人口的药物吸入umeclidinium vilanterol在慢性阻塞性肺疾病患者。

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Goyal N, Beerahee M, Kalberg C,教堂,梅塔基尔布赖德S, R

人口的药物吸入umeclidinium vilanterol在慢性阻塞性肺疾病患者。

Pharmacokinet。2014年7月,53 (7):637 - 48。doi: 10.1007 / s40262 - 014 - 0143 - 4。

PubMed ID
24756395 (在PubMed
]
文摘

背景和目的:支气管扩张剂的固定剂量组合umeclidinium vilanterol发展长期,每天换一次治疗慢性阻塞性肺疾病(COPD)。我们umeclidinium的药物动力学特征和vilanterol大约1635名慢性阻塞性肺病患者,评估病人的影响人口和基线特征umeclidinium和vilanterol曝光。方法:等离子体浓度umeclidinium和vilanterol评估病人参加两三期,随机,双盲,与这些相应平行的组织,安慰剂对照试验使用吸入umeclidinium / vilanterol联合治疗和吸入umeclidinium vilanterol单方治疗。Population-pharmacokinetic模型使用非线性mixed-effects开发分析,使用NONMEM执行((R))软件。基于可能性的方法被用来描述下面的数据量化的极限。Umeclidinium vilanterol暴露在临床剂量模拟基于人口模型。结果:umeclidinium和vilanterol population-pharmacokinetic分析,1635年和1637年的病人提供了8498年和8405年的观察,分别。vilanterol Umeclidinium和药效最好的描述了两舱制模型与一阶吸收。umeclidinium、体重、年龄和肌酐清除率(CLCR)协变量在统计上显著的明显吸入间隙(CL / F);体重是一个统计上显著的协变量的体积分布的中央室2 (V / F)。The population parameter estimates namely CL/F and V 2/F for umeclidinium were 218 L/h and 1,160 L and 40.9 L/h and 268 L for vilanterol. For vilanterol, bodyweight and age were statistically significant covariates for CL/F. The effect of covariates on umeclidinium and vilanterol systemic exposure was marginal. The population model indicates that a 10 % increase in bodyweight will result in a 2 % increase in CL/F for umeclidinium and vilanterol and 6 % increase in umeclidinium V 2/F. A 10 % increase in age will provide a 7 and 4 % decrease in umeclidinium and vilanterol CL/F, respectively. A 10 % decrease in CLCR will result in a 3 % decrease in umeclidinium CL/F. Umeclidinium and vilanterol population-pharmacokinetic model-based systemic exposure predictions showed no pharmacokinetic interactions between umeclidinium and vilanterol when administered in combination. CONCLUSIONS: There were no apparent pharmacokinetic interactions when umeclidinium and vilanterol were co-administered in patients with COPD. The effects of patient demographics, including age, bodyweight, and CLCR, on umeclidinium or vilanterol systemic exposure were minimal, and therefore no dose adjustments are necessary.

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