title: Thrombomodulin alfa treatment in patients with acute promyelocytic leukemia and disseminated intravascular coagulation: a retrospective analysis of an open-label, multicenter, post-marketing surveillance study cohort.
abstract: BACKGROUND
  Patients 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.
  
  
  METHODS
  A retrospective evaluation was performed on a cohort of 172 patients with APL from an open-label, multicenter, post-marketing surveillance study of TM-α.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: 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.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Matsushita
authors.affiliation: ART Project, Asahi Kasei Pharma Corporation, Tokyo, Japan.
authors.forename: Jyunichi
authors.initials: J
authors.lastname: Watanabe
authors.affiliation: ART Project, Asahi Kasei Pharma Corporation, Tokyo, Japan.
authors.forename: Goichi
authors.initials: G
authors.lastname: Honda
authors.affiliation: Division of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Mimuro
authors.affiliation: Department of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Hoyu
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Blood Transfusion, Kyoto Prefectural University of Medicine, Kyoto, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Tsuji
authors.affiliation: Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Eguchi
authors.affiliation: Department of Clinical Laboratory and Molecular Pathology, Graduate School of Medical and Pharmaceutical Science, University of Toyama, Toyama, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Kitajima
authors.affiliation: Division of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D015331:Cohort Studies; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D018180:Thrombomodulin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C546931:THBD protein, human; D018180:Thrombomodulin
keywords: Acute promyelocytic leukemia; Disseminated intravascular coagulation; Recombinant human soluble thrombomodulin