• Tadashi Matsushita, Jyunichi Watanabe, Goichi Honda, Jun Mimuro, Hoyu Takahashi, Hajime Tsuji, Yutaka Eguchi, Isao Kitajima, and Yoichi Sakata.
• Department of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan. Electronic address: tmatsu@med.nagoya-u.ac.jp.
• Thromb. Res. 2014 May 1; 133 (5): 772-81.

IntroductionPatients with acute promyelocytic leukemia (APL) can develop disseminated intravascular coagulation (DIC) that results in life-threatening hemorrhagic complications. Studies regarding the safety and efficacy of thrombomodulin alfa (TM-α; recombinant human soluble thrombomodulin) in patients with APL and DIC are limited.Materials And MethodsA retrospective evaluation was performed on a cohort of 172 patients with APL from an open-label, multicenter, post-marketing surveillance study of TM-α.ResultsOf the 172 patients, 31 were relapse/refractory APL patients, and 141 were newly diagnosed APL patients. Within the first 30 days, 24 patients (14.0%) died, and six of those deaths (3.5%) were due to hemorrhage. In total, 12 patients (7.0%) had severe hemorrhagic complications. Both the early death rate due to hemorrhage as well as the severe hemorrhage rate did not exceed those in some recent population-based studies of patients with APL. Forty-nine patients received TM-α prior to the initiation of antileukemic treatment, and one patient experienced hemorrhagic early death (ED), suggesting that early TM-α treatment appeared to result in a reduction in the hemorrhagic ED rate. Moreover, TM-α improved coagulopathy regardless of concomitant all-trans retinoic acid treatment.ConclusionsThis study confirmed the safety and efficacy of TM-α in daily clinical practice for patients with APL and DIC. TM-α appeared to reduce hemorrhagic early deaths due to DIC in patients with APL who were receiving antileukemic treatment.Copyright © 2014 Elsevier Ltd. All rights reserved.

25 keywords...

hide…