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Effects of Long-Acting Beraprost Sodium (TRK-100STP) in Japanese Patients With Pulmonary Arterial Hypertension

  • Kunieda Takeyoshi
    Department of Cardiovascular Medicine, Kaken Hospital, Clinical Medical Research Center, International University of Health and Welfare
  • Nakanishi Norifumi
    Division of Cardiology, Department of Medicine, National Cardiovascular Center
  • Matsubara Hiromi
    Division of Cardiology, National Hospital Organization Okayama Medical Center
  • Ohe Tohru
    Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  • Okano Yoshiaki
    Department of Clinical Laboratory Medicine, Kyoto University Graduate School of Medicine
  • Kondo Hirobumi
    Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine
  • Nishimura Masaharu
    First Department of Medicine, Hokkaido University Graduate School of Medicine
  • Shirato Kunio
    Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
  • Tanabe Nobuhiro
    Department of Respirology, Chiba University Graduate School of Medicine
  • Homma Satoshi
    Cardiovascular Division, Institute of Clinical Medicine, Graduate School of Comprehensive Human Science, University of Tsukuba
  • Yoshida Shunji
    Division of Rheumatology and Infectious Diseases, Department of Internal Medicine, Fujita Health University School of Medicine
  • Inokuma Shigeko
    Department of Allergy and Immunological Diseases, Tokyo Metropolitan Komagome Hospital
  • Kodama Makoto
    First Department of Internal Medicine, Niigata University Graduate School of Medical and Dental Sciences
  • Koike Takao
    Second Department of Medicine, Hokkaido University Graduate School of Medicine
  • Hishida Hitoshi
    Division of Cardiology, Department of Internal Medicine, Fujita Health University School of Medicine

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Abstract

The long-acting beraprost preparation TRK-100STP is formulated to provide sustained release of an orally active prostacyclin derivative to maintain the optimal plasma concentration for a longer period of time compared with the currently used conventional beraprost sodium. In the present study, we evaluated the efficacy of this newly developed formulation for pulmonary arterial hypertension (PAH).<br>An open-label, 12-week multicenter clinical trial was performed in 46 patients with PAH. They were initially treated with 120 μg of TRK-100STP divided into 60 μg twice daily, followed by a stepwise increase to 360 μg given as 180 μg twice daily. The 6-minute walking distance showed a significant increase by 33.4 ± 66.0 m (95% confidence interval [CI], 13.4 to 53.5) from the baseline measurement. Mean pulmonary artery pressure, total pulmonary vascular resistance, and pulmonary vascular resistance decreased by –2.8 ± 5.5 mmHg (95% CI, –4.6 to –1.0), by –0.92 ± 2.63 mmHg•L–1•min (95% CI, –1.78 to –0.05), and by –0.89 ± 2.81 mmHg•L–1•min (95% CI, –1.84 to 0.06), respectively, from the baseline measurements. A higher efficacy was observed in patients with a maximum tolerated dose of 360 μg daily than those of 240 μg daily or less.<br>Treatment with TRK-100STP for a 12-week period improved the exercise capacity, mean pulmonary artery pressure, and total pulmonary vascular resistance. TRK-100STP was effective for Japanese patients with PAH.

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