No net benefit with rivaroxaban for hospital patients with acute illnesses
For patients in hospital with acute illnesses, extended prophylaxis with rivaroxaban leads to fewer thromboembolic events than shorter duration of prophylaxis with enoxaparin. However, the risk of bleeding is more than double, according to a paper published in The New England Journal of Medicine (2013;368:513-23).
Patients aged 40 years or older admitted to hospital for acute illnesses (n=8,101) were randomised to receive 35 days of oral rivaroxaban 10mg and 10 days of concomitant subcutaneous placebo or 10 days of subcutaneous enoxaparin 40mg and concomitant 35 days of oral placebo.
The co-primary outcomes were occurrence of a composite of thromboembolic events at day 10 and at day 35 and the primary safety outcome was clinically relevant bleeding. At day 10, rivaroxaban was found to be just as effective as enoxaparin. Thromboembolic events were comparable in both groups (78 of 2,938 patients receiving rivaroxaban and 82 of 2,993 patients receiving enoxaparin, both 2.7 per cent). However, bleeding occurred at more than double the rate in the rivaroxaban group compared with the enoxaparin group (111 of 3,997, 2.8 per cent and 49 of 4,001, 1.2 per cent, respectively; P<0.001).
Results at day 35
At day 35, those in the rivaroxaban group were at less risk of thromboembolic events than those in the enoxaparin group (131 of 2,967, 4.4 per cent and 175 of 3,057, 5.7 per cent, respectively; P=0.02). But bleeding events occurred in 4.1 per cent of the rivaroxaban group compared with 1.7 per cent in the enoxaparin group (P=0.001).
The authors conclude: "A reduction in the rate of death related to venous thromboembolism and an increase in the rate of death related to bleeding were seen with extended-duration rivaroxaban prophylaxis. . . . The prespecified analysis of net clinical benefit or harm did not show a benefit with rivaroxaban at either day 10 or day 35."
The study was funded by Bayer and Janssen and the study data were collected and analysed by them.
Citation: Electronicjuice DOI: 10.1211/PJ.2013.11116598
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