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Cardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.

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. Out... Full description

Journal Title: The Journal of urology December 2010, Vol.184(6), pp.2313-2319
Main Author: Smith, Matthew R
Other Authors: Klotz, Laurence , Persson, Bo-Eric , Olesen, Tine Kold , Wilde, Arthur A M
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1527-3792 ; DOI: 1527-3792 ; DOI: 10.1016/j.juro.2010.08.012
Link: http://search.proquest.com/docview/764546383/?pq-origsite=primo
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title: Cardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.
format: Article
creator:
  • Smith, Matthew R
  • Klotz, Laurence
  • Persson, Bo-Eric
  • Olesen, Tine Kold
  • Wilde, Arthur A M
subjects:
  • Aged–Adverse Effects
  • Aged, 80 and Over–Therapeutic Use
  • Antineoplastic Agents, Hormonal–Chemically Induced
  • Cardiovascular Diseases–Antagonists & Inhibitors
  • Gonadotropin-Releasing Hormone–Adverse Effects
  • Humans–Therapeutic Use
  • Leuprolide–Adverse Effects
  • Male–Therapeutic Use
  • Middle Aged–Drug Therapy
  • Oligopeptides–Drug Therapy
  • Prostatic Neoplasms–Drug Therapy
  • Time Factors–Drug Therapy
  • Abridged
  • Antineoplastic Agents, Hormonal
  • Oligopeptides
  • Acetyl-2-Naphthylalanyl-3-Chlorophenylalanyl-1-Oxohexadecyl-Seryl-4-Aminophenylalanyl(Hydroorotyl)-4-Aminophenylalanyl(Carbamoyl)-Leucyl-Ilys-Prolyl-Alaninamide
  • Gonadotropin-Releasing Hormone
  • Leuprolide
ispartof: The Journal of urology, December 2010, Vol.184(6), pp.2313-2319
description: 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.
language: eng
source:
identifier: E-ISSN: 1527-3792 ; DOI: 1527-3792 ; DOI: 10.1016/j.juro.2010.08.012
fulltext: fulltext
issn:
  • 15273792
  • 1527-3792
url: Link


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titleCardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.
creatorSmith, Matthew R ; Klotz, Laurence ; Persson, Bo-Eric ; Olesen, Tine Kold ; Wilde, Arthur A M
contributorSmith, Matthew R (correspondence author) ; Smith, Matthew R (record owner)
ispartofThe Journal of urology, December 2010, Vol.184(6), pp.2313-2319
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subjectAged–Adverse Effects ; Aged, 80 and Over–Therapeutic Use ; Antineoplastic Agents, Hormonal–Chemically Induced ; Cardiovascular Diseases–Antagonists & Inhibitors ; Gonadotropin-Releasing Hormone–Adverse Effects ; Humans–Therapeutic Use ; Leuprolide–Adverse Effects ; Male–Therapeutic Use ; Middle Aged–Drug Therapy ; Oligopeptides–Drug Therapy ; Prostatic Neoplasms–Drug Therapy ; Time Factors–Drug Therapy ; Abridged ; Antineoplastic Agents, Hormonal ; Oligopeptides ; Acetyl-2-Naphthylalanyl-3-Chlorophenylalanyl-1-Oxohexadecyl-Seryl-4-Aminophenylalanyl(Hydroorotyl)-4-Aminophenylalanyl(Carbamoyl)-Leucyl-Ilys-Prolyl-Alaninamide ; Gonadotropin-Releasing Hormone ; Leuprolide
descriptionPURPOSEWe 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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titleCardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.
descriptionPURPOSEWe 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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titleCardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open label, parallel group phase III trial in patients with prostate cancer.
authorSmith, Matthew R ; Klotz, Laurence ; Persson, Bo-Eric ; Olesen, Tine Kold ; Wilde, Arthur A M
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abstractPURPOSEWe 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.
doi10.1016/j.juro.2010.08.012
urlhttp://search.proquest.com/docview/764546383/
issn00225347
date2010-12-01