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Long-term safety of combination therapy with nintedanib and pirfenidone in Japanese patients with IPF

Hiroyuki Taniguchi, Takashi Ogura, Yoshikazu Inoue, Manabu Akimoto, Arata Azuma
European Respiratory Journal 2016 48: PA2089; DOI: 10.1183/13993003.congress-2016.PA2089
Hiroyuki Taniguchi
1Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Japan
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Takashi Ogura
2Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan
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Yoshikazu Inoue
3Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
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Manabu Akimoto
4Clinical Trials Management, Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan
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Arata Azuma
5Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
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Abstract

Background: A randomised, placebo-controlled, 14- or 28-day, dose-finding, Phase II trial evaluated the safety and pharmacokinetics of nintedanib alone and when added to ongoing pirfenidone therapy in Japanese patients with idiopathic pulmonary fibrosis (IPF). Patients who completed this trial and were still receiving pirfenidone could receive combination therapy with nintedanib and pirfenidone open-label in an extension study.

Aim: To investigate the long-term safety and tolerability of nintedanib in combination with pirfenidone in patients with IPF.

Methods: Patients received open-label nintedanib 150 mg twice daily (bid) and pirfenidone (400 or 600 mg three times daily) in the extension trial. Nintedanib treatment interruption and/or dose reduction to 100 mg bid were permitted.

Results: Twenty patients were treated in the extension trial. Mean (SD) duration of exposure in the extension was 27.0 (15.8) months. The most frequently reported adverse events in the extension were progression of IPF (which included disease worsening and acute exacerbations) (13 patients; 65%), diarrhoea (13 patients; 65%), nausea (12 patients; 60%), constipation (8 patients; 40%) and decreased appetite (8 patients; 40%). One patient discontinued treatment due to a gastrointestinal adverse event (diarrhoea).

Conclusion: In Japanese patients with IPF, treatment with nintedanib in combination with pirfenidone had an acceptable safety and tolerability profile, in line with the adverse event profiles for each drug. No new safety signals were identified. However, no definite conclusions on the safety and tolerability of combination treatment can be drawn based on the small number of patients in this study.

  • Idiopathic pulmonary fibrosis
  • Treatments
  • Interstitial lung disease
  • Copyright ©the authors 2016
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Long-term safety of combination therapy with nintedanib and pirfenidone in Japanese patients with IPF
Hiroyuki Taniguchi, Takashi Ogura, Yoshikazu Inoue, Manabu Akimoto, Arata Azuma
European Respiratory Journal Sep 2016, 48 (suppl 60) PA2089; DOI: 10.1183/13993003.congress-2016.PA2089

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Long-term safety of combination therapy with nintedanib and pirfenidone in Japanese patients with IPF
Hiroyuki Taniguchi, Takashi Ogura, Yoshikazu Inoue, Manabu Akimoto, Arata Azuma
European Respiratory Journal Sep 2016, 48 (suppl 60) PA2089; DOI: 10.1183/13993003.congress-2016.PA2089
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