ELIQUIS (Page 4 of 11)

Treatment of DVT and PE and Reduction in the Risk of Recurrence of DVT or PE

The safety of ELIQUIS has been evaluated in the AMPLIFY and AMPLIFY-EXT studies, including 2676 patients exposed to ELIQUIS 10 mg twice daily, 3359 patients exposed to ELIQUIS 5 mg twice daily, and 840 patients exposed to ELIQUIS 2.5 mg twice daily.

Common adverse reactions (≥1%) were gingival bleeding, epistaxis, contusion, hematuria, rectal hemorrhage, hematoma, menorrhagia, and hemoptysis.

AMPLIFY Study

The mean duration of exposure to ELIQUIS was 154 days and to enoxaparin/warfarin was 152 days in the AMPLIFY study. Adverse reactions related to bleeding occurred in 417 (15.6%) ELIQUIS-treated patients compared to 661 (24.6%) enoxaparin/warfarin-treated patients. The discontinuation rate due to bleeding events was 0.7% in the ELIQUIS-treated patients compared to 1.7% in enoxaparin/warfarin-treated patients in the AMPLIFY study.

In the AMPLIFY study, ELIQUIS was statistically superior to enoxaparin/warfarin in the primary safety endpoint of major bleeding (relative risk 0.31, 95% CI [0.17, 0.55], P-value <0.0001).

Bleeding results from the AMPLIFY study are summarized in Table 5.

Table 5: Bleeding Results in the AMPLIFY Study
ELIQUIS N=2676n (%) Enoxaparin/WarfarinN=2689n (%) Relative Risk (95% CI)
* CRNM = clinically relevant nonmajor bleeding.Events associated with each endpoint were counted once per subject, but subjects may have contributed events to multiple endpoints.

Major

15 (0.6)

49 (1.8)

0.31 (0.17, 0.55)p<0.0001

CRNM*

103 (3.9)

215 (8.0)

Major + CRNM

115 (4.3)

261 (9.7)

Minor

313 (11.7)

505 (18.8)

All

402 (15.0)

676 (25.1)

Adverse reactions occurring in ≥1% of patients in the AMPLIFY study are listed in Table 6.

Table 6: Adverse Reactions Occurring in ≥1% of Patients Treated for DVT and PE in the AMPLIFY Study
ELIQUIS N=2676 n (%) Enoxaparin/Warfarin N=2689 n (%)

Epistaxis

77 (2.9)

146 (5.4)

Contusion

49 (1.8)

97 (3.6)

Hematuria

46 (1.7)

102 (3.8)

Menorrhagia

38 (1.4)

30 (1.1)

Hematoma

35 (1.3)

76 (2.8)

Hemoptysis

32 (1.2)

31 (1.2)

Rectal hemorrhage

26 (1.0)

39 (1.5)

Gingival bleeding

26 (1.0)

50 (1.9)

AMPLIFY-EXT Study

The mean duration of exposure to ELIQUIS was approximately 330 days and to placebo was 312 days in the AMPLIFY-EXT study. Adverse reactions related to bleeding occurred in 219 (13.3%) ELIQUIS-treated patients compared to 72 (8.7%) placebo-treated patients. The discontinuation rate due to bleeding events was approximately 1% in the ELIQUIS-treated patients compared to 0.4% in those patients in the placebo group in the AMPLIFY-EXT study.

Bleeding results from the AMPLIFY-EXT study are summarized in Table 7.

Table 7: Bleeding Results in the AMPLIFY-EXT Study
ELIQUIS 2.5 mg bidN=840n (%) ELIQUIS 5 mg bid N=811n (%) Placebo N=826n (%)
* CRNM = clinically relevant nonmajor bleeding.Events associated with each endpoint were counted once per subject, but subjects may have contributed events to multiple endpoints.

Major

2 (0.2)

1 (0.1)

4 (0.5)

CRNM*

25 (3.0)

34 (4.2)

19 (2.3)

Major + CRNM

27 (3.2)

35 (4.3)

22 (2.7)

Minor

75 (8.9)

98 (12.1)

58 (7.0)

All

94 (11.2)

121 (14.9)

74 (9.0)

Adverse reactions occurring in ≥1% of patients in the AMPLIFY-EXT study are listed in Table 8.

Table 8: Adverse Reactions Occurring in ≥1% of Patients Undergoing Extended Treatment for DVT and PE in the AMPLIFY-EXT Study
ELIQUIS 2.5 mg bidN=840 n (%) ELIQUIS 5 mg bidN=811n (%) Placebo N=826 n (%)

Epistaxis

13 (1.5)

29 (3.6)

9 (1.1)

Hematuria

12 (1.4)

17 (2.1)

9 (1.1)

Hematoma

13 (1.5)

16 (2.0)

10 (1.2)

Contusion

18 (2.1)

18 (2.2)

18 (2.2)

Gingival bleeding

12 (1.4)

9 (1.1)

3 (0.4)

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