Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries

Marcelino, Gisela; Hemett, Ould Maouloud; Descombes, Éric

doi:10.1155/2020/6940183

Cited by 11 publications

(8 citation statements)

References 29 publications

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“…These data are consistent with the results of recent analyses extracted from the International Pharmacovigilance Registry, which show that the reported annual rate of renal adverse events is almost 10 times higher for DOACs (7725 cases in 15 years) than for antivitamin K drugs (2145 cases reported in 50 years). According to this database, dabigatran and rivaroxaban are the drugs associated with a higher proportion of kidney-related adverse events, being 4.6% and 3.5%, respectively [ 15 ]. In the set of clinical cases of ARN, the median age of patients treated with dabigatran and rivaroxaban was 78 years.…”

Section: Discussionmentioning

confidence: 99%

Management of Anticoagulant-Related Nephropathy: A Single Center Experience

Mikič

Kojc

Frelih

et al. 2021

JCM

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Background: Anticoagulant-related nephropathy (ARN) is a form of acute kidney injury that mainly occurs in patients with previously unrecognized glomerular disease in addition to excessive anticoagulation. Since a renal biopsy is not performed in most cases, the diagnosis is often presumptive. Methods: Here, we present the characteristics of a national Slovenian patient cohort with histologically verified ARN, from the first case in 2014 to December 2020, and a review of the current literature (Pubmed database). Results: In Slovenia, ARN has been detected in 13 patients, seven of whom were treated with coumarins, and others with direct oral anticoagulants. In seven patients, ARN appeared after excessive anticoagulation. As many as 11 patients had underlying IgA nephropathy. Similar to the global data presented here, the pathohistological impairment associated with pre-existing glomerulopathy was mild and disproportionate to the degree of functional renal impairment. The majority of our patients with ARN experienced severe deterioration of renal function associated with histological signs of accompanying acute tubular injury, interstitial edema, and occlusive red blood cell casts. These patients were treated with corticosteroids, which (in addition to supportive treatment and discontinuation of the anticoagulant drug) led to a further improvement in renal function. Conclusions: Anticoagulant therapy combined with a pre-existing glomerular injury may lead to ARN. In addition to discontinuation of the anticoagulant and supportive care, corticosteroids, which are currently listed in only a few cases in the world literature, may have a positive influence on the course of treatment. However, the benefits of steroid treatment must be weighed against the risk of complications, especially life-threatening infections.

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Section: Discussionmentioning

confidence: 99%

Management of Anticoagulant-Related Nephropathy: A Single Center Experience

Mikič

Kojc

Frelih

et al. 2021

JCM

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“…Warfarin-related nephropathy is a significant risk factor for the progression of CKD and mortality [15]. Many case reports have mentioned that DOACs (dabigatran, apixaban, or rivaroxaban) could also cause AKI due to the induction of tubular red blood cell (RBC) casts and tubular necrosis or interstitial nephritis [16][17][18]. Therefore, all anticoagulants cause anticoagulant-related nephropathy (ARN).…”

Section: Anticoagulant-related Nephropathymentioning

confidence: 99%

The impact on renal function after long-term use of anticoagulants in atrial fibrillation patients

Lee

et al. 2021

Thrombosis J

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Objective Long-term oral anticoagulant should be considered or recommended in patients with atrial fibrillation (AF) and CHA2DS2VASc score ≥ 1 for stroke prevention. Warfarin and different direct oral anticoagulants (DOACs) are metabolized differently by the kidney. The impact on renal function after long-term use of anticoagulants in the patients with AF remains unclear. This study aimed to compare DOACs and warfarin’s impact on the decline in renal function from a large cohort with AF. Methods This study included patients with nonvalvular AF from 2000 to 2018, mainly through the medical history (ICD code) of the Chang Gung Research Database. Baseline estimated glomerular filtration rate (eGFR), follow-up eGFR and the change in eGFR between 2-year eGFR and baseline eGFR were compared between different DOACs and warfarin after propensity score matching. The primary study endpoint was acute kidney injury (AKI). Results 3657 patients were enrolled in this study and the mean observation time was 3.3 ± 0.9 years. During the observation period, there was a significantly higher incidence of AKI during follow-up in the warfarin group than in the different DOAC groups before and after propensity score matching (before: warfarin vs. DOAC: 9.2% vs. 5.2%, p < 0.001; after: warfarin vs. DOAC: 8.9% vs. 4.4%, p < 0.001). There was no difference in the incidence of AKI between dabigatran group and anti-factor Xa inhibitor group after propensity score matching. The incidence of AKI was similar among rivaroxaban, apixaban and edoxaban groups after propensity score matching. The change in eGFR between 2-year eGFR and baseline eGFR did not differ between the warfarin and DOAC groups after propensity score matching (warfarin vs. DOAC: − 1.27 ± 20.32 vs. -1.94 ± 17.24 mL/min/1.73 m2, p = 0.461). Conclusions During the mean observation time of 3.3 ± 0.9 years, warfarin was associated with a higher incidence of AKI compared with DOACs. The decline in renal function did not differ among warfarin and different DOAC groups.

