Cardiovascular Safety of Degarelix: Results From a 12-Month, Comparative, Randomized, Open Label, Parallel Group Phase III Trial in Patients With Prostate Cancer
| Autor: | Tine Kold Olesen, Arthur A.M. Wilde, Matthew R. Smith, Bo-Eric Persson, Laurence Klotz |
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| Přispěvatelé: | Amsterdam Cardiovascular Sciences, Cardiology |
| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Male
medicine.medical_specialty Randomization Time Factors Antineoplastic Agents Hormonal Urology Hormone antagonist QT interval Article law.invention Gonadotropin-Releasing Hormone chemistry.chemical_compound Randomized controlled trial law Internal medicine Medicine Humans Degarelix Adverse effect Aged Aged 80 and over business.industry Hazard ratio Prostatic Neoplasms Middle Aged Surgery Clinical trial chemistry Cardiovascular Diseases Leuprolide business Oligopeptides |
| Zdroj: | Journal of urology, 184(6), 2313-2319. Elsevier Inc. |
| ISSN: | 0022-5347 |
| DOI: | 10.1016/j.juro.2010.08.012 |
| Popis: | Purpose We assessed the cardiovascular safety profile of degarelix, a new gonadotropin-releasing hormone antagonist. Materials and Methods This 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. Results There 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). Conclusions In 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. |
| Databáze: | OpenAIRE |
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