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ELIQUIS Clinical Outcomes

ELIQUIS was studied in 7 registrational RCTs, including 18,201 patients in ARISTOTLE and 5598 patients in AVERROES. ELIQUIS has clinical information from registrational trials as well as real-world data that provide additional information using various sources, such as Medicare and commercial claims data.1-4 A few of these are included below. For more information, use the Request More Information form.

Download the study presentations below to learn more.

Stroke/SE Risk Reduction in NVAF

ARISTOTLE (18,201 patients)5

AVERROES (5598 patients)6

U.S. FULL PRESCRIBING INFORMATION

Treatment of VTE and Reduction of Risk of Recurrence Following Initial Treatment

AMPLIFY (5400 patients)7

AMPLIFY-EXT (1671 patients)8

U.S. FULL PRESCRIBING INFORMATION

NVAF=nonvalvular atrial fibrillation; RCT=randomized clinical trial; SE=systemic embolism; VTE=venous thromboembolism.

Download the study presentations below to learn more.

Select characteristics of randomized clinical trials and real-world evidence9-12

Randomized clinical trials icon

RANDOMIZED
CLINICAL TRIALS

  • Prospective design with prespecified, well-defined inclusion/exclusion criteria, outcomes, and endpoints
  • Patients are randomly assigned to treatment or comparator
  • RCTs are designed to show causality (ie, efficacy and safety data)
vs
Randomized clinical trials icon

REAL-WORLD
OBSERVATIONAL STUDIES

  • Observational in nature and use data from routine clinical practice
  • Patients are not randomized
  •  Can only evaluate association and therefore unable to determine causality
Randomized clinical trials icon

Select RWE in patients with NVAF

RWE should be reviewed in the context of RCT data. All RWE resources below also include data from the ARISTOTLE clinical trial.

Athens analysis

ATHENS analysis

Published in the Journal of Clinical Medicine

A retrospective, observational real-world database analysis evaluating the outcomes of ELIQUIS compared to XARELTO® (rivaroxaban) in patients with NVAF.13

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Ray et al analysis

Ray et al analysis

Published in the Journal of the American Medical Association (JAMA)

The largest independently funded, retrospective, observational real-world database analysis evaluating the association of ELIQUIS vs XARELTO® (rivaroxaban) with major ischemic or hemorrhagic events in Medicare beneficiaries with NVAF (n=581,451).14

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Fralick et al analysis

Fralick et al analysis

Published in the Annals of Internal Medicine

An independently funded, retrospective, observational real-world database analysis on the effectiveness and safety of ELIQUIS compared to XARELTO® (rivaroxaban) for patients with NVAF in routine practice.15

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

NVAF Hospital Readmissions analysis

NVAF Hospital Readmissions analysis

Published in the Journal of Drug Assessment

A retrospective, observational real-world database analysis comparing stroke-related readmissions among hospitalized patients with NVAF treated with OACs in the US.16

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Randomized clinical trials icon

Select RWE in patients with DVT/PE

RWE should be reviewed in the context of RCT data. All RWE resources below also include data from the AMPLIFY clinical trial.

Jin et al analysis

Jin et al analysis

Published in Thrombosis Research

The largest independently funded, retrospective, observational real-world database analysis comparing the effectiveness and safety of ELIQUIS vs XARELTO® (rivaroxaban) for commercially insured and Medicare Advantage patients with DVT/PE (n=41,830).17

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Dawwas et al analysis

Dawwas et al analysis

Published in the Annals of Internal Medicine

An independently funded, retrospective cohort, real-world database analysis on the risk of recurrent VTE and bleeding with ELIQUIS compared with XARELTO® (rivaroxaban).18

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

Athens analysis

VTE Hospital Readmissions analysis

Published in Hospital Practice

A retrospective real-world data analysis on the ED: hospital readmissions (Inpatient or ED) of patients treated with ELIQUIS or warfarin.19

Explore the Analysis >

U.S. FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS

DVT=deep vein thrombosis; ED=emergency department; NVAF=nonvalvular atrial fibrillation; OAC=oral anticoagulant; PE=pulmonary embolism; RCT=randomized clinical trial; RWE=real-world evidence; VTE=venous thromboembolism.

XARELTO® (rivaroxaban) is a registered trademark of Bayer Aktiengesellschaft.

