Evidence map›Paper›PMID 23616817›Full record

Observational studyDeutsches Arzteblatt international2013

Bleeding complications and liver injuries during phenprocoumon treatment: a multicentre prospective observational study in internal medicine departments.

Sven Schmiedl, Marietta Rottenkolber, Jacek Szymanski, Werner Siegmund, Marion Hippius, Katrin Farker, Bernd Drewelow, Joerg Hasford, Petra Thürmann

Open access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Deutsches Arzteblatt international, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 18% 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

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. [Warfarin-induced autoimmune hepatitis: a case report].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2015
    Article
  5. Article
  6. [Gastrointestinal bleeding in cardiological patients].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2013
    Review
  7. Anticoagulation in atrial fibrillation: NOAC's the word.Deutsches Arzteblatt international · 2013
    Article
  8. In reply.Deutsches Arzteblatt international · 2013
    Article
  9. Education for patients taking anticoagulants.Deutsches Arzteblatt international · 2013
    Article
  10. Excessive treatment with anticoagulants.Deutsches Arzteblatt international · 2013
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Sven SchmiedlPhilipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University.
Marietta Rottenkolber
Jacek Szymanski
Werner Siegmund
Marion Hippius
Katrin Farker
Bernd Drewelow
Joerg Hasford
Petra Thürmann
Institute of Pharmacology · CZSophien-und Hufeland Klinikum · DEUniversity of Rostock · DELudwig-Maximilians-Universität München · DEZimmer Biomet (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEven after the recent approval of newer oral anticoagulants for clinical use, the vitamin K antagonist phenprocoumon remains an important treatment option for many patients. In order to quantify the hitherto "accepted" risks of phenprocoumon treatment, we analyzed adverse drug reactions (ADRs) that led to hospitalization on the internal medicine wards of four German pharmacovigilance centers.

methodsWe prospectively analyzed ADRs leading to hospitalization on the internal medicine wards of the hospitals belonging to the German Network of Regional Pharmacovigilance Centers (Rostock, Greifswald, Jena, and the Sophien- und Hufeland-Klinikum in Weimar) in the years 2000 to 2008.

resultsThe 851 patients hospitalized for a phenprocoumon-associated ADR accounted for 12.4% of the 6887 ADR-related hospitalizations in the period of the study. 723 (85%) were admitted for a hemorrhage, usually in the gastrointestinal tract (482 patients); 8 patients died as a consequence of hemorrhage associated with phenprocoumon exposure. Using drug utilization data for the catchment areas of the participating hospitals, we calculate a rate of 5 to 7 hemorrhages leading to hospitalization in an internal medicine ward per 1000 patient-years under phenprocoumon treatment. One-third of the patients who had a hemorrhage were taking other interacting drugs, mainly inhibitors of platelet aggregation and non-steroidal anti-inflammatory drugs. Among the patients who were taking phenprocoumon because of a history of thromboembolic events or for atrial fibrillation, 60% to 70% of those who had hemorrhages had an international normalized ratio (INR) that was above the upper limit of the therapeutic range. Phenprocoumon-associated impairment of liver function arose in 23 patients (2.7%).

conclusionIn this study, about one-eighth of all ADR-related admissions to hospital internal medicine wards were associated with phenprocoumon. There is a need for a comparative risk-benefit assessment of phenprocoumon and the newer oral anticoagulants under real-life conditions.

Indexed as

AgedAnticoagulantsChemical and Drug Induced Liver InjuryComorbidityFemaleGermanyHemorrhageHospitalizationHumansInternal MedicineMalePharmacovigilancePhenprocoumonPrevalenceProspective StudiesRisk AssessmentAnticoagulantsPhenprocoumon

Identifiers

PMID23616817
PMCPMC3632811
OpenAlexW2115543888

What OpenQuestion holds

Textmetadata
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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.