Evidence map›Paper›PMID 33890242›Full record

Trial reportAdvances in therapy2021

Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY.

Alexander T Cohen, Sharon Pan, Wonkyung Byon, Bushra S Ilyas, Thomas Taylor, Theodore C Lee

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00643201 (A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism), which is not on this map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT00643201 phase3completednot on this map

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

TypeinterventionalSponsorBristol-Myers SquibbRan2008 to 2013Enrolled5,614ConditionsVenous ThrombosisArmsEnoxaparin, warfarin, Placebo for apixaban, Placebo for enoxaparin, Placebo for warfarin
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Observational
  14. Review
  15. Review
  16. Article
  17. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Review
  18. Review
  19. Pharmacokinetics and Dosing Regimens of Direct Oral Anticoagulants in Morbidly Obese Patients: An Updated Literature Review.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Alexander T CohenGuy's and St Thomas' Hospitals, Westminster Bridge Road, London, UK. alexander.cohen@kcl.ac.uk.ORCID http://orcid.org/0000-0002-9398-4621
Sharon PanPfizer, New York, USA.
Wonkyung ByonPfizer, New York, USA.
Bushra S IlyasPfizer, New York, USA.
Thomas TaylorGuy's and St Thomas' Hospitals, Westminster Bridge Road, London, UK.
Theodore C LeePfizer, New York, USA.
Pfizer (United States) · USSt Thomas' Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAs a result of limited clinical data, guidelines do not recommend the use of non-vitamin K antagonist oral anticoagulants in patients who weigh > 120 kg or have a body mass index (BMI) > 40 kg/m

methodsThis post hoc analysis of the AMPLIFY trial evaluated the efficacy (venous thromboembolism [VTE]/VTE-related death), safety (major and composite of major and clinically relevant non-major [CRNM] bleeding), and exposure of apixaban compared with enoxaparin followed by warfarin for the treatment of VTE by body weight (≤ 60, > 60 to < 100, ≥ 100 to < 120, ≥ 120 kg) and BMI (≤ 25, > 25 to 30, > 30 to 35, > 35 to 40, > 40 kg/m

resultsAmong the AMPLIFY safety population, 5384 and 5359 patients had recorded body weight (range 28.9 to 222.0 kg; ≥ 120 kg, n = 290) and BMI (range 12.5-71.8 kg/m

conclusionsThe findings of this post hoc analysis support the use of apixaban in patients with body weight ≥ 120 kg or BMI > 40 kg/m TRIAL REGISTRATION NUMBER: NCT00643201.

Indexed as

Venous ThromboembolismAnticoagulantsHumansObesityPyrazolesPyridonesTreatment OutcomeAnticoagulantsapixabanPyrazolesPyridonesApixabanBody mass indexBody weightEnoxaparinVenous thromboembolismWarfarin

Identifiers

PMID33890242
PMCPMC8189985
OpenAlexW3155364577

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.