Evidence map›Paper›PMID 22271904›Full record

ArticleHaematologica2012

Clinical cardiac safety profile of nilotinib.

Theo D Kim, Philipp le Coutre, Michaela Schwarz, Peggy Grille, Michal Levitin, Suzanne Fateh-Moghadam, Francis J Giles, Bernd Dörken, Wilhelm Haverkamp, Clemens Köhncke

Abstract read
In one paragraph

Article in Haematologica, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
–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.

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

48 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  5. Review
  6. Article
  7. Article
  8. Article
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  10. Recommendations on the use of azole antifungals in hematology-oncology patients.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023
    Review
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  13. Article
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  15. Article
  16. Article
  17. Targeting OCT3 attenuates doxorubicin-induced cardiac injury.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  18. Review
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  20. 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

10 authors.

Theo D KimMedizinische Klinik mS Hämatologie und Onkologie, Charité -Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany.
Philipp le Coutre
Michaela Schwarz
Peggy Grille
Michal Levitin
Suzanne Fateh-Moghadam
Francis J Giles
Bernd Dörken
Wilhelm Haverkamp
Clemens Köhncke

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNilotinib is a second-generation tyrosine kinase inhibitor with significant efficacy as first- or second-line treatment in patients with chronic myeloid leukemia. Despite preclinical evidence indicating a risk of prolongation of the QT interval, which was confirmed in clinical trials, detailed information on nilotinib's cardiac safety profile is lacking. DESIGN AND

methodsHere, we retrospectively assessed cardiovascular risk factors in 81 patients who were being or had previously been treated with nilotinib therapy and evaluated cardiovascular parameters by longitudinal monitoring of the QT interval and left ventricular ejection fraction. Detailed information on the occurrence and management of defined cardiac adverse events was extracted.

resultsThe median duration of nilotinib therapy was 26 months (range, 1-72). The median QT interval at baseline was 413 msec (range, 368-499 msec). During follow-up, the median QT was not significantly different from the baseline value at any time-point. Sixteen of 81 patients (20%) had new electrocardiographic changes. Cardiac function, as assessed by measurement of left ventricular ejection fraction, did not change significantly from baseline at any time-point. During a median follow-up of 44 months (range, 2-73), seven patients (9%), all of whom had received prior imatinib therapy, developed 11 clinical cardiac adverse events requiring treatment. The median time from the start of nilotinib therapy to an event was 14.5 months (range, 2-68). Five of seven patients were able to continue nilotinib therapy with only one brief interruption.

conclusionsWhereas new electrocardiographic abnormalities were recorded in 20% of all patients and some of them developed severe or even life-threatening coronary artery disease, QT prolongation, changes in left ventricular ejection fraction, and clinical cardiac adverse events were uncommon in patients treated with nilotinib.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzamidesCoronary Artery DiseaseElectrocardiographyFemaleFollow-Up StudiesFusion Proteins, bcr-ablHeartHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedAntineoplastic AgentsBenzamidesFusion Proteins, bcr-ablImatinib MesylatenilotinibPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID22271904
PMCPMC3366654

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.