Degarelix Improves CV, Mortality Outcomes

NIAGARA FALLS, Ont.—A pooled analysis of six phase 3 trials shows men with prostate cancer and a history of cardiovascular (CV) events are significantly less likely to have another event or to die while taking degarelix rather than a leutinizing-hormone-releasing hormone (LHRH) agonist.

This is welcome news, said lead investigator Laurence Klotz, MD, because androgen deprivation therapy (ADT) is linked to an increased risk of cardiovascular events like heart attack and stroke via a reduction of testosterone levels.

“I was skeptical that a different method of reducing testosterone would make a difference with respect to rates of cardiovascular events, but it did,” Dr. Klotz, of the Sunnybrook Health Sciences Centre in Toronto, told Renal & Urology News. “The message is that degarelix is not just a way to lower testosterone but it has some real advantage over LHRH agonists besides reducing flares.”

Degarelix is a gonadotropin releasing hormone antagonist and therefore has a significantly different mode of action than the LHRH-agonist class of ADT agents.

Dr. Klotz and his co-investigators received funding from Ferring Pharmaceuticals to analyze data on cerebrovascular events and death from three three-month and three 12-month randomized, controlled trials of ADT agents. The trials involved a total of 1,491 patients who took degarelix, 458 who received the LHRH agonist goserelin and 379 who received the LHRH agonist leuprolide.

The patients on degarelix and LHRH agonists had similar baseline characteristics such as an average age of 71.7 and 71.6 years, respectively, and 59% and 52%, respectively, who smoked.

Fifty-three (3.6%) patients receiving degarelix and 48 (5.7%) patients taking an LHRH agonist had a cardiovascular event or died from any cause during the trials. This translated into a significantly lower risk of a cardiovascular event or death with degarelix over one year of treatment.  The majority of the effect appears to be in men with a history of cardiovascular disease (CVD), as they experienced a significant reduction in events or death with degarelix versus the LHRH agonists while those without such a history did not. Among men with a history of CVD, those who took degarelix had a significant 51% decreased likelihood of cardiovascular events or death compared with patients treated with an LHRH agonist.

The researchers also observed a significantly increased probability of overall survival among degarelix-treated men.

Other factors that were protective against a cardiovascular event or death were alcohol consumption and a serum testosterone level below 1 ng/mL.

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