PMID- 32297284
OWN - NLM
STAT- MEDLINE
DCOM- 20201207
LR  - 20210526
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 5
DP  - 2020 May
TI  - Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A 
      Nationwide Post-Marketing Surveillance Study in Korean Patients.
PG  - 2303-2316
LID - 10.1007/s12325-020-01328-8 [doi]
AB  - AIM: The efficacy and safety of pirfenidone have been previously demonstrated in 
      patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF). However, the 
      effect of pirfenidone in patients with advanced IPF remains unclear. Here, we 
      investigated the effects of pirfenidone against advanced IPF in a real-world 
      setting. METHODS: A prospective nationwide post-marketing study was conducted on 
      258 patients from 10 Korean institutions. Patients with a predicted forced vital 
      capacity (FVC) less than 50% or a diffusing capacity of the lung for carbon 
      monoxide (DLco) less than 35% at baseline were classified as the advanced IPF 
      group. RESULTS: Of 219 patients included in the analysis, the majority were male 
      (76.3%); the mean age was 67.3 years, and the advanced group accounted for 17.8% 
      of the patients. The median treatment duration was 298 days. Among the subjects, 
      86.3% experienced adverse events (AEs), of which a decreased appetite (32.4%) and 
      a photosensitivity reaction (13.7%) were the most frequent. The incidence of AEs 
      was similar between the advanced and non-advanced groups (92.3% vs. 85.0%, 
      respectively; p = 0.229). Although the overall discontinuation rate was higher in 
      the advanced group than in the non-advanced group (74.4% vs. 50.0%, respectively; 
      p = 0.006), the percentages of the patients who discontinued treatment as a 
      result of AEs were similar in both groups (20.5% vs. 23.3%, respectively; 
      p = 0.704). In all patients, the rates of decline in the predicted FVC and DLco 
      over 48 weeks were - 4.3 +/- 1.3% and - 4.4 +/- 1.7%, respectively. There was no 
      between-group difference in the rate of lung function decline. CONCLUSIONS: 
      Pirfenidone used for the treatment of patients with IPF in a real-world setting 
      was well tolerated, with an acceptable safety profile and a consistent 
      therapeutic effect, regardless of the disease severity. TRIAL REGISTRATION: 
      ClinicalTrials.gov NCT03761082; the trial was retrospectively registered on 
      December 3, 2018.
FAU - Chung, Man Pyo
AU  - Chung MP
AD  - Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung 
      Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
FAU - Park, Moo Suk
AU  - Park MS
AD  - Division of Pulmonary and Critical Care Medicine, Department of Internal 
      Medicine, Yonsei University College of Medicine, Yonsei University Health System, 
      Seoul, South Korea.
FAU - Oh, In Jae
AU  - Oh IJ
AD  - Department of Internal Medicine, Lung and Esophageal Cancer Clinic, Chonnam 
      National University Medical School, Hwasun, South Korea.
FAU - Lee, Heung Bum
AU  - Lee HB
AD  - Department of Internal Medicine, Research Institute of Clinical Medicine, Medical 
      School of Jeonbuk National University, Jeonju, South Korea.
FAU - Kim, Young Whan
AU  - Kim YW
AD  - Division of Pulmonary and Critical Care Medicine, Department of Internal 
      Medicine, Seoul National University Hospital, Seoul, South Korea.
FAU - Park, Jong Sun
AU  - Park JS
AD  - Division of Pulmonary and Critical Care Medicine, Department of Internal 
      Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
FAU - Uh, Soo Taek
AU  - Uh ST
AD  - Division of Allergy and Respiratory Medicine, Department of Internal Medicine, 
      Soonchunhyang University Seoul Hospital, Seoul, South Korea.
FAU - Kim, Yun Seong
AU  - Kim YS
AD  - Department of Internal Medicine, Pusan National University Yangsan Hospital, 
      Yangsan, South Korea.
FAU - Jegal, Yangjin
AU  - Jegal Y
AD  - Division of Pulmonary Medicine, Department of Internal Medicine, Ulsan University 
      Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
FAU - Song, Jin Woo
AU  - Song JW
AD  - Department of Pulmonary and Critical Care Medicine, Asan Medical Centre, 
      University of Ulsan College of Medicine, Seoul, South Korea. 
      jwsongasan@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03761082
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200415
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Pyridones)
RN  - D7NLD2JX7U (pirfenidone)
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/therapeutic use
MH  - Female
MH  - Humans
MH  - *Idiopathic Pulmonary Fibrosis/diagnosis/drug therapy/epidemiology
MH  - *Lung/diagnostic imaging/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - *Pyridones/administration & dosage/adverse effects
MH  - Republic of Korea/epidemiology
MH  - Respiratory Function Tests/methods
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC7467484
OTO - NOTNLM
OT  - Advanced disease
OT  - Disease progression
OT  - Idiopathic pulmonary fibrosis
OT  - Pirfenidone
OT  - Safety
OT  - Treatment outcome
EDAT- 2020/04/17 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/04/15
CRDT- 2020/04/17 06:00
PHST- 2020/02/29 00:00 [received]
PHST- 2020/04/17 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/04/17 06:00 [entrez]
PHST- 2020/04/15 00:00 [pmc-release]
AID - 10.1007/s12325-020-01328-8 [pii]
AID - 1328 [pii]
AID - 10.1007/s12325-020-01328-8 [doi]
PST - ppublish
SO  - Adv Ther. 2020 May;37(5):2303-2316. doi: 10.1007/s12325-020-01328-8. Epub 2020 
      Apr 15.