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Degarelix had similar cardiovascular safety profile as leuprolide in prostate cancer
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Men with prostate cancer assigned to degarelix had similar incidence of arrhythmia and less incidence of ischemic heart disease compared with men assigned to leuprolide, according to 1-year results of a randomized, controlled trial.
In the original study, 169 men assigned to 240/80 mg degarelix (Firmagon, Ferring), a novel gonadotropin-releasing hormone antagonist, completed treatment along with 163 assigned to 240/160 mg degarelix and 172 assigned to 7.5 mg leuprolide.
The original primary endpoint was suppression of testosterone to 0.5 ng/mL or less from day 28 to 364. In the 240/80 group, 97.2% of men reached that endpoint along with 98.3% of the 240/160 group and 96.4% of patients in the leuprolide group.
In this safety analysis, researchers found that 17% of all patients assigned to degarelix and 15% of those assigned to leuprolide had a post-baseline QTcF of 450 msec or greater. Only seven patients (2%) in the degarelix groups and four patients (2%) in the leuprolide group had a post-baseline correction of 480 msec or more.
Only 1% of patients in both groups had post-baseline QTcF of 500 msec or more.
Supraventricular arrhythmia was the most common type, occurring in 2% of patients assigned to degarelix and 4% of those assigned to leuprolide. Other arrhythmias occurred in up to 1% of the entire cohort, including atriovatricular conduction disturbances, bundle branch block, bradycardia, cardiac arrest and ventricular arrhythmias.
Two patients assigned degarelix experienced cardiac arrest. Those incidents were determined to be serious adverse events and those patients discontinued treatment.
Ten percent of patients assigned to degarelix reported weight gain, as did 12% of those assigned to leuprolide. Hypercholesterolemia (2%) and hypertension (6%) occurred in similar rates in both groups.
Researchers observed diabetes mellitus in 2% of the degarelix group and 1% of the leuprolide group. Other cardiac risk factors generally occurred in 1% or less of patients.
The most common cardiac disorder was ischemic heart disease, which occurred in 4% of the pooled degarelix group and 10% of the leuprolide group. Myocardial ischemia and myocardial infarction were the most common such events, occurring in 2% of the leuprolide group and less than 1% of the degarelix group.
For more information:
- Smith MR. J Urology. 2010; doi:10.1016/j.juro.2010.08.012.