title: Effects of raloxifene and continuous combined hormone therapy on haemostasis variables: a multicenter, randomized, double-blind study.
abstract: BACKGROUND
  Hormone replacement therapy is known to increase the risk of thromboembolic events. We compared the effects of HRT and raloxifene on some haemostasis variables.
  
  
  METHODS
  In a multicenter, double-blind study, 54 healthy postmenopausal women were randomized to receive either continuous treatment with 2 mg 17beta-estradiol plus 1 mg norethisterone acetate (n=30) or 60 mg raloxifene (n=24) daily for 12 months. Blood samples were collected at baseline and at 3, 6 and 12 months to evaluate therapy effects on some haemostasis variables (factor VII, factor VIII, prothrombin fragments 1 and 2, protein C, protein C activity, protein S, thrombin-antithrombin complex, D-dimer, antithrombin, fibrinogen and plasminogen activator inhibitor).
  
  
  RESULTS
  Both raloxifene and continuous combined hormone therapy modified the haemostasis variables toward a more prothrombotic profile. Factor VIII (p<0.01) and fibrinogen (p<0.05) plasma levels significantly increased at 6 months, prothrombin fragments 1 and 2 (p<0.05) significantly increased at 12 months, whereas protein C activity (p<0.001) and antithrombin (p<0.01) significantly decreased at 12 months in both groups.
  
  
  CONCLUSIONS
  Our results demonstrate that raloxifene and continuous combined hormone therapy exhibit the same prothrombotic profile. Both treatments induced an increase in procoagulant parameters at 6 months and a decrease in anticoagulant parameters at 12 months.
authors.affiliation: Department of Obstetrics, Gynecologic and Neonatology. Parma University-Italy, v. Gramsci 14, Parma, Italy. M.Sgarabotto@libero.it
authors.forename: Mariapaola
authors.initials: M
authors.lastname: Sgarabotto
authors.forename: Monica
authors.initials: M
authors.lastname: Baldini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Dei Cas
authors.forename: Cesare
authors.initials: C
authors.lastname: Manotti
authors.forename: Angela
authors.initials: A
authors.lastname: Luciana Barilli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Luigi
authors.initials: L
authors.lastname: Benassi
authors.forename: Alberto
authors.initials: A
authors.lastname: Bacchi Modena
mesh_terms: D000368:Aged; D015992:Body Mass Index; D003280:Contraceptives, Oral, Synthetic / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000627:therapeutic use*; D004964:Estriol / Q000627:therapeutic use; D005260:Female; D006487:Hemostasis / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D004958:Estradiol; C032040:Trisequens; D000077563:Norethindrone Acetate; D004964:Estriol; D009640:Norethindrone