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Rivaroxaban showing efficacy in VTE and PAD

Rivaroxaban showing efficacy in VTE and PAD

Publication date: Friday, 19 May 2017
Contributor(s): Jeremy Bray

The direct factor Xa inhibitor rivaroxaban has been showing promise in trials in venous thromboembolism (VTE) and peripheral arterial disease (PAD).

Rivaroxaban appears to reduce the risk of recurrent VTE without increasing the risk for bleeding, according to data published from the EINSTEIN CHOICE study.

The study drugs (rivaroxaban 20 mg or 10 mg daily or aspirin 100 mg daily) were given to over 3000 patients for up to 12 months. Recurrent VTE occurred in 17 of 1107 patients taking 20 mg rivaroxaban and in 13 of the 1127 treated with the 10-mg dose. A total of 50 VTEs were reported among 1131 patients receiving aspirin (Table).

The major bleeding rate was similar in both rivaroxaban doses (0.5% and 0.4% for 20 mg and 10 mg, respectively). The rate was also low, 0.3%, in the aspirin control group. The rates of clinically relevant non-major bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups.

The phase III COMPASS study of rivaroxaban in patients with coronary or PAD has been halted early after a pre-specified interim analysis showed that the trial had met its primary endpoint (cardiovascular death, myocardial infarction and stroke).

COMPASS is the largest study of rivaroxaban to date and has enrolled 27,402 patients from more than 600 sites in more than 30 countries. Patients were randomized to rivaroxaban 2.5 mg twice-daily plus aspirin 100 mg once-daily, rivaroxaban 5 mg twice-daily alone, or aspirin 100 mg once-daily alone. Full results of the trial will be presented at an upcoming medical meeting this year.

 

Hazard ratio (95% CI)

Rivaroxaban 20 mg vs aspirin

0.34 (0.20-0.59)

Rivaroxaban 10 mg vs aspirin

0.26 (0.14-0.47)

Table: Hazard ratios for recurrent VTE.

ACTION

Rivaroxaban is indicated for the treatment of a number of conditions including deep vein thrombosis and pulmonary embolism, and for prevention of stroke and atherothrombotic events following an acute coronary syndrome. Ongoing studies are showing promise in other conditions including extended treatment of VTE and PAD.
Weitz JI et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med 2017;376:1211-22. www.nejm.org/doi/full/10.1056/NEJMoa1700518

COMPASS trial press release www.janssen.com/phase-3-compass-study-xarelto-rivaroxaban-stopping-early-efficacy-study-meets-primary-endpoint-0

Rivaroxaban Summary of Product Characteristics www.medicines.org.uk/emc/medicine/25586

Topics covered:
Category: Evidence in Practice
Edition: Volume 2 Number 4 PCCJ Online 2017
Contributor(s): Jeremy Bray

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