Surveillance of the safety and efficacy of recombinant human soluble thrombomodulin in patients with obstetrical disseminated intravascular coagulation.

Thromb Res

Medical Affairs Department, Pharmaceuticals Business Administration Division, Asahi Kasei Pharma Corporation, 1-105 Kanda, Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan.

Published: November 2017

AI Article Synopsis

  • Recombinant human soluble thrombomodulin (TM-α) has been shown to be effective in treating disseminated intravascular coagulation (DIC) in obstetrical patients, with a study analyzing its safety and efficacy in 117 cases.
  • Most patients had underlying conditions like postpartum hemorrhage or placental abruption, and TM-α treatment demonstrated significant improvements in various hemostatic test results over time.
  • The surveillance indicated that TM-α is safe for clinical use, with a high efficacy rate comparable to existing DIC treatments, and only minor bleeding adverse reactions reported.

Article Abstract

Background: Recombinant human soluble thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study, and has been available for clinical use in Japan since 2008. However, use of TM-α for obstetrical DIC has not yet been established, so efficacy and safety were analyzed in 117 obstetrical DIC patients identified from post-marketing surveillance.

Materials And Methods: From June 2010 to March 2012, the cases of 117 patients with obstetrical DIC treated with TM-α were registered.

Results: In the majority of cases, the underlying disease was DIC-type postpartum hemorrhage (n=43) or placental abruption (n=37). Mean (±standard deviation) obstetrical DIC score was 10.6±4.9. Mean duration of TM-α administration was 2.2±1.7days. The most commonly used concomitant anticoagulants were antithrombin (n=60) and gabexate mesilate (n=37). Concomitantly used blood components products included red blood cell concentrate (n=72), fresh frozen plasma (n=70), and platelet concentrate (n=31). Hemostatic test result profiles revealed significant improvement of fibrinogen/fibrin degradation products, D-dimer, fibrinogen, prothrombin time and activated partial thromboplastin time. Efficacies of TM-α as evaluated by "The efficacy evaluation criteria for DIC in obstetrics" at 24h, 48h and the day after last administration of TM-α were 72.3%, 82.4% and 90.2%, respectively. Total bleeding adverse drug reactions occurred in 6 patients (5.1%).

Conclusions: This surveillance confirmed the safety and efficacy of TM-α in clinical practice. These findings thus indicated that the efficacy of TM-α is comparable to that of previously investigated obstetrical DIC pharmacotherapies.

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Source
http://dx.doi.org/10.1016/j.thromres.2017.08.017DOI Listing

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