Evidence map›Paper›PMID 30697670›Full record

Observational studyClinical drug investigation2019

Investigation on Dabigatran Etexilate and Worsening of Renal Function in Patients with Atrial fibrillation: The IDEA Study.

Mauro Molteni, Matteo Crippa, Annalisa Orenti, Hernan Polo Friz, Anna Menghini, Pierluigi Tramacere, Giuseppe Marano, Claudio Cimminiello, Patrizia Boracchi

Open access · greenAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. 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

9 authors at 4 institutions in 1 country.

Mauro MolteniUOC Cure Subacute, IRCCS, Istituti Clinici Scientifici Maugeri, via Camaldoli 64, 20138, Milan, Italy. mauro.molteni@icsmaugeri.it.ORCID http://orcid.org/0000-0002-0071-2900
Matteo CrippaInternal Medicine, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Annalisa OrentiDepartment of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. Maccacaro, University of Milan, via Vanzetti 5, 20133, Milan, Italy.
Hernan Polo FrizInternal Medicine, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Anna MenghiniInternal Medicine, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Pierluigi TramacereClinical Pathology, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Giuseppe MaranoDepartment of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. Maccacaro, University of Milan, via Vanzetti 5, 20133, Milan, Italy.
Claudio CimminielloStudies and Research Office of Italian Society of Angiology and Vascular Pathology (SIAPAV), via Gorizia 22, 20144, Milan, Italy.
Patrizia BoracchiDepartment of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. Maccacaro, University of Milan, via Vanzetti 5, 20133, Milan, Italy.
Azienda Ospedaliera di Desio e Vimercate · ITUniversity of Milan · ITSocietà Italiana di Reumatologia · ITIstituti Clinici Scientifici Maugeri · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesWarfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function.

methodOne hundred and seven patients treated long term with dabigatran etexilate for non-valvular atrial fibrillation (NVAF) were followed up for 90 days. DPC, serum creatinine (SCr) and serum cystatin C were prospectively measured. Ninety five patients had complete follow-up data and were evaluable for primary endpoint.

resultsEleven patients had supratherapeutic DPC, defined as DPC higher than 200 ng/ml at study enrolment, but at the end of follow-up no patient showed a persistent increase in SCr. No patients experienced acute kidney injury.

conclusionsOur study shows that no persistent renal detrimental effect is associated with dabigatran treatment. An increase in SCr during dabigatran treatment is reversible and it seems to be unrelated to dabigatran itself.

Indexed as

AgedAged, 80 and overAntithrombinsAtrial FibrillationDabigatranFemaleFollow-Up StudiesHumansKidneyKidney Function TestsMaleProspective StudiesAntithrombinsDabigatran

Identifiers

PMID30697670
OpenAlexW2913555372

What OpenQuestion holds

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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.