Trial reportThe Journal of urology2010
Cardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.
Trial report in The Journal of urology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled 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.
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.
Who cites it
36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Hormonal prostate cancer therapies and cardiovascular disease: a systematic review.Heart failure reviews · 2022Pooled it
- Degarelix for treating advanced hormone-sensitive prostate cancer.The Cochrane database of systematic reviews · 2021Pooled it
- Pooled it
- Pooled it
- Pooled it
- Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.Cancer medicine · 2019Trial
- Effect of Degarelix, a Gonadotropin-Releasing Hormone Receptor Antagonist for the Treatment of Prostate Cancer, on Cardiac Repolarisation in a Randomised, Placebo and Active Comparator Controlled Thorough QT/QTc Trial in Healthy Men.Clinical drug investigation · 2017Trial
- Medical Castration Using the Investigational Oral GnRH Antagonist TAK-385 (Relugolix): Phase 1 Study in Healthy Males.The Journal of clinical endocrinology and metabolism · 2015Trial
- Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan.Japanese journal of clinical oncology · 2015Trial
- QT interval changes in transgender/gender diverse adolescents receiving gonadotropin-releasing hormone agonist and gender-affirming hormonal treatment.International journal of transgender health · 2026Article
- Supporting Transgender, Nonbinary, and Gender Diverse Youth During Solid Organ Transplantation.Pediatric transplantation · 2025Review
- Comparing the risk of cardiovascular disease between degarelix and gonadotropin-releasing hormone agonists:a systematic review and meta-analysis.Frontiers in oncology · 2025Review
- Acute toxicity outcomes from salvage high-dose-rate brachytherapy for locally recurrent prostate cancer after prior radiotherapy.Journal of contemporary brachytherapy · 2024Article
- Cardiovascular disease risk assessment and multidisciplinary care in prostate cancer treatment with ADT: recommendations from the APMA PCCV expert network.World journal of urology · 2024Review
- Cardiovascular Effects of GnRH Antagonists Compared With Agonists in Prostate Cancer: A Systematic Review.JACC. CardioOncology · 2023Article
- Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity.Drug safety · 2022Review
- Clinical Outcomes from Dose-Reduced Radiotherapy to the Prostate in Elderly Patients with Localized Prostate Cancer.Current oncology (Toronto, Ont.) · 2021Article
- Drug-Associated QTc Prolongation in Geriatric Hospitalized Patients: A Cross-Sectional Study in Internal Medicine.Drugs - real world outcomes · 2021Article
- Hormonal manipulation in androgen signaling: a narrative review on using novel androgen therapy agents to optimize clinical outcomes and minimize side effects for prostate cancer patients.Translational andrology and urology · 2021Review
- Shock From Twisting Peaks: A Rare Case of Recurrent Torsades de Pointes Secondary to Leuprolide-Induced Prolonged QT.Cureus · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 5 countries.
Funding
Abstract
purposeWe assessed the cardiovascular safety profile of degarelix, a new gonadotropin-releasing hormone antagonist. MATERIALS AND
methodsThis is the first report to our knowledge on cardiovascular safety data from a completed 1-year randomized controlled trial of leuprolide acetate vs degarelix. Outcomes considered in these analyses included the QT interval by central reading and analysis, and cardiovascular adverse events. On multivariate analyses relationships between selected baseline factors and cardiovascular events were evaluated.
resultsThere were no significant differences between treatment groups for mean change in Fridericia's correction of QT during the trial. Markedly abnormal Fridericia's correction of QT values (500 milliseconds or greater) were observed in only a small number of subjects by treatment group, that is 2 (less than 1%) in the pooled degarelix group and 2 (1%) in the leuprolide group. Supraventricular arrhythmias were the most common type of arrhythmias, affecting 2% of subjects in the pooled degarelix group and 4% in the leuprolide group. Other arrhythmias occurred in 1% or less of subjects by treatment group. The most frequently reported cardiac disorder was ischemic heart disease, which occurred in 4% of subjects treated with degarelix and 10% of those on leuprolide. Cox proportional hazard ratio estimates for selected baseline covariates showed a significantly increased risk of cardiovascular events by age (p=0.0459) and systolic blood pressure (p=0.0061).
conclusionsIn men with prostate cancer degarelix and leuprolide have similar cardiovascular safety profiles. These observations suggest that the cardiovascular events associated with both agents result from hypogonadism rather than a direct drug effect.
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What OpenQuestion holds
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.