Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance S
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ORIGINAL RESEARCH
Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide PostMarketing Surveillance Study in Korean Patients Man Pyo Chung . Moo Suk Park . In Jae Oh . Heung Bum Lee . Young Whan Kim . Jong Sun Park . Soo Taek Uh . Yun Seong Kim . Yangjin Jegal . Jin Woo Song
Received: February 29, 2020 Ó The Author(s) 2020
ABSTRACT 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.
Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12039624. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01328-8) contains supplementary material, which is available to authorized users. M. P. Chung Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea M. S. Park Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea I. J. Oh Department of Internal Medicine, Lung and Esophageal Cancer Clinic, Chonnam National University Medical School, Hwasun, South Korea H. B. Lee Department of Internal Medicine, Research Institute of Clinical Medicine, Medical School of Jeonbuk National University, Jeonju, South Korea
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
Y. W. Kim Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea J. S. Park Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea S. T. Uh Division of Allergy and Respiratory Medicine, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, South Korea Y. S. Kim Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea
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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 discontinu
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