American Society of Hirudotherapy

Acute Kidney Injury in Different Anticoagulation Strategies: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data

Research article published in Cardiovascular drugs and therapy (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Observational studyClinical TrialsXu et al. · Cardiovascular drugs and therapy, 2025

Abstract

PURPOSE: Acute kidney injury (AKI) following anticoagulant application has received growing attention as a significant emerging complication of anticoagulation. Nevertheless, there remains a lack of real-world studies to compare the incidence, clinical features, and prognosis of AKI across different anticoagulant regimens. METHODS: Disproportionality analysis and Bayesian analysis were used to identify suspected AKI cases after different anticoagulant use within the Food and Drug Administration's Adverse Event Reporting System from January 2004 to March 2023. The time to onset, fatality, and hospitalization rates of anticoagulant-associated AKI were also investigated. RESULTS: We identified 9313 anticoagulant-associated AKIs, which appeared to influence mostly patients over 65 years old (65.37%). Lepirudin displayed a stronger AKI association than others, based on the highest reporting odds ratio (ROR = 6.66, 95% CI = 3.97-11.18), proportional reporting ratio (PRR = 6.08, χ2 = 69.12), and empirical Bayes geometric mean (EBGM = 6.08, the lower 90% one-sided CI = 3.95). Warfarin showed the slightest association with AKI in oral anticoagulants, lower than any direct oral anticoagulants excluding apixaban. Edoxaban exhibited the highest potential renal risk among direct oral anticoagulants, with an ROR of 3.32 (95% CI = 2.95-3.72). The median time to AKI onset was 36 (IQR 7-205) days following the initiation of anticoagulation therapy, and most AKI cases occurred within the first month. CONCLUSION: Particular attention should be directed toward monitoring renal function in individuals receiving anticoagulants, including warfarin and direct oral anticoagulants, as well as other anticoagulant agents. This diligence is particularly imperative within the first month after anticoagulant administration for individuals with a tendency for AKI.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal ArticleComparative StudyResearch Support, Non-U.S. Gov't
Indexed MeSH termsHumansAcute Kidney InjuryAnticoagulantsAgedMaleFemaleIncidencePharmacoepidemiologyMiddle AgedBayes TheoremAged, 80 and overRisk Factors

Summary

Peer-reviewed clinical and outcomes research relevant to medicinal leech therapy and its biology. Indexed in PubMed and verified against the NCBI record.

Why This Matters for Hirudotherapy

This large pharmacoepidemiologic disproportionality and Bayesian analysis of the FDA Adverse Event Reporting System (Jan 2004–Mar 2023) identified 9,313 anticoagulant-associated acute kidney injury (AKI) reports, mostly in patients over 65, and found that lepirudin carried the strongest AKI signal of the agents studied (reporting odds ratio 6.66, 95% CI 3.97–11.18), with most events occurring within the first month of therapy. The hirudotherapy connection runs through lepirudin specifically — it is a recombinant hirudin, the direct thrombin inhibitor derived from medicinal-leech saliva — so this is a safety-signal data point in the wider leech-secretome anticoagulant story and a reminder that hirudin-class drugs warrant renal monitoring. The essential caveat is that spontaneous adverse-event reporting can only flag a disproportionate signal, not prove causation or true incidence (reporting bias, confounding by indication), and lepirudin the systemic drug is pharmacologically distinct from topical leech application.

Citation

Acute Kidney Injury in Different Anticoagulation Strategies: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data.

Xu et al. · Cardiovascular drugs and therapy, 2025

Added to ASH library: May 28, 2026 · Site last updated: June 18, 2026

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