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“…However, in a large study by Marcelino et al analyzing data from 134 national registries, dabigatran was associated with 4.6% of renal side effects, whereas other DOACs -rivaroxaban, apixaban and edoxaban -were shown to be related with 3.5%, 2.0% and 1.7% of renal side effects, respectively. 15 What is interesting, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation RCT (ARISTOTLE; https://clinicaltrials.gov/, NCT00412984) showed much higher incidence of kidney damage after apixaban, reaching 13.6% of the analyzed population, despite lower incidence of major bleeding and lower mortality. 16 Due to the lack of results from other clinical trials (Renal Hemodialysis Patients Allocated Apixaban versus Warfarin in Atrial Fibrillation trial (RENAL-AF; https://clinicaltrials.gov/, NCT02942407) was prematurely terminated because of no funding and inconclusive results) 6 and possibly much higher incidence of ARN than expected, new ongoing trials regarding the safety of dabigatran…”

Section: Epidemiologymentioning

confidence: 99%

“…10 Similar observations were made by Marcelino et al, who analyzed data from the World Health Organization (WHO) pharmacovigilance program in the VigiAccess™ database. 15 The authors showed that the annual risk of renal side effects was about 2 times higher for DOAC-treated patients as compared to patients receiving VKAs, and AKI was the most commonly reported clinical finding. 15 In the available studies, most patients with ARN did not have a CKD history, had variable renal outcomes, and quite often required hemodialysis procedures; however, in most cases, kidney function improvement was observed (Table 1).…”

Section: Effect On Renal Outcome and Survivalmentioning

confidence: 99%

Anticoagulant-related nephropathy: Focus on novel agents. A review

Zakrocka¹,

Załuska²

2022

Adv Clin Exp Med

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Anticoagulant-related nephropathy (ARN) is a novel and not well-studied cause of acute kidney injury (AKI). The prevalence of ARN varies significantly between studies and is estimated at 20% in patients treated with warfarin. Patients with ARN have a significantly higher mortality risk and an increased risk of chronic kidney disease (CKD). Unexplained AKI with hematuria are clinical manifestations of ARN. In most cases, ARN is diagnosed within the first 2 months of anticoagulant therapy, but later ARN occurrence is possible. Among the studied anticoagulants, most data concern warfarin toxicity, whereas cases of ARN caused by direct oral anticoagulants (DOACs) have also been presented. Tubular obstruction by red blood cell casts or hemoglobin and iron tubular toxicity are the postulated mechanisms of ARN. On the molecular level, the inhibition of thrombin and protease-activated receptor-1 (PAR-1), leading to endothelial susceptibility to damage or abnormal protein C endothelial signaling, is suggested to contribute to ARN. Older age, impaired kidney function, hypertension, and diabetes mellitus are the main risk factors for ARN, but their significance may differ between anticoagulants. From therapeutic options, the withdrawal of the anticoagulant and the administration of its antidote, as well as corticosteroids or N-acetylcysteine, are proposed. Since the number of patients with kidney diseases on anticoagulants increases, and DOACs are starting to be more useful in this group of patients, we aim to summarize the pathogenesis, clinical picture and possible ways of treatment of DOAC-induced ARN.

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Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries

Cited by 11 publications

References 29 publications

Management of Anticoagulant-Related Nephropathy: A Single Center Experience

Management of Anticoagulant-Related Nephropathy: A Single Center Experience

The impact on renal function after long-term use of anticoagulants in atrial fibrillation patients

Anticoagulant-related nephropathy: Focus on novel agents. A review

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