Risk of renal failure with the non-vitamin K antagonist oral anticoagulants: systematic review and meta-analysis

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#administration-oral #anticoagulants #clinical-trials-phase-iii-as-topic #humans #international-normalized-ratio

Risk of renal failure with the non-vitamin K antagonist oral anticoagulants: systematic review and meta-analysis

Caldeira et al., 2015 | Pharmacoepidemiol Drug Saf | Meta Analysis

Citation

Caldeira Daniel, Gonçalves Nilza, ... Ferreira Joaquim J. Risk of renal failure with the non-vitamin K antagonist oral anticoagulants: systematic review and meta-analysis. Pharmacoepidemiol Drug Saf. 2015-Jul;24(7):757-64. doi:10.1002/pds.3791

Abstract

PURPOSE: Vitamin K antagonists (VKA)-related nephropathy is a novel entity characterized by acute kidney injury related to International Normalized Ratio supratherapeutic levels. Non-vitamin K antagonists oral anticoagulants (NOACs) have a predictable dose-response relationship and an improved safety profile. We hypothesized that these drugs do not have an increased risk of incident renal failure, which may be detrimental for the use of NOACs. METHODS: Systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Trials were searched through Medline, Cochrane Library and public assessment reports in August 2014. Primary outcome was renal failure. NOACs were evaluated against any comparator. Random-effects meta-analysis was performed by default, and pooled estimates were expressed as Risk Ratio (RR) and 95%CI. Heterogeneity was evaluated with I(2) test. RESULTS: Ten RCTs fulfilled inclusion criteria (one apixaban RCT, three dabigatran RCTs, and six rivaroxaban RCTs), enrolling 75 100 patients. Overall NOACs did not increase the risk of renal failure with an RR 0.96, 95%CI 0.88-1.05 compared with VKA or Low-molecular weight heparin (LMWH), without significant statistical heterogeneity (I(2)  = 3.5%). Compared with VKA, NOACs did not increase the risk of renal failure (RR 0.96, 95%CI 0.87-1.07; I(2)  = 17.8%; six RCTs). Rivaroxaban did not show differences in the incidence of renal failure compared with LMWH (RR 1.20, 95%CI 0.37-3.94; four trials), but there was an increased risk of creatinine elevation RR 1.25, 95%CI 1.08-1.45; I(2)  = 0%. CONCLUSIONS: NOACs had a similar risk of renal failure compared with VKA/LMWH in phase III RCTs. Post-marketing surveillance should be warranted.

Key Findings

Ten RCTs fulfilled inclusion criteria (one apixaban RCT, three dabigatran RCTs, and six rivaroxaban RCTs), enrolling 75 100 patients. Overall NOACs did not increase the risk of renal failure with an RR 0.96, 95%CI 0.88-1.05 compared with VKA or Low-molecular weight heparin (LMWH), without significant statistical heterogeneity (I(2)  = 3.5%). Compared with VKA, NOACs did not increase the risk of renal failure (RR 0.96, 95%CI 0.87-1.07; I(2)  = 17.8%; six RCTs). Rivaroxaban did not show difference

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 100
Age Range See abstract
Condition See abstract

MeSH Terms

  • Administration, Oral
  • Anticoagulants
  • Clinical Trials, Phase III as Topic
  • Humans
  • International Normalized Ratio
  • Randomized Controlled Trials as Topic
  • Renal Insufficiency
  • Risk Assessment
  • Vitamin K

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Systematic Review
  • Vertical: vitamin-k

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09