Fondaparinux Sodium (Page 10 of 13)

14.4 Prophylaxis of Thromboembolic Events Following Knee Replacement Surgery

In a randomized, double-blind, clinical trial in patients undergoing knee replacement surgery (i.e., surgery requiring resection of the distal end of the femur or proximal end of the tibia), fondaparinux sodium 2.5 mg SC once daily was compared to enoxaparin sodium 30 mg SC every 12 hours. A total of 1,049 patients were randomized and 1,034 were treated. Patients ranged in age from 19 to 94 years (mean age 68 years) with 41% men and 59% women. Patients were 88% Caucasian, 8% black, <1% Asian, and 3% others. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from the trial. Fondaparinux sodium was initiated 6 ± 2 hours (mean 6.25 hours) after surgery in 94% of patients, and enoxaparin sodium was initiated 12 to 24 hours (mean 21 hours) after surgery in 96% of patients. For both drugs, treatment was continued for 7 ± 2 days. The efficacy data are provided in Table 10 and demonstrate that under the conditions of the trial, fondaparinux sodium was associated with a VTE rate of 12.5% compared with a VTE rate of 27.8% for enoxaparin sodium for a relative risk reduction of 55% (95% CI: 36%, 70%; P <0.001). Major bleeding episodes occurred in 2.1% of patients receiving fondaparinux sodium and 0.2% of enoxaparin sodium patients [see Adverse Reactions (6.1)].

Table 10. Efficacy of Fondaparinux Sodium in the Prophylaxis of Thromboembolic Events Following Knee Replacement Surgery
*
N = all evaluable knee replacement surgery patients. Evaluable patients were those who were treated and underwent the appropriate surgery (i.e., knee replacement surgery), with an adequate efficacy assessment up to Day 11.
VTE was a composite of documented DVT and/or documented symptomatic PE reported up to Day 11.
P value versus enoxaparin sodium <0.001.
§
P value versus enoxaparin sodium: NS.

Endpoint

Fondaparinux Sodium

2.5 mg SC once daily

Enoxaparin Sodium

30 mg SC every 12 hours

n/N *

% (95% CI)

n/N *

% (95% CI)

VTE

45/361

12.5% (9.2, 16.3)

101/363

27.8% (23.3, 32.7)

All DVT

45/361

12.5% (9.2, 16.3)

98/361

27.1% (22.6, 32.0)

Proximal DVT

9/368

2.4%§ (1.1, 4.6)

20/372

5.4% (3.3, 8.2)

Symptomatic PE

1/517

0.2%§ (0.0, 1.1)

4/517

0.8% (0.2, 2.0)

14.5 Prophylaxis of Thromboembolic Events Following Abdominal Surgery in Patients at Risk for Thromboembolic Complications

Abdominal surgery patients at risk included the following: Those undergoing surgery under general anesthesia lasting longer than 45 minutes who are older than 60 years with or without additional risk factors; and those undergoing surgery under general anesthesia lasting longer than 45 minutes who are older than 40 years with additional risk factors. Risk factors included neoplastic disease, obesity, chronic obstructive pulmonary disease, inflammatory bowel disease, history of deep vein thrombosis (DVT) or pulmonary embolism (PE), or congestive heart failure.

In a randomized, double-blind, clinical trial in patients undergoing abdominal surgery, fondaparinux sodium 2.5 mg SC once daily started postoperatively was compared to dalteparin sodium 5,000 IU SC once daily, with one 2,500 IU SC preoperative injection and a 2,500 IU SC first postoperative injection. A total of 2,927 patients were randomized and 2,858 were treated. Patients ranged in age from 17 to 93 years (mean age 65 years) with 55% men and 45% women. Patients were 97% Caucasian, 1% black, 1% Asian, and 1% others. Patients with serum creatinine level more than 2 mg/dL (180 micromol/L), or platelet count less than 100,000/mm3 were excluded from the trial. Sixty-nine percent (69%) of study patients underwent cancer-related abdominal surgery. Study treatment was continued for 7 ± 2 days. The efficacy data are provided in Table 11 and demonstrate that prophylaxis with fondaparinux sodium was associated with a VTE rate of 4.6% compared with a VTE rate of 6.1% for dalteparin sodium (P = NS).

Table 11. Efficacy of Fondaparinux Sodium In Prophylaxis of Thromboembolic Events Following Abdominal Surgery
*
N = all evaluable abdominal surgery patients. Evaluable patients were those who were randomized and had an adequate efficacy assessment up to Day 10; non-treated patients and patients who did not undergo surgery did not get a VTE assessment.
VTE was a composite of venogram positive DVT, symptomatic DVT, non-fatal PE and/or fatal PE reported up to Day 10.
P value versus dalteparin sodium: NS.

Endpoint

Fondaparinux Sodium

2.5 mg SC once daily

Dalteparin Sodium

5,000 IU SC once daily

n/N *

% (95% CI)

n/N *

% (95% CI)

VTE

47/1,027

4.6% (3.4, 6.0)

62/1,021

6.1% (4.7, 7.7)

All DVT

43/1,024

4.2% (3.1, 5.6)

59/1,018

5.8% (4.4, 7.4)

Proximal DVT

5/1,076

0.5% (0.2, 1.1)

5/1,077

0.5% (0.2, 1.1)

Symptomatic VTE

6/1,465

0.4% (0.2, 0.9)

5/1,462

0.3% (0.1, 0.8)

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