May 11, 2022

Anticoagulant drug Xarelto linked to higher rate of major side effects – study

By Leroy Léo

December 21 (Reuters)Elderly people taking Bayer AG BAYGn.DE The successful Xarelto anticoagulant pill for a common type of irregular heartbeat had significantly higher rates of severe bleeding and stroke than those taking the rival pill Eliquis, according to a US study.

Xarelto, also known as rivaroxaban, is sold in the United States by Johnson & Johnson JNJ.N Janssen Pharmaceuticals arm. Eliquis, also known as apixaban, was co-developed by Pfizer Inc PFE.N and Bristol Myers Squibb BMY.N.

The results are derived from Medicare claim data for 581,451 adults aged 65 or older with atrial fibrillation. In 1,000 people, the combined rate of major bleeding events and stroke due to blocked arteries or bleeding was about 16 per year with Xarelto compared to about 13 per year with Eliquis, researchers reported on Tuesday. in JAMA.

After taking into account participants’ other risk factors, the overall rate of these events was 18% higher with Xarelto, they said. Xarelto was linked to 12% higher rate of clot-related stroke, 26% higher rate of bleeding-related stroke, 41% higher rate of non-fatal bleeding stroke and about a double rate of non-fatal strokes. bleeding.

Blood thinners are used in patients with atrial fibrillation to prevent the arrhythmia from causing small clots in the heart that can cause strokes if they are dislodged.

The study cannot prove that Xarelto caused the adverse events. Still, it “provides pretty strong data indicating that for the treatment and prevention of stroke in atrial fibrillation, apixaban is the best drug,” said Wayne Ray, study director, Vanderbilt University. School of Medicine in Nashville, Tennessee.

Xarelto was approved by the United States Food and Drug Administration in 2011 while Eliquis was approved a year later. Generic forms of Eliquis were approved in 2020, but Pfizer and Bristol Myers have won a lawsuit that allows them to hold a patent on the drug until March 2028.

An accompanying editorial in the journal said that a potential explanation for the results is that if Eliquis is taken twice a day, Xarelto is only taken once a day, which can lead to greater variability in levels. of medication in the body.

“Patients treated with rivaroxaban may therefore have a higher risk of bleeding when peak levels are high and a higher risk of stroke when levels are low,” suggest Dr Peter Zimetbaum and colleagues at Beth Israel Deaconess Medical Center in Boston in the editorial.

Restricting the analysis to the elderly and lack of information about patients’ adherence to dosing regimens were among the study’s limitations, the researchers said.

“Retrospective studies as such have limitations: only prospective head-to-head clinical trials can directly compare the safety and efficacy of individual drugs. No such trials have been conducted for the apixaban and rivaroxaban, “Bayer said in a statement to Reuters.

J&J, Pfizer and Bristol Myers did not immediately respond to questions sent by email.

Bayer recorded nearly 3.5 billion euros ($ 3.95 billion) in Xarelto sales in the nine months ended September, while J&J recorded $ 1.8 billion. For Eliquis, Pfizer recorded $ 4.47 billion in sales over the same period, while Bristol Myers Squibb grossed $ 8.09 billion.

(Reporting by Leroy Leo in Bangalore; Editing by Nancy Lapid and Nick Zieminski)


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