Effect of a single day of increased as-needed budesonide–formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study

布地奈德 福莫特罗 布地奈德/福莫特罗 医学 特布他林 恶化 安慰剂 内科学 支气管扩张剂 麻醉 哮喘 析因分析 儿科 病理 替代医学
作者
Paul M. O’Byrne,J. Mark FitzGerald,Eric D. Bateman,Peter J. Barnes,Jinping Zheng,Per Gustafson,Rosa Lamarca,Margareta Puu,Christina Keen,Vijay Alagappan,Helen Reddel
出处
期刊:The Lancet Respiratory Medicine [Elsevier BV]
卷期号:9 (2): 149-158 被引量:42
标识
DOI:10.1016/s2213-2600(20)30416-1
摘要

Background In mild asthma, as-needed budesonide–formoterol reduces long-term exacerbation risk compared with as-needed short-acting β2-agonist (SABA), with a similar or increased reduction versus maintenance with budesonide plus as-needed SABA, despite a lower budesonide dose. In this post-hoc analysis of the SYmbicort Given as needed in Mild Asthma (SYGMA) 1 study, we investigated the short-term risk of severe exacerbations after a single day with various levels of reliever use. Methods SYGMA 1 was a 52-week, double-blind, randomised, controlled, phase 3 trial, in which patients aged 12 years or older with mild asthma were randomly assigned (1:1:1) to placebo twice daily plus as-needed terbutaline 0·5 mg, placebo twice daily plus as-needed budesonide–formoterol 200–6 μg, or budesonide 200 μg twice daily plus as-needed terbutaline (ie, budesonide maintenance group). In this post-hoc analysis, we assessed the frequency of reliever use and the risk of a severe exacerbation in the 21 days after first use of more than two, four, six, or eight reliever inhalations in 24 h. SYGMA 1 is registered with ClinicalTrials.gov, NCT02149199, and is now complete. Findings Of 5721 patients enrolled in SYGMA 1, 3849 were randomly assigned to as-needed terbutaline (n=1280), as-needed budesonide–formoterol (n=1279), or budesonide maintenance (n=1290), of whom 3836 had evaluable data (n=1277 as-needed terbutaline, n=1277 as needed budesonide–formoterol, and n=1282 budesonide maintenance). Median reliever use was 0·32 (IQR 0·08–0·91) inhalations per day for the as-needed terbutaline group, 0·29 (0·07–0·72) for the as-needed budesonide–formoterol group, and 0·16 (0·04–0·52) for the budesonide maintenance group. Compared with as-needed terbutaline, after adjustment for age, sex, randomly assigned treatment, pre-study treatment group, baseline % predicted post-bronchodilator FEV1, and severe exacerbation in the 12 months before enrolment in the study, the hazard ratio (HR) for severe exacerbation in the 21 days after a single day with more than two as-needed inhalations was 0·27 (95% CI 0·12–0·58; p=0·0008) with as-needed budesonide–formoterol and 0·39 (0·19–0·79; p=0·0091) with budesonide maintenance; after a single day of more than four as-needed inhalations the HR was 0·24 (0·10–0·62; p=0·0030) with as-needed budesonide–formoterol and 0·30 (0·13–0·72; p=0·0065) with budesonide maintenance; and after a single day of more than six as-needed inhalations the HR was 0·14 (0·02–1·06; p=0·057) with as-needed budesonide–formoterol and 0·43 (0·14–1·26; p=0·12) with budesonide maintenance. HRs were not calculated for more than eight as-needed inhalations due to the small number of events. Interpretation In mild asthma, as-needed budesonide–formoterol reduces the short-term risk of severe exacerbations after a single day of higher use (more than two as-needed inhalations), even when overall use is infrequent. Use of an anti-inflammatory reliever might reduce the risk of short-term severe exacerbations by the timely provision of increased doses of as-needed inhaled corticosteroids and formoterol when symptoms occur. These findings should be further assessed in prospective randomised clinical trials. Funding AstraZeneca.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
舒心渊思完成签到,获得积分10
1秒前
iNk应助经绮梅采纳,获得10
1秒前
savesunshine1022完成签到,获得积分10
1秒前
Koi发布了新的文献求助20
2秒前
4秒前
Owen应助娜娜采纳,获得10
4秒前
七日春信发布了新的文献求助10
5秒前
fanfan完成签到 ,获得积分10
7秒前
7秒前
10秒前
旧梦发布了新的文献求助10
15秒前
李爱国应助大青山采纳,获得10
16秒前
17秒前
NexusExplorer应助潇湘雪月采纳,获得10
20秒前
20秒前
娜娜完成签到,获得积分20
22秒前
wanci应助zpc采纳,获得10
24秒前
26秒前
一行完成签到,获得积分10
26秒前
xxddw发布了新的文献求助10
27秒前
29秒前
英姑应助fengliurencai采纳,获得10
32秒前
32秒前
xxddw完成签到,获得积分10
34秒前
逝月完成签到,获得积分10
34秒前
Koi完成签到,获得积分10
35秒前
思源应助大青山采纳,获得10
35秒前
yuqinghui98发布了新的文献求助10
35秒前
科研通AI2S应助mariawang采纳,获得10
36秒前
恋雅颖月应助潇湘雪月采纳,获得10
36秒前
Rain发布了新的文献求助10
36秒前
36秒前
37秒前
归尘应助小绵羊采纳,获得10
37秒前
我爱看文献是假的完成签到,获得积分10
40秒前
JW完成签到,获得积分10
41秒前
小星历险记完成签到 ,获得积分10
42秒前
43秒前
躺平girl完成签到,获得积分10
43秒前
Bran应助Koi采纳,获得20
44秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989390
求助须知:如何正确求助?哪些是违规求助? 3531487
关于积分的说明 11254109
捐赠科研通 3270153
什么是DOI,文献DOI怎么找? 1804887
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809174