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Table 2 Clinical evidence from randomized controlled trials for the efficacy and safety of parenteral anticoagulants in the prophylaxis of VTE

From: Differentiation of parenteral anticoagulants in the prevention and treatment of venous thromboembolism

Indication/agent

Ref.

N

Dose

Comparator

VTE, %

Major bleeding, %

Hip replacement surgery

     

   Enoxaparin

[19]

100

30 mg bid

Placebo

12 vs 42 (p = 0.0007)

2 vs 4

 

[20]

665

30 mg bid

UFH bid

17.1 vs 19.0

3.3 vs 5.7

 

[21]

607

40 mg once daily

UFH tid

15 vs 12

1 vs 6 (p = 0.014)

   

30 mg bid

 

5 vs 12 (p = 0.03)

4 vs 6

 

[22]

3,011

30 mg bid

Warfarin

0.3 vs 1.1* (p = 0.0083)

0.6 vs 0.3

   Dalteparin

[23]

1,472

2,500 pre-op and post-op, 5,000 IU once daily

Warfarin

10.7 vs 24 (p < 0.001)

2.2 vs 0.4 (p = 0.01)

   

2,500 post-op, 5,000 IU once daily

 

13.1 vs 24 (p < 0.001)

0.8 vs 0.4

   Tinzaparin

[24]

440

4,500 IU

Enoxaparin 40 mg once daily

21.7 vs 20.1

0.9 vs 1.8

   Fondaparinux

[25]

2,309

2.5 mg once daily

Enoxaparin 40 mg once daily

4 vs 9 (p < 0.0001)

4 vs 3

 

[26]

1,584

2.5 mg once daily

Enoxaparin 30 mg bid

6 vs 8

2.0 vs 0.7

Knee replacement surgery

     

   Enoxaparin

[27]

670

30 mg bid

Warfarin

36.9 vs 51.7 (p = 0.003)

2.1 vs 1.8

 

[28]

349

30 mg bid

Warfarin

25.4 vs 45.5 (p = 0.0001)

5.2 vs 2.3

   Fondaparinux

[29]

724

2.5 mg bid

Enoxaparin 30 mg bid

12.5 vs 27.8 (p < 0.001)

2.1 vs 0.2 (p = 0.006)

Hip fracture surgery

     

   Fondaparinux

[30]

1,250

2.5 mg once daily

Enoxaparin 40 mg once daily

8.3 vs 19.1 (p < 0.001)

2.2 vs 2.3

Abdominal surgery

     

   Enoxaparin

ENOXACAN [31]

631

40 mg once daily

UFH tid

14.7 vs 18.2

4.1 vs 2.9

   Dalteparin

[13]

3,809

2,500 IU

UFH bid

1.0 vs 1.1*

3.6 vs 4.8

 

[32]

1,957†

5,000 IU

Dalteparin 2,500 IU

6.6 vs 12.7 (p < 0.001)

1.3 vs 0.3

   Fondaparinux

[33]

2,048

2.5 mg once daily

Dalteparin 2,500 pre-op and post-op, 5,000 IU once daily

4.6 vs 6.1 (p = 0.144)

3.4 vs 2.4 (p = 0.122)

Acutely ill medical inpatients

     

   Enoxaparin

MEDENOX [34]

866

40 mg once daily

Placebo

5.5 vs 14.9 (p < 0.001)

3.4 vs 2.0

 

[35]

959

40 mg once daily

UFH tid

0.2 vs 1.4*

0.4 vs 1.5

 

[36]

451

40 mg once daily

UFH tid

8.4 vs 10.4 (p = 0.015 for equivalence)

0.3 vs 0.3

 

[37]

212

40 mg once daily

UFH 5,000 U tid

19.7 vs 34.7 (p = 0.044)

2.8 vs 1.9

 

[38]

1,762

40 mg once daily

UFH 5,000 U bid

10 vs 18 (p = 0.0001)

1 vs 0 (p = 0.015)

   Dalteparin

PREVENT [39]

3,706

5,000 IU

Placebo

2.77 vs 4.96 (p = 0.0015)

0.49 vs 0.16 (p = 0.15)

   Fondaparinux

ARTEMIS [40]

849

2.5 mg once daily

Placebo

5.6 vs 10.5 (p = 0.029)

0.2 vs 0.2

  1. *Incidence of symptomatic VTE diagnosed during hospitalization.
  2. †Intent-to-treat population.
  3. bid, twice daily; tid, three times daily; UFH, unfractionated heparin; VTE, venous thromboembolism.