Evidence map›Paper›PMID 28689179›Full record

Trial reportHeart (British Cardiac Society)2017

Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism.

Alexander G Vandell, Joseph Walker, Karen S Brown, George Zhang, Min Lin, Michael A Grosso, Michele F Mercuri

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Heart (British Cardiac Society), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00986154 (A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.6field-weighted citation impact, top 7% 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.

NCT00986154 phase3completednot on this map

A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

TypeinterventionalSponsorDaiichi SankyoRan2009 to 2013Enrolled8,292ConditionsVenous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), ThromboembolismArmsedoxaban tosylate(DU-176b), low molecular weight heparin/unfractionated heparin, warfarin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Warfarin: The End or the End of One Size Fits All Therapy?Journal of personalized medicine · 2018
    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

7 authors at 1 institution in 3 countries.

Alexander G VandellTranslational Medicine Clinical Pharmacology, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA.
Joseph WalkerTranslational Medicine Clinical Pharmacology, Formerly of Daiichi Sankyo Pharma Development, Edison, New Jersey, USA.
Karen S BrownTranslational Medicine Clinical Pharmacology, Formerly of Daiichi Sankyo Pharma Development, Edison, New Jersey, USA.
George ZhangBiostatistics, Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Min LinBiostatistics, Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Michael A GrossoCardiovascular and Metabolism Therapeutic Area Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA.
Michele F MercuriCardiovascular and Metabolism Therapeutic Area Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA.
Daiichi Sankyo (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to investigate whether genetic variants can identify patients with venous thromboembolism (VTE) at an increased risk of bleeding with warfarin.

methodsHokusai-venous thromboembolism (Hokusai VTE), a randomised, multinational, double-blind, non-inferiority trial, evaluated the safety and efficacy of edoxaban versus warfarin in patients with VTE initially treated with heparin. In this subanalysis of Hokusai VTE, patients genotyped for variants in

resultsThe analysis included 47.7% (3956/8292) of the patients in Hokusai VTE. Among 1978 patients randomised to warfarin, 63.0% (1247) were normal responders, 34.1% (675) were sensitive responders and 2.8% (56) were highly sensitive responders. Compared with normal responders, sensitive and highly sensitive responders had heparin therapy discontinued earlier (p<0.001), had a decreased final weekly warfarin dose (p<0.001), spent more time overanticoagulated (p<0.001) and had an increased bleeding risk with warfarin (sensitive responders HR 1.38 [95% CI 1.11 to 1.71], p=0.0035; highly sensitive responders 1.79 [1.09 to 2.99]; p=0.0252).

conclusionIn this study, TRIAL REGISTRATION NUMBER: NCT00986154.

Indexed as

Pharmacogenomic VariantsAdultAgedAnticoagulantsBlood CoagulationCytochrome P-450 CYP2C9Double-Blind MethodDrug MonitoringFactor Xa InhibitorsFemaleGenetic Predisposition to DiseaseHemorrhageHumansMaleMiddle AgedPharmacogeneticsAnticoagulantsCYP2C9 protein, humanCytochrome P-450 CYP2C9edoxabanFactor Xa InhibitorsPyridinesThiazolesVitamin K Epoxide ReductasesVKORC1 protein, humanWarfarinCYP2C9edoxabanvenous thromboembolismVKORC1warfarin sensitivity

Identifiers

PMID28689179
PMCPMC5749368
OpenAlexW2728110284

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.