Bayer said that it has presented two real-world research results that have confirmed the superior renal preservation benefits of Xarelto (ingredient: rivaroxaban), its anticoagulant medication, compared to vitamin K antagonist (VKA).
|Bayer's anticoagulant treatment Xarelto|
Presented at the 2019 European Society of Cardiology Congress, both real-world researches – RELOADED and CALLIPER – showed that Xarelto had similar stroke risk reduction and improved safety compared to VKA in patients who had atrial fibrillation with associated diseases such as kidney disease.
The RELOADED study, which retrospectively analyzed 22,339 anonymized data recorded in German medical insurance claims data, assessed the relative risk of developing late renal failure requiring dialysis in patients with atrial fibrillation with kidney disease treated with non-vitamin K antagonist oral anticoagulant (NOAC), including Xarelto, or VKA.
The study showed that Xarelto reduced the risk of developing kidney failure by 73 percent and lowered the risk of acute kidney injury by 44 percent compared to VKA.
The CALLIPER study, which analyzed 7,372 patients enrolled in the U.S. medical billing database from 2012 to 2017, compared the efficacy and safety of Xarelto with warfarin in patients with renal disease. The study, participated in by patients who had atrial fibrillation with both type 2 diabetes and chronic kidney disease, showed that Xarelto superior safety and a 47 percent reduction in the relative risk of renal failure compared to VKA (warfarin) while showing similar efficacy.
In patients with chronic kidney disease who did not have type 2 diabetes, Xarelto also lowered the relative risk of renal insufficiency by 50 percent compared to warfarin, resulting in a consistent reinforcement benefit regardless of diabetes.
The company expects that the results from the two real-world studies will reinforce Xarelto's positive clinical trial evidence proved previous trials.
According to the company, a recent report from cardiovascular health and policy experts from eight countries in the Asia-Pacific region, NOAC's role in the health system is expected to grow significantly.
"NOAC's prophylaxis to reduce the risk of stroke is similar to VKA, so regular monitoring is not necessary, making medication easy and the risk of severe bleeding low," the company said. "Such benefits have had a positive impact on patients with atrial fibrillation in Asia."
As the two real-world researches have confirmed additional benefits of NOAC, the company believes it will further help elderly patients with renal disease in the Asia-Pacific region, Bayer added.