All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis

Respiratory Investigation
Takashi OguraT Nukiwa

Abstract

Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease with a median survival of 2-5 years and limited treatment options. In 2008, pirfenidone became the first drug to be approved for IPF treatment in Japan. The aim of this study was to assess the safety of pirfenidone for IPF treatment in a clinical setting. We conducted a safety-oriented post-marketing surveillance of all patients with IPF who were administered pirfenidone in the first year after its launch in Japan. This was a prospective, non-interventional, observational study. Case report forms were used to collect survey data, comprising adverse events, acute exacerbations, patient demographics, concomitant drug use, and concurrent treatment data. Of the 1371 patients available for safety evaluation, two-thirds had stage III-IV disease. The incidence of total adverse drug reactions (ADRs) was 64.6%. ADRs with an incidence of ≥3% were decreased appetite, photosensitivity reaction, nausea, abdominal discomfort, malaise, somnolence, and hepatic function abnormal. This safety profile was consistent with the findings in phase II and III trials in Japan. The discontinuation rates due to adverse events at 12 months for each disease stage were similar; however, d...Continue Reading

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Citations

May 14, 2016·Expert Opinion on Drug Safety·Adam AndersonSteven D Nathan
Mar 21, 2017·Respirology : Official Journal of the Asian Pacific Society of Respirology·Jonathan A GalliGerard J Criner
Mar 28, 2017·Expert Review of Respiratory Medicine·Keith C Meyer
Apr 26, 2017·Respirology : Official Journal of the Asian Pacific Society of Respirology·Takashi Ogura, Hideya Kitamura
Oct 21, 2017·Nature Reviews. Disease Primers·Fernando J MartinezAthol U Wells
Aug 9, 2017·Respirology : Official Journal of the Asian Pacific Society of Respirology·Yasuhiro KondohSakae Homma
Jul 19, 2017·Internal Medicine·Isano HaseYoshiki Ishii
Jul 18, 2018·Frontiers in Medicine·Paolo SpagnoloFrancesco Bonella
Aug 30, 2017·Respirology : Official Journal of the Asian Pacific Society of Respirology·Masahiro UeharaTakafumi Suda
May 10, 2019·Cardiovascular Drugs and Therapy·Gavin A LewisChristopher A Miller
Apr 27, 2021·Experimental Lung Research·Tatsuya HosonoYukihiko Sugiyama
Aug 29, 2020·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Satoshi IkedaHiroaki Okamoto
Oct 18, 2018·Respiration; International Review of Thoracic Diseases·Hee-Young YoonJin Woo Song

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