An investigation by The BMJ has questioned the validity of a pivotal trial used to support the use of the world’s best selling new oral anticoagulant.
There are now calls from the medical community for an independent investigation and access to the original trial data to clarify the drug’s benefits and harms.
The investigation by The BMJ questions the results of the ROCKET-AF trial that was published in the New England Journal of Medicine in 2011. The study compared rivaroxaban (Xarelto) with the older anti-clotting drug warfarin for preventing strokes in patients with atrial fibrillation.
Concerns first came to light after the journal discovered that the INRatio device used in the trial had been recalled in December 2014 after giving falsely low-test results.
“In terms of the trial results, it could make rivaroxaban seem safer than it was with respect to the risk of bleeding and throws doubt onto outcomes used to support the use of the world’s best selling new oral anticoagulant,” said The BMJ’s Associate Editor, Dr Deborah Cohen in a special report.
Spokespeople for manufacturers Johnson and Johnson and Bayer issued the following statement in December last year: “We have conducted a number of sensitivity analyses. These sensitivity analyses confirm the results of the ROCKET-AF study and the positive benefit-risk profile of Xarelto (rivaroxaban) in patients with non valvular atrial fibrillation.”