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The EINSTEIN-PE study compared rivaroxaban to enoxaparin followed by vitamin K antagonist (VKA) in the treatment of 4,833 patients with acute symptomatic PE for the prevention of recurrent VTE. Patients received treatment for three, six or 12 months. In the study, rivaroxaban succeeded in demonstrating non-inferiority to standard therapy for the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE [2.1% vs. 1.8%, respectively (p=0.003 for non-inferiority)]. Rivaroxaban also demonstrated similar results compared to standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [10.3% vs. 11.4% (p=0.23), respectively]. Rivaroxaban treatment also resulted in a significant reduction in major bleeding events [1.1% vs. 2.2% (p=0.003), respectively] compared to standard therapy.
The treatment of venous thromboembolism currently requires a two drug regimen: a rapidly acting, injectable anticoagulant followed by long-term treatment with an oral VKA such as warfarin. According to
VTE is the collective term for both DVT and PE. DVT occurs when blood clots form in one of the large, deep veins in the legs. PE is a serious, clinical condition that most commonly occurs when part or all of a DVT dislodges and travels to the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots, or when the patient already has pre-existing heart or lung disease, the event may be fatal. Each year an estimated 900,000 Americans experience an episode of VTE, resulting in an estimated 300,000 annual deaths.
"The average patient with venous thromboembolism carries the risk of recurrence for a year after the initial event and, for some patients, the risk can persist beyond that," said
The company plans to file the EINSTEIN studies in a supplemental New Drug Application with the
About the EINSTEIN Program
EINSTEIN-PE is one of three Phase 3 studies in the global EINSTEIN program, evaluating the safety and efficacy of rivaroxaban in the treatment and prevention of a recurrent, symptomatic VTE in patients with acute symptomatic DVT or PE. Combined, these trials have enrolled more than 9,400 patients.
The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial that compared oral rivaroxaban —15 mg twice daily for three weeks, followed by 20 mg once daily — with the current standard of care of enoxaparin followed by a VKA in patients with acute symptomatic PE with or without symptomatic DVT. The multinational study was led by
The EINSTEIN-DVT study compared the safety and efficacy of oral rivaroxaban — administered at 15 mg twice daily for three weeks followed by 20 mg once daily — with standard therapy. More than 3,400 patients with acute symptomatic DVT in the deep veins of the knee or thigh, but without any symptoms of PE, were enrolled and received treatment for three, six or 12 months of therapy. Results from EINSTEIN-DVT were presented at the annual
EINSTEIN-EXT evaluated 1,197 patients who had previously completed six to 12 months of treatment with a VKA for an acute episode of VTE or have participated in the Phase 3 EINSTEIN-DVT or EINSTEIN-PE trials, in which they were treated with either rivaroxaban or a VKA, for the same time duration. Upon enrolling in EINSTEIN-EXT, patients were randomized to receive either 20 mg of rivaroxaban dosed once-daily or placebo and were evaluated for an additional six or 12 months. Results from EINSTEIN-EXT were presented at the annual meeting of the
About XARELTO® (rivaroxaban)
XARELTO® belongs to a group of medicines called anticoagulants, and works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the U.S., XARELTO® is indicated to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery and to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. There is limited information on how XARELTO® compares to a medicine called warfarin in reducing the risk of stroke when the blood levels of warfarin are well-controlled. The blood levels of warfarin often vary in patients.
The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. Rivaroxaban is being developed jointly by
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Important Safety Information
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
For people taking XARELTO® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have an increased risk of forming a clot in your blood.
If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
For all people taking XARELTO®:
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding including:
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO® tell your doctor if you:
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding.
Especially tell your doctor if you take:
Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE XARELTO®?
Take XARELTO® exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
For people who have:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® can cause bleeding which can be serious, and rarely may lead to death. Please see "What is the most important information I should know about XARELTO®?"
Tell your doctor if you have any side effect that bothers you or that does not go away.
Discuss any side effects with your doctor. You are also encouraged to report side effects to the
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