PMID- 25015176
OWN - NLM
STAT- MEDLINE
DCOM- 20150417
LR  - 20231110
IS  - 1465-993X (Electronic)
IS  - 1465-9921 (Print)
IS  - 1465-9921 (Linking)
VI  - 15
IP  - 1
DP  - 2014 Jul 11
TI  - Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and 
      umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: 
      results from a 52-week, randomized, double-blind, placebo-controlled study.
PG  - 78
LID - 10.1186/1465-9921-15-78 [doi]
AB  - BACKGROUND: The long-acting muscarinic antagonist (LAMA) umeclidinium (UMEC) and 
      the combination of UMEC with the long-acting beta2-agonist (LABA) vilanterol 
      (UMEC/VI) are approved maintenance treatments for chronic obstructive pulmonary 
      disease (COPD) in the US and EU. They are not indicated for the treatment of 
      asthma. METHODS: In this 52-week, double-blind, placebo-controlled, 
      parallel-group safety study (GSK study DB2113359; NCT01316887), patients were 
      randomized 2:2:1 to UMEC/VI 125/25 mcg, UMEC 125 mcg, or placebo. Study endpoints 
      included adverse events (AEs), clinical chemistry and hematology parameters, 
      vital signs, 12-lead, and 24-hour Holter electrocardiograms. COPD exacerbations 
      and rescue medication use were assessed as safety parameters; lung function was 
      also evaluated. RESULTS: The incidence of on-treatment AEs, serious AEs (SAEs), 
      and drug-related AEs was similar between treatment groups (AEs: 52-58%; SAEs: 
      6-7%; drug-related AEs: 12-13%). Headache was the most common AE in each 
      treatment group (8-11%). AEs associated with the LAMA and LABA pharmacologic 
      classes occurred at a low incidence across treatment groups. No clinically 
      meaningful effects on vital signs or laboratory assessments were reported for 
      active treatments versus placebo. The incidences of atrial arrhythmias with 
      UMEC/VI 125/25 mcg were similar to placebo; for UMEC 125 mcg, the incidences of 
      ectopic supraventricular beats, sustained supraventricular tachycardia, and 
      ectopic supraventricular rhythm were >/=2% greater than placebo. With active 
      treatments, COPD exacerbations were fewer (13-15% of patients reporting >/=1 
      exacerbation) and on average less rescue medication was required (1.6-2.2 
      puffs/day) versus placebo (24% reporting >/=1 exacerbation, 2.6 puffs/day). Both 
      active treatments improved lung function versus placebo. CONCLUSION: UMEC/VI 
      125/25 mcg and UMEC 125 mcg were well tolerated over 12 months in patients with 
      COPD.
FAU - Donohue, James F
AU  - Donohue JF
AD  - Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. 
      james_donohue@med.unc.edu.
FAU - Niewoehner, Dennis
AU  - Niewoehner D
FAU - Brooks, Jean
AU  - Brooks J
FAU - O'Dell, Dianne
AU  - O'Dell D
FAU - Church, Alison
AU  - Church A
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140711
PL  - England
TA  - Respir Res
JT  - Respiratory research
JID - 101090633
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (GSK573719)
RN  - 0 (Quinuclidines)
RN  - 028LZY775B (vilanterol)
SB  - IM
MH  - Aged
MH  - Benzyl Alcohols/*administration & dosage/*adverse effects
MH  - Chlorobenzenes/*administration & dosage/*adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*diagnosis/*drug therapy
MH  - Quinuclidines/*administration & dosage/*adverse effects
PMC - PMC4113670
EDAT- 2014/07/13 06:00
MHDA- 2015/04/18 06:00
PMCR- 2014/07/11
CRDT- 2014/07/13 06:00
PHST- 2014/02/12 00:00 [received]
PHST- 2014/07/04 00:00 [accepted]
PHST- 2014/07/13 06:00 [entrez]
PHST- 2014/07/13 06:00 [pubmed]
PHST- 2015/04/18 06:00 [medline]
PHST- 2014/07/11 00:00 [pmc-release]
AID - 1465-9921-15-78 [pii]
AID - 10.1186/1465-9921-15-78 [doi]
PST - epublish
SO  - Respir Res. 2014 Jul 11;15(1):78. doi: 10.1186/1465-9921-15-78.