PMID- 25058845
OWN - NLM
STAT- MEDLINE
DCOM- 20150306
LR  - 20220408
IS  - 1931-3543 (Electronic)
IS  - 0012-3692 (Linking)
VI  - 146
IP  - 6
DP  - 2014 Dec
TI  - Long-acting bronchodilators and arterial stiffness in patients with COPD: a 
      comparison of fluticasone furoate/vilanterol with tiotropium.
PG  - 1521-1530
LID - S0012-3692(15)51522-5 [pii]
LID - 10.1378/chest.13-2859 [doi]
AB  - BACKGROUND: Increased arterial stiffness as measured by aortic pulse wave 
      velocity (aPWV) predicts cardiovascular events and mortality and is elevated in 
      patients with COPD. Prior investigation suggests that a long-acting beta-agonist 
      (LABA)/inhaled corticosteroid (ICS) lowers aPWV in patients with baseline aPWV >/= 
      11 m/s. This study compared the effect of the ICS/LABA fluticasone 
      furoate/vilanterol (FF/VI), 100/25 mug, delivered via the ELLIPTA dry powder 
      inhaler, with tiotropium bromide (TIO), 18 mug, on aPWV. METHODS: This 
      multicenter, randomized, blinded, double-dummy, parallel-group, 12-week study 
      compared FF/VI and TIO, both administered once daily. The primary end point was 
      aPWV change from baseline at 12 weeks. Safety end points included adverse events 
      (AEs), vital signs, and clinical laboratory tests. RESULTS: Two hundred 
      fifty-seven patients with COPD and aPWV >/= 11 m/s were randomized; 87% had prior 
      cardiovascular events and/or risk. The mean difference in aPWV between FF/VI and 
      TIO at week 12 was not significant (P = .484). Because the study did not contain 
      a placebo arm, a post hoc analysis was performed to show that both treatments 
      lowered aPWV by an approximate difference of 1 m/s compared with baseline. The 
      proportion of patients reporting AEs was similar with FF/VI (24%) and TIO (18%). 
      There were no changes in clinical concern for vital signs or clinical laboratory 
      tests. CONCLUSIONS: No differences on aPWV were observed between FF/VI and TIO. 
      However, further studies with a placebo arm are required to establish 
      definitively whether long-acting bronchodilators lower aPWV. Both treatments 
      demonstrated an acceptable tolerability profile. TRIAL REGISTRY: 
      ClinicalTrials.gov; No.: NCT01395888; URL: www.clinicaltrials.gov.
FAU - Pepin, Jean-Louis
AU  - Pepin JL
AD  - University Grenoble Alpes, Grenoble University Hospital, Grenoble, France.
FAU - Cockcroft, John R
AU  - Cockcroft JR
AD  - Wales Heart Research Institute, Cardiff University, Cardiff, Wales.
FAU - Midwinter, Dawn
AU  - Midwinter D
AD  - GlaxoSmithKline, Stockley Park, England.
FAU - Sharma, Sanjay
AU  - Sharma S
AD  - GlaxoSmithKline, Research Triangle Park, Durham, NC.
FAU - Rubin, David B
AU  - Rubin DB
AD  - GlaxoSmithKline, Research Triangle Park, Durham, NC.
FAU - Andreas, Stefan
AU  - Andreas S
AD  - Georg-August-Universitat Gottingen, Gottingen, Germany. Electronic address: 
      stefan.andreas@med.uni-goettingen.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT01395888
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Androstadienes)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Scopolamine Derivatives)
RN  - 028LZY775B (vilanterol)
RN  - JS86977WNV (fluticasone furoate)
RN  - XX112XZP0J (Tiotropium Bromide)
SB  - IM
MH  - Administration, Inhalation
MH  - Aged
MH  - Androstadienes/*administration & dosage/adverse effects
MH  - Benzyl Alcohols/*administration & dosage/adverse effects
MH  - Bronchodilator Agents/administration & dosage/adverse effects
MH  - Chlorobenzenes/*administration & dosage/adverse effects
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*diagnosis/*drug therapy
MH  - Pulse Wave Analysis/methods
MH  - Respiratory Function Tests
MH  - Scopolamine Derivatives/*administration & dosage/adverse effects
MH  - Severity of Illness Index
MH  - Tiotropium Bromide
MH  - Treatment Outcome
MH  - Vascular Stiffness/*drug effects
EDAT- 2014/07/25 06:00
MHDA- 2015/03/07 06:00
CRDT- 2014/07/25 06:00
PHST- 2014/07/25 06:00 [entrez]
PHST- 2014/07/25 06:00 [pubmed]
PHST- 2015/03/07 06:00 [medline]
AID - S0012-3692(15)51522-5 [pii]
AID - 10.1378/chest.13-2859 [doi]
PST - ppublish
SO  - Chest. 2014 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.