Xarelto Archives - Medical Design Sourcing

New study sheds light on Eliquis and Xarelto switching

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For patients with an elevated stroke risk, switching anticoagulant medications could be a health gamble. Those who change from Eliquis (apixaban) to Xarelto (rivaroxaban) could face almost double the risk of stroke or severe bleeding. Conversely, sticking with Eliquis or transitioning from rivaroxaban to Eliquis appears to be a safer option.

Those are key takeaways from a retrospective real-world data study presented at the European Society of Cardiology Congress 2023.

ATHENS Study: New insights into Eliquis and Xarelto switching

The ATHENS study focused on patients with non-valvular atrial fibrillation (NVAF) and used a hazard ratio (HR) to quantify the likelihood of stroke or systemic embolism. Specifically, the HR for increased risk for either condition was 1.99, and for major bleeding, it was 1.80, both indicating a substantially elevated risk.

Eliquis has been the subject of seve…

Xarelto wins two additional pediatric indications

Janssen (NYSE:JNJ) has received FDA approval for two new indications for the blockbuster blood thinner Xarelto (rivaroxaban).

The first new indication relates to treating venous thromboembolism (VTE, or blood clots) and reducing the risk of recurrent VTE in pediatric individuals from birth to less than 18 years after at least five days of parenteral anticoagulant treatment.

The second involves using rivaroxaban as a thromboprophylaxis in children at least two years older with congenital heart disease who underwent the Fontan procedure.

Xarelto now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC).

Last year, the drug brought in almost $6.5 billion in international revenue.

To win the two new approvals, Janssen submitted data from the EINSTEIN-Jr and UNIVERSE Phase 3 trials.

Pfizer and Bristol Myers Squibb worked with Janssen to develop rivaroxaban.

In related news, a recent study found that o…

Phase 3 study highlights Xarelto’s potential in pediatric Fontan procedure patients

Drugs that work well in adults don’t always translate well for treating pediatric patients.

The problem has inspired clinicians such as the pediatric cardiologist Dr. Brian McCrindle at the Hospital for Sick Children in Toronto to work with the pharma industry on trials focused on pediatric patient populations and introduce newer agents to clinical practice. Traditionally, the process of selecting drugs for younger populations has been “somewhat imperfect and somewhat derived from experience in adult patients,” McCrindle said.

Most recently, McCrindle was the co-author of a preprint study published in the Journal of the American Heart Association investigating the use of rivaroxaban (Xarelto) from Janssen in patients who underwent a surgical procedure to correct a congenital heart defect.

Blood thinners such as rivaroxaban and aspirin — acetylsalicylic acid (ASA) — can reduce the risk of thrombosis and its potential to cause stroke or other devastating c…

Xarelto similar to aspirin in pediatric Fontan procedure study

Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart.

Physicians have traditionally relied on aspirin (acetylsalicylic acid) to reduce the risk of thrombotic events following the Fontan procedure. Such thrombotic events are associated with significant morbidity and mortality.

The data, collected in the Phase 3 UNIVERSE trial, has been published in the Journal of the American Heart Association. The study concluded that “participants who received rivaroxaban for thromboprophylaxis [thrombosis prevention] had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the [acetylsalicylic acid] group.”

This summer, the Raritan,…