Evidence map›Paper›PMID 31925665›Full record

ArticleJournal of thrombosis and thrombolysis2020

The real world use of combined P-glycoprotein and moderate CYP3A4 inhibitors with rivaroxaban or apixaban increases bleeding.

Sarah Hanigan, Jessica Das, Kristen Pogue, Geoffrey D Barnes, Michael P Dorsch

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Journal of thrombosis and thrombolysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
9.4field-weighted citation impact, top 1% 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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.

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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 1 country.

Sarah HaniganDepartment of Pharmacy, Michigan Medicine, Ann Arbor, MI, USA. hanigan@med.umich.edu.ORCID http://orcid.org/0000-0003-4594-0496
Jessica DasDepartment of Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA.
Kristen PogueDepartment of Pharmacy, Michigan Medicine, Ann Arbor, MI, USA.
Geoffrey D BarnesDivision of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Michael P DorschDepartment of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA.
University of Michigan · USMichigan Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of direct oral anticoagulants for stroke prevention in atrial fibrillation continues to rise. Certain populations may be at higher risk for increased drug exposure and adverse events. Pharmacokinetic studies suggest increased exposure of rivaroxaban and apixaban with combined P-gp and moderate CYP3A4 inhibitors but the clinical relevance of this is unknown. This retrospective cohort study included patients receiving rivaroxaban or apixaban from January 1, 2012 to December 31, 2016 with a moderate inhibitor (amiodarone, dronedarone, diltiazem, verapamil) for at least 3 months in the drug-drug interaction (DDI) group. Propensity matching was used to identify similar control patients without the presence of the DDI. The primary outcome was a time to event analysis of any bleeding episode as defined by the International Society of Thrombosis and Hemostasis. After propensity matching, 213 patients with similar baseline characteristics were included in each group. The mean CHA2DS2-VASc score was 3.0 and median duration of follow-up was 1.45 years. The primary outcome occurred in 26.4% of patients in the DDI group and 18.4% in the control group (hazard ratio 1.8, 95% confidence interval [CI] 1.19 to 2.73; p-value = 0.006). There was no difference in bleeding rates based on type of inhibitor. Use of a combined P-gp and moderate CYP3A4 inhibitor with rivaroxaban or apixaban increased bleeding risk compared to patients without the DDI in this real world, retrospective study. Analysis in a larger patient population is needed to confirm these findings.

Indexed as

AgedAged, 80 and overATP Binding Cassette Transporter, Subfamily B, Member 1Cytochrome P-450 CYP3A InhibitorsDrug InteractionsFactor Xa InhibitorsFemaleHemorrhageHumansMaleMiddle AgedPyrazolesPyridonesRetrospective StudiesRivaroxabanapixabanATP Binding Cassette Transporter, Subfamily B, Member 1Cytochrome P-450 CYP3A InhibitorsFactor Xa InhibitorsPyrazolesPyridonesRivaroxabanApixabanBleedingInteractionRivaroxaban

Identifiers

PMID31925665
OpenAlexW3000465118

What OpenQuestion holds

Textmetadata
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.