Xarelto: first novel anticoagulant licensed for ACS

Bayer has launched a new 2.5mg strength of Xarelto (rivaroxaban) for the prevention of atherothrombotic events after acute coronary syndromes (ACS) in patients with elevated cardiac biomarkers.

Rivaroxaban is a selective direct factor Xa inhibitor. | SCIENCE PHOTO LIBRARY
Rivaroxaban is a selective direct factor Xa inhibitor. | SCIENCE PHOTO LIBRARY

In ACS patients, rivaroxaban is administered at a dose of 2.5mg twice daily in combination with aspirin 75—100mg daily, with or without clopidogrel 75mg daily.1

Efficacy

The safety and efficacy of rivaroxaban was evaluated in 15,526 patients with a recent ACS, defined as ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina.1

When added to standard therapy including low-dose aspirin, rivaroxaban 2.5mg twice daily significantly reduced the primary composite endpoint of death from cardiovascular causes, MI or stroke compared with placebo, with rates of 9.1% and 10.7%, respectively, over 24 months (HR 0.84, 95% CI 0.72—0.97, p=0.02).2

Rivaroxaban also significantly reduced the risk of death from cardiovascular causes (2.7%, vs 4.1% for placebo, p=0.002) and death from any cause (2.9%, vs 4.5% for placebo, p=0.002) over 24 months.2

Safety

Rivaroxaban increased the risk of major bleeding not associated with coronary-artery bypass grafting (1.8%, vs 0.6% with placebo; HR 3.46, 95% CI 2.08—5.77, p<0.001), as well as the rate of bleeding requiring medical attention and the rate of intracranial haemorrhage. However, there was no statistically significant difference in fatal bleeding.2

NICE decision pending

A technology appraisal assessing the clinical and cost effectiveness of rivaroxaban for secondary prevention in ACS is due to be published in March 2015.

References:

  1. Xarelto Summary of Product Characteristics, July 2014.
  2. Mega JL et al. N Engl J Med 2012; 366:9—19.

View Xarelto drug record

Further information: Bayer plc

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