Fondaparinux Sodium (Page 4 of 13)

Abdominal Surgery

In a randomized study of patients undergoing abdominal surgery, fondaparinux sodium 2.5 mg once daily (n = 1,433) was compared with dalteparin 5,000 IU once daily (n = 1,425). Bleeding rates are shown in Table 3.

Table 3. Bleeding in the Abdominal Surgery Study
*
Major bleeding was defined as bleeding that was (1) fatal, (2) bleeding at the surgical site leading to intervention, (3) non-surgical bleeding at a critical site (e.g. intracranial, retroperitoneal, intraocular, pericardial, spinal, or into adrenal gland), or leading to an intervention, and/or with a bleeding index (BI) ≥2.
Minor bleeding was defined as clinically overt bleeding that was not major.

Fondaparinux Sodium

2.5 mg SC once daily

Dalteparin Sodium

5,000 IU SC once daily

N = 1,433

N = 1,425

Major bleeding *

49 (3.4%)

34 (2.4%)

Fatal bleeding

2 (0.1%)

2 (0.1%)

Non-fatal bleeding at critical site

0 (0.0%)

0 (0.0%)

Other non-fatal major bleeding

Surgical site

38 (2.7%)

26 (1.8%)

Non-surgical site

9 (0.6%)

6 (0.4%)

Minor bleeding

31 (2.2%)

23 (1.6%)

The rates of major bleeding according to the time interval following the first fondaparinux sodium injection were as follows: <6 hours was 3.4% (9/263) and 6 to 8 hours was 2.9% (32/1112).

Treatment of Deep Vein Thrombosis and Pulmonary Embolism

The rates of bleeding events reported during a dose-response trial (n = 111) and an active-controlled trial with enoxaparin sodium in DVT treatment (n = 1,091) and an active-controlled trial with heparin in PE treatment (n = 1,092) with fondaparinux sodium are provided in Table 4.

Table 4. Bleeding * in Deep Vein Thrombosis and Pulmonary Embolism Treatment Studies
*
Bleeding rates are during the study drug treatment period (approximately 7 days). Patients were also treated with vitamin K antagonists initiated within 72 hours after the first study drug administration.
Major bleeding was defined as clinically overt: –and/or contributing to death – and/or in a critical organ including intracranial, retroperitoneal, intraocular, spinal, pericardial, or adrenal gland – and/or associated with a fall in hemoglobin level ≥2 g/dL – and/or leading to a transfusion ≥2 units of packed red blood cells or whole blood.
Clinically overt bleeding with a 2 g/dL fall in hemoglobin and/or leading to transfusion of PRBC or whole blood ≥2 units.
§
Minor bleeding was defined as clinically overt bleeding that was not major.

Fondaparinux Sodium

N = 2,294

Enoxaparin Sodium

N = 1,101

Heparin

aPTT adjusted IV

N = 1,092

Major bleeding

28 (1.2%)

13 (1.2%)

12 (1.1%)

Fatal bleeding

3 (0.1%)

0 (0.0%)

1 (0.1%)

Non-fatal bleeding at a critical site

3 (0.1%)

0 (0.0%)

2 (0.2%)

Intracranial bleeding

3 (0.1%)

0 (0.0%)

1 (0.1%)

Retro-peritoneal bleeding

0 (0.0%)

0 (0.0%)

1 (0.1%)

Other clinically overt bleeding

22 (1.0%)

13 (1.2%)

10 (0.9%)

Minor bleeding §

70 (3.1%)

33 (3.0%)

57 (5.2%)

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