PMID- 35046733
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220121
IS  - 1179-1454 (Print)
IS  - 1179-1454 (Electronic)
IS  - 1179-1454 (Linking)
VI  - 14
DP  - 2022
TI  - Clinical Interpretation of Efficacy Outcomes in Pharmacological Studies on Triple 
      Fixed-Dose Combination Therapy for Uncontrolled Asthma: Assessment of IRIDIUM and 
      ARGON Studies.
PG  - 1-5
LID - 10.2147/JEP.S336304 [doi]
AB  - The IRIDIUM and ARGON studies provided positive findings concerning the benefits 
      of the once-daily triple mometasone furoate/indacaterol/glycopyrronium 
      (MF/IND/GLY) fixed-dose combination (FDC) for the treatment of uncontrolled 
      asthma, at the least by a strict statistical point of view. In the IRIDIUM study 
      patients received medium-dose (MD) or high-dose (HD) MF/IND/GLY or MF/IND oncex 
      daily or HD fluticasone/salmeterol (FLU/SAL) twice daily; in the ARGON study 
      patients received MD or HD MF/IND/GLY once daily or HD FLU/SAL twice daily + 
      tiotropium (TIO) once daily. Since a detailed interpretation of clinical results 
      has not yet been performed, we provided the clinical interpretation of efficacy 
      outcomes resulting from the IRIDIUM and ARGON studies according to the currently 
      available minimal clinically important difference (MCID) thresholds. The triple 
      MF/IND/GLY FDC elicited beneficial clinically relevant effects compared to active 
      comparators in asthmatic patients, according to the levels of ICS doses, by 
      generally achieving and overcoming the MCID. The level of clinical benefit was 
      usually greater in patients treated with HD-MF/IND/GLY compared to those treated 
      with MD-MF/IND/GLY. Overall, HD-MF/IND/GLY induced greater clinically relevant 
      benefits even when compared to HD-FLU/SAL + TIO. Considering that a balanced 
      triple MF/IND/GLY FDC with MD ICS resulted as effective as HD-MF/IND in 
      preventing moderate or severe exacerbations, thus triple ICS/LABA/LAMA FDCs with 
      MD ICS should be considered for the treatment not only of uncontrolled asthma but 
      also for those patients suffering from less severe forms of disease with airflow 
      limitation as well as a possible as-needed therapeutic option.
CI  - (c) 2022 Rogliani and Calzetta.
FAU - Rogliani, Paola
AU  - Rogliani P
AUID- ORCID: 0000-0001-7801-5040
AD  - Unit of Respiratory Medicine, Department of Experimental Medicine, University of 
      Rome "Tor Vergata", Rome, Italy.
FAU - Calzetta, Luigino
AU  - Calzetta L
AUID- ORCID: 0000-0003-0456-069X
AD  - Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, 
      University of Parma, Parma, Italy.
LA  - eng
PT  - Journal Article
DEP - 20220111
PL  - New Zealand
TA  - J Exp Pharmacol
JT  - Journal of experimental pharmacology
JID - 101530345
PMC - PMC8762517
OTO - NOTNLM
OT  - ARGON study
OT  - IRIDIUM study
OT  - MCID
OT  - minimal clinically important difference
OT  - triple therapy
OT  - uncontrolled asthma
COIS- Professor Paola Rogliani reports grants, personal fees, non-financial support 
      from Novartis, outside the submitted work. Dr Luigino Calzetta reports grants, 
      personal fees from Novartis, outside the submitted work. The authors report no 
      other conflicts of interest in this work.
EDAT- 2022/01/21 06:00
MHDA- 2022/01/21 06:01
PMCR- 2022/01/11
CRDT- 2022/01/20 06:00
PHST- 2021/08/27 00:00 [received]
PHST- 2021/12/29 00:00 [accepted]
PHST- 2022/01/20 06:00 [entrez]
PHST- 2022/01/21 06:00 [pubmed]
PHST- 2022/01/21 06:01 [medline]
PHST- 2022/01/11 00:00 [pmc-release]
AID - 336304 [pii]
AID - 10.2147/JEP.S336304 [doi]
PST - epublish
SO  - J Exp Pharmacol. 2022 Jan 11;14:1-5. doi: 10.2147/JEP.S336304. eCollection 2022.