In a third double-blind, randomized study performed in patients undergoing major abdominal surgery with malignancy, FRAGMIN 5000 IU subcutaneous once daily was compared with FRAGMIN 2500 IU subcutaneous once daily. Treatment was continued for 6 to 8 days. A total of 1375 patients were enrolled and treated; 679 received FRAGMIN 5000 IU and 696 received 2500 IU. The mean age of the combined groups was 71 years (range 40 to 95 years). The majority of patients were female (51.0%). FRAGMIN 5000 IU once daily was more effective than FRAGMIN 2500 IU once daily in reducing the risk of DVT in patients undergoing abdominal surgery with malignancy (see Table 14).
  Table 14 
  Efficacy of FRAGMIN in the Prophylaxis of Deep Vein Thrombosis
Following Abdominal Surgery 
  Indication    Dosing Regimen 
 FRAGMIN
2500 IU once daily subcutaneous
n (%)   FRAGMIN
5000 IU once daily subcutaneous
n (%) 
  All Treated Abdominal Surgery Patients1   696    679 
  Treatment Failures in eva luable Patients
  Total Thromboembolic Reactions    99/656 (15.1)2   60/645 (9.3) 
       Proximal DVT    18/657 (2.7)    14/646 (2.2) 
       Distal DVT    80/657 (12.2)    41/646 (6.3) 
    PE     
       Fatal    1/674 (0.1)    1/669 (0.1) 
       Non-fatal    2    4 
1  Major abdominal surgery with malignancy
2  p-value = 0.001
14.4 Prophylaxis of Deep Vein Thrombosis in Medical Patients at Risk for Thromboembolic Complications Due to Severely Restricted Mobility During Acute IllnessIn a double-blind, multi-center, randomized, placebo-controlled clinical trial, general medical patients with severely restricted mobility who were at risk of venous thromboembolism were randomized to receive either FRAGMIN 5000 IU or placebo subcutaneously once daily during Days 1 to 14 of the study. These patients had an acute medical condition requiring a projected hospital stay of at least 4 days, and were confined to bed during waking hours. The study included patients with congestive heart failure (NYHA Class III or IV), acute respiratory failure not requiring ventilatory support, and the following acute conditions with at least one risk factor occurring in &