Phase III results demonstrated that rivaroxaban once daily was better in lowering stroke and non-CNS systemic embolism risk in atrial fibrillation patients than Warfarin. Johnson & Johnson presented the findings of the ROCKET AF trial at the Annual Meeting of the American Heart Association, Chicago. The trial also found rivaroxaban to be as safe as Warfarin. Warfarin is currently the most commonly prescribed drug for atrial fibrillation patients for the prevention of stroke.

Rivaroxaban, an oral anticoagulant, was invented and is manufactured by German pharmaceutical company Bayer. It is marketed in several countries with the brand name Xarelto. If the FDA approves it in the USA, it will be marketed by Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson.

The trail demonstrated sustained and superior benefits over a long period for rivaroxaban versus Warfarin while patients continued on their medication. Apart from showing a 21% relative risk reduction for non-CNS systemic embolism and stroke, those on rivaroxaban had slightly fewer myocardial infections as well as slightly fewer deaths from any cause than those on Warfarin.

14.9% of patients on rivaroxaban had a clinically relevant bleeding event, compared to 14.5% of those on Warfarin; comparably similar rates. Incidences of major bleeding were 3.6% for those on rivaroxaban and 3.5% for those on Warfarin. Overall, the safety of both drugs were similar.

Robert M. Califf, M.D., study co-chairman and Vice Chancellor for Clinical Research from Duke University, said:

    Given the prevalence and morbidity associated with atrial fibrillation, and the well-known difficulties with warfarin use, it is exciting to have an alternative which was documented in this study to be effective with no increase in significant bleeding.

Johnson & Johnson explained that the ROCKET AF trial (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation), which involved 14,264 randomized patients, is the largest ever that looked at stroke prevention for individuals with atrial fibrillation. Patients on once daily 20mg or 15mg rivaroxaban were compared to those on dose-adjusted Warfarin.

Peter M. DiBattiste, M.D., VP of Cardiovascular Development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., said:

    “Results from the ROCKET AF study suggest that rivaroxaban has the potential to offer protection for the millions of Americans living with atrial fibrillation who carry the risk of suffering a stroke, which is often devastating and disabling.”

The company informs that this is the 7th consecutive Phase III trial that shows that rivaroxaban is either equal to or better than standard treatments.

Patients on rivaroxaban do not have to undergo the repeat lab tests required to make sure Warfarin levels are adequate.

Rivaroxaban was approved in Canada and the European Union in 2008 as a 10mg tablet once-daily for prevention of VTE (venous thromboembolism) in hip or knee replacement patients. An FDA (Food and Drug Administration) Advisory Panel recommended the approval of rivaroxaban 10mg once daily for hip and knee replacement patients – they concluded that a trial (RECORD) showed that the medication is either equal to and possibly better than subcutaneous enoxaparin 40mg once daily. The Panel also wondered whether there might be a link between bleeding risk and long-term rivaroxaban use, which was not covered in that trial.

Source: Johnson & Johnson

Written by Christian Nordqvist