Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting beta2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care.
OBJECTIVE: The inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform((R))) has been available as fixed-dose combination (FDC) therapy for asthma patients aged >/= 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months.
METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged >/= 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.
RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label".
CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.
|投稿者||Price, David B; Carter, Victoria; Martin, Jessica; Gardener, Elizabeth A; Skinner, Derek; Yang, Sen; Hoffman, Matthias; Willis, Jenna C; Cooper, Andrew J|
|組織名||Centre of Academic Primary Care, Division of Applied Health Services, University;of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.;firstname.lastname@example.org.;Observational and Pragmatic Research Institute, Singapore City, Singapore.;Mundipharma Research GmbH and Co. KG, Hohenstrasse 10, 65549, Limburg, Germany.;Mundipharma Research Ltd., Cambridge Science Park, Milton Road, Cambridge, CB4;0AB, UK.|