• Thrombosis research · May 2013

    Impact of recombinant soluble thrombomodulin (thrombomodulin alfa) on disseminated intravascular coagulation.

    • Jun Mimuro, Hoyu Takahashi, Isao Kitajima, Hajime Tsuji, Yutaka Eguchi, Tadashi Matsushita, Tatsuhiko Kuroda, and Yoichi Sakata.
    • The Japanese Society on Thrombosis and Hemostasis Post-marketing Surveillance Committee for Thrombomodulin Alfa, Japan. mimuro-j@jichi.ac.jp
    • Thromb. Res. 2013 May 1;131(5):436-43.

    IntroductionWe assessed the safety and effectiveness of recombinant soluble thrombomodulin (thrombomodulin alfa, TM-α) in the treatment of disseminated intravascular coagulation (DIC) in a post-marketing surveillance.MethodsThe cases of 3548 patients with DIC caused by infection (n=2516, Infection-DIC) or hematological malignancy (n=1032, Hemat-DIC) were analyzed and compared to the results of a phase III (P-III) study.ResultsThe DIC scores were significantly decreased in the Infection-DIC and Hemat-DIC groups with TM-α treatment (both P<0.001). The incidences of critical bleeding adverse drug reactions (ADRs) in the Infection-DIC and Hemat-DIC groups were 2.6% and 2.4%, and the survival rates were 64.1% and 70.7%, respectively. Patients with DIC were subcategorized into three groups (Infection-DIC-1 or Hemat-DIC-1, P-III criteria-matched patients; Infection-DIC-2 or Hemat-DIC-2, P-III criteria-non-matched patients treated solely with TM-α; and Infection-DIC-3 or Hemat-DIC-3, P-III criteria-non-matched patients treated with TM-α and other concomitant anticoagulants). Subcategory analysis revealed that the incidences of critical bleeding ADRs of Hemat-DIC-2 and Hemat-DIC-3 were significantly higher and their survival rates were significantly lower than those of Hemat-DIC-1. By multivariate analysis in Hemat-DIC, younger age (odds ratio: 2.629, P=0.0033) and pre-existing bleeding (odds ratio: 2.044, P=0.019) were found to affect bleeding ADRs and the severity of underlying disease was the most important factor for survival rate (odds ratio: 0.288, P<0.001).ConclusionsThis surveillance provided real-world data for the safety and effectiveness of TM-α in the treatment of Infection-DIC and Hemat-DIC in general practice settings.Copyright © 2013 Elsevier Ltd. All rights reserved.

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