Efficacy and Safety of Inhaled Iloprost in Japanese Patients With Pulmonary Arterial Hypertension　– Insights From the IBUKI and AIR Studies –

• Saji Tsutomu

  Department of Pediatrics, Toho University Omori Medical Center

• Myoishi Masafumi

  Bayer Yakuhin Ltd

• Sugimura Koichiro

  Tohoku University Graduate School of Medicine

• Tahara Nobuhiro

  Kurume University

• Takeda Yutaka

  Nagoya City University

• Fukuda Keiichi

  Keio University School of Medicine

• Olschewski Horst

  Medical University of Graz

• Matsuda Yoshimi

  Bayer Yakuhin Ltd

• Nikkho Sylvia

  Bayer Pharma AG

• Satoh Toru

  Kyorin University Hospital

Bibliographic Information

Other Title

• LATE BREAKING CLINICAL TRIAL (JCS 2016) : Efficacy and Safety of Inhaled Iloprost in Japanese Patients With Pulmonary Arterial Hypertension : Insights From the IBUKI and AIR Studies

Abstract

Background:Inhaled iloprost is approved for pulmonary arterial hypertension (PAH) in many countries. IBUKI was a phase III, non-randomized, open-label study of the efficacy and safety of inhaled iloprost in Japanese patients with PAH.Methods and Results:Adults with PAH who were treatment-naïve or administered endothelin receptor antagonists (ERAs) and/or phosphodiesterase type 5 inhibitors (PDE5-Is) and in NYHA/WHO functional class (FC) III/IV had inhaled iloprost (2.5 µg, increased to 5.0 µg if tolerated) 6–9 times daily for 12 weeks. Eligible patients entered a 40-week extension phase. Endpoints included change from baseline to week 12 in pulmonary vascular resistance (PVR; primary endpoint), other efficacy parameters, and safety. Data were compared with new subgroup analyses of treatment-naïve Western PAH patients from the global phase III AIR study. 27 patients received iloprost: 89% were treated with an ERA and/or PDE5-I; 70% with both. At week 12, PVR improved from baseline by –124 dyn·sec·cm⁻⁵(95% CI, –177 to –72) and 6-min walking distance increased by 36.0 m (95% CI, 14.9 to 57.1). NYHA/WHO FC improved in 62%; none worsened. Common drug-related adverse events were headache (37%) and cough (15%); 1 patient experienced hypotension; none reported syncope or hemoptysis. There were no deaths and no unexpected long-term safety findings. AIR PAH subgroup analyses showed similar results.Conclusions:Inhaled iloprost appeared effective and safe in Japanese PAH patients, including ERA- and PDE5-I-treated patients, consistent with findings of the AIR PAH subpopulation and previous iloprost studies. (Circ J 2016; 80: 835–842)

Journal

• Circulation Journal

  Circulation Journal 80 (4), 835-842, 2016

  The Japanese Circulation Society

Keywords

• Idiopathic pulmonary arterial hypertension
• Japanese
• Pulmonary arterial hypertension
• Pulmonary hypertension

Details

• CRID: 1390282680085740800
• NII Article ID: 130005139552
• NII Book ID: AA11591968
• DOI: 10.1253/circj.cj-16-0097
• ISSN: 13474820
• ISSN: 13469843
• NDL BIB ID: 027202857
• PubMed: 27001191
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I027202857
• Web Site: https://www.jstage.jst.go.jp/article/circj/80/4/80_CJ-16-0097/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2016250695
• Text Lang: en
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed