Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: An open-label, extension study

Shinya Katsutani, Yoshiaki Tomiyama, Akiro Kimura, Yoshitaka Miyakawa, Shinichiro Okamoto, Yasushi Okoshi, Haruhiko Ninomiya, Hiroshi Kosugi, Kazuyoshi Ishii, Yasuo Ikeda, Toshihiro Hattori, Koichi Katsura, Yuzuru Kanakura

研究成果: Article

12 引用 (Scopus)

抄録

Eltrombopag is an oral, nonpeptide, thrombopoietin receptor agonist approved for treatment of chronic immune thrombocytopenia (ITP). The safety, tolerability, and efficacy of eltrombopag for up to 3 years were evaluated in 19 Japanese patients with chronic ITP who had completed a prior 6-month study. Patients received eltrombopag once daily at the last dosage received in the prior study (12.5, 25, or 50 mg). Dose adjustments and treatment interruptions were permitted to maintain platelet counts of 50,000-200,000/μL. Primary evaluations were safety and tolerability of long-term eltrombopag treatment. The median duration of exposure was 27.5 months (range, 9.9-32.3). Adverse events were similar to those reported with short-term use of eltrombopag, and none led to treatment discontinuation. Nine serious adverse events were reported. Median platelet counts began to increase after 1 week of treatment and remained above 50,000/μL for most assessments. Bleeding episodes decreased from 63 % at baseline to 21 % after 2 weeks of treatment and remained below baseline for all assessments. Of 15 patients receiving concomitant baseline ITP medications, 10 permanently discontinued or achieved a sustained reduction of at least one treatment without requiring rescue treatment. Long-term treatment with eltrombopag was safe, well tolerated, and effective in Japanese patients with chronic ITP.

元の言語English
ページ(範囲)323-330
ページ数8
ジャーナルInternational Journal of Hematology
98
発行部数3
DOI
出版物ステータスPublished - 2013 9

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Idiopathic Thrombocytopenic Purpura
Therapeutics
Platelet Count
Thrombopoietin Receptors
Safety
eltrombopag
Hemorrhage

ASJC Scopus subject areas

  • Hematology

これを引用

Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia : An open-label, extension study. / Katsutani, Shinya; Tomiyama, Yoshiaki; Kimura, Akiro; Miyakawa, Yoshitaka; Okamoto, Shinichiro; Okoshi, Yasushi; Ninomiya, Haruhiko; Kosugi, Hiroshi; Ishii, Kazuyoshi; Ikeda, Yasuo; Hattori, Toshihiro; Katsura, Koichi; Kanakura, Yuzuru.

:: International Journal of Hematology, 巻 98, 番号 3, 09.2013, p. 323-330.

研究成果: Article

Katsutani, S, Tomiyama, Y, Kimura, A, Miyakawa, Y, Okamoto, S, Okoshi, Y, Ninomiya, H, Kosugi, H, Ishii, K, Ikeda, Y, Hattori, T, Katsura, K & Kanakura, Y 2013, 'Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: An open-label, extension study', International Journal of Hematology, 巻. 98, 番号 3, pp. 323-330. https://doi.org/10.1007/s12185-013-1401-1
Katsutani, Shinya ; Tomiyama, Yoshiaki ; Kimura, Akiro ; Miyakawa, Yoshitaka ; Okamoto, Shinichiro ; Okoshi, Yasushi ; Ninomiya, Haruhiko ; Kosugi, Hiroshi ; Ishii, Kazuyoshi ; Ikeda, Yasuo ; Hattori, Toshihiro ; Katsura, Koichi ; Kanakura, Yuzuru. / Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia : An open-label, extension study. :: International Journal of Hematology. 2013 ; 巻 98, 番号 3. pp. 323-330.
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abstract = "Eltrombopag is an oral, nonpeptide, thrombopoietin receptor agonist approved for treatment of chronic immune thrombocytopenia (ITP). The safety, tolerability, and efficacy of eltrombopag for up to 3 years were evaluated in 19 Japanese patients with chronic ITP who had completed a prior 6-month study. Patients received eltrombopag once daily at the last dosage received in the prior study (12.5, 25, or 50 mg). Dose adjustments and treatment interruptions were permitted to maintain platelet counts of 50,000-200,000/μL. Primary evaluations were safety and tolerability of long-term eltrombopag treatment. The median duration of exposure was 27.5 months (range, 9.9-32.3). Adverse events were similar to those reported with short-term use of eltrombopag, and none led to treatment discontinuation. Nine serious adverse events were reported. Median platelet counts began to increase after 1 week of treatment and remained above 50,000/μL for most assessments. Bleeding episodes decreased from 63 {\%} at baseline to 21 {\%} after 2 weeks of treatment and remained below baseline for all assessments. Of 15 patients receiving concomitant baseline ITP medications, 10 permanently discontinued or achieved a sustained reduction of at least one treatment without requiring rescue treatment. Long-term treatment with eltrombopag was safe, well tolerated, and effective in Japanese patients with chronic ITP.",
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AU - Katsutani, Shinya

AU - Tomiyama, Yoshiaki

AU - Kimura, Akiro

AU - Miyakawa, Yoshitaka

AU - Okamoto, Shinichiro

AU - Okoshi, Yasushi

AU - Ninomiya, Haruhiko

AU - Kosugi, Hiroshi

AU - Ishii, Kazuyoshi

AU - Ikeda, Yasuo

AU - Hattori, Toshihiro

AU - Katsura, Koichi

AU - Kanakura, Yuzuru

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