Evidence map›Paper›PMID 26710337›Full record

Trial reportPloS one2015

A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naïve Patients with Non-Valvular Atrial Fibrillation.

Vittorio Pengo, Carlo-Federico Zambon, Paola Fogar, Andrea Padoan, Giovanni Nante, Michela Pelloso, Stefania Moz, Anna Chiara Frigo, Francesca Groppa, Dania Bozzato and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01178034 (Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT01178034 phase3completednot on this map

Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation: a Randomized Trial Evaluating a New Genotype-based Versus Usual Care Initiation of Treatment

TypeinterventionalSponsorUniversity of PadovaRan2009 to 2012Enrolled180ConditionsAtrial FibrillationArmsCalculate warfarin dose using demographic/genetic algorithm
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Ethnic Diversity and Warfarin Pharmacogenomics.Frontiers in pharmacology · 2022
    Review
  8. Article
  9. Review
  10. Optimizing quality care for the oral vitamin K antagonists (VKAs).Hematology. American Society of Hematology. Education Program · 2018
    Review
  11. Review
  12. Article
  13. Article
  14. 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

17 authors.

Vittorio PengoDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Carlo-Federico ZambonDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Paola FogarDepartment of Laboratory Medicine, University of Padova, Padova, Italy.
Andrea PadoanDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Giovanni NanteDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Michela PellosoDepartment of Laboratory Medicine, University of Padova, Padova, Italy.
Stefania MozDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Anna Chiara FrigoDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Francesca GroppaDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Dania BozzatoDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Enrico TisoDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Elisa GnattaDepartment of Laboratory Medicine, University of Padova, Padova, Italy.
Gentian DenasDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Seena Padayattil JoseDepartment of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Roberto PadriniDepartment of Medicine-DIMED, University of Padova, Padova, Italy.
Daniela BassoDepartment of Laboratory Medicine, University of Padova, Padova, Italy.
Mario PlebaniDepartment of Medicine-DIMED, University of Padova, Padova, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledGenotype-guided warfarin dosing have been proposed to improve patient’s management. This study is aimed to determine whether a CYP2C9- VKORC1- CYP4F2-based pharmacogenetic algorithm is superior to a standard, clinically adopted, pharmacodynamic method. Two-hundred naïve patients with non-valvular atrial fibrillation were randomized to trial arms and 180 completed the study. No significant differences were found in the number of out-of-range INRs (INR<2.0 or >3.0) (p = 0.79) and in the mean percentage of time spent in the therapeutic range (TTR) after 19 days in the pharmacogenetic (51.9%) and in the control arm (53.2%, p = 0.71). The percentage of time spent at INR>4.0 was significantly lower in the pharmacogenetic (0.7%) than in the control arm (1.8%) (p = 0.02). Genotype-guided warfarin dosing is not superior in overall anticoagulation control when compared to accurate clinical standard of care.

trial registrationClinicalTrials.gov NCT01178034.

Indexed as

AdultAgedAged, 80 and overAlgorithmsAnticoagulantsAtrial FibrillationCytochrome P-450 CYP2C9Cytochrome P-450 Enzyme SystemCytochrome P450 Family 4Drug MonitoringFemaleHumansInternational Normalized RatioMaleMiddle AgedPharmacogeneticsAnticoagulantsCYP2C9 protein, humanCYP4F2 protein, humanCytochrome P-450 CYP2C9Cytochrome P-450 Enzyme SystemCytochrome P450 Family 4Vitamin K Epoxide ReductasesVKORC1 protein, humanWarfarin

Identifiers

PMID26710337
PMCPMC4692529

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Registered trials

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.