P N Richard Dekhuijzen1, Maria Batsiou2, Leif Bjermer3, Sinthia Bosnic-Anticevich4, Henry Chrystyn5, Alberto Papi6, Roberto Rodríguez-Roisin7, Monica Fletcher8, Lucy Wood9, Alessandra Cifra2, Joan B Soriano10, David B Price11. 1. Radboud University Medical Center, Nijmegen, The Netherlands. 2. Cambridge Research Support Ltd, Cambridge, UK; Observational and Pragmatic Research Institute Pte Ltd, Singapore. 3. Lung Medicine and Allergology, Department of Clinical Sciences, Lund University, Lund, Sweden. 4. Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. 5. Observational and Pragmatic Research Institute Pte Ltd, Singapore; Faculty of Health and Human Sciences, Plymouth University, Plymouth, UK. 6. Respiratory Diseases Unit, Department of Medical Sciences, University of Ferrara, Ferrara, Italy. 7. Universitat de Barcelona, Hospital Clínic-IDIBAPS, Barcelona, Spain. 8. Education for Health, Warwick, UK. 9. Observational and Pragmatic Research Institute Pte Ltd, Singapore. 10. Instituto de Investigación Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Madrid, Spain. 11. Observational and Pragmatic Research Institute Pte Ltd, Singapore; Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. Electronic address: dprice@opri.sg.
Abstract
BACKGROUND AND AIMS: Little information is available on real-life occurrence of oral thrush in COPD patients treated with ICS. We investigated oral thrush incidence in COPD patients prescribed FDC ICS/LABA therapies and assessed whether it is modulated by the ICS type, dose, and delivery device. METHODS: We conducted a historical, observational, matched cohort study (one baseline year before and one outcome year after initiation of therapy) using data from the UK Optimum Patient Care Research Database. We assessed oral thrush incidence in patients initiating long-acting bronchodilators or FDC ICS/LABA therapy. We then compared different combination therapies (budesonide/formoterol fumarate dihydrate [BUD/FOR] and fluticasone propionate/salmeterol xinafoate [FP/SAL]) and devices (DPI and pMDI). RESULTS: Patients prescribed FDC ICS/LABA had significantly greater odds of experiencing oral thrush than those prescribed long-acting bronchodilators alone (adjusted OR 2.18 [95% CI 1.84-2.59]). Significantly fewer patients prescribed BUD/FOR DPI developed oral thrush compared with FP/SAL DPI (OR 0.77 [0.63-0.94]) when allowing for differences in prescribed doses between the drugs. A significantly smaller proportion of patients developed oral thrush in the FP/SAL pMDI arm than in the FP/SAL DPI arm (OR 0.67 [0.55-0.82]). Additionally, in the FP/SAL cohort (both DPI and pMDI), increased risk of oral thrush was significantly associated with high ICS daily dose (OR 1.97 [1.22-3.17] vs low daily dose). CONCLUSIONS: ICS use increases oral thrush incidence in COPD and this effect is dose-dependent for FP/SAL therapies. Of the therapies assessed, FP/SAL pMDI and BUD/FOR DPI may be more protective against oral thrush.
BACKGROUND AND AIMS: Little information is available on real-life occurrence of oral thrush in COPDpatients treated with ICS. We investigated oral thrush incidence in COPDpatients prescribed FDC ICS/LABA therapies and assessed whether it is modulated by the ICS type, dose, and delivery device. METHODS: We conducted a historical, observational, matched cohort study (one baseline year before and one outcome year after initiation of therapy) using data from the UK Optimum Patient Care Research Database. We assessed oral thrush incidence in patients initiating long-acting bronchodilators or FDC ICS/LABA therapy. We then compared different combination therapies (budesonide/formoterol fumarate dihydrate [BUD/FOR] and fluticasone propionate/salmeterol xinafoate [FP/SAL]) and devices (DPI and pMDI). RESULTS:Patients prescribed FDC ICS/LABA had significantly greater odds of experiencing oral thrush than those prescribed long-acting bronchodilators alone (adjusted OR 2.18 [95% CI 1.84-2.59]). Significantly fewer patients prescribed BUD/FOR DPI developed oral thrush compared with FP/SAL DPI (OR 0.77 [0.63-0.94]) when allowing for differences in prescribed doses between the drugs. A significantly smaller proportion of patients developed oral thrush in the FP/SAL pMDI arm than in the FP/SAL DPI arm (OR 0.67 [0.55-0.82]). Additionally, in the FP/SAL cohort (both DPI and pMDI), increased risk of oral thrush was significantly associated with high ICS daily dose (OR 1.97 [1.22-3.17] vs low daily dose). CONCLUSIONS: ICS use increases oral thrush incidence in COPD and this effect is dose-dependent for FP/SAL therapies. Of the therapies assessed, FP/SAL pMDI and BUD/FOR DPI may be more protective against oral thrush.
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