GnRH antagonist linked to lower CV event, death risk

April 1, 2013

The gonadotropin-releasing hormone (GnRH) antagonist degarelix (Firmagon) may be associated with lower risk of a cardiovascular event or death compared to commonly prescribed luteinizing hormone-releasing hormone (LHRH) agonists, data presented at the European Association of Urology annual congress in Milan, Italy indicate.

The gonadotropin-releasing hormone (GnRH) antagonist degarelix (Firmagon) may be associated with lower risk of a cardiovascular event or death compared to commonly prescribed luteinizing hormone-releasing hormone (LHRH) agonists, data presented at the European Association of Urology annual congress in Milan, Italy indicate.

The data are based on a pooled analysis of 2,328 men with prostate cancer from six prospective, randomized trials. Analysis of the data also revealed that men in the studies treated with degarelix had significantly higher overall survival and improved disease control as evidenced by fewer fractures and a lower incidence of renal or urinary tract adverse events compared to men treated with LHRH agonists.

For the study, results were pooled and retrospectively analyzed from six prospective, comparative trials of 2,328 patients randomized to receive degarelix (1,491 patients) or an LHRH agonist (either goserelin acetate [Zoladex], 458 patients or leuprolide, 379 patients). Both treatment groups were well balanced for baseline characteristics and history of cardiovascular disease (CVD). Characteristics associated with CVD (eg, statin medication, hypertension, diabetes, cholesterol >6.2 mmol/L) were also similar between groups.

The CV event analysis was based on death from any cause or a serious CV event (life-threatening or requiring hospitalization). CV events were defined as arterial, embolic/thrombotic; hemorrhagic/ischemic cerebrovascular; myocardial infarction or other ischemic heart disease, whatever came first. A time-to-event analysis for patients with baseline CVD demonstrated that the risk of a serious CV event or death was significantly lower for those men receiving degarelix, compared to those receiving an LHRH agonist during the first year of treatment (p=.0066 based on the log-rank test).

"Our findings suggest that prostate cancer patients with a history of CVD treated with degarelix have a decreased incidence of a serious CV event or death during the first year of therapy compared to treatment with an LHRH agonist," said study investigator Bertrand Tombal, MD, PhD, from the Cliniques Universitaires Saint Luc, Brussels, Belgium. "These results are from a pooled analysis of prospective randomized trials. Although preliminary, health care professionals starting patients on androgen deprivation therapy should be aware of these important findings, including the fact that the observed difference in cardiovascular risk in patients with baseline CVD was approximately 50% lower for Firmagon versus LHRH agonists."

Dr. Tombal is an investigator for Ferring.

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