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Consistency of safety profile of new oral anticoagulants in patients with renal failure.
J Thromb Haemost. 2013 Dec 18;
Authors: Lega JC, Bertoletti L, Gremillet C, Boissier C, Mismetti P, Laporte S
Abstract
BACKGROUND: The use of new oral anticoagulants (NOACs) in patients with impaired renal function raised major concerns, in particular the possibility of an increased bleeding risk due to accumulation. The aims of this work were to assess the safety of NOAC in patients with renal failure and described the relationship between clinical events and drug renal excretion magnitude.
METHODS: All phase III trials comparing NOACs to vitamin K antagonists (VKA) in patients with estimated glomerular filtration (eGFR) rate <50 mL/min were eligible. The main safety and efficacy outcomes were major bleeding and thrombosis. A meta-regression was performed to estimate the correlation between the treatment effect estimate and the percent of renal excretion.
RESULTS: Nine studies (12272 patients) were included. A significantly greater relative reduction in major bleeding was seen for NOACs with eGFR <50 mL/min (RR 0.61; CI 0.51-0.74) than those with high renal excretion (RR 0.96; CI 0.85-1.07) (interaction test: p <0.0001). A linear relationship between the relative risk of major bleeding and the magnitude of renal excretion was found by meta-regression (R(2) =0.66, p =0.03). For thrombosis, a greater treatment effect of NOA versus INR-adjusted VKA was observed in patients with eGFR <50 mL/min (RR 0.78, CI 0.67-0.92), but no correlation between treatment effect and renal excretion was found.
CONCLUSIONS: New oral anticoagulants were at least as effective as VKA with reduced risks of major bleeding and thrombosis in patients with eGFR <50 mL/min. The renal excretion of these new drugs seemed to modify the safety profile, contrary to the efficacy. This article is protected by copyright. All rights reserved.
PMID: 24350682 [PubMed - as supplied by publisher]