Evidence map›Paper›PMID 31602680›Full record

ArticleJournal of clinical pharmacy and therapeutics2020

Effect of the number of dose adjustment factors on bleeding risk in patients receiving 30 mg/day edoxaban.

Tomoki Takase, Hiroaki Ikesue, Haruna Nakagawa, Megumi Kinoshita, Nobuyuki Muroi, Takeshi Kitai, Yutaka Furukawa, Tohru Hashida

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 35% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Article
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

8 authors at 1 institution in 1 country.

Tomoki TakaseDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.ORCID https://orcid.org/0000-0001-8744-2183
Hiroaki IkesueDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Haruna NakagawaDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Megumi KinoshitaDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Nobuyuki MuroiDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Takeshi KitaiDepartment of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Yutaka FurukawaDepartment of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Tohru HashidaDepartment of Pharmacy, Kobe City Medical Center General Hospital, Kobe-city, Japan.
Kobe City Medical Center General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

WHAT IS KNOWN AND

objectiveEdoxaban has three dose adjustment factors (creatinine clearance, 15-50 mL/min; body weight, 60 kg or less; and concomitant medication with potent P-glycoprotein inhibitors) to prevent bleeding that results from elevated blood concentrations of the drug. A dose reduction (from 60 to 30 mg/day of edoxaban) is recommended for patients with even one of those. However, it is not clear whether 30 mg/day of edoxaban is adequate for patients with multiple dose adjustment factors. We thus investigated the association between the number of the dose adjustment factors and bleeding risk in patients receiving edoxaban.

methodsWe retrospectively analysed 198 patients who received 30 mg/day of edoxaban between April 2015 and March 2017 with follow-up for 1 year.

resultsThe incidences of major bleeding were 1.4%, 7.3% and 20.0% in patients with 0-1, 2 and 3 dose adjustment factors, respectively. The Cox proportional hazards regression model revealed that the risk of major bleeding was higher in patients with 2 (hazard ratio [HR]: 5.80, 95% confidence interval [CI]: 0.96-44.05, P = .055) or 3 (HR: 17.70, 95% CI: 2.12-147.70, P = .012) dose adjustment factors than in those with 0-1 dose adjustment factor. WHAT IS NEW AND

conclusionThis is the first study to evaluate the risk of bleeding in patients administered 30 mg/day of edoxaban based on the number of dose adjustment factors in clinical practice. For patients receiving edoxaban, as the number of the dose adjustment factors increases, the risk of major bleeding is elevated. In patients with multiple dose adjustment factors, not only one level of dose reduction, but further dose reductions may be considered. Further studies with a larger sample size are needed to confirm these findings.

Indexed as

AgedAged, 80 and overCreatinineDose-Response Relationship, DrugFactor Xa InhibitorsFemaleFollow-Up StudiesHemorrhageHumansIncidenceMaleMiddle AgedPyridinesRetrospective StudiesRiskThiazolesCreatinineedoxabanFactor Xa InhibitorsPyridinesThiazolesatrial fibrillationbleedingdirect oral anticoagulantsdose reductionedoxabanvenous thromboembolism

Identifiers

PMID31602680
PMCPMC7079038
OpenAlexW2979384892

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Registered trials

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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.