Chest:中重度COPD患者 茚达特罗有效性和安全性良好
2011-07-29 MedSci原创 MedSci原创
在为期1年的治疗中,慢性阻塞性肺疾病(COPD)患者对茚达特罗(Indacaterol)耐受性良好,该药显著扩张支气管,同时改善患者转归。 此项随机双盲对照研究为期26周,415例中重度COPD患者被随机分至茚达特罗(150 μg/d或300 μg/d)治疗组或安慰剂组。 结果显示,茚达特罗150 μg 组、300 μg组和安慰剂组
在为期1年的治疗中,慢性阻塞性肺疾病(COPD)患者对茚达特罗(Indacaterol)耐受性良好,该药显著扩张支气管,同时改善患者转归。
此项随机双盲对照研究为期26周,415例中重度COPD患者被随机分至茚达特罗(150 μg/d或300 μg/d)治疗组或安慰剂组。
结果显示,茚达特罗150 μg 组、300 μg组和安慰剂组不良事件(主要为轻、中度)发生率分别为76%、77%和68%;严重不良事件发生率分别为10.4%、12.3%和10.5%。茚达特罗对患者心电图(如QT间期)、血钾和血糖水平无显著影响。
与安慰剂组相比,茚达特罗组患者FEV1值增加(52周时两组FEV1差异≥170 ml),COPD急性加重例数和沙丁胺醇按需应用次数显著减少。茚达特罗治疗改善患者健康状况,总圣乔治呼吸调查问卷(SGRQ)评分平均降低>4单位。
英文原始文献:
Source
Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Rm 7-451 E Wing, 399 Bathurst St, Toronto, ON, M5T 2S8, Canada. kchapman@ca.inter.net.
Abstract
BACKGROUND:
Indacaterol is an inhaled, long-acting β(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD.
METHODS:
Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV(1) at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]).
RESULTS:
Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV(1) relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units.
CONCLUSIONS:
During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. Trial registry: ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov.
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