European Respiratory Journal ( IF 16.6 ) Pub Date : 2021-09-02 , DOI: 10.1183/13993003.04233-2020 Paola Rogliani 1 , Beatrice Ludovica Ritondo 2 , Luigino Calzetta 3
Conflicting evidence is currently available concerning the impact on asthma exacerbation of triple inhaled corticosteroid (ICS)/long-acting β2-adrenoceptor agonist (LABA)/long-acting muscarinic receptor antagonist (LAMA) fixed-dose combination (FDC).
Since meta-analyses allow settling controversies of apparently inconsistent results, we performed a network meta-analysis of phase III randomised controlled trials including 9535 patients to assess the effect of ICS/LABA/LAMA combinations in uncontrolled asthma.
Triple combination therapies with an ICS administered at high dose (HD) were more effective (p<0.05) than medium-dose (MD) ICS/LABA/LAMA FDC and both MD and HD ICS/LABA FDCs against moderate to severe exacerbation (relative risk 0.61–0.80) and increasing trough forced expiratory volume in 1 s (from +33 to +114 mL). Triple combination therapies including HD ICS were superior (p<0.05) to MD ICS/LABA/LAMA FDC in preventing severe exacerbation (relative risk 0.46–0.65), but not with respect to moderate exacerbation (p>0.05). Triple combination therapies were equally effective on asthma control, with no safety concerns.
This quantitative synthesis suggests that ICS/LABA/LAMA FDCs are effective and safe in uncontrolled asthma, and that the dose of ICS in the combination represents the discriminating factor to treat patients with a history of moderate or severe exacerbation.
中文翻译:
未控制哮喘的三联疗法:III期研究的网络荟萃分析
目前关于三联吸入皮质类固醇 (ICS)/长效 β2-肾上腺素受体激动剂 (LABA)/长效毒蕈碱受体拮抗剂 (LAMA) 固定剂量组合 (FDC) 对哮喘发作的影响存在相互矛盾的证据。
由于荟萃分析可以解决明显不一致的结果的争议,我们对包括 9535 名患者的 III 期随机对照试验进行了网络荟萃分析,以评估 ICS/LABA/LAMA 组合对不受控制的哮喘的影响。
与中剂量 (MD) ICS/LABA/LAMA FDC 以及 MD 和 HD ICS/LABA FDC 相比,采用高剂量 (HD) 的 ICS 三联疗法对中度至重度恶化(相对风险 0.61–0.80)并在 1 秒内增加用力呼气谷量(从 +33 到 +114 mL)。包括 HD ICS 在内的三联疗法在预防严重恶化(相对风险 0.46-0.65)方面优于 MD ICS/LABA/LAMA FDC(p<0.05),但在中度恶化方面则不强(p>0.05)。三联疗法对哮喘控制同样有效,没有安全问题。
这种定量综合表明 ICS/LABA/LAMA FDCs 在不受控制的哮喘中是有效和安全的,并且组合中的 ICS 剂量代表了治疗有中度或重度恶化史的患者的区别因素。