real life; Withdrawal
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