Evidence map›Paper›PMID 31030414›Full record

ArticleAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2019

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

Samira Garonzik, Wonkyung Byon, Elsa Myers, Xiodong Li, David Marchisin, Bindu Murthy

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02912234 (Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT02912234 phase1completednot on this map

Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2016Enrolled20ConditionsVenous ThromboembolismArmsApixaban, Clarithromycin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. 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

6 authors at 3 institutions in 3 countries.

Samira GaronzikBristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA. samira.garonzik@bms.com.ORCID http://orcid.org/0000-0001-6659-3687
Wonkyung ByonPfizer Inc., 445 Eastern Point Road MS 8260-2212, Groton, CT, 06340, USA.
Elsa MyersBristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Xiodong LiBristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
David MarchisinBristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Bindu MurthyBristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Germany) · DEPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis was an open-label, phase I, nonrandomized, single-sequence, crossover study to evaluate the effect of concomitant administration of multiple doses of clarithromycin on the single-dose exposure, safety, and tolerability of apixaban in healthy subjects.

methodsIn total, 19 subjects received a single oral dose of apixaban 10 mg on day 1. On day 4, subjects began receiving oral clarithromycin immediate release (IR) 500 mg twice daily (bid) for 4 days. On day 8, subjects received oral apixaban 10 mg and oral clarithromycin IR 500 mg bid. Oral clarithromycin IR 500 mg bid was given alone on days 9 and 10.

resultsCompared with apixaban alone, coadministration of apixaban with clarithromycin resulted in increased apixaban exposure. The adjusted geometric mean ratio (GMR) was 1.299 (90% confidence interval [CI] 1.220-1.384) for peak plasma concentration (C

conclusionsApixaban C CLINICAL

trial registrationClinicalTrials.gov identifier number NCT02912234.

Indexed as

ClarithromycinCytochrome P-450 CYP3A InhibitorsFactor Xa InhibitorsPyrazolesPyridonesAdultArea Under CurveCross-Over StudiesFemaleHalf-LifeHealthy VolunteersHumansMaleapixabanClarithromycinCytochrome P-450 CYP3A InhibitorsFactor Xa InhibitorsPyrazolesPyridones

Identifiers

PMID31030414
PMCPMC6885504
OpenAlexW2941465038

What OpenQuestion holds

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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.