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Xarelto: two new indications for oral anticoagulant

01 February 2012, 9:16am

The direct oral factor Xa inhibitor, rivaroxaban (Xarelto), has been approved for two new indications.

Xarelto 15mg and 20mg tablets should be taken with food

Xarelto 15mg and 20mg tablets should be taken with food

In addition to the prevention of venous thromboembolism (VTE) following hip or knee replacement, Xarelto (rivaroxaban) is now licensed for:

  • prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and one or more risk factors (including congestive heart failure, hypertension, ≥75 years of age, diabetes mellitus and prior stroke or transient ischaemic attack);
  • treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT.

Stroke prevention in AF

Rivaroxaban (20mg once daily) was compared with dose-adjusted warfarin (target INR 2.5, range 2.0–3.0) in the pivotal randomised double-blind ROCKET AF study (n=14,264). The primary efficacy endpoint (a composite of stroke and systemic embolism) occurred in 188 patients taking rivaroxaban (1.7% per year) compared with 241 in the warfarin group (2.2% per year); hazard ratio (HR) 0.79 from the per-protocol analysis (95% CI, 0.66–0.96; p<0.001 for non-inferiority). Patients with renal impairment (CrCl 30–49ml/min; n=2950) were given a lower dose of rivaroxaban (15mg once daily) and in a subgroup analysis displayed a similar treatment effect to that found in the overall trial.


The open-label non-inferiority EINSTEIN DVT study (n=3449) investigated rivaroxaban in the treatment of acute symptomatic DVT. Patients were randomised to receive rivaroxaban 15mg twice daily for 3 weeks then 20mg once daily for 3, 6 or 12 months (n=1731), or subcutaneous enoxaparin plus warfarin or acenocoumarol (n=1718). Rivaroxaban was equally efficacious as the active control in reduction of recurrent VTE (36 events [2.1%] versus 51 events [3.0%], respectively; HR 0.68; 95% CI, 0.44–1.04; p<0.001 for non-inferiority).

The EINSTEIN-Extension trial (n=1197) investigated the efficacy of rivaroxaban (20mg once daily) against placebo in the prevention of VTE recurrence, following treatment for DVT or PE. Rivaroxaban displayed superior efficacy to placebo (8 events [1.3%] versus 42 [7.1%], respectively; HR 0.18; 95% CI, 0.09–0.39; p<0.001).


Rates of major and non-major clinically relevant bleeding were similar in the two arms of the ROCKET AF study, but fatal bleeding and rates of intracranial haemorrhage were less frequent with rivaroxaban. Additionally, similar rates of all-cause mortality and myocardial infarction were observed but major gastrointestinal bleeding was more common in the rivaroxaban group. In the EINSTEIN trial, similar rates of adverse events occurred in the two groups; however, in the EINSTEIN-Extension study, non-fatal major bleeding occurred in 4 patients in the rivaroxaban group but no patients in the placebo group (p=0.11).

New tablets

To support the new indications, Xarelto is now available as 15mg and 20mg tablets in addition to the existing 10mg tablets licensed for prevention of VTE following hip or knee replacement surgery.

View Xarelto drug record

Further information: Bayer plc


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