The Woolcock Institute of Medical Research, The University of Sydney, Sydney, NSW, Australia.
Firestone Institute for Respiratory Health, St Joseph's Healthcare and Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
J Allergy Clin Immunol Pract. 2021 Aug;9(8):3069-3077.e6. doi: 10.1016/j.jaip.2021.04.016. Epub 2021 Apr 22.
Medication adherence is challenging for adolescents. In mild asthma, as-needed budesonide-formoterol (BUD-FORM) reduces severe exacerbations compared with as-needed short-acting beta-agonists, similar to the reduction with maintenance budesonide.
This post hoc pooled analysis of Symbicort Given as-needed in Mild Asthma (SYGMA) 1 and 2 assessed the efficacy and safety of as-needed BUD-FORM in adolescents.
SYGMA 1 and 2 were 52-week, double-blind studies (NCT022149199; NCT02224157) in patients 12 years or older with mild asthma. Patients were randomized to twice-daily placebo + as-needed BUD-FORM 200/6 μg, twice-daily BUD 200 μg + as-needed terbutaline (BUD maintenance), or twice-daily placebo + as-needed terbutaline 0.5 mg (SYGMA 1 only). Annualized severe exacerbation rates, maintenance treatment adherence, and safety (including change in height) were compared between treatment groups in adolescents (aged ≥12 to <18 years).
Severe exacerbation rate was similar with as-needed BUD-FORM and BUD maintenance (pooled analysis: 0.08 vs 0.07/y; P = .634), and was significantly lower with as-needed BUD-FORM versus as-needed terbutaline (SYGMA 1: 0.04 vs 0.17/y; P = .005). Median adherence was 73% in SYGMA 1 and 51% in SYGMA 2. Change in height from baseline in adolescents aged ≥12 years to <14 years was significantly greater with as-needed BUD-FORM (4.8 cm) versus BUD maintenance (3.9 cm) (pooled: P < .046), and was similar between as-needed BUD-FORM (4.5 cm) and as-needed terbutaline (4.1 cm) (SYGMA 1: P = .500). No new or unexpected safety concerns were identified.
In adolescents with mild asthma, as-needed BUD-FORM was superior to as-needed terbutaline for severe exacerbation reduction, with similar efficacy to BUD maintenance. As-needed BUD-FORM provides an alternative treatment option for adolescents with mild asthma, without needing daily treatment.
青少年用药依从性具有挑战性。在轻度哮喘中，按需使用布地奈德福莫特罗（BUD-FORM）与按需使用短效β激动剂相比可减少重度恶化，与维持治疗布地奈德相比同样如此。
Symbicort 按需给予轻度哮喘 1 期和 2 期（SYGMA 1 和 2）的这一事后汇总分析评估了按需使用 BUD-FORM 在青少年患者中的疗效和安全性。
SYGMA 1 和 2 是两项为期 52 周的双盲研究（NCT022149199；NCT02224157），纳入了年龄 12 岁及以上的轻度哮喘患者。患者随机分组，接受每日 2 次安慰剂+按需使用 BUD-FORM 200/6 μg、每日 2 次布地奈德 200 μg+按需使用特布他林（布地奈德维持治疗）或每日 2 次安慰剂+按需使用特布他林 0.5 mg（仅 SYGMA 1）。比较了青少年（12-<18 岁）中各治疗组的年化重度恶化率、维持治疗依从性和安全性（包括身高变化）。
按需使用 BUD-FORM 与布地奈德维持治疗的重度恶化率相似（汇总分析：0.08 比 0.07/年；P=0.634），与按需使用特布他林相比，重度恶化率显著降低（SYGMA 1：0.04 比 0.17/年；P=0.005）。SYGMA 1 中依从性中位数为 73%，SYGMA 2 中为 51%。12 岁至<14 岁青少年的身高自基线变化，与布地奈德维持治疗相比，按需使用 BUD-FORM （4.8 cm）显著更大（汇总：P<.046），与按需使用特布他林（4.5 cm）相似（SYGMA 1：P=0.500）。未发现新的或意外的安全性问题。
在轻度哮喘青少年中，与按需使用特布他林相比，按需使用 BUD-FORM 可降低重度恶化风险，且疗效与布地奈德维持治疗相当。按需使用 BUD-FORM 为轻度哮喘青少年提供了一种替代治疗选择，无需每日治疗。
