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06-04-2011 | Cardiology | Article

Rivaroxaban effective, but causes more bleeding than enoxaparin

Abstract

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MedWire News: Rivaroxaban is noninferior in efficacy to enoxaparin for prevention of venous thromboembolism (VTE) in acutely ill patients, but causes significantly higher rates of bleeding, show results from the MAGELLAN trial.

While there was no difference in efficacy between the two drugs at 10 days, the researchers did find evidence of superior efficacy with rivaroxaban at 35 days.

Nevertheless, study investigator Alexander Cohen, from Kings College London in the UK, said: "We did not see a consistently positive benefit-risk balance with rivaroxaban use, and thus further analysis is required to identify which groups of patients in MAGELLAN may derive benefit from thromboprophylaxis with rivaroxaban," said study investigator

The Multicenter, randomized, parallel Group Efficacy and safety study for the prevention of VTE in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin (MAGELLAN) phase III trial compared the efficacy of oral rivaroxaban (10 mg/day) with subcutaneous enoxaparin (40 mg/day) for prevention of VTE in acutely ill patients.

"VTE is often associated with recent surgery or trauma, but 50% to 70% of symptomatic thromboembolic events and 70% to 80% of fatal pulmonary embolism (PE) occur in non-surgical patients. Thus, this study population of acutely ill medical patients is an important group in which to test the optimal therapy for preventing VTE," Cohen pointed out at the American College of Cardiology Annual Scientific Sessions in New Orleans, Louisiana, USA.

The patients were aged 71 years on average and were admitted to hospital for a variety of conditions including heart failure, infectious disease, respiratory insufficiency, and active cancer. Total hospital stay lasted an average of 11 days.

The researchers found that the rate of the primary efficacy outcome, a combination of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic non-fatal pulmonary embolism, and VTE-related death, at 10 days was similar for those taking rivaroxaban or enoxaparin, at 2.7% for both groups.

But at 35 days, there was a significant difference in efficacy between the two groups, with the primary efficacy endpoint occurring in fewer patients taking rivaroxaban, at 4.4% compared with 5.7% of those taking enoxaparan.

Bleeding rates, however, including major and non-major bleeding, were significantly higher with rivaroxaban than enoxaparin, at both 10 days (2.8% vs 1.2%; p<0.0001) and 35 days (4.1% vs 1.7%; p<0.0001).

Rates of other adverse events such as cardiovascular problems, impacted liver function, and mortality were similar between the two groups, Cohen noted.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

By Helen Albert

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