References

  1. ELIQUIS® (apixaban) Package Insert. Bristol-Myers Squibb Company, Princeton, NJ, and Pfizer Inc, New York, NY.
  2. Lip GYH, Keshishian A, Li X, et al. Effectiveness and safety of oral anticoagulants among nonvalvular atrial fibrillation patients. Stroke. 2018;49:2933-2944. doi:10.1161/STROKEAHA.118.020232
  3. Yao X, Abraham NS, Sangaralingham LR, et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. 2016;5(6):e003725. doi:10.1161/JAHA.116.003725
  4. Amin A, Keshishian A, Trocio J, et al. Risk of stroke/systemic embolism, major bleeding and associated costs in non-valvular atrial fibrillation patients who initiated apixaban, dabigatran or rivaroxaban compared with warfarin in the United States Medicare population. Curr Med Res Opin. 2017;33(9):1595-1604. doi:10.1080/03007995.2017.1345729
  5. Granger CB, Alexander JH, McMurray JJV, et al; for the ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992. doi:10.1056/NEJMoa1107039
  6. Connolly SJ, Eikelboom J, Joyner C, et al; for the AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364(9):806-817. doi:10.1056/NEJMoa1007432
  7. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015;13:2187-2191. doi:10.1111/jth.13153
  8. Agnelli G, Buller HR, Cohen A, et al; for the AMPLIFY-EXT Investigators. Apixaban for the extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699-708. doi:10.1056/NEJMoa1207541
  9. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv. 2008;1(3):211-217. doi:10.1016/j.jcin.2008.01.008
  10. Stanley K. Design of randomized controlled trials. Circulation. 2007;115(9):1164-1169. doi:10.1161/CIRCULATIONAHA.105.594945
  11. Kovesdy CP, Kalantar-Zadeh K. Observational studies versus randomized controlled trials: avenues to causal inference in nephrology. Adv Chronic Kidney Dis. 2012;19(1):11-18. doi:10.1053/j.ackd.2011.09.004
  12. Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007;10(5):326-335. doi:10.1111/j.1524-4733.2007.00186.x
  13. Deitelzweig S, Kang A, Jiang J, et al. Clinical impact of switching or continuation of apixaban or rivaroxaban among patients with non-valvular atrial fibrillation. J Clin Med. 2024;13(4):1073. doi:10.3390/jcm13041073
  14. Ray WA, Chung CP, Stein CM, et al. Association of rivaroxaban vs apixaban with major ischemic or hemorrhagic events in patients with atrial fibrillation. JAMA. 2021;326(23):2395-2404. doi:10.1001/jama.2021.21222
  15. Fralick M, Colacci M, Schneeweiss S, Huybrechts KF, Lin KJ, Gagne JJ. Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study. Ann Intern Med. 2020;172(7):463-473. doi:10.7326/M19-2522
  16. Deitelzweig S, Baker CL, Dhamane AD, et al. Comparison of readmissions among hospitalized nonvalvular atrial fibrillation patients treated with oral anticoagulants in the United States. J Drug Assess. 2020;9(1):87-96. doi:10.1080/21556660.2020.1750418
  17. Jin MC, Sussman ES, Feng AY, et al. Hemorrhage risk of direct oral anticoagulants in real-world venous thromboembolism patients. Thromb Res. 2021;204:126-133. doi:10.1016/j.thromres.2021.06.015
  18. Dawwas GK, Leonard CE, Lewis JD, Cuker A. Risk for recurrent venous thromboembolism and bleeding with apixaban compared with rivaroxaban: an analysis of real-world data. Ann Intern Med. 2022;175(1):20-28. doi:10.7326/M21-0717
  19. Deitelzweig S, Hlavacek P, Mardekian J, et al. Comparison of inpatient admission rates of patients treated with apixaban vs. warfarin for venous thromboembolism in the emergency department. Hosp Pract (1995). 2020;48(1):41-48. doi:10.1080/21548331.2020.1718925

IMPORTANT SAFETY INFORMATION

WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

- use of indwelling epidural catheters

- concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants

- a history of traumatic or repeated epidural or spinal punctures

- a history of spinal deformity or spinal surgery

- optimal timing between the administration of ELIQUIS and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

CONTRAINDICATIONS

  • Active pathological bleeding
  • Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)

WARNINGS AND PRECAUTIONS

  • Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
  • Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
    • Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
    • Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
    • The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). An agent to reverse the anti-factor Xa activity of apixaban is available. Please visit  www.andexxa.com  for more information on availability of a reversal agent.
  • Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.

    The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.

    Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.

  • Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
  • Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
  • Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome (APS): Direct-acting oral anticoagulants (DOACs), including ELIQUIS, are not recommended for use in patients with triple-positive APS. For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

ADVERSE REACTIONS

  • The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.

TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS

  • ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

DRUG INTERACTIONS

  • Combined P-gp and Strong CYP3A4 Inhibitors: Inhibitors of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with combined P-gp and strong CYP3A4 inhibitors.
    Clarithromycin
    Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.
  • Combined P-gp and Strong CYP3A4 Inducers: Avoid concomitant use of ELIQUIS with combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban.
  • Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.

PREGNANCY

  • The limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery, and in the fetus and neonate.
    • Labor or delivery: ELIQUIS use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider use of a shorter acting anticoagulant as delivery approaches.

LACTATION

  • Breastfeeding is not recommended during treatment with ELIQUIS.

FEMALES AND MALES OF REPRODUCTIVE POTENTIAL

  • Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including ELIQUIS should be assessed in these patients and those with abnormal uterine bleeding.


INDICATIONS

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and MEDICATION GUIDE.

ELIQUIS is available in 2.5 mg and 5 mg tablets.

 

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