PMID- 24636871 OWN - NLM STAT- MEDLINE DCOM- 20150414 LR - 20140424 IS - 1879-2472 (Electronic) IS - 0049-3848 (Linking) VI - 133 IP - 5 DP - 2014 May TI - 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. PG - 772-81 LID - S0049-3848(14)00104-2 [pii] LID - 10.1016/j.thromres.2014.02.025 [doi] AB - INTRODUCTION: 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-alpha; recombinant human soluble thrombomodulin) in patients with APL and DIC are limited. MATERIALS AND 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-alpha. 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-alpha prior to the initiation of antileukemic treatment, and one patient experienced hemorrhagic early death (ED), suggesting that early TM-alpha treatment appeared to result in a reduction in the hemorrhagic ED rate. Moreover, TM-alpha improved coagulopathy regardless of concomitant all-trans retinoic acid treatment. CONCLUSIONS: This study confirmed the safety and efficacy of TM-alpha in daily clinical practice for patients with APL and DIC. TM-alpha appeared to reduce hemorrhagic early deaths due to DIC in patients with APL who were receiving antileukemic treatment. CI - Copyright (c) 2014 Elsevier Ltd. All rights reserved. FAU - Matsushita, Tadashi AU - Matsushita T AD - Department of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin((R)) Injection, Japan. Electronic address: tmatsu@med.nagoya-u.ac.jp. FAU - Watanabe, Jyunichi AU - Watanabe J AD - ART Project, Asahi Kasei Pharma Corporation, Tokyo, Japan. FAU - Honda, Goichi AU - Honda G AD - ART Project, Asahi Kasei Pharma Corporation, Tokyo, Japan. FAU - Mimuro, Jun AU - Mimuro J AD - 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((R)) Injection, Japan. FAU - Takahashi, Hoyu AU - Takahashi H AD - Department of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin((R)) Injection, Japan. FAU - Tsuji, Hajime AU - Tsuji H AD - Department of Blood Transfusion, Kyoto Prefectural University of Medicine, Kyoto, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin((R)) Injection, Japan. FAU - Eguchi, Yutaka AU - Eguchi Y AD - 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((R)) Injection, Japan. FAU - Kitajima, Isao AU - Kitajima I AD - 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((R)) Injection, Japan. FAU - Sakata, Yoichi AU - Sakata Y AD - 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((R)) Injection, Japan. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20140304 PL - United States TA - Thromb Res JT - Thrombosis research JID - 0326377 RN - 0 (Recombinant Proteins) RN - 0 (THBD protein, human) RN - 0 (Thrombomodulin) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Child MH - Cohort Studies MH - Disseminated Intravascular Coagulation/*drug therapy MH - Female MH - Humans MH - Leukemia, Promyelocytic, Acute/blood/*drug therapy MH - Male MH - Middle Aged MH - Product Surveillance, Postmarketing MH - Recombinant Proteins/adverse effects/therapeutic use MH - Retrospective Studies MH - Thrombomodulin/*therapeutic use MH - Young Adult OTO - NOTNLM OT - Acute promyelocytic leukemia OT - Disseminated intravascular coagulation OT - Recombinant human soluble thrombomodulin EDAT- 2014/03/19 06:00 MHDA- 2015/04/15 06:00 CRDT- 2014/03/19 06:00 PHST- 2013/12/11 00:00 [received] PHST- 2014/02/09 00:00 [revised] PHST- 2014/02/25 00:00 [accepted] PHST- 2014/03/19 06:00 [entrez] PHST- 2014/03/19 06:00 [pubmed] PHST- 2015/04/15 06:00 [medline] AID - S0049-3848(14)00104-2 [pii] AID - 10.1016/j.thromres.2014.02.025 [doi] PST - ppublish SO - Thromb Res. 2014 May;133(5):772-81. doi: 10.1016/j.thromres.2014.02.025. Epub 2014 Mar 4.