Indications

Indications

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Based on the results from large clinical studies, ELIQUIS is FDA approved to treat DVT/PE blood clots and reduce the risk of them happening again. Explore more information about ELIQUIS on this page.

In clinical studies for patients with DVT/PE, ELIQUIS:

Treated DVT/PE blood clots and had less major bleeding in a 6-month study vs. LOVENOX® (enoxaparin) followed by warfarin.

Reduced the risk of another DVT/PE in a separate 12-month study vs. placebo.

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.

In the 6-month study vs LOVENOX® followed by warfarin: ELIQUIS and LOVENOX®/warfarin had similar efficacy results.

Almost 98% of patients on ELIQUIS didn’t experience another DVT/PE blood clot after initial treatment for DVT/PE.

In this study, 2.7% of LOVENOX®/warfarin patients had a recurring DVT/PE vs. 2.3% of ELIQUIS patients.

If you’re taking warfarin, consider talking to your doctor about ELIQUIS for both these reasons: ELIQUIS was proven effective to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots. Plus, ELIQUIS had significantly less major bleeding* than the standard of care at the time, LOVENOX® followed by warfarin.

*Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.

Please see Important Safety Information, including Boxed WARNINGS, below.

LOVENOX® is a registered trademark of sanofi-aventis U.S. LLC.

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Questions about DVT/PE and blood thinners? Learn more about DVT/PE.

ELIQUIS was evaluated in the following 2 clinical studies

Clinical study results are important because they can help doctors consider and choose the right treatment for you based on their efficacy and safety results.

ELIQUIS was proven to treat DVT/PE

In a clinical study, ELIQUIS was tested against LOVENOX® (enoxaparin) followed by warfarin (LOVENOX®/warfarin), a standard treatment at the time, for the first 6 months after DVT/PE.

This study included more than 5,200 patients who had DVT/PE—about half were on LOVENOX®/warfarin and the other half were on ELIQUIS. ELIQUIS and LOVENOX®/warfarin had similar efficacy results.

CLINICAL STUDY EFFICACY RESULTS

In the study, ELIQUIS and LOVENOX®/warfarin had similar efficacy results.

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2.7%

2.7% OR 71 OUT OF 2,635

patients on LOVENOX®/warfarin experienced DVT/PE

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2.3%

2.3% OR 59 OUT OF 2,609

patients on ELIQUIS experienced DVT/PE

In this study, bleeding events were also compared.

CLINICAL STUDY SAFETY RESULTS

In the study, those who were on ELIQUIS had significantly less major bleeding compared to those who were on LOVENOX®/warfarin.

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On LOVENOX®/warfarin

1.8%

49 OUT OF 2,689 PATIENTS

had major bleeding

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On ELIQUIS

0.6%

15 OUT OF 2,676 PATIENTS

had major bleeding

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.

Absolute reduction was 1.2% (1.8% – 0.6% = 1.2%). Relative risk reduction was 69%, which means that patients on ELIQUIS had 69% less chance of major bleeding than patients on LOVENOX®/warfarin.

HOW WAS MAJOR BLEEDING DEFINED?

Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.

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STUDY OUTCOME

In this study, ELIQUIS had similar efficacy and significantly less major bleeding than LOVENOX®/warfarin.

Based on these results, ELIQUIS was approved to treat DVT/PE blood clots.

ELIQUIS significantly reduced the risk of another DVT/PE after initial treatment

This study evaluated ELIQUIS versus placebo in more than 1,600 patients for reducing the risk of a DVT/PE happening again. It looked at the effects of treating patients with ELIQUIS for an additional 12 months after they had completed their initial 6-12 month treatment for DVT/PE with a blood thinner. In this study, there were a similar number of patients on ELIQUIS compared to placebo. 829 patients were taking placebo; 840 were taking 2.5 mg ELIQUIS twice a day.

Versus placebo.

CLINICAL STUDY EFFICACY RESULTS

Those who took ELIQUIS to reduce the risk of recurrence had less chance of having another DVT/PE clot compared to placebo.

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On placebo

11.6%

96 OUT OF 829 PATIENTS

had a recurrence

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On ELIQUIS

3.8%

32 OUT OF 840 PATIENTS

had a recurrence

Absolute reduction was 7.8% (11.6% – 3.8% = 7.8%). Relative risk reduction was 67%, which means that patients on ELIQUIS had 67% less chance of DVT/PE recurrence than patients on placebo.

WHAT IS A PLACEBO?

A placebo is a pill that contains no medicine. It’s sometimes called a sugar pill. In “double-blind” clinical studies—like this one for ELIQUIS—neither the patients nor the doctors conducting the studies know who is given placebo and who is given the actual medicine—the pills look the same.

CLINICAL STUDY SAFETY RESULTS

MAJOR BLEEDING WAS ALSO STUDIED

This study compared major bleeding in patients on ELIQUIS and in patients on placebo.

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On placebo

0.5%

4 OUT OF 826 PATIENTS

had major bleeding

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On ELIQUIS

0.2%

2 OUT OF 840 PATIENTS

had major bleeding

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.

HOW WAS MAJOR BLEEDING DEFINED?

Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.

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STUDY OUTCOME

In this study, ELIQUIS significantly reduced the risk of having another DVT/PE after initial treatment versus placebo. Based on these results, ELIQUIS was approved to reduce the risk of DVT/PE blood clots occurring again.

SELECTED IMPORTANT SAFETY INFORMATION

ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting. While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.

You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, such as aspirin, nonsteroidal anti-inflammatory drugs (called NSAIDs), warfarin, heparin, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and other medicines to help prevent or treat blood clots. Tell your doctor about all of the medicines you take, including any over-the-counter medicines, vitamins, and herbal supplements.

Spinal or epidural blood clots (hematoma). People who take ELIQUIS, and have medicine injected into their spinal or epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis).

Please see additional Important Safety Information, including Boxed WARNINGS, below.

LOVENOX® is a registered trademark of sanofi-aventis U.S. LLC.

More reasons to consider ELIQUIS

It’s important for you and your doctor to discuss your lifestyle when choosing a blood thinner. Here are some other things to know about taking ELIQUIS.

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With ELIQUIS there are no known dietary restrictions or watch-outs for foods like leafy greens.

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Patients taking ELIQUIS do not have to go for routine INR* blood testing.
*International Normalized Ratio.

Be sure to talk to your healthcare professional to learn more about how ELIQUIS compares to warfarin.

Keep in mind that warfarin and ELIQUIS are both prescription medicines. Only your doctor can decide which blood thinner is right for you.

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Learn about some possible side effects of ELIQUIS.

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Talking With Your Doctor

Get tips from a nurse for talking with a doctor and download a discussion guide to help you make the most of your time with your healthcare professional.

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How ELIQUIS Works

Watch a video to learn how ELIQUIS works.

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ELIQUIS 360 Support

Connect with ELIQUIS 360 Support for prescription coverage assistance and to sign up to receive helpful information about your condition and taking ELIQUIS.

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