University of North Carolina, Chapel Hill, NC 27599, USA.
Int J Chron Obstruct Pulmon Dis. 2011;6:477-92. doi: 10.2147/COPD.S23816. Epub 2011 Sep 22.
Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-agonist for chronic obstructive pulmonary disease (COPD).
Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 μg (n = 449), 150 μg (n = 2611), 300 μg (n = 1157), or 600 μg once daily (n = 547); formoterol 12 μg twice daily (n = 556); salmeterol 50 μg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 μg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs.
The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were < 1 for all indacaterol doses. Notable values for vital signs and measures of systemic β(2)-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008).
Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.
对慢性阻塞性肺疾病（COPD）患者接受每日 1 次吸入性长效β2-激动剂茚达特罗的安全性和耐受性进行汇总数据分析。
汇总了为期 3-12 个月的临床试验数据，纳入中度至重度 COPD 患者，这些患者接受双盲茚达特罗 75μg（n=449）、150μg（n=2611）、300μg（n=1157）或 600μg 每日 1 次（n=547）；福莫特罗 12μg 每日 2 次（n=556）；沙美特罗 50μg 每日 2 次（n=895）；安慰剂（n=2012）；或噻托溴铵 18μg 每日 1 次，给予开放标签或盲法治疗（n=1214）。结局为不良事件、严重不良事件和死亡、血浆钾、血糖和 QTc 间期及生命体征。
茚达特罗最常见的不良事件为 COPD 恶化、鼻咽炎和头痛；多数病例为轻度或中度，发生率与安慰剂和其他活性治疗基本相似。与安慰剂相比，任何一种活性治疗急性呼吸道严重不良事件（导致住院、插管或死亡）的风险均未显著增加。与安慰剂相比，所有活性治疗均显著降低 COPD 加重率（意向治疗人群分析）。与安慰剂相比，茚达特罗所有剂量的主要心血管不良事件的危害比均＜1。茚达特罗的生命体征和全身β2-肾上腺素能活性测量值显著变化的情况很少见。与安慰剂相比，茚达特罗（所有剂量）调整后的患者年死亡数更低（相对风险 0.21[95%置信区间 0.07-0.660]，P=0.008）。
茚达特罗具有良好的安全性和耐受性，适合 COPD 患者的维持治疗。
