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Rivaroxaban prophylaxis too risky for medical inpatients

BMJ 2013; 346 doi: (Published 13 February 2013) Cite this as: BMJ 2013;346:f875

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Medical inpatients who need thromboprophylaxis usually stop treatment when they go home, but the manufacturers of the oral anticoagulant rivaroxaban have been investigating the risks and benefits of extending treatment from the usual 10 days to 35 days. The overall balance did not look favourable in their large multinational trial comparing 35 days of oral rivaroxaban with 10 days of subcutaneous enoxaparin. In a double dummy design, both groups had active or placebo injections for 10 days and active or placebo tablets for 35 days.

Risk of venous thromboembolism was virtually identical in both groups after 10 days of active treatment. Participants given extended rivaroxaban had a significantly lower risk than controls over the full 35 days (4.4% (131/2967) v 5.7% (175/3057); relative risk 0.77, 95% CI 0.62 to 0.96), but they also had significantly more bleeding (4.1% (164/3997) v 1.7% (67/4001); 2.5, 1.85 to 3.25). Harms clearly outweighed benefits. The authors reported seven deaths from bleeding complications in the group given extended rivaroxaban and just one such death in the control group.

Participants had a median age of 71 years and stayed in hospital for a median of 11 days. They had a selection of high risk medical conditions, most commonly infections, heart failure, respiratory insufficiency, and stroke. Almost a third had at least two different conditions and a fifth had impaired renal function.

Extended thromboprophylaxis does not look as safe and effective for medical inpatients as it does for patients having major orthopaedic surgery, say the authors, perhaps because medical patients have a riskier clinical profile.


Cite this as: BMJ 2013;346:f875

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