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Bayer announces new Xarelto safety studies in diabetic patients

According to a new press release from the pharmaceutical companies, the 13 presentations will be shown at the ACC’s 65th Annual Scientific Session (ACC.16). Xarelto (rivaroxaban) is an anticoagulant drug indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (Afib). In 2012, the Food and Drug Administration (FDA) expanded its approved uses to the treatment and risk reduction of deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery.

Evidence included in these 13 presentations comes from over 91,000 patients selected among the over 275,000 involved in the Xarelto EXPLORER program. This large clinical trial evaluates the use of rivaroxaban in a broad range of cardiovascular conditions and new indications beyond those currently approved. Data from the 13 abstracts evaluated a high-risk group of diabetic patients affected by concomitant non-valvular atrial fibrillation (NVAF), whose risk of stroke is 1.5 times higher than non-diabetic subjects. The studies investigated rivaroxaban safety and effectiveness compared to older blood thinners such as Warfarin, as well as adherence to therapy, hospitalization length of stay and even hospital costs.

Since it was approved by the FDA in 2011, the new-generation anticoagulant drug raised several controversies about its safety. Although the side effects of many blood thinners do include dangerous bleeding events that may threaten a patient’s life, rivaroxaban’s absence of a proper antidote to reverse its effects made this drug one of the most dangerous ones in this category. The “one-size-fits-all” formula and lack of constant monitoring that made this drug so popular, is, in fact, allegedly considered as the one reason that prevents many doctors to assess properly whether a patient is taking a proper Xarelto dosage or a dangerous one.

In the course of a few years, thousands of Xarelto lawsuits have been filed by disgruntled patients or their families. Many of them who suffered serious injuries allegedly caused by the effects of the medication are now asking compensation for the damage sustained. Plaintiffs claim that Bayer and Janssen Pharmaceuticals failed to warn adequately the patients about rivaroxaban’s dangers.

Recently, the U.S. regulatory agency questioned the reliability of ROCKET-AF, the largest clinical trial that supposedly demonstrated the drug’s safety. Due to a defective device providing skewed monitoring parameters, in fact, the results that proved Bayer’s blood thinner superior safety profile have been contested.

With the large amount of real-world data included in the 13 abstracts, the two pharmaceutical companies that manufacture Xarelto hope to provide the public with new evidence that confirms the medication’s safety. Dr. Paul Burton, MD, Vice President of Janssen Medical Affairs explained how critically important is to assess this medication’s performance in everyday practice, explaining that together with his company they “look forward to sharing further data on this important topic.”

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