Hardy Jo, Tewhaiti-Smith Jordan, Baggott Christina, Fingleton James, Semprini Alex, Holliday Mark, Hancox Robert J, Weatherall Mark, Harwood Matire
Senior Clinical Research Fellow, Medical Research Institute of New Zealand, Wellington.
Clinical Research Fellow, Medical Research Institute of New Zealand, Wellington.
N Z Med J. 2020 Aug 21;133(1520):61-72.
In the PRACTICAL study, as-needed budesonide/formoterol reduced the rate of severe exacerbations compared with maintenance budesonide plus as-needed terbutaline. In a pre-specified analysis we analysed the efficacy in Māori and Pacific peoples, populations with worse asthma outcomes.
The PRACTICAL study was a 52-week, open-label, parallel group, randomised controlled trial of 890 adults with mild to moderate asthma, who were randomised to budesonide/formoterol Turbuhaler 200/6mcg one actuation as required or budesonide Turbuhaler 200mcg one actuation twice daily and terbutaline Turbuhaler 250mcg two actuations as required. The primary outcome was rate of severe exacerbations. The analysis strategy was to test an ethnicity-treatment interaction term for each outcome variable.
Seventy-two participants (8%) identified as Māori, 36 participants (4%) as Pacific ethnicity. There was no evidence that ethnicity was an effect modifier for severe exacerbations (P interaction 0.70).
The reduction in severe exacerbation risk with budesonide-formoterol reliever compared with maintenance budesonide was similar in Māori and Pacific adults compared with New Zealand European/Other.
在PRACTICAL研究中,与维持使用布地奈德加按需使用特布他林相比,按需使用布地奈德/福莫特罗可降低严重加重发作的发生率。在一项预先指定的分析中,我们分析了该药物在毛利人和太平洋岛民(哮喘预后较差的人群)中的疗效。
PRACTICAL研究是一项为期52周的开放标签、平行组随机对照试验,纳入了890名轻度至中度哮喘成人患者,他们被随机分为按需使用布地奈德/福莫特罗都保200/6微克(每次1吸)组,或布地奈德都保200微克(每日2次每次1吸)加按需使用特布他林都保250微克(每次2吸)组。主要结局是严重加重发作的发生率。分析策略是对每个结局变量检验种族-治疗交互作用项。
72名参与者(8%)为毛利人,36名参与者(4%)为太平洋岛民种族。没有证据表明种族是严重加重发作的效应修饰因素(交互作用P值为0.70)。
与新西兰欧洲人/其他种族相比,在毛利人和太平洋岛民成年人中,与维持使用布地奈德相比,使用布地奈德-福莫特罗缓解剂降低严重加重发作风险的效果相似。