Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroupsCitation formats

  • External authors:
  • Nawar Diar Bakerly
  • Ashley Woodcock
  • Susan Collier
  • David A. Leather
  • Jodie Crawford
  • Catherine Harvey
  • Isabelle Boucot

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Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups. / Bakerly, Nawar Diar; Woodcock, Ashley; Collier, Susan; Leather, David A.; New, John P.; Crawford, Jodie; Harvey, Catherine; Vestbo, Jørgen; Boucot, Isabelle.

In: Respiratory Medicine, Vol. 147, 01.02.2019, p. 58-65.

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Bakerly, Nawar Diar ; Woodcock, Ashley ; Collier, Susan ; Leather, David A. ; New, John P. ; Crawford, Jodie ; Harvey, Catherine ; Vestbo, Jørgen ; Boucot, Isabelle. / Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups. In: Respiratory Medicine. 2019 ; Vol. 147. pp. 58-65.

Bibtex

@article{93da5da1002e4ed8949b4a86bd05c914,
title = "Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups",
abstract = "Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups. Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months’ follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed. Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0{\%} [0.1, 15.4]), except in patients without baseline airflow limitation (−0.5{\%} [–29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6{\%} [3.4, 26.3]), and with baseline CAT score <10 (25.3{\%} [–0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA. Conclusions: Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.",
keywords = "Chronic obstructive pulmonary disease, Effectiveness, Exacerbation, Fluticasone furoate, Inhaled corticosteroid, Salford Lung Study, Vilanterol",
author = "Bakerly, {Nawar Diar} and Ashley Woodcock and Susan Collier and Leather, {David A.} and New, {John P.} and Jodie Crawford and Catherine Harvey and J{\o}rgen Vestbo and Isabelle Boucot",
year = "2019",
month = "2",
day = "1",
doi = "10.1016/j.rmed.2018.12.016",
language = "English",
volume = "147",
pages = "58--65",
journal = "Respiratory Medicine",
issn = "0954-6111",
publisher = "W.B. Saunders Co. Ltd.",

}

RIS

TY - JOUR

T1 - Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups

AU - Bakerly, Nawar Diar

AU - Woodcock, Ashley

AU - Collier, Susan

AU - Leather, David A.

AU - New, John P.

AU - Crawford, Jodie

AU - Harvey, Catherine

AU - Vestbo, Jørgen

AU - Boucot, Isabelle

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups. Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months’ follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed. Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (−0.5% [–29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [–0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA. Conclusions: Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.

AB - Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups. Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months’ follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed. Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (−0.5% [–29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [–0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA. Conclusions: Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.

KW - Chronic obstructive pulmonary disease

KW - Effectiveness

KW - Exacerbation

KW - Fluticasone furoate

KW - Inhaled corticosteroid

KW - Salford Lung Study

KW - Vilanterol

UR - http://www.scopus.com/inward/record.url?scp=85060170884&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2018.12.016

DO - 10.1016/j.rmed.2018.12.016

M3 - Article

VL - 147

SP - 58

EP - 65

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

ER -