Safety of formoterol in adults and children with asthma: a meta-analysis

被引:3
|
作者
Kemp, James [2 ]
Armstrong, Linda [1 ]
Wan, Ying [1 ]
Alagappan, Vijay Kumar Thygarajan [3 ]
Ohlssen, David [1 ]
Pascoe, Steve [4 ]
机构
[1] Novartis Pharmaceut, E Hanover, NJ 07936 USA
[2] Univ Calif San Diego, Sch Med, San Diego, CA 92103 USA
[3] Novartis Horsham Res Ctr, Horsham, W Sussex, England
[4] Novartis Pharma AG, Basel, Switzerland
关键词
ACTING BETA-AGONISTS; DRY POWDER; INHALED CORTICOSTEROIDS; DOUBLE-BLIND; SALMETEROL; THERAPY; PLACEBO;
D O I
10.1016/j.anai.2011.03.010
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: The safety of long-acting beta 2 agonists (LABA) for the treatment of persistent asthma remains a topic of ongoing debate. Objective: 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. Methods: 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. Results: 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. Conclusions: This analysis supports current guideline recommendations for the use of LABAs only as add-on therapy to ICS. Ann Allergy Asthma Immunol. 2011;107:71-78.
引用
收藏
页码:71 / 78
页数:8
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