Evidence map›Paper›PMID 25229619›Full record

ArticleCPT: pharmacometrics & systems pharmacology2014

Model-based exposure-response analysis of apixaban to quantify bleeding risk in special populations of subjects undergoing orthopedic surgery.

T A Leil, C Frost, X Wang, M Pfister, F LaCreta

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 12% 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

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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  4. The non-vitamin K antagonist oral anticoagulants (NOACs) and extremes of body weight-a systematic literature review.Clinical research in cardiology : official journal of the German Cardiac Society · 2017
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  11. Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Review
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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

5 authors at 2 institutions in 2 countries.

T A LeilBristol-Myers Squibb Company, Princeton, New Jersey, USA.
C FrostBristol-Myers Squibb Company, Princeton, New Jersey, USA.
X WangBristol-Myers Squibb Company, Princeton, New Jersey, USA.
M Pfister1] Bristol-Myers Squibb Company, Princeton, New Jersey, USA [2] Current address: Quantitative Solutions, Inc., Menlo Park, CA, USA; and University Children's Hospital Basel, University of Basel, Basel, Switzerland.
F LaCretaBristol-Myers Squibb Company, Princeton, New Jersey, USA.
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (Sweden) · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Population pharmacokinetic (PK) and exposure-response analyses of apixaban were performed using data from phase I-III studies to predict bleeding risks for patients receiving apixaban 2.5 mg b.i.d. after total knee or hip replacement (TKR, THR) surgery (N = 5,510). Renal function, age, gender, and body weight impacted apixaban exposure. Bleeding risk increased as a function of exposure. Predicted bleeding frequencies for TKR and THR populations at risk for high apixaban exposure (female, age > 75 years, calculated creatinine clearance (cCrCL) < 30 ml/min, body weight < 50 kg) (6.85 and 10.3%, respectively) were comparable to the reference population (male/female, age 65-75 years, cCrCL ≥ 80 ml/min, body weight 65-85 kg) (6.18 and 9.32%, respectively). A 100% increase in apixaban exposure is expected to raise bleeding frequencies to 7.25% (TKR) and 10.9% (THR), whereas a 200% increase would raise them to 8.49 and 12.7%. Coexistence of combined patient risk factors or doubling of exposure is not likely to result in a substantial, clinically relevant increase in bleeding risk with 2.5 mg b.i.d. apixaban.

Identifiers

PMID25229619
PMCPMC4211262
OpenAlexW1976934051

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.