Abstract:
BACKGROUND:The combination of umeclidinium (UMEC), a long-acting muscarinic receptor antagonist, and vilanterol (VI), a selective long-acting β₂ agonist, is in development for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the pharmacokinetics, safety and tolerability, and pharmacodynamics of once-daily, inhaled UMEC and UMEC/VI when co-administered with oral verapamil, a moderate P-glycoprotein transporter and moderate cytochrome P450 3A4 (CYP3A4) inhibitor frequently used by patients with COPD and cardiovascular comorbidities. METHODS:Subjects were randomized to one of two 13-day treatment regimens: UMEC 500 μg or UMEC 500 μg/VI 25 μg. All subjects received a single tablet containing 240 mg verapamil on each of days 9-13. RESULTS:Repeat doses of UMEC and UMEC/VI in combination with and without verapamil were safe and well tolerated. There was no increase in systemic exposure of UMEC when administered in combination with VI compared to UMEC alone. UMEC maximum concentration was similar with or without verapamil; a moderate increase in UMEC area under the curve (approximately 1.4-fold) was observed with verapamil. Verapamil did not increase systemic exposure to VI following administration of the UMEC/VI combination. CONCLUSION:Administration of UMEC and UMEC/VI combination was well tolerated and did not show clinically relevant increases in systemic exposure for either drug. The UMEC/VI combination is unlikely to have a clinically meaningful drug-drug interaction with moderate P-glycoprotein transporter and CYP3A4 inhibitor drugs.
journal_name
Int J Chron Obstruct Pulmon Disauthors
Mehta R,Kelleher D,Preece A,Hughes S,Crater Gdoi
10.2147/COPD.S40859subject
Has Abstractpub_date
2013-01-01 00:00:00pages
159-67eissn
1176-9106issn
1178-2005pii
copd-8-159journal_volume
8pub_type
杂志文章,随机对照试验abstract::Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease where treatment decisions should be based on disease severity and also should be equally distributed across age, gender, and social situation. The aim of this study was to determine to what extent patients with COPD are offered evidence-base...
journal_title:International journal of chronic obstructive pulmonary disease
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abstract::The course of COPD is punctuated by acute exacerbations that are associated with an increase in the morbidity and mortality related to this chronic disease and may contribute to its rate of progression. Therefore, preventing and treating exacerbations are major goals of COPD management. The role of tiotropium in the p...
journal_title:International journal of chronic obstructive pulmonary disease
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abstract:Background:Despite wide use of the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) 2011, little is known about between-stage transitions and what factors predict worsening transitions in patients with chronic obstructive pulmonary disease (COPD). Objective:To investigate the transition frequency bet...
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journal_title:International journal of chronic obstructive pulmonary disease
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journal_title:International journal of chronic obstructive pulmonary disease
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更新日期:2015-07-15 00:00:00
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更新日期:2011-01-06 00:00:00