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.
| 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.
| 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.
| 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.
| 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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