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

Takeyoshi Kunieda; Norifumi Nakanishi; Hiromi Matsubara; Tohru Ohe; Yoshiaki Okano; Hirobumi Kondo; Masaharu Nishimura; Kunio Shirato; Nobuhiro Tanabe; Satoshi Homma; Shunji Yoshida; Shigeko Inokuma; Makoto Kodama; Takao Koike; Hitoshi Hishida

doi:10.1536/ihj.50.513

Clinical Studies

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

Takeyoshi Kunieda, Norifumi Nakanishi, Hiromi Matsubara, Tohru Ohe, Yoshiaki Okano, Hirobumi Kondo, Masaharu Nishimura, Kunio Shirato, Nobuhiro Tanabe, Satoshi Homma, Shunji Yoshida, Shigeko Inokuma, Makoto Kodama, Takao Koike, Hitoshi Hishida

Author information

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

Keywords: Long-acting beraprost, TRK-100STP, Beraprost, Pulmonary arterial hypertension, 6-minute walking distance

JOURNAL FREE ACCESS

2009 Volume 50 Issue 4 Pages 513-529

DOI https://doi.org/10.1536/ihj.50.513

Details

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).
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.
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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