Safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis in clinical practice

Okuda, Ryo; Hagiwara, Eri; Baba, Tomohisa; Kitamura, Hideya; Kato, Terufumi; Ogura, Takashi

doi:10.1016/j.rmed.2013.06.011

Cited by 90 publications

(96 citation statements)

References 16 publications

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“…Yearly FVC decline in the first year of treatment was 30 mL, which was even less than that obtained in a phase III trial (80-90 mL) (5). Recently, Okuda et al reported that the mean change in FVC during the 6-month period prior to therapy initiation was -188 mL, which improved to -19 mL during the 6-month period after the therapy (9). Meanwhile, in the present study, the yearly decline in FVC in the second and third years was 158 mL and 201 mL, respectively, and long-term pirfenidone treatment improved FVC in only a fraction of the cases.…”

Section: Discussioncontrasting

confidence: 41%

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Clinical Experience of the Long-term Use of Pirfenidone for Idiopathic Pulmonary Fibrosis

et al. 2016

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Objective Long-term effects of pirfenidone have been poorly understood to date. This study investigated the clinical efficacy and safety of long-term pirfenidone use for idiopathic pulmonary fibrosis (IPF) in clinical practice. Methods This survey study was a retrospective observational study. A survey was used to collect clinical information on IPF cases that were treated with pirfenidone. This survey sheet came from physicians belonging to the Diffuse Lung Diseases Research Group. Results 502 patients at 22 institutes received pirfeidone treatment. Of the 502 cases, pirfenidone treatment was terminated in under one year in 186 cases (37.1%); adverse effect was the most frequent reason for termination. The pirfenidone treatment lasted for two years or longer in 111 cases (22.1%). The mean change in the forced vital capacity (FVC) was -30±224 (SD) mL in the first year of treatment, -158±258 mL in the second year, and -201±367 mL in the third year. FVC improved by 10% or more in the first year in 10 (14.7%) of 68 cases, and showed a change of ±10% in 47 (69.1%) cases. It showed a change of ±10% in the second and third years in 61.7% and 62.5% of the patients, respectively. Conclusion The FVC improved in only a small percentage of patients who received pirfenidone treatment for a long period of time. However, a decrease in the FVC was prevented for three years in over half of the cases.

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Section: Discussioncontrasting

confidence: 41%

“…It is important to balance efficacy and adverse events in the clinical use of pirfenidone (9,12). In the present study, the most common dose of pirfenidone administered for the longest period of time was 1,800 mg/day among cases that continued pirfenidone treatment for two years or longer.…”

Section: Discussionmentioning

confidence: 73%

Clinical Experience of the Long-term Use of Pirfenidone for Idiopathic Pulmonary Fibrosis

et al. 2016

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“…In addition to long-term observational studies, a number of recent single-centre studies have been published reporting the efficacy and tolerability of pirfenidone in a real-world setting (table 3) [13][14][15][16][17][18][19][20]. Generally, these single-centre observational studies demonstrate that in daily clinical practice the tolerability of pirfenidone is comparable to the literature with a positive effect in terms of clinical efficacy in the majority of patients treated, particularly regarding disease stabilisation and prevention of pulmonary function decline.…”

Section: Single-centre Real-world Experience With Pirfenidonementioning

confidence: 99%

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

2015

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Idiopathic pulmonary fibrosis (IPF) is a chronic, irreversible, progressively destructive lung disease that culminates in respiratory failure and death. Randomised controlled trials have demonstrated that treatment of IPF patients with pirfenidone reduces lung function decline, improves progression-free survival and significantly reduces the risk of all-cause mortality at 1 year. Pirfenidone has been shown to have a favourable safety profile and was generally well tolerated over the long term in clinical trials and realworld experience. However, side-effect management is critical to help some patients remain on treatment over the long term. The primary treatment-related adverse events associated with pirfenidone therapy are gastrointestinal upset, rash and photosensitivity. Gastrointestinal events may be mitigated by ensuring that pirfenidone is taken with food, while skin symptoms may be reduced by avoiding sun exposure and frequent use of sunblock. Educating patients about the potential for these adverse events to occur and providing instructions prior to treatment to avoid adverse drug reactions are an important means of ensuring patients may derive the important benefits provided by long-term treatment with pirfenidone. @ERSpublications Patient education is critical to help IPF patients manage side-effects of pirfenidone and remain on treatment http://ow.ly/HaPak

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“…2011-2014: long-term and real-world experience in the treatment of IPF with pirfenidone Since the approval of pirfenidone in 2011 by the EMA, important data on the use of pirfenidone from clinical studies, long-term observational studies and real-world practice has been accumulated, demonstrating that pirfenidone significantly reduces forced vital capacity (FVC) decline and slows disease progression in IPF [22][23][24][25][26][27][28][29][30]. These longer term studies also showed that pirfenidone is generally well tolerated.…”

Section: Introductionmentioning

confidence: 99%

The changing treatment landscape in idiopathic pulmonary fibrosis

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2015

Eur Respir Rev

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Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and irreversible fibrotic disease of the lung that has greatly frustrated clinicians for a long time. The prognosis of IPF (median survival 2-5 years following diagnosis) is poorer than that of some cancers and for many years no significant advances were made in its management. However, between 2011 and 2014 a number of pivotal developments were made that have improved the outlook for patients with IPF. Herein, we review this rapidly changing landscape, discussing key events whilst still acknowledging that IPF remains a challenging disease to diagnose and manage. @ERSpublications Idiopathic pulmonary fibrosis has become a treatable disease, with two drugs now approved for this indication

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Safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis in clinical practice

Abstract: These results showed that pirfenidone was well-tolerated and had beneficial effects in patients with mild-to-severe and/or progressive IPF. The degree of disease progression prior to the initiation of pirfenidone therapy had an impact on the response to the therapy.

Cited by 90 publications

References 16 publications

Clinical Experience of the Long-term Use of Pirfenidone for Idiopathic Pulmonary Fibrosis

Clinical Experience of the Long-term Use of Pirfenidone for Idiopathic Pulmonary Fibrosis

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

The changing treatment landscape in idiopathic pulmonary fibrosis

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