title: Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients.
abstract: BACKGROUND
  Unfractionated heparin (UFH) is the standard drug for the initial treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) in Japan, whereas fondaparinux is the standard drug in Europe and the United States. Here, we examine the efficacy and safety of fondaparinux in Japanese patients.
  
  
  RESULTS
  In 2 randomized, open-label, multicenter studies, 80 Japanese patients with acute PE or DVT received either subcutaneous fondaparinux or intravenous UFH as a non-comparative reference, in a 3:1 ratio, for 5-10 days. Concomitant warfarin therapy was continued until Day 90. Multidetector-row computed tomography-based assessment showed that 57.9% and 45.9% of the patients with acute PE and acute proximal DVT had proximal DVT and PE as a complication, respectively. There was no recurrence of symptomatic venous thromboembolism. In the fondaparinux group, the respective improvement rates at the end of the initial treatment and follow-up periods were 71.4% and 86.8% for 42 patients with PE, and 57.8% and 83.3% for 46 patients with DVT; similar results were noted in the UFH group. One patient in the fondaparinux group experienced major bleeding during the initial treatment, but no such episode in the UFH group.
  
  
  CONCLUSIONS
  Once-daily, subcutaneous fondaparinux is as effective and safe without monitoring as adjusted-dose intravenous UFH for the initial treatment of acute PE and DVT in Japanese patients.
authors.affiliation: Department of Cardiology, Mie University Graduate School of Medicine, Tsu, Japan. mashio@clin.medic.mie-u.ac.jp
authors.forename: Mashio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Okano
authors.forename: Hiroki
authors.initials: H
authors.lastname: Minamiguchi
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Munemasa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sonoda
authors.forename: Norikazu
authors.initials: N
authors.lastname: Yamada
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Hanzawa
authors.forename: Narumi
authors.initials: N
authors.lastname: Aoyagi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsujimoto
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Sarai
authors.forename: Hiromu
authors.initials: H
authors.lastname: Nakajima
authors.forename: Takeyoshi
authors.initials: T
authors.lastname: Kunieda
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D044466:Asian People / Q000706:statistics & numerical data; D003287:Contrast Media; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D007564:Japan; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011655:Pulmonary Embolism / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000208:ethnology; D012008:Recurrence; D018570:Risk Assessment; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000208:ethnology; D014859:Warfarin / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D003287:Contrast Media; D011134:Polysaccharides; D014859:Warfarin; D006493:Heparin; D000077425:Fondaparinux