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…

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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,…

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