Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study

The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.
An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years at least.

Start Date01 Feb 2015

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT00966290 / CompletedPhase 4IIT

Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study

Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear.
Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events.
Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.

Start Date01 Feb 2003

Sponsor / Collaborator

Toulouse University Hospital

100 Clinical Results associated with Fluindione

100 Translational Medicine associated with Fluindione

100 Patents (Medical) associated with Fluindione

157

Literatures (Medical) associated with Fluindione

01 Aug 2023·Clinica chimica acta; international journal of clinical chemistry

Quantitative determination of plasma free and total concentrations of antivitamin K drugs using a new sensitive and rapid LC-MS/MS method: Application in hemodialysis patients.

Article

Author: Renou, Marianne ; Demagny, Julien ; Liabeuf, Sophie ; Mernissi, Touria ; Choukroun, Gabriel ; Le Guyader, Mailys ; Bodeau, Sandra ; Kamel, Saïd

BACKGROUND AND AIMSVitamin K antagonists (VKAs) are the first-line anticoagulants used in end stage renal disease. This population experiences a significant variability in their International Normalized Ratio (INR) over time. There is a need for methods allowing the study of the pharmacokinetics of free and total concentrations of VKAs to explain INR variability.MATERIALS AND METHODSWe developed and validated a high-performance liquid chromatography-tandem mass spectrometry method allowing the quantification of warfarin and fluindione free and total plasma concentrations. Chromatographic separation was achieved in a raptor biphenyl column and the spectrometry acquisition was set in multiple reaction monitoring mode after negative electrospray ionization. We then applied it in describing the plasma free and total concentrations of VKAs in samples from 50 hemodialysis patients.RESULTSThe developed method is rapid, sensitive and specific. Our cohort results showed a correlation between free and total VKA concentrations. The free VKA concentrations tended to be higher in patients with higher INR. Although VKAs are highly albumin-bound drugs, albumin concentration did not totally explain the high inter-individual total VKA concentrations variability.CONCLUSIONThis opens the door to further studies to understand the factors involved in their variability.

01 Jan 2023·Frontiers in immunology

Incidence and risk factors of acute kidney injury in cancer patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis.

Review

Author: Yi, Cheng ; Fu, Ping ; Zhao, Yuliang ; Zhang, Ling ; Liu, Caihong ; Yang, Letian ; Wei, Wei ; Yin, Ting ; Li, Jian ; Pu, Yajun ; Na, Feifei

BackgroundThe incidence and risk factors of acute kidney injury (AKI) in patients with malignancies receiving immune checkpoint inhibitors (ICIs) are being extensively reported with their widespread application.ObjectiveThis study aimed to quantify the incidence and identify risk factors of AKI in cancer patients treated with ICIs.MethodsWe searched the electronic databases of PubMed/Medline, Web of Science, Cochrane and Embase before 1 February 2023 on the incidence and risk factors of AKI in patients receiving ICIs and registered the protocol in PROSPERO (CRD42023391939). A random-effect meta-analysis was performed to quantify the pooled incidence estimate of AKI, identify risk factors with pooled odds ratios (ORs) and 95% confidence intervals (95% CIs) and investigate the median latency period of ICI-AKI in patients treated with ICIs. Assessment of study quality, meta-regression, and sensitivity and publication bias analyses were conducted.ResultsIn total, 27 studies consisting of 24048 participants were included in this systematic review and meta-analysis. The overall pooled incidence of AKI secondary to ICIs was 5.7% (95% CI: 3.7%-8.2%). Significant risk factors were older age (OR: 1.01, 95% CI: 1.00-1.03), preexisting chronic kidney disease (CKD) (OR: 2.90, 95% CI: 1.65-5.11), ipilimumab (OR: 2.66, 95% CI: 1.42-4.98), combination of ICIs (OR: 2.45, 95% CI: 1.40-4.31), extrarenal immune-related adverse events (irAEs) (OR: 2.34, 95% CI: 1.53-3.59), and proton pump inhibitor (PPI) (OR: 2.23, 95% CI: 1.88-2.64), nonsteroidal anti-inflammatory drug (NSAID) (OR: 2.61, 95% CI: 1.90-3.57), fluindione (OR: 6.48, 95% CI: 2.72-15.46), diuretic (OR: 1.78, 95% CI: 1.32-2.40) and angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) (pooled OR: 1.76, 95% CI: 1.15-2.68) use. Median time from ICIs initiation to AKI was 108.07 days. Sensitivity and publication bias analyses indicated robust results for this study.ConclusionThe occurrence of AKI following ICIs was not uncommon, with an incidence of 5.7% and a median time interval of 108.07 days after ICIs initiation. Older age, preexisting chronic kidney disease (CKD), ipilimumab, combined use of ICIs, extrarenal irAEs, and PPI, NSAID, fluindione, diuretics and ACEI/ARB use are risk factors for AKI in patients receiving ICIs.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023391939.

