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Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance Study in Korean Patients

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dc.contributor.author박무석-
dc.date.accessioned2020-09-28T11:42:41Z-
dc.date.available2020-09-28T11:42:41Z-
dc.date.issued2020-05-
dc.identifier.issn0741-238X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179260-
dc.description.abstractAim: 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.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherHealth Communications-
dc.relation.isPartOfADVANCES IN THERAPY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleSafety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance Study in Korean Patients-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorMan Pyo Chung-
dc.contributor.googleauthorMoo Suk Park-
dc.contributor.googleauthorIn Jae Oh-
dc.contributor.googleauthorHeung Bum Lee-
dc.contributor.googleauthorYoung Whan Kim-
dc.contributor.googleauthorJong Sun Park-
dc.contributor.googleauthorSoo Taek Uh-
dc.contributor.googleauthorYun Seong Kim-
dc.contributor.googleauthorYangjin Jegal-
dc.contributor.googleauthorJin Woo Song-
dc.identifier.doi10.1007/s12325-020-01328-8-
dc.contributor.localIdA01457-
dc.relation.journalcodeJ00048-
dc.identifier.eissn1865-8652-
dc.identifier.pmid32297284-
dc.identifier.urlhttps://link.springer.com/article/10.1007%2Fs12325-020-01328-8-
dc.subject.keywordAdvanced disease-
dc.subject.keywordDisease progression-
dc.subject.keywordIdiopathic pulmonary fibrosis-
dc.subject.keywordPirfenidone-
dc.subject.keywordSafety-
dc.subject.keywordTreatment outcome-
dc.contributor.alternativeNamePark, Moo Suk-
dc.contributor.affiliatedAuthor박무석-
dc.citation.volume37-
dc.citation.number5-
dc.citation.startPage2303-
dc.citation.endPage2316-
dc.identifier.bibliographicCitationADVANCES IN THERAPY, Vol.37(5) : 2303-2316, 2020-05-
dc.identifier.rimsid67466-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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