van Zyl-Smit Richard N, Chapman Kenneth R, Kerstjens Huib A M, Gessner Christian, Sagara Hironori, Tanase Ana-Maria, Hosoe Motoi, Pethe Abhijit, Lawrence David, Tillmann Hanns-Christian, D'Andrea Peter
Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
J Asthma Allergy. 2023 Jan 20;16:123-134. doi: 10.2147/JAA.S392975. eCollection 2023.
Once-daily, single-inhaler mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY, an ICS/LABA/LAMA) and MF/IND (an ICS/LABA) via Breezhaler have been approved for the maintenance treatment of patients with asthma inadequately controlled with medium-or high-dose ICS or medium-or high-dose ICS/LABA treatment.
Once-daily (o.d.) formulations of MF/IND/GLY and MF/IND at different MF dose strengths have been compared with twice-daily (b.i.d.) fluticasone propionate/salmeterol xinafoate (FLU/SAL), and b.i.d. FLU/SAL+ o.d. tiotropium (TIO) in the PALLADIUM, IRIDIUM and ARGON studies.
The similarity in study design and consistent outcomes in these studies prompted the pooling of data in this review to better characterise these novel once-daily controller formulations.
Pooled data from PALLADIUM and IRIDIUM studies showed comparable or greater efficacy with o.d. MF/IND formulations versus b.i.d. FLU/SAL. The o.d. MF/IND/GLY was superior to b.i.d. FLU/SAL in the IRIDIUM study, and similar to, if not more efficacious than b.i.d. FLU/SAL + o.d. TIO in the ARGON study.
These formulations therefore provide novel once-daily treatment options for patients across asthma severity and flexibility for clinicians to step-up or step-down the treatment using the same device and formulations.
每日一次的单吸入器糠酸莫米松/茚达特罗乙酸酯/格隆溴铵(MF/IND/GLY,一种吸入性糖皮质激素/长效β2受体激动剂/长效抗胆碱能药物)和通过Breezhaler吸入的MF/IND(一种吸入性糖皮质激素/长效β2受体激动剂)已被批准用于对中高剂量吸入性糖皮质激素或中高剂量吸入性糖皮质激素/长效β2受体激动剂治疗控制不佳的哮喘患者的维持治疗。
在钯、铱和氩研究中,比较了不同MF剂量强度的每日一次(o.d.)MF/IND/GLY和MF/IND制剂与每日两次(b.i.d.)丙酸氟替卡松/沙美特罗昔萘酸盐(FLU/SAL),以及每日两次FLU/SAL加每日一次噻托溴铵(TIO)的疗效。
这些研究中相似的研究设计和一致的结果促使在本综述中汇总数据,以更好地表征这些新型每日一次的控制制剂。
钯和铱研究的汇总数据显示,与每日两次的FLU/SAL相比,每日一次的MF/IND制剂疗效相当或更高。在铱研究中,每日一次的MF/IND/GLY优于每日两次的FLU/SAL,在氩研究中,其疗效与每日两次的FLU/SAL加每日一次的TIO相似,甚至更有效。
因此,这些制剂为不同哮喘严重程度的患者提供了新型的每日一次治疗选择,并为临床医生提供了灵活性,使其能够使用相同的装置和制剂加强或减少治疗。