Is Xarelto Approved for Preventing VTE in Acute Medical Illness?

The FDA has approved Xarelto (rivaroxaban) to prevent venous thromboembolism (VTE) and related death in adults hospitalized for acute medical illnesses. This includes those with moderate to severely restricted mobility and other related risk factors, excluding those at high risk of bleeding.

Millions of people in the USA undergoing acute medical treatment are at risk for VTE. Now that the Xarelto 2.5 mg tablet has been approved, patients can access a versatile and convenient option that may transform treatment. In this article, we’ll explore the need for VTE prevention, the role of Xarelto in its prevention, and its impact on patient care.

The Need for VTE Prevention in Acute Illness

In acute illnesses, such as severe infections or major surgeries, the risk of venous thromboembolism (VTE) rises due to factors like immobility and inflammation. The prevention is crucial as it lowers the likelihood of serious complications such as:

• Organ Damage: Blood clots can clog blood flow to important organs, leading to tissue damage and dysfunction.
• Recurrent Hospitalizations: VTE complications may necessitate additional hospital stays for treatment and monitoring.
• Long-term Disability: Severe events can result in lasting impairment, affecting daily activities and quality of life.
• Death: In severe cases, untreated VTE can be fatal due to blockage of blood flow to the lungs or other critical organs.

According to a 2020 study published in the ASH publications, the risk of VTE is substantial for patients hospitalized with acute medical illnesses. 50% of all the events occur during or shortly after hospitalization for surgery (24% of all events) or an acute medical illness (22%). An acute medical illness increases the risk of VTE eightfold compared to the general population. This data underscores the critical need for prevention strategies in healthcare settings.

The Role of Xarelto in VTE Prevention

Xarelto (rivaroxaban), developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, is an oral anticoagulant that has gained prominence for its efficacy in preventing and treating VTE across various patient populations. It is used to:

• Reducing stroke and blood clot risks in people with atrial fibrillation, which is not caused by problems with the heart valve. Atrial fibrillation occurs when part of the heart doesn’t beat normally. In this situation, blood clots can form, which can enter your brain, leading to a stroke or other parts of the body.
• Treat deep vein thrombosis (DVT) or pulmonary embolisms (P.E.).
• Reduce the chances of blood clots happening again after receiving treatment for them for at least 6 months.
• Prevent a blood clot from forming in hip and knee replacement patients’ legs and lungs.
• During acute illnesses and after discharge, hospitalized patients risk forming blood clots due to their inability to move or decreased mobility. Their bleeding risk is low.
• It reduces the chances of coronary artery disease (a condition that reduces or blocks blood supply to the heart) and peripheral artery disease (reduced blood flow to the legs).

With the FDA approval of Xarelto in October 2019, it is now a viable option for acutely ill adults who are at increased risk of thromboembolic complications. Here are the key points:

• Approval: The FDA has granted Xarelto eight indications, making it the most versatile direct oral anticoagulant (DOAC). The approval specifically targets acutely ill medical patients who may suffer from thromboembolic complications but not bleeding complications.
• Oral Option: Unlike traditional injectable anticoagulants, Xarelto 20 mg tablet is administered orally. This shift from injections to oral medication simplifies patient management during hospitalization and post-discharge.
• Duration: The recommended duration of treatment with Xarelto is 31 to 39 days, beginning during hospitalization and ending after discharge. VTE is continuously protected by this extended coverage.
• Safety and Efficacy: Real-World Study 2022 demonstrates that Xarelto at the 10mg dose effectively prevents blood clots without significantly increasing bleeding risk. This balance between efficacy and safety is crucial for acutely ill patients.

The Clinical Evidence

The approval was given based on findings from the MAGELLAN and MARINER trials. The MAGELLAN study showed that Xarelto was comparable to enoxaparin when taken for 10 days but superior after 35 days when compared to short-term enoxaparin followed by placebo. However, the Xarelto group experienced higher rates of major clinically relevant bleeding. A post-hoc analysis documented a promising benefit-risk profile for Xarelto in VTE prevention after excluding patients at high bleeding risk based on five additional criteria: recent bleeding, active gastroduodenal ulcer, severe bronchiectasis or pulmonary cavitation history, active cancer, and dual antiplatelet therapy at baseline.

The MARINER trial, which assessed Xarelto for VTE and VTE-related death prevention in medically ill patients post-hospital discharge, showed that Xarelto did not decrease the composite endpoint of VTE and related death. However, it did significantly decrease symptomatic VTE with consistent and favorable safety outcomes.

How Does Xarelto Impact Acutely Ill Patient Care?

With this new approval, Xarelto has the potential to revolutionize how acutely ill medical patients are managed for VTE prevention. Here’s how it impacts patient care:

1. In-Hospital Use: Xarelto can be initiated promptly during hospitalization, ensuring early protection against blood clots.
2. Post-discharge Continuation: Patients continue the Xarelto 20 mg tablet after leaving the hospital, reducing the risk of VTE during the critical post-hospitalization period.
3. Enhanced Safety Profile: Xarelto’s lower risk of bleeding than other anticoagulants offers reassurance to acutely ill patients and their healthcare providers. 
4. Prevention of Complications: Blood clots can lead to severe problems such as stroke, heart attack, or pulmonary embolism. By effectively preventing clot formation, Xarelto helps reduce the risk of these life-threatening complications.

Healthcare professionals must familiarize patients with the importance of adherence to the Xarelto 2.5 mg tablet and recognize signs of bleeding or clotting. Additionally, you can buy Xarelto online at Polar Bear Meds, the best Canadian online pharmacy, at exclusive discounts with timely delivery.

Conclusion

Xarelto’s FDA approval marks a significant advance in treating acutely ill patients at risk of venous thromboembolism (VTE). Xarelto’s oral administration and proven efficacy make it an effective and convenient solution for mitigating the risks of blood clots during and after hospitalization. This approval is likely to revolutionize the management of VTE, reduce hospital stays, and provide a safer alternative to injectable anticoagulants. Patient education is the most important factor in ensuring adherence and vigilance for bleeding or clotting. With Xarelto’s approval, millions of patients undergoing acute medical treatment will benefit from improved safety and outcomes.