22 Sep 2022·Clinical Kidney Journal

Risk factors associated with immune checkpoint inhibitor–induced acute kidney injury compared with other immune-related adverse events: a case–control study

Article

Author: Borchiellini, Delphine ; Gérard, Alexandre O ; Andreani, Marine ; Parassol, Nadège ; Bourneau-Martin, Delphine ; Sicard, Antoine ; Laurain, Audrey ; Drici, Milou-Daniel ; Pinel, Sylvine ; Merino, Diane ; Esnault, Vincent L M ; Barbosa, Susana ; Rocher, Fanny ; Cremoni, Marion

ABSTRACTBackgroundImmune checkpoint inhibitors (ICIs) foster anti-cancer immune responses. Their efficacy comes at the cost of immune-related adverse events (IRAEs). The latter affects various organs, including kidneys, mostly as acute tubulointerstitial nephritis, the pathophysiology of which remains unclear. We conducted a multicentre case–control study to compare the characteristics of patients with renal IRAEs (ICI-AKI) with those of patients diagnosed with other IRAEs.MethodsWe queried the French pharmacovigilance database for all adverse events involving ICIs. Reports were classified as ICI-AKI or extrarenal IRAE. For each ICI-AKI report, four reports of extrarenal IRAEs were randomly included (control group, 4:1 ratio). Variables showing an association with a P < 0.05 were included as covariates in a multivariate analysis.ResultsTherefore, 167 ICI-AKI reports were compared with 668 extrarenal IRAEs. At least one concomitant extrarenal IRAE was mentioned in 44.3% of ICI-AKI reports. Patients with ICI-AKI were significantly older than patients with extrarenal IRAEs (69.1 versus 64.6 years; P = 0.0135), and chronic kidney disease was significantly more prevalent (12.0% versus 3.3%; P = 0.0125). Patients with ICI-AKI were significantly more likely to be treated with fluindione [adjusted odds ratio (OR) 6.53, 95% confidence interval (95% CI) 2.21–19.31; P = 0.0007], a non-steroidal anti-inflammatory drug (NSAID, OR 3.18, 95% CI 1.07–9.4; P = 0.0368) or a proton-pump inhibitor (PPI, OR 2.18, 95% CI 1.42–3.34; P = 0.0004).ConclusionThis study is limited by a lack of data, preventing confirmation of numerous reports therefore not included in the analysis. We are unable to draw definite pathophysiological conclusions from our data. Nonetheless, we suggest that ICIs may be a ‘second-hit’ that precipitates acute kidney injury caused by another concomitant drug (fluindione, NSAID or PPI).

100 Deals associated with Fluindione

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-	Fluindione	B01AA12	DB13136

R&D Status

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Indication	Country/Location	Organization	Date
Blood Coagulation Disorders	FR	-	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2014	Not Applicable	Nephrosis	7	Fluindione	utucvhbhyt(ragskmwlag) = WRN was initially suspected in patients treated with warfarin while initial diagnosis was incorrect in 4 of 5 patients treated with fluindione (acute interstitial nephritis for 3 patients and acute tubular necrosis for the last patient) qzjxnpagjk (hwwgmqtefr ) View more	Negative	11 Nov 2014

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