Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations
P.M.A. Calverley, M.T. Dransfield, J. Bourbeau, P. Jones, N.A. Hanania, D.A. Mahler, J. Vestbo, A. Wachtel, F. Martinez, F. Barnhart, L. Sanford, S. Lettis, C. Crim (Liverpool, London, Manchester, Uxbridge, United Kingdom; Houston, Hanover, Los Angeles, Ann Arbor, Research Triangle Park, United States Of America; Montreal, Canada)
Source: Annual Congress 2012 - COPD treatments: efficacy and safety
Session: COPD treatments: efficacy and safety
Session type: Thematic Poster Session
Number: 2113
Disease area: Airway diseases
Abstract Introduction: FF and VI are in development as combined once-daily (OD) therapy for COPDObjectives: Assess the safety of FF/VI (3 strengths) and VI in COPDMethods: In two replicate 1 year studies, after a 28 day run-in with ADVAIR DISKUS® 250/50mcg, subjects received FF/VI 50/25, 100/25, 200/25mcg or VI 25mcg OD. Primary endpoint: annual rate of moderate/severe exacerbations (described separately). Safety endpoints included all, serious and fatal Adverse Events (AEs), Local Steroid Effects (LSE, including candidiasis), bone disorders (BD, including fractures) and pneumoniaResults: Pooled safety findings are shown in the table.
VI FF/VI ITT: n( %) 25 (N=818) 50/25 (N=820) 100/25 (N=806) 200/25 (N=811) AE* 575 (70) 620 (76) 621 (77) 622 (77) AE* (drug-related) 113 (14) 169 (21) 134 (17) 140 (17) Serious AE* 126 (15) 136 (17) 123 (15) 124 (15) Fatal AE† 13 (2) 16 (2) 10 (1) 14 (2) LSE* 96 (12) 142 (17) 121 (15) 140 (17) BD* 9 (1) 24 (3) 27 (3) 21 (3) Pneumonia* 27 (3) 48 (6) 51 (6) 55 (7) Pneumonia Hazard Ratio (HR) (95%CI) vs VI 1.7 (1.1, 2.8) p=0.025 1.8 (1.2, 3.0) p=0.010 2.0 (1.3, 3.2) p=0.003 * On-treatment † On-/Post-treatment
HR for LSE and BD were significantly higher for FF/VI vs VI in all comparisons except LSE at 100/25 (p=0.065) Conclusions: In COPD patients FF/VI exhibited similar rates of serious and fatal AEs to VI, although rates of AE, BD, LSE and pneumonia were greater with FF/VI than VI alone. The efficacy of the combination is reported separately Funded by GSK: HZC102871:NCT01009463, HZC102970:NCT01017952.
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P.M.A. Calverley, M.T. Dransfield, J. Bourbeau, P. Jones, N.A. Hanania, D.A. Mahler, J. Vestbo, A. Wachtel, F. Martinez, F. Barnhart, L. Sanford, S. Lettis, C. Crim (Liverpool, London, Manchester, Uxbridge, United Kingdom; Houston, Hanover, Los Angeles, Ann Arbor, Research Triangle Park, United States Of America; Montreal, Canada). Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations. Eur Respir J 2012; 40: Suppl. 56, 2113
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