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Saji, T; Myoishi, M; Sugimura, K; Tahara, N; Takeda, Y; Fukuda, K; Olschewski, H; Matsuda, Y; Nikkho, S; Satoh, T.
Efficacy and Safety of Inhaled Iloprost in Japanese Patients With Pulmonary Arterial Hypertension - Insights From the IBUKI and AIR Studies.
Circ J. 2016; 80(4):835-842
Doi: 10.1253/circj.CJ-16-0097
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- Olschewski Horst
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- Abstract:
- 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. 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. 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Inhalation -
- Adult -
- Asian Continental Ancestry Group -
- Endothelin Receptor Antagonists - administration & dosage
- Endothelin Receptor Antagonists - adverse effects
- Female -
- Humans -
- Hypertension, Pulmonary - drug therapy
- Hypertension, Pulmonary - physiopathology
- Iloprost - administration & dosage
- Iloprost - adverse effects
- Japan -
- Male -
- Middle Aged -
- Phosphodiesterase 5 Inhibitors - administration & dosage
- Phosphodiesterase 5 Inhibitors - adverse effects
- Find related publications in this database (Keywords)
- Idiopathic pulmonary arterial hypertension
- Japanese
- Pulmonary arterial hypertension
- Pulmonary hypertension