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Eliquis (Apixaban) Clinical Trials

The approved indications for ELIQUIS are based on a robust
clinical trial programme1–7

Learn more about ELIQUIS in NVAF and
DVT / PE
.

Pivotal clinical trial in NVAF: ARISTOTLE

In the ARISTOTLE trial, ELIQUIS demonstrated superior stroke / systemic embolism prevention with significantly less major bleeding vs. warfarin in patients with NVAF.4

Adapted from Granger et al. 2011.4
* ARISTOTLE: Phase III trial, with a total of 18,201 patients with NVAF and ≥1 risk factor for stroke and a mean CHADS2 score of 2.1 randomised to ELIQUIS 5 mg BD (or 2.5 mg BD in selected patients [4.7%]) or warfarin adjusted to target INR range 2.0–3.0, for a median of 1.8 years. A 2.5 mg BD dose of ELIQUIS was used in patients who met two or more of the following criteria: ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dl (133 μmol/l). Patients with the exclusive criteria of severe renal impairment (creatinine clearance 15–29 ml/min) should also receive a lower dose of 2.5 mg twice daily. Stroke or systemic embolism was the primary efficacy endpoint of the ARISTOTLE trial (haemorrhagic stroke and ischaemic or undetermined stroke were components of stroke) and major bleeding defined per International Society on Thrombosis and Haemostasis (ISTH) criteria was the primary safety endpoint. Efficacy analyses based on ITT population. Safety analyses based on patients who had at least one dose of study drug.4

View the full overview of study design and results from the ARISTOTLE trial.

432UK1800479-01 – May 2018

Pivotal clinical trials in DVT / PE: AMPLIFY and AMPLIFY-EXT

In the AMPLIFY trial, ELIQUIS demonstrated both comparable efficacy and significantly less major bleeding vs. standard of care (enoxaparin / warfarin) in the treatment of
DVT / PE.6

Adapted from Agnelli et al. 2013.6
† AMPLIFY: Phase III, randomised, double-blind trial in 5,395 patients with DVT and / or PE. The duration of the trial was 6 months. The primary efficacy endpoint was the rate of recurrent VTE / VTE-related death vs. enoxaparin / warfarin. Efficacy analyses based on ITT population for whom the outcome status at 6 months was documented; safety analyses based on patients who had at least one dose of study drug.6

View the full overview of study design and results from the AMPLIFY trial.

432UK1800479-02 – May 2018


In the AMPLIFY-EXT trial, extended treatment with ELIQUIS demonstrated superior efficacy and a
comparable bleeding profile
vs. placebo.7

Adapted from the ELIQUIS SmPC1 and Agnelli et al. 2013.7
‡ AMPLIFY-EXT: Phase III, randomised, double-blind trial in 2,482 patients with DVT or PE who had completed 6 to 12 months of anticoagulation therapy. The duration of the trial was 12 months. Efficacy analyses based on ITT population for whom the outcome status at 12 months was documented; safety analyses based on patients who had at least one dose of study drug.7

View the full overview of study design and results from the AMPLIFY-EXT trial.

432UK1800479-03 – May 2018


Diagnosemethoden

It’s simple to switch your patients to ELIQUIS1

ELIQUIS is available for your patients with NVAF1

ELIQUIS is available for your patients with
DVT / PE1


ELIQUIS (apixaban) SmPC

Please click here to access the ELIQUIS SmPC.

ELIQUIS (apixaban) Patient Information Leaflet

Please click here to access the ELIQUIS Patient Information Leaflet.

AMPLIFY = Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy   
AMPLIFY-EXT = Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy–Extended Treatment   
ARISTOTLE = Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation   
ARR = Absolute Risk Reduction   
BD = Twice Daily   
CI = Confidence Interval   
DVT = Deep Vein Thrombosis   
HR = Hazard Ratio   
ITT = Intention to Treat   
INR = International Normalised Ratio   
n = number of patients with event   
NS = Not Significant   
NVAF = Non-Valvular Atrial Fibrillation   
PE = Pulmonary Embolism   
RR = Relative Risk   
RRR = Relative Risk Reduction   
VTE = Venous Thromboembolic Events

References

  1. ELIQUIS® (apixaban) Summary of Product Characteristics.
  2. Lassen MR et al. Lancet 2010; 375: 807–815.
  3. Lassen MR et al. N Engl J Med 2010; 363: 2487–2498.
  4. Granger CB et al. N Engl J Med 2011; 365: 981–992.
  5. Connolly SJ et al. N Engl J Med 2011; 364: 806–817.
  6. Agnelli G et al. N Engl J Med 2013; 369: 799–808.
  7. Agnelli G et al. N Engl J Med 2013; 368: 699–708.