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Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial

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Harvard

Day, NC, Kumar, S, Criner, G, Dransfield, M, Halpin, DMG, Han, MK, Jones, CE, Kaisermann, MC, Kilbride, S, Lange, P, Lomas, DA, Martin, N, Martinez, FJ, Singh, D, Wise, R & Lipson, DA 2020, 'Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial', Respiratory Research, vol. 21, no. 1, 139, pp. 139. https://doi.org/10.1186/s12931-020-01398-w

APA

Day, N. C., Kumar, S., Criner, G., Dransfield, M., Halpin, D. M. G., Han, M. K., Jones, C. E., Kaisermann, M. C., Kilbride, S., Lange, P., Lomas, D. A., Martin, N., Martinez, F. J., Singh, D., Wise, R., & Lipson, D. A. (2020). Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respiratory Research, 21(1), 139. [139]. https://doi.org/10.1186/s12931-020-01398-w

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MLA

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Author

Day, Nicola C ; Kumar, Subramanya ; Criner, Gerard ; Dransfield, Mark ; Halpin, David M G ; Han, MeiLan K ; Jones, C Elaine ; Kaisermann, Morrys C ; Kilbride, Sally ; Lange, Peter ; Lomas, David A ; Martin, Neil ; Martinez, Fernando J ; Singh, Dave ; Wise, Robert ; Lipson, David A. / Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD : results on cardiovascular safety from the IMPACT trial. In: Respiratory Research. 2020 ; Vol. 21, No. 1. pp. 139.

Bibtex

@article{e12c8775b8884c45a9f02c5f05f38f64,
title = "Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial",
abstract = "BACKGROUND: This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy.METHODS: IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death.RESULTS: Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments.CONCLUSIONS: In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10-11% and 1-3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.TRIAL REGISTRATION: NCT02164513 (GSK study number CTT116855).",
keywords = "Cardiovascular safety, COPD, ICS/LABA, LAMA/LABA, Triple therapy",
author = "Day, {Nicola C} and Subramanya Kumar and Gerard Criner and Mark Dransfield and Halpin, {David M G} and Han, {MeiLan K} and Jones, {C Elaine} and Kaisermann, {Morrys C} and Sally Kilbride and Peter Lange and Lomas, {David A} and Neil Martin and Martinez, {Fernando J} and Dave Singh and Robert Wise and Lipson, {David A}",
year = "2020",
month = jun,
day = "5",
doi = "10.1186/s12931-020-01398-w",
language = "English",
volume = "21",
pages = "139",
journal = "Respiratory Research",
issn = "1465-9921",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD

T2 - results on cardiovascular safety from the IMPACT trial

AU - Day, Nicola C

AU - Kumar, Subramanya

AU - Criner, Gerard

AU - Dransfield, Mark

AU - Halpin, David M G

AU - Han, MeiLan K

AU - Jones, C Elaine

AU - Kaisermann, Morrys C

AU - Kilbride, Sally

AU - Lange, Peter

AU - Lomas, David A

AU - Martin, Neil

AU - Martinez, Fernando J

AU - Singh, Dave

AU - Wise, Robert

AU - Lipson, David A

PY - 2020/6/5

Y1 - 2020/6/5

N2 - BACKGROUND: This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy.METHODS: IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death.RESULTS: Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments.CONCLUSIONS: In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10-11% and 1-3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.TRIAL REGISTRATION: NCT02164513 (GSK study number CTT116855).

AB - BACKGROUND: This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy.METHODS: IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death.RESULTS: Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments.CONCLUSIONS: In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10-11% and 1-3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.TRIAL REGISTRATION: NCT02164513 (GSK study number CTT116855).

KW - Cardiovascular safety

KW - COPD

KW - ICS/LABA

KW - LAMA/LABA

KW - Triple therapy

UR - http://www.scopus.com/inward/record.url?scp=85086008264&partnerID=8YFLogxK

U2 - 10.1186/s12931-020-01398-w

DO - 10.1186/s12931-020-01398-w

M3 - Journal article

C2 - 32503599

VL - 21

SP - 139

JO - Respiratory Research

JF - Respiratory Research

SN - 1465-9921

IS - 1

M1 - 139

ER -

ID: 62032986