perative day 1. The third group of patients received warfarin sodium the evening of the day of surgery, then continued daily at a dose adjusted to maintain INR 2 to 3. Treatment for all groups was continued for 4 to 8 days postoperatively, after which time all patients underwent bilateral venography.
In the total enrolled study population of 1501 patients, 1472 patients were treated; 496 received FRAGMIN (first dose before surgery), 487 received FRAGMIN (first dose after surgery) and 489 received warfarin sodium. The mean age of the study population was 63 years (range 18 to 91 years) and the majority of patients were white (94.4%) and female (51.8%).
Administration of the first dose of FRAGMIN after surgery was as effective in reducing the incidence of thromboembolic reactions as administration of the first dose of FRAGMIN before surgery (44/336 vs 37/338; p=0.448). Both dosing regimens of FRAGMIN were more effective than warfarin sodium in reducing the incidence of thromboembolic reactions following hip replacement surgery.
14.3 Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery in Patients at Risk for Thromboembolic ComplicationsAbdominal surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes, or who have additional risk factors such as malignancy or a history of deep vein thrombosis or pulmonary embolism.
FRAGMIN administered once daily subcutaneously beginning prior to surgery and continued for 5 to 10 days after surgery, reduced the risk of DVT in patients at risk for thromboembolic complications in two double-blind, randomized, controlled clinical trials performed in patients undergoing major abdominal surgery. In the first study, a total of 204 patients were enrolled and treated; 102 received FRAGMIN and 102 received placebo. The mean age of the study population was 64 years (range 40 to 98 years) and the majority of patients were female (54.9%). In the second study, a total of 391 patients were enrolled and treated; 195 received FRAGMIN and 196 received heparin. The mean age of the study population was 59 years (range 30 to 88 years) and the majority of patients were female (51.9%). FRAGMIN 2500 IU was superior to placebo and similar to heparin in reducing the risk of DVT (see Tables 12 and 13).
Table 12
Efficacy of FRAGMIN in the Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery
Indication Dosing Regimen
FRAGMIN
2500 IU once daily subcutaneous
n (%) Placebo
once daily subcutaneous
n (%)
All Treated Abdominal Surgery Patients 102 102
Treatment Failures in eva luable Patients
Total Thromboembolic Reactions 4/91 (4.4)1 16/91 (17.6)
Proximal DVT 0 5/91 (5.5)
Distal DVT 4/91 (4.4) 11/91 (12.1)
PE 0 2/91 (2.2)2
1 p-value = 0.008
2 Both patients also had DVT, 1 proximal and 1 distal
Table 13
Efficacy of FRAGMIN in the Prophylaxis of Deep Vein Thrombosis
Following Abdominal Surgery
Indication Dosing Regimen
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