Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD : Results of Two Randomized, Double-Blind Studies
Siler, Thomas M. (Midwest Chest Consultants, PC, St. Charles)
Kerwin, Edward (Clinical Research Institute of Southern Oregon)
Singletary, Karen (GlaxoSmithKline)
Brooks, Jean (GSK, Respiratory Medicines Development Centre, Stockley Park)
Church, Alison (GlaxoSmithKline)

Data:	2015
Resum:	Combinations of drugs with distinct and complementary mechanisms of action may offer improved efficacy in the treatment of chronic obstructive pulmonary disease (COPD). In two 12-week, double-blind, parallel-group studies, patients with COPD were randomized 1:1:1 to once-daily umeclidinium (UMEC; 62. 5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL; 250/50 μg). In both studies, the primary efficacy measure was trough forced expiratory volume in 1 second (FEV) at Day 85. Secondary endpoints were weighted-mean (WM) FEV over 0-6 hours post-dose (Day 84) and rescue albuterol use. Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT]) were also examined. Safety was assessed throughout. Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV (Day 85: 0. 127-0. 148 L) versus PBO+FP/SAL. Similarly, both UMEC+FP/SAL doses provided statistically-significant improvements in 0-6 hours post-dose WM FEV versus PBO+FP/SAL (Day 84: 0. 144-0. 165 L). Rescue use over Weeks 1-12 decreased with UMEC+FP/SAL in both studies versus PBO+FP/SAL (Study 1, 0. 3 puffs/day [both doses]; Study 2, 0. 5 puffs/day [UMEC 125+FP/SAL]). Decreases from baseline in CAT score were generally larger for both doses of UMEC+FP/SAL versus PBO+FP/SAL (except for Day 84 Study 2). In Study 1, no differences in SGRQ score were observed between UMEC+FP/SAL and PBO+FP/SAL; however, in Study 2, statistically significant improvements were observed with UMEC 62. 5+FP/SAL (Day 28) and UMEC 125+FP/SAL (Days 28 and 84) versus PBO+FP/SAL. The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2. Overall, these data indicate that the combination of UMEC+FP/SAL can provide additional benefits over FP/SAL alone in patients with COPD.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Bronchodilation ; Inhaled corticosteroid ; Long-acting beta agonist ; Long-acting muscarinic antagonist
Publicat a:	COPD : Journal of chronic obstructive pulmonary disease, Vol. 13 (october 2015) , p. 1-10, ISSN 1541-2563

DOI: 10.3109/15412555.2015.1034256
PMID: 26417965
PMID: 26451734

10 p, 1.7 MB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats