Safety and effectiveness of rivaroxaban and warfarin in moderate-to-advanced CKD: real world data

Lullo, Luca Di; Tripepi, Giovanni; Ronco, Claudio; Pascalis, Antonio De; Barbera, Vincenzo; Granata, Antonio; Russo, Domenico; Iorio, Biagio Raffaele Di; Paoletti, Ernesto; Ravera, Maura; Fusaro, Maria; Bellasi, Antonio

doi:10.1007/s40620-018-0501-7

Cited by 31 publications

(24 citation statements)

References 23 publications

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“…Так, в рамках наблюдательного ретроспективного исследования, которое включало 347 больных с ФП и ХБП 3b -4-й стадии, из которых 247 получали ривароксабан, 100 -варфарин, в течение 16±0,3 мес наблюдения было зарегистрировано 25 инсультов (15 геморрагиче-КЛИНИЧЕСКИЕ СЕМИНАРЫ § ских и 10 ишемических): 24 из них на фоне варфарина и только 1 на фоне ривароксабана [53]. Из 5 тромбозов глубоких вен все возникли при приеме варфарина, из 10 больших кровотечений -8 при использовании варфарина.…”

Section: эффективность и безопасность ппоак в лечении больных с фп нunclassified

Atrial Fibrillation in Patients on Dialysis Therapy: Epidemiology, Prognosis and Choice of Anticoagulant Therapy

et al. 2019

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The review presents data on the prevalence of atrial fibrillation in patients on dialysis therapy. It is shown that dialysis-dependent patients with non-valve atrial fibrillation prognosis is extremely unfavorable, significantly increased risk of death due to both ischemic and hemorrhagic complications. Scales to assess the risk of thromboembolic and hemorrhagic complications in patients with atrial fibrillation on program dialysis are not validated. The lack of data from randomized clinical trials makes it much more difficult to choose anticoagulant therapy in patients with terminal stage of chronic kidney disease on dialysis who have undergone kidney transplantation. Therefore, the need for anticoagulant therapy and the choice of drugs in patients in this category should be made on the basis of a personalized multidisciplinary approach, taking into account comorbid pathology and the patient’s preferences.

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Section: эффективность и безопасность ппоак в лечении больных с фп нunclassified

Atrial Fibrillation in Patients on Dialysis Therapy: Epidemiology, Prognosis and Choice of Anticoagulant Therapy

et al. 2019

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“…Two recent reallife observational studies have examined the effect of DOAC versus warfarin in CKD patients. The first study was performed in a cohort of over 340 patients (247 being treated with rivaroxaban and 100 with warfarin) and in patients with impaired renal function (CKD stage 3B-4); it clearly shows how the use of rivaroxaban at the "renal" dosage of 15 mg/day is significantly associated with a net clinical benefit both in terms of efficacy and safety [27]. The second study was performed in a limited sample of patients with the same characteristics in terms of CKD and confirmed the best risk/benefit ratio of edoxaban compared to warfarin [28].…”

Section: Introductionmentioning

confidence: 99%

Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

et al. 2020

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Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI < 1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.The studies analyzed meet the requirements regulatory authorities (e.g., EMA) usually demand of pharmaceutical companies for primary endpoint completion (e.g., assessment of drug safety).

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“…Research has shown that it has reduced the damage caused by cisplatin to the kidney [26]. It has been shown that rivaroxaban can be used as a therapeutic option in chronic kidney disease (CKD) patients [28]. Mitochondria is one of the vital organelle that has unique functions, and considered as the main source of ROS, cellular energy production, ionic regulation, and cell death [29].…”

Section: Discussionmentioning

confidence: 99%

Contrasting Role of Concentration in Rivaroxaban Induced Toxicity and Oxidative Stress in Isolated Kidney Mitochondria

et al. 2019

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Rivaroxaban as a small molecule is able to directly and reversibly inhibit the factor Xa. This study was designed to figure out the evaluation effect of rivaroxaban on mitochondria obtained from rat kidneys. We isolated mitochondria from rat kidneys using gradient centrifugation. Then, the toxicity parameters including succinate dehydrogenase (SDH) activity, reactive oxygen species (ROS) formation, mitochondrial swelling, mitochondrial membrane potential (MMP) collapse and cytochrome c release were measured in kidneys mitochondria following the exposure to rivaroxaban. The results showed that rivaroxaban (1.4 and 2.8 mM) raised the reactive oxygen species (ROS) generation, swelling in the mitochondria, collapse in the mitochondrial membrane potential (MMP) and cytochrome c release in the mitochondria isolated from kidneys. While, rivaroxaban at a higher concentration of 5.6 mM showed the opposite effect compared to other lower concentrations. The results indicate that rivaroxaban may have antioxidant effects at high concentrations. The results suggest that rivaroxaban (5.6 mM) has protective effects against oxidative stress and mitochondrial toxicity.

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Safety and effectiveness of rivaroxaban and warfarin in moderate-to-advanced CKD: real world data

Abstract: Rivaroxaban seems a safe and effective therapeutic option in CKD stage 3b-4 patients. However, future randomized controlled trials are needed to definitively establish the role of rivaroxaban in CKD patients.

Cited by 31 publications

References 23 publications

Atrial Fibrillation in Patients on Dialysis Therapy: Epidemiology, Prognosis and Choice of Anticoagulant Therapy

Atrial Fibrillation in Patients on Dialysis Therapy: Epidemiology, Prognosis and Choice of Anticoagulant Therapy

Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

Contrasting Role of Concentration in Rivaroxaban Induced Toxicity and Oxidative Stress in Isolated Kidney Mitochondria

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