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2016 ; 11
(ä): 971-9
Nephropedia Template TP
gab.com Text
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English Wikipedia
A randomized, parallel-group study to evaluate the efficacy of
umeclidinium/vilanterol 62 5/25 ?g on health-related quality of life in patients
with COPD
#MMPMID27274218
Siler TM
; Donald AC
; O'Dell D
; Church A
; Fahy WA
Int J Chron Obstruct Pulmon Dis
2016[]; 11
(ä): 971-9
PMID27274218
show ga
BACKGROUND: The combination of the inhaled muscarinic antagonist umeclidinium
(UMEC) with the long-acting ?2-agonist vilanterol (VI) has been shown to provide
significant improvements in lung function compared with UMEC, VI, or placebo
(PBO) in patients with chronic obstructive pulmonary disease (COPD). This study
was specifically designed to support these findings by assessing health-related
quality of life and symptomatic outcomes in a similar population. METHODS: This
was a 12-week multicenter, randomized, double-blind, parallel-group,
placebo-controlled study. Eligible patients were randomized 1:1 to receive
once-daily UMEC/VI 62.5/25 ?g (via ELLIPTA(®) dry powder inhaler) or PBO for 12
weeks. The primary endpoint was St George's Respiratory Questionnaire (SGRQ)
total score at day 84. Secondary efficacy endpoints included rescue albuterol use
(puffs/day) over weeks 1-12 and trough forced expiratory volume in 1 second on
day 84. Adverse events were also assessed. RESULTS: A total of 496 patients were
included in the intent-to-treat population in the UMEC/VI (n=248) and PBO (n=248)
treatment groups. UMEC/VI 62.5/25 ?g provided a significant and clinically
meaningful improvement in SGRQ total score at day 84 versus PBO (difference
between treatments in SGRQ total score change from baseline: -4.03 [95%
confidence interval {CI}: -6.28, -1.79]; P<0.001). UMEC/VI 62.5/25 ?g resulted in
a statistically significant reduction in rescue albuterol use versus PBO (-0.7
puffs/day [95% CI: -1.1, -0.4]; P<0.001). UMEC/VI 62.5/25 ?g provided a
significant and clinically meaningful improvement in trough forced expiratory
volume in 1 second on day 84 versus PBO (122 mL [95% CI: 71, 172]; P<0.001). The
incidence of adverse events was similar between treatments (32% and 30% of
patients in the UMEC/VI 62.5/25 ?g and PBO groups, respectively). CONCLUSION: The
results of this study demonstrate that treatment with UMEC/VI 62.5/25 ?g provides
clinically important improvements in SGRQ and rescue medication use versus PBO in
patients with moderate-to-very-severe COPD.