MAGELLAN

Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of VTE in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin (2011)

Condition

Prophylaxis for VTE in hospitalized acutely medically ill patients

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Objective

To prove non-inferiority of standard-duration (~10 days) anticoagulation with rivaroxaban compared to enoxaparin and to prove superiority of extended-duration (~35 days) rivaroxaban compared to standard-duration enoxaparin in the prevention of VTE in acutely medically ill patients

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Trial design

Randomized, double-blind phase III study
Active treatment: rivaroxaban 10 mg p.o. once daily for 35±4 days; placebo injections as in control treatment (n=4050)
Control treatment: enoxaparin 40 mg s.c. once daily for 10±4 days; placebo tablets as in active treatment (n=4051)

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Endpoints

Primary efficacy endpoint: composite of asymptomatic and symptomatic DVT, non-fatal PE, and VTE-related death at day 10 and 35
Secondary efficacy endpoint: composite of asymptomatic proximal DVT, symptomatic DV, symptomatic non-fatal PE and all-cause mortality at day 10 and 35
Primary safety endpoint: composite of major bleeding and clinically relevant non-major bleeding during treatment and within 2 days after the last dose
Secondary safety endpoints: treatment-emergent adverse events and abnormal laboratory parameters

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Trial participants

8101 patients ≥40 years hospitalized and immobilized for acute medical illness

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Results

Efficacy outcome: In the population with evaluable efficacy outcome the primary efficacy endpoint at day 10 occurred in 78 of 2939 patients (2.7%) given rivaroxaban and in 82 of 2993 patients (2.7%) given enoxaparin. At day 35 it occurred in 131 of 2967 patients (4.4%) receiving rivaroxaban and in 175 of 3057 patients (5.7%) receiving enoxaparin/placebo
Safety outcome: In the safety population major bleeding and clinically relevant non-major bleeding up to day 10 occurred in 111 of 3997 patients (2.8%) receiving rivaroxaban and in 49 of 4001 patients (1.2%) receiving enoxaparin. Up to day 35 the primary safety endpoint occurred in 164 (4.1%) patients in the rivaroxaban group and in 67 (1.7%) in the enoxaparin group. The incidence of other adverse events (cardiac events) and abnormal laboratory parameters (liver function) was similar in the 2 groups

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Summary

Efficacy: Rivaroxaban was non-inferior to enoxaparin in reducing the risk of VTE at day 10. Extended thromboprophylaxis with rivaroxaban was superior to enoxaparin followed by placebo in reducing the risk of VTE at day 35
Safety: Overall bleeding rates were low, but significantly higher in the rivaroxaban arm across the entire study period. Rates of other adverse events were similar in both arms

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Reference

(1) Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis 2011;4:407-416
(2) Bayer press release. In the prevention of VTE in acutely ill patients, rivaroxaban compares favorably with enoxaparin but does not show a consistent net clinical benefit. April 5, 2011

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Corresponding author

Cohen AT, Department of Surgery and Vascular Medicine, King’s College Hospital, London SE5 9RS, UK, e-mail: alexander.cohen@kcl.ac.uk

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