A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol versus placebo to determine effects on arterial stiffness in COPD

Bhatt, Surya P.; Cockcroft, John R.; Wang‐Jairaj, Jie; Midwinter, Dawn; Rubin, David B.; Scott-Wilson, Catherine; Crim, Courtney

doi:10.2147/copd.s117373

Cited by 20 publications

(18 citation statements)

References 46 publications

(67 reference statements)

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“… 32 The long-term influence of such medications on the vascular health of patients with COPD is thus difficult to gauge, but trial data have showed no beneficial effect on aPWV, of 6-month treatment of combined inhaled corticosteroid and long-acting β-agonist versus placebo. 33 …”

Section: Discussionmentioning

confidence: 99%

Surrogate Markers of Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

et al. 2018

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Section: Discussionmentioning

confidence: 99%

Surrogate Markers of Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

et al. 2018

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“…Treatment with ICS/LABA also reduced arterial stiffness to a similar extent as tiotropium in a study of 257 patients with COPD, suggesting that the long-acting bronchodilator component of the combination drives this effect [80]. However, no reduction in aortic pulse wave velocity (aPWV) was observed compared with placebo [90,93].…”

Section: Muscarinic Antagonistsmentioning

confidence: 99%

Cardiovascular disease and COPD: dangerous liaisons?

2018

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Chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) frequently occur together and their coexistence is associated with worse outcomes than either condition alone. Pathophysiological links between COPD and CVD include lung hyperinflation, systemic inflammation and COPD exacerbations. COPD treatments may produce beneficial cardiovascular (CV) effects, such as long-acting bronchodilators, which are associated with improvements in arterial stiffness, pulmonary vasoconstriction, and cardiac function. However, data are limited regarding whether these translate into benefits in CV outcomes. Some studies have suggested that treatment with long-acting β2-agonists and long-acting muscarinic antagonists leads to an increase in the risk of CV events, particularly at treatment initiation, although the safety profile of these agents with prolonged use appears reassuring. Some CV medications may have a beneficial impact on COPD outcomes, but there have been concerns about β-blocker use leading to bronchospasm in COPD, which may result in patients not receiving guideline-recommended treatment. However, there are few data suggesting harm with these agents and patients should not be denied β-blockers if required. Clearer recommendations are necessary regarding the identification and management of comorbid CVD in patients with COPD in order to facilitate early intervention and appropriate treatment.

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“…study HZC113108; ClinicalTrials.gov ID NCT01336608) conducted from March 2011 to November 2014 evaluated the effect of 24 weeks’ treatment with once-daily fluticasone furoate/vilanterol (FF/VI) 100/25 μg in patients with moderate COPD and elevated CV risk, indicated by high arterial stiffness (defined as an aPWV of ≥11 m/s). 15 This study provided a suitable data set independent of the SUMMIT trial for validation of risk stratification tools. Using this data set our present analysis evaluated the Summit Lab Score and, secondarily, IMRS as predictors of the first episode of moderate-to-severe AECOPD and other outcomes in patients with moderate COPD and high arterial stiffness.…”

Section: Introductionmentioning

confidence: 99%

Validation of the Summit Lab Score in Predicting Exacerbations of Chronic Obstructive Pulmonary Disease Among Individuals with High Arterial Stiffness

Horne¹,

Ali²,

Midwinter³

et al. 2021

COPD

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Introduction:The presence of cardiovascular (CV) risk factors and CV disease in patients with chronic obstructive pulmonary disease (COPD) leads to worse outcomes. A number of tools are currently available to stratify the risk of adverse outcomes in these patients with COPD. This post hoc analysis evaluated the Summit Lab Score for validation as a predictor of the first episode of moderate-to-severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and other outcomes, in patients with COPD and high arterial pulse wave velocity (aPWV). Methods: Data from a multicenter, randomized, placebo-controlled, double-blind study were retrospectively analyzed to evaluate treatment effects of once-daily fluticasone furoate/vilanterol 100/25 μg in patients with COPD and an elevated CV risk (aPWV≥11m/s) over 24 weeks. The previously derived Summit Lab Score and, secondarily, the Intermountain Risk Score (IMRS) were computed for each patient, with patients then stratified into tertiles for each score. Risk of moderate-to-severe AECOPD was analyzed across tertiles using Kaplan-Meier survival curve and Cox regression analyses. Results: In 430 patients with COPD, Kaplan-Meier probabilities of no moderate-to-severe AECOPD for Summit Lab Score tertiles 1, 2, and 3 were 92.3%, 95.5%, and 85.1%, respectively (P trend = 0.015), over 24 weeks. Grouped by IMRS tertiles, the respective probabilities were 92.9%, 91.2%, and 88.3%, respectively (P trend = 0.141). Length of stay in the hospital (P = 0.034) and the hospital ward (P = 0.042) were also significantly different between Summit Lab Score tertiles but not for intensive care (P = 0.191). Conclusion:The Summit Lab Score was associated with the 24-week risk of moderate-tosevere AECOPD in COPD patients with elevated CV risk. Secondarily, IMRS showed a trend towards differences in the risk of AECOPD, which was not statistically significant.

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A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol versus placebo to determine effects on arterial stiffness in COPD

Cited by 20 publications

References 46 publications

Surrogate Markers of Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Surrogate Markers of Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

Cardiovascular disease and COPD: dangerous liaisons?

Validation of the Summit Lab Score in Predicting Exacerbations of Chronic Obstructive Pulmonary Disease Among Individuals with High Arterial Stiffness

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