Evidence map›Paper›PMID 27158246›Full record

ArticleThrombosis journal2016

Evaluation of the chromogenic anti-factor IIa assay to assess dabigatran exposure in geriatric patients with atrial fibrillation in an outpatient setting.

Luigi Brunetti, Betty Sanchez-Catanese, Leonid Kagan, Xia Wen, Min Liu, Brian Buckley, James P Luyendyk, Lauren M Aleksunes

Open access · goldAbstract read
In one paragraph

Article in Thrombosis journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Luigi BrunettiDepartment of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA.
Betty Sanchez-CataneseDepartment of Medicine, Robert Wood Johnson University Hospital-Somerset, Somerville, USA.
Leonid KaganDepartment of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA.
Xia WenDepartment of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA.
Min LiuChemical Analytical Core Laboratory, Environmental and Occupational Health Sciences Institute, Rutgers, The State University of New Jersey, Piscataway, USA.
Brian BuckleyChemical Analytical Core Laboratory, Environmental and Occupational Health Sciences Institute, Rutgers, The State University of New Jersey, Piscataway, USA.
James P LuyendykPathology and Diagnostic Inv., Michigan State University, East Lansing, USA.
Lauren M AleksunesDepartment of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, USA.
Rutgers, The State University of New Jersey · USMichigan State University · USSomerset Medical Center · US

Funding

Translational Research Support CoreP30ES005022 · NIEHS · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI ROBERT John LAUMBACH · 1988 to 2026
$47.4M
NIEHS NIH HHS P30 ES005022
6 · The paper itself

Abstract

backgroundDabigatran etexilate may be underutilized in geriatric patients because of inadequate clinical experience in individuals with severe renal impairment and post-marketing reports of bleeding events. Assessing the degree of anticoagulation may improve the risk:benefit ratio for dabigatran. The aim of this prospective study was to identify whether therapeutic drug monitoring of dabigatran anticoagulant activity using a chromogenic anti-factor IIa assay is a viable option for therapy individualization.

methodsPlasma dabigatran concentration was assessed in nine patients with nonvalvular atrial fibrillation aged 75 years or older currently receiving dabigatran etexilate for prevention of stroke, using an anti-factor IIa chromogenic assay and HPLC-MS/MS. Trough concentrations were evaluated on two separate occasions to determine intrapatient variation.

resultsBlood was collected at 13.1 ± 2.3 h (mean ± SD) post dose from patients prescribed dabigatran etexilate 150 mg twice daily (5/9 patients) or dabigatran etexilate 75 mg twice daily (4/9 patients). Results from the anti-factor IIa chromogenic assay correlated with dabigatran concentrations as assessed by HPLC-MS/MS (r (2)  = 0.81, n = 16). There was no correlation between dabigatran trough values taken at separate visits (r (2)  = 0.002, n = 7). Furthermore, there was no correlation found between the drug concentrations and patients' renal function determined by both creatinine and cystatin-C based equations. None of the patients enrolled in the study were in the proposed on-therapy trough range during at least one visit.

conclusionThe chromogenic anti-factor IIa assay demonstrated similar performance in quantifying dabigatran plasma trough concentrations to HPLC-MS/MS. Single measurement of dabigatran concentration by either of two methods during routine visits may not be reliable in identifying patients at consistently low or high dabigatran concentrations.

Indexed as

Atrial fibrillationChromogenic anti-factor IIaDabigatranGeriatricHPLC-MS/MS

Identifiers

PMID27158246
PMCPMC4858862
OpenAlexW2345005148

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.