Evidence map›Paper›PMID 39978320›Full record

ArticleUrologia internationalis2025

Cardiovascular Safety of GnRH Agonist-Based Androgen Deprivation Therapy in a Real-World Setting: Results from a Prospective Cohort Study (LEAN).

Bernd J Schmitz-Dräger, Bernd J Schmitz-Dräger, Ekkehardt Bismarck, Thomas Ebert, Roland Starlinger, Kerstin Dienes, Bertram Ottillinger, Peter J Goebell, Stephan Mühlich, Natalya Benderska-Söder and 2 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Urologia internationalis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Bernd J Schmitz-Dräger
Bernd J Schmitz-DrägerUrologie 24, St. Theresien-Krankenhaus, Nuremberg, Germany.
Ekkehardt BismarckUrologie 24, St. Theresien-Krankenhaus, Nuremberg, Germany.
Thomas EbertUrologie 24, St. Theresien-Krankenhaus, Nuremberg, Germany.
Roland StarlingerSandoz GmbH, Kundl, Austria.
Kerstin DienesHexal AG, Holzkirchen, Germany.
Bertram OttillingerOttillinger Life Sciences, Brunnthal, Germany.
Peter J GoebellDepartment of Urology and Pediatric Urology, Friedrich-Alexander University, Erlangen, Germany.
Stephan MühlichUrology Practice, Bamberg, Germany.
Natalya Benderska-SöderUrologie 24, St. Theresien-Krankenhaus, Nuremberg, Germany.
Jutta Bergler-KleinDepartment of Cardiology, University Clinic of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Oliver W HakenbergDepartment of Urology, University of Rostock, Rostock, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLEAN is a prospective, multicenter, noninterventional, German cohort study in patients with locally advanced and metastatic hormone-sensitive prostate cancer (PC). This analysis explores the efficacy and safety of leuprorelin in patients with PC and an indication for androgen deprivation therapy (ADT) in routine practice.

methodsSafety assessment focused on the incidence of major adverse cardiovascular (CV) events (MACEs; a composite of all-cause death, myocardial infarction, or stroke) over the 12-month study period. Patients initiating ADT before enrollment were excluded from the analysis.

resultsOf the 1,372 patients included, MACEs occurred in 57 (4.2%) patients and in 18/532 (3.4%) versus 39/840 (4.6%) patients without and with a pre-existing CV comorbidity, respectively (p = 0.264). Of the 57 MACEs, 17 were CV events and 20 were considered PC-related events; in 20 patients, events were classed as "other" or the context remained unknown. Only one MACE, nonserious arrhythmia, was considered drug related by the urologist. Of the 52 deaths reported in patients with MACEs, 12 were related to a CV event and 20 were related to disease progression.

conclusionIn a large European patient cohort, leuprorelin-based ADT demonstrated an acceptable safety profile, with a low incidence of CV events.

Indexed as

Androgen AntagonistsAntineoplastic Agents, HormonalCardiovascular DiseasesGonadotropin-Releasing HormoneLeuprolideProstatic NeoplasmsAgedAged, 80 and overGermanyHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAndrogen AntagonistsAntineoplastic Agents, HormonalGonadotropin-Releasing HormoneLeuprolideAndrogen deprivation therapyCardio-oncologyCardiotoxicityCardiovascular riskHormone-sensitive prostate cancerLeuprorelinNoninterventional studyProstate cancer

Identifiers

PMID39978320
PMCPMC12490847

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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.