PMID- 28176907
OWN - NLM
STAT- MEDLINE
DCOM- 20171010
LR  - 20220408
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 12
DP  - 2017
TI  - A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol 
      versus placebo to determine effects on arterial stiffness in COPD.
PG  - 351-365
LID - 10.2147/COPD.S117373 [doi]
AB  - INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with 
      increased cardiovascular morbidity and mortality. Elevated arterial stiffness, 
      measured by aortic pulse wave velocity (aPWV), is a cardiovascular risk surrogate 
      and is potentially modifiable by inhaled corticosteroid/long-acting 
      beta(2)-agonist combinations in patients with COPD. MATERIALS AND METHODS: The 
      effects of once-daily inhaled fluticasone furoate/vilanterol (FF/VI) 100/25 microg, 
      VI 25 microg, versus placebo on arterial stiffness in patients with COPD and baseline 
      aPWV >/=11.0 m/s were investigated in a 24-week, multicenter, double-blind, 
      randomized, stratified (by COPD exacerbation history), parallel-group, 
      placebo-controlled trial. Eligible patients were >/=40 years old, with >/=10 
      pack-year smoking history, forced expiratory volume in 1 s (FEV(1))/forced vital 
      capacity </=0.70, and post-bronchodilator FEV(1) </=70% of predicted. Patients with a 
      major cardiovascular event in the previous 6 months/current severe heart 
      failure/uncontrolled hypertension were excluded. Primary endpoint is change from 
      baseline in aPWV after 24 weeks of treatment. Safety analyses included adverse 
      events (AEs). RESULTS: The intent-to-treat population included 430 patients: 
      FF/VI (n=135), VI (n=154), and placebo (n=141). Patients were predominantly male 
      (79%) and Asian or White (each 48%), with a mean age of 68.5 years (standard 
      deviation [SD] =7.9), percentage predicted post-bronchodilator FEV(1) 50.1% (SD 
      =13.3), and aPWV 13.26 m/s (SD =2.22) at screening. At 24 weeks, mean (standard 
      error [SE]) changes from baseline in aPWV were -1.75 m/s (SE =0.26, FF/VI), -1.95 
      m/s (SE =0.24, VI), and -1.97 m/s (SE =0.28, placebo). AEs occurred in 57% 
      (FF/VI), 51% (VI), and 41% (placebo) of patients. CONCLUSION: No differences were 
      observed in aPWV-adjusted mean change from baseline for FF/VI 100/25 microg, compared 
      with placebo.
FAU - Bhatt, Surya P
AU  - Bhatt SP
AD  - Division of Pulmonary, Allergy and Critical Care Medicine and UAB Lung Health 
      Center, University of Alabama at Birmingham, Birmingham, AL, USA.
FAU - Dransfield, Mark T
AU  - Dransfield MT
AD  - Division of Pulmonary, Allergy and Critical Care Medicine and UAB Lung Health 
      Center, University of Alabama at Birmingham, Birmingham, AL, USA.
FAU - Cockcroft, John R
AU  - Cockcroft JR
AD  - Department of Cardiology, Wales Heart Research Institute, Cardiff.
FAU - Wang-Jairaj, Jie
AU  - Wang-Jairaj J
AD  - GSK, Stockley Park, Uxbridge, UK.
FAU - Midwinter, Dawn A
AU  - Midwinter DA
AD  - GSK, Stockley Park, Uxbridge, UK.
FAU - Rubin, David B
AU  - Rubin DB
AD  - GSK, Research Triangle Park, NC, USA.
FAU - Scott-Wilson, Catherine A
AU  - Scott-Wilson CA
AD  - GSK, Research Triangle Park, NC, USA.
FAU - Crim, Courtney
AU  - Crim C
AD  - GSK, Research Triangle Park, NC, USA.
LA  - eng
GR  - KL2 TR001419/TR/NCATS NIH HHS/United States
GR  - UL1 TR001417/TR/NCATS NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170119
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Androstadienes)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (fluticasone furoate-vilanterol trifenatate)
RN  - 028LZY775B (vilanterol)
SB  - IM
MH  - Administration, Inhalation
MH  - Aged
MH  - Androstadienes/*administration & dosage/adverse effects
MH  - Asia
MH  - Benzyl Alcohols/*administration & dosage/adverse effects
MH  - Bronchodilator Agents/*administration & dosage/adverse effects
MH  - Chlorobenzenes/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Europe
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Lung/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pulmonary Disease, Chronic Obstructive/diagnosis/*drug therapy/physiopathology
MH  - Pulse Wave Analysis
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Vascular Stiffness/*drug effects
MH  - Vital Capacity
PMC - PMC5261599
OTO - NOTNLM
OT  - aortic pulse wave velocity
OT  - chronic obstructive pulmonary disease
OT  - fluticasone furoate
OT  - vilanterol
COIS- SPB has received an NIH KL2 Scholarship (1KL2TR001419); MTD has acted as a 
      consultant for GSK, AstraZeneca, and Boston Scientific; JRC has acted as a 
      consultant for GSK, NIVALIS, and Novartis and has received research support from 
      GSK (NCT01656421); JW-J, DAM, DBR, CAS-W, and CC are employees of GSK and hold 
      restricted/unrestricted GSK shares. Study HZC113108 (NCT01336608) was sponsored 
      by GSK. The abstract of this paper was published in the American Thoracic Society 
      International Conference Abstracts, B.23 Cardiovascular and Respiratory 
      Interactions in COPD, Poster Discussion Session, Monday, May 16, 9:00 am to 11:00 
      am as an abstract with interim findings. The authors report no other conflicts of 
      interest in this work.
EDAT- 2017/02/09 06:00
MHDA- 2017/10/11 06:00
PMCR- 2017/01/19
CRDT- 2017/02/09 06:00
PHST- 2017/02/09 06:00 [entrez]
PHST- 2017/02/09 06:00 [pubmed]
PHST- 2017/10/11 06:00 [medline]
PHST- 2017/01/19 00:00 [pmc-release]
AID - copd-12-351 [pii]
AID - 10.2147/COPD.S117373 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2017 Jan 19;12:351-365. doi: 
      10.2147/COPD.S117373. eCollection 2017.