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document
Cardiovascular safety of degarelix : results from a 12-month , comparative , randomized , open label , parallel group phase III trial in patients with prostate cancer . 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 .
47794
Intervention_Pharmacological
degarelix
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Intervention_Pharmacological
degarelix
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Intervention_Pharmacological
leuprolide acetate
47797
Intervention_Pharmacological
degarelix
47798
Intervention_Pharmacological
degarelix
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Intervention_Pharmacological
leuprolide
47800
Intervention_Pharmacological
degarelix
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Intervention_Pharmacological
leuprolide
47802
Intervention_Pharmacological
degarelix
47803
Intervention_Pharmacological
leuprolide
47804
Intervention_Pharmacological
degarelix
47805
Intervention_Pharmacological
leuprolide
47806
Outcome_Physical
QT interval by central reading and analysis
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Outcome_Adverse-effects
cardiovascular adverse events
47808
Outcome_Physical
cardiovascular events
47809
Outcome_Physical
Markedly abnormal Fridericia 's correction of QT values
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Outcome_Physical
Supraventricular arrhythmias
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Outcome_Adverse-effects
Other arrhythmias
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Outcome_Physical
ischemic heart disease
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Participant_Condition
patients with prostate cancer .
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Participant_Sex
men
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Participant_Condition
prostate cancer