School of Medicine, University of California-San Diego, CA, USA.
Ann Allergy Asthma Immunol. 2011 Jul;107(1):71-8. doi: 10.1016/j.anai.2011.03.010. Epub 2011 Apr 22.
The safety of long-acting β2 agonists (LABA) for the treatment of persistent asthma remains a topic of ongoing debate.
To evaluate the risk of serious asthma-related events among patients treated with formoterol, a meta-analysis of all Novartis-sponsored controlled clinical trials was conducted.
Forty-five randomized, placebo- and active-controlled, parallel-group or crossover studies with formoterol were included. Background inhaled corticosteroid (ICS) use was permitted in all studies; however, in only 2 studies was ICS randomized as study medication. Sub-analyses of the pooled data were performed according to age (5-12; 13-18; >18 years), baseline ICS use, and lung function. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated between formoterol (twice-daily), albuterol (salbutamol) 4 times per day (active control), and placebo.
Patients were randomized to formoterol (n = 5,367), placebo (n = 2,026), and albuterol (n = 976). Two deaths were reported, 1 each in the formoterol (asthma exacerbation) and the placebo (hemorrhagic pancreatitis) groups. No statistically significant differences in serious asthma exacerbations were observed compared with placebo in adolescents and adults. In children, a higher frequency of hospitalizations was observed among patients treated with formoterol compared with placebo (OR 8.4; 95% CI: 1.1-65.3). A trend toward fewer exacerbations was observed among subjects reporting concomitant ICS use at baseline.
This analysis supports current guideline recommendations for the use of LABAs only as add-on therapy to ICS.
长效β2 激动剂（LABA）治疗持续性哮喘的安全性仍然是一个持续争论的话题。
评估使用福莫特罗治疗的患者发生严重哮喘相关事件的风险，这是对所有诺华赞助的对照临床试验进行的荟萃分析。
纳入了 45 项随机、安慰剂和阳性对照、平行组或交叉研究，这些研究均使用了福莫特罗。所有研究均允许使用背景吸入性皮质类固醇（ICS）；但只有 2 项研究将 ICS 随机作为研究药物。根据年龄（5-12 岁、13-18 岁、>18 岁）、基线 ICS 使用情况和肺功能对汇总数据进行了亚组分析。计算了福莫特罗（每日 2 次）、沙丁胺醇（沙美特罗）每日 4 次（阳性对照）和安慰剂之间的比值比（OR）和 95%置信区间（CI）。
患者被随机分配至福莫特罗（n=5367）、安慰剂（n=2026）和沙丁胺醇（n=976）组。报告了 2 例死亡，分别发生在福莫特罗（哮喘恶化）和安慰剂（出血性胰腺炎）组。与安慰剂相比，在青少年和成人中，未观察到严重哮喘恶化的发生率有统计学显著差异。在儿童中，与安慰剂相比，福莫特罗治疗组住院治疗的频率更高（OR 8.4；95%CI：1.1-65.3）。在基线时报告同时使用 ICS 的患者中，观察到发作次数减少的趋势。
这项分析支持目前关于 LABA 仅作为 ICS 附加治疗的使用指南建议。
