PMID- 33612668
OWN - NLM
STAT- MEDLINE
DCOM- 20210803
LR  - 20231107
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 60
IP  - 15
DP  - 2021 Aug 1
TI  - Real-world Safety and Efficacy of Indacaterol Maleate in Patients with Chronic 
      Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing 
      Surveillance in Japan.
PG  - 2385-2394
LID - 10.2169/internalmedicine.5571-20 [doi]
AB  - Objective Evidence concerning the safety and efficacy of indacaterol maleate in a 
      real-life setting is limited. The objective of this post-marketing surveillance 
      was to evaluate the real-life safety and efficacy of indacaterol maleate in 
      Japanese patients with chronic obstructive pulmonary disease (COPD). Methods This 
      was a 52-week post-marketing surveillance conducted between April 2012 and 
      December 2018. The safety endpoints included the incidence of adverse events 
      (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). The 
      efficacy endpoints included the physician-reported global evaluation of treatment 
      effectiveness (GETE), change from baseline in the COPD assessment test (CAT) 
      results, forced vital capacity (FVC), forced expiratory volume in 1 second 
      (FEV(1)), and %FEV(1) following 4, 12, 26, and 52 weeks of indacaterol 
      administration. Results Of the 1,846 enrolled patients, 1,726 were included in 
      the safety and efficacy analyses. The mean age of the patients was 72.5 years 
      old. Cough, pneumonia and COPD worsening were the most common AEs reported, while 
      pneumonia (1.04%) was the most common SAE, and cough (1.68%) was the most common 
      ADR. GETE showed that 69.70% of patients achieved an excellent/good/moderate 
      response following indacaterol treatment. The CAT score decreased, and lung 
      function parameters (FVC, FEV(1) and %FEV(1)) improved across all the COPD stages 
      following treatment with indacaterol. Conclusion Indacaterol showed a favorable 
      safety and tolerability profile in Japanese patients with COPD without new safety 
      signals observed in real-life settings. These findings demonstrated that 
      indacaterol is an effective maintenance treatment in real-life practice for 
      Japanese patients with COPD.
FAU - Taniguchi, Tomoko
AU  - Taniguchi T
AD  - Novartis Pharma K.K., Japan.
FAU - Wang, Dong
AU  - Wang D
AD  - Novartis Pharma K.K., Japan.
FAU - Yoshisue, Hajime
AU  - Yoshisue H
AD  - Novartis Pharma K.K., Japan.
FAU - Nagasaki, Makoto
AU  - Nagasaki M
AD  - Novartis Pharma K.K., Japan.
FAU - Sasajima, Takayoshi
AU  - Sasajima T
AD  - Novartis Pharma K.K., Japan.
LA  - eng
PT  - Journal Article
DEP - 20210222
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Indans)
RN  - 0 (Maleates)
RN  - 0 (Quinolones)
RN  - 8OR09251MQ (indacaterol)
SB  - IM
MH  - *Adrenergic beta-2 Receptor Agonists/adverse effects
MH  - Bronchodilator Agents/adverse effects
MH  - Double-Blind Method
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Indans/adverse effects
MH  - Japan/epidemiology
MH  - Maleates/pharmacology/therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - *Pulmonary Disease, Chronic Obstructive/drug therapy
MH  - Quinolones
MH  - Treatment Outcome
PMC - PMC8381178
OTO - NOTNLM
OT  - COPD
OT  - COPD assessment test
OT  - adverse events
OT  - indacaterol maleate
OT  - lung function
OT  - post-marketing surveillance
OT  - safety
COIS- Author's disclosure of potential Conflicts of Interest (COI). Tomoko Taniguchi: 
      Employment, Novartis Pharma. Dong Wang: Employment, Novartis Pharma. Hajime 
      Yoshisue: Employment, Novartis Pharma. Makoto Nagasaki: Employment, Novartis 
      Pharma. Takayoshi Sasajima: Employment, Novartis Pharma.
EDAT- 2021/02/23 06:00
MHDA- 2021/08/04 06:00
PMCR- 2021/08/01
CRDT- 2021/02/22 05:50
PHST- 2021/02/23 06:00 [pubmed]
PHST- 2021/08/04 06:00 [medline]
PHST- 2021/02/22 05:50 [entrez]
PHST- 2021/08/01 00:00 [pmc-release]
AID - 10.2169/internalmedicine.5571-20 [doi]
PST - ppublish
SO  - Intern Med. 2021 Aug 1;60(15):2385-2394. doi: 10.2169/internalmedicine.5571-20. 
      Epub 2021 Feb 22.