InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations

被引：14

作者：

Singh, Dave ^{[1
]}

Criner, Gerard J. ^{[2
]}

Dransfield, Mark T. ^{[3
]}

Halpin, David M. G. ^{[4
]}

Han, MeiLan K. ^{[5
]}

Lange, Peter ^{[6
]}

Lettis, Sally ^{[7
]}

Lipson, David A. ^{[8
,9
]}

Mannino, David ^{[10
]}

Martin, Neil ^{[11
,12
]}

Martinez, Fernando J. ^{[13
]}

Miller, Bruce E. ^{[8
]}

Wise, Robert ^{[14
]}

Zhu, Chang-Qing ^{[7
]}

Lomas, David ^{[15
]}

机构：

[1] Manchester Univ NHS Fdn Trust, Univ Manchester, Manchester Acad Hlth Sci Ctr, Ctr Resp Med & Allergy,Inst Inflammat & Repair, Manchester, Lancs, England

[2] Temple Univ, Pulm & Crit Care Med, Lewis Katz Sch Med, Philadelphia, PA 19122 USA

[3] Univ Alabama Birmingham, Lung Hlth Ctr, Div Pulm Allergy & Crit Care Med, Birmingham, AL USA

[4] Univ Exeter, Med Sch, Coll Med & Hlth, Exeter, Devon, England

[5] Univ Michigan, Pulm & Crit Care, Ann Arbor, MI 48109 USA

[6] Univ Copenhagen, Dept Publ Hlth, Copenhagen, Denmark

[7] GlaxoSmithKline, Biostat, Stockley Pk West, Uxbridge, Middx, England

[8] GlaxoSmithKline, Clin Sci, Collegeville, PA USA

[9] Univ Penn, Dept Med, Pulm Allergy & Crit Care Div, Perelman Sch Med, Philadelphia, PA 19104 USA

[10] Univ Kentucky, Coll Publ Hlth, Lexington, KY USA

[11] GlaxoSmithKline, Global Med Affairs, Brentford, Middx, England

[12] Univ Leicester, Inst Lung Hlth, Leicester, Leics, England

[13] Weill Cornell Med, New York, NY USA

[14] Johns Hopkins Univ, Sch Med, Div Pulm & Crit Care Med, Baltimore, MD USA

[15] UCL, Div Med, UCL Resp, Rayne Bldg, London WC1E 6BN, England

来源：

RESPIRATORY RESEARCH | 2021年 / 22卷 / 01期

关键词：

Fibrinogen; COPD exacerbations; Pharmacotherapy; COPD; OBSTRUCTIVE PULMONARY-DISEASE; PLASMA-FIBRINOGEN; HEART-FAILURE; BIOMARKER; ASSOCIATION; MORTALITY;

D O I：

10.1186/s12931-021-01706-y

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Background Fibrinogen is the first qualified prognostic/predictive biomarker for exacerbations in patients with chronic obstructive pulmonary disease (COPD). The IMPACT trial investigated fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI and UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This analysis used IMPACT trial data to examine the relationship between fibrinogen levels and exacerbation outcomes in patients with COPD. Methods 8094 patients with a fibrinogen assessment at Week 16 were included, baseline fibrinogen data were not measured. Post hoc analyses were performed by fibrinogen quartiles and by 3.5 g/L threshold. Endpoints included on-treatment exacerbations and adverse events of special interest (AESIs). Results Rates of moderate, moderate/severe, and severe exacerbations were higher in the highest versus lowest fibrinogen quartile (0.75, 0.92 and 0.15 vs 0.67, 0.79 and 0.10, respectively). The rate ratios (95% confidence interval [CI]) for exacerbations in patients with fibrinogen levels >= 3.5 g/L versus those with fibrinogen levels < 3.5 g/L were 1.03 (0.95, 1.11) for moderate exacerbations, 1.08 (1.00, 1.15) for moderate/severe exacerbations, and 1.30 (1.10, 1.54) for severe exacerbations. There was an increased risk of moderate/severe exacerbation (hazard ratio [95% CI]: highest vs lowest quartile 1.16 [1.04, 1.228]; >= 3.5 g/L vs < 3.5 g/L: 1.09 [1.00, 1.16]) and severe exacerbation (1.35 [1.09, 1.69]; 1.27 [1.08, 1.47], respectively) with increasing fibrinogen level. Cardiovascular AESIs were highest in patients in the highest fibrinogen quartile. Conclusions Rate and risk of exacerbations was higher in patients with higher fibrinogen levels. This supports the validity of fibrinogen as a predictive biomarker for COPD exacerbations, and highlights the potential use of fibrinogen as an enrichment strategy in trials examining exacerbation outcomes. Trial registration: NCT02164513

引用

页数：14

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