Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis
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Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD : IMPACT trial post hoc analysis. / Bardsley, Samuel; Criner, Gerard J.; Halpin, David M. G.; Han, MeiLan K.; Hanania, Nicola A.; Hill, David; Lange, Peter; Lipson, David A.; Martinez, Fernando J.; Midwinter, Dawn; Siler, Thomas M.; Singh, Dave; Wise, Robert A.; Van Zyl-Smit, Richard N.; Berkman, Neville.
I: Respiratory Medicine, Bind 205, 107040, 2022.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD
T2 - IMPACT trial post hoc analysis
AU - Bardsley, Samuel
AU - Criner, Gerard J.
AU - Halpin, David M. G.
AU - Han, MeiLan K.
AU - Hanania, Nicola A.
AU - Hill, David
AU - Lange, Peter
AU - Lipson, David A.
AU - Martinez, Fernando J.
AU - Midwinter, Dawn
AU - Siler, Thomas M.
AU - Singh, Dave
AU - Wise, Robert A.
AU - Van Zyl-Smit, Richard N.
AU - Berkman, Neville
PY - 2022
Y1 - 2022
N2 - Background: Smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). In IMPACT, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy significantly reduced moderate/severe exacerbation rates and improved lung function and health status versus FF/VI or UMEC/VI in COPD patients. This post hoc analysis investigated trial outcomes by smoking status.Methods: IMPACT was a double-blind, 52-week trial. Patients aged >= 40 years with symptomatic COPD and >= 1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. Endpoints assessed by smoking status at screening included rate and risk of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score at Week 52. Safety was also assessed.Results: Of the 10,355 patients in the intent-to-treat population, 3,587 (35%) were current smokers. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in current (rate ratio 0.85 [95% confidence interval: 0.77-0.95]; P = 0.003 and 0.86 [0.76-0.98]; P = 0.021) and former smokers (0.85 [0.78-0.91]; P < 0.001 and 0.70 [0.64-0.77]; P < 0.001). FF/UMEC/VI significantly reduced time-to-first on-treatment moderate/severe exacerbation versus FF/VI and UMEC/VI in former smokers, and versus FF/VI in current smokers. Similar trends were seen for lung function and health status. Former smokers receiving inhaled corticosteroid-containing therapy had higher pneumonia incidence than current smokers.Conclusions: FF/UMEC/VI improved clinical outcomes versus dual therapy regardless of smoking status. Benefits of FF/UMEC/VI versus UMEC/VI were greatest in former smokers, potentially due to relative corticosteroid resistance in current smokers.
AB - Background: Smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). In IMPACT, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy significantly reduced moderate/severe exacerbation rates and improved lung function and health status versus FF/VI or UMEC/VI in COPD patients. This post hoc analysis investigated trial outcomes by smoking status.Methods: IMPACT was a double-blind, 52-week trial. Patients aged >= 40 years with symptomatic COPD and >= 1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. Endpoints assessed by smoking status at screening included rate and risk of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score at Week 52. Safety was also assessed.Results: Of the 10,355 patients in the intent-to-treat population, 3,587 (35%) were current smokers. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in current (rate ratio 0.85 [95% confidence interval: 0.77-0.95]; P = 0.003 and 0.86 [0.76-0.98]; P = 0.021) and former smokers (0.85 [0.78-0.91]; P < 0.001 and 0.70 [0.64-0.77]; P < 0.001). FF/UMEC/VI significantly reduced time-to-first on-treatment moderate/severe exacerbation versus FF/VI and UMEC/VI in former smokers, and versus FF/VI in current smokers. Similar trends were seen for lung function and health status. Former smokers receiving inhaled corticosteroid-containing therapy had higher pneumonia incidence than current smokers.Conclusions: FF/UMEC/VI improved clinical outcomes versus dual therapy regardless of smoking status. Benefits of FF/UMEC/VI versus UMEC/VI were greatest in former smokers, potentially due to relative corticosteroid resistance in current smokers.
KW - Single-inhaler triple therapy
KW - Smoking
KW - Lung function
KW - Health-related quality of life
KW - Symptoms
KW - OBSTRUCTIVE PULMONARY-DISEASE
KW - SMOKING-CESSATION
KW - INFLAMMATION
U2 - 10.1016/j.rmed.2022.107040
DO - 10.1016/j.rmed.2022.107040
M3 - Journal article
C2 - 36470149
VL - 205
JO - Respiratory Medicine
JF - Respiratory Medicine
SN - 0954-6111
M1 - 107040
ER -
ID: 338412891