Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials
| Autor: | Alex C. Spyropoulos, John Albanese, Concetta Lipardi, Theodore E. Spiro, Yoriko De Sanctis, Jianfeng Xu, Eunyoung Suh, Domenick Argenti, Elliot S. Barnathan, Wentao Lu, Gary E. Raskob, Jeffrey I. Weitz, Haitao Yang |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty Renal function Hemorrhage 030204 cardiovascular system & hematology Placebo Kidney Function Tests law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method Rivaroxaban law Risk Factors Internal medicine medicine Humans Enoxaparin Stroke Aged business.industry Incidence Anticoagulants Thrombosis Hematology Venous Thromboembolism Middle Aged medicine.disease Regimen 030104 developmental biology Treatment Outcome Relative risk Acute Disease Female Kidney Diseases business medicine.drug |
| Zdroj: | Thrombosis and haemostasis. 120(3) |
| ISSN: | 2567-689X |
| Popis: | Patients with renal impairment are at higher risk of thrombosis and bleeding than those with normal renal function. The optimal rivaroxaban dose for thromboprophylaxis in acutely ill medical patients with renal impairment is unknown. MARINER and MAGELLAN were multicenter, randomized clinical trials of rivaroxaban in acutely ill medical patients. Efficacy and safety outcomes in patients with renal impairment in MARINER (7.5 mg once daily) were compared with those in patients with normal renal function in MARINER (10 mg once daily) and in a subpopulation of MAGELLAN that excluded patients at high risk for bleeding at baseline (10 mg once daily). Compared with enoxaparin/placebo in the MAGELLAN subpopulation, the relative risk (RR) of symptomatic venous thromboembolism (VTE) and VTE-related death with rivaroxaban 10 mg in patients with renal impairment (RR = 0.62; 95% confidence interval [CI] 0.27–1.44) was similar to that in those with normal renal function (RR = 0.78; 95% CI 0.44–1.40), while in MARINER, the 7.5 mg dose did not reduce the risk in patients with renal impairment (hazard ratio = 1.00; 95% CI 0.52–1.92). Major bleeding with rivaroxaban 10 mg once daily was higher in patients with renal impairment than in those with normal renal function in MAGELLAN (1.54% vs. 0.98%) and in the MAGELLAN subpopulation (0.94% vs. 0.61%). At a dose of 10 mg once daily, rivaroxaban is effective for thromboprophylaxis in acutely ill medical patients with impaired or normal renal function. The safety of this regimen is enhanced without loss of efficacy by excluding patients at high risk for bleeding, but not by using a reduced-dose strategy. Trial Registration ClinicalTrials.gov identifiers: NCT00571649 for the MAGELLAN trial, NCT02111564 for the MARINER trial. |
| Databáze: | OpenAIRE |
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