Evidence map›Paper›PMID 31050868›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2019

Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran.

Stephan Glund, Kelly Coble, Dietmar Gansser, Joachim Stangier, Karin Hoermann, Charles V Pollack, Paul Reilly

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02104947 (A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT02104947 phase3completednot on this map

A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

TypeinterventionalSponsorBoehringer IngelheimRan2014 to 2016Enrolled503ConditionsHemorrhageArmsidarucizumab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

7 authors.

Stephan GlundBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach an der Riss, Germany.
Kelly CobleBoehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.
Dietmar GansserBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach an der Riss, Germany.
Joachim StangierBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach an der Riss, Germany.
Karin HoermannBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach an der Riss, Germany.
Charles V PollackThomas Jefferson University, Philadelphia, Pennsylvania.
Paul ReillyBoehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdarucizumab is a monoclonal antibody fragment that reverses dabigatran anticoagulation. Pharmacokinetics (PK) of idarucizumab have been described in healthy, elderly, or renally impaired (RI) volunteers, but PK data in patients are lacking.

objectivesThis analysis describes the PK of idarucizumab and its target dabigatran in bleeding/surgical patients. PATIENTS AND

methodsResults from the Reversal Effects of Idarucizumab on Active Dabigatran study, a prospective, multicenter, single-arm study demonstrated the reversal of dabigatran anticoagulation by idarucizumab in patients with uncontrollable bleeding (group A) or who needed urgent surgery (group B). Idarucizumab and unbound dabigatran concentrations, immunogenicity, and pharmacodynamics were assessed.

resultsTotal and unbound dabigatran levels at baseline were 165 ng/mL vs 110 ng/mL and 103 ng/mL vs 69.5 ng/mL in group A and B patients, respectively. Maximum plasma concentrations and area under the curves (AUC

conclusionIdarucizumab PK in target patients was consistent with phase I data. Patient characteristics had no impact on PK, whereas RI increased the exposure of idarucizumab and dabigatran. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02104947.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntithrombinsBlood CoagulationCoagulantsDabigatranDrug MonitoringFemaleHemorrhageHumansMaleModels, BiologicalProspective StudiesAntibodies, Monoclonal, HumanizedAntithrombinsCoagulantsDabigatranidarucizumabanti-drug antibodiesdabigatranidarucizumabpharmacokineticsreversal agent

Identifiers

PMID31050868
PMCPMC6852568

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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.